SB 349: Courthouses: Privilege from civil arrest.
- Session Year: 2017-2018
- House: Senate
- Latest Version Date: 2018-09-06
Existing law prohibits specified conduct inside public buildings owned and occupied, or leased and occupied, by the state. Existing law provides that a judicial officer has the power to preserve and enforce order in judicial proceedings and to compel obedience to judicial orders, as specified.
This bill would clarify the power of judicial officers to prevent activities that threaten access to courthouses, including by protecting the privilege from arrest. The bill would provide that no person shall be subject to civil arrest in a courthouse while attending a court proceeding or having legal business in the courthouse, and that a violation of these provisions constitutes contempt of court. The bill would also authorize the Attorney General to bring a civil action to obtain equitable and declaratory relief for a violation of this section, and it would allow a party in a successful action to enforce liability for a violation of this section to recover court costs and reasonable attorneys fees.
By expanding the scope of an existing crime, this bill would impose a state-mandated local program.
The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.
This bill would provide that no reimbursement is required by this act for a specified reason.
Existing law prohibits specified conduct inside public buildings owned and occupied, or leased and occupied, by the state. Existing law provides that a judicial officer has the power to preserve and enforce order in judicial proceedings and to compel obedience to judicial orders, as specified.
This bill would clarify the power of judicial officers to prevent activities that threaten access to courthouses, including by protecting the privilege from arrest. The bill would provide that no person shall be subject to civil arrest in a courthouse while attending a court proceeding or having legal business in the courthouse, and that a violation of these provisions constitutes contempt of court. The bill would also authorize the Attorney General to bring a civil action to obtain equitable and declaratory relief for a violation of this section, and it would allow a party in a successful action to enforce liability for a violation of this section to recover court costs and reasonable attorneys fees.
By expanding the scope of an existing crime, this bill would impose a state-mandated local program.
The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.
This bill would provide that no reimbursement is required by this act for a specified reason.
(1)Existing law establishes the State Department of Public Health and sets forth its powers and duties, including, but not limited to, the licensure and regulation of chronic dialysis clinics. Existing law requires the department to adopt regulations to implement these provisions, and requires those regulations to prescribe, among other things, minimum standards for staffing with duly qualified personnel. Violation of these provisions is a crime.This bill would establish minimum staffing requirements for chronic dialysis clinics and establish a minimum transition time between patients receiving dialysis services at a treatment station. The bill would require chronic dialysis clinics to maintain certain information relating to the minimum staffing and minimum transition time requirements and provide that information, certified by the chief executive officer or administrator, to the department on a schedule and in a format specified by the department, but no less frequently than 4 times per year. The bill would authorize the department to assess an administrative penalty for a violation of these provisions and other licensing provisions and would require the department to promulgate regulations to establish criteria for assessing these penalties. The bill would authorize a chronic dialysis clinic that disputes an alleged deficiency or failure to correct a deficiency, or the reasonableness of a proposed deadline for correction of a violation or an amount of an administrative penalty, to request a hearing. Because failure to comply with the minimum staffing and minimum transition time requirements would be a crime, this bill would impose a state-mandated local program. (2)Existing law requires every clinic for which a license or special permit has been issued to be periodically inspected, with the frequency to be determined based on the type and complexity of the clinic or special service to be inspected. Existing law makes this provision inapplicable to an end-stage renal disease facility.This bill would delete that exception and require the department to conduct an inspection of a chronic dialysis clinic at least once per year and as often as necessary to, among other things, ensure compliance with the minimum staffing and minimum transition time requirements and ensure the adequacy of care being provided.The bill would generally require the department to issue regulations necessary to implement the bill no later than 2 years following its effective date.(3)The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.This bill would provide that no reimbursement is required by this act for a specified reason.(1)Existing law establishes the State Department of Public Health and sets forth its powers and duties, including, but not limited to, the licensure and regulation of chronic dialysis clinics. Existing law requires the department to adopt regulations to implement these provisions, and requires those regulations to prescribe, among other things, minimum standards for staffing with duly qualified personnel. Violation of these provisions is a crime.
This bill would establish minimum staffing requirements for chronic dialysis clinics and establish a minimum transition time between patients receiving dialysis services at a treatment station. The bill would require chronic dialysis clinics to maintain certain information relating to the minimum staffing and minimum transition time requirements and provide that information, certified by the chief executive officer or administrator, to the department on a schedule and in a format specified by the department, but no less frequently than 4 times per year. The bill would authorize the department to assess an administrative penalty for a violation of these provisions and other licensing provisions and would require the department to promulgate regulations to establish criteria for assessing these penalties. The bill would authorize a chronic dialysis clinic that disputes an alleged deficiency or failure to correct a deficiency, or the reasonableness of a proposed deadline for correction of a violation or an amount of an administrative penalty, to request a hearing. Because failure to comply with the minimum staffing and minimum transition time requirements would be a crime, this bill would impose a state-mandated local program.
(2)Existing law requires every clinic for which a license or special permit has been issued to be periodically inspected, with the frequency to be determined based on the type and complexity of the clinic or special service to be inspected. Existing law makes this provision inapplicable to an end-stage renal disease facility.
This bill would delete that exception and require the department to conduct an inspection of a chronic dialysis clinic at least once per year and as often as necessary to, among other things, ensure compliance with the minimum staffing and minimum transition time requirements and ensure the adequacy of care being provided.
The bill would generally require the department to issue regulations necessary to implement the bill no later than 2 years following its effective date.
(3)The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.
This bill would provide that no reimbursement is required by this act for a specified reason.
(1)Existing law establishes the State Department of Public Health and sets forth its powers and duties, including, but not limited to, the licensure and regulation of chronic dialysis clinics. Existing law requires the department to adopt regulations to implement these provisions, and requires those regulations to prescribe, among other things, minimum standards for staffing with duly qualified personnel. Violation of these provisions is a crime.
This bill would establish minimum staffing requirements for chronic dialysis clinics and establish a minimum transition time between patients receiving dialysis services at a treatment station. The bill would require chronic dialysis clinics to maintain certain information relating to the minimum staffing and minimum transition time requirements and provide that information, certified by the chief executive officer or administrator, to the department on a schedule and in a format specified by the department, but no less frequently than 4 times per year. The bill would authorize the department to assess an administrative penalty for a violation of these provisions and would require the department to promulgate regulations to establish criteria for assessing these penalties. The bill would authorize a chronic dialysis clinic that disputes an alleged deficiency or failure to correct a deficiency, or the reasonableness of a proposed deadline for correction of a violation, violation or an amount of an administrative penalty penalty, to request a hearing. Because failure to comply with the minimum staffing and minimum transition time requirements would be a crime, this bill would impose a state-mandated local program.
(2)Existing law requires every clinic for which a license or special permit has been issued to be periodically inspected, with the frequency to be determined based on the type and complexity of the clinic or special service to be inspected. Existing law makes this provision inapplicable to an end-stage renal disease facility.
This bill would delete that exception and require the department to conduct an inspection of a chronic dialysis clinic at least once per year and as often as necessary to, among other things, ensure compliance with the minimum staffing and minimum transition time requirements and ensure the adequacy of care being provided.
The bill would generally require the department to issue regulations necessary to implement the bill no later than 180 days 2 years following its effective date.
(3)The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.
This bill would provide that no reimbursement is required by this act for a specified reason.
(1)Existing law establishes the State Department of Public Health and sets forth its powers and duties, including, but not limited to, the licensure and regulation of chronic dialysis clinics. Existing law requires the department to adopt regulations to implement these provisions, and requires those regulations to prescribe, among other things, minimum standards for staffing with duly qualified personnel. Violation of these provisions is a crime.
This bill would establish minimum staffing requirements for chronic dialysis clinics and establish a minimum transition time between patients receiving dialysis services at a treatment station. The bill would require chronic dialysis clinics to maintain certain information relating to the minimum staffing and minimum transition time requirements and provide that information, certified by the chief executive officer or administrator, to the department on a schedule and in a format specified by the department, but no less frequently than 4 times per year. The bill would establish a schedule of penalties and actions to be taken for failing to comply with the minimum staffing and minimum transition time requirements, including, among other things, the imposition of civil fines and the requirement that a chronic dialysis clinic submit a corrective action plan. authorize the department to assess an administrative penalty for a violation of these provisions and would require the department to promulgate regulations to establish criteria for assessing these penalties. The bill would authorize a chronic dialysis clinic that disputes an alleged deficiency or failure to correct a deficiency, or the reasonableness of a proposed deadline for correction of a violation, or an amount of an administrative penalty to request a hearing. Because failure to comply with the minimum staffing and minimum transition time requirements would be a crime, this bill would impose a state-mandated local program.
Existing(2)Existing law requires every clinic for which a license or special permit has been issued to be periodically inspected, with the frequency to be determined based on the type and complexity of the clinic or special service to be inspected. Existing law makes this provision inapplicable to an end-stage renal disease facility.
This bill would delete that exception and require the department to conduct an inspection of a chronic dialysis clinic at least once per year and as often as necessary to, among other things, ensure compliance with the minimum staffing and minimum transition time requirements and ensure the adequacy of care being provided.
The bill would generally require the department to issue regulations necessary to implement the bill no later than 180 days following its effective date.
The(3)The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.
This bill would provide that no reimbursement is required by this act for a specified reason.
Existing law establishes the State Department of Public Health and sets forth its powers and duties, including, but not limited to, the licensure and regulation of chronic dialysis clinics. Existing law requires the department to adopt regulations to implement these provisions, and requires those regulations to prescribe, among other things, minimum standards for staffing with duly qualified personnel. Violation of these provisions is a crime.
This bill would establish minimum staffing requirements for chronic dialysis clinics and establish a minimum transition time between patients receiving dialysis services at a treatment station. The bill would require chronic dialysis clinics to maintain certain information relating to the minimum staffing and minimum transition time requirements and provide that information, certified by the chief executive officer or administrator, to the department on a schedule and in a format specified by the department, but no less frequently than 4 times per year. The bill would establish a schedule of penalties and actions to be taken for failing to comply with the minimum staffing and minimum transition time requirements, including, among other things, the imposition of civil fines and the requirement that a chronic dialysis clinic submit a corrective action plan. Because failure to comply with the minimum staffing and minimum transition time requirements would be a crime, this bill would impose a state-mandated local program.
Existing law requires every clinic for which a license or special permit has been issued to be periodically inspected, with the frequency to be determined based on the type and complexity of the clinic or special service to be inspected. Existing law makes this provision inapplicable to an end-stage renal disease facility.
This bill would delete that exception and require the department to conduct an inspection of a chronic dialysis clinic at least once per year and as often as necessary to, among other things, ensure compliance with the minimum staffing and minimum transition time requirements and ensure the adequacy of care being provided.
The bill would require the department to issue regulations necessary to implement the bill no later than 180 days following its effective date.
The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.
This bill would provide that no reimbursement is required by this act for a specified reason.
Existing law establishes the State Department of Public Health and sets forth its powers and duties, including, but not limited to, the licensure and regulation of chronic dialysis clinics. Existing law requires the department to adopt regulations to implement these provisions, and requires those regulations to prescribe, among other things, minimum standards for staffing with duly qualified personnel. Violation of these provisions is a crime.
This bill would establish minimum staffing requirements for chronic dialysis clinics and establish a minimum transition time between patients receiving dialysis services at a treatment station. The bill would require chronic dialysis clinics to maintain certain information relating to the minimum staffing and minimum transition time requirements and provide that information, certified by the chief executive officer or administrator under penalty of perjury, administrator, to the department on a schedule and in a format specified by the department, but no less frequently than 4 times per year. The bill would establish a schedule of penalties and actions to be taken for failing to comply with the minimum staffing and minimum transition time requirements, including, among other things, the imposition of civil fines and the requirement that a chronic dialysis clinic submit a corrective action plan. Because failure to comply with the minimum staffing and minimum transition time requirements would be a crime, and by expanding the crime of perjury, this bill would impose a state-mandated local program.
Existing law requires every clinic for which a license or special permit has been issued to be periodically inspected, with the frequency to be determined based on the type and complexity of the clinic or special service to be inspected. Existing law makes this provision inapplicable to an end-stage renal disease facility.
This bill would delete that exception and require the department to conduct an inspection of a chronic dialysis clinic at least once per year and as often as necessary to, among other things, ensure compliance with the minimum staffing and minimum transition time requirements and ensure the adequacy of care being provided.
The bill would require the department to issue regulations necessary to implement the bill no later than 180 days following its effective date.
Existing constitutional provisions require that a statute that limits the right of access to the meetings of public bodies or the writings of public officials and agencies be adopted with findings demonstrating the interest protected by the limitation and the need for protecting that interest.This bill would make legislative findings to that effect.The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.
This bill would provide that no reimbursement is required by this act for a specified reason.
Existing law establishes the State Department of Public Health and sets forth its powers and duties, including, but not limited to, the licensure and regulation of chronic dialysis clinics. Existing law requires the department to adopt regulations to implement these provisions, and requires those regulations to prescribe, among other things, minimum standards for staffing with duly qualified personnel. Violation of these provisions is a crime.
This bill would establish minimum staffing requirements for chronic dialysis clinics and establish a minimum transition time between patients receiving dialysis services at a treatment station. The bill would require chronic dialysis clinics to maintain certain information relating to the minimum staffing and minimum transition time requirements and provide that information, certified by the medical director and the chief executive officer or administrator under penalty of perjury, to the department on a schedule and in a format specified by the department, but no less frequently than 4 times per year. The bill would establish a schedule of penalties and actions to be taken for failing to comply with the minimum staffing and minimum transition time requirements, including, among other things, the imposition of civil fines and the requirement that a chronic dialysis clinic submit a correction corrective action plan. Because failure to comply with the minimum staffing and minimum transition time requirements would be a crime, and by expanding the crime of perjury, this bill would impose a state-mandated local program.
Existing law requires every clinic for which a license or special permit has been issued to be periodically inspected, with the frequency to be determined based on the type and complexity of the clinic or special service to be inspected. Existing law makes this provision inapplicable to an end stage end-stage renal disease facility.
This bill would delete that exception and require the department to conduct an inspection of a chronic dialysis clinic at least once per year and as often as necessary to, among other things, ensure compliance with the minimum staffing and minimum transition time requirements and ensure the adequacy of care being provided.
The bill would require the department to issue regulations necessary to implement the bill no later than 180 days following its effective date.
Existing constitutional provisions require that a statute that limits the right of access to the meetings of public bodies or the writings of public officials and agencies be adopted with findings demonstrating the interest protected by the limitation and the need for protecting that interest.
This bill would make legislative findings to that effect.
The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.
This bill would provide that no reimbursement is required by this act for a specified reason.
Existing law establishes the State Department of Public Health and sets forth its powers and duties, including, but not limited to, the licensure and regulation of chronic dialysis clinics. Existing law requires the department to adopt regulations to implement these provisions, and requires those regulations to prescribe, among other things, minimum standards for staffing with duly qualified personnel. Violation of these provisions is a crime.
This bill would establish minimum staffing requirements for chronic dialysis clinics and establish a minimum transition time between patients receiving dialysis services at a treatment station. The bill would require chronic dialysis clinics to maintain certain information relating to the minimum staffing and minimum transition time requirements and provide that information, certified by the medical director and the chief executive officer or administrator under penalty of perjury, to the department on a schedule and in a format specified by the department, but no less frequently than 4 times per year. The bill would establish a schedule of penalties and actions to be taken for failing to comply with the minimum staffing and minimum transition time requirements, including, among other things, the imposition of civil fines and the requirement that a chronic dialysis clinic submit a correction action plan. The bill would also establish a private right of action to enforce the minimum staffing and minimum transition time requirements. Because failure to comply with the minimum staffing and minimum transition time requirements would be a crime, and by expanding the crime of perjury, this bill would impose a state-mandated local program.
Existing law requires every clinic for which a license or special permit has been issued to be periodically inspected, with the frequency to be determined based on the type and complexity of the clinic or special service to be inspected. Existing law makes this provision inapplicable to an end stage renal disease facility.
This bill would delete that exception and require the department to conduct an inspection of a chronic dialysis clinic at least once per year and as often as necessary to, among other things, ensure compliance with the minimum staffing and minimum transition time requirements and ensure the adequacy of care being provided.
The bill would require the department to issue regulations necessary to implement the bill no later than 180 days following its effective date.
Existing constitutional provisions require that a statute that limits the right of access to the meetings of public bodies or the writings of public officials and agencies be adopted with findings demonstrating the interest protected by the limitation and the need for protecting that interest.
This bill would make legislative findings to that effect.
The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.
This bill would provide that no reimbursement is required by this act for a specified reason.
Existing law establishes the State Department of Public Health and sets forth its powers and duties, including, but not limited to, the licensure and regulation of chronic dialysis clinics. Existing law requires the department to adopt regulations to implement these provisions, and requires those regulations to prescribe, among other things, minimum standards for staffing with duly qualified personnel. Violation of these provisions is a crime.
This bill would establish minimum staffing requirements for chronic dialysis clinics and establish a minimum transition time between patients receiving dialysis services at a treatment station. The bill would require chronic dialysis clinics to maintain certain information relating to the minimum staffing and minimum transition time requirements and provide that information, certified by the medical director and the chief executive officer or administrator under penalty of perjury, to the department on a schedule and in a format specified by the department, but no less frequently than 4 times per year. The bill would establish a schedule of penalties and actions to be taken for failing to comply with the minimum staffing and minimum transition time requirements, including, among other things, the imposition of civil fines and the requirement that chronic dialysis clinic submit a correction action plan. The bill would also establish a private right of action to enforce the minimum staffing and minimum transition time requirements. Because failure to comply with the minimum staffing and minimum transition time requirements would be a crime, and by expanding the crime of perjury, this bill would impose a state-mandated local program.
Existing law requires every clinic for which a license or special permit has been issued to be periodically inspected, with the frequency to be determined based on the type and complexity of the clinic or special service to be inspected. Existing law makes this provision inapplicable to an end stage renal disease facility.
This bill would delete that exception and require the department to conduct an inspection of a chronic dialysis clinic at least once per year and as often as necessary to, among other things, ensure compliance with the minimum staffing and minimum transition time requirements and ensure the adequacy of care being provided.
The bill would require the department to issue regulations necessary to implement the bill no later than 180 days following its effective date.
Existing constitutional provisions require that a statute that limits the right of access to the meetings of public bodies or the writings of public officials and agencies be adopted with findings demonstrating the interest protected by the limitation and the need for protecting that interest.
This bill would make legislative findings to that effect.
The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.
This bill would provide that no reimbursement is required by this act for a specified reason.
The Legislature finds and declares the following:
(a)The threat that persons may be subject to civil arrest while in Californias courthouses or attending judicial proceedings is a threat to the proper functioning of Californias government and to the rights enjoyed by all Californians.
(b)The United States Supreme Court has recognized that the unhindered and untrammeled functioning of our courts is part of the very foundation of our constitutional democracy, and that a state may therefore adopt measures necessary and appropriate to safeguarding the administration of justice by its courts. (United States v. Grace (1983) 461 U.S. 171, 178.)
(c)The United States Supreme Court has likewise acknowledged that a state has the power to preserve the property under its control for the use to which it is lawfully dedicated, and that [t]here is little doubt that in some circumstances the Government may ban the entry on to public property that is not a public forum of all persons except those who have legitimate business on the premises. (United States v. Grace (1983) 461 U.S. 171, 178.)
(d)Accordingly, California may regulate entry and access to the courts, and activity on courthouse premises and vicinities, that threatens the fair and nondiscriminatory administration of justice or the openness of courts.
(e)Proceedings in Californias courts in both criminal and civil matters have historically been open to the public, and this presumption of openness has been codified under the Code of Civil Procedure section 124, which provides that, with certain exceptions, the sittings of every court shall be public.
(f)The United States Supreme Court has said that, courts of justice ought everywhere to be open, accessible, free from interruption, and to cast a perfect protection around every [person] who necessarily approaches them. (Stewart v. Ramsay (1916) 242 U.S. 128, 129.)
(g)Public access to courts serves a vital role in the functioning of Californias judicial process and the preservation of our republican form of government, which is a government of lawslaws for California and Californians.
(h)Public scrutiny of judicial proceedings allows the public to observe the functioning of their government and determine whether justice is meted out fairly.
(i)Access fosters an appearance of fairness, promoting public confidence in, and respect for, the judicial process.
(j)Providing this transparency also serves as a critical check on the use and abuse of judicial powera check that is essential to our structure of self-government.
(k)Public access to Californias courts also enhances the truth-finding function of judicial proceedings, safeguarding their integrity.
(l)Accordingly, protecting persons from civil arrest while in Californias courthouses or attending judicial proceedings is necessary to preserve the vital role served by public access to courts.
(m)Protecting persons from civil arrest while in Californias courthouses or attending judicial proceedings is also necessary to ensure that litigants, witnesses, and others are not deterred from participating in such proceedings which are often necessary to protect and vindicate rights guaranteed by the laws of California; that courts and parties have access to testimony and other evidence critical to factfinding; and that the dignity of judicial proceedings is upheld and not disturbed or diminished, all of which ensures California courts ability to administer justice.
(n)Protecting persons from civil arrest while in Californias courthouses or attending judicial proceedings is also necessary to preserve the individual rights of all Californians.
(o)Access to courts is part of the right to free speech enshrined in the California and United States constitutions, because access to government ensures that Californians constitutionally protected right to discuss the government is the right to engage in informed discussion.
(p)Access, being vital, should be universal in so far as possible, to protect Californians rights to equal protection of the lawsand Californias right to benefit from the informed views of all.
(q)Access is necessary to preserve the right to petition government for redress, and to preserve numerous trial rights of individuals, including the right to be present, to present claims and defenses, to testify at trial, to call witnesses, to compulsory process, and of course to have a public trial.
(r)Civil arrests of persons in Californias courthouses or attending judicial proceedings threatens all of the foregoing public and private values of public access as well as the core functions of California courts, and must be considered unreasonable and unlawful seizures whether undertaken by local, state, or federal officers.
(s)The provisions of this act are thus necessary to protect and preserve the integrity of the proceedings of the judicial branch of California government.
(t)Courts being essential to a republican form of government and to the functioning of Californias government, California has the reserved power under the Tenth Amendment to protect their proceedings, as well as the obligation under the United States Constitution to preserve Californias republican form of government.
(u)A person who is arrested or detained in violation of this act may, like any other person unlawfully arrested or detained, seek a writ of habeas corpus.
SEC. 2.Section 177 of the Code of Civil Procedure is amended to read:177.A judicial officer shall have power:
1.To preserve and enforce order in the officers immediate presence, and in proceedings before the officer, when the officer is engaged in the performance of official duty;
2.To compel obedience to the officers lawful orders as provided in this code;
3.To compel the attendance of persons to testify in a proceeding before the officer, in the cases and manner provided in this code;
4.To administer oaths to persons in a proceeding pending before the officer, and in all other cases where it may be necessary in the exercise of his powers and duties.
5.To prevent activities that threaten access to state courthouses and court proceedings, and to prevent interruption of judicial administration, including protecting the privilege from civil arrest at courthouses and court proceedings.
SEC. 3.Section 43.54 is added to the Civil Code, to read:43.54.(a)A person shall not be subject to civil arrest of any type in a courthouse while attending a court proceeding or having legal business in the courthouse.
(b)This section does not narrow, or in any way lessen, any existing common law privilege.
(c)A violation of this section is a contempt of the authority of the court as provided in Title 5 of Part 3 of the Code of Civil Procedure.
(d)The Attorney General may bring a civil action in the name of the people to obtain appropriate equitable and declaratory relief if the Attorney General has reasonable cause to believe that a violation of this section has occurred.
(e)A party in a successful action to enforce liability for a violation of this section may recover court costs and reasonable attorneys fees.
SEC. 4.The provisions of this act are severable. If any provision of this act or its application is held invalid, that invalidity shall not affect other provisions or applications that be given effect without the invalid provision or application.
SEC. 5.No reimbursement is required by this act pursuant to Section 6 of Article XIIIB of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIIIB of the California Constitution.
The Legislature finds and declares the following:
(a)The threat that persons may be subject to civil arrest while in Californias courthouses or attending judicial proceedings is a threat to the proper functioning of Californias government and to the rights enjoyed by all Californians.
(b)The United States Supreme Court has recognized that the unhindered and untrammeled functioning of our courts is part of the very foundation of our constitutional democracy, and that a state may therefore adopt measures necessary and appropriate to safeguarding the administration of justice by its courts. (United States v. Grace (1983) 461 U.S. 171, 178.)
(c)The United States Supreme Court has likewise acknowledged that a state has the power to preserve the property under its control for the use to which it is lawfully dedicated, and that [t]here is little doubt that in some circumstances the Government may ban the entry on to public property that is not a public forum of all persons except those who have legitimate business on the premises. (United States v. Grace (1983) 461 U.S. 171, 178.)
(d)Accordingly, California may regulate entry and access to the courts, and activity on courthouse premises and vicinities, that threatens the fair and nondiscriminatory administration of justice or the openness of courts.
(e)Proceedings in Californias courts in both criminal and civil matters have historically been open to the public, and this presumption of openness has been codified under the Code of Civil Procedure section 124, which provides that, with certain exceptions, the sittings of every court shall be public.
(f)The United States Supreme Court has said that, courts of justice ought everywhere to be open, accessible, free from interruption, and to cast a perfect protection around every [person] who necessarily approaches them. (Stewart v. Ramsay (1916) 242 U.S. 128, 129.)
(g)Public access to courts serves a vital role in the functioning of Californias judicial process and the preservation of our republican form of government, which is a government of lawslaws for California and Californians.
(h)Public scrutiny of judicial proceedings allows the public to observe the functioning of their government and determine whether justice is meted out fairly.
(i)Access fosters an appearance of fairness, promoting public confidence in, and respect for, the judicial process.
(j)Providing this transparency also serves as a critical check on the use and abuse of judicial powera check that is essential to our structure of self-government.
(k)Public access to Californias courts also enhances the truth-finding function of judicial proceedings, safeguarding their integrity.
(l)Accordingly, protecting persons from civil arrest while in Californias courthouses or attending judicial proceedings is necessary to preserve the vital role served by public access to courts.
(m)Protecting persons from civil arrest while in Californias courthouses or attending judicial proceedings is also necessary to ensure that litigants, witnesses, and others are not deterred from participating in such proceedings which are often necessary to protect and vindicate rights guaranteed by the laws of California; that courts and parties have access to testimony and other evidence critical to fact-finding; and that the dignity of judicial proceedings is upheld and not disturbed or diminished, all of which ensures California courts ability to administer justice.
(n)Protecting persons from civil arrest while in Californias courthouses or attending judicial proceedings is also necessary to preserve the individual rights of all Californians.
(o)Access to courts is part of the right to free speech enshrined in the California and United States constitutions, because access to government ensures that Californians constitutionally protected right to discuss the government is the right to engage in informed discussion.
(p)Access, being vital, should be universal in so far as possible, to protect Californians rights to equal protection of the lawsand Californias right to benefit from the informed views of all.
(q)Access is necessary to preserve the right to petition government for redress, and to preserve numerous trial rights of individuals, including the right to be present, to present claims and defenses, to testify at trial, to call witnesses, to compulsory process, and of course to have a public trial.
(r)Civil arrests of persons in Californias courthouses or attending judicial proceedings threatens all of the foregoing public and private values of public access as well as the core functions of California courts, and must be considered unreasonable and unlawful seizures whether undertaken by local, state, or federal officers.
(s)The provisions of this act are thus necessary to protect and preserve the integrity of the proceedings of the judicial branch of California government.
(t)Courts being essential to a republican form of government and to the functioning of Californias government, California has the reserved power under the Tenth Amendment to protect their proceedings, as well as the obligation under the United States Constitution to preserve Californias republican form of government.
(u)A person who is arrested or detained in violation of this act may, like any other person unlawfully arrested or detained, seek a writ of habeas corpus.
SEC. 2.Section 177 of the Code of Civil Procedure is amended to read:177.Every A judicial officer shall have power:
1.To preserve and enforce order in his the officers immediate presence, and in proceedings before him, the officer, when he the officer is engaged in the performance of official duty;
2.To compel obedience to his the officers lawful orders as provided in this Code; code;
3.To compel the attendance of persons to testify in a proceeding before him, the officer, in the cases and manner provided in this Code; code;
4.To administer oaths to persons in a proceeding pending before him, the officer, and in all other cases where it may be necessary in the exercise of his powers and duties.
5.To prevent activities that threaten access to state courthouses and court proceedings, and to prevent interruption of judicial administration, including protecting the privilege from civil arrest at courthouses and court proceedings.
SEC. 3.Section 43.54 is added to the Civil Code, to read:43.54.(a)A person shall not be subject to civil arrest of any type in a courthouse while attending a court proceeding or having legal business in the courthouse.
(b)This section does not narrow, or in any way lessen, any existing common law privilege.
(c)A violation of this section is a contempt of the authority of the court as provided in Title 5 of Part 3 of the Code of Civil Procedure.
(d)The Attorney General may bring a civil action in the name of the people to obtain appropriate equitable and declaratory relief if the Attorney General has reasonable cause to believe that a violation of this section has occurred.
(e)A party in a successful action to enforce liability for a violation of this section may recover court costs and reasonable attorneys fees.
SEC. 4.The provisions of this act are severable. If any provision of this act or its application is held invalid, that invalidity shall not affect other provisions or applications that be given effect without the invalid provision or application.
SEC. 5.No reimbursement is required by this act pursuant to Section 6 of Article XIIIB of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIIIB of the California Constitution.
SECTION 1.The Legislature finds and declares all of the following:(a)Dialysis is a critical, lifesaving treatment for Californians suffering from end-stage renal disease.(b)There are currently more than 66,000 dialysis patients, and more than 570 licensed outpatient dialysis clinics, in California.(c)There is broad consensus among medical professionals, academics, and other experts that higher ratios of direct caregiving staff to patients at outpatient dialysis clinics improve patient outcomes, including by reducing the rate at which patients suffer infections or must be hospitalized.(d)There is also broad consensus among medical professionals, academics, and other experts that adequate time to prepare a treatment station for a patient to be dialyzed is necessary to ensure safety and hygiene protocols are followed, and directly improve patient outcomes, including by reducing the rate at which patients suffer infections or must be unnecessarily hospitalized.(e)Worker safety is also enhanced by higher ratios of caregiving staff to patients and transition time between patients, including by reducing the risk of injury on the job.(f)Current staffing levels in outpatient dialysis clinics in California are inadequate to protect patient health and worker safety, and therefore are presently causing harm to dialysis patients, including unnecessary and avoidable deaths, hospitalizations, infections, and medication errors.(g)Other states mandate minimum direct care staffing requirements in order to enhance patient safety and health at outpatient dialysis clinics.SEC. 2.Section 1226 of the Health and Safety Code is amended to read:1226.(a)The regulations shall prescribe the kinds of services which may be provided by clinics in each category of licensure and shall prescribe minimum standards of adequacy, safety, and sanitation of the physical plant and equipment, and, subject to Section 1226.4, minimum standards for staffing with duly qualified personnel and minimum standards for providing the services offered. These minimum standards shall be based on the type of facility, the needs of the patients served, and the types and levels of services provided.(b)The Office of Statewide Health Planning and Development, in consultation with the Community Clinics Advisory Committee, shall prescribe minimum construction standards of adequacy and safety for the physical plant of clinics as found in the California Building Standards Code.(c)(1)A city or county, as applicable, shall have plan review and building inspection responsibilities for the construction or alteration of buildings described in paragraphs (1) and (2) of subdivision (b) of Section 1204 and shall apply the provisions of the latest edition of the California Building Standards Code in conducting these plan review responsibilities. For these buildings, construction and alteration shall include conversion of a building to a purpose specified in paragraphs (1) and (2) of subdivision (b) of Section 1204.(2)Upon the initial submittal to a city or county by the governing authority or owner of these clinics for plan review and building inspection services, the city or county shall reply in writing to the clinic whether or not the plan review by the city or county will include a certification as to whether or not the clinic project submitted for plan review meets the standards as propounded by the office in the California Building Standards Code.(3)If the city or county indicates that its review will include this certification, it shall do both of the following:(A)Apply the applicable clinic provisions of the latest edition of the California Building Standards Code.(B)Certify in writing, to the applicant within 30 days of completion of construction whether or not these standards have been met.(d)If upon initial submittal, the city or county indicates that its plan review will not include this certification, the governing authority or owner of the clinic shall submit the plans to the Office of Statewide Health Planning and Development, which shall review the plans for certification whether or not the clinic project meets the standards, as propounded by the office in the California Building Standards Code.(e)When the office performs review for certification, the office shall charge a fee in an amount that does not exceed its actual costs.(f)The Office of the State Fire Marshal shall prescribe minimum safety standards for fire and life safety in surgical clinics.(g)Notwithstanding subdivision (c), the governing authority or owner of a clinic may request the office to perform plan review services for buildings described in subdivision (c). If the office agrees to perform these services, after consultation with the local building official, the office shall charge an amount not to exceed its actual costs. The construction or alteration of these buildings shall conform to the applicable provisions of the latest edition of the California Building Standards Code for purposes of the plan review by the office pursuant to this subdivision.(h)Regulations adopted pursuant to this chapter establishing standards for laboratory services shall not be applicable to any clinic that operates a clinical laboratory licensed pursuant to Section 1265 of the Business and Professions Code.SEC. 3.Section 1226.4 is added to the Health and Safety Code, to read:1226.4.(a)For purposes of this section, the following terms have the following meanings:(1)At all times includes times during which employees, including, but not limited to, nurses and technicians, are provided meal periods and rest or other breaks.(2)Charge nurse means a charge nurse as described in Section 494.140(b)(3) of Title 42 of the Code of Federal Regulations as it read on December 31, 2016.(3)Direct care means initiating and discontinuing dialysis, monitoring patients during treatment, and administering medications, and physical presence in the dialysis treatment area.(4)Full-time equivalent means employment by a chronic dialysis clinic for 2,080 hours of work in 12 consecutive months.(5)Nurse means a registered nurse licensed pursuant to Chapter 6 (commencing with Section 2700) of Division 2 of the Business and Professions Code.(6)Nurse manager means a nurse manager as described in Section 494.140(b)(1) of Title 42 of the Code of Federal Regulations as it read on December 31, 2016.(7)Registered dietitian means a dietitian as described in Section 494.140(c) of Title 42 of the Code of Federal Regulations, as it read on December 31, 2016.(8)Rural county means a county that has a population of less than 250,000 and does not have a single urbanized area with a population of greater than 50,000.(9)Social worker means a social worker as described in Section 494.140(d) of Title 42 of the Code of Federal Regulations as it read on December 31, 2016.(10)Technician means a person who holds both of the following qualifications:(A)The person is a patient care dialysis technician, as described in Section 494.140(e) of Title 42 of the Code of Federal Regulations as it read on December 31, 2016.(B)The person is a Certified Hemodialysis Technician certified pursuant to Article 3.5 (commencing with Section 1247) of Chapter 3 of Division 2 of the Business and Professions Code.(11)Trainee means a person who is undergoing training to become a technician, but who has not yet been certified as a Certified Hemodialysis Technician pursuant to Article 3.5 (commencing with Section 1247) of Chapter 3 of Division 2 of the Business and Professions Code.(12)Transition time means the period of time beginning when one patient has completed treatment and has been disconnected from the dialysis machine and ending when the next patient is placed in the treatment station, but does not mean the period of time after the last patient of the day leaves the treatment station.(13)Treatment station means a physical location within a chronic dialysis clinic where an individual patient is dialyzed.(b)(1)Commencing January 1, 2020, a chronic dialysis clinic shall ensure that the following minimum staffing ratios are met at all times that patients are receiving, or preparing to receive, direct care:(A)At least one nurse is providing direct care for every eight patients. A nurse shall only count toward this ratio during time periods the nurse has no responsibilities other than direct care. A nurse manager or charge nurse shall not count toward this ratio.(B)At least one technician is providing direct care for every three patients. A technician shall only count toward this ratio during time periods the technician has no responsibilities other than direct care. Trainees shall not count toward this ratio. Nurses counted toward the nurse-to-patient ratio shall not count toward this ratio.(2)Commencing January 1, 2020, a chronic dialysis clinic shall ensure that a full-time equivalent individual social worker is not assigned more than 75 patients receiving care from the chronic dialysis clinic, regardless of the location where each patient undergoes dialysis.(3)Commencing January 1, 2020, a chronic dialysis clinic shall ensure that a full-time equivalent individual registered dietitian is not assigned more than 75 patients receiving care from the chronic dialysis clinic, regardless of the location where each patient undergoes dialysis.(4)The ratios described in paragraphs (1), (2), and (3) shall constitute the minimum number of nurses, technicians, social workers, and registered dietitians assigned to patients at all times. Additional nurses, technicians, social workers, and registered dietitians shall be assigned to the extent necessary to ensure the patient-to-staff ratio is appropriate to the level of dialysis care given and meets the needs of patients.(5)No later than January 1, 2020, the department shall issue regulations that specify an appropriate minimum transition time. This appropriate minimum transition time shall give patients sufficient time to recuperate after treatment and provide sufficient time to comply with safety and hygiene protocols, including, but not limited to, compliance with recommendations from the Centers for Disease Control and Prevention regarding hygiene practices. If the department has not issued those regulations on or before January 1, 2020, a chronic dialysis clinic shall ensure that the minimum transition time is at least 45 minutes.(c)The department shall not issue a license to any chronic dialysis clinic unless that chronic dialysis clinic demonstrates the ability and intention to comply with this section.(d)(1)Every chronic dialysis clinic for which a license has been issued shall maintain, and provide to the department on a form prescribed by the department, at a minimum, the following information:(A)Actual staffing ratio and transition time data for the period covered by the submission, which shall include, at a minimum, all of the following: (1) daily totals of the total number and actual hours worked by nurses and technicians; (2) the total number of patients and actual hours receiving direct care; (3) the daily average transition time for each treatment station; and (4) for each week, the total number of full-time equivalent social workers and registered dietitians and the total number of patients assigned to social workers and registered dietitians.(B)Every instance, no matter how brief, during the period covered by the submission when staffing ratios or transition times did not meet the requirements of subdivision (b) and the reasons and circumstances therefor.(2)The chief executive officer or administrator of the chronic dialysis clinic shall personally certify that he or she is satisfied, after review, that all information submitted pursuant to paragraph (1) is accurate and complete.(3)The chronic dialysis clinic shall periodically submit the information described in paragraph (1) to the department on a schedule and in a format prescribed by the department, provided that the clinic shall submit that information no less frequently than four times per year.(e)The department may grant a waiver of subdivisions (b), (c), and (d) to a chronic dialysis clinic in a rural county if the waiver does not jeopardize the health, safety, and well-being of affected patients and is needed for increased operational efficiency.(f)The department shall inspect each chronic dialysis clinic for which a license has been issued at least once per year, and shall conduct such inspections as often as necessary to ensure compliance with the requirements of subdivision (b), the accuracy and completeness of information provided pursuant to subdivision (d), and the adequacy of the quality of care being provided.(g)Within 60 days of receiving a complaint from an employee, an association of employees, a vendor, a contractor, a patient, an association of patients, or a family member of a patient of a chronic dialysis clinic that the chronic dialysis clinic has committed a violation of the requirements of this chapter, the department shall investigate the chronic dialysis clinic and, if the evidence shows a violation has occurred, the department shall impose discipline pursuant to Section 1240.1.(h)(1)Any writing, record, or document received, owned, used, or retained by the department in connection with subdivisions (c), (d), and (f) of this section, subdivisions (b) to (g), inclusive, of Section 1240.1, and Section 1240.2, is a public record within the meaning of subdivision (e) of Section 6252 of the Government Code, and, as such, is open to public inspection pursuant to the California Public Records Act (Chapter 3.5 (commencing with Section 6250) of Division 7 of Title 1 of the Government Code).(2)The department shall redact from any writing, record, or document described in this subdivision personal identifying information associated with named individuals to the extent required to prevent an unwarranted invasion of personal privacy, as that term is used in subdivision (c) of Section 6254 of the Government Code, but the department shall not withhold any such writing, record, or document in its entirety under subdivision (c) of Section 6254 of the Government Code.(3)Information required to be submitted under subdivision (d), and complaints submitted under subdivision (g), shall not be withheld on the basis of subdivision (f) of Section 6254 of the Government Code.(i)(1)With the exception of paragraphs (2) and (3) of subdivision (b), the provisions of this section shall not apply to home dialysis, as defined in Section 494.10 of Title 42 of the Code of Federal Regulations, as it read on December 31, 2016, and home dialysis-related services and training, as described in Section 494.100 of Title 42 of the Code of Federal Regulations as it read on December 31, 2016.(2)Home dialysis-related services and training, as described in Section 494.100 of Title 42 of the Code of Federal Regulations, as it read on December 31, 2016, are not included within the definition of direct care for the purposes of this section.SEC. 4.Section 1228 of the Health and Safety Code is amended to read:1228.(a)Except as provided in subdivision (c), every clinic for which a license or special permit has been issued shall be periodically inspected. Except as provided in Section 1226.4, the frequency of inspections shall depend upon the type and complexity of the clinic or special service to be inspected. Inspections shall be conducted no less often than once every three years and as often as necessary to ensure the quality of care being provided.(b) (1)During inspections, representatives of the department shall offer any advice and assistance to the clinic as they deem appropriate. The department may contract with local health departments for the assumption of any of the departments responsibilities under this chapter. In exercising this authority, the local health department shall conform to the requirements of this chapter and to the rules, regulations, and standards of the department.(2)The department shall reimburse local health departments for services performed pursuant to this section, and these payments shall not exceed actual cost. Reports of each inspection shall be prepared by the representative conducting it upon forms prepared and furnished by the department and filed with the department.(c)This section shall not apply to any of the following:(1)A rural health clinic.(2)A primary care clinic accredited by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), the Accreditation Association for Ambulatory Health Care (AAAHC), or any other accrediting organization recognized by the department.(3)An ambulatory surgical center.(4)A comprehensive outpatient rehabilitation facility that is certified to participate either in the Medicare Program under Title XVIII (42 U.S.C. Sec. 1395 et seq.) of the federal Social Security Act, or the Medicaid program under Title XIX (42 U.S.C. Sec. 1396 et seq.) of the federal Social Security Act, or both.(d)Notwithstanding paragraph (2) of subdivision (c), the department shall retain the authority to inspect a primary care clinic pursuant to Section 1227, or as necessary to ensure the quality of care being provided.SEC. 5.The heading of Article 5 (commencing with Section 1240) of Chapter 1 of Division 2 of the Health and Safety Code is repealed.SEC. 6.The heading of Article 5 (commencing with Section 1240) is added to Chapter 1 of Division 2 of the Health and Safety Code, to read:5.Suspension, Revocation, and PenaltiesSEC. 7.Section 1240.1 is added to the Health and Safety Code, to read:1240.1.(a)The director may assess an administrative penalty against a chronic dialysis clinic for a violation of this chapter. Each penalty issued pursuant to this chapter shall be classified as a major violation, an intermediate violation, or a minor violation according to the nature of the violation and the threat of harm to patients. A major violation shall be subject to an administrative penalty of up to ten thousand dollars ($10,000), and an intermediate violation shall be subject to an administrative penalty of up to five thousand dollars ($5,000). The director shall not assess an administrative penalty for a minor violation.(b)The department shall promulgate regulations establishing the criteria to assess an administrative penalty against a chronic dialysis clinic that shall include, but not be limited to, a consideration of all the following:(1)The probability and severity of the risk that the violation presents to the patient.(2)The actual harm to patients, if any.(3)The nature, scope, and severity of the violation.(4)The chronic dialysis clinics history of compliance with related state and federal statutes and regulations, including, but not limited to, the similarity in circumstances of the violation to any previous violation by the chronic dialysis clinic within a 24-month period.(5)Factors beyond the control of the chronic dialysis clinic that restricts its ability to comply with this chapter or the rules and regulations promulgated thereunder.(6)The demonstrated willfulness of the violation.(7)The extent to which the chronic dialysis clinic detected the violation and took immediate action to correct the violation and prevent that type of violation from recurring.(c)If a chronic dialysis clinic disputes a determination by the director regarding an alleged deficiency or failure to correct a deficiency, or the reasonableness of a proposed deadline for correction of a violation or an amount of an administrative penalty, the chronic dialysis clinic may, within 10 working days, request a hearing pursuant to Section 131071. A chronic dialysis clinic shall pay all administrative penalties when all appeals have been exhausted and the departments position has been upheld.SEC. 8.Section 1240.2 is added to the Health and Safety Code, to read:1240.2.(a)Subject to subdivision (d), prior to the effective date of regulations adopted to implement Section 1240.1, if a chronic dialysis clinic receives a notice of deficiency constituting an immediate jeopardy to the health or safety of a patient or employee and is required to submit a plan of correction, the department may assess the licensee an administrative penalty of up to ten thousand dollars ($10,000).(b)If a licensee disputes a determination by the department regarding an alleged deficiency or the alleged failure to correct a deficiency, or regarding the reasonableness of the proposed deadline for correction or the amount of the penalty, the licensee may, within 10 days, request an administrative hearing pursuant to Section 131071. Penalties shall be paid when appeals have been exhausted and if the departments position has been upheld.(c)For purposes of this section immediate jeopardy means a situation in which the licensees noncompliance with one or more requirements of licensure has caused, or is likely to cause, serious injury or death to one or more patients or employees.(d)This section shall only apply to incidents occurring on or after January 1, 2018, except that this section shall only apply to violations of subdivision (b) of Section 1226.4 occurring on or after January 1, 2020.(e)Notwithstanding Section 11 of the act that added this section, new regulations are not required or authorized for implementation of this section.(f)This section shall become inoperative on the effective date of regulations promulgated by the department pursuant to Section 1240.1.SEC. 9.Section 1266.2 is added to the Health and Safety Code, to read:1266.2.It is the intent of the Legislature that California taxpayers not be financially responsible for implementation and enforcement of minimum staffing requirements at chronic dialysis clinics. In order to effectuate that intent, when calculating, assessing, and collecting fees imposed on chronic dialysis clinics pursuant to Section 1266, the department shall take into account all costs associated with implementing and enforcing Sections 1226.4 and 1240.1.SEC. 10.Nothing in this act is intended to impact nurse-to-patient ratios applicable to health facilities licensed pursuant to subdivision (a), (b), or (f) of Section 1250 of the Health and Safety Code.SEC. 11.The State Department of Public Health shall issue regulations necessary to implement this act no later than two years following its effective date.SEC. 12.The provisions of this act are severable. If any provision of this act or its application is held invalid, that invalidity shall not affect other provisions or applications that can be given effect without the invalid provision or application.SEC. 13.No reimbursement is required by this act pursuant to Section 6 of Article XIIIB of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIIIB of the California Constitution.The Legislature finds and declares all of the following:
(a)Dialysis is a critical, lifesaving treatment for Californians suffering from end-stage renal disease.
(b)There are currently more than 66,000 dialysis patients, and more than 570 licensed outpatient dialysis clinics, in California.
(c)There is broad consensus among medical professionals, academics, and other experts that higher ratios of direct caregiving staff to patients at outpatient dialysis clinics improve patient outcomes, including by reducing the rate at which patients suffer infections or must be hospitalized.
(d)There is also broad consensus among medical professionals, academics, and other experts that adequate time to prepare a treatment station for a patient to be dialyzed is necessary to ensure safety and hygiene protocols are followed, and directly improve patient outcomes, including by reducing the rate at which patients suffer infections or must be unnecessarily hospitalized.
(e)Worker safety is also enhanced by higher ratios of caregiving staff to patients and transition time between patients, including by reducing the risk of injury on the job.
(f)Current staffing levels in outpatient dialysis clinics in California are inadequate to protect patient health and worker safety, and therefore are presently causing harm to dialysis patients, including unnecessary and avoidable deaths, hospitalizations, infections, and medication errors.
(g)Other states mandate minimum direct care staffing requirements in order to enhance patient safety and health at outpatient dialysis clinics.
SEC. 2.Section 1226 of the Health and Safety Code is amended to read:1226.(a)The regulations shall prescribe the kinds of services which may be provided by clinics in each category of licensure and shall prescribe minimum standards of adequacy, safety, and sanitation of the physical plant and equipment, and, subject to Section 1226.4, minimum standards for staffing with duly qualified personnel and minimum standards for providing the services offered. These minimum standards shall be based on the type of facility, the needs of the patients served, and the types and levels of services provided.
(b)The Office of Statewide Health Planning and Development, in consultation with the Community Clinics Advisory Committee, shall prescribe minimum construction standards of adequacy and safety for the physical plant of clinics as found in the California Building Standards Code.
(c)(1)A city or county, as applicable, shall have plan review and building inspection responsibilities for the construction or alteration of buildings described in paragraphs (1) and (2) of subdivision (b) of Section 1204 and shall apply the provisions of the latest edition of the California Building Standards Code in conducting these plan review responsibilities. For these buildings, construction and alteration shall include conversion of a building to a purpose specified in paragraphs (1) and (2) of subdivision (b) of Section 1204.
(2)Upon the initial submittal to a city or county by the governing authority or owner of these clinics for plan review and building inspection services, the city or county shall reply in writing to the clinic whether or not the plan review by the city or county will include a certification as to whether or not the clinic project submitted for plan review meets the standards as propounded by the office in the California Building Standards Code.
(3)If the city or county indicates that its review will include this certification, it shall do both of the following:
(A)Apply the applicable clinic provisions of the latest edition of the California Building Standards Code.
(B)Certify in writing, to the applicant within 30 days of completion of construction whether or not these standards have been met.
(d)If upon initial submittal, the city or county indicates that its plan review will not include this certification, the governing authority or owner of the clinic shall submit the plans to the Office of Statewide Health Planning and Development, which shall review the plans for certification whether or not the clinic project meets the standards, as propounded by the office in the California Building Standards Code.
(e)When the office performs review for certification, the office shall charge a fee in an amount that does not exceed its actual costs.
(f)The Office of the State Fire Marshal shall prescribe minimum safety standards for fire and life safety in surgical clinics.
(g)Notwithstanding subdivision (c), the governing authority or owner of a clinic may request the office to perform plan review services for buildings described in subdivision (c). If the office agrees to perform these services, after consultation with the local building official, the office shall charge an amount not to exceed its actual costs. The construction or alteration of these buildings shall conform to the applicable provisions of the latest edition of the California Building Standards Code for purposes of the plan review by the office pursuant to this subdivision.
(h)Regulations adopted pursuant to this chapter establishing standards for laboratory services shall not be applicable to any clinic that operates a clinical laboratory licensed pursuant to Section 1265 of the Business and Professions Code.
SEC. 3.Section 1226.4 is added to the Health and Safety Code, to read:1226.4.(a)For purposes of this section, the following terms have the following meanings:
(1)At all times includes times during which employees, including, but not limited to, nurses and technicians, are provided meal periods and rest or other breaks.
(2)Charge nurse means a charge nurse as described in Section 494.140(b)(3) of Title 42 of the Code of Federal Regulations as it read on December 31, 2016.
(3)Direct care means initiating and discontinuing dialysis, monitoring patients during treatment, and administering medications, and physical presence in the dialysis treatment area.
(4)Full-time equivalent means employment by a chronic dialysis clinic for 2,080 hours of work in 12 consecutive months.
(5)Nurse means a registered nurse licensed pursuant to Chapter 6 (commencing with Section 2700) of Division 2 of the Business and Professions Code.
(6)Nurse manager means a nurse manager as described in Section 494.140(b)(1) of Title 42 of the Code of Federal Regulations as it read on December 31, 2016.
(7)Registered dietitian means a dietitian as described in Section 494.140(c) of Title 42 of the Code of Federal Regulations, as it read on December 31, 2016.
(8)Rural county means a county that has a population of less than 250,000 and does not have a single urbanized area with a population of greater than 50,000.
(9)Social worker means a social worker as described in Section 494.140(d) of Title 42 of the Code of Federal Regulations as it read on December 31, 2016.
(10)Technician means a person who holds both of the following qualifications:
(A)The person is a patient care dialysis technician, as described in Section 494.140(e) of Title 42 of the Code of Federal Regulations as it read on December 31, 2016.
(B)The person is a Certified Hemodialysis Technician certified pursuant to Article 3.5 (commencing with Section 1247) of Chapter 3 of Division 2 of the Business and Professions Code.
(11)Trainee means a person who is undergoing training to become a technician, but who has not yet been certified as a Certified Hemodialysis Technician pursuant to Article 3.5 (commencing with Section 1247) of Chapter 3 of Division 2 of the Business and Professions Code.
(12)Transition time means the period of time beginning when one patient has completed treatment and has been disconnected from the dialysis machine and ending when the next patient is placed in the treatment station, but does not mean the period of time after the last patient of the day leaves the treatment station.
(13)Treatment station means a physical location within a chronic dialysis clinic where an individual patient is dialyzed.
(b)(1)Commencing January 1, 2020, a chronic dialysis clinic shall ensure that the following minimum staffing ratios are met at all times that patients are receiving, or preparing to receive, direct care:
(A)At least one nurse is providing direct care for every eight patients. A nurse shall only count toward this ratio during time periods the nurse has no responsibilities other than direct care. A nurse manager or charge nurse shall not count toward this ratio.
(B)At least one technician is providing direct care for every three patients. A technician shall only count toward this ratio during time periods the technician has no responsibilities other than direct care. Trainees shall not count toward this ratio. Nurses counted toward the nurse-to-patient ratio shall not count toward this ratio.
(2)Commencing January 1, 2020, a chronic dialysis clinic shall ensure that a full-time equivalent individual social worker is not assigned more than 75 patients. patients receiving care from the chronic dialysis clinic, regardless of the location where each patient undergoes dialysis.
(3)Commencing January 1, 2020, a chronic dialysis clinic shall ensure that a full-time equivalent individual registered dietitian is not assigned more than 75 patients. patients receiving care from the chronic dialysis clinic, regardless of the location where each patient undergoes dialysis.
(4)The ratios described in paragraphs (1), (2), and (3) shall constitute the minimum number of nurses, technicians, social workers, and registered dietitians assigned to patients at all times. Additional nurses, technicians, social workers, and registered dietitians shall be assigned to the extent necessary to ensure that an adequate number of qualified personnel are present whenever patients are undergoing dialysis so that the patient-to-staff ratio is appropriate to the level of dialysis care given and meets the needs of patients.
(5)Commencing January 1, 2020, a chronic dialysis clinic shall ensure that the transition time is at least 45 minutes.(5)No later than January 1, 2020, the department shall issue regulations that specify an appropriate minimum transition time. This appropriate minimum transition time shall give patients sufficient time to recuperate after treatment and provide sufficient time to comply with safety and hygiene protocols, including, but not limited to, compliance with recommendations from the Centers for Disease Control and Prevention regarding hygiene practices. If the department has not issued those regulations on or before January 1, 2020, a chronic dialysis clinic shall ensure that the minimum transition time is at least 45 minutes.
(c)The department shall not issue a license to any chronic dialysis clinic unless that chronic dialysis clinic demonstrates the ability and intention to comply with this section.
(d)(1)Every chronic dialysis clinic for which a license has been issued shall maintain, and provide to the department on a form prescribed by the department, at a minimum, the following information:
(A)Actual staffing ratio and transition time data for the period covered by the submission, which shall include, at a minimum,daily all of the following: (1) daily totals of the total number and actual hours worked by nurses, technicians, social workers, and registered dietitians, nurses and technicians; (2) the total number of patients and actual hours receiving direct care, and care; (3) the daily average transition time for each treatment station. station; and (4) for each week, the total number of full-time equivalent social workers and registered dietitians and the total number of patients assigned to social workers and registered dietitians.
(B)Every instance, no matter how brief, during the period covered by the submission when staffing ratios or transition times did not meet the requirements of subdivision (b) and the reasons and circumstances therefor.
(2)The chief executive officer or administrator of the chronic dialysis clinic shall personally certify that he or she is satisfied, after review, that all information submitted pursuant to paragraph (1) is accurate and complete.
(3)The chronic dialysis clinic shall periodically submit the information described in paragraph (1) to the department on a schedule and in a format prescribed by the department, provided that the clinic shall submit that information no less frequently than four times per year.
(e)The department may grant a waiver of subdivisions (b), (c), and (d) to a chronic dialysis clinic in a rural county if the waiver does not jeopardize the health, safety, and well-being of affected patients and is needed for increased operational efficiency.
(f)The department shall inspect each chronic dialysis clinic for which a license has been issued at least once per year, and shall conduct such inspections as often as necessary to ensure compliance with the requirements of subdivision (b), the accuracy and completeness of information provided pursuant to subdivision (d), and the adequacy of the quality of care being provided.
(g)Within 60 days of receiving a complaint from an employee, an association of employees, a vendor, a contractor, a patient, an association of patients, or a family member of a patient of a chronic dialysis clinic that the chronic dialysis clinic has committed a violation of the requirements of this chapter, the department shall investigate the chronic dialysis clinic and, if the evidence shows a violation has occurred, the department shall impose discipline pursuant to Section 1240.1.
(h)(1)Any writing, record, or document received, owned, used, or retained by the department in connection with subdivisions (c), (d), and (f) of this section, subdivisions (b) to (g), inclusive, of Section 1240.1, and Section 1240.2, is a public record within the meaning of subdivision (e) of Section 6252 of the Government Code, and, as such, is open to public inspection pursuant to the California Public Records Act (Chapter 3.5 (commencing with Section 6250) of Division 7 of Title 1 of the Government Code).
(2)The department shall redact from any writing, record, or document described in this subdivision personal identifying information associated with named individuals to the extent required to prevent an unwarranted invasion of personal privacy, as that term is used in subdivision (c) of Section 6254 of the Government Code, but the department shall not withhold any such writing, record, or document in its entirety under subdivision (c) of Section 6254 of the Government Code.
(3)Information required to be submitted under subdivision (d), and complaints submitted under subdivision (g), shall not be withheld on the basis of subdivision (f) of Section 6254 of the Government Code.
(i)(1)With the exception of paragraphs (2) and (3) of subdivision (b), the provisions of this section shall not apply to home dialysis, as defined in Section 494.10 of Title 42 of the Code of Federal Regulations, as it read on December 31, 2016, and home dialysis-related services and training, as described in Section 494.100 of Title 42 of the Code of Federal Regulations as it read on December 31, 2016.
(2)Home dialysis-related services and training, as described in Section 494.100 of Title 42 of the Code of Federal Regulations, as it read on December 31, 2016, are not included within the definition of direct care for the purposes of this section.
SEC. 4.Section 1228 of the Health and Safety Code is amended to read:1228.(a)Except as provided in subdivision (c), every clinic for which a license or special permit has been issued shall be periodically inspected. Except as provided in Section 1226.4, the frequency of inspections shall depend upon the type and complexity of the clinic or special service to be inspected. Inspections shall be conducted no less often than once every three years and as often as necessary to ensure the quality of care being provided.
(b) (1)During inspections, representatives of the department shall offer any advice and assistance to the clinic as they deem appropriate. The department may contract with local health departments for the assumption of any of the departments responsibilities under this chapter. In exercising this authority, the local health department shall conform to the requirements of this chapter and to the rules, regulations, and standards of the department.
(2)The department shall reimburse local health departments for services performed pursuant to this section, and these payments shall not exceed actual cost. Reports of each inspection shall be prepared by the representative conducting it upon forms prepared and furnished by the department and filed with the department.
(c)This section shall not apply to any of the following:
(1)A rural health clinic.
(2)A primary care clinic accredited by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), the Accreditation Association for Ambulatory Health Care (AAAHC), or any other accrediting organization recognized by the department.
(3)An ambulatory surgical center.
(4)A comprehensive outpatient rehabilitation facility that is certified to participate either in the Medicare Program under Title XVIII (42 U.S.C. Sec. 1395 et seq.) of the federal Social Security Act, or the Medicaid program under Title XIX (42 U.S.C. Sec. 1396 et seq.) of the federal Social Security Act, or both.
(d)Notwithstanding paragraph (2) of subdivision (c), the department shall retain the authority to inspect a primary care clinic pursuant to Section 1227, or as necessary to ensure the quality of care being provided.
SEC. 5.The heading of Article 5 (commencing with Section 1240) of Chapter 1 of Division 2 of the Health and Safety Code is repealed.SEC. 6.The heading of Article 5 (commencing with Section 1240) is added to Chapter 1 of Division 2 of the Health and Safety Code, to read:5.Suspension, Revocation, and PenaltiesSEC. 7.Section 1240.1 is added to the Health and Safety Code, to read:1240.1.(a)The director may assess an administrative penalty against a chronic dialysis clinic for a violation of this chapter. Each penalty issued pursuant to this chapter shall be classified as a major violation, an intermediate violation, or a minor violation according to the nature of the violation and the threat of harm to patients. A major violation shall be subject to an administrative penalty of up to ten thousand dollars ($10,000), and an intermediate violation shall be subject to an administrative penalty of up to five thousand dollars ($5,000). The director shall not assess an administrative penalty for a minor violation.
(b)The department shall promulgate regulations establishing the criteria to assess an administrative penalty against a chronic dialysis clinic, clinic that shall include, but not be limited to, a consideration of all of the following:
(1)The probability and severity of the risk that the violation presents to the patient.
(2)The actual harm to patients, if any.
(3)The nature, scope, and severity of the violation.
(4)The chronic dialysis clinics history of compliance with related state and federal statutes and regulations, including, but not limited to, the similarity in circumstances of the violation to any previous violation by the chronic dialysis clinic within a 24-month period.
(5)Factors beyond the control of the chronic dialysis clinic that restricts its ability to comply with this chapter or the rules and regulations promulgated thereunder.
(6)The demonstrated willfulness of the violation.
(7)The extent to which the chronic dialysis clinic detected the violation and took immediate action to correct the violation and prevent that type of violation from recurring.
(c)If a chronic dialysis clinic disputes a determination by the director regarding an alleged deficiency or failure to correct a deficiency, or the reasonableness of a proposed deadline for correction of a violation or an amount of an administrative penalty, the chronic dialysis clinic may, within 10 working days, request a hearing pursuant to Section 131071. A chronic dialysis clinic shall pay all administrative penalties when all appeals have been exhausted and the departments position has been upheld.
SEC. 8.Section 1240.2 is added to the Health and Safety Code, to read:1240.2.(a)Subject to subdivision (d), prior to the effective date of regulations adopted to implement Section 1240.1, if a chronic dialysis clinic receives a notice of deficiency constituting an immediate jeopardy to the health or safety of a patient or employee and is required to submit a plan of correction, the department may assess the licensee an administrative penalty of up to ten thousand dollars ($10,000).
(b)If a licensee disputes a determination by the department regarding an alleged deficiency or the alleged failure to correct a deficiency, or regarding the reasonableness of the proposed deadline for correction or the amount of the penalty, the licensee may, within 10 days, request an administrative hearing pursuant to Section 131071. Penalties shall be paid when appeals have been exhausted and if the departments position has been upheld.
(c)For purposes of this section immediate jeopardy means a situation in which the licensees noncompliance with one or more requirements of licensure has caused, or is likely to cause, serious injury or death to one or more patients or employees.
(d)This section shall only apply to incidents occurring on or after January 1, 2018, except that this section shall only apply to violations of subdivision (b) of Section 1226.4 occurring on or after January 1, 2020.
(e)Notwithstanding Section 11 of the act that added this section, new regulations are not required or authorized for implementation of this section.
(f)This section shall become inoperative on the effective date of regulations promulgated by the department pursuant to Section 1240.1.
SEC. 9.Section 1266.2 is added to the Health and Safety Code, to read:1266.2.It is the intent of the Legislature that California taxpayers not be financially responsible for implementation and enforcement of minimum staffing requirements at chronic dialysis clinics. In order to effectuate that intent, when calculating, assessing, and collecting fees imposed on chronic dialysis clinics pursuant to Section 1266, the department shall take into account all costs associated with implementing and enforcing Sections 1226.4 and 1240.1.
SEC. 10.Nothing in this act is intended to impact nurse-to-patient ratios applicable to health facilities licensed pursuant to subdivision (a), (b), or (f) of Section 1250 of the Health and Safety Code.
SEC. 11.The State Department of Public Health shall issue regulations necessary to implement this act no later than two years following its effective date.
SEC. 12.The provisions of this act are severable. If any provision of this act or its application is held invalid, that invalidity shall not affect other provisions or applications that can be given effect without the invalid provision or application.
SEC. 13.No reimbursement is required by this act pursuant to Section 6 of Article XIIIB of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIIIB of the California Constitution.
The Legislature finds and declares all of the following:
(a)Dialysis is a critical, lifesaving treatment for Californians suffering from end-stage renal disease.
(b)There are currently more than 63,000 66,000 dialysis patients, and 562 more than 570 licensed outpatient dialysis clinics, in California.
(c)There is broad consensus among medical professionals, academics, and other experts that higher ratios of direct caregiving staff to patients at outpatient dialysis clinics improve patient outcomes, including by reducing the rate at which patients suffer infections or must be hospitalized.
(d)There is also broad consensus among medical professionals, academics, and other experts that adequate time to prepare a treatment station for a patient to be dialyzed is necessary to ensure safety and hygiene protocols are followed, and directly improve patient outcomes, including by reducing the rate at which patients suffer infections or must be unnecessarily hospitalized.
(e)Worker safety is also enhanced by higher ratios of caregiving staff to patients and transition time between patients, including by reducing the risk of injury on the job.
(f)Current staffing levels in outpatient dialysis clinics in California are inadequate to protect patient health and worker safety, and therefore are presently causing harm to dialysis patients, including unnecessary and avoidable deaths, hospitalizations, infections, and medication errors.
(g)Other states mandate minimum direct care staffing requirements in order to enhance patient safety and health at outpatient dialysis clinics.
SEC. 2.Section 1226 of the Health and Safety Code is amended to read:1226.(a)The regulations shall prescribe the kinds of services which may be provided by clinics in each category of licensure and shall prescribe minimum standards of adequacy, safety, and sanitation of the physical plant and equipment, and, subject to Section 1226.4, minimum standards for staffing with duly qualified personnel and minimum standards for providing the services offered. These minimum standards shall be based on the type of facility, the needs of the patients served, and the types and levels of services provided.
(b)The Office of Statewide Health Planning and Development, in consultation with the Community Clinics Advisory Committee, shall prescribe minimum construction standards of adequacy and safety for the physical plant of clinics as found in the California Building Standards Code.
(c)(1)A city or county, as applicable, shall have plan review and building inspection responsibilities for the construction or alteration of buildings described in paragraphs (1) and (2) of subdivision (b) of Section 1204 and shall apply the provisions of the latest edition of the California Building Standards Code in conducting these plan review responsibilities. For these buildings, construction and alteration shall include conversion of a building to a purpose specified in paragraphs (1) and (2) of subdivision (b) of Section 1204.
(2)Upon the initial submittal to a city or county by the governing authority or owner of these clinics for plan review and building inspection services, the city or county shall reply in writing to the clinic whether or not the plan review by the city or county will include a certification as to whether or not the clinic project submitted for plan review meets the standards as propounded by the office in the California Building Standards Code.
(3)If the city or county indicates that its review will include this certification, it shall do both of the following:
(A)Apply the applicable clinic provisions of the latest edition of the California Building Standards Code.
(B)Certify in writing, to the applicant within 30 days of completion of construction whether or not these standards have been met.
(d)If upon initial submittal, the city or county indicates that its plan review will not include this certification, the governing authority or owner of the clinic shall submit the plans to the Office of Statewide Health Planning and Development, which shall review the plans for certification whether or not the clinic project meets the standards, as propounded by the office in the California Building Standards Code.
(e)When the office performs review for certification, the office shall charge a fee in an amount that does not exceed its actual costs.
(f)The Office of the State Fire Marshal shall prescribe minimum safety standards for fire and life safety in surgical clinics.
(g)Notwithstanding subdivision (c), the governing authority or owner of a clinic may request the office to perform plan review services for buildings described in subdivision (c). If the office agrees to perform these services, after consultation with the local building official, the office shall charge an amount not to exceed its actual costs. The construction or alteration of these buildings shall conform to the applicable provisions of the latest edition of the California Building Standards Code for purposes of the plan review by the office pursuant to this subdivision.
(h)Regulations adopted pursuant to this chapter establishing standards for laboratory services shall not be applicable to any clinic that operates a clinical laboratory licensed pursuant to Section 1265 of the Business and Professions Code.
SEC. 3.Section 1226.4 is added to the Health and Safety Code, to read:1226.4.(a)For purposes of this section, the following terms have the following meanings:
(1)At all times includes times during which employees, including, but not limited to, nurses and technicians, are provided meal periods and rest or other breaks.
(2)Charge nurse means a charge nurse as described in Section 494.140(b)(3) of Title 42 of the Code of Federal Regulations as it read on December 31, 2016.
(3)Direct care means initiating and discontinuing dialysis, monitoring patients during treatment, and administering medications, and physical presence in the dialysis treatment area.
(4)Full-time equivalent means employment by a chronic dialysis clinic for 2,080 hours of work in 12 consecutive months.
(4)(5)Nurse means a registered nurse licensed pursuant to Chapter 6 (commencing with Section 2700) of Division 2 of the Business and Professions Code.
(5)(6)Nurse manager means a nurse manager as described in Section 494.140(b)(1) of Title 42 of the Code of Federal Regulations as it read on December 31, 2016.
(6)(7)Registered dietitian means a dietitian as described in Section 494.140 (c) 494.140(c) of Title 42 of the Code of Federal Regulations, as it read on December 31, 2016.
(8)Rural county means a county that has a population of less than 250,000 and does not have a single urbanized area with a population of greater than 50,000.
(7)(9)Social worker means a social worker as described in Section 494.140(d) of Title 42 of the Code of Federal Regulations as it read on December 31, 2016.
(8)(10)Technician means a person who holds both of the following qualifications:
(A)The person is a patient care dialysis technician, as described in Section 494.140(e) of Title 42 of the Code of Federal Regulations as it read on December 31, 2016.
(B)The person is a Certified Hemodialysis Technician certified pursuant to Article 3.5 (commencing with Section 1247) of Chapter 3 of Division 2 of the Business and Professions Code.
(9)(11)Trainee means a person who is undergoing training to become a technician, but who has not yet been certified as a Certified Hemodialysis Technician pursuant to Article 3.5 (commencing with Section 1247) of Chapter 3 of Division 2 of the Business and Professions Code.
(10)(12)Transition time means the period of time beginning when one patient has completed treatment and has been disconnected from the dialysis machine and ending when the next patient is placed in the treatment station, but does not mean the period of time after the last patient of the day leaves the treatment station.
(11)(13)Treatment station means a physical location within a chronic dialysis clinic where an individual patient is dialyzed.
(b)(1)Commencing January 1, 2019, 2020, a chronic dialysis clinic shall ensure that the following minimum staffing ratios are met at all times that patients are receiving, or preparing to receive, direct care:
(A)At least one nurse is providing direct care for every eight patients. A nurse shall only count toward this ratio during time periods the nurse has no responsibilities other than direct care. A nurse manager or charge nurse shall not count toward this ratio.
(B)At least one technician is providing direct care for every three patients. A technician shall only count toward this ratio during time periods the technician has no responsibilities other than direct care. Trainees shall not count toward this ratio. Nurses counted toward the nurse-to-patient ratio shall not count toward this ratio.
(2)Commencing January 1, 2019, 2020, a chronic dialysis clinic shall ensure that a full-time equivalent individual social worker is not assigned more than 75 patients.
(3)Commencing January 1, 2019, 2020, a chronic dialysis clinic shall ensure that a full-time equivalent individual registered dietitian is not assigned more than 75 patients.
(4)The ratios described in paragraphs (1), (2), and (3) shall constitute the minimum number of nurses, technicians, social workers, and registered dietitians assigned to patients at all times. Additional nurses, technicians, social workers, and registered dietitians shall be assigned to the extent necessary to ensure that an adequate number of qualified personnel are present whenever patients are undergoing dialysis so that the patient-to-staff ratio is appropriate to the level of dialysis care given and meets the needs of patients.
(5)Commencing January 1, 2019, 2020, a chronic dialysis clinic shall ensure that the transition time is at least 45 minutes.
(c)The department shall not issue a license to any chronic dialysis clinic unless that chronic dialysis clinic demonstrates the ability and intention to comply with this section.
(d)(1)Every chronic dialysis clinic for which a license has been issued shall maintain, and provide to the department on a form prescribed by the department, at a minimum, the following information:
(A)Actual staffing ratio and transition time data for the period covered by the submission, which shall include, at a minimum, daily totals of the total number and actual hours worked by nurses, technicians, social workers, and registered dietitians dietitians, the total number of patients and actual hours receiving direct care, and the daily average transition time for each treatment station.
(B)Every instance, no matter how brief, during the period covered by the submission when staffing ratios or transition times did not meet the requirements of subdivision (b) and the reasons and circumstances therefor.
(2)The chief executive officer or administrator of the chronic dialysis clinic shall personally certify that he or she is satisfied, after review, that all information submitted pursuant to paragraph (1) is accurate and complete.
(3)The chronic dialysis clinic shall periodically submit the information described in paragraph (1) to the department on a schedule and in a format prescribed by the department, provided that the clinic shall submit that information no less frequently than four times per year.
(e)The department may grant a waiver of subdivisions (b), (c), and (d) to a chronic dialysis clinic in a rural county if the waiver does not jeopardize the health, safety, and well-being of affected patients and is needed for increased operational efficiency.
(e)(f)The department shall inspect each chronic dialysis clinic for which a license has been issued at least once per year, and shall conduct such inspections as often as necessary to ensure compliance with the requirements of subdivision (b), the accuracy and completeness of information provided pursuant to subdivision (d), and the adequacy of the quality of care being provided.
(f)(g)Within 60 days of receiving a complaint from an employee, an association of employees, a vendor, a contractor, a patient, an association of patients, or a family member of a patient of a chronic dialysis clinic that the chronic dialysis clinic has committed a violation of the requirements of this chapter, the department shall investigate the chronic dialysis clinic and, if the evidence shows a violation has occurred, the department shall impose discipline pursuant to Section 1240.1.
(g)(h)(1)Any writing, record, or document received, owned, used, or retained by the department in connection with subdivisions (c), (d), and (e) (f) of this section, and subdivisions (b) to (g), inclusive, of Section 1240.1, and Section 1240.2, is a public record within the meaning of subdivision (e) of Section 6252 of the Government Code, and, as such, is open to public inspection pursuant to the California Public Records Act (Chapter 3.5 (commencing with Section 6250) of Division 7 of Title 1 of the Government Code).
(2)The department shall redact from any writing, record, or document described in this subdivision personal identifying information associated with named individuals to the extent required to prevent an unwarranted invasion of personal privacy, as that term is used in subdivision (c) of Section 6254 of the Government Code, but the department shall not withhold any such writing, record, or document in its entirety under subdivision (c) of Section 6254 of the Government Code.
(3)Information required to be submitted under subdivision (d), and complaints submitted under subdivision (f), (g), shall not be withheld on the basis of subdivision (f) of Section 6254 of the Government Code.
SEC. 4.Section 1228 of the Health and Safety Code is amended to read:1228.(a)Except as provided in subdivision (c), every clinic for which a license or special permit has been issued shall be periodically inspected. Except as provided in Section 1226.4, the frequency of inspections shall depend upon the type and complexity of the clinic or special service to be inspected. Inspections shall be conducted no less often than once every three years and as often as necessary to ensure the quality of care being provided.
(b) (1)During inspections, representatives of the department shall offer any advice and assistance to the clinic as they deem appropriate. The department may contract with local health departments for the assumption of any of the departments responsibilities under this chapter. In exercising this authority, the local health department shall conform to the requirements of this chapter and to the rules, regulations, and standards of the department.
(2)The department shall reimburse local health departments for services performed pursuant to this section, and these payments shall not exceed actual cost. Reports of each inspection shall be prepared by the representative conducting it upon forms prepared and furnished by the department and filed with the department.
(c)This section shall not apply to any of the following:
(1)A rural health clinic.
(2)A primary care clinic accredited by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), the Accreditation Association for Ambulatory Health Care (AAAHC), or any other accrediting organization recognized by the department.
(3)An ambulatory surgical center.
(4)A comprehensive outpatient rehabilitation facility that is certified to participate either in the Medicare Program under Title XVIII (42 U.S.C. Sec. 1395 et seq.) of the federal Social Security Act, or the Medicaid program under Title XIX (42 U.S.C. Sec. 1396 et seq.) of the federal Social Security Act, or both.
(d)Notwithstanding paragraph (2) of subdivision (c), the department shall retain the authority to inspect a primary care clinic pursuant to Section 1227, or as necessary to ensure the quality of care being provided.
SEC. 5.The heading of Article 5 (commencing with Section 1240) of Chapter 1 of Division 2 of the Health and Safety Code is repealed.SEC. 6.The heading of Article 5 (commencing with Section 1240) is added to Chapter 1 of Division 2 of the Health and Safety Code, to read:5.Suspension, Revocation, and PenaltiesSEC. 7.Section 1240.1 is added to the Health and Safety Code, to read:1240.1.(a)The director may assess an administrative penalty against a chronic dialysis clinic for a violation of this chapter. Each penalty issued pursuant to this chapter shall be classified as a major violation, an intermediate violation, or a minor violation according to the nature of the violation and the threat of harm to patients. A major violation shall be subject to an administrative penalty of up to ten thousand dollars ($10,000), and an intermediate violation shall be subject to an administrative penalty of up to five thousand dollars ($5,000). The director shall not assess an administrative penalty for a minor violation.
(b)The department shall promulgate regulations establishing the criteria to assess an administrative penalty against a chronic dialysis clinic, that shall include, but not be limited to, a consideration of all of the following:
(1)The probability and severity of the risk that the violation presents to the patient.
(2)The actual harm to patients, if any.
(3)The nature, scope, and severity of the violation.
(4)The chronic dialysis clinics history of compliance with related state and federal statutes and regulations, including, but not limited to, the similarity in circumstances of the violation to any previous violation by the chronic dialysis clinic within a 24-month period.
(5)Factors beyond the control of the chronic dialysis clinic that restricts its ability to comply with this chapter or the rules and regulations promulgated thereunder.
(6)The demonstrated willfulness of the violation.
(7)The extent to which the chronic dialysis clinic detected the violation and took immediate action to correct the violation and prevent that type of violation from recurring.
(c)If a chronic dialysis clinic disputes a determination by the director regarding an alleged deficiency or failure to correct a deficiency, or the reasonableness of a proposed deadline for correction of a violation or an amount of an administrative penalty, the chronic dialysis clinic may, within 10 working days, request a hearing pursuant to Section 131071. A chronic dialysis clinic shall pay all administrative penalties when all appeals have been exhausted and the departments position has been upheld.
SEC. 8.Section 1240.2 is added to the Health and Safety Code, to read:1240.2.(a)Subject to subdivision (d), prior to the effective date of regulations adopted to implement Section 1240.1, if a chronic dialysis clinic receives a notice of deficiency constituting an immediate jeopardy to the health or safety of a patient or employee and is required to submit a plan of correction, the department may assess the licensee an administrative penalty of up to ten thousand dollars ($10,000).
(b)If a licensee disputes a determination by the department regarding an alleged deficiency or the alleged failure to correct a deficiency, or regarding the reasonableness of the proposed deadline for correction or the amount of the penalty, the licensee may, within 10 days, request an administrative hearing pursuant to Section 131071. Penalties shall be paid when appeals have been exhausted and if the departments position has been upheld.
(c)For purposes of this section immediate jeopardy means a situation in which the licensees noncompliance with one or more requirements of licensure has caused, or is likely to cause, serious injury or death to one or more patients or employees.
(d)This section shall only apply to incidents occurring on or after January 1, 2018, except that this section shall only apply to violations of subdivision (b) of Section 1226.4 occurring on or after January 1, 2020.
(e)Notwithstanding Section 11 of the act that added this section, new regulations are not required or authorized for implementation of this section.
(f)This section shall become inoperative on the effective date of regulations promulgated by the department pursuant to Section 1240.1.
SEC. 8.SEC. 9.Section 1266.2 is added to the Health and Safety Code, to read:1266.2.It is the intent of the Legislature that California taxpayers not be financially responsible for implementation and enforcement of minimum staffing requirements at chronic dialysis clinics. In order to effectuate that intent, when calculating, assessing, and collecting fees imposed on chronic dialysis clinics pursuant to Section 1266, the department shall take into account all costs associated with implementing and enforcing Sections 1226.4 and 1240.1.
SEC. 9.SEC. 10.Nothing in this act is intended to impact nurse-to-patient ratios applicable to health facilities licensed pursuant to subdivision (a), (b), or (f) of Section 1250 of the Health and Safety Code.
SEC. 10.SEC. 11.The State Department of Public Health shall issue regulations necessary to implement this act no later than 180 days two years following its effective date.
SEC. 11.SEC. 12.The provisions of this act are severable. If any provision of this act or its application is held invalid, that invalidity shall not affect other provisions or applications that can be given effect without the invalid provision or application.
SEC. 12.SEC. 13.No reimbursement is required by this act pursuant to Section 6 of Article XIIIB of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIIIB of the California Constitution.
The Legislature finds and declares all of the following:
(a)Dialysis is a critical, lifesaving treatment for Californians suffering from end-stage renal disease.
(b)There are currently more than 63,000 dialysis patients, and 562 licensed outpatient dialysis clinics, in California.
(c)There is broad consensus among medical professionals, academics, and other experts that higher ratios of direct caregiving staff to patients at outpatient dialysis clinics improve patient outcomes, including by reducing the rate at which patients suffer infections or must be hospitalized.
(d)There is also broad consensus among medical professionals, academics, and other experts that adequate time to prepare a treatment station for a patient to be dialyzed is necessary to ensure safety and hygiene protocols are followed, and directly improve patient outcomes, including by reducing the rate at which patients suffer infections or must be unnecessarily hospitalized.
(e)Worker safety is also enhanced by higher ratios of caregiving staff to patients and transition time between patients, including by reducing the risk of injury on the job.
(f)Current staffing levels in outpatient dialysis clinics in California are inadequate to protect patient health and worker safety, and therefore are presently causing harm to dialysis patients, including unnecessary and avoidable deaths, hospitalizations, infections, and medication errors.
(g)Other states mandate minimum direct care staffing requirements in order to enhance patient safety and health at outpatient dialysis clinics.
SEC. 2.Section 1226 of the Health and Safety Code is amended to read:1226.(a)The regulations shall prescribe the kinds of services which may be provided by clinics in each category of licensure and shall prescribe minimum standards of adequacy, safety, and sanitation of the physical plant and equipment, and, subject to Section 1226.4, minimum standards for staffing with duly qualified personnel and minimum standards for providing the services offered. These minimum standards shall be based on the type of facility, the needs of the patients served, and the types and levels of services provided.
(b)The Office of Statewide Health Planning and Development, in consultation with the Community Clinics Advisory Committee, shall prescribe minimum construction standards of adequacy and safety for the physical plant of clinics as found in the California Building Standards Code.
(c)(1)A city or county, as applicable, shall have plan review and building inspection responsibilities for the construction or alteration of buildings described in paragraphs (1) and (2) of subdivision (b) of Section 1204 and shall apply the provisions of the latest edition of the California Building Standards Code in conducting these plan review responsibilities. For these buildings, construction and alteration shall include conversion of a building to a purpose specified in paragraphs (1) and (2) of subdivision (b) of Section 1204.
(2)Upon the initial submittal to a city or county by the governing authority or owner of these clinics for plan review and building inspection services, the city or county shall reply in writing to the clinic whether or not the plan review by the city or county will include a certification as to whether or not the clinic project submitted for plan review meets the standards as propounded by the office in the California Building Standards Code.
(3)If the city or county indicates that its review will include this certification, it shall do both of the following:
(A)Apply the applicable clinic provisions of the latest edition of the California Building Standards Code.
(B)Certify in writing, to the applicant within 30 days of completion of construction whether or not these standards have been met.
(d)If upon initial submittal, the city or county indicates that its plan review will not include this certification, the governing authority or owner of the clinic shall submit the plans to the Office of Statewide Health Planning and Development, which shall review the plans for certification whether or not the clinic project meets the standards, as propounded by the office in the California Building Standards Code.
(e)When the office performs review for certification, the office shall charge a fee in an amount that does not exceed its actual costs.
(f)The Office of the State Fire Marshal shall prescribe minimum safety standards for fire and life safety in surgical clinics.
(g)Notwithstanding subdivision (c), the governing authority or owner of a clinic may request the office to perform plan review services for buildings described in subdivision (c). If the office agrees to perform these services, after consultation with the local building official, the office shall charge an amount not to exceed its actual costs. The construction or alteration of these buildings shall conform to the applicable provisions of the latest edition of the California Building Standards Code for purposes of the plan review by the office pursuant to this subdivision.
(h)Regulations adopted pursuant to this chapter establishing standards for laboratory services shall not be applicable to any clinic that operates a clinical laboratory licensed pursuant to Section 1265 of the Business and Professions Code.
SEC. 3.Section 1226.4 is added to the Health and Safety Code, to read:1226.4.(a)For purposes of this section, the following terms have the following meanings:
(1)At all times includes times during which employees, including, but not limited to, nurses and technicians, are provided meal periods and rest or other breaks.
(2)Charge nurse means a charge nurse as described in Section 494.140(b)(3) of Title 42 of the Code of Federal Regulations as it read on December 31, 2016.
(3)Direct care means initiating and discontinuing dialysis, monitoring patients during treatment, and administering medications, and physical presence in the immediate area where patients are dialyzed. dialysis treatment area.
(4)Nurse means a registered nurse licensed pursuant to Chapter 6 (commencing with Section 2700) of Division 2 of the Business and Professions Code.
(5)Nurse manager means a nurse manager as described in Section 494.140(b)(1) of Title 42 of the Code of Federal Regulations as it read on December 31, 2016.
(6)Registered dietitian means a dietitian as described in Section 494.140 (c) of Title 42 of the Code of Federal Regulations, as it read on December 31, 2016.
(6)(7)Social worker means a social worker as described in Section 494.140(d) of Title 42 of the Code of Federal Regulations as it read on December 31, 2016.
(7)(8)Technician means a person who holds both of the following qualifications:
(A)The person is a patient care dialysis technician, as described in Section 494.140(e) of Title 42 of the Code of Federal Regulations as it read on December 31, 2016.
(B)The person is a Certified Hemodialysis Technician certified pursuant to Article 3.5 (commencing with Section 1247) of Chapter 3 of Division 2 of the Business and Professions Code.
(8)(9)Trainee means a person who is undergoing training to become a technician, but who has not yet been certified as a Certified Hemodialysis Technician pursuant to Article 3.5 (commencing with Section 1247) of Chapter 3 of Division 2 of the Business and Professions Code.
(9)(10)Transition time means the period of time beginning when one patient has completed treatment and has been disconnected from the dialysis machine and ending when the next patient is placed in the treatment station, but does not mean the period of time after the last patient of the day leaves the treatment station.
(10)(11)Treatment station means a physical location within a chronic dialysis clinic where an individual patient is dialyzed.
(b)(1)Commencing January 1, 2019, a chronic dialysis clinic shall ensure that the following minimum staffing ratios are met at all times that patients are receiving, or preparing to receive, direct care:
(A)At least one nurse is providing direct care for every eight patients. A nurse shall only count toward this ratio during time periods the nurse has no responsibilities other than direct care. A nurse manager or charge nurse shall not count toward this ratio.
(B)At least one technician is providing direct care for every three patients. A technician shall only count toward this ratio during time periods the technician has no responsibilities other than direct care. Trainees shall not count toward this ratio. Nurses counted toward the nurse-to-patient ratio shall not count toward this ratio.
(2)Commencing January 1, 2019, a chronic dialysis clinic shall ensure that a social worker is not assigned more than 75 patients.
(3)Commencing January 1, 2019, a chronic dialysis clinic shall ensure that a registered dietitian is not assigned more than 75 patients.
(3)(4)The ratios described in paragraphs (1) and (2) (1), (2), and (3) shall constitute the minimum number of nurses, technicians, and social workers social workers, and registered dietitians assigned to patients at all times. Additional nurses, technicians, and social workers social workers, and registered dietitians shall be assigned to the extent necessary to ensure that an adequate number of qualified personnel are present whenever patients are undergoing dialysis so that the patient-to-staff ratio is appropriate to the level of dialysis care given and meets the needs of patients.
(4)(5)Commencing January 1, 2019, a chronic dialysis clinic shall ensure that the transition time is at least 45 minutes.
(c)The department shall not issue a license to any chronic dialysis clinic unless that chronic dialysis clinic demonstrates the ability and intention to comply with this section.
(d)(1)Every chronic dialysis clinic for which a license has been issued shall maintain, and provide to the department on a form prescribed by the department, at a minimum, the following information:
(A)Actual staffing ratio and transition time data for the period covered by the submission, which shall include, at a minimum, daily totals of the total number and actual hours worked by nurses, technicians, and social workers, social workers, and registered dietitians the total number of patients and actual hours receiving direct care, and the daily average transition time for each treatment station.
(B)Every instance, no matter how brief, during the period covered by the submission when staffing ratios or transition times did not meet the requirements of subdivision (b) and the reasons and circumstances therefor.
(2)The chief executive officer or administrator of the chronic dialysis clinic shall personally certify that he or she is satisfied, after review, that all information submitted pursuant to paragraph (1) is accurate and complete.
(3)The chronic dialysis clinic shall periodically submit the information described in paragraph (1) to the department on a schedule and in a format prescribed by the department, provided that the clinic shall submit that information no less frequently than four times per year.
(e)The department shall inspect each chronic dialysis clinic for which a license has been issued at least once per year, and shall conduct such inspections as often as necessary to ensure compliance with the requirements of subdivision (b), the accuracy and completeness of information provided pursuant to subdivision (d), compliance with corrective action plans, if any, approved under subdivision (b) or (d) of Section 1240.1, and the adequacy of the quality of care being provided.
(f)Within 60 days of receiving a complaint from an employee, an association of employees, a vendor, a contractor, a patient, an association of patients, or a family member of a patient of a chronic dialysis clinic that the chronic dialysis clinic has engaged in a staffing-related violation or gross staffing-related violation, as those terms are defined in subdivision (a) of Section 1240.1, committed a violation of the requirements of this chapter, the department shall investigate the chronic dialysis clinic and, if the evidence shows a violation has occurred, the department shall impose discipline pursuant to Section 1240.1.
(g)(1)Any writing, record, or document received, owned, used, or retained by the department in connection with subdivisions (c), (d), and (e) of this section, and subdivisions (b) to (g), inclusive, of Section 1240.1, is a public record within the meaning of subdivision (e) of Section 6252 of the Government Code, and, as such, is open to public inspection pursuant to the California Public Records Act (Chapter 3.5 (commencing with Section 6250) of Division 7 of Title 1 of the Government Code).
(2)The department shall redact from any writing, record, or document described in this subdivision personal identifying information associated with named individuals to the extent required to prevent an unwarranted invasion of personal privacy, as that term is used in subdivision (c) of Section 6254 of the Government Code, but the department shall not withhold any such writing, record, or document in its entirety under subdivision (c) of Section 6254 of the Government Code.
(3)Information required to be submitted under subdivision (d), and complaints submitted under subdivision (f), shall not be withheld on the basis of subdivision (f) of Section 6254 of the Government Code.
SEC. 4.Section 1228 of the Health and Safety Code is amended to read:1228.(a)Except as provided in subdivision (c), every clinic for which a license or special permit has been issued shall be periodically inspected. Except as provided in Section 1226.4, the frequency of inspections shall depend upon the type and complexity of the clinic or special service to be inspected. Inspections shall be conducted no less often than once every three years and as often as necessary to ensure the quality of care being provided.
(b) (1)During inspections, representatives of the department shall offer any advice and assistance to the clinic as they deem appropriate. The department may contract with local health departments for the assumption of any of the departments responsibilities under this chapter. In exercising this authority, the local health department shall conform to the requirements of this chapter and to the rules, regulations, and standards of the department.
(2)The department shall reimburse local health departments for services performed pursuant to this section, and these payments shall not exceed actual cost. Reports of each inspection shall be prepared by the representative conducting it upon forms prepared and furnished by the department and filed with the department.
(c)This section shall not apply to any of the following:
(1)A rural health clinic.
(2)A primary care clinic accredited by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), the Accreditation Association for Ambulatory Health Care (AAAHC), or any other accrediting organization recognized by the department.
(3)An ambulatory surgical center.
(4)A comprehensive outpatient rehabilitation facility that is certified to participate either in the Medicare Program under Title XVIII (42 U.S.C. Sec. 1395 et seq.) of the federal Social Security Act, or the Medicaid program under Title XIX (42 U.S.C. Sec. 1396 et seq.) of the federal Social Security Act, or both.
(d)Notwithstanding paragraph (2) of subdivision (c), the department shall retain the authority to inspect a primary care clinic pursuant to Section 1227, or as necessary to ensure the quality of care being provided.
SEC. 5.The heading of Article 5 (commencing with Section 1240) of Chapter 1 of Division 2 of the Health and Safety Code is repealed.SEC. 6.The heading of Article 5 (commencing with Section 1240) is added to Chapter 1 of Division 2 of the Health and Safety Code, to read:5.Suspension, Revocation, and PenaltiesSEC. 7.Section 1240.1 is added to the Health and Safety Code, to read:1240.1.(a)For purposes of this section, the following terms have the following meanings:(1)Staffing-related violation means any of the following:(A)Violation by the chronic dialysis clinic, or any of its officers, employees, vendors, or contractors, of subdivision (b) of Section 1226.4.(B)Conduct by the chronic dialysis clinic, or any of its officers, employees, vendors, or contractors, intended to conceal a violation of subdivision (b) of Section 1226.4.(C)A misrepresentation of information provided to the department pursuant to this section or subdivision (d) of Section 1226.4.(D)Violation by the chronic dialysis clinic, or any of its officers, employees, vendors, or contractors, of any part of a corrective action plan described in subdivision (d) or (e).(2)Gross staffing-related violation means any of the following:(A)A staffing-related violation that causes or exacerbates harm to a patient, or that has a substantial possibility of causing or exacerbating harm to a patient.(B)A willful or intentional staffing-related violation.(C)A staffing-related violation that occurred following reckless disregard of a substantial likelihood of a staffing-related violation.(D)Five or more staffing-related violations in a 12-month period.(E)Being out of compliance with one of the staffing ratios specified in paragraph (1) of subdivision (b) of Section 1226.4 for a period of time that extends beyond a single working shift of a nurse, for purposes of the nurse staffing requirement, or a single working shift of a technician, for purposes of the technician staffing requirement. For purposes of this subparagraph, the terms nurse and technician shall have the same meanings as in Section 1226.4.(F)A continuous period of one week or longer in which the staffing ratio is at or above one social worker assigned to 90 or more patients. For purposes of this subparagraph, social worker has the same meaning as in Section 1226.4.(G)A daily average transition time for a treatment station that is 20 minutes or shorter.(3)Governing entity means a person, firm, association, partnership, corporation, or other entity that owns or operates a chronic dialysis clinic for which a license has been issued, without respect to whether the person or entity itself directly holds that license.(4)Responsible individual means a person described in subparagraph (A) or (B) who, with respect to a staffing-related violation or gross staffing-related violation, knew or should have known that the violation would occur and possessed, but failed to exercise, direct responsibility and authority to prevent the violation from occurring, or knew or should have known that the violation had occurred and possessed, but failed to exercise, direct responsibility and authority to substantially remedy the violation. A nonmanagerial employee shall not be deemed a responsible individual.(A)A member of the governing body, designated person, chief executive officer, and administrator, as those terms are used in Section 494.180 of Title 42 of the Code of Federal Regulations as it read on December 31, 2016.(B)Managerial employees, officers, or directors of the governing entity.(b)(1)The department may impose civil penalties of up to one thousand dollars ($1,000) on a chronic dialysis clinic for repeated staffing-related violations in the manner provided in this chapter. Action taken under this subdivision shall be in addition to the actions required or authorized under subdivisions (d) and (e).(2)For the third staffing-related violation in any 12-month period:(A)The department may impose a civil penalty on the chronic dialysis clinic of up to two thousand dollars ($2,000).(B)The department may impose a civil penalty on each responsible individual, if any, of up to five hundred dollars ($500).(3)For the fourth staffing-related violation in any 12-month period:(A)The department shall impose a civil penalty on the chronic dialysis clinic of not less than two thousand dollars ($2,000) and not more than five thousand dollars ($5,000).(B)The department shall impose a civil penalty on each responsible individual, if any, of not less than two hundred dollars ($200) and not more than four thousand dollars ($4,000).(c)Notwithstanding Section 1240, and subject to Section 1241, the department shall take the following action in the manner provided in this chapter. Action taken under this subdivision shall be in addition to actions required or authorized under subdivisions (d) and (e).(1)For the first gross staffing-related violation in any 24-month period, the department may impose a civil penalty on the chronic dialysis clinic of not less than two thousand five hundred dollars ($2,500) and not more than five thousand dollars ($5,000).(2)For the second gross staffing-related violation in any 24-month period, the department shall impose a civil penalty on the chronic dialysis clinic of not less than two thousand five hundred dollars ($2,500) and not more than ten thousand dollars ($10,000).(3)For the third gross staffing-related violation in any 24-month period, the department shall impose a civil penalty on the chronic dialysis clinic of not less than five thousand dollars ($5,000) and not more than ten thousand dollars ($10,000), and may suspend the license issued to the chronic dialysis clinic for a period not to exceed 30 days.(4)For the fourth gross staffing-related violation in any 24-month period, the department shall impose a civil penalty on the chronic dialysis clinic of not less than five thousand dollars ($5,000) and not more than ten thousand dollars ($10,000), and shall suspend the license issued to the chronic dialysis clinic for a period not to exceed 90 days.(5)For the fifth gross staffing-related violation in any 24-month period:(A)The department shall impose a civil penalty on the chronic dialysis clinic of not less than five thousand dollars ($5,000) and not more than ten thousand dollars ($10,000), and may revoke the license issued to the chronic dialysis clinic or, if the department does not revoke the license, the department shall suspend the license for a period not to exceed 180 days.(B)For a period not to exceed 180 days, the department may refuse to issue or renew a license, and may refuse to authorize a transfer of an existing license, with respect to a chronic dialysis clinic owned or operated by the same, or an affiliated, governing entity of the chronic dialysis clinic at which the gross staffing-related violation occurred.(6)For the sixth and each subsequent gross staffing-related violation in any 24-month period:(A)The department may revoke the license issued to the chronic dialysis clinic or, if the department does not revoke the license, the department shall suspend the license for a period not to exceed one year.(B)For a period not to exceed three years, the department may refuse to issue or renew a license, and may refuse to authorize a transfer of an existing license, with respect to a chronic dialysis clinic owned or operated by the same, or an affiliated, governing entity of the chronic dialysis clinic at which the gross staffing-related violation occurred.(d)Following any enforcement action taken by the department under subdivision (b) or (c), the chronic dialysis clinic shall submit a corrective action plan to the department describing how the chronic dialysis clinic will avoid committing any further staffing-related violations or gross staffing-related violations, as applicable. The corrective action plan shall be reviewed and approved by the department.(e)Notwithstanding Section 1240, and subject to Section 1241, the department shall take the following action with respect to a governing entity in the manner provided in this chapter. Action taken under this subdivision shall be in addition to action required or authorized under subdivisions (b), (c), and (d).(1)Except as provided in paragraph (2), when chronic dialysis clinics owned or operated by a governing entity or affiliated governing entities commit, in the aggregate, 25 or more gross staffing-related violations within any 24-month period:(A)The governing entity or governing entities shall submit a corrective action plan to the department describing affirmative steps the governing entity or governing entities and associated chronic dialysis clinics will take to prevent every chronic dialysis clinic owned or operated by the governing entity or governing entities from committing any further gross staffing-related violations. The corrective action plan shall be revised and approved by the department.(B)The department may refuse to issue or renew a license, and may refuse to authorize a transfer of an existing license, to the governing entity or governing entities or a chronic dialysis clinic owned or operated by the governing entity or governing entities, for a period that ends on or before the later of either:(i)Three years after the latest gross staffing-related violation occurred.(ii)The date on which the department is satisfied that the governing entity or governing entities and associated chronic dialysis clinics have taken all affirmative steps set forth in the corrective action plan submitted under subparagraph (A).(C)In making the determination under subparagraph (B) the department shall consider the actual average of violations among the chronic dialysis clinics of the governing entity or governing entities.(2)When chronic dialysis clinics owned or operated by a governing entity or affiliated governing entities commit, in the aggregate, 50 or more gross staffing-related violations within any 24-month period:(A)The governing entity or governing entities shall submit a corrective action plan to the department describing affirmative steps the governing entity or governing entities and associated chronic dialysis clinics will take to prevent every chronic dialysis clinic owned or operated by the governing entity or governing entities from committing any further gross staffing-related violations of any kind. The corrective action plan shall be revised and approved by the department.(B)The department may revoke or suspend licenses issued to the governing entity or governing entities or any chronic dialysis clinic that they own or operate, and may refuse to issue, renew, or authorize a transfer of, a license to the governing entity or governing entities or any chronic dialysis clinic owned or operated by the governing entity or governing entities.(C)In making this determination the department shall consider the actual average of violations among the chronic dialysis clinics of the governing entity or governing entities.(f)(1)The department shall consider the factors described in paragraph (2) for all of the following:(A)When determining the penalties to be imposed under subdivision (b).(B)The revisions, if any, to corrective action plans submitted under subdivision (d) or (e).(C)The extent to which to refuse to issue or transfer, to revoke, or to suspend a license under subdivision (c) or (e).(D)Whether to take any other action authorized under subdivision (b), (c), or (e).(2)The department shall consider all of the following factors when taking the actions described in paragraph (1):(A)The duration and severity of the violation.(B)The willfulness of the violation.(C)The history of the chronic dialysis clinic or governing entity of noncompliance with Section 1226.4, including, but not limited to, the similarity in circumstances of the violation to any previous violation within a 24-month period.(D)The ability and good faith effort of the chronic dialysis clinic, and any responsible individual, to have foreseen or avoided the violation.(E)The good faith effort by the chronic dialysis clinic, and any responsible individual, to remedy the violation.(F)The harm to any patient, or exacerbation of that harm, resulting from the violation.(G)The extent to which the chronic dialysis clinic fully and completely reported the violation pursuant to subdivision (c) of Section 1226.4.(g)Penalties collected pursuant to this section shall be used by the department to implement and enforce Section 1226.4 and this section.(h)For purposes of Article 9 (commencing with Section 12650) of Chapter 6 of Part 2 of Division 3 of Title 2 of the Government Code, the information required to be provided under subdivision (d) of Section 1226.4 shall be deemed material to any claim for payment submitted by a chronic dialysis clinic within six months of the submission of that information.(i)If a chronic dialysis clinic or a responsible individual disputes a determination by the department regarding the imposition of a penalty pursuant to this section, the chronic dialysis clinic or responsible individual may, within 10 working days, request a hearing pursuant to Section 131071. Penalties shall be paid when all appeals have been exhausted and the departments position has been upheld.SEC. 7.Section 1240.1 is added to the Health and Safety Code, to read:1240.1.(a)The director may assess an administrative penalty against a chronic dialysis clinic for a violation of this chapter. Each penalty issued pursuant to this chapter shall be classified as a major violation, an intermediate violation, or a minor violation according to the nature of the violation and the threat of harm to patients. A major violation shall be subject to an administrative penalty of up to ten thousand dollars ($10,000), and an intermediate violation shall be subject to an administrative penalty of up to five thousand dollars ($5,000). The director shall not assess an administrative penalty for a minor violation.
(b)The department shall promulgate regulations establishing the criteria to assess an administrative penalty against a chronic dialysis clinic, that shall include, but not be limited to, a consideration of all of the following:
(1)The probability and severity of the risk that the violation presents to the patient.
(2)The actual harm to patients, if any.
(3)The nature, scope, and severity of the violation.
(4)The chronic dialysis clinics history of compliance with related state and federal statutes and regulations, including, but not limited to, the similarity in circumstances of the violation to any previous violation by the chronic dialysis clinic within a 24-month period.
(5)Factors beyond the control of the chronic dialysis clinic that restricts its ability to comply with this chapter or the rules and regulations promulgated thereunder.
(6)The demonstrated willfulness of the violation.
(7)The extent to which the chronic dialysis clinic detected the violation and took immediate action to correct the violation and prevent that type of violation from recurring.
(c)If a chronic dialysis clinic disputes a determination by the director regarding an alleged deficiency or failure to correct a deficiency, or the reasonableness of a proposed deadline for correction of a violation or an amount of an administrative penalty, the chronic dialysis clinic may, within 10 working days, request a hearing pursuant to Section 131071. A chronic dialysis clinic shall pay all administrative penalties when all appeals have been exhausted and the departments position has been upheld.
SEC. 8.Section 1266.2 is added to the Health and Safety Code, to read:1266.2.It is the intent of the Legislature that California taxpayers not be financially responsible for implementation and enforcement of minimum staffing requirements at chronic dialysis clinics. In order to effectuate that intent, when calculating, assessing, and collecting fees imposed on chronic dialysis clinics pursuant to Section 1266, the department shall take into account all costs associated with implementing and enforcing Sections 1226.4 and 1240.1.
SEC. 9.Nothing in this act is intended to impact nurse-to-patient ratios applicable to health facilities licensed pursuant to subdivision (a), (b), or (f) of Section 1250 of the Health and Safety Code.
SEC. 10.The State Department of Public Health shall issue regulations necessary to implement this act no later than 180 days following its effective date.
SEC. 11.The provisions of this act are severable. If any provision of this act or its application is held invalid, that invalidity shall not affect other provisions or applications that can be given effect without the invalid provision or application.
SEC. 12.No reimbursement is required by this act pursuant to Section 6 of Article XIIIB of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIIIB of the California Constitution.
The Legislature finds and declares all of the following:
(a)Dialysis is a critical, lifesaving treatment for Californians suffering from end-stage renal disease.
(b)There are currently more than 63,000 dialysis patients, and 562 licensed outpatient dialysis clinics, in California.
(c)There is broad consensus among medical professionals, academics, and other experts that higher ratios of direct caregiving staff to patients at outpatient dialysis clinics improve patient outcomes, including by reducing the rate at which patients suffer infections or must be hospitalized.
(d)There is also broad consensus among medical professionals, academics, and other experts that adequate time to prepare a treatment station for a patient to be dialyzed is necessary to ensure safety and hygiene protocols are followed, and directly improve patient outcomes, including by reducing the rate at which patients suffer infections or must be unnecessarily hospitalized.
(e)Worker safety is also enhanced by higher ratios of caregiving staff to patients and transition time between patients, including by reducing the risk of injury on the job.
(f)Current staffing levels in outpatient dialysis clinics in California are inadequate to protect patient health and worker safety, and therefore are presently causing harm to dialysis patients, including unnecessary and avoidable deaths, hospitalizations, infections, and medication errors.
(g)Other states mandate minimum direct care staffing requirements in order to enhance patient safety and health at outpatient dialysis clinics.
SEC. 2.Section 1226 of the Health and Safety Code is amended to read:1226.(a)The regulations shall prescribe the kinds of services which may be provided by clinics in each category of licensure and shall prescribe minimum standards of adequacy, safety, and sanitation of the physical plant and equipment, and, subject to Section 1226.4, minimum standards for staffing with duly qualified personnel and minimum standards for providing the services offered. These minimum standards shall be based on the type of facility, the needs of the patients served, and the types and levels of services provided.
(b)The Office of Statewide Health Planning and Development, in consultation with the Community Clinics Advisory Committee, shall prescribe minimum construction standards of adequacy and safety for the physical plant of clinics as found in the California Building Standards Code.
(c)(1)A city or county, as applicable, shall have plan review and building inspection responsibilities for the construction or alteration of buildings described in paragraphs (1) and (2) of subdivision (b) of Section 1204 and shall apply the provisions of the latest edition of the California Building Standards Code in conducting these plan review responsibilities. For these buildings, construction and alteration shall include conversion of a building to a purpose specified in paragraphs (1) and (2) of subdivision (b) of Section 1204.
(2)Upon the initial submittal to a city or county by the governing authority or owner of these clinics for plan review and building inspection services, the city or county shall reply in writing to the clinic whether or not the plan review by the city or county will include a certification as to whether or not the clinic project submitted for plan review meets the standards as propounded by the office in the California Building Standards Code.
(3)If the city or county indicates that its review will include this certification, it shall do both of the following:
(A)Apply the applicable clinic provisions of the latest edition of the California Building Standards Code.
(B)Certify in writing, to the applicant within 30 days of completion of construction whether or not these standards have been met.
(d)If upon initial submittal, the city or county indicates that its plan review will not include this certification, the governing authority or owner of the clinic shall submit the plans to the Office of Statewide Health Planning and Development, which shall review the plans for certification whether or not the clinic project meets the standards, as propounded by the office in the California Building Standards Code.
(e)When the office performs review for certification, the office shall charge a fee in an amount that does not exceed its actual costs.
(f)The Office of the State Fire Marshal shall prescribe minimum safety standards for fire and life safety in surgical clinics.
(g)Notwithstanding subdivision (c), the governing authority or owner of a clinic may request the office to perform plan review services for buildings described in subdivision (c). If the office agrees to perform these services, after consultation with the local building official, the office shall charge an amount not to exceed its actual costs. The construction or alteration of these buildings shall conform to the applicable provisions of the latest edition of the California Building Standards Code for purposes of the plan review by the office pursuant to this subdivision.
(h)Regulations adopted pursuant to this chapter establishing standards for laboratory services shall not be applicable to any clinic that operates a clinical laboratory licensed pursuant to Section 1265 of the Business and Professions Code.
SEC. 3.Section 1226.4 is added to the Health and Safety Code, to read:1226.4.(a)For purposes of this section, the following terms have the following meanings:
(1)At all times includes times during which employees, including, but not limited to, nurses and technicians, are provided meal periods and rest or other breaks.
(2)Charge nurse means a charge nurse as described in Section 494.140(b)(3) of Title 42 of the Code of Federal Regulations as it read on December 31, 2016.
(3)Direct care means initiating and discontinuing dialysis, monitoring patients during treatment, and administering medications, and physical presence in the immediate area where patients are dialyzed.
(4)Nurse means a registered nurse licensed pursuant to Chapter 6 (commencing with Section 2700) of Division 2 of the Business and Professions Code.
(5)Nurse manager means a nurse manager as described in Section 494.140(b)(1) of Title 42 of the Code of Federal Regulations as it read on December 31, 2016.
(6)Social worker means a social worker as described in Section 494.140(d) of Title 42 of the Code of Federal Regulations as it read on December 31, 2016.
(7)Technician means a person who holds both of the following qualifications:
(A)The person is a patient care dialysis technician, as described in Section 494.140(e) of Title 42 of the Code of Federal Regulations as it read on December 31, 2016.
(B)The person is a Certified Hemodialysis Technician certified pursuant to Article 3.5 (commencing with Section 1247) of Chapter 3 of Division 2 of the Business and Professions Code.
(8)Trainee means a person who is undergoing training to become a technician, but who has not yet been certified as a Certified Hemodialysis Technician pursuant to Article 3.5 (commencing with Section 1247) of Chapter 3 of Division 2 of the Business and Professions Code.
(9)Transition time means the period of time beginning when one patient has completed treatment and has been disconnected from the dialysis machine and ending when the next patient is placed in the treatment station, but does not mean the period of time after the last patient of the day leaves the treatment station.
(10)Treatment station means a physical location within a chronic dialysis clinic where an individual patient is dialyzed.
(b)(1)Commencing January 1, 2019, a chronic dialysis clinic shall ensure that the following minimum staffing ratios are met at all times that patients are receiving, or preparing to receive, direct care:
(A)At least one nurse is providing direct care for every eight patients. A nurse shall only count toward this ratio during time periods the nurse has no responsibilities other than direct care. A nurse manager or charge nurse shall not count toward this ratio.
(B)At least one technician is providing direct care for every three patients. A technician shall only count toward this ratio during time periods the technician has no responsibilities other than direct care. Trainees shall not count toward this ratio. Nurses counted toward the nurse-to-patient ratio shall not count toward this ratio.
(2)Commencing January 1, 2019, a chronic dialysis clinic shall ensure that a social worker is not assigned more than 75 patients.
(3)The ratios described in paragraphs (1) and (2) shall constitute the minimum number of nurses, technicians, and social workers assigned to patients at all times. Additional nurses, technicians, and social workers shall be assigned to the extent necessary to ensure that an adequate number of qualified personnel are present whenever patients are undergoing dialysis so that the patient-to-staff ratio is appropriate to the level of dialysis care given and meets the needs of patients.
(4)Commencing January 1, 2019, a chronic dialysis clinic shall ensure that the transition time is at least 45 minutes.
(c)The department shall not issue a license to any chronic dialysis clinic unless that chronic dialysis clinic demonstrates the ability and intention to comply with this section.
(d)(1)Every chronic dialysis clinic for which a license has been issued shall maintain, and provide to the department on a form prescribed by the department, at a minimum, the following information:
(A)Actual staffing ratio and transition time data for the period covered by the submission, which shall include, at a minimum, daily totals of the total number and actual hours worked by nurses, technicians, and social workers, the total number of patients and actual hours receiving direct care, and the daily average transition time for each treatment station.
(B)Every instance, no matter how brief, during the period covered by the submission when staffing ratios or transition times did not meet the requirements of subdivision (b) and the reasons and circumstances therefor.
(2)The chief executive officer or administrator of the chronic dialysis clinic shall personally certify that he or she is satisfied, after review, that all information submitted pursuant to paragraph (1) is accurate and complete.
(3)The chronic dialysis clinic shall periodically submit the information described in paragraph (1) to the department on a schedule and in a format prescribed by the department, provided that the clinic shall submit that information no less frequently than four times per year.
(e)The department shall inspect each chronic dialysis clinic for which a license has been issued at least once per year, and shall conduct such inspections as often as necessary to ensure compliance with the requirements of subdivision (b), the accuracy and completeness of information provided pursuant to subdivision (d), compliance with corrective action plans, if any, approved under subdivision (b) or (d) of Section 1240.1, and the adequacy of the quality of care being provided.
(f)Within 60 days of receiving a complaint from an employee, an association of employees, a vendor, a contractor, a patient, an association of patients, or a family member of a patient of a chronic dialysis clinic that the chronic dialysis clinic has engaged in a staffing-related violation or gross staffing-related violation, as those terms are defined in subdivision (a) of Section 1240.1, the department shall investigate the chronic dialysis clinic and, if the evidence shows a violation has occurred, the department shall impose discipline pursuant to Section 1240.1.
(g)(1)Any writing, record, or document received, owned, used, or retained by the department in connection with subdivisions (c), (d), and (e) of this section, and subdivisions (b) to (g), inclusive, of Section 1240.1, is a public record within the meaning of subdivision (e) of Section 6252 of the Government Code, and, as such, is open to public inspection pursuant to the California Public Records Act (Chapter 3.5 (commencing with Section 6250) of Division 7 of Title 1 of the Government Code).
(2)The department shall redact from any writing, record, or document described in this subdivision personal identifying information associated with named individuals to the extent required to prevent an unwarranted invasion of personal privacy, as that term is used in subdivision (c) of Section 6254 of the Government Code, but the department shall not withhold any such writing, record, or document in its entirety under subdivision (c) of Section 6254 of the Government Code.
(3)Information required to be submitted under subdivision (d), and complaints submitted under subdivision (f), shall not be withheld on the basis of subdivision (f) of Section 6254 of the Government Code.
SEC. 4.Section 1228 of the Health and Safety Code is amended to read:1228.(a)Except as provided in subdivision (c), every clinic for which a license or special permit has been issued shall be periodically inspected. Except as provided in Section 1226.4, the frequency of inspections shall depend upon the type and complexity of the clinic or special service to be inspected. Inspections shall be conducted no less often than once every three years and as often as necessary to ensure the quality of care being provided.
(b) (1)During inspections, representatives of the department shall offer any advice and assistance to the clinic as they deem appropriate. The department may contract with local health departments for the assumption of any of the departments responsibilities under this chapter. In exercising this authority, the local health department shall conform to the requirements of this chapter and to the rules, regulations, and standards of the department.
(2)The department shall reimburse local health departments for services performed pursuant to this section, and these payments shall not exceed actual cost. Reports of each inspection shall be prepared by the representative conducting it upon forms prepared and furnished by the department and filed with the department.
(c)This section shall not apply to any of the following:
(1)A rural health clinic.
(2)A primary care clinic accredited by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), the Accreditation Association for Ambulatory Health Care (AAAHC), or any other accrediting organization recognized by the department.
(3)An ambulatory surgical center.
(4)A comprehensive outpatient rehabilitation facility that is certified to participate either in the Medicare Program under Title XVIII (42 U.S.C. Sec. 1395 et seq.) of the federal Social Security Act, or the Medicaid program under Title XIX (42 U.S.C. Sec. 1396 et seq.) of the federal Social Security Act, or both.
(d)Notwithstanding paragraph (2) of subdivision (c), the department shall retain the authority to inspect a primary care clinic pursuant to Section 1227, or as necessary to ensure the quality of care being provided.
SEC. 5.The heading of Article 5 (commencing with Section 1240) of Chapter 1 of Division 2 of the Health and Safety Code is repealed.SEC. 6.The heading of Article 5 (commencing with Section 1240) is added to Chapter 1 of Division 2 of the Health and Safety Code, to read:5.Suspension, Revocation, and PenaltiesSEC. 7.Section 1240.1 is added to the Health and Safety Code, to read:1240.1.(a)For purposes of this section, the following terms have the following meanings:
(1)Staffing-related violation means any of the following:
(A)Violation by the chronic dialysis clinic, or any of its officers, employees, vendors, or contractors, of subdivision (b) of Section 1226.4.
(B)Conduct by the chronic dialysis clinic, or any of its officers, employees, vendors, or contractors, intended to conceal a violation of subdivision (b) of Section 1226.4.
(C)A misrepresentation of information provided to the department pursuant to this section or subdivision (d) of Section 1226.4.
(D)Violation by the chronic dialysis clinic, or any of its officers, employees, vendors, or contractors, of any part of a corrective action plan described in subdivision (d) or (e).
(2)Gross staffing-related violation means any of the following:
(A)A staffing-related violation that causes or exacerbates harm to a patient, or that has a substantial possibility of causing or exacerbating harm to a patient.
(B)A willful or intentional staffing-related violation.
(C)A staffing-related violation that occurred following reckless disregard of a substantial likelihood of a staffing-related violation.
(D)Five or more staffing-related violations in a 12-month period.
(E)Being out of compliance with one of the staffing ratios specified in paragraph (1) of subdivision (b) of Section 1226.4 for a period of time that extends beyond a single working shift of a nurse, for purposes of the nurse staffing requirement, or a single working shift of a technician, for purposes of the technician staffing requirement. For purposes of this subparagraph, the terms nurse and technician shall have the same meanings as in Section 1226.4.
(F)A continuous period of one week or longer in which the staffing ratio is at or above one social worker assigned to 90 or more patients. For purposes of this subparagraph, social worker has the same meaning as in Section 1226.4.
(G)A daily average transition time for a treatment station that is 20 minutes or shorter.
(3)Governing entity means a person, firm, association, partnership, corporation, or other entity that owns or operates a chronic dialysis clinic for which a license has been issued, without respect to whether the person or entity itself directly holds that license.
(4)Responsible individual means a person described in subparagraph (A) or (B) who, with respect to a staffing-related violation or gross staffing-related violation, knew or should have known that the violation would occur and possessed, but failed to exercise, direct responsibility and authority to prevent the violation from occurring, or knew or should have known that the violation had occurred and possessed, but failed to exercise, direct responsibility and authority to substantially remedy the violation. A nonmanagerial employee shall not be deemed a responsible individual.
(A)A member of the governing body, designated person, chief executive officer, and administrator, as those terms are used in Section 494.180 of Title 42 of the Code of Federal Regulations as it read on December 31, 2016.
(B)Managerial employees, officers, or directors of the governing entity.
(b)(1)The department may impose civil penalties of up to one thousand dollars ($1,000) on a chronic dialysis clinic for repeated staffing-related violations in the manner provided in this chapter. Action taken under this subdivision shall be in addition to the actions required or authorized under subdivisions (d) and (e).
(2)For the third staffing-related violation in any 12-month period:
(A)The department may impose a civil penalty on the chronic dialysis clinic of up to two thousand dollars ($2,000).
(B)The department may impose a civil penalty on each responsible individual, if any, of up to five hundred dollars ($500).
(3)For the fourth staffing-related violation in any 12-month period:
(A)The department shall impose a civil penalty on the chronic dialysis clinic of not less than two thousand dollars ($2,000) and not more than five thousand dollars ($5,000).
(B)The department shall impose a civil penalty on each responsible individual, if any, of not less than two hundred dollars ($200) and not more than four thousand dollars ($4,000).
(c)Notwithstanding Section 1240, and subject to Section 1241, the department shall take the following action in the manner provided in this chapter. Action taken under this subdivision shall be in addition to actions required or authorized under subdivisions (d) and (e).
(1)For the first gross staffing-related violation in any 24-month period, the department may impose a civil penalty on the chronic dialysis clinic of not less than two thousand five hundred dollars ($2,500) and not more than five thousand dollars ($5,000).
(2)For the second gross staffing-related violation in any 24-month period, the department shall impose a civil penalty on the chronic dialysis clinic of not less than two thousand five hundred dollars ($2,500) and not more than ten thousand dollars ($10,000).
(3)For the third gross staffing-related violation in any 24-month period, the department shall impose a civil penalty on the chronic dialysis clinic of not less than five thousand dollars ($5,000) and not more than ten thousand dollars ($10,000), and may suspend the license issued to the chronic dialysis clinic for a period not to exceed 30 days.
(4)For the fourth gross staffing-related violation in any 24-month period, the department shall impose a civil penalty on the chronic dialysis clinic of not less than five thousand dollars ($5,000) and not more than ten thousand dollars ($10,000), and shall suspend the license issued to the chronic dialysis clinic for a period not to exceed 90 days.
(5)For the fifth gross staffing-related violation in any 24-month period:
(A)The department shall impose a civil penalty on the chronic dialysis clinic of not less than five thousand dollars ($5,000) and not more than ten thousand dollars ($10,000), and may revoke the license issued to the chronic dialysis clinic or, if the department does not revoke the license, the department shall suspend the license for a period not to exceed 180 days.
(B)For a period not to exceed 180 days, the department may refuse to issue or renew a license, and may refuse to authorize a transfer of an existing license, with respect to a chronic dialysis clinic owned or operated by the same, or an affiliated, governing entity of the chronic dialysis clinic at which the gross staffing-related violation occurred.
(6)For the sixth and each subsequent gross staffing-related violation in any 24-month period:
(A)The department may revoke the license issued to the chronic dialysis clinic or, if the department does not revoke the license, the department shall suspend the license for a period not to exceed one year.
(B)For a period not to exceed three years, the department may refuse to issue or renew a license, and may refuse to authorize a transfer of an existing license, with respect to a chronic dialysis clinic owned or operated by the same, or an affiliated, governing entity of the chronic dialysis clinic at which the gross staffing-related violation occurred.
(d)Following any enforcement action taken by the department under subdivision (b) or (c), the chronic dialysis clinic shall submit a corrective action plan to the department describing how the chronic dialysis clinic will avoid committing any further staffing-related violations or gross staffing-related violations, as applicable. The corrective action plan shall be reviewed and approved by the department.
(e)Notwithstanding Section 1240, and subject to Section 1241, the department shall take the following action with respect to a governing entity in the manner provided in this chapter. Action taken under this subdivision shall be in addition to action required or authorized under subdivisions (b), (c), and (d).
(1)Except as provided in paragraph (2), when chronic dialysis clinics owned or operated by a governing entity or affiliated governing entities commit, in the aggregate, 25 or more gross staffing-related violations within any 24-month period:
(A)The governing entity or governing entities shall submit a corrective action plan to the department describing affirmative steps the governing entity or governing entities and associated chronic dialysis clinics will take to prevent every chronic dialysis clinic owned or operated by the governing entity or governing entities from committing any further gross staffing-related violations. The corrective action plan shall be revised and approved by the department.
(B)The department may refuse to issue or renew a license, and may refuse to authorize a transfer of an existing license, to the governing entity or governing entities or a chronic dialysis clinic owned or operated by the governing entity or governing entities, for a period that ends on or before the later of either:
(i)Three years after the latest gross staffing-related violation occurred.
(ii)The date on which the department is satisfied that the governing entity or governing entities and associated chronic dialysis clinics have taken all affirmative steps set forth in the corrective action plan submitted under subparagraph (A).
(C)In making the determination under subparagraph (B) the department shall consider the actual average of violations among the chronic dialysis clinics of the governing entity or governing entities.
(2)When chronic dialysis clinics owned or operated by a governing entity or affiliated governing entities commit, in the aggregate, 50 or more gross staffing-related violations within any 24-month period:
(A)The governing entity or governing entities shall submit a corrective action plan to the department describing affirmative steps the governing entity or governing entities and associated chronic dialysis clinics will take to prevent every chronic dialysis clinic owned or operated by the governing entity or governing entities from committing any further gross staffing-related violations of any kind. The corrective action plan shall be revised and approved by the department.
(B)The department may revoke or suspend licenses issued to the governing entity or governing entities or any chronic dialysis clinic that they own or operate, and may refuse to issue, renew, or authorize a transfer of, a license to the governing entity or governing entities or any chronic dialysis clinic owned or operated by the governing entity or governing entities.
(C)In making this determination the department shall consider the actual average of violations among the chronic dialysis clinics of the governing entity or governing entities.
(f)(1)The department shall consider the factors described in paragraph (2) for all of the following:
(A)When determining the penalties to be imposed under subdivision (b).
(B)The revisions, if any, to corrective action plans submitted under subdivision (d) or (e).
(C)The extent to which to refuse to issue or transfer, to revoke, or to suspend a license under subdivision (c) or (e).
(D)Whether to take any other action authorized under subdivision (b), (c), or (e).
(2)The department shall consider all of the following factors when taking the actions described in paragraph (1):
(A)The duration and severity of the violation.
(B)The willfulness of the violation.
(C)The history of the chronic dialysis clinic or governing entity of noncompliance with Section 1226.4, including, but not limited to, the similarity in circumstances of the violation to any previous violation within a 24-month period.
(D)The ability and good faith effort of the chronic dialysis clinic, and any responsible individual, to have foreseen or avoided the violation.
(E)The good faith effort by the chronic dialysis clinic, and any responsible individual, to remedy the violation.
(F)The harm to any patient, or exacerbation of that harm, resulting from the violation.
(G)The extent to which the chronic dialysis clinic fully and completely reported the violation pursuant to subdivision (c) of Section 1226.4.
(g)Penalties collected pursuant to this section shall be used by the department to implement and enforce Section 1226.4 and this section.
(h)For purposes of Article 9 (commencing with Section 12650) of Chapter 6 of Part 2 of Division 3 of Title 2 of the Government Code, the information required to be provided under subdivision (d) of Section 1226.4 shall be deemed material to any claim for payment submitted by a chronic dialysis clinic within six months of the submission of that information.
(i)If a licensee chronic dialysis clinic or a responsible individual disputes a determination by the department regarding the imposition of a penalty pursuant to this section, the licensee chronic dialysis clinic or responsible individual may, within 10 working days, request a hearing pursuant to Section 131071. Penalties shall be paid when all appeals have been exhausted and the departments position has been upheld.
SEC. 8.Section 1266.2 is added to the Health and Safety Code, to read:1266.2.It is the intent of the Legislature that California taxpayers not be financially responsible for implementation and enforcement of minimum staffing requirements at chronic dialysis clinics. In order to effectuate that intent, when calculating, assessing, and collecting fees imposed on chronic dialysis clinics pursuant to Section 1266, the department shall take into account all costs associated with implementing and enforcing Sections 1226.4 and 1240.1.
SEC. 9.Nothing in this act is intended to impact nurse-to-patient ratios applicable to health facilities licensed pursuant to subdivision (a), (b), or (f) of Section 1250 of the Health and Safety Code.
SEC. 9.SEC. 10.The State Department of Public Health shall issue regulations necessary to implement this act no later than 180 days following its effective date.
SEC. 10.SEC. 11.The provisions of this act are severable. If any provision of this act or its application is held invalid, that invalidity shall not affect other provisions or applications that can be given effect without the invalid provision or application.
SEC. 11.SEC. 12.No reimbursement is required by this act pursuant to Section 6 of Article XIIIB of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIIIB of the California Constitution.
The Legislature finds and declares all of the following:
(a)Dialysis is a critical, lifesaving treatment for Californians suffering from end-stage renal disease.
(b)There are currently more than 63,000 dialysis patients, and 562 licensed outpatient dialysis clinics, in California.
(c)There is broad consensus among medical professionals, academics, and other experts that higher ratios of direct caregiving staff to patients at outpatient dialysis clinics improve patient outcomes, including by reducing the rate at which patients suffer infections or must be hospitalized.
(d)There is also broad consensus among medical professionals, academics, and other experts that adequate time to prepare a treatment station for a patient to be dialyzed is necessary to ensure safety and hygiene protocols are followed, and directly improve patient outcomes, including by reducing the rate at which patients suffer infections or must be unnecessarily hospitalized.
(e)Worker safety is also enhanced by higher ratios of caregiving staff to patients and transition time between patients, including by reducing the risk of injury on the job.
(f)Current staffing levels in outpatient dialysis clinics in California are inadequate to protect patient health and worker safety, and therefore are presently causing harm to dialysis patients, including unnecessary and avoidable deaths, hospitalizations, infections, and medication errors.
(g)Other states mandate minimum direct care staffing requirements in order to enhance patient safety and health at outpatient dialysis clinics.
SEC. 2.Section 1226 of the Health and Safety Code is amended to read:1226.(a)The regulations shall prescribe the kinds of services which may be provided by clinics in each category of licensure and shall prescribe minimum standards of adequacy, safety, and sanitation of the physical plant and equipment, and, subject to Section 1226.4, minimum standards for staffing with duly qualified personnel and minimum standards for providing the services offered. These minimum standards shall be based on the type of facility, the needs of the patients served, and the types and levels of services provided.
(b)The Office of Statewide Health Planning and Development, in consultation with the Community Clinics Advisory Committee, shall prescribe minimum construction standards of adequacy and safety for the physical plant of clinics as found in the California Building Standards Code.
(c)(1)A city or county, as applicable, shall have plan review and building inspection responsibilities for the construction or alteration of buildings described in paragraphs (1) and (2) of subdivision (b) of Section 1204 and shall apply the provisions of the latest edition of the California Building Standards Code in conducting these plan review responsibilities. For these buildings, construction and alteration shall include conversion of a building to a purpose specified in paragraphs (1) and (2) of subdivision (b) of Section 1204.
(2)Upon the initial submittal to a city or county by the governing authority or owner of these clinics for plan review and building inspection services, the city or county shall reply in writing to the clinic whether or not the plan review by the city or county will include a certification as to whether or not the clinic project submitted for plan review meets the standards as propounded by the office in the California Building Standards Code.
(3)If the city or county indicates that its review will include this certification, it shall do both of the following:
(A)Apply the applicable clinic provisions of the latest edition of the California Building Standards Code.
(B)Certify in writing, to the applicant within 30 days of completion of construction whether or not these standards have been met.
(d)If upon initial submittal, the city or county indicates that its plan review will not include this certification, the governing authority or owner of the clinic shall submit the plans to the Office of Statewide Health Planning and Development, which shall review the plans for certification whether or not the clinic project meets the standards, as propounded by the office in the California Building Standards Code.
(e)When the office performs review for certification, the office shall charge a fee in an amount that does not exceed its actual costs.
(f)The Office of the State Fire Marshal shall prescribe minimum safety standards for fire and life safety in surgical clinics.
(g)Notwithstanding subdivision (c), the governing authority or owner of a clinic may request the office to perform plan review services for buildings described in subdivision (c). If the office agrees to perform these services, after consultation with the local building official, the office shall charge an amount not to exceed its actual costs. The construction or alteration of these buildings shall conform to the applicable provisions of the latest edition of the California Building Standards Code for purposes of the plan review by the office pursuant to this subdivision.
(h)Regulations adopted pursuant to this chapter establishing standards for laboratory services shall not be applicable to any clinic that operates a clinical laboratory licensed pursuant to Section 1265 of the Business and Professions Code.
SEC. 3.Section 1226.4 is added to the Health and Safety Code, to read:1226.4.(a)For purposes of this section, the following terms have the following meanings:
(1)At all times includes times during which employees, including, but not limited to, nurses and technicians, are provided meal periods and rest or other breaks.
(2)Charge nurse means a charge nurse as described in Section 494.140(b)(3) of Title 42 of the Code of Federal Regulations as it read on December 31, 2016.
(3)Direct care means initiating and discontinuing dialysis, monitoring patients during treatment, and administering medications, and physical presence in the immediate area where patients are dialyzed.
(4)Nurse means a registered nurse licensed pursuant to Chapter 6 (commencing with Section 2700) of Division 2 of the Business and Professions Code.
(5)Nurse manager means a nurse manager as described in Section 494.140(b)(1) of Title 42 of the Code of Federal Regulations as it read on December 31, 2016.
(6)Social worker means a social worker as described in Section 494.140(d) of Title 42 of the Code of Federal Regulations as it read on December 31, 2016.
(7)Technician means a person who holds both of the following qualifications:
(A)The person is a patient care dialysis technician, as described in Section 494.140(e) of Title 42 of the Code of Federal Regulations as it read on December 31, 2016.
(B)The person is a Certified Hemodialysis Technician certified pursuant to Article 3.5 (commencing with Section 1247) of Chapter 3 of Division 2 of the Business and Professions Code.
(8)Trainee means a person who is undergoing training to become a technician, but who has not yet been certified as a Certified Hemodialysis Technician pursuant to Article 3.5 (commencing with Section 1247) of Chapter 3 of Division 2 of the Business and Professions Code.
(9)Transition time means the period of time beginning when one patient has completed treatment and has been disconnected from the dialysis machine and ending when the next patient is placed in the treatment station, but does not mean the period of time after the last patient of the day leaves the treatment station.
(10)Treatment station means a physical location within a chronic dialysis clinic where an individual patient is dialyzed.
(b)(1)Commencing January 1, 2019, a chronic dialysis clinic shall ensure that the following minimum staffing ratios are met at all times that patients are receiving, or preparing to receive, direct care:
(A)At least one nurse is providing direct care for every eight patients. A nurse shall only count toward this ratio during time periods the nurse has no responsibilities other than direct care. A nurse manager or charge nurse shall not count toward this ratio.
(B)At least one technician is providing direct care for every three patients. A technician shall only count toward this ratio during time periods the technician has no responsibilities other than direct care. Trainees shall not count toward this ratio. Nurses counted toward the nurse-to-patient ratio shall not count toward this ratio.
(2)Commencing January 1, 2019, a chronic dialysis clinic shall ensure that a social worker is not assigned more than 75 patients.
(3)The ratios described in paragraphs (1) and (2) shall constitute the minimum number of nurses, technicians, and social workers assigned to patients at all times. Additional nurses, technicians, and social workers shall be assigned to the extent necessary to ensure that an adequate number of qualified personnel are present whenever patients are undergoing dialysis so that the patient-to-staff ratio is appropriate to the level of dialysis care given and meets the needs of patients.
(4)Commencing January 1, 2019, a chronic dialysis clinic shall ensure that the transition time is at least 45 minutes.
(c)The department shall not issue a license to any chronic dialysis clinic unless that chronic dialysis clinic demonstrates the ability and intention to comply with this section.
(d)(1)Every chronic dialysis clinic for which a license has been issued shall maintain, and provide to the department on a form prescribed by the department, at a minimum, the following information:
(A)Actual staffing ratio and transition time data for the period covered by the submission, which shall include, at a minimum, daily totals of the total number and actual hours worked by nurses, technicians, and social workers, the total number of patients and actual hours receiving direct care, and the daily average transition time for each treatment station.
(B)Every instance, no matter how brief, during the period covered by the submission when staffing ratios or transition times did not meet the requirements of subdivision (b) and the reasons and circumstances therefor.
(2)The chief executive officer or administrator of the chronic dialysis clinic shall personally certify under penalty of perjury that he or she is satisfied, after review, that all information submitted pursuant to paragraph (1) is accurate and complete.
(3)The chronic dialysis clinic shall periodically submit the information described in paragraph (1) to the department on a schedule and in a format prescribed by the department, provided that the clinic shall submit that information no less frequently than four times per year.
(e)The department shall inspect each chronic dialysis clinic for which a license has been issued at least once per year, and shall conduct such inspections as often as necessary to ensure compliance with the requirements of subdivision (b), the accuracy and completeness of information provided pursuant to subdivision (d), compliance with corrective action plans, if any, approved under subdivision (b) or (d) of Section 1240.1, and the adequacy of the quality of care being provided.
(f)Within 60 days of receiving a complaint from an employee, an association of employees, a vendor, a contractor, a patient, an association of patients, or a family member of a patient of a chronic dialysis clinic that the chronic dialysis clinic has engaged in a staffing-related violation or gross staffing-related violation, as those terms are defined in subdivision (a) of Section 1240.1, the department shall investigate the chronic dialysis clinic and, if the evidence shows a violation has occurred, the department shall impose discipline pursuant to Section 1240.1.
(g)(1)Any writing, record, or document received, owned, used, or retained by the department in connection with subdivisions (c), (d), and (e) of this section, and subdivisions (b) to (g), inclusive, of Section 1240.1, is a public record within the meaning of subdivision (e) of Section 6252 of the Government Code, and, as such, is open to public inspection pursuant to the California Public Records Act (Chapter 3.5 (commencing with Section 6250) of Division 7 of Title 1 of the Government Code). However, the name and other identifying or confidential information of a person that is contained in those records, except the names of duly authorized officers, employees, or agents of the department conducting an investigation or inspection in response to a complaint filed pursuant to subdivision (f), shall be redacted from copies of those records that are made available for public inspection.
(2)The department shall redact from any writing, record, or document described in this subdivision personal identifying information associated with named individuals to the extent required to prevent an unwarranted invasion of personal privacy, as that term is used in subdivision (c) of Section 6254, 6254 of the Government Code, but the department shall not withhold any such writing, record, or document in its entirety under subdivision (c) of Section 6254. 6254 of the Government Code.
(3)Information required to be submitted under subdivision (d), and complaints submitted under subdivision (f), shall not be withheld on the basis of subdivision (f) of Section 6254 of the Government Code.
SEC. 4.Section 1228 of the Health and Safety Code is amended to read:1228.(a)Except as provided in subdivision (c), every clinic for which a license or special permit has been issued shall be periodically inspected. Except as provided in Section 1226.4, the frequency of inspections shall depend upon the type and complexity of the clinic or special service to be inspected. Inspections shall be conducted no less often than once every three years and as often as necessary to ensure the quality of care being provided.
(b) (1)During inspections, representatives of the department shall offer any advice and assistance to the clinic as they deem appropriate. The department may contract with local health departments for the assumption of any of the departments responsibilities under this chapter. In exercising this authority, the local health department shall conform to the requirements of this chapter and to the rules, regulations, and standards of the department.
(2)The department shall reimburse local health departments for services performed pursuant to this section, and these payments shall not exceed actual cost. Reports of each inspection shall be prepared by the representative conducting it upon forms prepared and furnished by the department and filed with the department.
(c)This section shall not apply to any of the following:
(1)A rural health clinic.
(2)A primary care clinic accredited by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), the Accreditation Association for Ambulatory Health Care (AAAHC), or any other accrediting organization recognized by the department.
(3)An ambulatory surgical center.
(4)A comprehensive outpatient rehabilitation facility that is certified to participate either in the Medicare Program under Title XVIII (42 U.S.C. Sec. 1395 et seq.) of the federal Social Security Act, or the Medicaid program under Title XIX (42 U.S.C. Sec. 1396 et seq.) of the federal Social Security Act, or both.
(d)Notwithstanding paragraph (2) of subdivision (c), the department shall retain the authority to inspect a primary care clinic pursuant to Section 1227, or as necessary to ensure the quality of care being provided.
SEC. 5.The heading of Article 5 (commencing with Section 1240) of Chapter 1 of Division 2 of the Health and Safety Code is repealed.SEC. 6.The heading of Article 5 (commencing with Section 1240) is added to Chapter 1 of Division 2 of the Health and Safety Code, to read:5.Suspension, Revocation, and PenaltiesSEC. 7.Section 1240.1 is added to the Health and Safety Code, to read:1240.1.(a)For purposes of this section, the following terms have the following meanings:
(1)Staffing-related violation means any of the following:
(A)Violation by the chronic dialysis clinic, or any of its officers, employees, vendors, or contractors, of subdivision (b) of Section 1226.4.
(B)Conduct by the chronic dialysis clinic, or any of its officers, employees, vendors, or contractors, intended to conceal a violation of subdivision (b) of Section 1226.4.
(C)A misrepresentation of information provided to the department pursuant to this section or subdivision (d) of Section 1226.4.
(D)Violation by the chronic dialysis clinic, or any of its officers, employees, vendors, or contractors, of any part of a corrective action plan described in subdivision (d) or (e).
(E)Other violations that the department has defined in regulation.(2)Gross staffing-related violation means any of the following:
(A)A staffing-related violation that causes or exacerbates harm to a patient, or that has a substantial possibility of causing or exacerbating harm to a patient.
(B)A willful or intentional staffing-related violation.
(C)Reckless A staffing-related violation that occurred following reckless disregard of a substantial likelihood of a staffing-related violation.
(D)Five or more staffing-related violations in a 12-month period.
(E)Being out of compliance with one of the staffing ratios specified in paragraph (1) of subdivision (b) of Section 1226.4 for a period of time that extends beyond a single working shift of a nurse, for purposes of the nurse staffing requirement, or a single working shift of a technician, for purposes of the technician staffing requirement. For purposes of this subparagraph, the terms nurse and technician shall have the same meanings as in Section 1226.4.
(F)A continuous period of one week or longer in which the staffing ratio is at or above one social worker assigned to 90 or more patients. For purposes of this subparagraph, social worker has the same meaning as in Section 1226.4.
(G)A daily average transition time for a treatment station that is 20 minutes or shorter.
(H)Other violations that the department has defined in regulation.(3)Governing entity means a person, firm, association, partnership, corporation, or other entity that owns or operates a chronic dialysis clinic for which a license has been issued, without respect to whether the person or entity itself directly holds that license.
(4)Responsible individual means a person described in subparagraph (A) or (B) who, with respect to a staffing-related violation or gross staffing-related violation, knew or should have known that the violation would occur and possessed, but failed to exercise, direct responsibility and authority to prevent the violation from occurring, or knew or should have known that the violation had occurred and possessed, but failed to exercise, direct responsibility and authority to substantially remedy the violation.
(A)A member of the governing body, designated person, chief executive officer, and administrator, as those terms are used in Section 494.180 of Title 42 of the Code of Federal Regulations as it read on December 31, 2016.
(B)Managerial employees, officers, or directors of the governing entity.
(b)(1)The department may impose civil penalties of up to one thousand dollars ($1,000) on a chronic dialysis clinic for repeated staffing-related violations in the manner provided in this chapter. Action taken under this subdivision shall be in addition to the actions required or authorized under subdivisions (d) and (e).
(2)For the third staffing-related violation in any 12-month period:
(A)The department may impose a civil penalty on the chronic dialysis clinic of up to two thousand dollars ($2,000).
(B)The department may impose a civil penalty on each responsible individual, if any, of up to five hundred dollars ($500).
(3)For the fourth staffing-related violation in any 12-month period:
(A)The department shall impose a civil penalty on the chronic dialysis clinic of not less than two thousand dollars ($2,000) and not more than five thousand dollars ($5,000).
(B)The department shall impose a civil penalty on each responsible individual, if any, of not less than two hundred dollars ($200) and not more than four thousand dollars ($4,000).
(c)Notwithstanding Section 1240, and subject to Section 1241, the department shall take the following action in the manner provided in this chapter. Action taken under this subdivision shall be in addition to actions required or authorized under subdivisions (d) and (e).
(1)For the first gross staffing-related violation in any 24-month period, the department may impose a civil penalty on the chronic dialysis clinic of not less than two thousand five hundred dollars ($2,500) and not more than five thousand dollars ($5,000).
(2)For the second gross staffing-related violation in any 24-month period, the department shall impose a civil penalty on the chronic dialysis clinic of not less than two thousand five hundred dollars ($2,500) and not more than ten thousand dollars ($10,000).
(3)For the third gross staffing-related violation in any 24-month period, the department shall impose a civil penalty on the chronic dialysis clinic of not less than five thousand dollars ($5,000) and not more than ten thousand dollars ($10,000), and may suspend the license issued to the chronic dialysis clinic for a period not to exceed 30 days.
(4)For the fourth gross staffing-related violation in any 24-month period, the department shall impose a civil penalty on the chronic dialysis clinic of not less than five thousand dollars ($5,000) and not more than ten thousand dollars ($10,000), and shall suspend the license issued to the chronic dialysis clinic for a period not to exceed 90 days.
(5)For the fifth gross staffing-related violation in any 24-month period:
(A)The department shall impose a civil penalty on the chronic dialysis clinic of not less than five thousand dollars ($5,000) and not more than ten thousand dollars ($10,000), and may revoke the license issued to the chronic dialysis clinic or, if the department does not revoke the license, the department shall suspend the license for a period not to exceed 180 days.
(B)For a period not to exceed 180 days, the department may refuse to issue or renew a license, and may refuse to authorize a transfer of an existing license, with respect to a chronic dialysis clinic owned or operated by the same, or an affiliated, governing entity of the chronic dialysis clinic at which the gross staffing-related violation occurred.
(6)For the sixth and each subsequent gross staffing-related violation in any 24-month period:
(A)The department may revoke the license issued to the chronic dialysis clinic or, if the department does not revoke the license, the department shall suspend the license for a period not to exceed one year.
(B)For a period not to exceed three years, the department may refuse to issue or renew a license, and may refuse to authorize a transfer of an existing license, with respect to a chronic dialysis clinic owned or operated by the same, or an affiliated, governing entity of the chronic dialysis clinic at which the gross staffing-related violation occurred.
(d)Following any enforcement action taken by the department under subdivision (b) or (c), the chronic dialysis clinic shall submit a corrective action plan to the department describing how the chronic dialysis clinic will avoid committing any further staffing-related violations or gross staffing-related violations, as applicable. The corrective action plan shall be reviewed and approved by the department.
(e)Notwithstanding Section 1240, and subject to Section 1241, the department shall take the following action with respect to a governing entity in the manner provided in this chapter. Action taken under this subdivision shall be in addition to action required or authorized under subdivisions (b), (c), and (d).
(1)Except as provided in paragraph (2), when chronic dialysis clinics owned or operated by a governing entity or affiliated governing entities commit, in the aggregate, 25 or more gross staffing-related violations within any 24-month period:
(A)The governing entity or governing entities shall submit a corrective action plan to the department describing affirmative steps the governing entity or governing entities and associated chronic dialysis clinics will take to prevent every chronic dialysis clinic owned or operated by the governing entity or governing entities from committing any further gross staffing-related violations. The corrective action plan shall be revised and approved by the department.
(B)The department may refuse to issue or renew a license, and may refuse to authorize a transfer of an existing license, to the governing entity or governing entities or a chronic dialysis clinic owned or operated by the governing entity or governing entities, for a period that ends on or before the later of either:
(i)Three years after the latest gross staffing-related violation occurred.
(ii)The date on which the department is satisfied that the governing entity or governing entities and associated chronic dialysis clinics have taken all affirmative steps set forth in the corrective action plan submitted under subparagraph (A).
(2)When chronic dialysis clinics owned or operated by a governing entity or affiliated governing entities commit, in the aggregate, 50 or more gross staffing-related violations within any 24-month period:
(A)The governing entity or governing entities shall submit a corrective action plan to the department describing affirmative steps the governing entity or governing entities and associated chronic dialysis clinics will take to prevent every chronic dialysis clinic owned or operated by the governing entity or governing entities from committing any further gross staffing-related violations of any kind. The corrective action plan shall be revised and approved by the department.
(B)The department may revoke or suspend licenses issued to the governing entity or governing entities or any chronic dialysis clinic that they own or operate, and may refuse to issue, renew, or authorize a transfer of, a license to the governing entity or governing entities or any chronic dialysis clinic owned or operated by the governing entity or governing entities.
(f)(1)The department shall consider the factors described in paragraph (2) for all of the following:
(A)When determining the penalties to be imposed under subdivision (b).
(B)The revisions, if any, to corrective action plans submitted under subdivision (d) or (e).
(C)The extent to which to refuse to issue or transfer, to revoke, or to suspend a license under subdivision (c) or (e).
(D)Whether to take any other action authorized under subdivision (b), (c), or (e).
(2)The department shall consider all of the following factors when taking the actions described in paragraph (1):
(A)The duration and severity of the violation.
(B)The willfulness of the violation.
(C)The history of the chronic dialysis clinic or governing entity of noncompliance with Section 1226.4, including, but not limited to, the similarity in circumstances of the violation to any previous violation within a 24-month period.
(D)The ability and good faith effort of the chronic dialysis clinic, and any responsible individual, to have foreseen or avoided the violation.
(E)The good faith effort by the chronic dialysis clinic, and any responsible individual, to remedy the violation.
(F)The harm to any patient, or exacerbation of that harm, resulting from the violation.
(G)The extent to which the chronic dialysis clinic fully and completely reported the violation pursuant to subdivision (c) of Section 1226.4.
(g)Penalties collected pursuant to this section shall be used by the department to implement and enforce Section 1226.4 and this section.
(h)For purposes of Article 9 (commencing with Section 12650) of Chapter 6 of Part 2 of Division 3 of Title 2 of the Government Code, the information required to be provided under subdivision (d) of Section 1226.4 shall be deemed material to any claim for payment submitted by a chronic dialysis clinic within six months of the submission of that information.
(i)If a licensee disputes a determination by the department regarding the imposition of a penalty pursuant to this section, the licensee may, within 10 working days, request a hearing pursuant to Section 131071. Penalties shall be paid when all appeals have been exhausted and the departments position has been upheld.
SEC. 8.Section 1266.2 is added to the Health and Safety Code, to read:1266.2.It is the intent of the Legislature that California taxpayers not be financially responsible for implementation and enforcement of minimum staffing requirements at chronic dialysis clinics. In order to effectuate that intent, when calculating, assessing, and collecting fees imposed on chronic dialysis clinics pursuant to Section 1266, the department shall take into account all costs associated with implementing and enforcing Sections 1226.4 and 1240.1.
SEC. 9.The State Department of Public Health shall issue regulations necessary to implement this act no later than 180 days following its effective date.
SEC. 10.The provisions of this act are severable. If any provision of this act or its application is held invalid, that invalidity shall not affect other provisions or applications that can be given effect without the invalid provision or application.
SEC. 11.The Legislature finds and declares that Section 3 of this act, which adds Section 1226.4 to the Health and Safety Code, imposes a limitation on the publics right of access to the meetings of public bodies or the writings of public officials and agencies within the meaning of Section 3 of Article I of the California Constitution. Pursuant to that constitutional provision, the Legislature makes the following findings to demonstrate the interest protected by this limitation and the need for protecting that interest:In order to protect the privacy of employees and patients of chronic dialysis clinics, it is necessary that their names be redacted from the writings described in subdivision (g) of Section 1226.4 of the Health and Safety Code when those writings are made available to the public.SEC. 12.SEC. 11.No reimbursement is required by this act pursuant to Section 6 of Article XIIIB of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIIIB of the California Constitution.
The Legislature finds and declares all of the following:
(a)Dialysis is a critical, life-saving lifesaving treatment for Californians suffering from end-stage renal disease.
(b)There are currently more than 63,000 dialysis patients, and 562 licensed outpatient dialysis clinics, in California.
(c)There is broad consensus among medical professionals, academics, and other experts that higher ratios of direct caregiving staff to patients at outpatient dialysis clinics improve patient outcomes, including by reducing the rate at which patients suffer infections or must be hospitalized.
(d)There is also broad consensus among medical professionals, academics, and other experts that adequate time to prepare a treatment station for a patient to be dialyzed is necessary to ensure safety and hygiene protocols are followed, and directly improve patient outcomes, including by reducing the rate at which patients suffer infections or must be unnecessarily hospitalized.
(e)Worker safety is also enhanced by higher ratios of caregiving staff to patients and transition time between patients, including by reducing the risk of injury on the job.
(f)Current staffing levels in outpatient dialysis clinics in California are inadequate to protect patient health and worker safety, and therefore are presently causing harm to dialysis patients, including unnecessary and avoidable deaths, hospitalizations, infections, and medication errors.
(g)Other states mandate minimum direct care staffing requirements in order to enhance patient safety and health at outpatient dialysis clinics.
SEC. 2.Section 1226 of the Health and Safety Code is amended to read:1226.(a)The regulations shall prescribe the kinds of services which may be provided by clinics in each category of licensure and shall prescribe minimum standards of adequacy, safety, and sanitation of the physical plant and equipment, and, subject to Section 1226.4, minimum standards for staffing with duly qualified personnel and minimum standards for providing the services offered. These minimum standards shall be based on the type of facility, the needs of the patients served, and the types and levels of services provided.
(b)The Office of Statewide Health Planning and Development, in consultation with the Community Clinics Advisory Committee, shall prescribe minimum construction standards of adequacy and safety for the physical plant of clinics as found in the California Building Standards Code.
(c)(1)A city or county, as applicable, shall have plan review and building inspection responsibilities for the construction or alteration of buildings described in paragraphs (1) and (2) of subdivision (b) of Section 1204 and shall apply the provisions of the latest edition of the California Building Standards Code in conducting these plan review responsibilities. For these buildings, construction and alteration shall include conversion of a building to a purpose specified in paragraphs (1) and (2) of subdivision (b) of Section 1204.
(2)Upon the initial submittal to a city or county by the governing authority or owner of these clinics for plan review and building inspection services, the city or county shall reply in writing to the clinic whether or not the plan review by the city or county will include a certification as to whether or not the clinic project submitted for plan review meets the standards as propounded by the office in the California Building Standards Code.
(3)If the city or county indicates that its review will include this certification certification, it shall do both of the following:
(A)Apply the applicable clinic provisions of the latest edition of the California Building Standards Code.
(B)Certify in writing, to the applicant within 30 days of completion of construction whether or not these standards have been met.
(d)If upon initial submittal, the city or county indicates that its plan review will not include this certification, the governing authority or owner of the clinic shall submit the plans to the Office of Statewide Health Planning and Development who Development, which shall review the plans for certification whether or not the clinic project meets the standards, as propounded by the office in the California Building Standards Code.
(e)When the office performs review for certification, the office shall charge a fee in an amount that does not exceed its actual costs.
(f)The office Office of the State Fire Marshal shall prescribe minimum safety standards for fire and life safety in surgical clinics.
(g)Notwithstanding subdivision (c), the governing authority or owner of a clinic may request the office to perform plan review services for buildings described in subdivision (c). If the office agrees to perform these services, after consultation with the local building official, the office shall charge an amount not to exceed its actual costs. The construction or alteration of these buildings shall conform to the applicable provisions of the latest edition of the California Building Standards Code for purposes of the plan review by the office pursuant to this subdivision.
(h)Regulations adopted pursuant to this chapter establishing standards for laboratory services shall not be applicable to any clinic that operates a clinical laboratory licensed pursuant to Section 1265 of the Business and Professions Code.
SEC. 3.Section 1226.4 is added to the Health and Safety Code, to read:1226.4.(a)For purposes of this section, the following terms have the following meanings:
(1)At all times includes times during which employees, including, but not limited to, nurses and technicians, are provided meal periods and rest or other breaks.
(2)Charge nurse means a charge nurse as described in Section 494.140(b)(3) of Title 42 of the Code of Federal Regulations as it read on December 31, 2016.
(3)Direct care means initiating and discontinuing dialysis, monitoring patients during treatment, and administering medications, and physical presence in the immediate area where patients are dialyzed.
(4)Nurse means a registered nurse licensed pursuant to Chapter 6 (commencing with Section 2700) of Division 2 of the Business and Professions Code.
(5)Nurse manager means a nurse manager as described in Section 494.140(b)(1) of Title 42 of the Code of Federal Regulations as it read on December 31, 2016.
(6)Social worker means a social worker as described in Section 494.140(d) of Title 42 of the Code of Federal Regulations as it read on December 31, 2016.
(7)Technician means a person who holds both of the following qualifications:
(A)The person is a patient care dialysis technician, as described in Section 494.140(e) of Title 42 of the Code of Federal Regulations as it read on December 31, 2016.
(B)The person is a Certified Hemodialysis Technician certified pursuant to Article 3.5 (commencing with Section 1247) of Chapter 3 of Division 2 of the Business and Professions Code.
(8)Trainee means a person who is undergoing training to become a technician, but who has not yet been certified as a Certified Hemodialysis Technician pursuant to Article 3.5 (commencing with Section 1247) of Chapter 3 of Division 2 of the Business and Professions Code.
(9)Transition time means the period of time beginning when one patient leaves a treatment station has completed treatment and has been disconnected from the dialysis machine and ending when the next patient is placed in the treatment station, but does not mean the period of time after the last patient of the day leaves the treatment station.
(10)Treatment station means a physical location within a chronic dialysis clinic where an individual patient is dialyzed.
(b)(1)Commencing July 1, 2018, January 1, 2019, a chronic dialysis clinic shall ensure that the following minimum staffing ratios are met at all times that patients are receiving, or preparing to receive, direct care:
(A)At least one nurse is providing direct care for every eight patients. A nurse shall only count toward this ratio during time periods the nurse has no responsibilities other than direct care. A nurse manager or charge nurse shall not count toward this ratio.
(B)At least one technician is providing direct care for every three patients. A technician shall only count toward this ratio during time periods the technician has no responsibilities other than direct care. Trainees shall not count toward this ratio. Nurses counted toward the nurse-to-patient ratio shall not count toward this ratio.
(2)Commencing July 1, 2018, January 1, 2019, a chronic dialysis clinic shall ensure that a social worker is not assigned more than 75 patients.
(3)The ratios described in paragraphs (1) and (2) shall constitute the minimum number of nurses, technicians, and social workers assigned to patients at all times. Additional nurses, technicians, and social workers shall be assigned to the extent necessary to ensure that an adequate number of qualified personnel are present whenever patients are undergoing dialysis so that the patient-to-staff ratio is appropriate to the level of dialysis care given and meets the needs of patients.
(4)Commencing July 1, 2018, January 1, 2019, a chronic dialysis clinic shall ensure that the transition time is at least 45 minutes.
(c)The department shall not issue a license to any chronic dialysis clinic unless that chronic dialysis clinic demonstrates the ability and intention to comply with this section.
(d)(1)Every chronic dialysis clinic for which a license has been issued shall maintain, and provide to the department on a form prescribed by the department, at a minimum, the following information:
(A)Actual staffing ratio and transition time data for the period covered by the submission, which shall include, at a minimum, daily totals of the total number and actual hours worked by nurses, technicians, and social workers, the total number of patients and actual hours receiving direct care, and the daily average transition time for each treatment station.
(B)Every instance, no matter how brief, during the period covered by the submission when staffing ratios or transition times did not meet the requirements of subdivision (b) and the reasons and circumstances therefor.
(2)The medical director and the chief executive officer or administrator of the chronic dialysis clinic shall both personally certify under penalty of perjury that each of them he or she is satisfied, after review, that all information submitted pursuant to paragraph (1) is accurate and complete.
(3)The chronic dialysis clinic shall periodically submit the information described in paragraph (1) to the department on a schedule and in a format prescribed by the department, provided that the clinic shall submit that information no less frequently than four times per year.
(e)The department shall inspect each chronic dialysis clinic for which a license has been issued at least once per year, and shall conduct such inspections as often as necessary to ensure compliance with the requirements of subdivision (b), the accuracy and completeness of information provided pursuant to subdivision (d), compliance with corrective action plans, if any, approved under subdivision (b) or (d) of Section 1240.1, and the adequacy of the quality of care being provided.
(f)Within 60 days of receiving a complaint from an employee, an association of employees, a vendor, a contractor, a patient, an association of patients, or a family member of a patient of a chronic dialysis clinic that the chronic dialysis clinic has engaged in a staffing-related violation or gross staffing-related violation, as those terms are defined in subdivision (a) of Section 1240.1, the department shall investigate the chronic dialysis clinic and, if the evidence shows a violation has occurred, the department shall impose discipline pursuant to Section 1240.1.
(g)(1)Any writing, record, or document received, owned, used, or retained by the department in connection with subdivisions (c), (d), and (e) of this section, and subdivisions (b) to (f), (g), inclusive, of Section 1240.1, is a public record within the meaning of subdivision (e) of Section 6252 of the Government Code, and, as such, is open to public inspection pursuant to the California Public Records Act (Chapter 3.5 (commencing with Section 6250) of Division 7 of Title 1 of the Government Code). However, the name and other identifying or confidential information of a person that is contained in those records, except the names of duly authorized officers, employees, or agents of the department conducting an investigation or inspection in response to a complaint filed pursuant to subdivision (f), shall be redacted from copies of those records that are made available for public inspection.
(2)The department shall redact from any writing, record, or document described in this subdivision personal identifying information associated with named individuals to the extent required to prevent an unwarranted invasion of personal privacy, as that term is used in subdivision (c) of Section 6254, but the department shall not withhold any such writing, record, or document in its entirety under subdivision (c) of Section 6254.
(3)Information required to be submitted under subdivision (d), and complaints submitted under subdivision (f), shall not be withheld on the basis of subdivision (f) of Section 6254 of the Government Code.
SEC. 4.Section 1228 of the Health and Safety Code is amended to read:1228.(a)Except as provided in subdivision (c), every clinic for which a license or special permit has been issued shall be periodically inspected. Except as provided in Section 1226.4, the frequency of inspections shall depend upon the type and complexity of the clinic or special service to be inspected. Inspections shall be conducted no less often than once every three years and as often as necessary to ensure the quality of care being provided.
(b) (1)During inspections, representatives of the department shall offer any advice and assistance to the clinic as they deem appropriate. The department may contract with local health departments for the assumption of any of the departments responsibilities under this chapter. In exercising this authority, the local health department shall conform to the requirements of this chapter and to the rules, regulations, and standards of the department.
(2)The department shall reimburse local health departments for services performed pursuant to this section, and these payments shall not exceed actual cost. Reports of each inspection shall be prepared by the representative conducting it upon forms prepared and furnished by the department and filed with the department.
(c)This section shall not apply to any of the following:
(1)A rural health clinic.
(2)A primary care clinic accredited by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), the Accreditation Association for Ambulatory Health Care (AAAHC), or any other accrediting organization recognized by the department.
(3)An ambulatory surgical center.
(4)A comprehensive outpatient rehabilitation facility that is certified to participate either in the Medicare Program under Title XVIII (42 U.S.C. Sec. 1395 et seq.) of the federal Social Security Act, or the Medicaid program under Title XIX (42 U.S.C. Sec. 1396 et seq.) of the federal Social Security Act, or both.
(d)Notwithstanding paragraph (2) of subdivision (c), the department shall retain the authority to inspect a primary care clinic pursuant to Section 1227, or as necessary to ensure the quality of care being provided.
SEC. 5.The heading of Article 5 (commencing with Section 1240) of Chapter 1 of Division 2 of the Health and Safety Code is repealed.SEC. 6.The heading of Article 5 (commencing with Section 1240) is added to Chapter 1 of Division 2 of the Health and Safety Code, to read:5.Suspension, Revocation, and PenaltiesSEC. 7.Section 1240.1 is added to the Health and Safety Code, to read:1240.1.(a)For purposes of this section, the following terms have the following meanings:
(1)Staffing-related violation means any of the following:
(A)Violation by the chronic dialysis clinic, or any of its officers, employees, vendors, or contractors, of Section 1226.4.
(B)Conduct by the chronic dialysis clinic, or any of its officers, employees, vendors, or contractors, intended to conceal a violation of Section 1226.4.
(C)A misrepresentation of information provided to the department pursuant to this section or subdivision (d) of Section 1226.4.
(D)Violation by the chronic dialysis clinic, or any of its officers, employees, vendors, or contractors, of any part of a corrective action plan described in subdivision (b) or (d). (d) or (e).
(E)Other violations that the department has defined in regulation.
(2)Gross staffing-related violation means any of the following:
(A)A staffing-related violation that causes or exacerbates harm to a patient, or that has a substantial possibility of causing or exacerbating harm to a patient.
(B)A willful or intentional staffing-related violation.
(C)Reckless disregard of a substantial likelihood of a staffing-related violation.
(D)A continuous period of one hour or longer in which the staffing ratio is at or above one nurse providing direct care for nine or more patients, or one technician providing direct care for four or more patients. For(D)Five or more staffing-related violations in a 12-month period.
(E)Being out of compliance with one of the staffing ratios specified in paragraph (1) of subdivision (b) of Section 1226.4 for a period of time that extends beyond a single working shift of a nurse, for purposes of the nurse staffing requirement, or a single working shift of a technician, for purposes of the technician staffing requirement. For purposes of this subparagraph, the terms nurse and technician shall have the same meanings as in Section 1226.4.
(E)(F)A continuous period of one week or longer in which the staffing ratio is at or above one social worker assigned to 90 or more patients. For purposes of this subparagraph, social worker has the same meaning as in Section 1226.4.
(F)(G)A daily average transition time for a treatment station that is 20 minutes or shorter.
(G)(H)Other violations that the department has defined in regulation.
(3)Governing entity means a person, firm, association, partnership, corporation, or other entity that owns or operates a chronic dialysis clinic for which a license has been issued, without respect to whether the person or entity itself directly holds that license.
(4)Responsible individual means a person described in subparagraph (A) or (B) who, with respect to a staffing-related violation or gross staffing-related violation, knew or should have known of the substantial likelihood that the violation could would occur and possessed, but failed to exercise, direct responsibility and authority to prevent the violation from occurring, or knew or should have known that the violation had occurred and possessed, but failed to exercise, direct responsibility and authority to substantially remedy the violation.
(A)A member of the governing body, designated person, chief executive officer, and administrator, and medical director, as those terms are used in Section 494.180 of Title 42 of the Code of Federal Regulations as it read on December 31, 2016.
(B)Managerial employees, officers, or directors of the governing entity, and persons who provide services under contract to that governing entity. entity.
(b)(1)The department shall impose the following civil penalties may impose civil penalties of up to one thousand dollars ($1,000) on a chronic dialysis clinic for a repeated staffing-related violation violations in the manner provided in this chapter. Action taken under this subdivision shall be in addition to the actions required or authorized under subdivisions (c) and (d). (d) and (e).
(1)For the first staffing-related violation in any 12-month period:(A)The department shall impose a civil penalty on the chronic dialysis clinic of not less than five hundred dollars ($500) and not more than two thousand five hundred dollars ($2,500).(B)The department shall impose a civil penalty on each responsible individual, if any, of not less than one hundred dollars ($100) and not more than one thousand dollars ($1,000).(C)The chronic dialysis clinic shall submit a corrective action plan to the department describing how the chronic dialysis clinic will avoid committing any further staffing-related violations. The corrective action plan shall be revised and approved by the department.(2)For the second staffing-related violation in any 12-month period:(A)The department shall impose a civil penalty on the chronic dialysis clinic of not less than one thousand dollars ($1,000) and not more than five thousand dollars ($5,000).(B)The department shall impose a civil penalty on each responsible individual, if any, of not less than one hundred dollars ($100) and not more than two thousand dollars ($2,000).(C)The chronic dialysis clinic shall submit a corrective action plan to the department describing how the chronic dialysis clinic will avoid committing any further staffing-related violations. The corrective action plan shall be revised and approved by the department.(3)(2)For the third staffing-related violation in any 12-month period:
(A)The department shall may impose a civil penalty on the chronic dialysis clinic of not less than up to two thousand dollars ($2,000) and not more than seven thousand five hundred dollars ($7,500). ($2,000).
(B)The department shall may impose a civil penalty on each responsible individual, if any, of not less than two hundred dollars ($200) and not more than three thousand dollars ($3,000). up to five hundred dollars ($500).
(C)The chronic dialysis clinic shall submit a corrective action plan to the department describing how the chronic dialysis clinic will avoid committing any further staffing-related violations. The corrective action plan shall be revised and approved by the department.(4)(3)For the fourth staffing-related violation in any 12-month period:
(A)The department shall impose a civil penalty on the chronic dialysis clinic of not less than three thousand dollars ($3,000) and not more than ten thousand dollars ($10,000). two thousand dollars ($2,000) and not more than five thousand dollars ($5,000).
(B)The department shall impose a civil penalty on each responsible individual, if any, of not less than two hundred dollars ($200) and not more than four thousand dollars ($4,000).
(C)The chronic dialysis clinic shall submit a corrective action plan to the department describing how the chronic dialysis clinic will avoid committing any further staffing-related violations. The corrective action plan shall be revised and approved by the department.(5)For the fifth staffing-related violation in any 12-month period:(A)The department shall impose a civil penalty on the chronic dialysis clinic of not less than four thousand dollars ($4,000) and not more than twelve thousand five hundred dollars ($12,500).(B)The department shall impose a civil penalty on each responsible individual, if any, of not less than three hundred dollars ($300) and not more than five thousand dollars ($5,000).(C)The chronic dialysis clinic shall submit a corrective action plan to the department describing how the chronic dialysis clinic will avoid committing any further staffing-related violations. The corrective action plan shall be revised and approved by the department.(6)For the sixth and each subsequent staffing-related violation in any 12-month period:(A)The department shall impose a civil penalty on the chronic dialysis clinic of not less than five thousand dollars ($5,000) and not more than twenty-five thousand dollars ($25,000).(B)The department shall impose a civil penalty on each responsible individual, if any, of not less than three hundred dollars ($300) and not more than six thousand dollars ($6,000).(C)The chronic dialysis clinic shall submit a corrective action plan to the department describing how the chronic dialysis clinic will avoid committing any further staffing-related violations. The corrective action plan shall be revised and approved by the department.(c)Notwithstanding Section 1240, and subject to Section 1241, the department shall take the following action in the manner provided in this chapter. Action taken under this subdivision shall be in addition to actions required or authorized under subdivisions (b) and (d). (d) and (e).
(1)For the first gross staffing-related violation in any 24-month period, the department may suspend the license issued to the chronic dialysis clinic for a period not to exceed seven days. impose a civil penalty on the chronic dialysis clinic of not less than two thousand five hundred dollars ($2,500) and not more than five thousand dollars ($5,000).
(2)For the second gross staffing-related violation in any 24-month period, the department shall suspend the license issued to the chronic dialysis clinic for a period not to exceed seven days. impose a civil penalty on the chronic dialysis clinic of not less than two thousand five hundred dollars ($2,500) and not more than ten thousand dollars ($10,000).
(3)For the third gross staffing-related violation in any 24-month period, the department shall impose a civil penalty on the chronic dialysis clinic of not less than five thousand dollars ($5,000) and not more than ten thousand dollars ($10,000), and may suspend the license issued to the chronic dialysis clinic for a period not to exceed 30 days.
(4)For the fourth gross staffing-related violation in any 24-month period, the department shall impose a civil penalty on the chronic dialysis clinic of not less than five thousand dollars ($5,000) and not more than ten thousand dollars ($10,000), and shall suspend the license issued to the chronic dialysis clinic for a period not to exceed 90 days.
(5)For the fifth gross staffing-related violation in any 24-month period:
(A)The department shall impose a civil penalty on the chronic dialysis clinic of not less than five thousand dollars ($5,000) and not more than ten thousand dollars ($10,000), and may revoke the license issued to the chronic dialysis clinic or, if the department does not revoke the license, the department shall suspend the license for a period not to exceed 180 days.
(B)For a period not to exceed 180 days, the department may refuse to issue or renew a license, and may refuse to authorize a transfer of an existing license, with respect to a chronic dialysis clinic owned or operated by the same, or an affiliated, governing entity of the chronic dialysis clinic at which the gross staffing-related violation occurred.
(6)For the sixth and each subsequent gross staffing-related violation in any 24-month period:
(A)The department may revoke the license issued to the chronic dialysis clinic or, if the department does not revoke the license, the department shall suspend the license for a period not to exceed one year.
(B)For a period not to exceed three years, the department may refuse to issue or renew a license, and may refuse to authorize a transfer of an existing license, with respect to a chronic dialysis clinic owned or operated by the same, or an affiliated, governing entity of the chronic dialysis clinic at which the gross staffing-related violation occurred.
(d)Following any enforcement action taken by the department under subdivision (b) or (c), the chronic dialysis clinic shall submit a corrective action plan to the department describing how the chronic dialysis clinic will avoid committing any further staffing-related violations or gross staffing-related violations, as applicable. The corrective action plan shall be reviewed and approved by the department.
(d)(e)Notwithstanding Section 1240, and subject to Section 1241, the department shall take the following action with respect to a governing entity in the manner provided in this chapter. Action taken under this subdivision shall be in addition to action required or authorized under subdivisions (b) and (c). (b), (c), and (d).
(1)Except as provided in paragraph (2), when chronic dialysis clinics owned or operated by a governing entity or affiliated governing entities commit, in the aggregate, 25 or more gross staffing-related violations within any 24-month period:
(A)The governing entity or governing entities shall submit a corrective action plan to the department describing affirmative steps the governing entity or governing entities and associated chronic dialysis clinics will take to prevent every chronic dialysis clinic owned or operated by the governing entity or governing entities from committing any further gross staffing-related violations. The corrective action plan shall be revised and approved by the department.
(B)The department may refuse to issue or renew a license, and may refuse to authorize a transfer of an existing license, to the governing entity or governing entities or a chronic dialysis clinic owned or operated by the governing entity or governing entities, for a period that ends on or before the later of either:
(i)Three years after the latest gross staffing-related violation occurred.
(ii)The date on which the department is satisfied that the governing entity or governing entities and associated chronic dialysis clinics have taken all affirmative steps set forth in the corrective action plan submitted under subparagraph (A).
(2)When chronic dialysis clinics owned or operated by a governing entity or affiliated governing entities commit, in the aggregate, 50 or more gross staffing-related violations within any 24-month period:
(A)The governing entity or governing entities shall submit a corrective action plan to the department describing affirmative steps the governing entity or governing entities and associated chronic dialysis clinics will take to prevent every chronic dialysis clinic owned or operated by the governing entity or governing entities from committing any further gross staffing-related violations of any kind. The corrective action plan shall be revised and approved by the department.
(B)The department may revoke or suspend licenses issued to the governing entity or governing entities or any chronic dialysis clinic that they own or operate, and may refuse to issue, renew, or authorize a transfer of, a license to the governing entity or governing entities or any chronic dialysis clinic owned or operated by the governing entity or governing entities.
(e)(f)(1)The department shall consider the factors described in paragraph (2) for all of the following:
(A)When determining the penalties to be imposed under subdivision (b).
(B)The revisions, if any, to corrective action plans submitted under subdivision (b) or (d). (d) or (e).
(C)The extent to which to refuse to issue or transfer, to revoke, or to suspend a license under subdivision (c) or (d). (e).
(D)Whether to take any other action authorized under subdivision (b), (c), or (d). (e).
(2)The department shall consider all of the following factors when taking the actions described in paragraph (1):
(A)The duration and severity of the violation.
(B)The willfulness of the violation.
(C)The history of the chronic dialysis clinic or governing entity of noncompliance with Section 1226.4, including, but not limited to, the similarity in circumstances of the violation to any previous violation within a 24-month period.
(D)The ability and good faith effort of the chronic dialysis clinic, and any responsible individual, to have foreseen or avoided the violation.
(E)The good faith effort by the chronic dialysis clinic, and any responsible individual, to remedy the violation.
(F)The harm to any patient, or exacerbation of that harm, resulting from the violation.
(G)The extent to which the chronic dialysis clinic fully and completely reported the violation pursuant to subdivision (c) of Section 1226.4.
(f)(g)Penalties collected pursuant to this section shall be used by the department to implement and enforce Section 1226.4 and this section.
(g)(h)For purposes of Article 9 (commencing with Section 12650) of Chapter 6 of Part 2 of Division 3 of Title 2 of the Government Code, the information required to be provided under subdivision (d) of Section 1226.4 shall be deemed material to any claim for payment submitted by a chronic dialysis clinic within six months of the submission of that information.
SEC. 8.Section 1266.2 is added to the Health and Safety Code, to read:1266.2.It is the intent of the Legislature that California taxpayers not be financially responsible for implementation and enforcement of minimum staffing requirements at chronic dialysis clinics. In order to effectuate that intent, when calculating, assessing, and collecting fees imposed on chronic dialysis clinics pursuant to Section 1266, the department shall take into account all costs associated with implementing and enforcing Sections 1226.4 and 1240.1.
SEC. 9.The State Department of Public Health shall issue regulations necessary to implement this act no later than 180 days following its effective date.
SEC. 10.The provisions of this act are severable. If any provision of this act or its application is held invalid, that invalidity shall not affect other provisions or applications that can be given effect without the invalid provision or application.
SEC. 11.The Legislature finds and declares that Section 3 of this act, which adds Section 1226.4 to the Health and Safety Code, imposes a limitation on the publics right of access to the meetings of public bodies or the writings of public officials and agencies within the meaning of Section 3 of Article I of the California Constitution. Pursuant to that constitutional provision, the Legislature makes the following findings to demonstrate the interest protected by this limitation and the need for protecting that interest:
In order to protect the privacy of employees and patients of chronic dialysis clinics, it is necessary that their names be redacted from the writings described in subdivision (g) of Section 1226.4 of the Health and Safety Code when those writings are made available to the public.
SEC. 12.No reimbursement is required by this act pursuant to Section 6 of Article XIIIB of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIIIB of the California Constitution.
The Legislature finds and declares all of the following:
(a)Dialysis is a critical, life-saving treatment for Californians suffering from end-stage renal disease.
(b)There are currently over 50,000 more than 63,000 dialysis patients, and almost 500 562 licensed outpatient dialysis clinics, in California.
(c)There is broad consensus among medical professionals, academics, and other experts that higher ratios of direct caregiving staff to patients at outpatient dialysis clinics improve patient outcomes, including by reducing the rate at which patients suffer infections or must be hospitalized.
(d)There is also broad consensus among medical professionals, academics, and other experts that adequate time to prepare a treatment station for a patient to be dialyzed is necessary to ensure safety and hygiene protocols are followed, and directly improve patient outcomes, including by reducing the rate at which patients suffer infections or must be unnecessarily hospitalized.
(e)Worker safety is also enhanced by higher ratios of caregiving staff to patients and transition time between patients, including by reducing the risk of injury on the job.
(f)Current staffing levels in outpatient dialysis clinics in California are inadequate to protect patient health and worker safety, and therefore are presently causing harm to dialysis patients, including unnecessary and avoidable deaths, hospitalizations, infections, and medication errors.
(g)Other states mandate minimum direct care staffing requirements in order to enhance patient safety and health at outpatient dialysis clinics.
SEC. 2.Section 1226 of the Health and Safety Code is amended to read:1226.(a)The regulations shall prescribe the kinds of services which may be provided by clinics in each category of licensure and shall prescribe minimum standards of adequacy, safety, and sanitation of the physical plant and equipment, and, subject to Section 1226.4, minimum standards for staffing with duly qualified personnel and minimum standards for providing the services offered. These minimum standards shall be based on the type of facility, the needs of the patients served, and the types and levels of services provided.
(b)The Office of Statewide Health Planning and Development, in consultation with the Community Clinics Advisory Committee, shall prescribe minimum construction standards of adequacy and safety for the physical plant of clinics as found in the California Building Standards Code.
(c)(1)A city or county, as applicable, shall have plan review and building inspection responsibilities for the construction or alteration of buildings described in paragraph (1) and paragraph paragraphs (1) and (2) of subdivision (b) of Section 1204 and shall apply the provisions of the latest edition of the California Building Standards Code in conducting these plan review responsibilities. For these buildings, construction and alteration shall include conversion of a building to a purpose specified in paragraphs (1) and (2) of subdivision (b) of Section 1204.
(2)Upon the initial submittal to a city or county by the governing authority or owner of these clinics for plan review and building inspection services, the city or county shall reply in writing to the clinic whether or not the plan review by the city or county will include a certification as to whether or not the clinic project submitted for plan review meets the standards as propounded by the office in the California Building Standards Code.
(3)If the city or county indicates that its review will include this certification it shall do both of the following:
(A)Apply the applicable clinic provisions of the latest edition of the California Building Standards Code.
(B)Certify in writing, to the applicant within 30 days of completion of construction whether or not these standards have been met.
(d)If upon initial submittal, the city or county indicates that its plan review will not include this certification, the governing authority or owner of the clinic shall submit the plans to the Office of Statewide Health Planning and Development who shall review the plans for certification whether or not the clinic project meets the standards, as propounded by the office in the California Building Standards Code.
(e)When the office performs review for certification, the office shall charge a fee in an amount that does not exceed its actual costs.
(f)The office of the State Fire Marshal shall prescribe minimum safety standards for fire and life safety in surgical clinics.
(g)Notwithstanding subdivision (c), the governing authority or owner of a clinic may request the office to perform plan review services for buildings described in subdivision (c). If the office agrees to perform these services, after consultation with the local building official, the office shall charge an amount not to exceed its actual costs. The construction or alteration of these buildings shall conform to the applicable provisions of the latest edition of the California Building Standards Code for purposes of the plan review by the office pursuant to this subdivision.
(h)Regulations adopted pursuant to this chapter establishing standards for laboratory services shall not be applicable to any clinic that operates a clinical laboratory licensed pursuant to Section 1265 of the Business and Professions Code.
SEC. 3.Section 1226.4 is added to the Health and Safety Code, to read:1226.4.(a)For purposes of this section section, the following terms have the following meanings:
(1)At all times includes times during which employees, including, but not limited to, nurses and technicians, are provided meal periods and rest or other breaks.
(2)Charge nurse means a charge nurse as described in Section 494.140(b)(3) of Title 42 of the Code of Federal Regulations as it read on December 31, 2016.
(3)Direct care means initiating and discontinuing dialysis, monitoring patients during treatment, and administering medications, and physical presence in the immediate area where patients are dialyzed.
(4)Nurse means a registered nurse licensed pursuant to Chapter 6 (commencing with Section 2700) of Division 2 of the Business and Professions Code.
(5)Nurse manager means a nurse manager as described in Section 494.140(b)(1) of Title 42 of the Code of Federal Regulations as it read on December 31, 2016.
(6)Social worker means a social worker as described in Section 494.140(d) of Title 42 of the Code of Federal Regulations as it read on December 31, 2016.
(7)Technician means a person who holds both of the following qualifications:
(A)The person is a patient care dialysis technician, as described in Section 494.140(e) of Title 42 of the Code of Federal Regulations as it read on December 31, 2016.
(B)The person is a Certified Hemodialysis Technician certified pursuant to Article 3.5 (commencing with Section 1247) of Chapter 3 of Division 2 of the Business and Professions Code.
(8)Trainee means a person who is undergoing training to become a technician, but who has not yet been certified as a Certified Hemodialysis Technician pursuant to Article 3.5 (commencing with Section 1247) of Chapter 3 of Division 2 of the Business and Professions Code.
(9)Transition time means the period of time beginning when one patient leaves a treatment station and ending when the next patient is placed in the treatment station, but does not mean the period of time after the last patient of the day leaves the treatment station.
(10)Treatment station means a physical location within a chronic dialysis clinic where an individual patient is dialyzed.
(b)(1)Commencing July 1, 2018, a chronic dialysis clinic shall ensure that the following minimum staffing ratios are met at all times that patients are receiving, or preparing to receive, direct care:
(A)At least one nurse is providing direct care for every eight patients. A nurse shall only count toward this ratio during time periods the nurse has no responsibilities other than direct care. A nurse manager or charge nurse shall not count toward this ratio.
(B)At least one technician is providing direct care for every three patients. A technician shall only count toward this ratio during time periods the technician has no responsibilities other than direct care. Trainees shall not count toward this ratio. Nurses counted toward the nurse-to-patient ratio shall not count toward this ratio.
(2)Commencing July 1, 2018, a chronic dialysis clinic shall ensure that a social worker is not assigned more than 75 patients.
(3)The ratios described in paragraphs (1) and (2) shall constitute the minimum number of nurses, technicians, and social workers assigned to patients at all times. Additional nurses, technicians, and social workers shall be assigned to the extent necessary to ensure that an adequate number of qualified personnel are present whenever patients are undergoing dialysis so that the patient-to-staff ratio is appropriate to the level of dialysis care given and meets the needs of patients.
(4)Commencing July 1, 2018, a chronic dialysis clinic shall ensure that the transition time is at least 45 minutes.
(c)The department shall not issue a license to any chronic dialysis clinic unless that chronic dialysis clinic demonstrates the ability and intention to comply with this section.
(d)(1)Every chronic dialysis clinic for which a license has been issued shall maintain, and provide to the department on a form prescribed by the department, at a minimum, the following information:
(A)Actual staffing ratio and transition time data for the period covered by the submission, which shall include, at a minimum, daily totals of the total number and actual hours worked by nurses, technicians, and social workers, the total number of patients and actual hours receiving direct care, and the daily average transition time for each treatment station.
(B)Every instance, no matter how brief, during the period covered by the submission when staffing ratios or transition times did not meet the requirements of subdivision (b) and the reasons and circumstances therefor.
(2)The medical director and the chief executive officer or administrator of the chronic dialysis clinic shall both personally certify under penalty of perjury that each of them is satisfied, after review, that all information submitted pursuant to paragraph (1) is accurate and complete.
(3)The chronic dialysis clinic shall periodically submit the information described in paragraph (1) to the department on a schedule and in a format prescribed by the department, provided that the clinic shall submit that information no less frequently than four times per year.
(e)The department shall inspect each chronic dialysis clinic for which a license has been issued at least once per year, and shall conduct such inspections as often as necessary to ensure compliance with the requirements of subdivision (b), the accuracy and completeness of information provided pursuant to subdivision (d), compliance with corrective action plans, if any, approved under subdivision (b) or (d) of Section 1240.1, and the adequacy of the quality of care being provided.
(f)Within 60 days of receiving a complaint from an employee, an association of employees, a vendor, a contractor, a patient, an association of patients, or a family member of a patient of a chronic dialysis clinic that the chronic dialysis clinic has engaged in a staffing-related violation or gross staffing-related violation, as those terms are defined in subdivision (a) of Section 1240.1, the department shall investigate the chronic dialysis clinic and, if the evidence shows a violation has occurred, the department shall impose discipline pursuant to Section 1240.1.
(g)(1)Any writing, record, or document received, owned, used, or retained by the department in connection with subdivisions (c), (d), and (e), (e) of this section, and subdivisions (b) to (f), inclusive, of Section 1240.1, is a public record within the meaning of subdivision (e) of Section 6252 of the Government Code, and, as such, is open to public inspection pursuant to the California Public Records Act (Chapter 3.5 (commencing with Section 6250) of Division 7 of Title 1 of the Government Code). However, the name and other identifying or confidential information of a person that is contained in those records, except the names of duly authorized officers, employees, or agents of the department conducting an investigation or inspection in response to a complaint filed pursuant to subdivision (f), shall be redacted from copies of those records that are made available for public inspection.
(2)The department shall redact from any writing, record, or document described in this subdivision personal identifying information associated with named individuals to the extent required to prevent an unwarranted invasion of personal privacy, as that term is used in subdivision (c) of Section 6254, but the department shall not withhold any such writing, record, or document in its entirety under subdivision (c) of Section 6254.
(3)Information required to be submitted under subdivision (d), and complaints submitted under subdivision (f), shall not be withheld on the basis of subdivision (f) of Section 6254 of the Government Code.
SEC. 4.Section 1228 of the Health and Safety Code is amended to read:1228.(a)Except as provided in subdivision (c), every clinic for which a license or special permit has been issued shall be periodically inspected. Except as provided in Section 1226.4, the frequency of inspections shall depend upon the type and complexity of the clinic or special service to be inspected. Inspections shall be conducted no less often than once every three years and as often as necessary to ensure the quality of care being provided.
(b) (1)During inspections, representatives of the department shall offer any advice and assistance to the clinic as they deem appropriate. The department may contract with local health departments for the assumption of any of the departments responsibilities under this chapter. In exercising this authority, the local health department shall conform to the requirements of this chapter and to the rules, regulations, and standards of the department.
(2)The department shall reimburse local health departments for services performed pursuant to this section, and these payments shall not exceed actual cost. Reports of each inspection shall be prepared by the representative conducting it upon forms prepared and furnished by the department and filed with the department.
(c)This section shall not apply to any of the following:
(1)A rural health clinic.
(2)A primary care clinic accredited by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), the Accreditation Association for Ambulatory Health Care (AAAHC), or any other accrediting organization recognized by the department.
(3)An ambulatory surgical center.
(4)A comprehensive outpatient rehabilitation facility that is certified to participate either in the Medicare Program under Title XVIII (42 U.S.C. Sec. 1395 et seq.) of the federal Social Security Act, or the Medicaid program under Title XIX (42 U.S.C. Sec. 1396 et seq.) of the federal Social Security Act, or both.
(d)Notwithstanding paragraph (2) of subdivision (c), the department shall retain the authority to inspect a primary care clinic pursuant to Section 1227, or as necessary to ensure the quality of care being provided.
SEC. 5.The heading of Article 5 (commencing with Section 1240) of Chapter 1 of Division 2 of the Health and Safety Code is repealed.SEC. 6.The heading of Article 5 (commencing with Section 1240) is added to Chapter 1 of Division 2 of the Health and Safety Code, to read:5.Suspension, Revocation, and PenaltiesSEC. 7.Section 1240.1 is added to the Health and Safety Code, to read:1240.1.(a)For purposes of this section, the following terms have the following meanings:
(1)Staffing-related violation means any of the following:
(A)Violation by the chronic dialysis clinic, or any of its officers, employees, vendors, or contractors contractors, of Section 1226.4.
(B)Conduct by the chronic dialysis clinic, or any of its officers, employees, vendors, or contractors contractors, intended to conceal a violation of Section 1226.4.
(C)A misrepresentation of information provided to the department pursuant to this section or subdivision (c) (d) of Section 1226.4.
(D)Violation by the chronic dialysis clinic, or any of its officers, employees, vendors, or contractors, of any part of a corrective action plan described in subdivision (b) or (d).
(E)Other violations that the department has defined in regulation.
(2)Gross staffing-related violation means any of the following:
(A)A staffing-related violation that causes or exacerbates harm to a patient, or that has a substantial possibility of causing or exacerbating harm to a patient.
(B)A willful or intentional staffing-related violation.
(C)Reckless disregard of a substantial likelihood of a staffing-related violation.
(D)A continuous period of one hour or longer in which the staffing ratio is at or above one nurse providing direct care for nine or more patients, or one technician providing direct care for four or more patients. For purposes of this subparagraph, the terms nurse and technician shall have the same meanings as in Section 1226.4.
(E)A continuous period of one week or longer in which the staffing ratio is at or above one social worker assigned to 90 or more patients. For purposes of this subparagraph, social worker has the same meaning as in Section 1226.4.
(F)A daily average transition time for a treatment station that is 20 minutes or shorter.
(G)Other violations that the department has defined in regulation.
(3)Governing entity means a person, firm, association, partnership, corporation, or other entity that owns or operates a chronic dialysis clinic for which a license has been issued, without respect to whether the person or entity itself directly holds that license.
(4)Responsible individual means any of the following:
(A)A person in a position of authority within a chronic dialysis clinic means a person described in subparagraph (A) or (B) who, with respect to a staffing-related violation or gross staffing-related violation, knew or should have known of the substantial likelihood that the violation could occur and possessed, but failed to exercise, authority to prevent the violation from occurring, or knew or should have known that the violation had occurred and possessed, but failed to exercise, authority to substantially remedy the violation.
(B)(A)A member of the governing body, designated person, chief executive officer, administrator, and medical director, as those terms are used in Section 494.180 of Title 42 of the Code of Federal Regulations as it read on December 31, 2016.
(C)(B)Managerial employees, officers, or directors of the governing entity, and persons who provide services under contract to that governing entity.
(b)The department shall impose the following civil penalties on a chronic dialysis clinic for a staffing-related violation and in the manner provided in this chapter. Action taken under this subdivision shall be in addition to the actions required or authorized under subdivisions (c) and (d).
(1)For the first staffing-related violation in any 12-month period:
(A)The department shall impose a civil penalty on the chronic dialysis clinic of not less than five hundred dollars ($500) and not more than two thousand five hundred dollars ($2,500).
(B)The department shall impose a civil penalty on each responsible individual individual, if any, of not less than one hundred dollars ($100) and not more than one thousand dollars ($1,000).
(C)The chronic dialysis clinic shall submit a corrective action plan to the department describing how the chronic dialysis clinic will avoid committing any further staffing-related violations. The corrective action plan shall be revised and approved by the department.
(2)For the second staffing-related violation in any 12-month period:
(A)The department shall impose a civil penalty on the chronic dialysis clinic of not less than one thousand dollars ($1,000) and not more than five thousand dollars ($5,000).
(B)The department shall impose a civil penalty on each responsible individual individual, if any, of not less than one hundred dollars ($100) and not more than two thousand dollars ($2,000).
(C)The chronic dialysis clinic shall submit a corrective action plan to the department describing how the chronic dialysis clinic will avoid committing any further staffing-related violations. The corrective action plan shall be revised and approved by the department.
(3)For the third staffing-related violation in any 12-month period:
(A)The department shall impose a civil penalty on the chronic dialysis clinic of not less than two thousand dollars ($2,000) and not more than seven thousand five hundred dollars ($7,500).
(B)The department shall impose a civil penalty on each responsible individual individual, if any, of not less than two hundred dollars ($200) and not more than three thousand dollars ($3,000).
(C)The chronic dialysis clinic shall submit a corrective action plan to the department describing how the chronic dialysis clinic will avoid committing any further staffing-related violations. The corrective action plan shall be revised and approved by the department.
(4)For the fourth staffing-related violation in any 12-month period:
(A)The department shall impose a civil penalty on the chronic dialysis clinic of not less than three thousand dollars ($3,000) and not more than ten thousand dollars ($10,000).
(B)The department shall impose a civil penalty on each responsible individual individual, if any, of not less than two hundred dollars ($200) and not more than four thousand dollars ($4,000).
(C)The chronic dialysis clinic shall submit a corrective action plan to the department describing how the chronic dialysis clinic will avoid committing any further staffing-related violations. The corrective action plan shall be revised and approved by the department.
(5)For the fifth staffing-related violation in any 12-month period:
(A)The department shall impose a civil penalty on the chronic dialysis clinic of not less than four thousand dollars ($4,000) and not more than twelve thousand five hundred dollars ($12,500).
(B)The department shall impose a civil penalty on each responsible individual individual, if any, of not less than three hundred dollars ($300) and not more than five thousand dollars ($5,000).
(C)The chronic dialysis clinic shall submit a corrective action plan to the department describing how the chronic dialysis clinic will avoid committing any further staffing-related violations. The corrective action plan shall be revised and approved by the department.
(6)For the sixth and each subsequent staffing-related violation in any 12-month period:
(A)The department shall impose a civil penalty on the chronic dialysis clinic of not less than five thousand dollars ($5,000) and not more than twenty-five thousand dollars ($25,000).
(B)The department shall impose a civil penalty on each responsible individual individual, if any, of not less than three hundred dollars ($300) and not more than six thousand dollars ($6,000).
(C)The chronic dialysis clinic shall submit a corrective action plan to the department describing how the chronic dialysis clinic will avoid committing any further staffing-related violations. The corrective action plan shall be revised and approved by the department.
(c)Notwithstanding Section 1240, and subject to Section 1241, the department shall take the following action in the manner provided in this chapter. Action taken under this subdivision shall be in addition to actions required or authorized under subdivisions (b) and (d).
(1)For the first gross staffing-related violation in any 24-month period, the department may suspend the license issued to the chronic dialysis clinic for a period not to exceed seven days.
(2)For the second gross staffing-related violation in any 24-month period, the department shall suspend the license issued to the chronic dialysis clinic for a period not to exceed seven days.
(3)For the third gross staffing-related violation in any 24-month period, the department shall suspend the license issued to the chronic dialysis clinic for a period not to exceed 30 days.
(4)For the fourth gross staffing-related violation in any 24-month period, the department shall suspend the license issued to the chronic dialysis clinic for a period not to exceed 90 days.
(5)For the fifth gross staffing-related violation in any 24-month period:
(A)The department may revoke the license issued to the chronic dialysis clinic or, if the department does not revoke the license, the department shall suspend the license for a period not to exceed 180 days.
(B)For a period not to exceed 180 days, the department may refuse to issue or renew a license, and may refuse to authorize a transfer of an existing license, with respect to a chronic dialysis clinic owned or operated by the same, or an affiliated, governing entity of the chronic dialysis clinic at which the gross staffing-related violation occurred.
(6)For the sixth and each subsequent gross staffing-related violation in any 24-month period:
(A)The department may revoke the license issued to the chronic dialysis clinic or, if the department does not revoke the license, the department shall suspend the license for a period not to exceed one year.
(B)For a period not to exceed three years, the department may refuse to issue or renew a license, and may refuse to authorize a transfer of an existing license, with respect to a chronic dialysis clinic owned or operated by the same, or an affiliated, governing entity of the chronic dialysis clinic at which the gross staffing-related violation occurred.
(d)Notwithstanding Section 1240, and subject to Section 1241, the department shall take the following action with respect to a governing entity in the manner provided in this chapter. Action taken under this subdivision shall be in addition to action required or authorized under subdivisions (b) and (c).
(1)Except as provided in paragraph (2), when chronic dialysis clinics owned or operated by a governing entity or affiliated governing entities commit, in the aggregate, 25 or more gross staffing-related violations within any 24-month period:
(A)The governing entity or governing entities shall submit a corrective action plan to the department describing affirmative steps the governing entity or governing entities and associated chronic dialysis clinics will take to prevent every chronic dialysis clinic owned or operated by the governing entity or governing entities from committing any further gross staffing-related violations. The corrective action plan shall be revised and approved by the department.
(B)The department shall may refuse to issue or renew a license, and shall may refuse to authorize a transfer of an existing license, to the governing entity or governing entities or a chronic dialysis clinic owned or operated by the governing entity or governing entities, for a period that ends on or before the later of either:
(i)Three years after the latest gross staffing-related violation occurred.
(ii)The date on which the department is satisfied that the governing entity or governing entities and associated chronic dialysis clinics have taken all affirmative steps set forth in the corrective action plan submitted under subparagraph (A).
(2)When chronic dialysis clinics owned or operated by a governing entity or affiliated governing entities commit, in the aggregate, 50 or more gross staffing-related violations within any 24-month period:
(A)The governing entity or governing entities shall submit a corrective action plan to the department describing affirmative steps the governing entity or governing entities and associated chronic dialysis clinics will take to prevent every chronic dialysis clinic owned or operated by the governing entity or governing entities from committing any further gross staffing-related violations of any kind. The corrective action plan shall be revised and approved by the department.
(B)The department may revoke or suspend licenses issued to the governing entity or governing entities or any chronic dialysis clinic that they own or operate, and may refuse to issue, renew, or authorize a transfer of, a license to the governing entity or governing entities or any chronic dialysis clinic owned or operated by the governing entity or governing entities.
(e)(1)The department shall consider the factors described in paragraph (2) for all of the following:
(A)When determining the penalties to be imposed under subdivision (b).
(B)The revisions, if any, to corrective action plans submitted under subdivision (b) or (d).
(C)The extent to which to refuse to issue or transfer, to revoke, or to suspend a license under subdivision (c) or (d).
(D)Whether to take any other action authorized under subdivision (b), (c), or (d).
(2)The factors the department shall consider all of the following factors as when taking the actions described in paragraph (1):
(A)The duration and severity of the violation.
(B)The willfulness of the violation.
(C)The history of the chronic dialysis clinic or governing entity of noncompliance with Section 1226.4, including, but not limited to, the similarity in circumstances of the violation to any previous violation within a 24-month period.
(D)The ability and good faith effort of the chronic dialysis clinic, and any responsible individual, to have foreseen or avoided the violation.
(E)The good faith effort by the chronic dialysis clinic, and any responsible individual, to remedy the violation.
(F)The harm to any patient, or exacerbation of that harm, resulting from the violation.
(G)The extent to which the chronic dialysis clinic fully and completely reported the violation pursuant to subdivision (c) of Section 1226.4.
(f)Penalties collected pursuant to this section shall be used by the department to implement and enforce Section 1226.4 and this section.
(g)For purposes of Article 9 (commencing with Section 12650) of Chapter 6 of Part 2 of Division 3 of Title 2 of the Government Code, the information required to be provided under subdivision (d) of Section 1226.4 shall be deemed material to any claim for payment submitted by a chronic dialysis clinic within six months of the submission of that information.
(h)(1)For purposes of this subdivision, the following terms have the following meanings: (A)Enforcing plaintiff means an employee, an association of employees, a vendor, a contractor, a patient, an association of patients, or a family member of a patient of a chronic dialysis clinic.(B)Actionable violation means a gross staffing-related violation that a chronic dialysis clinic did not report to the department pursuant to subdivision (d) of Section 1226.4.(2)A civil action for an actionable violation may be brought against a chronic dialysis clinic or a governing entity by the Attorney General, or by an enforcing plaintiff, on behalf of the people of the State of California, for injunctive relief, civil penalties, and other appropriate equitable relief. A governing entity shall be held jointly and severally liable with any chronic dialysis clinic that the governing entity owns or operates.(3)Before filing an action under this section, an enforcing plaintiff shall give written notice of the alleged violation and his or her intent to bring suit to the Attorney General. If the Attorney General commences a civil action for the same alleged violation within 60 days of receiving the notice, a separate action by the enforcing plaintiff shall be barred.(4)Civil penalties shall not exceed twenty-five thousand dollars ($25,000) for each actionable violation. The court shall determine the civil penalty by reference to the factors enumerated in subdivision (e).(5)Seventy-five percent of civil penalties recovered in an action brought by an enforcing plaintiff under this section shall be distributed to the department for the purposes described in subdivision (f) and the remaining 25 percent shall be distributed to the enforcing plaintiff.(6)An enforcing plaintiff who prevails in an action under this subdivision is entitled to recover reasonable attorneys fees and costs. A chronic dialysis clinic that prevails in any action under this subdivision is not entitled to recover reasonable attorneys fees and costs unless the defendant demonstrates that the action was frivolous and without foundation.(7)The private right of action established under this subdivision shall not be construed to abridge or limit any other right, claim, or cause of action of an enforcing plaintiff.SEC. 8.Section 1266.2 is added to the Health and Safety Code, to read:1266.2.It is the intent of the Legislature that California taxpayers not be financially responsible for implementation and enforcement of minimum staffing requirements at chronic dialysis clinics. In order to effectuate that intent, when calculating, assessing, and collecting fees imposed on chronic dialysis clinics pursuant to Section 1266, the department shall take into account all costs associated with implementing and enforcing Sections 1226.4 and 1240.1.
SEC. 9.The State Department of Public Health shall issue regulations necessary to implement this act no later than 180 days following its effective date.
SEC. 10.The provisions of this act are severable. If any provision of this act or its application is held invalid, that invalidity shall not affect other provisions or applications that can be given effect without the invalid provision or application.
SEC. 11.The Legislature finds and declares that Section 3 of this act, which adds Section 1226.4 to the Health and Safety Code, imposes a limitation on the publics right of access to the meetings of public bodies or the writings of public officials and agencies within the meaning of Section 3 of Article I of the California Constitution. Pursuant to that constitutional provision, the Legislature makes the following findings to demonstrate the interest protected by this limitation and the need for protecting that interest:
In order to protect the privacy of employees and patients of chronic dialysis clinics, it is necessary that their names be redacted from the writings described in subdivision (g) of Section 1226.4 of the Health and Safety Code when those writings are made available to the public.
SEC. 12.No reimbursement is required by this act pursuant to Section 6 of Article XIIIB of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIIIB of the California Constitution.
The Legislature finds and declares all of the following:
(a)Dialysis is a critical, life-saving treatment for Californians suffering from end-stage renal disease.
(b)There are currently over 50,000 dialysis patients, and almost 500 licensed outpatient dialysis clinics, in California.
(c)There is broad consensus among medical professionals, academics, and other experts that higher ratios of direct caregiving staff to patients at outpatient dialysis clinics improve patient outcomes, including by reducing the rate at which patients suffer infections or must be hospitalized.
(d)There is also broad consensus among medical professionals, academics, and other experts that adequate time to prepare a treatment station for a patient to be dialyzed is necessary to ensure safety and hygiene protocols are followed, and directly improve patient outcomes, including by reducing the rate at which patients suffer infections or must be unnecessarily hospitalized.
(e)Worker safety is also enhanced by higher ratios of caregiving staff to patients and transition time between patients, including by reducing the risk of injury on the job.
(f)Current staffing levels in outpatient dialysis clinics in California are inadequate to protect patient health and worker safety, and therefore are presently causing harm to dialysis patients, including unnecessary and avoidable deaths, hospitalizations, infections, and medication errors.
(g)Other states mandate minimum direct care staffing requirements in order to enhance patient safety and health at outpatient dialysis clinics.
SEC. 2.Section 1226 of the Health and Safety Code is amended to read:1226.(a) The regulations shall prescribe the kinds of services which may be provided by clinics in each category of licensure and shall prescribe minimum standards of adequacy, safety, and sanitation of the physical plant and equipment, and, subject to Section 1226.4, minimum standards for staffing with duly qualified personnel, personnel and minimum standards for providing the services offered. These minimum standards shall be based on the type of facility, the needs of the patients served, and the types and levels of services provided.
(b) The Office of Statewide Health Planning and Development, in consultation with the Community Clinics Advisory Committee, shall prescribe minimum construction standards of adequacy and safety for the physical plant of clinics as found in the California Building Standards Code.
(c) (1)A city or county, as applicable, shall have plan review and building inspection responsibilities for the construction or alteration of buildings described in paragraph (1) and paragraph (2) of subdivision (b) of Section 1204 and shall apply the provisions of the latest edition of the California Building Standards Code in conducting these plan review responsibilities. For these buildings, construction and alteration shall include conversion of a building to a purpose specified in paragraphs (1) and (2) of subdivision (b) of Section 1204.
Upon(2)Upon the initial submittal to a city or county by the governing authority or owner of these clinics for plan review and building inspection services, the city or county shall reply in writing to the clinic whether or not the plan review by the city or county will include a certification as to whether or not the clinic project submitted for plan review meets the standards as propounded by the office in the California Building Standards Code.
If(3)If the city or county indicates that its review will include this certification it shall do all both of the following:
(1)(A)Apply the applicable clinic provisions of the latest edition of the California Building Standards Code.
(2)(B)Certify in writing, to the applicant within 30 days of completion of construction whether or not these standards have been met.
(d) If upon initial submittal, the city or county indicates that its plan review will not include this certification, the governing authority or owner of the clinic shall submit the plans to the Office of Statewide Health Planning and Development who shall review the plans for certification whether or not the clinic project meets the standards, as propounded by the office in California Building Standards Code.
(e) When the office performs review for certification, the office shall charge a fee in an amount that does not exceed its actual costs.
(f) The office of the State Fire Marshal shall prescribe minimum safety standards for fire and life safety in surgical clinics.
(g) Notwithstanding subdivision (c), the governing authority or owner of a clinic may request the office to perform plan review services for buildings described in subdivision (c). If the office agrees to perform these services, after consultation with the local building official, the office shall charge an amount not to exceed its actual costs. The construction or alteration of these buildings shall conform to the applicable provisions of the latest edition of the California Building Standards Code for purposes of the plan review by the office pursuant to this subdivision.
(h) Regulations adopted pursuant to this chapter establishing standards for laboratory services shall not be applicable to any clinic that operates a clinical laboratory licensed pursuant to Section 1265 of the Business and Professions Code.
SEC. 3.Section 1226.4 is added to the Health and Safety Code, to read:1226.4.(a)For purposes of this section the following terms have the following meanings:
(1)At all times includes times during which employees, including, but not limited to, nurses and technicians, are provided meal periods and rest or other breaks.
(2)Charge nurse means a charge nurse as described in Section 494.140(b)(3) of Title 42 of the Code of Federal Regulations as it read on December 31, 2016.
(3)Direct care means initiating and discontinuing dialysis, monitoring patients during treatment, and administering medications, and physical presence in the immediate area where patients are dialyzed.
(4)Nurse means a registered nurse licensed pursuant to Chapter 6 (commencing with Section 2700) of Division 2 of the Business and Professions Code.
(5)Nurse manager means a nurse manager as described in Section 494.140(b)(1) of Title 42 of the Code of Federal Regulations as it read on December 31, 2016.
(6)Social worker means a social worker as described in Section 494.140(d) of Title 42 of the Code of Federal Regulations as it read on December 31, 2016.
(7)Technician means a person who holds both of the following qualifications:
(A)The person is a patient care dialysis technician, as described in Section 494.140(e) of Title 42 of the Code of Federal Regulations as it read on December 31, 2016.
(B)The person is a Certified Hemodialysis Technician certified pursuant to Article 3.5 (commencing with Section 1247) of Chapter 3 of Division 2 of the Business and Professions Code.
(8)Trainee means a person who is undergoing training to become a technician, but who has not yet been certified as a Certified Hemodialysis Technician pursuant to Article 3.5 (commencing with Section 1247) of Chapter 3 of Division 2 of the Business and Professions Code.
(9)Transition time means the period of time beginning when one patient leaves a treatment station and ending when the next patient is placed in the treatment station, but does not mean the period of time after the last patient of the day leaves the treatment station.
(10)Treatment station means a physical location within a chronic dialysis clinic where an individual patient is dialyzed.
(b)(1)Commencing July 1, 2018, a chronic dialysis clinic shall ensure that the following minimum staffing ratios are met at all times that patients are receiving, or preparing to receive, direct care:
(A)At least one nurse is providing direct care for every eight patients. A nurse shall only count toward this ratio during time periods the nurse has no responsibilities other than direct care. A nurse manager or charge nurse shall not count toward this ratio.
(B)At least one technician is providing direct care for every three patients. A technician shall only count toward this ratio during time periods the technician has no responsibilities other than direct care. Trainees shall not count toward this ratio. Nurses counted toward the nurse-to-patient ratio shall not count toward this ratio.
(2)Commencing July 1, 2018, a chronic dialysis clinic shall ensure that a social worker is not assigned more than 75 patients.
(3)The ratios described in paragraphs (1) and (2) shall constitute the minimum number of nurses, technicians, and social workers assigned to patients at all times. Additional nurses, technicians, and social workers shall be assigned to the extent necessary to ensure that an adequate number of qualified personnel are present whenever patients are undergoing dialysis so that the patient-to-staff ratio is appropriate to the level of dialysis care given and meets the needs of patients.
(4)Commencing July 1, 2018, a chronic dialysis clinic shall ensure that the transition time is at least 45 minutes.
(c)The department shall not issue a license to any chronic dialysis clinic unless that chronic dialysis clinic demonstrates the ability and intention to comply with this section.
(d)(1)Every chronic dialysis clinic for which a license has been issued shall maintain, and provide to the department on a form prescribed by the department, at a minimum, the following information:
(A)Actual staffing ratio and transition time data for the period covered by the submission, which shall include, at a minimum, daily totals of the total number and actual hours worked by nurses, technicians, and social workers, the total number of patients and actual hours receiving direct care, and the daily average transition time for each treatment station.
(B)Every instance, no matter how brief, during the period covered by the submission when staffing ratios or transition times did not meet the requirements of subdivision (b) and the reasons and circumstances therefor.
(2)The medical director and the chief executive officer or administrator of the chronic dialysis clinic shall both personally certify under penalty of perjury that each of them is satisfied, after review, that all information submitted pursuant to paragraph (1) is accurate and complete.
(3)The chronic dialysis clinic shall periodically submit the information described in paragraph (1) to the department on a schedule and in a format prescribed by the department, provided that the clinic shall submit that information no less frequently than four times per year.
(e)The department shall inspect each chronic dialysis clinic for which a license has been issued at least once per year, and shall conduct such inspections as often as necessary to ensure compliance with the requirements of subdivision (b), the accuracy and completeness of information provided pursuant to subdivision (d), compliance with corrective action plans, if any, approved under subdivision (b) or (d) of Section 1240.1, and the adequacy of the quality of care being provided.
(f)Within 60 days of receiving a complaint from an employee, an association of employees, a vendor, a contractor, a patient, an association of patients, or a family member of a patient of a chronic dialysis clinic that the chronic dialysis clinic has engaged in a staffing-related violation or gross staffing-related violation, as those terms are defined in subdivision (a) of Section 1240.1, the department shall investigate the chronic dialysis clinic and, if the evidence shows a violation has occurred, the department shall impose discipline pursuant to Section 1240.1.
(g)(1)Any writing, record, or document received, owned, used, or retained by the department in connection with subdivisions (c), (d), and (e), and subdivisions (b) to (f), inclusive, of Section 1240.1, is a public record within the meaning of subdivision (e) of Section 6252 of the Government Code, and, as such, is open to public inspection pursuant to the California Public Records Act (Chapter 3.5 (commencing with Section 6250) of Division 7 of Title 1 of the Government Code). However, the name and other identifying or confidential information of a person that is contained in those records, except the names of duly authorized officers, employees, or agents of the department conducting an investigation or inspection in response to a complaint filed pursuant to subdivision (f), shall be redacted from copies of those records that are made available for public inspection.
(2)The department shall redact from any writing, record, or document described in this subdivision personal identifying information associated with named individuals to the extent required to prevent an unwarranted invasion of personal privacy, as that term is used in subdivision (c) of Section 6254, but the department shall not withhold any such writing, record, or document in its entirety under subdivision (c) of Section 6254.
(3)Information required to be submitted under subdivision (d), and complaints submitted under subdivision (f), shall not be withheld on the basis of subdivision (f) of Section 6254 of the Government Code.
SEC. 4.Section 1228 of the Health and Safety Code is amended to read:1228.(a) Except as provided in subdivision (c), every clinic for which a license or special permit has been issued shall be periodically inspected. The Except as provided in Section 1226.4, the frequency of inspections shall depend upon the type and complexity of the clinic or special service to be inspected. Inspections shall be conducted no less often than once every three years and as often as necessary to ensure the quality of care being provided.
(b) (1) During inspections, representatives of the department shall offer any advice and assistance to the clinic as they deem appropriate. The department may contract with local health departments for the assumption of any of the departments responsibilities under this chapter. In exercising this authority, the local health department shall conform to the requirements of this chapter and to the rules, regulations, and standards of the department.
(2) The department shall reimburse local health departments for services performed pursuant to this section, and these payments shall not exceed actual cost. Reports of each inspection shall be prepared by the representative conducting it upon forms prepared and furnished by the department and filed with the department.
(c) This section shall not apply to any of the following:
(1) A rural health clinic.
(2) A primary care clinic accredited by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), the Accreditation Association for Ambulatory Health Care (AAAHC), or any other accrediting organization recognized by the department.
(3) An ambulatory surgical center.
(4) An end stage renal disease facility.(5)(4)A comprehensive outpatient rehabilitation facility that is certified to participate either in the Medicare program under Title XVIII (42 U.S.C. Sec. 1395 et seq.) of the federal Social Security Act, or the medicaid program under Title XIX (42 U.S.C. Sec. 1396 et seq.) of the federal Social Security Act, or both.
(d) Notwithstanding paragraph (2) of subdivision (c), the department shall retain the authority to inspect a primary care clinic pursuant to Section 1227, or as necessary to ensure the quality of care being provided.
SEC. 5.The heading of Article 5 (commencing with Section 1240) of Chapter 1 of Division 2 of the Health and Safety Code is repealed.5.Suspension and RevocationSEC. 6.The heading of Article 5 (commencing with Section 1240) is added to Chapter 1 of Division 2 of the Health and Safety Code, to read:5.Suspension, Revocation, and PenaltiesSEC. 7.Section 1240.1 is added to the Health and Safety Code, to read:1240.1.(a)For purposes of this section, the following terms have the following meanings:
(1)Staffing-related violation means any of the following:
(A)Violation by the chronic dialysis clinic, or any of its officers, employees, vendors, or contractors of Section 1226.4.
(B)Conduct by the chronic dialysis clinic, or any of its officers, employees, vendors, or contractors intended to conceal a violation of Section 1226.4.
(C)A misrepresentation of information provided to the department pursuant to this section or subdivision (c) of Section 1226.4.
(D)Violation by the chronic dialysis clinic, or any of its officers, employees, vendors, or contractors, of any part of a corrective action plan described in subdivision (b) or (d).
(E)Other violations that the department has defined in regulation.
(2)Gross staffing-related violation means any of the following:
(A)A staffing-related violation that causes or exacerbates harm to a patient, or that has a substantial possibility of causing or exacerbating harm to a patient.
(B)A willful or intentional staffing-related violation.
(C)Reckless disregard of a substantial likelihood of a staffing-related violation.
(D)A continuous period of one hour or longer in which the staffing ratio is at or above one nurse providing direct care for nine or more patients, or one technician providing direct care for four or more patients. For purposes of this subparagraph, the terms nurse and technician shall have the same meanings as in Section 1226.4.
(E)A continuous period of one week or longer in which the staffing ratio is at or above one social worker assigned to 90 or more patients. For purposes of this subparagraph, social worker has the same meaning as in Section 1226.4.
(F)A daily average transition time for a treatment station that is 20 minutes or shorter.
(G)Other violations that the department has defined in regulation.
(3)Governing entity means a person, firm, association, partnership, corporation, or other entity that owns or operates a chronic dialysis clinic for which a license has been issued, without respect to whether the person or entity itself directly holds that license.
(4)Responsible individual means any of the following:
(A)A person in a position of authority within a chronic dialysis clinic who, with respect to a staffing-related violation or gross staffing-related violation, knew or should have known of the substantial likelihood that the violation could occur and possessed, but failed to exercise, authority to prevent the violation from occurring, or knew or should have known that the violation had occurred and possessed, but failed to exercise, authority to substantially remedy the violation.
(B)A member of the governing body, designated person, chief executive officer, administrator, and medical director, as those terms are used in Section 494.180 of Title 42 of the Code of Federal Regulations as it read on December 31, 2016.
(C)Managerial employees, officers, or directors of the governing entity, and persons who provide services under contract to that governing entity.
(b)The department shall impose the following civil penalties on a chronic dialysis clinic for a staffing-related violation and in the manner provided in this chapter. Action taken under this subdivision shall be in addition to the actions required or authorized under subdivisions (c) and (d).
(1)For the first staffing-related violation in any 12-month period:
(A)The department shall impose a civil penalty on the chronic dialysis clinic of not less than five hundred dollars ($500) and not more than two thousand five hundred dollars ($2,500).
(B)The department shall impose a civil penalty on each responsible individual of not less than one hundred dollars ($100) and not more than one thousand dollars ($1,000).
(C)The chronic dialysis clinic shall submit a corrective action plan to the department describing how the chronic dialysis clinic will avoid committing any further staffing-related violations. The corrective action plan shall be revised and approved by the department.
(2)For the second staffing-related violation in any 12-month period:
(A)The department shall impose a civil penalty on the chronic dialysis clinic of not less than one thousand dollars ($1,000) and not more than five thousand dollars ($5,000).
(B)The department shall impose a civil penalty on each responsible individual of not less than one hundred dollars ($100) and not more than two thousand dollars ($2,000).
(C)The chronic dialysis clinic shall submit a corrective action plan to the department describing how the chronic dialysis clinic will avoid committing any further staffing-related violations. The corrective action plan shall be revised and approved by the department.
(3)For the third staffing-related violation in any 12-month period:
(A)The department shall impose a civil penalty on the chronic dialysis clinic of not less than two thousand dollars ($2,000) and not more than seven thousand five hundred dollars ($7,500).
(B)The department shall impose a civil penalty on each responsible individual of not less than two hundred dollars ($200) and not more than three thousand dollars ($3,000).
(C)The chronic dialysis clinic shall submit a corrective action plan to the department describing how the chronic dialysis clinic will avoid committing any further staffing-related violations. The corrective action plan shall be revised and approved by the department.
(4)For the fourth staffing-related violation in any 12-month period:
(A)The department shall impose a civil penalty on the chronic dialysis clinic of not less than three thousand dollars ($3,000) and not more than ten thousand dollars ($10,000).
(B)The department shall impose a civil penalty on each responsible individual of not less than two hundred dollars ($200) and not more than four thousand dollars ($4,000).
(C)The chronic dialysis clinic shall submit a corrective action plan to the department describing how the chronic dialysis clinic will avoid committing any further staffing-related violations. The corrective action plan shall be revised and approved by the department.
(5)For the fifth staffing-related violation in any 12-month period:
(A)The department shall impose a civil penalty on the chronic dialysis clinic of not less than four thousand dollars ($4,000) and not more than twelve thousand five hundred dollars ($12,500).
(B)The department shall impose a civil penalty on each responsible individual of not less than three hundred dollars ($300) and not more than five thousand dollars ($5,000).
(C)The chronic dialysis clinic shall submit a corrective action plan to the department describing how the chronic dialysis clinic will avoid committing any further staffing-related violations. The corrective action plan shall be revised and approved by the department.
(6)For the sixth and each subsequent staffing-related violation in any 12-month period:
(A)The department shall impose a civil penalty on the chronic dialysis clinic of not less than five thousand dollars ($5,000) and not more than twenty-five thousand dollars ($25,000).
(B)The department shall impose a civil penalty on each responsible individual of not less than three hundred dollars ($300) and not more than six thousand dollars ($6,000).
(C)The chronic dialysis clinic shall submit a corrective action plan to the department describing how the chronic dialysis clinic will avoid committing any further staffing-related violations. The corrective action plan shall be revised and approved by the department.
(c)Notwithstanding Section 1240, and subject to Section 1241, the department shall take the following action in the manner provided in this chapter. Action taken under this subdivision shall be in addition to actions required or authorized under subdivisions (b) and (d).
(1)For the first gross staffing-related violation in any 24-month period, the department may suspend the license issued to the chronic dialysis clinic for a period not to exceed seven days.
(2)For the second gross staffing-related violation in any 24-month period, the department shall suspend the license issued to the chronic dialysis clinic for a period not to exceed seven days.
(3)For the third gross staffing-related violation in any 24-month period, the department shall suspend the license issued to the chronic dialysis clinic for a period not to exceed 30 days.
(4)For the fourth gross staffing-related violation in any 24-month period, the department shall suspend the license issued to the chronic dialysis clinic for a period not to exceed 90 days.
(5)For the fifth gross staffing-related violation in any 24-month period:
(A)The department may revoke the license issued to the chronic dialysis clinic or, if the department does not revoke the license, the department shall suspend the license for a period not to exceed 180 days.
(B)For a period not to exceed 180 days, the department may refuse to issue or renew a license, and may refuse to authorize a transfer of an existing license, with respect to a chronic dialysis clinic owned or operated by the same, or an affiliated, governing entity of the chronic dialysis clinic at which the gross staffing-related violation occurred.
(6)For the sixth and each subsequent gross staffing-related violation in any 24-month period:
(A)The department may revoke the license issued to the chronic dialysis clinic or, if the department does not revoke the license, the department shall suspend the license for a period not to exceed one year.
(B)For a period not to exceed three years, the department may refuse to issue or renew a license, and may refuse to authorize a transfer of an existing license, with respect to a chronic dialysis clinic owned or operated by the same, or an affiliated, governing entity of the chronic dialysis clinic at which the gross staffing-related violation occurred.
(d)Notwithstanding Section 1240, and subject to Section 1241, the department shall take the following action with respect to a governing entity in the manner provided in this chapter. Action taken under this subdivision shall be in addition to action required or authorized under subdivisions (b) and (c).
(1)Except as provided in paragraph (2), when chronic dialysis clinics owned or operated by a governing entity or affiliated governing entities commit, in the aggregate, 25 or more gross staffing-related violations within any 24-month period:
(A)The governing entity or governing entities shall submit a corrective action plan to the department describing affirmative steps the governing entity or governing entities and associated chronic dialysis clinics will take to prevent every chronic dialysis clinic owned or operated by the governing entity or governing entities from committing any further gross staffing-related violations. The corrective action plan shall be revised and approved by the department.
(B)The department shall refuse to issue or renew a license, and shall refuse to authorize a transfer of an existing license, to the governing entity or governing entities or a chronic dialysis clinic owned or operated by the governing entity or governing entities, for a period that ends on or before the later of either:
(i)Three years after the latest gross staffing-related violation occurred.
(ii)The date on which the department is satisfied that the governing entity or governing entities and associated chronic dialysis clinics have taken all affirmative steps set forth in the corrective action plan submitted under subparagraph (A).
(2)When chronic dialysis clinics owned or operated by a governing entity or affiliated governing entities commit, in the aggregate, 50 or more gross staffing-related violations within any 24-month period:
(A)The governing entity or governing entities shall submit a corrective action plan to the department describing affirmative steps the governing entity or governing entities and associated chronic dialysis clinics will take to prevent every chronic dialysis clinic owned or operated by the governing entity or governing entities from committing any further gross staffing-related violations of any kind. The corrective action plan shall be revised and approved by the department.
(B)The department may revoke or suspend licenses issued to the governing entity or governing entities or any chronic dialysis clinic that they own or operate, and may refuse to issue, renew, or authorize a transfer of, a license to the governing entity or governing entities or any chronic dialysis clinic owned or operated by the governing entity or governing entities.
(e)(1)The department shall consider the factors described in paragraph (2) for all of the following:
(A)When determining the penalties to be imposed under subdivision (b).
(B)The revisions, if any, to corrective action plans submitted under subdivision (b) or (d).
(C)The extent to which to refuse to issue or transfer, to revoke, or to suspend a license under subdivision (c) or (d).
(D)Whether to take any other action authorized under subdivision (b), (c), or (d).
(2)The factors the department shall consider all of the following factors as described in paragraph (1):
(A)The duration and severity of the violation.
(B)The willfulness of the violation.
(C)The history of the chronic dialysis clinic or governing entity of noncompliance with Section 1226.4, including, but not limited to, the similarity in circumstances of the violation to any previous violation within a 24-month period.
(D)The ability and good faith effort of the chronic dialysis clinic, and any responsible individual, to have foreseen or avoided the violation.
(E)The good faith effort by the chronic dialysis clinic, and any responsible individual, to remedy the violation.
(F)The harm to any patient, or exacerbation of that harm, resulting from the violation.
(G)The extent to which the chronic dialysis clinic fully and completely reported the violation pursuant to subdivision (c) of Section 1226.4.
(f)Penalties collected pursuant to this section shall be used by the department to implement and enforce Section 1226.4 and this section.
(g)For purposes of Article 9 (commencing with Section 12650) of Chapter 6 of Part 2 of Division 3 of Title 2 of the Government Code, the information required to be provided under subdivision (d) of Section 1226.4 shall be deemed material to any claim for payment submitted by a chronic dialysis clinic within six months of the submission of that information.
(h)(1)For purposes of this subdivision, the following terms have the following meanings:
(A)Enforcing plaintiff means an employee, an association of employees, a vendor, a contractor, a patient, an association of patients, or a family member of a patient of a chronic dialysis clinic.
(B)Actionable violation means a gross staffing-related violation that a chronic dialysis clinic did not report to the department pursuant to subdivision (d) of Section 1226.4.
(2)A civil action for an actionable violation may be brought against a chronic dialysis clinic or a governing entity by the Attorney General, or by an enforcing plaintiff, on behalf of the people of the State of California, for injunctive relief, civil penalties, and other appropriate equitable relief. A governing entity shall be held jointly and severally liable with any chronic dialysis clinic that the governing entity owns or operates.
(3)Before filing an action under this section, an enforcing plaintiff shall give written notice of the alleged violation and his or her intent to bring suit to the Attorney General. If the Attorney General commences a civil action for the same alleged violation within 60 days of receiving the notice, a separate action by the enforcing plaintiff shall be barred.
(4)Civil penalties shall not exceed twenty-five thousand dollars ($25,000) for each actionable violation. The court shall determine the civil penalty by reference to the factors enumerated in subdivision (e).
(5)Seventy-five percent of civil penalties recovered in an action brought by an enforcing plaintiff under this section shall be distributed to the department for the purposes described in subdivision (f) and the remaining 25 percent shall be distributed to the enforcing plaintiff.
(6)An enforcing plaintiff who prevails in an action under this subdivision is entitled to recover reasonable attorneys fees and costs. A chronic dialysis clinic that prevails in any action under this subdivision is not entitled to recover reasonable attorneys fees and costs unless the defendant demonstrates that the action was frivolous and without foundation.
(7)The private right of action established under this subdivision shall not be construed to abridge or limit any other right, claim, or cause of action of an enforcing plaintiff.
SEC. 8.Section 1266.2 is added to the Health and Safety Code, to read:1266.2.It is the intent of the Legislature that California taxpayers not be financially responsible for implementation and enforcement of minimum staffing requirements at chronic dialysis clinics. In order to effectuate that intent, when calculating, assessing, and collecting fees imposed on chronic dialysis clinics pursuant to Section 1266, the department shall take into account all costs associated with implementing and enforcing Sections 1226.4 and 1240.1.
SEC. 9.The State Department of Public Health shall issue regulations necessary to implement this act no later than 180 days following its effective date.
SEC. 10.The provisions of this act are severable. If any provision of this act or its application is held invalid, that invalidity shall not affect other provisions or applications that can be given effect without the invalid provision or application.
SEC. 11.The Legislature finds and declares that Section 3 of this act, which adds Section 1226.4 to the Health and Safety Code, imposes a limitation on the publics right of access to the meetings of public bodies or the writings of public officials and agencies within the meaning of Section 3 of Article I of the California Constitution. Pursuant to that constitutional provision, the Legislature makes the following findings to demonstrate the interest protected by this limitation and the need for protecting that interest:
In order to protect the privacy of employees and patients of chronic dialysis clinics, it is necessary that their names be redacted from the writings described in subdivision (g) of Section 1226.4 of the Health and Safety Code when those writings are made available to the public.
SEC. 12.No reimbursement is required by this act pursuant to Section 6 of Article XIIIB of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIIIB of the California Constitution.
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Date
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Status
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|---|---|
| Sep 27, 2018 | In Senate. Consideration of Governor's veto pending. |
| Sep 27, 2018 | Vetoed by the Governor. |
| Sep 11, 2018 | Enrolled and presented to the Governor at 4 p.m. |
| Aug 31, 2018 | Assembly amendments concurred in. (Ayes 28. Noes 10.) Ordered to engrossing and enrolling. |
| Aug 30, 2018 | From committee: That the Assembly amendments be concurred in. (Ayes 5. Noes 1.) |
| Aug 30, 2018 | From committee: Be re-referred to Com. on JUD. pursuant to Senate Rule 29.10(d). (Ayes 5. Noes 0.) Re-referred to Com. on JUD. |
| Aug 30, 2018 | Re-referred to Com. on RLS. pursuant to Senate Rule 29.10(d). |
| Aug 29, 2018 | In Senate. Concurrence in Assembly amendments pending. |
| Aug 29, 2018 | Read third time. Passed. Ordered to the Senate. |
| Aug 24, 2018 | Read third time and amended. |
| Aug 20, 2018 | From inactive file. |
| Aug 16, 2018 | Notice of intention to remove from inactive file given by Assembly Member Calderon. |
| Sep 12, 2017 | Ordered to inactive file on request of Assembly Member Calderon. |
| Sep 5, 2017 | Read second time. Ordered to third reading. |
| Sep 1, 2017 | From committee: Do pass. (Ayes 10. Noes 5.) (September 1). |
| Sep 1, 2017 | Joint Rule 62(a) suspended. |
| Aug 30, 2017 | August 30 set for first hearing. Placed on APPR. suspense file. |
| Aug 22, 2017 | From committee with author's amendments. Read second time and amended. Re-referred to Com. on APPR. |
| Jun 29, 2017 | Read second time and amended. Re-referred to Com. on APPR. |
| Jun 28, 2017 | From committee: Do pass as amended and re-refer to Com. on APPR. (Ayes 10. Noes 4.) (June 27). |
| Jun 12, 2017 | Referred to Com. on HEALTH. |
| Jun 1, 2017 | In Assembly. Read first time. Held at Desk. |
| May 31, 2017 | Read third time. Passed. (Ayes 24. Noes 15. Page 1322.) Ordered to the Assembly. |
| May 26, 2017 | Read second time and amended. Ordered to third reading. |
| May 25, 2017 | From committee: Do pass as amended. (Ayes 5. Noes 2. Page 1182.) (May 25). |
| May 19, 2017 | Set for hearing May 25. |
| May 15, 2017 | May 15 hearing: Placed on APPR. suspense file. |
| May 5, 2017 | Set for hearing May 15. |
| May 3, 2017 | Read second time and amended. Re-referred to Com. on APPR. |
| May 2, 2017 | From committee: Do pass as amended and re-refer to Com. on APPR. (Ayes 5. Noes 2. Page 852.) (April 25). |
| Apr 17, 2017 | From committee with author's amendments. Read second time and amended. Re-referred to Com. on JUD. |
| Apr 13, 2017 | Set for hearing April 25. |
| Apr 3, 2017 | Read second time and amended. Re-referred to Com. on JUD. |
| Mar 30, 2017 | From committee: Do pass as amended and re-refer to Com. on JUD. (Ayes 7. Noes 2. Page 559.) (March 29). |
| Mar 20, 2017 | From committee with author's amendments. Read second time and amended. Re-referred to Com. on HEALTH. |
| Mar 10, 2017 | Set for hearing March 29. |
| Feb 23, 2017 | Referred to Coms. on HEALTH and JUD. |
| Feb 15, 2017 | From printer. May be acted upon on or after March 17. |
| Feb 14, 2017 | Introduced. Read first time. To Com. on RLS. for assignment. To print. |
|
Date
|
Description
|
Location
|
Votes
|
|
|---|---|---|---|---|
| Aug 31, 2018 | Unfinished Business SB349 Lara et al. Concurrence | Senate Floor |
Passed |
|
| Aug 30, 2018 | That the Assembly amendments be concurred in | Senate Standing Committee on Judiciary |
Passed |
|
| Aug 29, 2018 | SB 349 Lara Senate Third Reading By GONZALEZ FLETCHER | Assembly Floor |
Passed |
|
| Aug 24, 2018 | SB 349 Lara Senate Third Reading By GONZALEZ FLETCHER Amendment Set #1 | Assembly Floor |
Passed |
|
| Sep 1, 2017 | Do pass. | Assembly Standing Committee on Appropriations |
Passed |
|
| Jun 27, 2017 | Do pass as amended and be re-referred to the Committee on [Appropriations] | Assembly Standing Committee on Health |
Passed |
|
| May 31, 2017 | Senate 3rd Reading SB349 Lara et al. | Senate Floor |
Passed |
|
| May 25, 2017 | Do pass as amended | Senate Standing Committee on Appropriations |
Passed |
|
| May 15, 2017 | Placed on suspense file | Senate Standing Committee on Appropriations |
Passed |
|
| Apr 25, 2017 | Do pass as amended, but first amend, and re-refer to the Committee on [Appropriations] | Senate Standing Committee on Judiciary |
Passed |
|
| Mar 29, 2017 | Do pass as amended, but first amend, and re-refer to the Committee on [Judiciary] | Senate Standing Committee on Health |
Passed |
This list shows positions taken on this bill by organizations on the date displayed, which is linked to the original source.
Positions by individuals are not included.
|
Organization
|
Position
|
Date
|
|---|---|---|
| 319-2097 | ** Against | Jun 23, 2017 |
| Alliance Management, Llc | ** Against | Jun 23, 2017 |
| American Federation Of State County And Municipal Employees Afl-Cio | * Support | Jun 27, 2017 |
| American G.I. Forum of California | ** Against | Jun 23, 2017 |
| American Legion-Department of California | ** Against | Jun 23, 2017 |
| american nurses association - california | ** Against | Jun 23, 2017 |
| AMVETS-Department of California | ** Against | Jun 23, 2017 |
| Association of California Healthcare Districts | ** Against | Jun 23, 2017 |
| Association of California Nurse Leaders | ** Against | Jun 23, 2017 |
| Av Kidney Institute | ** Against | Jun 23, 2017 |
| Black AIDS Institute | ** Support | Jun 23, 2017 |
| black women for wellness | ** Support | Jun 23, 2017 |
| Cal Chamber | ** Against | Jun 23, 2017 |
| California Academy of Dietetics and Nutrition | * Support | Jun 27, 2017 |
| California Academy of Nutrition & Dietetics | ** Support | Jun 23, 2017 |
| California Alliance For Retired Americans | ** Support | Jun 23, 2017 |
| California Applicants' Attorneys Association | ** Support | Oct 12, 2018 |
| California Association Of County Veterans Service Officers | ** Against | Jun 23, 2017 |
| California Association of Rural Health Clinics | ** Against | Jun 23, 2017 |
| California Chapter National Association of Social Workers | * Support | Jun 27, 2017 |
| California Children'S Hospital Association | ** Against | Jun 23, 2017 |
| California Dialysis Council | ** Against | Jun 23, 2017 |
| California Hospital Association | ** Against | Jun 23, 2017 |
| California Labor Federation, Afl-Cio | * Support | Jun 27, 2017 |
| California Medical Transportation Association | ** Against | Jun 23, 2017 |
| California Nurses Association | * Against Unless Amend | Apr 25, 2017 |
| California Retired Teachers Association | ** Support | Jun 23, 2017 |
| California Rural Indian Health Board | * Neutral | Jun 27, 2017 |
| California State Commanders Veterans Council | ** Against | Jun 23, 2017 |
| Calvine Dialysis | * Against | Apr 25, 2017 |
| Capital Nephrology Medical Group | ** Against | Jun 23, 2017 |
| Care Professionals | ** Support | Mar 27, 2017 |
| Central Labor Council Contra Costa County, Afl-Cio | ** Support | Jun 23, 2017 |
| centro binacional para el desarrollo indigena oaxaqueno | ** Support | Jun 23, 2017 |
| Centro La Familia Advocacy Services | ** Support | Jun 23, 2017 |
| Chronic Disease Coalition | ** Against | Jun 23, 2017 |
| City of Sherman Oaks | * Against | Jun 27, 2017 |
| Coalition for Humane Immigrant Rights | ** Support | Oct 12, 2018 |
| Congress of California Seniors | ** Support | Jun 23, 2017 |
| Davita Valley View Dialysis | * Indeterminate | Jun 27, 2017 |
| DCI | * Against | Apr 25, 2017 |
| Desert Cities Dialysis | ** Against | Jun 23, 2017 |
| Dialysis Clinics Incorportated | * Support | Apr 25, 2017 |
| District Hospital Leadership Forum | ** Against | Jun 23, 2017 |
| El Concicio De Fresno, Inc. | ** Support | Jun 23, 2017 |
| El Concilio de Fresno, Inc. | ** Support | May 27, 2017 |
| Ellison Wilson Advocacy | * Support | Apr 25, 2017 |
| FMC South Bay | * Indeterminate | Jun 27, 2017 |
| Fresenius Chula Vista South | * Support | Jun 27, 2017 |
| Fresenius Medical Care | ** Against | Jun 23, 2017 |
| Fresenius West Covina | * Indeterminate | Apr 25, 2017 |
| Fresno Center for New Americans | ** Support | Jun 23, 2017 |
| Fresno Immigration Coalition | ** Support | Jun 23, 2017 |
| Greater Coachella Valley Chamber of Commerce | ** Against | Jun 23, 2017 |
| HEALTH | ** Against | Jun 23, 2017 |
| Individual | ** Support | Jun 23, 2017 |
| Latino Coalition for a Health California | ** Support | Jun 23, 2017 |
| Latino Diabetes Association | ** Support | Jun 23, 2017 |
| latino equality alliance | ** Support | Jun 23, 2017 |
| Loma Linda University | ** Against | May 27, 2017 |
| Loma Linda University Health | ** Against | Jun 23, 2017 |
| Los Angeles | * Support | Jun 27, 2017 |
| Los Angeles County Business Federation | ** Against | Jun 23, 2017 |
| Lupus Foundation of Southern California | ** Against | Jun 23, 2017 |
| Memorial Hospital Gardena | * Support | Jun 27, 2017 |
| Men of Imperial Courts | ** Support | Jun 23, 2017 |
| Mi Familia Vota | ** Support | Jun 23, 2017 |
| Naacp - Fresno, #1038 | ** Support | Jun 23, 2017 |
| National Guard Association Of California | ** Against | Jun 23, 2017 |
| National Kidney Foundation | * Neutral | Jun 27, 2017 |
| National Medical Association | ** Against | Jun 23, 2017 |
| National Renal Administrators Association | ** Against | Jun 23, 2017 |
| New Congregational Church | ** Support | Jun 23, 2017 |
| Numerous Physicians, Patients, Caregivers And Individuals | ** Against | Jun 23, 2017 |
| Orange County Business Council | ** Against | Jun 23, 2017 |
| Outset Medical | ** Against | Jun 23, 2017 |
| Oxnard Chamber of Commerce | ** Against | Jun 23, 2017 |
| Premier Nephrology Medical Group | ** Against | Jun 23, 2017 |
| Providence Health & Services | ** Against | May 27, 2017 |
| Providence St. Joseph Health | ** Against | Jun 23, 2017 |
| Radio Bilingue, Inc. | ** Support | Jun 23, 2017 |
| Renal Physicians Association | ** Against | Jun 23, 2017 |
| Renal Support Network | ** Against | Jun 23, 2017 |
| San Diego | * Support | Jun 27, 2017 |
| satellite healthcare | ** Against | Jun 23, 2017 |
| Scripps | ** Against | Jun 23, 2017 |
| SEIU United Healthcare Workers | * Support | Jun 27, 2017 |
| Seven Individuals | ** Against | May 27, 2017 |
| Sistahs in Sync | ** Support | Jun 23, 2017 |
| St. Joseph Hoag Health | ** Against | May 27, 2017 |
| street level health | ** Support | Jun 23, 2017 |
| Toiyabe Dialysis Center | * Neutral | Jun 27, 2017 |
| Toiyabe Indian Health Project, Inc. | ** Against | Jun 23, 2017 |
| U.S. Renal Care | ** Against | May 27, 2017 |
| Union of Health Care Professionals | ** Support | Jun 23, 2017 |
| Unitarian Universalist Church Of Fresno | ** Support | Jun 23, 2017 |
| United Chambers of Commerce | ** Against | Jun 23, 2017 |
| United Hospital Association | ** Against | Jun 23, 2017 |
| United Nurses Associations of California | ** Support | Jun 23, 2017 |
| University of Minnesota | * Support | Mar 29, 2017 |
| V Dot Chino | * Support | Jun 27, 2017 |
| VALLEY INDUSTRY AND COMMERCE ASSOCIATION | ** Against | Jun 23, 2017 |
| Vietnam Veterans of America-California State Council | ** Against | Jun 23, 2017 |
| Watt Century Latino Organization | ** Support | Jun 23, 2017 |
| Watts Labor Community Action Committee | ** Support | Jun 23, 2017 |
| WDA Bellevue Dialysis | * Support | Apr 25, 2017 |
| Wideman Group | * Support | Apr 25, 2017 |
Office of Senate Floor Analyses (916) 651-1520 Fax: (916) 327-4478 | SB 349 |
VETO
Bill No: SB 349
Amended: 8/24/18
PRIOR VOTES NOT RELEVANT
SENATE JUDICIARY COMMITTEE: 5-1, 8/30/18 (Pursuant to Senate Rule 29.10)
AYES: Jackson, Hertzberg, Monning, Stern, Wieckowski
NOES: Anderson
NO VOTE RECORDED: Moorlach
SENATE FLOOR: 28-10, 8/31/18
AYES: Allen, Atkins, Beall, Bradford, Cannella, De León, Delgado, Dodd, Galgiani, Glazer, Hernandez, Hertzberg, Hill, Hueso, Jackson, Lara, Leyva, McGuire, Mitchell, Monning, Pan, Portantino, Roth, Skinner, Stern, Vidak, Wieckowski, Wiener
NOES: Anderson, Bates, Chang, Fuller, Gaines, Moorlach, Morrell, Nielsen, Stone, Wilk
NO VOTE RECORDED: Berryhill, Nguyen
ASSEMBLY FLOOR: 54-23, 8/29/18 - See last page for vote
SUBJECT: Courthouses: Privilege from civil arrest
SOURCE: California Applicants’ Attorneys Association
Coalition for Humane Immigrant Rights
DIGEST:
This bill codifies key components of the common law privilege against civil arrest, under which a person may not be subjected to civil arrest in relation to one legal matter while attending a judicial proceeding for another. To facilitate enforcement of the privilege, this bill also codifies judicial authority to enforce the common law privilege against civil arrest, in keeping with the inherent power of judicial officers to prevent activities that would otherwise undermine the administration of justice. This bill enables enforcement of the privilege by the Attorney General as well.
Existing law:
- Holds that courts of justice ought everywhere to be open, accessible, free from interruption, and to cast a perfect protection around every [person] who necessarily approaches them. (Stewart v. Ramsey (1916) 242 U.S. 128, 129.)
- Makes the following acts, in respect to a court of justice, or proceedings therein, contempts of the authority of the court:
- Unlawfully detaining a witness or party to an action while going to, remaining at, or returning from the court where the action is on the calendar for trial; and
- Any other unlawful interference with the process or proceedings of a court. (Code Civ. Proc. Sec. 1209.)
- Provides that California Code of Civil Procedure Section 1209 is to be liberally construed to effect its objects and promote justice. (Burns v. Superior Court of San Francisco (1903) 140 Cal. 1, 9.)
- Gives judicial officers the power to:
- Preserve and enforce order in their immediate presence, and in proceedings before them, when they are engaged in the performance of their official duties; and
- Compel obedience to their lawful orders as provided in the Code of Civil Procedure. (Code Civ. Proc. Sec. 177.)
- Holds that a court has inherent power to exercise reasonable control over all proceedings connected with the litigation before it in order to ensure the orderly administration of justice and maintain the dignity and authority of the court, and to summarily punish for acts committed in the immediate view and presence of the court when they impede, embarrass or obstruct it in the discharge of its duties. (Mowrer v. Superior Court of Los Angeles County (1969) 3 Cal.App.3d 223, 230.)
This bill:
- Makes findings and declarations regarding, among other things:
- The importance of keeping courts of justice open, accessible, and free from interruption as a vital component of republican government and the exercise of constitutional rights;
- U.S. Supreme Court doctrine affirming state authority to adopt measures to safeguard the administration of justice and declaring that courts of justice ought everywhere… to cast a perfect protection around every [person] who necessarily approaches them; and
- The necessity of protecting people from civil arrests while at courthouses both to protect witnesses and litigants as well as to ensure that courts have access to testimony and other evidence critical to their fact-finding mission.
- Codifies and specifies that judicial officers have the power to prevent activities that threaten access to state courthouses and court proceedings, and to prevent interruption of judicial administration, including protecting the privilege from civil arrest at courthouses and court proceedings.
- Provides that no person shall be subject to civil arrest of any type in a courthouse while attending a court proceeding or having legal business in the courthouse. Specifies that this provision shall not be construed to narrow, or in any way lessen, the pre-existing common law privilege from arrest.
- Makes it a contempt of the authority of the court to subject another person to civil arrest of any type in a courthouse while that person is attending a court proceeding or having legal business in the courthouse.
- Authorizes the Attorney General to bring a civil action in the name of the people to obtain appropriate equitable and declaratory relief if the Attorney General has reasonable cause to believe that a violation of the privilege against arrest has occurred.
- Authorizes the recovery of court costs and reasonable attorney’s fees for a successful action to enforce liability for a violation of the privilege against civil arrest as expressed in this bill.
- Specifies that its provisions are severable, and if any provision or its application is held invalid, that invalidity shall not affect the bill’s other provisions or applications.
Background
For centuries, English and American courts have held that people attending, going to, or returning from a court proceeding may not be placed under arrest in relation to an unrelated civil matter. (Lasch, A Common-Law Privilege to Protect State and Local Courts During the Crimmigration Crisis (2017) 127 Yale L.J.F. 410, 423.) This longstanding rule is known as the common law privilege from civil arrest.
In recent decades, the use of civil arrests as a mechanism for initiating a civil lawsuit has mostly fallen by the wayside. (Levy, Jr., Mense Process in Personal Actions at Common Law and the Power Doctrine (1968) 78 Yale L.J. 52, 61-68.) Instead, most civil actions today commence through delivery of paperwork – the summons and complaint – to the defendant. As a result, familiarity with the common law privilege against civil arrest has faded among legal practitioners and judges.
The passage of time does not alter the basic policy rationale giving rise to the privilege as it pertains to civil arrest, however. If attending court puts people’s liberty at risk on account of an unrelated civil matter, they will be afraid of participating and are likely to choose not to. That dynamic creates a practical barrier to access to justice and deprives the courts of valuable testimony that may be critical to ascertaining the truth.
This bill seeks to address these concerns by codifying key components of the common law privilege against civil arrest and providing mechanisms for enforcement of the privilege.
Comments
- Historical origins of the common law privilege against civil arrest
According to law professor Christopher Lasch, “[t]he common law privilege from arrest dates back at least to the early fifteenth century.” (127 Yale L.J.F. 410, 423. Footnote omitted.) As articulated in William Blackstone’s famed 1877 treatise Commentaries on the Laws of England, the common law privilege from arrest meant that:
Suitors, witnesses, and other persons, necessarily attending any courts of record upon business, are not to be arrested during their actual attendance, which includes their necessary coming and returning. And no arrest can be made in the king’s presence, nor within the verge of his royal palace, nor in any place where the king’s justices are actually sitting.[1]
Prof. Lasch traces two strands of the privilege in English and American case law: one applying to people attending court and the other applying to the place where judicial proceedings are occurring. (127 Yale L.J.F. 410 at 424.) The former appears in U.S. Supreme Court jurisprudence in 1932. In a case involving immunity for residents of one state while traveling to attend court in another state, the Court noted the “general rule that witnesses, suitors, and their attorneys, while in attendance in connection with the conduct of one suit are immune from service of process[2] in another.” (Lamb v. Schmitt (1932) 285 U.S. 222, 225.) Lasch identifies references to the latter strand in U.S. federal cases in the 19th century. (See Blight v. Fisher (C.C.D.N.J. 1809) 3 F. Cas. 704, 704-705; Parker v. Hotchkiss (C.C.E.D. Pa. 1849) 18 F. Cas. 1137, 1138.)
In California, recognizable elements of the privilege from arrest appear in California Code of Civil Procedure Section 1209(a)(8). That provision makes it a contempt of the authority of the court to unlawfully detain a witness or party to an action while going to, remaining at, or returning from the court where the action is on the calendar for trial. The California Legislature enacted Code of Civil Procedure Section 1209(a)(8) in 1872. It appears to have remained unchanged since.
This history suggests that, although this bill newly codifies key components of the common law privilege against arrest, the existence of the privilege long pre-dates the bill.
- Significance of privilege against civil arrest for administration of justice and exercise of fundamental rights
The case law incorporating the common law privilege from arrest into American law also articulates the policy rationale behind the privilege: it is central to the effective administration of justice and critical to the exercise of fundamental rights.
In Lamb v. Schmitt, supra, the U.S. Supreme Court wrote that:
the due administration of justice requires that a court shall not permit interference with the progress of a cause pending before it, by the service of process[3] in other suits, which would prevent, or the fear of which might tend to discourage, the voluntary attendance of those whose presence is necessary or convenient to the judicial administration in the pending litigation. (Lamb, 285 U.S. at 225.)
More broadly, in Stewart v. Ramsay (1916) 242 U.S. 128, the U.S. Supreme Court stated that: “courts of justice ought everywhere to be open, accessible, free from interruption, and to cast a perfect protection around every man who necessarily approaches them.” (Id. at 129.)
Prof. Lasch points out that one New York State court even went so far as to describe enforcement of the privilege against arrest as a judicial obligation, stating: “[w]e have the power to compel the attendance of witnesses, and when they do attend, we are bound to protect them redundo.” (Norris v. Beach (1807) 2 Johns. 294, 294.)
Although many of these decisions were rendered long ago, the policy rationales articulated appear to be no less relevant today. An excruciating dilemma confronts the California worker who has been robbed of her wages but worries she will be arrested and civilly detained if she seeks redress at a courthouse. The same goes for the Californian who has information about the commission of a violent crime, but faces the prospect of civil arrest and detention if she appears as a witness to testify as to what she knows.
These examples illustrate that the policy interests at stake pertain not just to the individual, but also to the court, and the public more generally. The prospect of facing civil arrest and detention chills the individual worker from exercising her right to seek legal redress. That rewards the employer who has violated the law by enabling that employer to profit off of his wrongdoing. This, in turn, gives the dishonest employer a marketplace advantage over the employer’s honest competitors. From this perspective, the privilege against civil arrest protects both individual rights and the public interest. Similarly, if the witness to a violent crime is deterred by fear of civil arrest and detention from testifying as to what she knows, the court is deprived of key evidence that could help determine guilt or innocence. If, as a result, the violent criminal goes free or the innocent defendant gets convicted, the public at large is less safe and justice less certain.
As the findings and declarations accompanying the bill reflect, the intent of the bill is to respond to these concerns about the deleterious effect that civil arrests at the courthouse can have on the exercise of fundamental rights and the administration of justice.
- Inapplicability to criminal arrests
The common law privilege against arrests traditionally applied to civil arrest and service of process. It is not clear whether the common law privilege might also extend to criminal arrest. This bill only codifies that aspect of the common law privilege that pertains to civil arrest. It does not apply to criminal arrest. Thus, this bill does not protect a criminal suspect from arrest at a courthouse. The privilege would only apply to those alleged to have committed civil violations or where the arrest is related to a civil suit.
FISCAL EFFECT: Appropriation: No Fiscal Com.: Yes Local: Yes
According to the Assembly Appropriations Committee, unknown significant costs, likely in the hundreds of thousands of dollars annually, for the Department of Justice to handle increased workload associated with litigation.
California Applicants’ Attorneys Association (co-source)
Coalition for Humane Immigrant Rights (co-source)
OPPOSITION: (Verified 10/8/18)
None received
ARGUMENTS IN SUPPORT: According to the author:
The intent of SB 349 is to protect all individuals from civil arrest while at a courthouse or court proceeding. Protecting people from civil arrest while on legal business in our courthouses, or while attending judicial proceedings, is necessary to preserve public access to courts. California is harmed when our judicial system is interfered with in any way. Codifying this privilege from arrest doctrine will ensure that litigants, witnesses, and others are not deterred from participating in the proceedings necessary to protect and vindicate rights guaranteed by the State of California. It is critical that our courts and all parties have access to testimony and other evidence critical to fact-finding and that the dignity of judicial proceedings is upheld and not disturbed or diminished, which ensures our courts are able to effectively administer justice. The provisions of this measure are needed to protect and preserve the integrity of the proceedings of the judicial branch of California government. Courts are essential to a republican form of government and to the functioning of California’s government.
GOVERNOR'S VETO MESSAGE:
I am returning Senate Bill 349 without my signature.
This bill would protect individuals against civil arrest of any kind while attending a judicial proceeding in a courthouse.
I support the underlying intent of this measure, but I am concerned that it may have unintended consequences. Last year I signed SB 54 (De Leon), a provision of which tasked the Attorney General with publishing model policies limiting assistance with immigration enforcement to the fullest extent possible at courthouses and other public facilities to ensure that they remain safe and accessible to all California residents, regardless of immigration status. I believe the prudent path is to allow for that guidance to be released before enacting new laws in this area.
ASSEMBLY FLOOR: 54-23, 8/29/18
AYES: Aguiar-Curry, Arambula, Berman, Bloom, Bonta, Burke, Caballero, Calderon, Carrillo, Cervantes, Chau, Chiu, Chu, Cooper, Cunningham, Daly, Eggman, Friedman, Gabriel, Cristina Garcia, Eduardo Garcia, Gipson, Gloria, Gonzalez Fletcher, Grayson, Holden, Irwin, Jones-Sawyer, Kalra, Kamlager-Dove, Levine, Limón, Low, Maienschein, McCarty, Medina, Mullin, Muratsuchi, Nazarian, O'Donnell, Quirk, Quirk-Silva, Reyes, Rivas, Rodriguez, Rubio, Salas, Santiago, Mark Stone, Thurmond, Ting, Weber, Wood, Rendon
NOES: Acosta, Travis Allen, Baker, Bigelow, Brough, Chávez, Chen, Choi, Dahle, Flora, Fong, Gallagher, Harper, Kiley, Lackey, Mathis, Mayes, Melendez, Obernolte, Patterson, Steinorth, Voepel, Waldron
NO VOTE RECORDED: Cooley, Frazier, Gray
Prepared by: Timothy Griffiths / JUD. / (916) 651-4113
10/12/18 16:25:38
**** END ****
Blackstone, Commentaries on the Laws of England 766 (1877). Footnote omitted. ↑
The common law privilege from arrest encompassed civil arrest and, in some instances, extended to service of process as well. Though Lamb referred to service of process only, the federal case law to which it cited makes clear that the privilege was understood to extend primarily to civil arrest. (See Lasch, 127 Yale L.J. F. 410 at fn 93, collecting cases.) ↑
See footnote 2, above. ↑
Senator Hannah-Beth Jackson, Chair
2017-2018 Regular Session
Bill No: SB 349 (Author:Lara)
Version: August 24, 2018
Hearing Date: August 30, 2018
Fiscal: Yes
Urgency: No
Consultant: TSG
PURSUANT TO SENATE RULE 29.10
SUBJECT
Courthouses: Privilege from civil arrest
DESCRIPTION
This bill would codify key components of the common law privilege against civil arrest, under which a person may not be subjected to civil arrest in relation to one legal matter while attending a judicial proceeding for another. To facilitate enforcement of the privilege, this bill would also codify judicial authority to enforce the common law privilege against civil arrest, in keeping with the inherent power of judicial officers to prevent activities that would otherwise undermine the administration of justice. The bill would enable enforcement of the privilege by the Attorney General as well.
BACKGROUND
For centuries, English and American courts have held that people attending, going to, or returning from a court proceeding may not be placed under arrest in relation to an unrelated civil matter. (Lasch, A Common-Law Privilege to Protect State and Local Courts During the Crimmigration Crisis (2017) 127 Yale L.J.F. 410, 423.) This longstanding rule is known as the common law privilege from civil arrest.
In recent decades, the use of civil arrests as a mechanism for initiating a civil lawsuit has mostly fallen by the wayside. (Levy, Jr., Mense Process in Personal Actions at Common Law and the Power Doctrine (1968) 78 Yale L.J. 52, 61-68.) Instead, most civil actions today commence through delivery of paperwork – the summons and complaint – to the defendant. As a result, familiarity with the common law privilege against civil arrest has faded among legal practitioners and judges.
The passage of time does not alter the basic policy rationale giving rise to the privilege as it pertains to civil arrest, however. If attending court puts people’s liberty at risk on account of an unrelated civil matter, they will be afraid of participating and are likely to choose not to. That dynamic creates a practical barrier to access to justice and deprives the courts of valuable testimony that may be critical to ascertaining the truth.
This bill would seek to address these concerns by codifying key components of the common law privilege against civil arrest and providing mechanisms for enforcement of the privilege.
CHANGES TO EXISTING LAW
Existing law holds that courts of justice ought everywhere to be open, accessible, free from interruption, and to cast a perfect protection around every [person] who necessarily approaches them. (Stewart v. Ramsey (1916) 242 U.S. 128, 129.)
Existing law makes the following acts, in respect to a court of justice, or proceedings therein, contempts of the authority of the court:
- unlawfully detaining a witness or party to an action while going to, remaining at, or returning from the court where the action is on the calendar for trial; and
- any other unlawful interference with the process or proceedings of a court. (Code Civ. Proc. Sec. 1209.)
Existing law provides that California Code of Civil Procedure section 1209 is to be liberally construed to effect its objects and promote justice. (Burns v. Superior Court of San Francisco (1903) 140 Cal. 1, 9.)
Existing law gives judicial officers the power to:
- preserve and enforce order in their immediate presence, and in proceedings before them, when they are engaged in the performance of their official duties; and
- compel obedience to their lawful orders as provided in the Code of Civil Procedure. (Code Civ. Proc. Sec. 177.)
Existing law holds that a court has inherent power to exercise reasonable control over all proceedings connected with the litigation before it in order to ensure the orderly administration of justice and maintain the dignity and authority of the court, and to summarily punish for acts committed in the immediate view and presence of the court when they impede, embarrass or obstruct it in the discharge of its duties. (Mowrer v. Superior Court of Los Angeles County (1969) 3 Cal.App.3d 223, 230.)
This bill would make findings and declarations regarding, among other things:
- the importance of keeping courts of justice open, accessible, and free from interruption as a vital component of republican government and the exercise of constitutional rights;
- U.S. Supreme Court doctrine affirming state authority to adopt measures to safeguard the administration of justice and declaring that courts of justice ought everywhere… to cast a perfect protection around every [person] who necessarily approaches them; and
- the necessity of protecting people from civil arrests while at courthouses both to protect witnesses and litigants as well as to ensure that courts have access to testimony and other evidence critical to their fact-finding mission.
This bill would codify and specify that judicial officers have the power to prevent activities that threaten access to state courthouses and court proceedings, and to prevent interruption of judicial administration, including protecting the privilege from civil arrest at courthouses and court proceedings.
This bill would provide that no person shall be subject to civil arrest of any type in a courthouse while attending a court proceeding or having legal business in the courthouse. It would specify that this provision shall not be construed to narrow, or in any way lessen, the pre-existing common law privilege from arrest.
This bill would make it a contempt of the authority of the court to subject another person to civil arrest of any type in a courthouse while that person is attending a court proceeding or having legal business in the courthouse.
This bill would authorize the Attorney General to bring a civil action in the name of the people to obtain appropriate equitable and declaratory relief if the Attorney General has reasonable cause to believe that a violation of the privilege against arrest has occurred.
This bill would authorize the recovery of court costs and reasonable attorney’s fees for a successful action to enforce liability for a violation of the privilege against civil arrest as expressed in this bill.
This bill would specify that its provisions are severable, and if any provision or its application is held invalid, that invalidity shall not affect the bill’s other provisions or applications.
COMMENT
1. Stated need for the bill
According to the author:
The intent of SB 349 is to protect all individuals from civil arrest while at a courthouse or court proceeding. Protecting people from civil arrest while on legal business in our courthouses, or while attending judicial proceedings, is necessary to preserve public access to courts. California is harmed when our judicial system is interfered with in any way. Codifying this privilege from arrest doctrine will ensure that litigants, witnesses, and others are not deterred from participating in the proceedings necessary to protect and vindicate rights guaranteed by the State of California. It is critical that our courts and all parties have access to testimony and other evidence critical to fact-finding and that the dignity of judicial proceedings is upheld and not disturbed or diminished, which ensures our courts are able to effectively administer justice. The provisions of this measure are needed to protect and preserve the integrity of the proceedings of the judicial branch of California government. Courts are essential to a republican form of government and to the functioning of California’s government.
2. Historical origins of the common law privilege against civil arrest
According to law professor Christopher Lasch, “[t]he common law privilege from arrest dates back at least to the early fifteenth century.” (127 Yale L.J.F. 410, 423. Footnote omitted.) As articulated in William Blackstone’s famed 1877 treatise Commentaries on the Laws of England, the common law privilege from arrest meant that:
Suitors, witnesses, and other persons, necessarily attending any courts of record upon business, are not to be arrested during their actual attendance, which includes their necessary coming and returning. And no arrest can be made in the king’s presence, nor within the verge of his royal palace, nor in any place where the king’s justices are actually sitting.[1]
Prof. Lasch traces two strands of the privilege in English and American case law: one applying to people attending court and the other applying to the place where judicial proceedings are occurring. (127 Yale L.J.F. 410 at 424.) The former appears in U.S. Supreme Court jurisprudence in 1932. In a case involving immunity for residents of one state while traveling to attend court in another state, the Court noted the “general rule that witnesses, suitors, and their attorneys, while in attendance in connection with the conduct of one suit are immune from service of process[2] in another.” (Lamb v. Schmitt (1932) 285 U.S. 222, 225.) Lasch identifies references to the latter strand in U.S. federal cases in the 19th century. (See Blight v. Fisher (C.C.D.N.J. 1809) 3 F. Cas. 704, 704-705; Parker v. Hotchkiss (C.C.E.D. Pa. 1849) 18 F. Cas. 1137, 1138.)
In California, recognizable elements of the privilege from arrest appear in California Code of Civil Procedure Section 1209(a)(8). That provision makes it a contempt of the authority of the court to unlawfully detain a witness or party to an action while going to, remaining at, or returning from the court where the action is on the calendar for trial. The California Legislature enacted Code of Civil Procedure Section 1209(a)(8) in 1872. It appears to have remained unchanged since.
This history suggests that, although this bill would newly codify key components of the common law privilege against arrest, the existence of the privilege long pre-dates the bill.
3. Significance of privilege against civil arrest for administration of justice and exercise of fundamental rights
The case law incorporating the common law privilege from arrest into American law also articulates the policy rationale behind the privilege: it is central to the effective administration of justice and critical to the exercise of fundamental rights.
In Lamb v. Schmitt, supra, the U.S. Supreme Court wrote that:
the due administration of justice requires that a court shall not permit interference with the progress of a cause pending before it, by the service of process[3] in other suits, which would prevent, or the fear of which might tend to discourage, the voluntary attendance of those whose presence is necessary or convenient to the judicial administration in the pending litigation. (Lamb, 285 U.S. at 225.)
More broadly, in Stewart v. Ramsay (1916) 242 U.S. 128, the U.S. Supreme Court stated that: “courts of justice ought everywhere to be open, accessible, free from interruption, and to cast a perfect protection around every man who necessarily approaches them.” (Id. at 129.)
Prof. Lasch points out that one New York State court even went so far as to describe enforcement of the privilege against arrest as a judicial obligation, stating: “[w]e have the power to compel the attendance of witnesses, and when they do attend, we are bound to protect them redundo.” (Norris v. Beach (1807) 2 Johns. 294, 294.)
Although many of these decisions were rendered long ago, the policy rationales articulated appear to be no less relevant today. An excruciating dilemma confronts the California worker who has been robbed of her wages but worries she will be arrested and civilly detained if she seeks redress at a courthouse. The same goes for the Californian who has information about the commission of a violent crime, but faces the prospect of civil arrest and detention if she appears as a witness to testify as to what she knows.
These examples illustrate that the policy interests at stake pertain not just to the individual, but also to the court, and the public more generally. The prospect of facing civil arrest and detention chills the individual worker from exercising her right to seek legal redress. That rewards the employer who has violated the law by enabling that employer to profit off of his wrongdoing. This, in turn, gives the dishonest employer a marketplace advantage over the employer’s honest competitors. From this perspective, the privilege against civil arrest protects both individual rights and the public interest. Similarly, if the witness to a violent crime is deterred by fear of civil arrest and detention from testifying as to what she knows, the court is deprived of key evidence that could help determine guilt or innocence. If, as a result, the violent criminal goes free or the innocent defendant gets convicted, the public at large is less safe and justice less certain.
As the findings and declarations accompanying the bill reflect, the intent of the bill is to respond to these concerns about the deleterious effect that civil arrests at the courthouse can have on the exercise of fundamental rights and the administration of justice.
4. Inapplicability to criminal arrests
The common law privilege against arrests traditionally applied to civil arrest and service of process. It is not clear whether the common law privilege might also extend to criminal arrest. This bill would only codify that aspect of the common law privilege that pertains to civil arrest. It would not apply to criminal arrest. Thus, this bill would not protect a criminal suspect from arrest at a courthouse. The privilege would only apply to those alleged to have committed civil violations or those arrested in connection with a civil matter.
Support: None known
Opposition: None known
HISTORY
Source: California Applicants’ Attorneys Association; Coalition for Humane Immigrant Rights
Related Pending Legislation: None known
Prior Legislation: None known
Prior Vote:
Votes prior to the Assembly Floor are not relevant to the current content of this bill.
**************
Blackstone, Commentaries on the Laws of England 766 (1877). Footnote omitted. ↑
The common law privilege from arrest encompassed civil arrest and, in some instances, extended to service of process as well. Though Lamb referred to service of process only, the federal case law to which it cited makes clear that the privilege was understood to extend primarily to civil arrest. (See Lasch, 127 Yale L.J. F. 410 at fn 93, collecting cases.) ↑
See footnote 2, above. ↑
Office of Senate Floor Analyses (916) 651-1520 Fax: (916) 327-4478 | SB |
UNFINISHED BUSINESS
Bill No: SB 349
:
PRIOR VOTES NOT RELEVANT
SENATE JUDICIARY COMMITTEE: 5-1, 8/30/18 (Pursuant to Senate Rule 29.10)
AYES: Jackson, Hertzberg, Monning, Stern, Wieckowski
NOES: Anderson
NO VOTE RECORDED: Moorlach
ASSEMBLY FLOOR: 54-23, 8/29/18 - See last page for vote
SUBJECT: Courthouses: Privilege from civil arrest
SOURCE: California Applicants’ Attorneys Association
Coalition for Humane Immigrant Rights
DIGEST:
This bill codifies key components of the common law privilege against civil arrest, under which a person may not be subjected to civil arrest in relation to one legal matter while attending a judicial proceeding for another. To facilitate enforcement of the privilege, this bill also codifues judicial authority to enforce the common law privilege against civil arrest, in keeping with the inherent power of judicial officers to prevent activities that would otherwise undermine the administration of justice. This bill enables enforcement of the privilege by the Attorney General as well.
Assembly Amendments
delete the prior content of this bill, which related to staffing at chronic dialysis clinics, and replace it with the current content.
Existing law:
- Holds that courts of justice ought everywhere to be open, accessible, free from interruption, and to cast a perfect protection around every [person] who necessarily approaches them. (Stewart v. Ramsey (1916) 242 U.S. 128, 129.)
- Makes the following acts, in respect to a court of justice, or proceedings therein, contempts of the authority of the court:
- Unlawfully detaining a witness or party to an action while going to, remaining at, or returning from the court where the action is on the calendar for trial; and
- Any other unlawful interference with the process or proceedings of a court. (Code Civ. Proc. Sec. 1209.)
- Provides that California Code of Civil Procedure Section 1209 is to be liberally construed to effect its objects and promote justice. (Burns v. Superior Court of San Francisco (1903) 140 Cal. 1, 9.)
- Gives judicial officers the power to:
- Preserve and enforce order in their immediate presence, and in proceedings before them, when they are engaged in the performance of their official duties; and
- Compel obedience to their lawful orders as provided in the Code of Civil Procedure. (Code Civ. Proc. Sec. 177.)
- Holds that a court has inherent power to exercise reasonable control over all proceedings connected with the litigation before it in order to ensure the orderly administration of justice and maintain the dignity and authority of the court, and to summarily punish for acts committed in the immediate view and presence of the court when they impede, embarrass or obstruct it in the discharge of its duties. (Mowrer v. Superior Court of Los Angeles County (1969) 3 Cal.App.3d 223, 230.)
This bill:
- Makes findings and declarations regarding, among other things:
- The importance of keeping courts of justice open, accessible, and free from interruption as a vital component of republican government and the exercise of constitutional rights;
- U.S. Supreme Court doctrine affirming state authority to adopt measures to safeguard the administration of justice and declaring that courts of justice ought everywhere… to cast a perfect protection around every [person] who necessarily approaches them; and
- The necessity of protecting people from civil arrests while at courthouses both to protect witnesses and litigants as well as to ensure that courts have access to testimony and other evidence critical to their fact-finding mission.
- Codifies and specifies that judicial officers have the power to prevent activities that threaten access to state courthouses and court proceedings, and to prevent interruption of judicial administration, including protecting the privilege from civil arrest at courthouses and court proceedings.
- Provides that no person shall be subject to civil arrest of any type in a courthouse while attending a court proceeding or having legal business in the courthouse. Specifies that this provision shall not be construed to narrow, or in any way lessen, the pre-existing common law privilege from arrest.
- Makes it a contempt of the authority of the court to subject another person to civil arrest of any type in a courthouse while that person is attending a court proceeding or having legal business in the courthouse.
- Authorizes the Attorney General to bring a civil action in the name of the people to obtain appropriate equitable and declaratory relief if the Attorney General has reasonable cause to believe that a violation of the privilege against arrest has occurred.
- Authorizes the recovery of court costs and reasonable attorney’s fees for a successful action to enforce liability for a violation of the privilege against civil arrest as expressed in this bill.
- Specifies that its provisions are severable, and if any provision or its application is held invalid, that invalidity shall not affect the bill’s other provisions or applications.
Background
For centuries, English and American courts have held that people attending, going to, or returning from a court proceeding may not be placed under arrest in relation to an unrelated civil matter. (Lasch, A Common-Law Privilege to Protect State and Local Courts During the Crimmigration Crisis (2017) 127 Yale L.J.F. 410, 423.) This longstanding rule is known as the common law privilege from civil arrest.
In recent decades, the use of civil arrests as a mechanism for initiating a civil lawsuit has mostly fallen by the wayside. (Levy, Jr., Mense Process in Personal Actions at Common Law and the Power Doctrine (1968) 78 Yale L.J. 52, 61-68.) Instead, most civil actions today commence through delivery of paperwork – the summons and complaint – to the defendant. As a result, familiarity with the common law privilege against civil arrest has faded among legal practitioners and judges.
The passage of time does not alter the basic policy rationale giving rise to the privilege as it pertains to civil arrest, however. If attending court puts people’s liberty at risk on account of an unrelated civil matter, they will be afraid of participating and are likely to choose not to. That dynamic creates a practical barrier to access to justice and deprives the courts of valuable testimony that may be critical to ascertaining the truth.
This bill seeks to address these concerns by codifying key components of the common law privilege against civil arrest and providing mechanisms for enforcement of the privilege.
Comments
- Historical origins of the common law privilege against civil arrest
According to law professor Christopher Lasch, “[t]he common law privilege from arrest dates back at least to the early fifteenth century.” (127 Yale L.J.F. 410, 423. Footnote omitted.) As articulated in William Blackstone’s famed 1877 treatise Commentaries on the Laws of England, the common law privilege from arrest meant that:
Suitors, witnesses, and other persons, necessarily attending any courts of record upon business, are not to be arrested during their actual attendance, which includes their necessary coming and returning. And no arrest can be made in the king’s presence, nor within the verge of his royal palace, nor in any place where the king’s justices are actually sitting.[1]
Prof. Lasch traces two strands of the privilege in English and American case law: one applying to people attending court and the other applying to the place where judicial proceedings are occurring. (127 Yale L.J.F. 410 at 424.) The former appears in U.S. Supreme Court jurisprudence in 1932. In a case involving immunity for residents of one state while traveling to attend court in another state, the Court noted the “general rule that witnesses, suitors, and their attorneys, while in attendance in connection with the conduct of one suit are immune from service of process[2] in another.” (Lamb v. Schmitt (1932) 285 U.S. 222, 225.) Lasch identifies references to the latter strand in U.S. federal cases in the 19th century. (See Blight v. Fisher (C.C.D.N.J. 1809) 3 F. Cas. 704, 704-705; Parker v. Hotchkiss (C.C.E.D. Pa. 1849) 18 F. Cas. 1137, 1138.)
In California, recognizable elements of the privilege from arrest appear in California Code of Civil Procedure Section 1209(a)(8). That provision makes it a contempt of the authority of the court to unlawfully detain a witness or party to an action while going to, remaining at, or returning from the court where the action is on the calendar for trial. The California Legislature enacted Code of Civil Procedure Section 1209(a)(8) in 1872. It appears to have remained unchanged since.
This history suggests that, although this bill would newly codify key components of the common law privilege against arrest, the existence of the privilege long pre-dates the bill.
- Significance of privilege against civil arrest for administration of justice and exercise of fundamental rights
The case law incorporating the common law privilege from arrest into American law also articulates the policy rationale behind the privilege: it is central to the effective administration of justice and critical to the exercise of fundamental rights.
In Lamb v. Schmitt, supra, the U.S. Supreme Court wrote that:
the due administration of justice requires that a court shall not permit interference with the progress of a cause pending before it, by the service of process[3] in other suits, which would prevent, or the fear of which might tend to discourage, the voluntary attendance of those whose presence is necessary or convenient to the judicial administration in the pending litigation. (Lamb, 285 U.S. at 225.)
More broadly, in Stewart v. Ramsay (1916) 242 U.S. 128, the U.S. Supreme Court stated that: “courts of justice ought everywhere to be open, accessible, free from interruption, and to cast a perfect protection around every man who necessarily approaches them.” (Id. at 129.)
Prof. Lasch points out that one New York State court even went so far as to describe enforcement of the privilege against arrest as a judicial obligation, stating: “[w]e have the power to compel the attendance of witnesses, and when they do attend, we are bound to protect them redundo.” (Norris v. Beach (1807) 2 Johns. 294, 294.)
Although many of these decisions were rendered long ago, the policy rationales articulated appear to be no less relevant today. An excruciating dilemma confronts the California worker who has been robbed of her wages but worries she will be arrested and civilly detained if she seeks redress at a courthouse. The same goes for the Californian who has information about the commission of a violent crime, but faces the prospect of civil arrest and detention if she appears as a witness to testify as to what she knows.
These examples illustrate that the policy interests at stake pertain not just to the individual, but also to the court, and the public more generally. The prospect of facing civil arrest and detention chills the individual worker from exercising her right to seek legal redress. That rewards the employer who has violated the law by enabling that employer to profit off of his wrongdoing. This, in turn, gives the dishonest employer a marketplace advantage over the employer’s honest competitors. From this perspective, the privilege against civil arrest protects both individual rights and the public interest. Similarly, if the witness to a violent crime is deterred by fear of civil arrest and detention from testifying as to what she knows, the court is deprived of key evidence that could help determine guilt or innocence. If, as a result, the violent criminal goes free or the innocent defendant gets convicted, the public at large is less safe and justice less certain.
As the findings and declarations accompanying the bill reflect, the intent of the bill is to respond to these concerns about the deleterious effect that civil arrests at the courthouse can have on the exercise of fundamental rights and the administration of justice.
- Inapplicability to criminal arrests
The common law privilege against arrests traditionally applied to civil arrest and service of process. It is not clear whether the common law privilege might also extend to criminal arrest. This bill would only codify that aspect of the common law privilege that pertains to civil arrest. It would not apply to criminal arrest. Thus, this bill would not protect a criminal suspect from arrest at a courthouse. The privilege would only apply to those alleged to have committed civil violations or where the arrest is related to a civil suit.
FISCAL EFFECT: Appropriation: Fiscal Com.: Local:
According to the Assembly Appropriations Committee, unknown significant costs, likely in the hundreds of thousands of dollars annually, for the Department of Justice to handle increased workload associated with litigation.
California Applicants’ Attorneys Association (co-source)
Coalition for Humane Immigrant Rights (co-source)
OPPOSITION: (Verified 8/30/18)
None received
ARGUMENTS IN SUPPORT:
According to the author:
The intent of SB 349 is to protect all individuals from civil arrest while at a courthouse or court proceeding. Protecting people from civil arrest while on legal business in our courthouses, or while attending judicial proceedings, is necessary to preserve public access to courts. California is harmed when our judicial system is interfered with in any way. Codifying this privilege from arrest doctrine will ensure that litigants, witnesses, and others are not deterred from participating in the proceedings necessary to protect and vindicate rights guaranteed by the State of California. It is critical that our courts and all parties have access to testimony and other evidence critical to fact-finding and that the dignity of judicial proceedings is upheld and not disturbed or diminished, which ensures our courts are able to effectively administer justice. The provisions of this measure are needed to protect and preserve the integrity of the proceedings of the judicial branch of California government. Courts are essential to a republican form of government and to the functioning of California’s government.
ASSEMBLY FLOOR: 54-23, 8/29/18
AYES: Aguiar-Curry, Arambula, Berman, Bloom, Bonta, Burke, Caballero, Calderon, Carrillo, Cervantes, Chau, Chiu, Chu, Cooper, Cunningham, Daly, Eggman, Friedman, Gabriel, Cristina Garcia, Eduardo Garcia, Gipson, Gloria, Gonzalez Fletcher, Grayson, Holden, Irwin, Jones-Sawyer, Kalra, Kamlager-Dove, Levine, Limón, Low, Maienschein, McCarty, Medina, Mullin, Muratsuchi, Nazarian, O'Donnell, Quirk, Quirk-Silva, Reyes, Rivas, Rodriguez, Rubio, Salas, Santiago, Mark Stone, Thurmond, Ting, Weber, Wood, Rendon
NOES: Acosta, Travis Allen, Baker, Bigelow, Brough, Chávez, Chen, Choi, Dahle, Flora, Fong, Gallagher, Harper, Kiley, Lackey, Mathis, Mayes, Melendez, Obernolte, Patterson, Steinorth, Voepel, Waldron
NO VOTE RECORDED: Cooley, Frazier, Gray
Prepared by: Timothy Griffiths / JUD. / (916) 651-4113
8/30/18 18:21:38
**** END ****
Blackstone, Commentaries on the Laws of England 766 (1877). Footnote omitted. ↑
The common law privilege from arrest encompassed civil arrest and, in some instances, extended to service of process as well. Though Lamb referred to service of process only, the federal case law to which it cited makes clear that the privilege was understood to extend primarily to civil arrest. (See Lasch, 127 Yale L.J. F. 410 at fn 93, collecting cases.) ↑
See footnote 2, above. ↑
SENATE THIRD READING
STR Bill Id:SB 349
Author:(Lara)
As Amended Ver:August 24, 2018
Majority vote
SENATE VOTE: 24-15
Committee | Votes | Ayes | Noes |
Health | 10-4 | Wood, Maienschein, Bonta, Kalra, Limón, McCarty, Rodriguez, Santiago, Thurmond, Chau | Gallagher, Patterson, Ridley-Thomas, Waldron |
Appropriations | 10-5 | Gonzalez Fletcher, Bloom, Bocanegra, Bonta, Calderon, Chau, Friedman, Eduardo Garcia, Jones-Sawyer, Reyes | Bigelow, Brough, Fong, Gallagher, Obernolte |
SUMMARY: Codifies the common law privilege from civil arrest while attending court proceedings. Specifically, this bill:
- Makes findings and declarations on the importance of keeping courts of justice open, accessible, and free from interruption, and on the need to protect persons from civil arrest while in California's courts or attending judicial proceedings. Specifies that this protection is needed in order to ensure that litigants, witnesses, and others are not deterred from participating in such proceedings, and that the dignity of judicial proceedings are upheld and not disturbed.
- Provides that no person shall be subject to civil arrest of any type in a courthouse while attending a court proceeding or having legal business in the courthouse. Specifies that this provision does not narrow or lessen any existing common law privilege.
- Makes any violation of 2), above, punishable as a contempt of court.
- Authorizes the Attorney General to bring a civil action in the name of the people to obtain appropriate equitable and declaratory relief if the Attorney General has reasonable cause to believe that a violation has occurred.
- Provides that in any successful action to enforce liability for a violation of this bill, a party may recover court costs and reasonable attorney’s fees.
EXISTING LAW:
- Gives judicial officers the following powers:
- To preserve and enforce order in their immediate presence, and in proceedings before them, when they are engaged in the performance of official duty.
- To compel obedience to their lawful orders as provided in the Code of Civil Procedure.
- To compel the attendence of persons to testify in a proceeding before them, in the cases and manners provided by the Code of Civil Procedure.
- To administer oaths to persons in a proceeding pending before them, and in all other cases where it may be necessary in the exercise of their powers and duties.
- Authorizes the court to issue warrants for the civil arrest of a witness who fails to appear in court pursuant to a subpoena or court order.
- Provides that if a person comes into this State in obedience to a subpoena directing that person to attend and testify in this State, that person shall not, while in this State pursuant to the subpoena or order, be subject to arrest or the service of process, civil or criminal, in connection with matters which arose before his entrance into this State under the subpoena.
- Protects the right of the people to be secure in their persons, houses, papers and effects against unreasonable seizures and searches; specifies that a warrant may not issue except on probable cause, supported by oath or affirmation, particularly describing the place to be searched and the persons and things to be seized.
- Holds that courts of justice ought everywhere to be open, accessible, free from interruption, and to cast a perfect protection around every [person] who necessarily approaches them. (Stewart v. Ramsey (1916) 242 U.S. 128, 129.)
EXISTING FEDERAL LAW:
- Provides, under the United States Constitution, that "the right of the people to be secure in their persons, houses, papers, and effects, against unreasonable searches and seizures, shall not be violated, and no warrants shall issue, but upon probable cause, supported by Oath or affirmation, and particularly describing the place to be searched and the persons or things to be seized."
- Specify that the powers not delegated to the United States by the Constitution, nor prohibited by it to the states, are reserved to the states respectively, or to the people.
FISCAL EFFECT: According to the Assembly Appropriations Committee, unknown significant costs, likely in the hundreds of thousands of dollars annually, for the Department of Justice to handle increased workload associated with litigation.
COMMENTS: The common law "privilege from arrest" protects persons from "civil arrest" while they are attending a court proceeding. Unlike a "criminal" arrest, which is based on probable cause that the arrestee committed a crime, a "civil arrest" compels a person's attendance as a witness or party in a civil suit or proceeding. Civil arrests are not as common as they once were, but they have not completely disappeared.
In order to protect the sanctity and smooth operation of the courts of this state, this bill would effectively codify the common law privilege from civil arrest. Specifically, it does the following: 1) clarifies the power of judicial officers to prevent activities that threaten access to courthouses extends to protecting persons from civil arrest while in court; 2) provides that no person shall be subject to civil arrest of any type while attending a courthouse or court proceeding; 3) specifies that a violation of this section is punishable as a contempt of court; and (4) authorize the Attorney General to bring a civil action in the name of the people to obtain appropriate equitable and declaratory relief if the Attorney General has reasonable cause to believe that a violation has occurred.
Analysis Prepared by: Thomas Clark / JUD. / (916) 319-2334 FN: 0004735
SENATE THIRD READING
STR Bill Id:SB 349
Author:(Lara)
As Amended Ver:September 22, 2017
Majority vote
SENATE VOTE: 24-15
Committee | Votes | Ayes | Noes |
Health | 10-4 | Wood, Maienschein, Bonta, Kalra, Limón, McCarty, Rodriguez, Santiago, Thurmond, Chau | Gallagher, Patterson, Ridley-Thomas, Waldron |
Appropriations | 10-5 | Gonzalez Fletcher, Bloom, Bocanegra, Bonta, Calderon, Chau, Friedman, Eduardo Garcia, Jones-Sawyer, Reyes | Bigelow, Brough, Fong, Gallagher, Obernolte |
SUMMARY: Requires, commencing January 1, 2020, chronic dialysis clinics (CDCs) to meet minimum staffing ratios at all times for nurses, technicians, social workers, and registered dieticians, as specified. Requires the Department of Public Health (DPH), no later than January 1, 2020, to issue regulations that specify an appropriate amount of transition time between patients, and requires a CDC, if DPH has not issued regulation by January 1, 2020, to ensure that the minimum transition time is at least 45 minutes. Specifies that DPH may grant a waiver to a CDC in a rural county, as defined, if the waiver does not jeopardize the health, safety, and well-being of affected patients. Requires DPH to inspect CDCs annually and authorizes DPH to assess administrative penalties for violations of the staffing ratios. Specifically, this bill:
- Establishes the following definitions:
- "At all times" means times during which employees, including, but not limited to nurses and technicians, are provided meal periods and rest or other breaks;
- "Charge nurse," "nurse manager," "registered social worker," and "registered dietician" as having the same meaning as in specified federal regulations pertaining to Centers for Medicaid and Medicare Services (CMS) dialysis clinic requirements;
- "Nurse" is a licensed registered nurse (RN);
- "Technician" is a person who is a certified hemodialysis technician (CHT) and who also meets the CMS definition of a patient care dialysis technician, as specified;
- "Trainee" is a person who is undergoing training to become a technician, but who has not been certified as a CHT;
- "Transition time" is the period of time beginning when one patient has completed treatment and has been disconnected from the dialysis machine and ending when the next patient is placed in the treatment station, but does not mean the period of time after the last patient of the day leaves the treatment station;
- "Treatment station" is a physical location within a CDC where an individual patient is dialyzed; and,
- "Rural county" means a county that has a population of less than 250,000 and does not have a single urbanized area with a population of greater than 50,000.
- Requires a CDC, commencing January 1, 2020, to ensure that the following minimum staffing ratios are met at all times that patients are receiving, or preparing to receive, direct care:
- At least one nurse is providing direct care for every eight patients. Specifies that a nurse only counts toward this ratio during time periods the nurse has no responsibilities other than direct care, and that a nurse manager or charge nurse does not count toward this ratio; and,
- At least one technician is providing direct care for every three patients. Specifies that a technician only counts toward this ratio during time periods the technician has no responsibilities other than direct care, that trainees do not count toward this ratio, and that nurses counted toward the nurse-to-patient ratio do not count toward this ratio.
- Specifies that commencing January 1, 2020, a CDC must ensure that social workers and registered dieticians are not assigned more than 75 patients receiving care from the CDC, regardless of the location where each patient undergoes dialysis.
- Specifies that the ratios described in 2) and 3) above constitute the minimum number of nurses, technicians, social workers, and registered dietitians assigned to patients at all times, and that additional nurses, technicians, social workers, and registered dieticians must be assigned to the extent necessary to ensure the patient-to-staff ratio is appropriate to the level of dialysis care given and meets the needs of patients.
- Requires DPH, no later than January 1, 2020, to issue regulations that specify an appropriate minimum transition time that provides patients sufficient time to recuperate after treatment and provide sufficient time to comply with safety and hygiene protocols. Requires a CDC, if DPH has not issued those regulations on or before January 1, 2020, to ensure that the minimum transition time is at least 45 minutes. .
- Prohibits DPH from issuing a license to any CDC unless the CDC demonstrates the ability and intention to comply with these provisions.
- Requires every licensed CDC to maintain, and provide the following information to DPH on a form prescribed by DPH, including, at a minimum:
- Actual staffing ratio and transition time data for the period covered by the submission, including daily totals of the total number and actual hours worked by nurses and technicians; the total number of patients and actual hours receiving direct care; the daily average transition time for each station; and, for each week, the total number of full-time equivalent social workers and registered dietitians and the total number of patients assigned to social workers and registered dietitians; and,
- Every instance, no matter how brief, during the period covered by the submission when staffing ratios or transition times did not meet requirements, and the reasons and circumstances therefor.
- Requires the chief executive officer or administrator of the CDC to personally certify that he or she is satisfied, after review, that all information submitted pursuant to 7) above, is accurate and complete.
- Authorizes DPH to grant a waiver of the requirements in 2), 3), and 6) above, to a CDC in a rural county if the waiver does not jeopardize the health, safety, and well-being of affected patients and is needed for increased operational efficiency.
- Requires a CDC to submit the information specified in 7) above, to DPH on a schedule and in a format prescribed by DPH, but no less frequently than four times per year.
- Requires DPH to annually inspect each licensed CDC, and to conduct such inspections as often as necessary to ensure compliance with the staffing ratios, the accuracy and completeness of the information submitted pursuant to 7) above, and the adequacy of the quality of care being provided.
- Requires DPH, within 60 days of receiving a complaint that a CDC has committed a violation of this bill, to investigate the CDC and, if the evidence shows a violation has occurred, authorizes DPH to suspend or revoke the CDC's license.
- Specifies that any writing, record, or document received, owned, used, or retained by DPH in connection with these provisions is a public record and is open to inspection pursuant to the California Public Records Act. Requires DPH to redact any personal identifying information associated with named individuals to the extent required to prevent an unwarranted invasion of personal privacy.
- Deletes end stage renal disease (ESRD) facilities from the current exemption from required periodic inspections by DPH.
- Specifies that these provisions do not apply to home dialysis-related training and services, except as required in 3) above.
- Authorizes DPH to assess an administrative penalty against a CDC for violations of this bill. Requires penalties to be classified as a major violation, an intermediate violation, or a minor violation according to the nature of the violation and the threat of harm to patients. Specifies that a major violation is subject to an administrative penalty of up to $10,000, and an intermediate violation is subject to an administrative penalty of up to $5,000. Prohibits DPH from assessing a penalty for a minor violation.
- Requires DPH to adopt regulations establishing criteria to assess an administrative penalty against a CDC that includes, but is not limited to, consideration of all of the following:
- The probability and severity of the risk that the violation presents to the patient;
- The actual harm to patients, if any;
- The nature, scope, and severity of the violation;
- The CDC's history of compliance with related state and federal statutes and regulations, including, but not limited to, the similarity in circumstances of the violation to any previous violation by the CDC within a 24-month period;
- Factors beyond the control of the CDC that restricts its ability to comply with this chapter or the rules and regulations adopted by DPH;
- The demonstrated willfulness of the violation; and,
- The extent to which the CDC detected the violation and took immediate action to correct the violation and prevent that type of violation from recurring.
- Permits a CDC to dispute a determination by DPH regarding an alleged deficiency, or the reasonableness of a penalty, by requesting a hearing within 10 working days. Requires a CDC to pay all administrative penalties when all appeals have been exhausted and DPH's position has been upheld.
- States the intent of the Legislature that California taxpayers not be financially responsible for implementation and enforcement of minimum staffing requirements at CDCs, and requires DPH to take into account all costs associated with implementing and enforcing this bill when calculating, assessing, and collecting fees imposed on CDCs.
- Specifies that this bill is not intended to impact nurse-to-patient ratios applicable to general acute care hospitals, acute psychiatric hospitals, or special hospitals, as defined.
- Requires DPH to issue regulations necessary to implement this bill no later than two years following its effective date.
FISCAL EFFECT: According to the Assembly Appropriations Committee:
- DPH will incur $66,000 in costs this fiscal year and approximately $2.9 million annually ongoing to implement this bill. Most of the costs are associated with hiring new personnel to conduct annual inspections.
- Potential minor revenues to the State Facilities Citation Account if penalties are assessed using the new authority granted in the bill.
- Facilities report this bill will reduce their flexibility and efficiency, and will significantly increase their labor costs. Although increasing provider costs can result in pressure on provider rates generally, Medi-Cal rates do not automatically respond to provider cost increases. However, to the extent this bill increases the cost of providing dialysis services; it could result in cost pressure on dialysis payers, including Medi-Cal, to raise rates.
COMMENTS: According to the author, California currently regulates dialysis clinics using the bare minimum standards required by federal law. The author states that the purpose of this bill is to improve dialysis patient safety and reduce avoidable medical complications for patients receiving treatment at outpatient clinics. The author states this goal will be achieved by establishing minimum staffing ratios, increasing clinic inspections, and requiring adequate time to clean and prepare dialysis equipment between patients. The author concludes that without this bill, the more than 63,000 patients who rely on California's dialysis clinics to survive will continue to receive care in facilities that are not held accountable for failing to meet best practices related to patient safety.
A CDC provides care for the treatment of patients with ESRD, including renal dialysis services. ESRD, also known as kidney failure, is when the kidneys, which remove waste and excess water from the body, are no longer able to work at a level needed for day-to-day life. The most common causes of ESRD in the United States are diabetes and high blood pressure. Dialysis does some of the job of the kidneys when they stop working, including removing extra salt, water, and waste products so they do not build up in the body. A typical patient with ESRD will need to go to a CDC three times a week for dialysis treatment, with each treatment taking about four hours.
According to the United States Renal Data System (USRDS), ESRD affects almost 650,000 people per year in the United States. The disease disproportionately affects the nation's minority and low-income patients. Compared to whites: African Americans are 3.5 times more likely to have ESRD; Native Americans are 1.5 times more likely to have ESRD; and, Hispanics are 1.5 times more likely to have ESRD.
The number of patients in the United States diagnosed with ESRD is increasing by 5% each year. Mortality rates vary depending on the ESRD treatment. After one year of treatment, those on dialysis have a 20-25% mortality rate, with a five year survival rate of 35%. Persons who receive transplants have a 3% mortality rate after five years. USRDS data shows wide variation in the prevalence of ESRD throughout the United States, with the highest rates in the Ohio and Mississippi River valleys, the Southeast, Texas, and California.
Among hemodialysis patients, bloodstream and other types of infections are a leading cause of death, second only to vascular disease. In 2008, the Centers for Disease Control and Prevention estimated that 37,000 bloodstream infections occurred among hemodialysis patients with central lines. One in four of these infected patients may have died as a result of the infection. Since 1993, hospitalization rates among hemodialysis patients have increased 47% for bloodstream infection and 87% for vascular access infection.
In 2016, 10,067 Californians died while on dialysis, up from 9,777 in 2015, a 2.5% increase. The leading causes of death were cardiac-related and infection.
Cause of Death | Northern California | Southern California | California Total |
Cardiac-related | 1,244 | 3,303 | 4,547 |
Infection | 314 | 514 | 828 |
All other/unknown | 1,958 | 2,734 | 4,692 |
Total | 3,516 | 6,551 | 10,067 |
- CDCs in California, CMS certification standards, and staffing requirements. According to DPH, there are currently 570 licensed CDCs in California. Fourteen CDC applicants are awaiting their initial licensure survey. The length of time these 14 applications have been pending range from eight days to more than 400 days. Currently, there are 20 CDCs that have been licensed, but are awaiting the CMS certification survey. According to DPH, it cannot proceed with the CMS certification survey until it has received approval from CMS. Once DPH receives the approval from CMS, the CDC is informed that there will be an unannounced survey within one to two months. A CDC may apply for a priority exemption request from CMS to shorten this wait, but DPH states that these are rarely granted, except in areas where the CDC can demonstrate a shortage of providers.
While there has been a longstanding requirement for DPH to promulgate regulations governing CDCs, to date they have not done so. In 2013, legislation was passed allowing DPH to enforce federal CMS requirements pertaining to ESRD facilities, until DPH adopts regulations relating to the provision of services by a CDC. CMS contracts with DPH to evaluate facilities to certify that they meet federal requirements to become Medicare and Medi-Cal providers, including for CDCs. DPH performs these functions directly, through various field offices, in most of the state, but contracts with Los Angeles County for the licensing and CMS certification function of health facilities located in Los Angeles County.
CMS certification standards with respect to on-site staffing in CDCs require that an adequate number of qualified personnel must be present whenever patients are undergoing dialysis so that the patient-to-staff ratio is appropriate to the level of dialysis care given and meets the needs of patients. CMS guidance states that consideration should be given to the acuity and care needs of patients, and that sufficient numbers of staff must be present in the treatment area "to be able to see every patient during treatment (including lunch breaks, shift change, etc.); to deliver routine care, patient assessment and monitoring per facility policy; and to promptly respond to and address patient needs (such as changes in physical or mental condition) and machine alarms."
In addition to the on-site staffing, a CDC must also provide "adequate laboratory, social, and dietetic services to meet the needs" of the patient. With regard to the social services, CMS requires these to be provided by a qualified social worker that is either employed or contracted with the CDC, but there is no specific ratio, and the social worker is not required to be on site.
- CHTs. CHTs are certified and regulated by DPH. The scope of practice for CHTs includes performing venipuncture and arterial puncture for the purpose of providing dialysis treatment for a patient, including the administration of local anesthetics, pursuant to a protocol established by the medical director of the CDC. CHTs must work under the immediate supervision of either a physician or RN, unless treating patients in the home. CHTs must have a high school diploma or equivalent, have successfully completed an approved training program covering specified subjects, including, possible complications of dialysis, infection control, safety, and dialyzer reprocessing, and pass a standardized test. Training programs can be provided in a CDC, under the direction of an RN, a community or corporate-based training program, or a program offered by an educational institution. According to DPH, there are currently 7,717 active CHTs in California.
- University of California (UC), Davis Report. Pursuant to SB 534 (Hernandez), Chapter 722, Statutes of 2013, DPH requested the UC Davis Institute for Population Health Improvement to conduct a study that "describes the extent to which federal certification standards are or are not sufficient as a basis for state licensing standards," with regard to ambulatory surgery clinics, comprehensive outpatient rehabilitation facilities, and CDCs. As part of this report, the study looked at any known quality issues – defined broadly as concerns related to safety, effectiveness, patient-centeredness, timeliness, efficiency, and equity. The study concluded that California's use of CMS certification standards as the basis for state licensure is consistent with standard practice across the nation, that better compliance with existing federal regulations would likely address many of the documented quality problems DPH has cited in these facilities, and that expanded state-specific regulations would be of uncertain marginal value.
However, according to the study, the authors reviewed four journal articles focusing on efficiency, and three of the articles explored issues relating to staffing levels. The studies found large regional differences in patient-nurse staffing ratios, and staffing levels were significantly associated with clinical outcomes. High patient-to-nurse ratios were linked to an increased number of adverse events. - Complaints. According to DPH, between July 1, 2014 and February 15, 2017, it received 577 complaints for CDCs, and issued 370 deficiencies during this same time period as a result of all visits, including both periodic surveys and complaint investigations. Of these 577 complaints, 483 were received anonymously, patients or family members submitted 69 complaints, and facility staff or organizations submitted the remaining 25.
- Recent CMS guidance regarding cleaning patient dialysis stations. On June 2, 2017, CMS issued a letter to all state inspection authorities (including DPH) recommending that a dialysis station, in order to prevent cross contamination, be completely vacated by the previous patient before clinic staff may begin cleaning and disinfection of the station and set up for the next patient. The letter also noted that patients should not be moved from the dialysis station until they are clinically stable.
- Other states. According to information provided by both the author's office and the dialysis industry, there are eight states that have staffing ratios for RNs and CHTs, as follows:
State | Ratios |
Georgia | CHTs, 1:4; RNs, 1:10 |
Maryland | CHTs and RNs, 1:3 day shifts and 1:4 for nocturnal dialysis |
Massachusetts | Blended ratio of 1:3 |
Oregon | Blended ratio of 1:4 (with minimum RN ratio of 1:16)** |
New Jersey | Blended ratio of 1:3 (with minimum RN ratio of 1:9) |
South Carolina | Blended ratio of 1:4 (with minimum RN ratio of 1:10) |
Texas | Blended ratio of 1:4 (with minimum RN ratio of 1:12) |
Utah | CHTs, 1:4; RNs, 1:10; or 1:12 if clinic uses 3 pods of 4 patients |
** Note: If RN ratio exceeds 1:12, then RN cannot be included in 1:4 ratio
Only two states have ratios for social workers: Texas specifies a social worker ratio of 1:100, unless the social worker is given additional personnel to assist, in which case it can go to 1:125. Louisiana requires dialysis clinics to adhere to the Council of Nephrology Social Worker's Guideline, which is 1:75.
- DPH regulations. Currently, DPH is working on 20 regulatory packages that are at different stages in the development process, and there are currently 12 regulatory packages which have not been started, including several updates to standards of care for specified hospital services including Nursing, Surgical & Anesthesia, and Patient Rights, an update to Title 22 regulatory requirements establishing minimum, specific, and numerical nurse-to-patient ratios for direct care givers in acute psychiatric hospitals by licensed nurse classification and by unit, and regulations that are needed to establish standards that govern Congregate Living Health Facilities.
DPH states that the last regulatory package in the work plan is scheduled to be filed at the Secretary of State office in 2024, and as new laws are chaptered requiring clarification, Title 22 will continue to be updated.
- DPH Licensing and Certification Program (L&C). DPH L&C is responsible for regulatory oversight of licensed health facilities and health care professionals to ensure safe, effective, and quality healthcare for Californians. L&C fulfills this role by conducting periodic inspections and complaint investigation of health facilities to ensure that they comply with federal and state laws and regulations. However, there have been long-standing concerns about the L&C program. A 2014 California State Auditor report highlighted gaps in state oversight of health facilities and certain professionals that work in these facilities. While the focus of the audit was on nursing homes, DPH acknowledged that they also faced a backlog of complaint investigations that are hospital-based. The 2015-16 Budget provided DPH L&C with an additional $19.8 million for 237 positions over two years to address workload and to do licensing surveys of hospitals every three years, as is statutorily required.
At present, L&C is not caught up on the backlog and is unable to inspect each hospital every three years. According to DPH, it is prioritizing inspections at hospitals that have higher rates of infection compared to other facilities and this prioritization will occur until all hospitals are inspected every three years.
The California State Council of the Service Employees International Union (SEIU California) is a cosponsor of this bill and states in support that dialysis is a life-saving treatment for people with ESRD, and during each treatment, the patient's blood is removed, filtered, and returned to their body. SEIU California notes that while ongoing dialysis is essential for patients with ESRD, this treatment comes with serious potential risks, including blood infections from contaminated equipment, vitamin imbalances, nausea, bleeding, and heart failure. SEIU California contends that insufficient staff, insufficient time for health care workers to properly clean equipment and wash their hands, and long gaps between regular inspections may all increase the risk of these potential complications. SEIU California concludes, without this bill, the more than 63,000 patients who rely on California's dialysis clinics will continue to receive care in clinics that are not held accountable to best practices for staffing and patient transition times.
The United Nurses Associations of California/Union of Health Care Professionals (UNAC/UHCP) is also a cosponsor of this bill and states in support that California currently has approximately 550 dialysis clinics serving 50,000 patients per year. UNAC/UHCP notes that these clinics are governed by federal law that sets very ambiguous standards for ensuring patient safety, for example, clinics are required to ensure that an "adequate number of qualified personnel" are present during dialysis to ensure that an "appropriate" level of dialysis is given to meet the needs of the patients. UNAC/UHCP concludes that fortunately, federal law allows states to set higher standards, which this bill will do by establishing that dialysis technicians would be responsible for no more than three patients at a time and RNs no more than eight patients at a time, and would also require dialysis clinics to undergo annual inspections by DPH.
DaVita is opposed to this bill, and states that the bill's requirement to meet staffing ratios "at all times," and the 45-minute empty chair mandate between patient treatments, will impede the ability of healthcare professionals working in dialysis clinics to use their professional judgment to tailor treatments to individual patient needs. DaVita also contends that this bills' mandates will restrict the ability of many clinics to continue operating a fourth patient shift at times convenient for working patients, thereby drastically reducing treatment availability at a time when California needs additional dialysis treatment capacity, not less.
Fresenius Medical Care North America (FMCNA) states in opposition to this bill that the requirements are unnecessary, noting that in 2008 CMS evaluated whether staffing ratios should be required in dialysis facilities across the country as part of their revision of existing regulations, and instead of staffing ratios, instituted a national, multi-disciplinary Quality Assessment and performance Improvement program. FMCNA notes that this program is closely monitored, tracked, and improvement plans are conducted as needed, with Medicare reimbursement now tied to quality outcomes.
Analysis Prepared by: Lara Flynn / HEALTH / (916) 319-2097 FN: 0001738
Date of Hearing: August 30, 2017
ASSEMBLY COMMITTEE ON APPROPRIATIONS
Lorena Gonzalez Fletcher, Chair
SBPCA Bill Id:SB 349
Author:(Lara) – As Amended Ver:August 22, 2017
Policy Committee: | Health | Vote: | 10 - 4 |
Urgency: No State Mandated Local Program: Yes Reimbursable: No
SUMMARY:
This bill requires minimum staffing ratios for dialysis clinics and a minimum transition time between dialysis patients, as follows, commencing January 1, 2020:
- One nurse providing direct care for every eight patients, excluding a charge nurse or nurse manager (1:8), excluding patients on home dialysis.
- One technician providing direct care for every three patients, exclusive of nurses or technician trainees (1:3), excluding patients on home dialysis.
- Limits caseload of a full-time equivalent social worker and a full-time equivalent individual registered dietitian to no more than 75 patients (1:75).
- Requires the California Department of Public Health (CDPH) to issue regulations that specify an appropriate minimum transition time between patients, and requires facilities to ensure a minimum 45-minute transition time if regulations have not been adopted by January 1, 2020.
This bill also:
- Prohibits CDPH from issuing a license to any chronic dialysis clinic unless that chronic dialysis clinic demonstrates the ability and intention to comply with specified laws.
- Specifies record-keeping and reporting requirements, including quarterly reporting to CDPH.
- Authorizes CDPH to grant waivers of the staffing and transition time requirements for rural clinics, as specified.
- Requires CDPH to inspect chronic dialysis clinics annually, and requires the department to initiate complaint investigations within 60 days.
- Authorizes CDPH to assess administrative penalties of up to $10,000 against a chronic dialysis clinic for specified violations, provides for appeals of such assessments, and requires CDPH to promulgate regulations establishing criteria to assess an administrative penalty based on specified factors, and any other necessary regulations, within two years.
- Authorizes, prior to the adoption of regulations, administrative penalties of $10,000 per immediate jeopardy violations.
- Specifies fees shall be adjusted to account for any increased costs to enforce or implement this bill.
FISCAL EFFECT:
- CDPH will incur $66,000 in costs this fiscal year and approximately $2.9 million annually ongoing to implement this bill. Most of the costs are associated with hiring new personnel to conduct annual inspections.
- Potential minor revenues to the State Facilities Citation Account if penalties are assessed using the new authority granted in the bill.
- Facilities report this bill will reduce their flexibility and efficiency, and will significantly increase their labor costs. Although increasing provider costs can result in pressure on provider rates generally, Medi-Cal rates do not automatically respond to provider cost increases. However, to the extent this bill increases the cost of providing dialysis services, it could result in cost pressure on dialysis payers, including Medi-Cal, to raise rates.
COMMENTS:
- Purpose. This bill is intended to improve the quality of patient care at dialysis centers by increasing frequency of inspections, requiring a higher level of staffing, and imposing a minimum transition time between patients at dialysis machines.
- Background. A dialysis clinic provides treatment of patients with end-stage renal disease (ESRD). ESRD, also known as kidney failure, is a condition in which kidneys can no longer adequately remove waste and excess water from the body. Dialysis filters the blood, performs the functions of the failed kidney. A typical ESRD patient receives three four-hour treatments per week. The most common causes of ESRD in the United States are diabetes and high blood pressure, and it disproportionately affects minority and low-income patients.
- Dialysis Clinics in California. CDPH licenses about 570 clinics in California. CDPH is charged with promulgating regulations governing dialysis clinics, but to date they have not done so. Current law allows the department to enforce federal requirements pertaining to dialysis clinics, until state regulations are adopted. However, a recent report by the Institute for Population Health at UC Davis, commissioned by CDPH, concluded California’s use of CMS certification standards as the basis for state licensure is consistent with standard practice across the nation, and that expanded state-specific regulations for dialysis clinics would be of uncertain marginal value. The report noted improved compliance with existing regulations, including those related to infection control, would address many of the quality concerns that were cited. CDPH concurred with the findings that federal standards are adequate. Finally, the report notes consideration of the need for expanded regulatory oversight of dialysis clinics should be based on a detailed, evidence-based understanding of quality problems and how regulations would specifically address the root causes of such problems.
- Staffing. Federal Centers for Medicare and Medicaid Services (CMS) certification standards with respect to on-site staffing in dialysis clinics require an adequate number of qualified personnel to be present whenever patients are undergoing dialysis, such that the patient-to-staff ratio is appropriate to the level of care and meets the needs of patients. In addition to the on-site staffing, a clinic must also provide “adequate laboratory, social, and dietetic services to meet the needs” of the patient, but does not specify maximum caseloads for social workers and dieticians. Eight other states have minimum staffing ratios, which the dialysis industry notes were instituted prior to a 2008 CMS review of dialysis clinic standards. Compared to these other states, the 1:3 hemodialysis technician-to-patient ratio, and the 1:8 nurse to patient ratio proposed by SB 349 are similar but somewhat more aggressive.
The state-commissioned study mentioned above reviewed literature related to staffing. Although there was no systematic correlation observed in quality of care between states that imposed staff-to-patient ratios and states that did not, the review found large regional differences across the country in patient-nurse staffing ratios, and that actual staffing levels were significantly associated with clinical outcomes. Specifically, studies suggest higher staffing levels result in better patient outcomes. However, no studies established an evidence basis for a specific ratio.
- Transition time. This bill requires imposition of a minimum transition time on a dialysis station between patients, in order to allow adequate time for disinfection. On June 2, 2017, CMS issued a letter to all state inspection authorities (including CDPH) recommending that a dialysis station, in order to prevent cross contamination, be completely vacated by the previous patient before clinic staff may begin cleaning and disinfection of the station and set up for the next patient. The letter also noted that patients should not be moved from the dialysis station until they are clinically stable. There is no minimum length of time required in law or regulation; according to dialysis facilities, the transition time varies due to patient needs.
- Support. The California State Council of the Service Employees International Union (SEIU California), a co-sponsor of this bill, contends that insufficient staff, insufficient time for health care workers to properly clean equipment and wash their hands, and long gaps between regular inspections may all increase the risk of complications for dialysis patients.
The United Nurses Associations of California/Union of Health Care Professionals (UNAC/UHCP), also a co-sponsor, notes dialysis clinics are governed by federal law that sets very ambiguous standards for ensuring patient safety—for instance, clinics are required to ensure that an "adequate number of qualified personnel" are present during dialysis to ensure that an "appropriate" level of dialysis is given to meet the needs of the patients. UNAC/UHCP concludes that fortunately, federal law allows states to set higher standards, which this bill will do. - Opposition. DaVita is opposed to this bill, noting the bill's requirement to meet staffing ratios "at all times" and the imposition of a mandatory transition time between patient treatments will impede the ability of clinic staff to use their professional judgment to tailor treatments to individual patient needs. DaVita also contends this bill's mandates will restrict the ability of many clinics to continue operating a fourth patient shift at times convenient for working patients, thereby drastically reducing treatment availability at a time when California needs additional dialysis treatment capacity, not less.
Fresenius Medical Care North America states in opposition to this bill that the requirements are unnecessary, noting that in 2008 CMS evaluated whether staffing ratios should be required in dialysis facilities across the country as part of their revision of existing
regulations, and instead of staffing ratios, instituted a national, multi-disciplinary Quality Assessment and Performance Improvement program to improve care quality.
Analysis Prepared by: Lisa Murawski / APPR. / (916) 319-2081
Date of Hearing: June 27, 2017
ASSEMBLY COMMITTEE ON HEALTH
Jim Wood, Chair
SBPCA Bill Id:SB 349
Author:(Lara) – As Amended Ver:May 26, 2017
SENATE VOTE: 24-15
SUBJECT: Chronic dialysis clinics: staffing requirements.
SUMMARY: Requires, commencing January 1, 2019, chronic dialysis clinics (CDCs) to meet minimum staffing ratios at all times for nurses, technicians, social workers, and registered dieticians, as specified, and to ensure the transition time between patients is at least 45 minutes. Requires the Department of Public Health (DPH) to inspect CDCs annually and authorizes DPH to assess administrative penalties for violations of the staffing ratios. Specifically, this bill:
- Establishes the following definitions:
- "At all times" means times during which employees, including, but not limited to nurses and technicians, are provided meal periods and rest or other breaks;
- "Charge nurse," "nurse manager," "registered social worker," and "registered dietician" as having the same meaning as in specified federal regulations pertaining to Centers for Medicaid and Medicare Services (CMS) dialysis clinic requirements;
- "Nurse" is a licensed registered nurse (RN);
- “Technician” is a person who is a certified hemodialysis technician (CHT) and who also meets the CMS definition of a patient care dialysis technician, as specified;
- “Trainee” is a person who is undergoing training to become a technician, but who has not been certified as a CHT;
- “Transition time” is the period of time beginning when one patient has completed treatment and has been disconnected from the dialysis machine and ending when the next patient is placed in the treatment station, but does not mean the period of time after the last patient of the day leaves the treatment station; and,
- “Treatment station” is a physical location within a CDC where an individual patient is dialyzed.
- Requires a CDC, commencing January 1, 2019, to ensure that the following minimum staffing ratios are met at all times that patients are receiving, or preparing to receive, direct care:
- At least one nurse is providing direct care for every eight patients. Specifies that a nurse only counts toward this ratio during time periods the nurse has no responsibilities other than direct care, and that a nurse manager or charge nurse does not count toward this ratio; and,
- At least one technician is providing direct care for every three patients. Specifies that a technician only counts toward this ratio during time periods the technician has no responsibilities other than direct care, that trainees do not count toward this ratio, and that nurses counted toward the nurse-to-patient ratio do not count toward this ratio.
- Specifies that commencing January 1, 2019, a CDC must ensure that social workers and registered dieticians are not assigned more than 75 patients.
- Specifies that the ratios described in 2) and 3) above constitute the minimum number of nurses, technicians, social workers, and registered dietitians assigned to patients at all times, and that additional nurses, technicians, social workers, and registered dieticians must be assigned to the extent necessary to ensure that an adequate number of qualified personnel are present whenever patients are undergoing dialysis so that the patient-to-staff ratio is appropriate to the level of dialysis care given and meets the needs of patients.
- Requires, commencing January 1, 2019, a CDC to ensure that the transition time is at least 45 minutes.
- Prohibits DPH from issuing a license to any CDC unless the CDC demonstrates the ability and intention to comply with these provisions.
- Requires every licensed CDC to maintain, and provide the following information to DPH on a form prescribed by DPH, including, at a minimum:
- Actual staffing ratio and transition time data for the period covered by the submission, including daily totals of the total number and actual hours worked by nurses, technicians, social workers, and registered dietitians; the total number of patients and actual hours receiving direct care; and, the average transition time for each treatment station; and,
- Every instance, no matter how brief, during the period covered by the submission when staffing ratios or transition times did not meet requirements, and the reasons and circumstances therefor.
- Actual staffing ratio and transition time data for the period covered by the submission, including daily totals of the total number and actual hours worked by nurses, technicians, social workers, and registered dietitians; the total number of patients and actual hours receiving direct care; and, the average transition time for each treatment station; and,
- Requires the chief executive officer or administrator of the CDC to personally certify that he or she is satisfied, after review, that all information submitted pursuant to 7) above is accurate and complete.
- Requires a CDC to submit the information specified in 7) above to DPH on a schedule and in a format prescribed by DPH, but no less frequently than four times per year.
- Requires DPH to annually inspect each licensed CDC, and to conduct such inspections as often as necessary to ensure compliance with the staffing ratios, the accuracy and completeness of the information submitted pursuant to 7) above, and the adequacy of the quality of care being provided.
- Requires DPH, within 60 days of receiving a complaint that a CDC has committed a violation of this bill, to investigate the CDC and, if the evidence shows a violation has occurred, authorizes DPH to suspend or revoke the CDC's license.
- Specifies that any writing, record, or document received, owned, used, or retained by DPH in connection with these provisions is a public record and is open to inspection pursuant to the California Public Records Act. Requires DPH to redact any personal identifying information associated with named individuals to the extent required to prevent an unwarranted invasion of personal privacy.
- Deletes end stage renal disease (ESRD) facilities from the current exemption from required periodic inspections by DPH.
- Authorizes DPH to assess an administrative penalty against a CDC for violations of this bill. Requires penalties to be classified as a major violation, an intermediate violation, or a minor violation according to the nature of the violation and the threat of harm to patients. Specifies that a major violation is subject to an administrative penalty of up to $10,000, and an intermediate violation is subject to an administrative penalty of up to $5,000. Prohibits DPH from assessing a penalty for a minor violation.
- Requires DPH to adopt regulations establishing criteria to assess an administrative penalty against a CDC that includes, but is not limited to, consideration of all of the following:
- The probability and severity of the risk that the violation presents to the patient;
- The actual harm to patients, if any;
- The nature, scope, and severity of the violation;
- The CDC’s history of compliance with related state and federal statutes and regulations, including, but not limited to, the similarity in circumstances of the violation to any previous violation by the CDC within a 24-month period;
- Factors beyond the control of the CDC that restricts its ability to comply with this chapter or the rules and regulations adopted by DPH;
- The demonstrated willfulness of the violation; and,
- The extent to which the CDC detected the violation and took immediate action to correct the violation and prevent that type of violation from recurring.
- The probability and severity of the risk that the violation presents to the patient;
- Permits a CDC to dispute a determination by DPH regarding an alleged deficiency, or the reasonableness of a penalty, by requesting a hearing within 10 working days. Requires a CDC to pay all administrative penalties when all appeals have been exhausted and DPH’s position has been upheld.
- States the intent of the Legislature that California taxpayers not be financially responsible for implementation and enforcement of minimum staffing requirements at CDCs, and requires DPH to take into account all costs associated with implementing and enforcing this bill when calculating, assessing, and collecting fees imposed on CDCs.
- Specifies that this bill is not intended to impact nurse-to-patient ratios applicable to general acute care hospitals, acute psychiatric hospitals, or special hospitals, as defined.
- Requires DPH to issue regulations necessary to implement this bill no later than 180 days following its effective date.
EXISTING LAW:
- Licenses and regulates various clinics by DPH, including primary care clinics and specialty clinics which include: surgical clinics; CDCs; and, rehabilitation clinics. Requires DPH to adopt reasonable rules and regulations as necessary to enable DPH to carry out the licensure of clinics.
- Requires CDCs, until January 1, 2018, to comply with CMS certification standards for an ESRD clinic, as specified, until DPH adopts regulations relating to the provision of services by a CDC. Requires DPH to conduct a public hearing and submit a report that describes the extent to which the federal certification standards are or are not sufficient as a basis for state licensing standards, and to make recommendations for any California-specific standard that may be necessary.
- Requires DPH to periodically inspect every clinic for which a license or special permit has been issued; specifies that the frequency of inspections depends upon the type and complexity of the clinic or special service to be inspected; and requires inspections to be conducted no less often than once every three years and as often as necessary to ensure the quality of care being provided.
- Provides for the certification of CHTs by DPH, defined as unlicensed health care providers who are employed by a hemodialysis clinic or unit for the purpose of participating in the direct treatment of patients undergoing hemodialysis.
- Requires DPH to adopt regulations that establish minimum, specific, and numerical licensed nurse-to-patient ratios, by licensed nurse classification and by hospital unit, for hospitals, and requires these ratios to constitute the minimum number of registered and licensed nurses that must be allocated. Requires flexibility for rural general acute care hospitals in response to their special needs.
- Establishes a structure under which DPH is permitted to assess administrative fines to general acute care hospitals, acute psychiatric hospitals, and special hospitals for violation of any of their licensing laws and regulations, including nurse-to-patient ratios, as follows:
- Permits DPH to assess an administrative penalty against a hospital, for a deficiency constituting an immediate jeopardy violation (defined as causing, or likely to cause, serious injury or death), up to a maximum of $75,000 for the first administrative penalty, up to $100,000 for the second administrative penalty, and up to $125,000 for the third and every subsequent administrative penalty;
- Permits DPH to assess an administrative penalty of up to $25,000 per violation for those not deemed to constitute immediate jeopardy; and,
- Prohibits DPH from assessing an administrative penalty for minor violations, which are defined as any violation of law relating to the operation or maintenance of a hospital that DPH determines has only a minimal relation to the health and safety of patients.
- Permits DPH to assess an administrative penalty against a hospital, for a deficiency constituting an immediate jeopardy violation (defined as causing, or likely to cause, serious injury or death), up to a maximum of $75,000 for the first administrative penalty, up to $100,000 for the second administrative penalty, and up to $125,000 for the third and every subsequent administrative penalty;
- Establishes the minimum number of actual nursing hours per patient in a skilled nursing facility (SNF) be 3.2 hours, with a specified exception related to special mental disorder treatment units. Defines nursing hours to be the number of hours of work performed per patient day by aides, nursing assistants, RNs and licensed vocational nurses.
- Requires DPH to assess an administrative penalty if DPH determines that a SNF failed to meet the nursing hours per patient day requirements, as follows: $15,000 if the SNF failed to meet the requirements for 5% or more of the audited days up to 49%; and’ $30,000 if the facility failed to meet the requirements for more than 49% of the audited days. Requires compliance with nursing hours per patient per day requirements to be included in the criteria upon which supplemental payments are made under the Quality and Accountability Supplemental Payment System.
FISCAL EFFECT: According to the Senate Appropriations Committee:
- Likely ongoing costs in the low millions per year for increased licensing inspections, complaint investigations, and enforcement actions by DPH (Licensing and Certification Fund). This bill will significantly increase the level of regulatory oversight performed by DPH. Under this bill, DPH will increase its annual inspection frequency from once every three years to once per year. In addition, the stringency of the staffing requirements in this bill is projected to result in a significant increase in complaints to DPH.
- Unknown increase in the cost to provide dialysis services by Medi-Cal managed care plans (General Fund and federal funds). By imposing staffing requirements that exceed current practices in CDCs, this bill will increase the costs to operate those clinics. This is likely to increase Medi-Cal managed care payments to CDCs, but the size of the cost increase is unknown.
COMMENTS:
- PURPOSE OF THIS BILL. According to the author, California currently regulates dialysis clinics using the bare minimum standards required by federal law. The author states that the purpose of this bill is to improve dialysis patient safety and reduce avoidable medical complications for patients receiving treatment at outpatient clinics. The author states this goal will be achieved by establishing minimum staffing ratios, increasing clinic inspections, and requiring adequate time to clean and prepare dialysis equipment between patients. The author concludes that without this bill, the more than 63,000 patients who rely on California’s dialysis clinics to survive will continue to receive care in facilities that are not held accountable for failing to meet best practices related to patient safety.
- BACKGROUND. A CDC provides care for the treatment of patients with ESRD, including renal dialysis services. ESRD, also known as kidney failure, is when the kidneys, which remove waste and excess water from the body, are no longer able to work at a level needed for day-to-day life. The most common causes of ESRD in the United States are diabetes and high blood pressure. Dialysis does some of the job of the kidneys when they stop working, including removing extra salt, water, and waste products so they do not build up in the body. A typical patient with ESRD will need to go to a CDC three times a week for dialysis treatment, with each treatment taking about four hours.
According to the United States Renal Data System (USRDS), ESRD affects almost 650,000 people per year in the United States. The disease disproportionately affects the nation’s minority and low-income patients. Compared to whites: African Americans are 3.5 times more likely to have ESRD; Native Americans are 1.5 times more likely to have ESRD; and, Hispanics are 1.5 times more likely to have ESRD.
The number of patients in the United States diagnosed with ESRD is increasing by 5% each year. Mortality rates vary depending on the ESRD treatment. After one year of treatment, those on dialysis have a 20-25% mortality rate, with a five year survival rate of 35%. Persons who receive transplants have a 3% mortality rate after five years. USRDS data shows wide variation in the prevalence of ESRD throughout the United States, with the highest rates in the Ohio and Mississippi River valleys, the Southeast, Texas, and California.
Among hemodialysis patients, bloodstream and other types of infections are a leading cause of death, second only to vascular disease. In 2008, the Centers for Disease Control and Prevention estimated that 37,000 bloodstream infections occurred among hemodialysis patients with central lines. One in four of these infected patients may have died as a result of the infection. Since 1993, hospitalization rates among hemodialysis patients have increased 47% for bloodstream infection and 87% for vascular access infection.
In 2016, 10,067 Californians died while on dialysis, up from 9,777 in 2015, a 2.5% increase. The leading causes of death were cardiac-related and infection.
Cause of Death | Northern California | Southern California | California Total |
Cardiac-related | 1,244 | 3,303 | 4,547 |
Infection | 314 | 514 | 828 |
All other/unknown | 1,958 | 2,734 | 4,692 |
Total | 3,516 | 6,551 | 10,067 |
- CDCs in California, CMS certification standards, and staffing requirements. According to DPH, there are currently 570 licensed CDCs in California. Fourteen CDC applicants are awaiting their initial licensure survey. The length of time these 14 applications have been pending range from eight days to more than 400 days. Currently, there are 20 CDCs that have been licensed, but are awaiting the CMS certification survey. According to DPH, it cannot proceed with the CMS certification survey until it has received approval from CMS. Once DPH receives the approval from CMS, the CDC is informed that there will be an unannounced survey within one to two months. A CDC may apply for a priority exemption request from CMS to shorten this wait, but DPH states that these are rarely granted, except in areas where the CDC can demonstrate a shortage of providers.
While there has been a longstanding requirement for DPH to promulgate regulations governing CDCs, to date they have not done so. In 2013, legislation was passed allowing DPH to enforce federal CMS requirements pertaining to ESRD facilities, until DPH adopts regulations relating to the provision of services by a CDC. CMS contracts with DPH to evaluate facilities to certify that they meet federal requirements to become Medicare and Medi-Cal providers, including for CDCs. DPH performs these functions directly, through various field offices, in most of the state, but contracts with Los Angeles County for the licensing and CMS certification function of health facilities located in Los Angeles County.
CMS certification standards with respect to on-site staffing in CDCs require that an adequate number of qualified personnel must be present whenever patients are undergoing dialysis so that the patient-to-staff ratio is appropriate to the level of dialysis care given and meets the needs of patients. CMS guidance states that consideration should be given to the acuity and care needs of patients, and that sufficient numbers of staff must be present in the treatment area “to be able to see every patient during treatment (including lunch breaks, shift change, etc.); to deliver routine care, patient assessment and monitoring per facility policy; and to promptly respond to and address patient needs (such as changes in physical or mental condition) and machine alarms.”
In addition to the on-site staffing, a CDC must also provide “adequate laboratory, social, and dietetic services to meet the needs” of the patient. With regard to the social services, CMS requires these to be provided by a qualified social worker that is either employed or contracted with the CDC, but there is no specific ratio, and the social worker is not required to be on site.
- CHTs. CHTs are certified and regulated by DPH. The scope of practice for CHTs includes performing venipuncture and arterial puncture for the purpose of providing dialysis treatment for a patient, including the administration of local anesthetics, pursuant to a protocol established by the medical director of the CDC. CHTs must work under the immediate supervision of either a physician or RN, unless treating patients in the home. CHTs must have a high school diploma or equivalent, have successfully completed an approved training program covering specified subjects, including, possible complications of dialysis, infection control, safety, and dialyzer reprocessing, and pass a standardized test. Training programs can be provided in a CDC, under the direction of an RN, a community or corporate-based training program, or a program offered by an educational institution. According to DPH, there are currently 7,717 active CHTs in California.
- University of California (UC), Davis Report. Pursuant to SB 534 (Hernandez), Chapter 722, Statutes of 2013, DPH requested the UC Davis Institute for Population Health Improvement to conduct a study that “describes the extent to which federal certification standards are or are not sufficient as a basis for state licensing standards,” with regard to ambulatory surgery clinics, comprehensive outpatient rehabilitation facilities, and CDCs. As part of this report, the study looked at any known quality issues – defined broadly as concerns related to safety, effectiveness, patient-centeredness, timeliness, efficiency, and equity. The study concluded that California’s use of CMS certification standards as the basis for state licensure is consistent with standard practice across the nation, that better compliance with existing federal regulations would likely address many of the documented quality problems DPH has cited in these facilities, and that expanded state-specific regulations would be of uncertain marginal value.
However, according to the study, the authors reviewed four journal articles focusing on efficiency, and three of the articles explored issues relating to staffing levels. The studies found large regional differences in patient-nurse staffing ratios, and staffing levels were significantly associated with clinical outcomes. High patient-to-nurse ratios were linked to an increased number of adverse events.
The study also summarized the number and general types of deficiencies identified at dialysis clinics. DPH identified 9,591 discrete deficiencies in 537 CDCs between September 2005 and September 2015, an average of about 959 per year. The majority (98%) were federal deficiencies, and a small minority (2%) violated CMS conditions of participation. State deficiencies usually cited violations of the life safety code standards (e.g., building fire codes). Federal deficiencies were diverse, but commonly addressed infection control and prevention. Of the 792 deficiencies DPH identified in substantiated allegations (averaging about 79 per year), quality of care was the general type of allegation that surveyors cited most often. Among the potentially serious allegations were 14 general patient safety-related incidents, as well as two instances of sexual abuse, two patient falls, and one contaminated drug/device case. - Complaints. According to DPH, between July 1, 2014 and February 15, 2017, it received 577 complaints for CDCs, and issued 370 deficiencies during this same time period as a result of all visits, including both periodic surveys and complaint investigations. Of these 577 complaints, 483 were received anonymously, patients or family members submitted 69 complaints, and facility staff or organizations submitted the remaining 25.
- Recent CMS guidance regarding cleaning patient dialysis stations. On June 2, 2017, CMS issued a letter to all state inspection authorities (including DPH) recommending that a dialysis station, in order to prevent cross contamination, be completely vacated by the previous patient before clinic staff may begin cleaning and disinfection of the station and set up for the next patient. The letter also noted that patients should not be moved from the dialysis station until they are clinically stable.
- Other states. According to information provided by both the author’s office and the dialysis industry, there are eight states that have staffing ratios for RNs and CHTs, as follows:
State | Ratios |
Georgia | CHTs, 1:4; RNs, 1:10 |
Maryland | CHTs and RNs, 1:3 day shifts and 1:4 for nocturnal dialysis |
Massachusetts | Blended ratio of 1:3 |
Oregon | Blended ratio of 1:4 (with minimum RN ratio of 1:16)** |
New Jersey | Blended ratio of 1:3 (with minimum RN ratio of 1:9) |
South Carolina | Blended ratio of 1:4 (with minimum RN ratio of 1:10) |
Texas | Blended ratio of 1:4 (with minimum RN ratio of 1:12) |
Utah | CHTs, 1:4; RNs, 1:10; or 1:12 if clinic uses 3 pods of 4 patients |
** Note: If RN ratio exceeds 1:12, then RN cannot be included in 1:4 ratio
Only two states have ratios for social workers: Texas specifies a social worker ratio of 1:100, unless the social worker is given additional personnel to assist, in which case it can go to 1:125. Louisiana requires dialysis clinics to adhere to the Council of Nephrology Social Worker’s Guideline, which is 1:75.
- DPH regulations. Currently, DPH is working on 20 regulatory packages that are at different stages in the development process, and there are currently 12 regulatory packages which have not been started, including several updates to standards of care for specified hospital services including Nursing, Surgical & Anesthesia, and Patient Rights, an update to Title 22 regulatory requirements establishing minimum, specific, and numerical nurse-to-patient ratios for direct care givers in acute psychiatric hospitals by licensed nurse classification and by unit, and regulations that are needed to establish standards that govern Congregate Living Health Facilities.
DPH states that the last regulatory package in the work plan is scheduled to be filed at the Secretary of State office in 2024, and as new laws are chaptered requiring clarification, Title 22 will continue to be updated.
- DPH Licensing and Certification Program (L&C). DPH L&C is responsible for regulatory oversight of licensed health facilities and health care professionals to ensure safe, effective, and quality healthcare for Californians. L&C fulfills this role by conducting periodic inspections and complaint investigation of health facilities to ensure that they comply with federal and state laws and regulations. However, there have been long-standing concerns about the L&C program. A 2014 California State Auditor report highlighted gaps in state oversight of health facilities and certain professionals that work in these facilities. While the focus of the audit was on nursing homes, DPH acknowledged that they also faced a backlog of complaint investigations that are hospital-based. The 2015-16 Budget provided DPH L&C with an additional $19.8 million for 237 positions over two years to address workload and to do licensing surveys of hospitals every three years, as is statutorily required.
At present, L&C is not caught up on the backlog and is unable to inspect each hospital every three years. According to DPH, it is prioritizing inspections at hospitals that have higher rates of infection compared to other facilities and this prioritization will occur until all hospitals are inspected every three years.
- DPH Licensing and Certification Program (L&C). DPH L&C is responsible for regulatory oversight of licensed health facilities and health care professionals to ensure safe, effective, and quality healthcare for Californians. L&C fulfills this role by conducting periodic inspections and complaint investigation of health facilities to ensure that they comply with federal and state laws and regulations. However, there have been long-standing concerns about the L&C program. A 2014 California State Auditor report highlighted gaps in state oversight of health facilities and certain professionals that work in these facilities. While the focus of the audit was on nursing homes, DPH acknowledged that they also faced a backlog of complaint investigations that are hospital-based. The 2015-16 Budget provided DPH L&C with an additional $19.8 million for 237 positions over two years to address workload and to do licensing surveys of hospitals every three years, as is statutorily required.
- SUPPORT. The California State Council of the Service Employees International Union (SEIU California) is a cosponsor of this bill and states in support that dialysis is a life-saving treatment for people with ESRD, and during each treatment, the patient's blood is removed, filtered, and returned to their body. SEIU California notes that while ongoing dialysis is essential for patients with ESRD, this treatment comes with serious potential risks, including blood infections from contaminated equipment, vitamin imbalances, nausea, bleeding, and heart failure. SEIU California contends that insufficient staff, insufficient time for health care workers to properly clean equipment and wash their hands, and long gaps between regular inspections may all increase the risk of these potential complications. SEIU California concludes, without this bill, the more than 63,000 patients who rely on California's dialysis clinics will continue to receive care in clinics that are not held accountable to best practices for staffing and patient transition times.
The United Nurses Associations of California/Union of Health Care Professionals (UNAC/UHCP) is also a cosponsor of this bill and states in support that California currently has approximately 550 dialysis clinics serving 50,000 patients per year. UNAC/UHCP notes that these clinics are governed by federal law that sets very ambiguous standards for ensuring patient safety, for example, clinics are required to ensure that an "adequate number of qualified personnel" are present during dialysis to ensure that an "appropriate" level of dialysis is given to meet the needs of the patients. UNAC/UHCP concludes that fortunately, federal law allows states to set higher standards, which this bill will do by establishing that dialysis technicians would be responsible for no more than three patients at a time and RNs no more than eight patients at a time, and would also require dialysis clinics to undergo annual inspections by DPH. - OPPOSITION. DaVita is opposed to this bill, and states that the bill's requirement to meet staffing ratios "at all times," and the 45-minute empty chair mandate between patient treatments, will impede the ability of healthcare professionals working in dialysis clinics to use their professional judgment to tailor treatments to individual patient needs. DaVita also contends that this bills' mandates will restrict the ability of many clinics to continue operating a fourth patient shift at times convenient for working patients, thereby drastically reducing treatment availability at a time when California needs additional dialysis treatment capacity, not less.
Fresenius Medical Care North America (FMCNA) states in opposition to this bill that the requirements are unnecessary, noting that in 2008 CMS evaluated whether staffing ratios should be required in dialysis facilities across the country as part of their revision of existing regulations, and instead of staffing ratios, instituted a national, multi-disciplinary Quality Assessment and performance Improvement program. FMCNA notes that this program is closely monitored, tracked, and improvement plans are conducted as needed, with Medicare reimbursement now tied to quality outcomes.
- CONCERNS. The National Kidney Foundation (NKF) is unable to take a position on this bill, but offered some comments from the perspective of the largest patient centric organization in the U.S. NKF recognizes the importance of ensuring dialysis facilities are sufficiently staffed, however, NKF notes that the evidence that mandating specific ratios will lead to improvements in patient care is limited, and NKF is unaware of evidenced based guidelines requiring that the dialysis chairs remain empty for 45 minutes. NKF also notes that this bill may require facilities to hire more staff, which can be difficult in certain regions of the state.
- RELATED LEGISLATION. AB 251 (Bonta) extends from January 1, 2018 to January 1, 2019, the requirement that chronic dialysis, surgical, and rehabilitation clinics comply with federal certification standards pending the adoption of regulations by DPH. AB 251 is pending in the Senate Health Committee.
- PREVIOUS LEGISLATION.
- AB 2747 (Hadley) of 2016 would have required DPH to process license applications for CDCs within 90 days and to conduct federal certification surveys of these same clinics within 60 days of approval by CMS. AB 2747 was vetoed by the Governor, whose veto message read, in part:
"Currently, the Department is taking the necessary steps to reduce the time spent processing applications for all health facilities. I believe this is a better approach than mandating timeframes for one type of facility." - SB 534 (Hernandez) among other provisions requires CDCs to comply with applicable federal certification standards for ESRD clinics until DPH adopts regulations relating to the provision of services by a CDC. Additionally, requires DPH to submit a report on the extent to which federal certification standards are, or are not, sufficient as a basis for state licensing standards.
- AB 2747 (Hadley) of 2016 would have required DPH to process license applications for CDCs within 90 days and to conduct federal certification surveys of these same clinics within 60 days of approval by CMS. AB 2747 was vetoed by the Governor, whose veto message read, in part:
- SUGGESTED AMENDMENTS.
- As noted in section e) in the Background, DPH is currently in the process of updating regulations and has 12 pending regulatory packages that have not been started. In order to create a more realistic timeframe for the completion of the regulations required by this bill, and more certainty on the implementation date, the Committee may wish to amend this bill to delay its implementation from 2019 to 2020, and require DPH to issue regulations no later than two years after the effective date.
- In order to acknowledge the difficulty in hiring and retaining health care workers in rural areas, the Committee may wish to amend this bill to give DPH the authority to grant requests for waivers to this bill that do not jeopardize the health, safety, and well-being of patients and that are needed for increased operational efficiency in rural areas.
- Given the growing demand for dialysis treatment, in order to ensure that patient access to care is not compromised, the Committee may wish to amend this bill to delete the mandated 45-minute transition time, and instead require DPH to evaluate the CDC guidelines and develop the required transition time via regulation.
- Other technical and clarifying amendment to: i) define a "full time equivalent" employee; ii) clarify that social workers and dieticians do not have to be present at all times; and, iii) clarify DPHs' ability to enforce the provisions of this bill prior to the adoption of regulations.
REGISTERED SUPPORT / OPPOSITION:
SUPPORT
California State Council of the Service Employees International Union (cosponsor)
United Nurses Associations of California/Union of Health Care Professionals (cosponsor)
American Federation of State, County and Municipal Employees, AFL-CIO
Black AIDS institute
Black Women for Wellness
California Academy of Nutrition & Dietetics
California Alliance for Retired Americans
California Labor Federation
California Retired Teachers Association
Central Labor Council Contra Costa County, AFL-CIO
Centro Binacional para el Desarrollo Indigena Oaxaqueno
Centro La Familia Advocacy Services
Congress of California Seniors
El Concicio de Fresno, Inc.
Fresno Center for New Americans
Fresno Immigration Coalition
Latino Coalition for a Health California
Latino Diabetes Association
Latino Equality Alliance
Men of Imperial Courts
Mi Familia Vota
NAACP – Fresno, #1038
National Association of Social Workers – California Chapter
New Congregational Church
Radio Bilingue, Inc.
Sistahs in Sync
Street Level Health
Unitarian Universalist Church of Fresno
Watt Century Latino Organization
Watts Labor Community Action Committee
Individual
OPPOSE
Alliance Management, LLC
American G.I. Forum of California
American Legion-Department of California
American Nurses Association - California
AMVETS-Department of California
Association of California Healthcare Districts
Association of California Nurse Leaders
AV Kidney Institute
Cal Chamber
California Association of County Veterans Service Officers
California Association of Rural Health Clinics
California Children’s Hospital Association
California Dialysis Council
California Hospital Association
California Medical Transportation Association
California State Commanders Veterans Council
Capital Nephrology Medical Group
Chambers of Commerce Alliance of Ventura and Santa Barbara Counties
Chronic Disease Coalition
Davita
Desert Cities Dialysis
District Hospital Leadership Forum
Filipino American Chamber of Commerce of Greater Los Angeles
Fresenius Medical Care
Greater Coachella Valley Chamber of Commerce
Loma Linda University Health
Los Angeles County Business Federation
Lupus Foundation of Southern California
Military Officers Association of America, California Council of Chapters
National Guard Association of California
National Medical Association
National Renal Administrators Association
Orange County Business Council
Outset Medical
Oxnard Chamber of Commerce
Premier Nephrology Medical Group
Providence St. Joseph Health
Renal Physicians Association
Renal Support Network
Satellite Healthcare
Scripps
Toiyabe Indian Health Project, Inc.
United Chambers of Commerce
United Hospital Association
Valley Industry and Commerce Association (VICA)
Vietnam Veterans of America-California State Council
Numerous Physicians, Patients, Caregivers and Individuals
Analysis Prepared by: Lara Flynn / HEALTH / (916) 319-2097
Office of Senate Floor Analyses (916) 651-1520 Fax: (916) 327-4478 | SB 349 |
THIRD READING
Bill No: SB 349
Amended: 5/26/17
SENATE HEALTH COMMITTEE: 7-2, 3/29/17
AYES: Hernandez, Atkins, Leyva, Mitchell, Monning, Newman, Roth
NOES: Nguyen, Nielsen
SENATE JUDICIARY COMMITTEE: 5-2, 4/25/17
AYES: Jackson, Hertzberg, Monning, Stern, Wieckowski
NOES: Moorlach, Anderson
SENATE APPROPRIATIONS COMMITTEE: 5-2, 5/25/17
AYES: Lara, Beall, Bradford, Hill, Wiener
NOES: Bates, Nielsen
SUBJECT: Chronic dialysis clinics: staffing requirements
United Nurses Association of California/Union of Health Care Professionals
DIGEST:
This bill requires chronic dialysis clinics, commencing July 1, 2019, to ensure that at least one nurse is providing direct care for every eight patients and that at least one certified hemodialysis technician is providing direct care for every three patients; requires there to be a minimum of 45 minutes of transition time between dialysis patients at a treatment station; and establishes civil penalties for violating the staffing ratios established by this bill.
Existing law:
- Licenses and regulates various clinics by Department of Public Health (DPH), including primary care clinics as well as specialty clinics which include: surgical clinics, chronic dialysis clinics (CDCs), and rehabilitation clinics.
- Requires CDCs, until January 1, 2018, to comply with federal Centers for Medicare and Medicaid Services (CMS) certification standards for an end stage renal disease clinic, as specified, until DPH adopts regulations relating to the provision of services by a CDC. Requires DPH to conduct a public hearing and submit a report that describes the extent to which the federal certification standards are or are not sufficient as a basis for state licensing standards, and to make recommendations for any California-specific standard that may be necessary.
- Provides for the certification of hemodialysis technicians by DPH, which is defined as an unlicensed health care provider who is employed by a hemodialysis clinic or unit for the purpose of participating in the direct treatment of patients undergoing hemodialysis.
- Requires DPH to adopt regulations that establish minimum, specific, and numerical licensed nurse-to-patient ratios, by licensed nurse classification and by hospital unit, for hospitals, and requires these ratios to constitute the minimum number of registered and licensed nurses that must be allocated.
- Establishes the minimum number of actual nursing hours per patient in a skilled nursing facility to be 3.2 hours, with a specified exception related to special mental disorder treatment units. Defines “nursing hours” to be the number of hours of work performed per patient day by aides, nursing assistants, registered nurses and licensed vocational nurses.
This bill:
- Requires a CDC, commencing July 1, 2019, to ensure that the following minimum staffing ratios are met at all times that patients are receiving, or preparing to receive, direct care:
- At least one nurse is providing direct care for every eight patients. Specifies that a nurse only counts toward this ratio during time periods the nurse has no responsibilities other than direct care, and prohibits a nurse manager or charge nurse from counting toward this ratio;
- At least one technician is providing direct care for every three patients. Specifies a technician only counts toward this ratio during time periods the technician has no responsibilities other than direct care, and prohibits trainees from counting toward this ratio.
- Requires a CDC, commencing July 1, 2019, to ensure that a social worker is not assigned more than 75 patients, and that a registered dietitian is not assigned more than 75 patients.
- Requires the staffing ratios specified in 2), 3) and 4) above to constitute the minimum number of nurses, technicians, social workers and registered dietitians assigned to patients at all times. Requires additional nurses, technicians, social workers and registered dietitians to be assigned to the extent necessary to ensure that an adequate number of qualified personnel are present whenever patients are undergoing dialysis so that the patient-to-staff ratio is appropriate to the level of dialysis care given and meets the needs of patients.
- Requires a CDC, commencing July 1, 2019, to ensure that the transition time, as defined, is at least 45 minutes.
- Prohibits DPH from issuing a license to any CDC unless that CDC demonstrates the ability and intention to comply with the provisions of this bill.
- Requires every licensed CDC to maintain, and provide to DPH no less frequently than four times per year, at a minimum, the following information:
- Actual staffing ratio and transition time data for the period covered by the submission, which is required to include, at a minimum, daily totals of the total number and actual hours worked by nurses, technicians, social workers and registered dietitians, the total number of patients and actual hours receiving direct care, and the daily average transition time for each treatment station; and,
- Every instance, no matter how brief, during the period covered by the submission, when staffing ratios or transition times did not meet the requirements of this bill, and the reasons and circumstances therefor.
- Requires the medical director and the chief executive officer or administrator of the CDC to both personally certify that each of them is satisfied, after review, that all information submitted pursuant to 7) above is accurate and complete.
- Requires DPH to inspect each CDC for which a license has been issued at least once per year, and to conduct such inspections as often as necessary to ensure compliance with the requirements of this bill, the accuracy and completeness of the information provided to DPH, and the adequacy of the quality of care being provided.
- Requires DPH to investigate a CDC within 60 days of receiving a complaint from an employee, association of employees, a vendor, a contractor, a patient, an association of patients, or a family member of a patient, that the CDC has committed a violation, and if the evidence shows a violation occurred, to impose discipline as specified.
- Specifies that any writing, record, or document received owned, used or retained by DPH in connection with specified provisions of this bill is subject to the California Public Records Act, as specified.
- Permits DPH to assess an administrative penalty against a CDC for a violation of this bill. Requires penalties to be classified as a major violation, an intermediate violation, or a minor violation according to the nature of the violation and the threat of harm to patients. Specifies that a major violation is subject to an administrative penalty of up to $10,000, and an intermediate violation is subject to an administrative penalty of up to $5,000. Prohibits DPH from assessing a penalty for a minor violation.
- Requires DPH to adopt regulations establishing criteria to assess an administrative penalty against a CDC that includes, but is not limited to, a consideration of all of the following:
- The probability and severity of the risk that the violation presents to the patient;
- The actual harm to patients, if any;
- The nature, scope, and severity of the violation;
- The CDC’s history of compliance with related state and federal statutes and regulations, including, but not limited to, the similarity in circumstances of the violation to any previous violation by the CDC within a 24-month period;
- Factors beyond the control of the CDC that restricts its ability to comply with this chapter or the rules and regulations adopted by DPH;
- The demonstrated willfulness of the violation; and,
- The extent to which the CDC detected the violation and took immediate action to correct the violation and prevent that type of violation from recurring.
- Permits a CDC to dispute a determination by DPH regarding an alleged deficiency, or the reasonableness of a penalty, by requesting a hearing within 10 working days. Requires a CDC to pay all administrative penalties when all appeals have been exhausted and DPH’s position has been upheld.
- States the intent of the Legislature that California taxpayers not be financially responsible for implementation and enforcement of minimum staffing requirements at CDCs, and requires DPH to take into account all costs associated with implementing and enforcing this bill when calculating, assessing, and collecting fees imposed on CDCs.
- Requires DPH to issue regulations necessary to implement this bill no later than 180 days following its effective date.
Comments
Author’s statement. According to the author, California currently regulates dialysis clinics using the bare minimum standards required by federal law. The purpose of this bill is to improve dialysis patient safety and reduce avoidable medical complications for patients receiving treatment at outpatient clinics. This goal will be achieved by establishing minimum staffing ratios, increasing clinic inspections, and requiring adequate time to clean and prepare dialysis equipment between patients. Long-term patient outcomes can be improved by reducing infections, preventing unnecessary hospitalizations, and by more closely monitoring patients’ overall health. Research has shown that sufficient staffing in dialysis clinics is central to each of these aims. Without this bill, the more than 63,000 patients who rely on California’s dialysis clinics to survive will continue to receive care in facilities that are not held accountable for failing to meet best practices related to patient safety.
NOTE: See the Senate Health Committee analysis of this bill for more detailed background of this bill.
FISCAL EFFECT: Appropriation: No Fiscal Com.: Yes Local: Yes
According to the Senate Appropriations Committee:
- Likely ongoing costs in the low millions per year for increased licensing inspections, complaint investigations, and enforcement actions DPH (Licensing and Certification Fund). This bill will significantly increase the level of regulatory oversight performed by DPH. Under this bill, DPH will increase its annual inspection frequency from once every three years to once per year. In addition, the stringency of the staffing requirements in the bill is projected to result in a significant increase in complaints to DPH.
- Unknown increase in the cost to provide dialysis services by Medi-Cal managed care plans (General Fund and federal funds). By imposing staffing requirements that exceed current practices in CDCs, this bill will increase the costs to operate those clinics. This is likely to increase Medi-Cal managed care payments to CDCs, but the size of the cost increase is unknown
SEIU California (co-source)
United Nurses Association of California/Union of Health Care Professionals (co-source)
AFSCME, AFL-CIO
Black Aids Institute
Black Women for Wellness
California Alliance for Retired Americans
California Labor Federation
Congress of California Seniors
El Concilio de Fresno, Inc.
Fresno Center for New Americans
Fresno Immigration Coalition
Latino Diabetes Association
Men of Imperial Courts
NAACP-Fresno #1038
National Association of Social Workers, California Chapter
New Congregational Church
Sistahs in Sync
Watts Century Latino Organization
Watts Labor Community Action Committee
OPPOSITION: (Verified 5/26/17)
Association of California Healthcare Districts
California Dialysis Council
California Hospital Association
California Medical Transportation Association
DaVita
Fresenius Medical Care
Loma Linda University
National Renal Administrators Association
Orange County Business Council
Providence Health & Services
Renal Support Network
St. Joseph Hoag Health
Toiyabe Indian Health Project, Inc.
U.S. Renal Care
Valley Industry Commerce Association
Seven Individuals
ARGUMENTS IN SUPPORT: This bill is sponsored by the United Nurses Associations of California/Union of Health Care Professionals (UNAC/UHCP) and SEIU California. According to UNAC/UHCP, California currently has approximately 550 dialysis clinics serving 50,000 patients per year, which are governed by federal law that sets very ambiguous standards for ensuring patient safety. For example, UNAC/UHCP states that clinics are required to ensure that an “adequate number of qualified personnel” are present during dialysis to ensure that an “appropriate” level of dialysis is given to meet the needs of the patients. UNAC/UHCP states that this bill increases patient safety by establishing that technicians would be responsible for no more than three patients at a time, and registered nurses at the clinics would be responsible for no more than eight patients at a time. UNAC/UHCP states that perhaps most significantly, this bill will ensure that there is an adequate transition time of 45 minutes between patients, which will allow clinic staff to clean and sterilize equipment in order to prevent transmission of blood borne pathogens from patient to patient. Without mandatory transition times, patients are endangered because clinics place a premium on getting the patients into the seat before the workstation can be adequately cleaned and prepared for the next patient. SEIU California states that California has imposed state-level regulations on hospitals, nursing homes, and other care facilities, but has not gone beyond the minimum federal certification standards in its regulation of dialysis clinics. SEIU California states that insufficient staff, insufficient time for health care workers to properly clean equipment and wash wands, and long gaps between regular inspections all increase the risk of these potential complications. The California Labor Federation writes that this bill affirms California’s commitment to protecting patient and worker health and safety and to setting the highest standards for quality in the health care industry.
ARGUMENTS IN OPPOSITION: This bill is opposed by Fresenius Medical Care, which operates 145 dialysis facilities in California, caring for more than 14,400 Californians. Fresenius states that the requirements in this bill will be catastrophic to the current system of dialysis care in California, and will displace thousands of dialysis patients. According to Fresenius, the requirements in this bill increases staffing up to 50% for registered nurses and 40% for technicians, and would occur during an industry nursing and technician shortage. If required staffing is not obtained or if call-ins occur and staff cannot be replaced, the facility would have to shut down the impacted shift in order to avoid financial penalties or license suspension. Fresenius stages that patients scheduled for that day would have treatments re-scheduled, diverted to another facility, or sent to the emergency room, and the remaining staff scheduled for that day would be sent home, resulting in lost wages. Regarding the 45 minute transition time requirement, Fresenius states that currently, 47% of its clinics have four shifts, but adding a 45 minute transition time between shifts would result in all of their facilities eliminating the fourth shift, because each facility has to shut down by a certain time in order for the water treatment system to regenerate for the following day. According to Fresenius the end of the fourth shifts in their clinics would cause approximately 1,400 patients to be displaced from their current dialysis facility. Fresenius argues that California dialysis facilities have excellent quality outcomes and patient safety records, with patient hospitalizations decreasing by 21% and mortality down 25% over the past 10 years, and that California out performs the rest of the county and other states that already have staffing ratios in place. The National Renal Administrators Association (NRAA) states in opposition that in 2008, CMS released the conditions of care that all end stage renal disease programs must adhere to, and that during this review, CMS determined that a national staffing ratio requirement was not the appropriate direction for these programs. U.S. Renal Care states in opposition that mandating minimum staffing ratios and longer transition times between patients will not improve care at their clinics. Instead, U.S. Renal Care states that this bill will force the elimination of a shift, which would leave thousands of patients across California without access to care. DaVita states in opposition that this bill’s requirement to meeting staffing ratios at all times, plus the 45-minute empty chair mandate between patients treatments, will impede the ability of dialysis clinics to tailor treatments to individual patient needs. DaVita states this bill will also ultimately restrict the ability of many clinics to continue operating a fourth patient shift, thereby drastically reducing treatment availability at a time when California needs additional capacity, not less. The Renal Support Network (RSN) states that the 45-minute transition time raises a number of questions, such as what happens when a patient is delayed getting on dialysis because of difficulty cannulating a dialysis access, or post dialysis clotting problems extends a patients time. In these circumstances, a patient may get off the machine 30 minutes late, and another patient is waiting for their treatment. RSN states that the staff can clean and prep the area in 10 minutes, but will have to explain to the next patient that rules do not allow them to be put on the dialysis machine because of the 45-minute empty chair requirement.
SENATE COMMITTEE ON
Senator Ricardo Lara, Chair
2017 - 2018 Regular Session
SB 349 (Lara) - Chronic dialysis clinics: staffing requirements
Version: | Policy Vote: |
Urgency: | Mandate: |
Hearing Date: | Consultant: |
*********** ANALYSIS ADDENDUM – SUSPENSE FILE ***********
The following information is revised to reflect amendments
adopted by the committee on May 25, 2017
Bill Summary:
SB 349 would require chronic dialysis clinics to have at least one nurse for every eight patients and at least one certified hemodialysis technician for every three patients.
Fiscal Impact:
- Likely ongoing costs in the low millions per year for increased licensing inspections, complaint investigations, and enforcement actions by the Department of Public Health (Licensing and Certification Fund). The bill will significantly increase the level of regulatory oversight performed by the Department. Under the bill, the Department will increase its annual inspection frequency from once every three years to once per year. In addition, the stringency of the staffing requirements in the bill is projected to result in a significant increase in complaints to the Department.
- Unknown increase in the cost to provide dialysis services by Medi-Cal managed care plans (General Fund and federal funds). By imposing staffing requirements that exceed current practices in chronic dialysis clinics, the bill will increase the costs to operate those clinics. This is likely to increase Medi-Cal managed care payments to chronic dialysis clinics, but the size of the cost increase is unknown. See below.
Author Amendments:
also require chronic dialysis clinics to meet specified staffing ratios for dieticians.
Committee Amendments:
delete the enforcement and penalty provisions of the bill and instead require the Department of Public Health to use an enforcement process similar to the one used for hospitals.
-- END --
SENATE COMMITTEE ON APPROPRIATIONS
Senator Ricardo Lara, Chair
2017 - 2018 Regular Session
SB 349 (Lara) - Chronic dialysis clinics: staffing requirements
Version: May 3, 2017 | Policy Vote: HEALTH 7 - 2, JUD. 5 - 2 |
Urgency: No | Mandate: Yes |
Hearing Date: May 15, 2017 | Consultant: Brendan McCarthy |
This bill meets the criteria for referral to the Suspense File.
Bill Summary:
SB 349 would require chronic dialysis clinics to have at least one nurse for every eight patients and at least one certified hemodialysis technician for every three patients.
Fiscal Impact:
- Ongoing costs of $3 million per year for increased licensing inspections, complaint investigations, and enforcement actions by the Department of Public Health (Licensing and Certification Fund). The bill will significantly increase the level of regulatory oversight performed by the Department. Under the bill, the Department will increase its annual inspection frequency from once every three years to once per year. In addition, the stringency of the staffing requirements in the bill is projected to result in a significant increase in complaints to the Department.
- Unknown increase in the cost to provide dialysis services by Medi-Cal managed care plans (General Fund and federal funds). By imposing staffing requirements that exceed current practices in chronic dialysis clinics, the bill will increase the costs to operate those clinics. This is likely to increase Medi-Cal managed care payments to chronic dialysis clinics, but the size of the cost increase is unknown. See below.
Background:
Under current law, chronic dialysis clinics are licensed and regulated by the state Department of Public Health. In addition, in order for chronic dialysis clinics to provide services to Medicare and Medi-Cal patients, they must be certified by the federal Centers for Medicare and Medicaid Services. The federal government contracts with the Department to perform the certification inspections. Under current law, the Department is required to use the federal certification standards when regulating chronic dialysis clinics, until it adopts state regulations. The Department is in the process of developing those regulations.
The state imposes certain nurse to patient staff ratios in hospitals. Those staff to patient ratios do not apply to outpatient medical facilities, such as chronic dialysis clinics.
Proposed Law:
SB 349 would require chronic dialysis clinics to have at least one nurse for every eight patients and at least one certified hemodialysis technician for every three patients.
Specific provisions of the bill would:
- Beginning on January 1, 2019, require chronic dialysis clinics to ensure the following staff to patient ratios are met:
- One registered nurse for every eight patients;
- One certified technician for every three patients;
- One social worker for every 75 patients;
- Beginning on January 1, 2019, require that the transition time between one patient completing treatment and the next patient beginning treatment at that treatment station be at least 45 minutes;
- Require licensed chronic dialysis clinics to provide specified information to the Department;
- Require the Department to inspect chronic dialysis clinics at least once per year;
- Require the Department to investigate any complaint that a chronic dialysis clinic is not meeting the required staff ratios within 60 days;
- Provide for the penalties for violating the staff to patient ratios in the bill, including requirements that the Department suspend a clinic’s license for a fourth violation within two years and authority to revoke a clinic’s license for a sixth violation within two years;
- Require the Department to increase the licensing fees paid by chronic dialysis clinics to pay for any additional costs incurred by the Department to enforce the bill’s requirements.
Related Legislation:
AB 241 (Bonta) would extend the requirement that chronic dialysis clinics (and other facilities) comply with existing federal certification standards until January 1, 2019. That bill is pending referral in the Senate Rules Committee.
Staff Comments:
Chronic dialysis clinics provide treatment to individuals with end stage renal disease. Dialysis is used when a patient’s kidneys no longer effectively remove waste from the bloodstream. Typically, dialysis patients go to a chronic dialysis clinic three times per week and receive dialysis for around four hours. Some patients receive their dialysis overnight at dialysis clinics.
Most dialysis treatment is paid for by Medicare and/or Medi-Cal. Under current law, individuals with end stage renal disease are eligible for Medicare regardless of their age. Roughly 20 – 30% of dialysis patients in the state are enrolled in the Medi-Cal program (some of those individuals are dually enrolled in Medicare and so Medicare is the primary payer).
Under current federal certification standards, there are no specific staff to patient ratios. Rather, federal standards require staffing levels to be adequate to provide the appropriate level of care. According to a study of dialysis clinics nationwide, using 2009 data, the overall national ratio of registered nurses to patients was about 1 to 12 and the overall national ratio of technicians to patients was about 1 to 10. The overall composite staff to patient ratio (including registered nurses, licensed vocational nurses, and technicians) was about 1 to 5.
This bill would appear to substantially increase staff to patient requirements at chronic dialysis clinics. To the extent that this is the case, it is likely to substantially increase the costs of providing dialysis care, as staff costs are a significant portion of the overall cost to provide health care services in clinical settings.
Under current law, Medicare rates do not automatically increase as operational costs for chronic dialysis clinics increase and Medi-Cal fee-for-service rates are set based on Medicare rates. In addition, a only small percentage of chronic dialysis patients are covered by private insurance. Given that the operators of chronic dialysis clinics are not likely to be able to pass along cost increases to Medicare, Medi-Cal fee-for-service, or (significantly) to private health insurers, clinic operators may attempt to pass along their cost increases to Medi-Cal managed care plans. Whether they would be successful in doing so is unknown.
Opponents of the bill have raised concerns that the strict staff to patient ratios in the bill (including substantial penalties for noncompliance) will make it difficult for existing chronic dialysis clinics to consistently meet those staffing requirements at all times. To the extent that chronic dialysis clinics have difficulty meeting the required staff to patient ratios, it is possible that patients would seek treatment in emergency departments and/or hospital inpatient dialysis units. Receiving dialysis in those settings is likely to be substantially more expensive than receiving dialysis in a clinic. Any such increases in the cost to provide dialysis would impact Medi-Cal. The extent of that impact is unknown and will depend on the ability of the chronic dialysis clinic industry to consistently meet the requirements of the bill.
According to a study performed by researchers are UC Davis, there are published academic journal articles that indicate staffing levels are associated with clinical outcomes and that high ratios of patients to nurses are associated with an increased number of adverse events. On the other hand, the study also found that expanding state-specific regulation of chronic dialysis clinics beyond federal requirements would be of uncertain marginal value. It is not clear what the potential clinical benefit to patients would be from the increase in staff to patient ratios in the bill. To the extent that it would increase clinical outcomes, there could be a reduction in other health care spending, such as treatment for acquired infections or other complications. The extent to which that would occur is unknown.
The only costs that may be incurred by a local agency relate to crimes and infractions. Under the California Constitution, such costs are not reimbursable by the state.
-- END --
Senator Hannah-Beth Jackson, Chair
2017-2018 Regular Session
Bill No: SB 349 (Author:Lara)
Version: April 17, 2017
Hearing Date: April 25, 2017
Fiscal: Yes
Urgency: No
Consultant: MEC
SUBJECT
Chronic dialysis clinics: staffing requirements
DESCRIPTION
In an effort to improve patient outcomes at chronic dialysis clinics, including by reducing the rates at which patients suffer infections or must be hospitalized, and in an effort to enhance worker safety, including by reducing the risk of injury on the job, this bill would codify: direct care staffing requirements at chronic dialysis clinics; increased reporting requirements to the Department of Public Health (DPH) by the chronic dialysis clinics; and a system of oversight and enforcement by the DPH that would include increased inspections and investigations of chronic dialysis clinics, the possibility of civil penalties, licensure suspension and revocation, and implementation of corrective action plans.
BACKGROUND
Chronic dialysis clinics provide care for those with end stage renal disease. There are over 550 dialysis clinics in California serving 50,000 patients per year. People with end stage renal disease typically need to receive dialysis treatment three times a week at a chronic dialysis clinic. The treatment lasts about four hours. Dialysis patients rely on registered nurses, hemodialysis technicians, and social workers to ensure they receive safe treatment.
The DPH issues licenses to California chronic dialysis clinics. However, the standards that apply to these clinics are federal standards and will continue to be until the DPH enacts regulations as authorized under SB 534 (Hernandez, 2013, Chapter 722, Statutes of 2013).[1] The DPH has not enacted state regulations for chronic dialysis clinics. The bill before this Committee seeks to create California standards for the staffing and time between cleanings at these clinics. This bill also would subject chronic dialysis clinics to penalties and possible license suspension and revocation if the standards are not met.
(This measure passed out of Senate Health Committee with a 7 to 2 vote.)
CHANGES TO EXISTING LAW
Existing law establishes the State Department of Public Health (DPH) and sets forth its powers and duties, including, but not limited to, the licensure and regulation of chronic dialysis clinics.
Existing law provides that a chronic dialysis clinic shall comply with federal certification standards for an end stage renal disease clinic, as specified in Sections 494.1 to 494.180, inclusive, of Title 42 of the Code of Federal Regulations, until the DPH adopts regulations relating to the provision of services by a chronic dialysis clinic. (Health & Saf. Code Sec. 1225(d).)
Existing law requires the DPH to inspect licensed end stage renal disease facilities at least once every three years, as specified. (Health & Saf. Code Sec. 1228(a).)
This bill would: require the DPH to inspect licensed chronic dialysis clinics at least once every year, as specified; and prohibit the DPH from issuing a license to a chronic dialysis clinic unless the chronic dialysis clinic demonstrates the ability and intention to comply with the staffing ratios, transition time, and reporting requirements.
This bill would make findings and declarations outlining the purpose of this bill.
This bill would establish the following minimum staffing requirements for chronic dialysis clinics: at least one nurse providing direct care for every eight patients, as specified; at least one technician providing direct care for every three patients, as specified; and chronic dialysis clinics shall ensure that a social worker is not assigned more than 75 patients.
This bill would provide that a chronic dialysis clinic shall ensure that the transition time is at least 45 minutes and defines “transition time” as the period of time beginning when one patient has completed treatment and has been disconnected from the dialysis machine and ending when the next patient is placed in the treatment station, but does not mean the period of time after the last patient of the day leaves the treatment station.
This bill would require chronic dialysis clinics to: maintain certain information relating to the minimum staffing and minimum transition time requirements; and provide that information to the DPH on a schedule and in a format specified by the DPH, but no less frequently than 4 times per year. The bill would require that the chief executive officer or administrator of the chronic dialysis clinic personally certify that they are satisfied, after review, that all information submitted is accurate and complete.
This bill would require the DPH to investigate complaints from specified individuals within 60 days if the person asserts the clinic engaged in a staffing related violation, as defined, or gross staffing related violation as defined, and requires the DPH to impose discipline pursuant to this bill if the evidence shows a violation has occurred.
Existing law, the California Public Records Act, requires state and local agencies to make public records available upon receipt of a request that reasonably describes an identifiable record not otherwise exempt from disclosure. (Gov. Code Sec. 6253.)
This bill would clarify that any writing, record, or document received, owned, used, or retained by the DPH in connection with the reporting requirements, intention to comply with staffing requirements provision, inspection provision, suspension and revocation of license provisions, and penalties provisions are public records with the meaning of the California Public Records Act (CPRA). This bill would require the DPH to redact from any of these records any personal identifying information associated with named individuals to the extent required to prevent an unwarranted invasion of personal privacy. However, the bill would prohibit the DPH from withholding the record in its entirety under the provision of the CPRA that allows an agency to not disclose “personnel, medical, or similar files, the disclosure of which would constitute an unwarranted invasion of personal privacy.”
This bill would allow and, in some instances, require the DPH to assess penalties against a chronic dialysis clinic or responsible individual, as specified. In the event a licensee disputes a determination by the DPH regarding the imposition of these penalties, this bill would allow the licensee, within 10 working days, to request a hearing pursuant to Health & Safety Code Section 131071. This bill would provide that penalties shall be paid when all appeals have been exhausted and the DPH’s position has been upheld.
This bill would allow and, and in some instances, require the DPH to suspend or revoke a chronic dialysis clinic’s license, subject to the due process protections currently available to licensees subject to licensure loss by the DPH.
This bill would require the DPH to conduct an inspection of a chronic dialysis clinic at least once per year and as often as necessary to, among other things, ensure compliance with the minimum staffing and minimum transition time requirements and ensure the adequacy of care being provided.
This bill would require the DPH to issue regulations necessary to implement the bill no later than 180 days following its effective date.
This bill would provide that the staffing ratios and the transition time requirements would go into effect on January 1, 2019.
This bill includes a severability clause, and contains conforming and non-substantive provisions.
COMMENT
1. Stated need for the bill
According to the author:
California currently regulates dialysis clinics using the bare minimum standards required by federal law. The purpose of this bill is to improve dialysis patient safety and reduce avoidable medical complications for patients receiving treatment at outpatient clinics. This goal will be achieved by establishing minimum staffing ratios, increasing clinic inspections, and requiring adequate time to clean and prepare dialysis equipment between patients. Long-term patient outcomes can be improved by reducing infections, preventing unnecessary hospitalizations, and by more closely monitoring patients’ overall health. Research has shown that sufficient staffing in dialysis clinics is central to each of these aims. Without this bill, the more than 63,000 patients who rely on California’s dialysis clinics to survive will continue to receive care in facilities that are not held accountable for failing to meet best practices related to patient safety.
United Nurses Associations of California/Union of Health Care Professionals, co-sponsor of the bill, writes:
These clinics are governed by federal law that sets very ambiguous standards for ensuring patient safety. For example, clinics are required to ensure that an “adequate number of qualified personnel” are present during dialysis to ensure that an “appropriate” level of dialysis is given to meet the needs of the patients. As another example, federal law currently only requires clinics to be inspected once every six years, which is far less frequent than other care facilities in California, many of which must undergo annual or at least biannual inspections. Fortunately, federal law allows states to set higher standards, and a number of states have already done so.
SEIU California, co-sponsor of the bill, writes:
California has imposed state-level regulations on hospitals, nursing homes, and other health care facilities; but has not gone beyond the minimum federal certification standards in its regulation of dialysis clinics. In order to better protect patients, SB 349 would go beyond the baseline federal standards by setting minimum safe staffing levels and requiring enough time for dialysis workers to properly sanitize and prepare equipment. This bill would also increase provider accountability through more rigorous reporting and inspections.
The Latino Coalition for a Healthy California, in support, writes:
Insufficient staff, insufficient time for health care workers to properly clean equipment and wash their hands, and long gaps between regular inspections may all increase the risk of these potential complications. Without this bill, the more than 63,000 patients who rely on California’s dialysis clinics will continue to receive care in clinics that are not held accountable to best practices for staffing and patient transition times.
2. Establishes California standards for dialysis clinics
California would not be the first state in the nation to establish ratios of direct caregiving staff to patients at outpatient dialysis clinics. If this bill is enacted, however, California would lead the nation with the best nurse to patient ratio at outpatient dialysis clinics. Other states mandate minimum direct care staffing requirements in order to enhance patient safety and health at outpatient dialysis clinics. For example, Georgia and South Carolina require a minimum one to ten patient to Registered Nurse (RN) staffing ratio.[2] New Jersey requires a minimum RN staffing ratio of one to nine. This bill would require that at least one nurse is providing direct care for every eight patients. This bill would also require that at least one Certified Hemodialysis Technician is providing direct care for every three patients.[3] Georgia and Utah require the staffing ratio for a Certified Hemodialysis Technician to be 1 to 4.
Writing in opposition, the California Hospital Association asserts:
Currently, most dialysis procedures are performed in out-patient clinics. Hospitals are, however, keenly interested in this bill because of the unintended consequences. If this bill is enacted, dialysis services at the clinics will be reduced for the reasons articulated in DaVita’s letter of opposition. With fewer appointments available, patients will not receive timely treatment and are more likely to end up in the emergency department with complications that could have been prevented with timely treatment.
Moreover, hospitals have direct experience with staffing ratios. Numerous studies have found that there is no conclusive evidence that staffing ratios improve quality of care while there is substantial evidence that they increase costs. Because the reimbursement rate for dialysis services is very low, the increased cost will further restrict access to this vital service.
The California Labor Federation, writing in support states:
As a result of lax federal standards, staffing levels in California’s dialysis clinics are inadequate to protect patient health and worker safety, leading to unnecessary and avoidable death, hospitalizations, infections, and medical errors. Dialysis workers also report that some clinics currently rush transition times so workers do not have adequate time to clean and test dialysis machines between patients.
[. . .]
California already has experience with the benefits of minimum staffing ratios in health care settings, which numerous studies have shown measurably improves patient outcomes. Increased inspections will ensure compliance and identify issues before a patient is harmed. Transition time is simply a common-sense requirement to make sure equipment is clean and sanitized between patients to avoid infections or cross-contamination.
The California Nurses Association, in an “oppose unless amended” position, asserts:
The proposed RN to dialysis patient ratio of 1 RN to 8 patients establishes an inadequate standard for care of patients with severe physiologic instability requiring artificial life support. This standard is inferior to the 1 RN to 3 or fewer patients ratio in the “step-down unit” in general acute care hospitals where patients, who are comparable to chronic dialysis patients, receive care.
In response the author explains “outpatient dialysis is a significantly different treatment setting than in-patient care in a hospital.” The author offers to amend the bill as follows so as not to impact nurse-to-patient ratios.
Author’s Amendment
On page 15, after line 38, insert, “SEC. 9. Nothing in this Act is intended to impact nurse-to-patient ratios applicable to health facilities licensed pursuant to subdivision (a), (b), or (f) of Section 1250.”
The California Nurses Association requests an amendment to clarify that “[c]harge nurses who are acting in the capacity of a statutory supervisor should not count toward the RN to patient ratio.”
3. Establishes consequences for violations which can lead to monetary penalties and loss of licensure
The DPH is arguably the appropriate entity to have the authority to make determinations regarding imposing monetary penalties on chronic dialysis clinics. The DPH is their licensing entity. This bill would make it clear that in some circumstances the DPH may impose monetary penalties on chronic dialysis clinics and “responsible individuals” and in some other circumstances the DPH must impose monetary penalties on chronic dialysis clinics and “responsible individuals.” But, what happens when the “responsible individual” or chronic dialysis clinic believe the DPH erred in imposing the penalties? This bill contains an additional due process safeguard to be invoked when a licensee disputes the DPH’s determination of penalties. However, the bill should be amended to make it clear that both the chronic dialysis clinic and “responsible individual” can dispute the DPH determination. The bill currently provides that if “a licensee disputes a determination by the [DPH] regarding the imposition of a penalty pursuant to this section, the licensee may, within 10 working days, request a hearing pursuant to [Health and Safety Code] Section 131071.” While a chronic dialysis clinic is a licensee of the DPH, a “responsible individual” will likely not be a licensee of the DPH and thus would not be afforded an opportunity to dispute the DPH’s penalty determination. To make it clear that both the “chronic dialysis clinic” and the “responsible individual” can dispute the determination by the DPH regarding the imposition of a penalty, the author offers the following amendments.
Author’s Amendments:
On page 15, in line 24, strike out “licensee” and insert “chronic dialysis clinic or a responsible individual”
On page 15, in line 26, strike out “licensee” and insert “chronic dialysis clinic or responsible individual”
Under current law, the DPH may suspend or revoke a license of a licensee for a number of reasons[4], but must afford the licensee the procedural protections outlined in Government Code Section 11500, et. seq. SB 349 would subject a chronic dialysis clinic (a licensee of the DPH) to license revocation and suspension for the reasons clearly detailed in the bill. SB 349 makes clear that the same procedural safeguards would apply to the chronic dialysis clinics when the DPH attempts to suspend or revoke their licenses due to the provisions of this bill.
Davita, a corporation with multiple chronic dialysis clinics in California, asserts that “California’s dialysis clinics are already heavily regulated by state and federal agencies. The existing regulatory system works well with any deficiencies promptly remedied through plans of corrections approved and enforced by the California Department of Public Health.”
The Renal Physicians Association asserts in its opposition that “dialysis facility medical directors are the individuals who are assigned responsibility for ensuring that the dialysis facility is in compliance with state and federal regulations [and] civil penalties are not needed, and indeed inappropriate if assessed on the medical director who is not the employer directly empowered to make facility staffing decisions.”
The Renal Physicians Association writes the following in opposition:
We believe the proposed legislation to create staffing requirements in California’s dialysis facilities is: (1) unnecessary and distracting from more important factors; (2) unworkable in operations of a dialysis facility; and (3) incorrectly focused on penalizing medical directors.
Some dialysis corporations report that their non-managerial employees are worried about being deemed a “responsible individual” and thus would possibly be subject to civil penalties for violations of this bill even though they have no authority at the chronic dialysis clinic. The author suggests the following amendment to make it clear a non-managerial employee cannot be a “responsible individual.”
Author’s Amendment
On page 11, in line 15, after “violation.” insert “A non-managerial employee shall not be deemed a responsible individual.”
4. This bill would enact robust protections for patients of chronic dialysis clinics
Other patient protections included in this bill are:
- require annual inspections of chronic dialysis clinics by the DPH and require DPH to investigate certain complaints within 60 days;
- require chronic dialysis clinics to report to the DPH at least four times a year;
- would require chronic dialysis clinics to ensure minimum patient to staff ratios (1:8 for nurses; 1:3 for technicians; 1:75 for social workers) commencing January 1, 2019;
- require additional nurses, technicians, and social workers to be assigned to the extent necessary to ensure that the patient-to-staff ratio is appropriate to the level of dialysis care given and meets the needs of patients;
- require chronic dialysis clinics to ensure that the transition time is at least 45 minutes;
- prohibit the department from issuing a license to any chronic dialysis clinic unless the chronic dialysis clinic demonstrates the ability and intention to comply with the requirements of the Act, including, but not limited to ratios and transition time;
- define “staffing related violation” and “gross staffing related violation” and impose penalties and suspension and possible revocation of the chronic dialysis clinic’s license due to violations;
- impose penalties on “responsible individuals” for “staffing related violations” and “gross staffing related violations;” and
- require corrective action plans to be developed to bring chronic dialysis clinics into compliance.
Staff notes that the consequences of penalties and licensure loss are based on whether the clinic failed to do that which they are required to do under this Act. It is very clear what a clinic would need to do to be in compliance with the Act and avoid penalties and threats to licensure. A clinic would simply have to be in compliance with the staffing ratios, reporting requirements, transition times, etc. One could argue that there is very little margin of error before the consequences to the chronic dialysis clinic starts escalating. The threat of penalties will arguably force the clinics to take these statutory requirements very seriously, thus leading to strict adherence to the staffing ratio and transition time requirements.
There is a provision in the bill, however, that does not seem equitable because its punishment is based on aggregate violations of numerous entities as long as they are owned or operated by a governing entity or affiliated governing entity. Penalties arise when, for example, in a 24 month period there are 50 aggregate gross staffing violations across all of the affiliated facilities. If one company with 10 affiliated facilities is compared against a company with 50 affiliated facilities, one could see that the former entity could have an average of 5 gross staffing violations per facility over the 24 month period while the latter affiliated facilities could have an average of half of one gross staffing violation over the two year period. Both would nonetheless be subject to the same discipline and face possible revocation of all of the entity’s licenses and have to submit a corrective action plan describing affirmative steps it will take to not commit further violations. The entity in this example that averaged 5 gross staffing violations is arguably much more culpable and deserving of more consequences. To make these aggregate provisions equitable, the author proposes to amend the bill to require the DPH to consider the actual average of violations among the clinics of the governing entity before imposing the penalties for the aggregate gross staffing violations.[5]
Author’s Amendments
On page 14, after line 8 and before line 9, insert “C. In making the determination under subparagraph (B) the department shall consider the actual average of violations among the chronic dialysis clinics of the governing entity or governing entities.”
On page 14, in line 26, after “entities.” insert “In making this determination the department shall consider the actual average of violations among the chronic dialysis clinics of the governing entity or governing entities.”
Support: AFSCME; Black AIDS Institute; Black Women for Wellness; California Labor Federation; California Alliance for Retired Americans; California Retired Teachers Association; Centro La Familia Advocacy Services; California Labor Federation; Centro Binacional para el Desarrollo Inidgena Oaxaqueno; Congress for California Seniors; El Concilio de Fresno; Fresno Center for New Americans; Fresno Immigration Coalition; Latino Coalition for a Healthy California; Latino Diabetes Association; Latino Equity Alliance; Men of Imperial Courts; Mi Familia Vota; NAACP of Fresno; National Association of Social Workers; New Congregational Church; Sistahs in Sync; Street Level Health Project; Watts Century Latino Organization; Watts Labor Community Action Committee; individuals
Opposition: Alliance Management; American Nurses Association; Association of California Healthcare Districts; California Dialysis Council; California Hospital Association; California Medical Transportation Association; California Nurses Association; DaVita; Dialysis Clinic, Inc.; Dialysis Patient Citizens; Fresenius Medical Care; Loma Linda University; National Renal Administrators Association; National Renal Support Network; Orange County Business Council; Outset Medical; Providence Health & Services; Renal Physicians Association; St. Joseph Health; Toiyabe Indian Health Project, Inc.; U.S. Renal Care; Valley Industry Commerce Association; individuals
HISTORY
Source: SEIU State Council; United Nurses Associations of California/Union of Health Care Professionals (UNAC/UHCP)
Related Pending Legislation: AB 251 (Bonta, 2017) would extend from January 1, 2018 to January 1, 2019, the requirement that chronic dialysis, surgical, and rehabilitation clinics comply with federal certification standards pending the adoption of regulations by DPH. The bill is in pending referral in Senate Rules Committee. (See Background)
Prior Legislation: SB 534 (Hernandez, Ch. 722, Stats. of 2013) among other provisions, required CDCs to comply with applicable federal certification standards for end stage renal disease clinics until DPH adopts regulations relating to the provision of services by a CDC. Additionally, required DPH to submit a report on the extent to which federal certification standards are, or are not, sufficient as a basis for state licensing standards.
Prior Vote: Senate Health Committee (Ayes 7, Noes 2)
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SB 534 required clinics to comply with applicable federal certification standards for end stage renal disease clinics until the DPH adopts regulations relating to the provision of services by a chronic dialysis clinic. The DPH has yet to adopt the regulations. AB 251 (Bonta, 2017) would entend from January 1, 2018 to January 1, 2019, the requirement that chronic dialysis clinics comply with federal certification standards pending the adoption of the regulations by the DPH. AB 251 is currently in the Senate Rules Committee awaiting assignment to a policy committee. ↑
Under SB 349, “Nurse” is defined as a registered nurse licensed pursuant to Chapter 6 (commencing with Section 2700) of Division 2 of the Business and Professions Code. ↑
Under SB 349, “technician” is defined as a person who is a patient care dialysis technician, as defined in federal law, and a Certified Hemodialysis Technician, as defined in California law. ↑
(See Health & Saf. Code Sec. 1240, 1241, and Gov. Code Sec. 11500, et. seq.) ↑
The aggregate provisions are located at 1240.1(e). ↑
SENATE COMMITTEE ON HEALTH
Senator Ed Hernandez, O.D., Chair
BILL NO: SB 349
AUTHOR: | Lara | ||
VERSION: | March 20, 2017 | ||
HEARING DATE: | March 29, 2017 | ||
CONSULTANT: | Vince Marchand | ||
SUBJECT: Chronic dialysis clinics: staffing requirements
SUMMARY:
Requires chronic dialysis clinics, commencing July 1, 2018, to ensure that at least one nurse is providing direct care for every eight patients and that at least one certified hemodialysis technician is providing direct care for every three patients, requires there to be a minimum of 45 minutes of transition time between dialysis patients at a treatment station, and establishes civil penalties and license suspensions for violating the staffing ratios established by this bill.
Existing law:
- Licenses and regulates various clinics by Department of Public Health (DPH), including primary care clinics as well as specialty clinics which include: surgical clinics, chronic dialysis clinics, and rehabilitation clinics.
- Requires DPH to adopt reasonable rules and regulations as may be necessary to enable DPH to carry out the purposes of provisions of law governing the various types of clinics licensed by DPH.
- Requires chronic dialysis clinics (CDCs), until January 1, 2018, to comply with federal Centers for Medicare and Medicaid Services (CMS) certification standards for an end stage renal disease clinic, as specified, until DPH adopts regulations relating to the provision of services by a chronic dialysis clinic. Requires DPH to conduct a public hearing and submit a report that describes the extent to which the federal certification standards are or are not sufficient as a basis for state licensing standards, and to make recommendations for any California-specific standard that may be necessary.
- Provides for the certification of hemodialysis technicians (CHTs) by DPH, which is defined as an unlicensed health care provider who is employed by a hemodialysis clinic or unit for the purpose of participating in the direct treatment of patients undergoing hemodialysis.
- Requires DPH to adopt regulations that establish minimum, specific, and numerical licensed nurse-to-patient ratios, by licensed nurse classification and by hospital unit, for hospitals, and requires these ratios to constitute the minimum number of registered and licensed nurses that must be allocated.
- Establishes a structure under which DPH is permitted to assess administrative fines to general acute care hospitals, acute psychiatric hospitals, and special hospitals for violation of any of their licensing laws and regulations, including nurse-to-patient ratios, as follows:
- Permits DPH to assess an administrative penalty against a hospital, for a deficiency constituting an immediate jeopardy violation (defined as causing, or likely to cause, serious injury or death), up to a maximum of $75,000 for the first administrative penalty, up to $100,000 for the second administrative penalty, and up to $125,000 for the third and every subsequent administrative penalty;
- Permits DPH to assess an administrative penalty of up to $25,000 per violation for those not deemed to constitute immediate jeopardy; and,
- Prohibits DPH from assessing an administrative penalty for minor violations, which are defined as any violation of law relating to the operation or maintenance of a hospital that DPH determines has only a minimal relation to the health and safety of patients.
- Establishes the minimum number of actual nursing hours per patient in a skilled nursing facility (SNF) to be 3.2 hours, with a specified exception related to special mental disorder treatment units. Defines “nursing hours” to be the number of hours of work performed per patient day by aides, nursing assistants, registered nurses and licensed vocational nurses.
- Requires DPH to assess an administrative penalty if DPH determines that a SNF failed to meet the nursing hours per patient day requirements, as follows: $15,000 if the SNF failed to meet the requirements for 5% or more of the audited days up to 49%, and $30,000 if the facility failed to meet the requirements for more than 49% of the audited days. Requires compliance with nursing hours per patient per day requirements to be included in the criteria upon which supplemental payments are made under the Quality and Accountability Supplemental Payment System.
This bill:
- Defines, for purposes of the provisions of this bill, the following terms:
- “At all times” includes times during which employees including, but nurses and technicians, are provided meal periods and rest or other breaks;
- “Nurse” means a licensed registered nurse;
- “Charge nurse,” “nurse manager,” and “social worker” are defined as having the same meaning as in specified federal regulations pertaining to CMS dialysis clinic requirements;
- “Technician” is defined as a person who is a CHT and who also meets the federal CMS definition of a patient care dialysis technician, as specified;
- “Trainee” is defined as a person who is undergoing training to become a technician, but who has not been certified as a CHT;
- “Transition time” is defined as the period of time beginning when one patient leaves a treatment station and ending when the next patient is placed in the treatment station, but does not mean the period of time after the last patient of the day leaves the treatment station; and,
- “Treatment station” is defined as a physical location with a chronic dialysis clinic where an individual patient is dialyzed.
- Requires a CDC, commencing July 1, 2018, to ensure that the following minimum staffing ratios are met at all times that patients are receiving, or preparing to receive, direct care:
- At least one nurse is providing direct care for every eight patients (1:8). Specifies that a nurse only counts toward this ratio during time periods the nurse has no responsibilities other than direct care, and prohibits a nurse manager or charge nurse from counting toward this ratio;
- At least one technician is providing direct care for every three patients (1:3). Specifies a technician only counts toward this ratio during time periods the technician has no responsibilities other than direct care, and prohibits trainees from counting toward this ratio.
- Requires a CDC, commencing July 1, 2018, to ensure that a social worker is not assigned more than 75 patients (1:75).
- Requires the staffing ratios specified in 2) and 3) above to constitute the minimum number of nurses, technicians, and social workers assigned to patients at all times. Requires additional nurses, technicians, and social workers to be assigned to the extent necessary to ensure that an adequate number of qualified personnel are present whenever patients are undergoing dialysis so that the patient-to-staff ratio is appropriate to the level of dialysis care given and meets the needs of patients.
- Requires a CDC, commencing July 1, 2018, to ensure that the transition time, as defined, is at least 45 minutes.
- Prohibits DPH from issuing a license to any CDC unless that CDC demonstrates the ability and intention to comply with the provisions of this bill.
- Requires every licensed CDC to maintain, and provide to DPH no less frequently than four times per year, at a minimum, the following information:
- Actual staffing ratio and transition time data for the period covered by the submission, which is required to include, at a minimum, daily totals of the total number and actual hours worked by nurses, technicians, and social workers, the total number of patients and actual hours receiving direct care, and the daily average transition time for each treatment station; and,
- Every instance, no matter how brief, during the period covered by the submission, when staffing ratios or transition times did not meet the requirements of this bill, and the reasons and circumstances therefor.
- Requires the medical director and the chief executive officer or administrator of the CDC to both personally certify under penalty of perjury that each of them is satisfied, after review, that all information submitted pursuant to 7) above is accurate and complete.
- Requires DPH to inspect each CDC for which a license has been issued at least once per year, and to conduct such inspections as often as necessary to ensure compliance with the requirements of this bill, the accuracy and completeness of the information provided to DPH, compliance with corrective action plans, if any, and the adequacy of the quality of care being provided.
- Requires DPH to investigate a CDC within 60 days of receiving a complaint from an employee, association of employees, a vendor, a contractor, a patient, an association of patients, or a family member of a patient that the CDC has engaged in a staffing-related violation or gross staffing-related violation, as those terms are defined, and if the evidence shows a violation occurred, to impose discipline as specified.
- Specifies that any writing, record, or document received owned, used or retained by DPH in connection with specified provisions of this bill is subject to the California Public Records Act, as specified, with the exception of identifying or confidential information, as specified.
- Defines “Staffing-related violation” as any of the following:
- Violation by the CDC, or any of its officers, employees, vendors, or contractors, of the staffing ratios in this bill;
- Conduct by the CDC, or any of its officers, employees, vendors, or contractors intended to conceal a violation of the staffing ratios;
- A misrepresentation of information provided to DPH pursuant to this bill;
- Violation by the CDC, or any of its officers, employees, vendors, or contractors, of any part of a corrective action plan described in this bill; or,
- Other violations that DPH defines in regulation.
- Defines “gross staffing-related violation” as any of the following:
- A staffing-related violation that causes or exacerbates harm to a patient, or that has a substantial possibility of causing or exacerbating harm to a patient;
- A willful or intentional staffing-related violation;
- Reckless disregard of a substantial likelihood of a staffing-related violation;
- A continuous period of one hour or longer in which the staffing ratio is at or above one nurse providing direct care for nine or more patients, or one technician providing direct care for four or more patients;
- A continuous period of one week or longer in which the staffing ratio is at or above one social worker assigned to 90 or more patients;
- A daily average transition time for a treatment station that is 20 minutes or shorter; or,
- Other violations that DPH defines in regulation.
- Defines “Governing entity” as a person, firm, association, partnership, corporation, or other entity that owns or operates a CDC for which a license has been issued, without respect to whether the person or entity itself directly holds that license.
- Defines “Responsible individual” as one of the following types of people who, with respect to a staffing-related violation or gross staffing-related violation, knew or should have known of the substantial likelihood that the violation could occur and possessed, but failed to exercise, authority to prevent the violation from occurring, or knew or should have known that the violation had occurred and possessed, but failed to exercise, authority to substantially remedy the violation:
- A member of the governing body, designated person, chief executive officer, administrator, or medical director; or,
- Managerial employees, officers, or directors of the governing entity, and persons who provide services under contract to that governing entity.
- Requires DPH to impose the following civil penalties on a CDC for a staffing-related violation:
- For the first violation in any 12-month period, a penalty of between $500 and $2,500 on the CDC, and between $100 and $1,000 on each responsible individual, if any. Requires the CDC to submit a corrective action plan to DPH describing how it will avoid committing any further staffing-related violations, and requires this plan to be revised and approved by DPH;
- For the second staffing-related violation in any 12-month period, a penalty of between $1,000 and $5,000 on the CDC, and a penalty of between $100 and $2,000 on each responsible individual, if any;
- For the third staffing-related violation in any 12-month period, a penalty of between $2,000 and $7,500 on the CDC, and between $200 and $3,000 on each responsible individual, if any;
- For the fourth staffing-related violation in any 12-month period, a penalty of between $3,000 and $10,000 on the CDC, and between $200 and $4,000 on each responsible individual, if any;
- For the fifth staffing-related violation in any 12-month period, a penalty of between $4,000 and $12,500 on the CDC, and between $300 and $5,000 on each responsible individual, if any; and,
- For the sixth and each subsequent staffing-related violation in any 12-month period, a penalty of between $5,000 and $25,000 on the CDC, and between $300 and $6,000 on each responsible individual, if any.
- Requires, in addition to the civil penalty, the CDC to submit a corrective action plan to DPH describing how the CDC will avoid committing any further staffing-related violations, and requires the corrective action plan to be revised and approved by DPH.
- Permits DPH, in addition to the civil penalties described above for staffing-related violations, to suspend the license of a CDC for the first gross staffing-related violation in any 24-month period for up to seven days.
- Requires DPH, in addition to the civil penalties described above for staff-related violations, to suspend the license of a CDC as follows:
- For the second gross staff-related violation in any 24-month period, requires the license to be suspended for up to seven days;
- For the third gross staff-related violation in any 24-month period, requires the license to be suspended for up to 30 days;
- For the fourth gross staff-related violation in any 24-month period, requires the license to be suspended for up to 90 days;
- For the fifth gross staff-related violation in any 24-month period, requires the license to be suspended for up to 180 days, and permits DPH to revoke the license. Permits DPH, for up to 180 days, to refuse to issue or renew a license, or to refuse to authorize a transfer of an existing license, with respect to a CDC owned or operated by the same, or an affiliated, governing entity of the CDC at which the gross staffing-related violation occurred; and,
- For the sixth and each subsequent gross staff-related violation in any 24-month period, requires the license to be suspended for up to one year, and permits DPH to revoke the license. Permits DPH, for up to three years, to refuse to issue or renew a license, or to refuse to authorize a transfer of an existing license, with respect to a CDC owned or operated by the same, or an affiliated, governing entity of the CDC at which the gross staffing-related violation occurred.
- Requires the governing entity or governing entities of a CDC, when a CDC owned or operated by a governing entity or affiliated governing entities commit, in the aggregate, 25 or more gross staffing-related violations within any 24-month period, to submit a corrective action plan to DPH describing affirmative steps the governing entity or governing entities and associated CDCs will take to prevent every CDC owned or operated by the governing entity or governing entities from committing any further gross staffing-related violations. Requires the corrective action plan to be revised and approved by DPH.
- Permits DPH, when a CDC owned or operated by a governing entity or entities commits, in the aggregate, 25 or more gross staffing-related violations within any 24-month period, to refuse to issue or renew a license, or refuse to authorize a transfer of an existing license, to a the governing entity or governing entities or a CDC owned or operated by the governing entity or entities, for either three years after the latest gross staffing-related violation, or the date on which DPH is satisfied that the governing entity or entities and associated CDCs have taken all affirmative steps set forth in the corrective action plan, whichever is later.
- Permits DPH, when a CDC owned or operated by a governing entity or entities commits, in the aggregate, 50 or more gross staffing-related violations within any 24-month period, to revoke or suspend licenses issued to the governing entity or entities or any CDC that they own or operate, and to refuse to issue, renew, or authorize a transfer of, a license to the governing entity or entities or any CDC owned or operated by the governing entity or entities.
- Requires DPH to consider the following factors when determining whether and what action to take under this bill, including determining the civil penalties established under this bill, the revisions to corrective action plans required under this bill, and the extent to which to refuse to issue, transfer, revoke or suspend a license under this bill:
- The duration and severity of the violation;
- The willfulness of the violation;
- The history of the CDC or governing entity of noncompliance with the provisions of this bill, including the similarity in circumstances of the violation to any previous violation within a 24-month period;
- The ability and good faith effort of the CDC, and any responsible individual, to have foreseen or avoided the violation;
- The good faith effort by the CDC, and any responsible individual, to remedy the violation;
- The harm to any patient, or exacerbation of that harm, resulting from the violation; and,
- The extent to which the CDC fully and completely reported the violation to DPH;
- Requires penalties collected pursuant to this bill to be used by DPH to implement and enforce this bill.
- Requires, for purposes of the False Claims Act, which provides for treble damages in an action brought by the state for persons who make false claims to the state, that the information required to be submitted by CDCs to DPH regarding staffing levels, described in 7) above, are deemed material to any claim for payment submitted by a CDC within six months of the submission of that information.
- States the intent of the Legislature that California taxpayers not be financially responsible for implementation and enforcement of minimum staffing requirements at CDCs, and requires DPH to take into account all costs associated with implementing and enforcing this bill when calculating, assessing, and collecting fees imposed on CDCs.
- Requires DPH to issue regulations necessary to implement this bill no later than 180 days following its effective date.
- Makes various legislative findings and declarations, including there is broad consensus among medical professionals, academics, and other experts that adequate time to prepare a treatment station for a patient to be dialyzed is necessary to ensure safety and hygiene protocols are followed, and current staffing levels in CDCs are inadequate to protect patient health and worker safety, and therefore are presently causing harm to dialysis patients.
FISCAL EFFECT:
This bill has not been analyzed by a fiscal committee.
COMMENTS:
- Author’s statement. According to the author, California currently regulates dialysis clinics using the bare minimum standards required by federal law. The purpose of this bill is to improve dialysis patient safety and reduce avoidable medical complications for patients receiving treatment at outpatient clinics. This goal will be achieved by establishing minimum staffing ratios, increasing clinic inspections, and requiring adequate time to clean and prepare dialysis equipment between patients. Long-term patient outcomes can be improved by reducing infections, preventing unnecessary hospitalizations, and by more closely monitoring patients’ overall health. Research has shown that sufficient staffing in dialysis clinics is central to each of these aims. Without this bill, the more than 63,000 patients who rely on California’s dialysis clinics to survive will continue to receive care in facilities that are not held accountable for failing to meet best practices related to patient safety.
- Background on dialysis, CDCs and CHTs. A CDC provides care for the treatment of patients with end-stage renal disease (ESRD), including renal dialysis services. ESRD, also known as end-stage kidney disease or kidney failure, is when the kidneys, which remove waste and excess water from the body, are no longer able to work at a level needed for day-to-day life. The most common causes of ESRD in the United States are diabetes and high blood pressure. Dialysis does some of the job of the kidneys when they stop working, including removing extra salt, water, and waste products so they do not build up in the body. A typical patient with ESRD will need to go to a CDC three times a week for dialysis treatment, with each treatment taking about four hours. According to data from the United States Renal Data System, there is wide variation in the prevalence of ESRD throughout the United States, with the lowest rates in New England, and the highest rates in the Ohio and Mississippi River valleys, the Southeast, Texas and California. According to DPH, there are currently 542 licensed and CMS-certified CDCs in California, with another 23 CDCs that are licensed only (most of these waiting in line for CMS certification).
CHTs are certified and regulated by DPH. The scope of practice for CHTs include performing venipuncture and arterial puncture for the purpose of providing dialysis treatment for a patient. Additionally, the scope includes administration of local anesthetics (intradermal, subcutaneous, or topical administration only), heparin, and sodium chloride solutions, pursuant to protocol established by the medical director of the CDC. CHTs must work under the immediate supervision of either a physician or registered nurse, unless treating patients in the home and the CHT is certified by the Board of Nephrology Examination for Nurses and Technicians. To be certified as a CHT, a person must have a high school diploma or equivalent, have successfully completed an approved training program covering specified subjects, and pass a standardized test, as specified. Training programs can be provided in a CDC, under the direction of an RN, a community or corporate-based training program, or a program offered by an educational institution. A CHT certificate is valid for four years, and in order to renew a certification, the CHT must submit proof of completion of 30 hours of in-service training or continuing education. According to DPH, there are currently 7,717 active CHTs. - CMS requirements related to staffing. While there has been a longstanding requirement for DPH to promulgate regulations governing CDCs, to date they have not done so. In 2013, legislation was passed allowing DPH to enforce federal CMS requirements pertaining to ESRD facilities, until DPH adopts regulations relating to the provision of services by a CDC. CMS contracts with DPH to evaluate facilities to certify that they meet federal requirements to become Medicare and Medi-Cal providers, including for CDCs. DPH performs these functions directly, through various field offices, in most of the state, but contracts with Los Angeles County for the licensing and CMS certification function of health facilities located in Los Angeles county.
CMS certification standards with respect to on-site staffing in CDCs require that an adequate number of qualified personnel must be present whenever patients are undergoing dialysis so that the patient/staff ratio is appropriate to the level of dialysis care given and meets the needs of patients. CMS interpretive guidance states that consideration should be given to the acuity and care needs of patients, and that sufficient numbers of staff must be present in the treatment area “to be able to see every patient during treatment (including lunch breaks, shift change, etc.); to deliver routine care, patient assessment and monitoring per facility policy; and to promptly respond to and address patient needs (such as changes in physical or mental condition) and machine alarms.”
In addition to the on-site staffing, a CDC must also provide “adequate laboratory, social, and dietetic services to meet the needs” of the patient. With regard to the social services, CMS requires these to be provided by a qualified social worker that is either employed or contracted with the CDC, but there is no specific ratio, and the social worker is not required to be on site. - Other states. According to information provided by both the author’s office and the dialysis industry, there are eight states that have staffing ratios for RNs and CHTs, as follows:
Georgia: For CHTs, 1:4; for RNs, 1:10.
Maryland: Blended staffing ratio (combines CHTs and RNs) of 1:3 during day shifts, and 1:4 for nocturnal dialysis.
Mass.: Blended ratio of 1:3.
Oregon: Blended ratio of 1:4, including a minimum RN ratio of 1:16. However, if RN ratio exceeds 1:12, then RN cannot be included in 1:4 ratio.
New Jersey: Blended ratio of 1:3, with minimum RN ratio of 1:9
S. Carolina: Blended ratio of 1:4, with minimum RN ratio of 1:10
Texas: Blended ratio of 1:4, with minimum RN ratio of 1:12.
Utah: For CHTs, 1:4; for RNs, 1:10, or 1:12 if clinic uses 3 pods of 4 patients.
Only two states have ratios for social workers: Texas specifies a social worker ratio of 1:100, unless the social worker is given additional personnel to assist, in which case it can go to 1:125. Louisiana requires dialysis clinics to adhere to the Council of Nephrology Social Worker’s Guideline, which is 1:75.
- Characteristics of dialysis clinics and average staffing levels. The following information is from a 2013 article in the American Journal of Kidney Disease by Laura Yoder, entitled “Patient Care Staffing Levels and Facility Characteristics in U.S. Hemodialysis Facilities. This study used data from a 2009 CMS survey, and found that average staffing varies geographically, by size, and by for profit vs. nonprofit status. CDCs were divided into geographic regions using the four standard U.S. census regions (Northeast, Midwest, South, and West), and by size (small is 1-10 stations, medium 11-25 stations, and large 26 or more stations). Of the 4,800 facilities used in the study, 74% were mid-sized, and 84% were for-profit. Overall, the average RN-to-patient ratio was about 1:12, while the average CHT-to-patient ratio was about 1:10, but the study also separately included licensed vocational nurses, which this bill does not include. The composite ratio for all direct care staff (RNs, LVNs, and CHTs) is about 1:5 nationally. The West region generally had a slightly higher ratio for RNs (meaning fewer nurses) with a slightly lower ratio of CHTs (more CHTs), but again, when including LVNs, the direct caregiver ratio is somewhat better than the combination of these numbers.
- Complaint data. According to DPH, between July 1 2014 and February 15, 2017, it received 577 complaints for CDCs, and issued 370 deficiencies during this same time period as a result of all visits, including both periodic surveys and complaint investigations. Of these 577 complaints, 483 were received anonymously, patients or family members submitted 69 complaints, and facility staff or organizations submitted the remaining 25.
Under contract with CMS, there are 18 End Stage Renal Disease Network Organizations (ESRD Networks), which are funded by CMS to carry out a range of activities to improve the quality of care for individuals with end stage renal disease. Among other responsibilities, ESRD Networks are responsible for collecting, validating, and analyzing patient registry data, supporting use of the most appropriate treatment modalities to maximize quality of care, and identifying providers that do not contribute to the achievement of Network goals. In California, there are two ESRD Networks: ESRD Network 17 covers the northern portion of California, but also includes Hawaii and the territories of Guam, American Samoa, and the Northern Marianas Islands); and ESRD Network 18, which covers central and southern California. To limit it to California-only data, according to ESRD Network 18’s 2015 Annual Report (most recent available), there are 372 CDCs within its service area, serving about 39,000 patients. In 2015, ESRD Network 18 opened 108 grievance cases, and referred 33 of these to DPH as the survey agency under contract with CMS. At least nine of these cases referred to DPH specifically cited inadequate staffing in the complaint, and many of the others related to infection control or cleanliness.
- UC Report. Pursuant to SB 534 (Hernandez, Chapter 722, Statutes of 2013) DPH requested the UC Davis Institute for Population Health Improvement to conduct a study that “describes the extent to which federal certification standards are or are not sufficient as a basis for state licensing standards,” with regard to ambulatory surgery clinics, comprehensive outpatient rehabilitation facilities, and CDCs. As part of this report, this study looked at any known quality issues – defined broadly as concerns related to safety, effectiveness, patient-centeredness, timeliness, efficiency, and equity. The study concluded that California’s use of CMS certification standards as the basis for state licensure is consistent with standard practice across the nation, that better compliance with existing federal regulations would likely address many of the documented quality problems DPH has cited in these facilities, and that expanded state-specific regulations would be of uncertain marginal value.
However, according to the study, the authors reviewed four journal articles focusing on efficiency, and three of the articles explored issues relating to staffing levels. According to UC Davis, the studies found large regional differences in patient-nurse staffing ratios, and staffing levels were significantly associated with clinical outcomes. High patient-to-nurse ratios were linked to an increased number of adverse events.
This study also summarized the number and general types of deficiencies identified at dialysis clinics. DPH identified 9,591 discrete deficiencies in 537 CDCs between September 2005 and September 2015, an average of about 959 per year. The majority (98%) were federal deficiencies, and a small minority (2%) violated CMS conditions of participation. State deficiencies usually cited violations of the life safety code standards (e.g., building fire codes). Federal deficiencies were diverse, but commonly addressed infection control and prevention. Of the 792 deficiencies DPH identified in substantiated allegations (averaging about 79 per year), quality of care was the general type of allegation that surveyors cited most often. Among the potentially serious allegations were 14 general patient safety-related incidents, as well as two instances of sexual abuse, two patient falls, and one contaminated drug/device cases. - Double referral. This bill is double referred. Should it pass out of this committee, it will be referred to the Senate Judiciary Committee.
- Related legislation. AB 241 (Bonta) Extends from January 1, 2018 to January 1, 2019, the requirement that chronic dialysis, surgical, and rehabilitation clinics comply with federal certification standards pending the adoption of regulations by DPH. AB 251 is pending in the Assembly Health Committee.
- Prior legislation. SB 534 (Hernandez) among other provisions, required CDC’s to comply with applicable federal certification standards for end stage renal disease clinics until DPH adopts regulations relating to the provision of services by a CDC. Additionally, required DPH to submit a report on the extent to which federal certification standards are, or are not, sufficient as a basis for state licensing standards.
- Support. This bill is sponsored by the United Nurses Associations of California/Union of Health Care Professionals (UNAC/UHCP) and SEIU California. According to UNAC/UHCP, California currently has approximately 550 dialysis clinics serving 50,000 patients per year, which are governed by federal law that sets very ambiguous standards for ensuring patient safety. For example, UNAC/UHCP states that clinics are required to ensure that an “adequate number of qualified personnel” are present during dialysis to ensure that an “appropriate” level of dialysis is given to meet the needs of the patients. UNAC/UHCP states that this bill would increase patient safety by establishing that technicians would be responsible for no more than three patients at a time, and registered nurses at the clinics would be responsible for no more than eight patients at a time. UNAC/UHCP states that perhaps most significantly, this bill will ensure that there is an adequate transition time of 45 minutes between patients, which will allow clinic staff to clean and sterilize equipment in order to prevent transmission of blood borne pathogens from patient to patient. Without mandatory transition times, patients are endangered because clinics place a premium on getting the patients into the seat before the workstation can be adequately cleaned and prepared for the next patient. SEIU California states that California has imposed state-level regulations on hospitals, nursing homes, and other care facilities, but has not gone beyond the minimum federal certification standards in its regulation of dialysis clinics. SEIU California states that insufficient staff, insufficient time for health care workers to properly clean equipment and wash wands, and long gaps between regular inspections all increase the risk of these potential complications. The California Labor Federation writes that this bill affirms California’s commitment to protecting patient and worker health and safety and to setting the highest standards for quality in the health care industry.
A number of organizations state that dialysis is a life-saving treatment that comes with serious potential risks including blood infections from contaminated equipment, vitamin imbalances, nausea, bleeding and heart failure and that RNs and dialysis technicians are responsible for minimizing these risks and for responding in case of emergencies. The Congress of California Seniors states in support that a large number of dialysis patients are seniors, and that dialysis procedures must be safe, clean, and properly overseen. The California Alliance for Retired Americans states that without this bill, the more than 63,000 patients who rely on California’s dialysis clinics will continue to receive care in clinics that are not held accountable to best practices for staffing and patient transition times. The National Association of Social Workers, California Chapter, states in support that currently, staffing ratios are dangerously high, and that the United States has the worst dialysis patient outcomes in the industrialized world, with only one in three American patients on dialysis surviving after five years. - Opposition. This bill is opposed by Fresenius Medical Care, which operates 145 dialysis facilities in California, caring for more than 14,400 Californians. Fresenius states that the requirements in this bill would be catastrophic to the current system of dialysis care in California, and will displace thousands of dialysis patients. According to Fresenius, the requirements in this bill increases staffing up to 50% for registered nurses and 40% for technicians, and would occur during an industry nursing and technician shortage. If required staffing is not obtained or if call-ins occur and staff cannot be replaced, the facility would have to shut down the impacted shift in order to avoid financial penalties or license suspension. Fresenius stages that patients scheduled for that day would have treatments re-scheduled, diverted to another facility, or sent to the emergency room, and the remaining staff scheduled for that day would be sent home, resulting in lost wages. Regarding the 45 minute transition time requirement, Fresenius states that currently, 47% of its clinics have four shifts, but adding a 45 minute transition time between shifts would result in all of their facilities eliminating the 4th shift, because each facility has to shut down by a certain time in order for the water treatment system to regenerate for the following day. According to Fresenius the end of the 4th shifts in their clinics would cause approximately 1,400 patients to be displaced from their current dialysis facility. Fresenius argues that California dialysis facilities have excellent quality outcomes and patient safety records, with patient hospitalizations decreasing by 21% and mortality down 25% over the past 10 years, and that California out performs the rest of the county and other states that already have staffing ratios in place. Finally, Fresenius states that approximately 10% of its facilities in California are currently not profitable, and the proposed changes in this bill would increase the number of facilities losing money to 39%, which is an unsustainable loss.
The National Renal Administrators Association (NRAA) states in opposition that in 2008, CMS released the conditions of care that all end stage renal disease programs must adhere to, and that during this review, CMS determined that a national staffing ratio requirement was not the appropriate direction for these programs. NRAA also opposes the mandate on transition times, which will potentially decrease access to care and increase emergency department visits and hospitalizations, thereby increasing cost to the Medi-Cal program. U.S. Renal Care states in opposition that mandating minimum staffing ratios and longer transition times between patients will not improve care at their clinics. Instead, U.S. Renal Care states that this bill will force the elimination of a shift, which would leave thousands of patients across California without access to care. DaVita states in opposition that this bill’s requirement to meeting staffing ratios at all times, plus the 45-minute empty chair mandate between patients treatments, will impede the ability of dialysis clinics to tailor treatments to individual patient needs. DaVita states this bill will also ultimately restrict the ability of many clinics to continue operating a 4th patient shift, thereby drastically reducing treatment availability at a time when California needs additional capacity, not less. The California Hospital Association, Providence Health System, and the Association of California Healthcare Districts state in opposition that if this bill is enacted, dialysis services at clinics will be reduced, and with fewer appointments available, patients will not receive timely treatment and are more likely to end up in the emergency department with complications that could have been prevented with timely treatment. The Renal Support Network (RSN) states that the 45-minute transition time raises a number of questions, such as what happens when a patient is delayed getting on dialysis because of difficulty cannulating a dialysis access, or post dialysis clotting problems extends a patients time. In these circumstances, a patient may get off the machine 30 minutes late, and another patient is waiting for their treatment. RSN states that the staff can clean and prep the area in 10 minutes, but will have to explain to the next patient that rules do not allow them to be put on the dialysis machine because of the 45-minute empty chair requirement. RSN is also concerned about the staffing ratios for reasons similar to other opponents. - Letter of concern. CAPG submitted a letter of concern, stating that it supports policy measures that seek to ensure patient access to dialysis. However, CAPG states that it has serious concerns that exposing providers to additional civil penalties relating to these services will discourage and limit providers from providing this critical patient care.
- Policy comments.
- Transition time. This bill requires a mandatory transition time between patients of 45 minutes, which starts from the time a patient leaves the treatment area. Proponents assert that this time is necessary for staff to adequately clean the machines and perform non-patient care responsibilities before the next patient begins dialysis. Opponents argue that this is an arbitrary and inflexible time requirement, and that average time between patients is about 20 minutes currently. However, opponents also point out that when a patient finishes dialysis, they are often kept in the chair for a period of time before getting up, and staff can begin cleaning the machine and prepping the machine before the patient physically leaves the treatment area. It might, therefore, make more sense to set the transition time requirement based on when the patient completes treatment, rather than when the patient leaves the treatment area.
- Penalties. The penalty structure in this bill contains both fines, and license suspensions, and in most cases both are mandatory rather than discretionary. Even the very first violation of the provisions of this bill, no matter how minor, mandates a penalty of between $500 and $2,500 on the CDC, and between $100 and $1,000 on each responsible individual, if any. A responsible individual can be anyone from a member of the board of directors, to the medical director, to a managerial employee. In regards to license suspensions, DPH is given discretion as to whether to suspend a license for up to seven days for the first “gross violation” in a 24-month period – which can be simply failing to meet the required minimum staffing ratio for one hour. However, each subsequent gross violation requires in a mandatory license suspension. In practice, this means that if twice during a two-year period a CDC had an employee call in sick and was unable to replace that employee for an hour or more, DPH would be required to suspend the license, and all of the patients who receive treatment at that clinic would have to find another provider for the period of the suspension. Typically, regulatory agencies are given more discretion on when to fine or suspend licensees, especially for more minor violations. Given the degree to which patients who rely on dialysis could be harmed by a sudden lack of access as a result of a license suspension, the author may wish to consider granting DPH more discretion, especially for lesser violations.
- Annual inspection. This bill requires CDCs to be inspected annually. CMS currently requires an inspection once every three years, not to exceed 3.5 years between surveys. Other clinics licensed by DPH, such as primary care clinics or alternative birth centers, are required to be surveyed every three years as well. While this bill requires DPH to set the licensing fee of CDCs at a level necessary to comply with the requirements of this bill, it may take some time to hire and train a sufficient number of additional licensing and certification staff to meet the more frequent annual inspection requirements.
- Implementation date. Should this bill be enacted, it would take effect in July of next year, giving clinics only six months to hire and train additional staff to comply with the new staffing requirements to meet their current caseload. Without sufficient staff, the only way to meet this law would be to reduce caseload. In order to avoid disruption to patients who rely on dialysis treatment, the author may wish to consider delaying the implementation date to give clinics, as well as DPH, more time to staff up to the new requirements.
SUPPORT AND OPPOSITION:
Support: SEIU California (sponsor)
United Nurses Association of California/Union of Health
Care Professionals (sponsor)
American Federation of State, County and Municipal Employees, AFL-CIO
Black Aids Institute
Black Women for Wellness
California Alliance for Retired Americans
California Labor Federation
Congress of California Seniors
El Concilio de Fresno, Inc.
Fresno Center for New Americans
Fresno Immigration Coalition
Latino Diabetes Association
Men of Imperial Courts
NAACP-Fresno #1038
National Association of Social Workers, California Chapter (NASW-CA)
New Congregational Church
Sistahs in Sync
Watts Century Latino Organization
Watts Labor Community Action Committee
Oppose: Association of California Healthcare Districts
California Dialysis Council
California Hospital Association
California Medical Transportation Association
DaVita
Fresenius Medical Care
Loma Linda University
Orange County Business Council
National Renal Administrators Association
Providence Health & Services
Renal Support Network
St. Joseph Hoag Health
Toiyabe Indian Health Project, Inc.
U.S. Renal Care
Valley Industry Commerce Association
Seven Individuals
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Discussed in Hearing
Senate Floor
Senate Standing Committee on Judiciary
Assembly Floor
Assembly Floor
Assembly Standing Committee on Appropriations
Assembly Standing Committee on Health
Senate Floor
Senate Standing Committee on Appropriations
Bill Author
Bill Co-Author(s):