Existing law provides for the licensure and regulation of health facilities by the State Department of Public Health. A violation of these provisions is a crime. Existing law authorizes the department to promulgate rules and regulations regarding health facilities, in accordance with the provisions of the Administrative Procedure Act.

This bill would authorize the department to use a streamlined administrative process to update regulatory references to health care standards of practice adopted by a state or national association when outdated standards are already referenced in the California Code of Regulations. The procedure created by this bill would, among other things, require the department to post the update on the departments Internet Web site, notify stakeholders of the proposed change, submit notice of the proposed change to the Office of Administrative Law for publication in the California Regulatory Notice Register, accept comments, and consider those comments prior to the adoption of the new standards. The bill would require, if a member of the public requests a public hearing, that the department hold a hearing and consider any comments. The bill would, if comments are submitted in opposition to the proposed change, require the department to instead follow the procedures provided for by the Administrative Procedure Act.

Existing law requires inpatient treatment of eating disorders to be provided only in state licensed hospitals. Existing law defines eating disorders for these purposes as anorexia nervosa and bulimia as defined in the 1980 Diagnostic and Statistical Manual of Mental Disorders, published by the American Psychiatric Association.

This bill would instead define eating disorders to have the meaning of the term as defined in the most recent edition of the Diagnostic and Statistical Manual of Mental Disorders, as published by the American Psychiatric Association. By changing the definition of a crime applicable to health facilities, this bill would create 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 provides for the licensure and regulation of health facilities by the State Department of Public Health. A violation of these provisions is a crime. Existing law authorizes the department to promulgate rules and regulations regarding health facilities, in accordance with the provisions of the Administrative Procedure Act.

This bill would authorize the department to use a streamlined administrative process to update regulatory references to health care standards of practice adopted by a state or national association when outdated standards are already referenced in the California Code of Regulations. The procedure created by this bill would, among other things, require the department to post the update on the departments Internet Web site, notify stakeholders of the proposed change, submit notice of the proposed change to the Office of Administrative Law for publication in the California Regulatory Notice Register, accept comments, and consider those comments prior to the adoption of the new standards. The bill would require, if a member of the public requests a public hearing, that the department hold a hearing and consider any comments. The bill would, if comments are submitted in opposition to the proposed change, require the department to instead follow the procedures provided for by the Administrative Procedure Act.

Existing law requires inpatient treatment of eating disorders to be provided only in state licensed hospitals. Existing law defines eating disorders for these purposes as anorexia nervosa and bulimia as defined in the 1980 Diagnostic and Statistical Manual of Mental Disorders, published by the American Psychiatric Association.

This bill would instead define eating disorders to have the meaning of the term as defined in the most recent edition of the Diagnostic and Statistical Manual of Mental Disorders, as published by the American Psychiatric Association. By changing the definition of a crime applicable to health facilities, this bill would create 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 provides for the licensure and regulation of health facilities by the State Department of Health Care Services. Public Health. A violation of these provisions is a crime. Existing law authorizes the department to promulgate rules and regulations regarding health facilities, in accordance with the provisions of the Administrative Procedure Act.

This bill would authorize the department to use a streamlined administrative process to update regulatory references to health care standards of practice adopted by a state or national association when outdated standards are already referenced in the California Code of Regulations. The procedure created by this bill would, among other things, require the department to post the update on the departments Internet Web site, notify stakeholders of the proposed change, submit notice of the proposed change to the Office of Administrative Law for publication in the California Regulatory Notice Register, accept comments, and consider those comments prior to the adoption of the new standards. The bill would require, if a member of the public requests a public hearing, that the department hold a hearing and consider any comments. The bill would, if comments are submitted in opposition to the proposed change, require the department to instead follow the procedures provided for by the Administrative Procedure Act.

Existing law requires inpatient treatment of eating disorders to be provided only in state licensed hospitals. Existing law defines eating disorders for these purposes as anorexia nervosa and bulimia as defined in the 1980 Diagnostic and Statistical Manual of Mental Disorders, published by the American Psychiatric Association.

This bill would instead define eating disorders to have the meaning of the term as defined in the most recent edition of the Diagnostic and Statistical Manual of Mental Disorders, as published by the American Psychiatric Association. By changing the definition of a crime applicable to health facilities, this bill would create 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 provides for the licensure and regulation of health facilities by the State Department of Health Care Services. A violation of these provisions is a crime. Existing law authorizes the State Department of Public Health department to promulgate rules and regulations regarding health facilities, in accordance with the provisions of the Administrative Procedure Act.

This bill would authorize the department to use a streamlined administrative process to update regulatory references to health care standards of practice adopted by a state or national association when outdated standards are already referenced in the California Code of Regulations. The procedure created by this bill would, among other things, require the department to post the update on the departments Internet Web site, notify stakeholders of the proposed change, submit notice of the proposed change to the Office of Administrative Law for publication in the California Regulatory Notice Register, accept comments, and consider those comments prior to the adoption of the new standards. The bill would require, if a member of the public requests a public hearing, that the department hold a hearing and consider any comments. The bill would, if comments are submitted in opposition to the proposed change, require the department to instead follow the procedures provided for by the Administrative Procedure Act.

Existing law authorizes the State Department of Public Health to promulgate rules and regulations regarding health facilities, in accordance with the provisions of the Administrative Procedure Act.

This bill would authorize the department to use a streamlined administrative process to update regulatory references to health care standards of practice adopted by a state or national association when outdated standards are already referenced in the California Code of Regulations. The procedure created by this bill would, among other things, require the department to post the update on the departments Internet Web site, notify stakeholders of the proposed change, submit notice of the proposed change to the Office of Administrative Law for publication in the California Regulatory Notice Register, accept comments, and consider those comments prior to the adoption of the new regulations. This standards. The bill would require, if a member of the public requests a public hearing, that the department hold a hearing and consider any comments. This The bill would, if comments are submitted in opposition to the proposed change, require the department to instead follow the procedures provided for by the Administrative Procedure Act.

Existing law authorizes the State Department of Public Health to promulgate rules and regulations regarding health facilities, in accordance with the provisions of the Administrative Procedure Act.

This bill would authorize the department to use a streamlined administrative process to update regulatory references to health care standards of practice adopted by a state or national association when outdated standards are already referenced in the California Code of Regulations. The procedure created by this bill would, among other things, require the department to post the update on the departments Internet Web site, notify stakeholders of the proposed change, accept comments, and consider those comments prior to the adoption of the new regulations. This bill would require, if a member of the public requests a public hearing, that the department hold a hearing and consider any comments. This bill would, if comments are submitted in opposition to the proposed change, require the department to instead follow the procedures provided for by the Administrative Procedure Act.

CONCURRENCE IN SENATE AMENDMENTS

CSA1 Bill Id:AB 614

Author:(Brown)

As Amended Ver:June 2, 2015

Majority vote

Original Committee Reference: HEALTH

SUMMARY: Authorizes the California Department of Public Health (DPH) to use a streamlined administrative process to update regulatory references to health care standards of practice adopted by a state or national association when outdated standards are referenced in the California Code of Regulations (CCR).

The Senate amendments update the definition of eating disorders to reference the Diagnostic and Statistical Manual of Mental Disorders, as published by the American Psychiatric Association.

EXISTING LAW: Establishes DPH to license health facilities and requires DPH to adopt, amend or repeal, as specified, any reasonable rules and regulations as may be necessary or proper to carry out the exercise of its power. Establishes, under the Administrative Procedures Act (APA), a process for adopting, amending, or repealing regulations.

FISCAL EFFECT: According to the Senate Appropriations Committee, pursuant to Senate Rule 28.8, negligible state costs.

COMMENTS: According to the author, this bill will eliminate the need to revise regulations simply to update references to the most recent standards of practice when applicable. The author states that this will result in an efficient and cost effective method for ensuring that health facilities and DPH are referencing standards and providing care that is consistent with the most current nationally recognized professional standards, improving the quality of patient care provided in licensed health facilities.

The regulatory process, governed by the APA and enforced by the Office of Administrative Law (OAL) is designed to provide the public with a meaningful opportunity to participate in the adoption of regulations or rules that have the force of law and to ensure the creation of an adequate record for the public, OAL, and judicial review.

Generally, there are two types of rulemaking procedures that a state agency can pursue: regular or emergency. The regular rulemaking process requires that a state agency meet certain public hearing and notice requirements. The emergency rulemaking process has different requirements, which generally include a brief public notice period, a finding of emergency, a brief public comment period, review by OAL and an OAL decision. For the regular rulemaking process, once a state agency decides to conduct a rulemaking action, it develops four documents required during the preliminary stage: 1) the proposed text; 2) the Initial Statement of Reasons; 3) the Fiscal Impact Statement; and, 4) the Notice of Proposed Regulatory Action (notice).

The APA requires at a minimum a 45-day opportunity to comment to the agency, in writing, on the proposed regulation. An agency has the option as to whether it will hold a public hearing on a proposed rulemaking action. However, if an agency does not schedule a public hearing, any interested person can submit a written request within a specified timeframe requesting one to be held, and the agency must then give notice and hold a public hearing.

A rulemaking agency must summarize and respond on the record to timely comments that are directed at the proposal or at the procedures followed by the agency during the regulatory action. With each comment, the agency must either: 1) explain how it has amended the proposal to accommodate the comment; or, 2) explain the reasons for making no change to the proposal. The summary and response to comments is included as part of the rulemaking file in the Final Statement of Reasons.

According to DPH, their experience is that a relatively simple regulation packet could move through the process in as few as 15 months to 18 months, regulations pertaining to more complicated subject matter can sometimes take several years, depending on the volume of public comments.

Nationally recognized professional organizations use industry expertise, information gathered through research, patient outcomes, and best practices to develop standards that are accepted in various medical professions for providing the highest quality of care possible. For example, the American Academy of Pediatrics publishes a wide variety of clinical practice guidelines on a range of subjects including: The Diagnosis, Management, and Prevention of Bronchiolitis, Management of Newly Diagnosed Type 2 Diabetes Mellitus in Children and Adolescents, and Treatment of the School-Aged Child With Attention-Deficit/Hyperactivity Disorder, to name a few.

There are approximately 30 references to outdated standards of practice in CCR Title 22 (which apply to various health facilities, including clinics, and general acute care hospitals), some of which are referenced in more than one place, and dating as far back as 1961. The American Dietetic Association standards of practice referenced for educational programs for dietetic service staff in general acute care hospitals were adopted in June 1974. DPH is currently in the process of updating Title 22. Some of the regulatory packets could be completed later this year, other more complex packets will take several years to complete, and due to the volume (Title 22 effects up to 30 different types of health facilities) DPH estimates that the entire update will not be complete until sometime in 2025. Currently, health facilities affected by regulations which reference outdated standards of practice are requesting program flexibility from DPH to allow them to operate using more current medical standards.

DPH is the sponsor of this bill and notes they are the enforcement and regulatory agency for approximately 30 different types of health care facilities and clinics, and they have a backlog of regulations that are subject to the APA. DPH contends that in order to remain compliant with up-to-date clinical practices instead of being errantly held to antiquated practices in state regulations, facilities must request program flexibility from DPH, and this additional step creates hurdles for health facilities and clinics. DPH concludes that this bill will eliminate the need to revise regulations simply to update references to the most recent standards of practice.

There is no known opposition to this bill.

Analysis Prepared by: Lara Flynn / HEALTH / (916) 319-2097 FN: 0001201

 THIRD READING  

Bill No: AB 614

Author: Brown (D)

Amended: 6/2/15 in Senate

Vote: 21

SENATE HEALTH COMMITTEE: 8-0, 6/24/15

AYES: Hernandez, Nguyen, Mitchell, Monning, Nielsen, Pan, Roth, Wolk

NO VOTE RECORDED: Hall

SENATE APPROPRIATIONS COMMITTEE: Senate Rule 28.8

ASSEMBLY FLOOR: 77-0, 5/7/15 (Consent) - See last page for vote

SUBJECT: Health care standards of practice

SOURCE: California Department of Public Health

DIGEST: This bill permits the Department of Public Health (DPH), without taking regulatory action, to update references in the California Code of Regulations (CCR) to health care standards of practice adopted by a recognized state or national association when the state or national association and its outdated standards are already named in the CCR.

ANALYSIS:

Existing law:

1. Requires DPH’s Licensing and Certification Division (L&C) to inspect and license health facilities, including, but not limited to, clinics, skilled nursing facilities, acute care hospitals, and psychiatric hospitals.

2. Requires DPH to adopt, amend, or repeal, any reasonable rules and regulations necessary or proper to carry out the purposes and intent of existing law related to the licensing of health facilities and to enable DPH to exercise the powers and perform the duties conferred upon it by that law, as specified.

3. Establishes, under the Administrative Procedures Act (APA), a process for adopting, amending, or repealing regulations through the Office of Administrative Law (OAL).

This bill:

1. Permits DPH, without taking regulatory action, to update references in the CCR to health care standards of practice adopted by a recognized state or national association when the state or national association and its outdated standards are already named in the CCR.

2. Requires DPH, when updating these references, to:

1. Post notice of their proposed adoption of the state or national association’s health care standards of practice on its Web site for at least 45 days. Requires the notice to include the name of the state or national association, the title of the health care standards of practice, and the version of the updated health care standards of practice to be adopted.

2. Notify stakeholders that the proposed standards have been posted on the Web site by issuing a mailing to the most recent stakeholder list on file with the DPH’s Office of Regulations.

3. Submit the required notice to the OAL. Requires the OAL to publish in the California Regulatory Notice Register any notice received; and,

4. Accept public comment for at least 30 days after the conclusion of the 45-day posting period. Specifies that written responses to public comments are not required.

2. Requires a public hearing to be held if a member of the public requests one during the public comment period.

3. Requires DPH to consider any comments received during the public comment period prior to the adoption of the health care standards whether or not a public hearing is requested.

4. Requires DPH to seek adoption of new standards using the regulatory process if public comments are submitted in opposition to the adoption of the proposed standards, or the state or national association named in the CCR no longer exists. Specifies that a state or national association named in the CCR that has changed its name does not constitute an association that no longer exists.

5. Requires DPH to update its Internet Web site to notify the public that the standard has been adopted and the effective date of that standard if no opposition to the change is received.

6. Makes technical, clarifying changes to existing law related to the inpatient treatment of eating disorders.

Comments

1. Author’s statement. According to the author, this bill streamlines DPH’s process used to update health care standards of practice in health facilities and clinics. Currently, DPH’s L&C Program has a substantial backlog of regulations that are subject to the APA. The APA requires a full rulemaking process in order to update these standards, taking up to three years or longer for each regulation update to complete. AB 614 will also improve the quality of patient care provided in licensed health facilities by eliminating the need to revise regulations through the full APA process simply to update references to the most recent standards of practice. This change will lead to a more efficient and cost effective method for ensuring that health facilities and DPH are referencing standards and providing care that is consistent with the most current nationally recognized professional standards.

2. L&C Division. According to the L&C Annual Report for Fiscal Year 2015-16, it is responsible for regulatory oversight of licensed health care facilities and health care professionals to ensure safe, effective, and quality health care for all Californians. L&C licenses and certifies over 7,500 health care facilities and agencies in California in 30 different licensure and certification categories. In order to ensure compliance with federal and state laws, they conduct periodic inspections and complaint investigations of health care facilities. Facilities regulated by L&C include, but are not limited to, nursing homes, general and psychiatric hospitals, acute care hospitals, special hospitals, community clinics, congregate living health facilities, skilled nursing facilities, surgical clinics, rehabilitation clinics, dialysis clinics, correctional treatment centers and intermediate care facilities. L&C also certifies nurse assistants, home health aides, and hemodialysis technicians and licenses nursing home administrators.

3. Regulatory process. According to the OAL, the regulatory process is designed to provide the public with a meaningful opportunity to participate in the adoption of regulations or rules that have the force of law and to ensure the creation of an adequate record for the public, OAL, and judicial review. The OAL is responsible for reviewing administrative regulations proposed by over 200 state agencies for compliance with the standards set forth in the APA. To initiate a rulemaking action, an agency first issues a public notice, and has one year within which to complete the rulemaking and submit to OAL. The APA requires a minimum of 45-days comment to the agency, in writing, on the proposed regulation. After the initial public comment period, changes to the initial proposal may be made. Agencies must make each substantial, sufficiently related change available for public comment for at least 15 days before adoption. Upon receipt of a proposed regulation, OAL has 30 working days to conduct its review and determine whether it demonstrates that the agency satisfied the procedural requirement of the APA, and review the proposed regulations for compliance with the six legal standards set forth in the APA. According to DPH, their experience is that a relatively simple regulation packet could move through the process in as few as 15-18 months, while regulations pertaining to more complicated subject matter can sometimes take several years, depending on the volume of public comments.

4. Standards of practice. Nationally recognized professional organizations use industry expertise, information gathered through research, patient outcomes, and best practices to develop standards that are used by various health care professions in an effort to provide quality care. For example, the American Academy of Pediatrics publishes clinical practice guidelines on a range of subjects including: The Diagnosis, Management, and Prevention of Bronchiolitis, Management of Newly Diagnosed Type 2 Diabetes Mellitus in Children and Adolescents, and Treatment of the School-Aged Child With Attention-Deficit/Hyperactivity Disorder. Additionally, a number of national organizations publish standards intended to guide the profession in day-to-day practice, including the American Association of Nurse Practitioners, the American Nurses Association, and the American Association of Nurse Anesthetists. In addition, there are other documents relevant to specialties.  For example,  Pediatric Nursing: Scope and Standards of Practice is a collaborative effort of the ANA, the Society for Pediatric Nurses, and the National Association of Pediatric Nurse Practitioners and is meant to define the scope of practice and standards of practice for pediatric nursing.

5. DPH and outdated regulations. The author states that this bill is necessary because L&C has a substantial backlog of regulations that are subject to the APA. This is not the only case of outdated regulations not being addressed by DPH. In the fall of 2014, the Senate Health Committee asked the Senate Office of Research to identify outdated regulations under the purview of DPH. Working with DPH, there are approximately 25 instances in which statute required a regulation be promulgated or updated, but that had not completed (most of these in L&C – see Senate Health Committee analysis for detail). According to DPH, there are approximately 30 references to outdated standards of practice in Title 22 of the CCR (which apply to up to 30 types of health facilities, including clinics, and general acute care hospitals), some of which are referenced in more than one place, and dating as far back as 1961. DPH is currently in the process of updating Title 22. Some of the regulatory packets could be completed later this year, other more complex packets will take several years to complete, and due to the volume, DPH estimates that the entire update will not be complete until sometime in 2025. Currently, health facilities affected by regulations which reference outdated standards of practice are requesting program flexibility from DPH to allow them to operate using more current medical standards.

6. Policy comment. According to the Senate Health Committee, “There are numerous instances in which a regulated entity cannot operate effectively because factors in today’s world conflict with regulations that have not been updated by DPH in 20 to 30 years. This problem has affected health care facilities, labs, pharmacies, and narcotic treatment facilities, among others. There have been a number of bills that have come through the Health Committee to work around outdated regulations, without leaving facilities unregulated entirely. Those bills have been drafted to address specific instances in which an outdated regulation was limiting the ability of providers to practice in the most effective manner. For example, federal regulations were amended in 2001 to allow for Sunday or holiday closure of methadone clinics in certain cases while state regulations have not been updated for over 20 years and require methadone clinics to be open seven days a week. There are take-home doses of methadone available that are safe to use, ensuring that patients do not have a break in treatment if a facility were closed one day a week. Another bill heard by this Committee permits pharmacy technicians, rather than pharmacists, to check expiration dates on the labels of drugs in a hospital pharmacy – something currently prohibited by a regulation not updated since its promulgation in 1986. While the Health Committee has approved a piecemeal approach to the problem of outdated regulations, the longstanding reluctance of DPH to utilize the standard rulemaking process is troubling. It is encouraging that DPH is currently engaged in an effort to update Title 22 regs. DPH should also examine what the barriers have been to using the APA process in an effort to make that a more routine part of their role as a regulator.”

FISCAL EFFECT: Appropriation: No Fiscal Com.: Yes Local: Yes

SUPPORT: (Verified 7/8/15)

California Department of Public Health (source)

American Federation of State, County and Municipal Employees

Arc and United Cerebral Palsy California Collaboration

California Commission on Aging

California Senior Legislature

Congress of California Seniors

OPPOSITION: (Verified 7/8/15)

None received

ASSEMBLY FLOOR: 77-0, 5/7/15

AYES: Achadjian, Alejo, Travis Allen, Baker, Bigelow, Bloom, Bonilla, Bonta, Brough, Brown, Burke, Calderon, Chang, Chau, Chávez, Chiu, Chu, Cooley, Cooper, Dababneh, Dahle, Daly, Dodd, Eggman, Frazier, Beth Gaines, Gallagher, Cristina Garcia, Eduardo Garcia, Gatto, Gipson, Gomez, Gonzalez, Gordon, Gray, Grove, Hadley, Harper, Holden, Irwin, Jones, Jones-Sawyer, Kim, Lackey, Levine, Linder, Lopez, Low, Maienschein, Mathis, Mayes, McCarty, Medina, Melendez, Mullin, Nazarian, Obernolte, O'Donnell, Olsen, Patterson, Perea, Quirk, Rendon, Ridley-Thomas, Rodriguez, Salas, Santiago, Mark Stone, Thurmond, Ting, Wagner, Waldron, Weber, Wilk, Williams, Wood, Atkins

NO VOTE RECORDED: Campos, Roger Hernández, Steinorth

Prepared by: Melanie Moreno / HEALTH /

7/8/15 11:52:16

**** END ****

SENATE COMMITTEE ON HEALTH

Senator Ed Hernandez, O.D., Chair

BILL NO: AB 614

SUBJECT: Health care standards of practice

SUMMARY:

Permits the Department of Public Health, without taking regulatory action, to update references in the California Code of Regulations (CCR) to health care standards of practice adopted by a recognized state or national association when the state or national association and its outdated standards are already named in the CCR.

Existing law:

1. Requires the Licensing and Certification Division (L&C) of the Department of Public Health (DPH) to inspect and license health facilities, including but not limited to clinics, skilled nursing facilities, acute care hospitals, and psychiatric hospitals.

2. Requires DPH adopt, amend, or repeal, any reasonable rules and regulations necessary or proper to carry out the purposes and intent of existing law related to the licensing of health facilities and to enable DPH to exercise the powers and perform the duties conferred upon it by that law, as specified.

3. Establishes, under the Administrative Procedures Act (APA), a process for adopting, amending, or repealing regulations through the Office of Administrative Law (OAL).

This bill:

1. Permits DPH, without taking regulatory action, to update references in the CCR to health care standards of practice adopted by a recognized state or national association when the state or national association and its outdated standards are already named in the CCR.

2. Requires DPH, when updating these references, to:

1. Post notice of their proposed adoption of the state or national association’s health care standards of practice on its web site for at least 45 days. Requires the notice to include the name of the state or national association, the title of the health care standards of practice, and the version of the updated health care standards of practice to be adopted.

2. Notify stakeholders that the proposed standards have been posted on the web site by issuing a mailing to the most recent stakeholder list on file with the DPH’s Office of Regulations.

3. Submit the required notice to the OAL. Requires the OAL to publish in the California Regulatory Notice Register any notice received; and,

4. Accept public comment for at least 30 days after the conclusion of the 45-day posting period.

3. Requires a public hearing to be held if a member of the public requests one during the public comment period.

4. Requires DPH to consider any comments received during the public comment period prior to the adoption of the health care standards whether or not a public hearing is requested.

5. Specifies that written responses to public comments are not required.

6. Requires DPH to seek adoption of new standards using the regulatory process if public comments are submitted in opposition to the adoption of the proposed standards, or the state or national association named in the CCR no longer exists. Specifies that a state or national association named in the CCR that has changed its name does not constitute an association that no longer exists.

7. Requires DPH to update its Internet Web site to notify the public that the standard has been adopted and the effective date of that standard if no opposition to the change is received.

8. Makes technical, clarifying changes to existing law related to the inpatient treatment of eating disorders.

FISCAL EFFECT:

According to the Assembly Appropriations Committee, negligible state fiscal effect.

PRIOR VOTES:

COMMENTS:

1. Author’s statement. According to the author, this bill would streamline DPH’s process used to update health care standards of practice in health facilities and clinics. Currently, DPH’s L&C Program has a substantial backlog of regulations that are subject to the APA. The APA requires a full rulemaking process in order to update these standards, taking up to three years or longer for each regulation update to complete. AB 614 will also improve the quality of patient care provided in licensed health facilities by eliminating the need to revise regulations through the full APA process simply to update references to the most recent standards of practice. This change will lead to a more efficient and cost effective method for ensuring that health facilities and DPH are referencing standards and providing care that is consistent with the most current nationally recognized professional standards.

2. L&C division. According to the L&C Annual Report for Fiscal Year 2015-16, it is responsible for regulatory oversight of licensed health care facilities and health care professionals to ensure safe, effective, and quality health care for all Californians. L&C licenses and certifies over 7,500 health care facilities and agencies in California in 30 different licensure and certification categories. In order to ensure compliance with federal and state laws, they conduct periodic inspections and complaint investigations of health care facilities. Facilities regulated by L&C include, but are not limited to, nursing homes, general and psychiatric hospitals, acute care hospitals, special hospitals, community clinics, congregate living health facilities, skilled nursing facilities, surgical clinics, rehabilitation clinics, dialysis clinics, correctional treatment centers and intermediate care facilities. L&C also certifies nurse assistants, home health aides, and hemodialysis technicians and licenses nursing home administrators.

3. Regulatory process. According to the OAL, the regulatory process is designed to provide the public with a meaningful opportunity to participate in the adoption of regulations or rules that have the force of law and to ensure the creation of an adequate record for the public, OAL, and judicial review. The OAL is responsible for reviewing administrative regulations proposed by over 200 state agencies for compliance with the standards set forth in the APA. To initiate a rulemaking action, an agency first issues a public notice, and has one year within which to complete the rulemaking and submit to OAL. The APA requires a minimum of 45-days comment to the agency, in writing, on the proposed regulation. After the initial public comment period, changes to the initial proposal may be made. Agencies must make each substantial, sufficiently related change available for public comment for at least 15 days before adoption. Upon receipt of a proposed regulation, OAL has 30 working days to conduct its review and determine whether it demonstrates that the agency satisfied the procedural requirement of the APA, and review the proposed regulations for compliance with the six legal standards set forth in the APA. According to DPH, their experience is that a relatively simple regulation packet could move through the process in as few as 15-18 months, while regulations pertaining to more complicated subject matter can sometimes take several years, depending on the volume of public comments.

4. Standards of practice. Nationally recognized professional organizations use industry expertise, information gathered through research, patient outcomes, and best practices to develop standards that are used by various health care professions in an effort to provide quality care. For example, the American Academy of Pediatrics publishes clinical practice guidelines on a range of subjects including: The Diagnosis, Management, and Prevention of Bronchiolitis, Management of Newly Diagnosed Type 2 Diabetes Mellitus in Children and Adolescents, and Treatment of the School-Aged Child With Attention-Deficit/Hyperactivity Disorder. Additionally, a number of national organizations publish standards intended to guide the profession in day-to-day practice, including the American Association of Nurse Practitioners, the American Nurses Association, and the American Association of Nurse Anesthetists. In addition, there are other documents relevant to specialties.  For example,  Pediatric Nursing: Scope and Standards of Practice is a collaborative effort of the ANA, the Society for Pediatric Nurses (SPN), and the National Association of Pediatric Nurse Practitioners and is meant to define the scope of practice and standards of practice for pediatric nursing.

5. Obsolete references to standards of practice. According to DPH, there are approximately 30 references to outdated standards of practice in Title 22 of the CCR (which apply to various health facilities, including clinics, and general acute care hospitals), some of which are referenced in more than one place, and dating as far back as 1961. The American Dietetic Association standards of practice referenced for educational programs for dietetic service staff in general acute care hospitals were adopted in June 1974. DPH is currently in the process of updating Title 22. Some of the regulatory packets could be completed later this year, other more complex packets will take several years to complete, and due to the volume (Title 22 affects up to 30 different types of health facilities), DPH estimates that the entire update will not be complete until sometime in 2025. Currently, health facilities affected by regulations which reference outdated standards of practice are requesting program flexibility from DPH to allow them to operate using more current medical standards.

6. DPH and outdated regulations. The author states that this bill is necessary because L&C has a substantial backlog of regulations that are subject to the APA. This is not the only case of outdated regulations not being addressed by DPH. In the fall of 2014, this Committee asked the Senate Office of Research to identify outdated regulations under the purview of DPH. Working with DPH, approximately 25 instances were identified in which statute required a regulation be promulgated or updated, but that had not been done (most of these in L&C):

DPH Center/Office	Regulations Identified	Regulations In Process	Regulations Completed Since 2009
Center for Chronic Disease Prevention and Health Promotion-Environmental and Occupational Disease Control	3	0	0
Center for Chronic Disease Prevention and Health Promotion	1	0	1
Center for Environmental Health-Food, Drug, and Radiation Safety	9	8	3
Center for Environmental Health- Environmental Management Branch	6	0	1
Center for Family Health- Genetic Disease Screening Program	5	4	3
Center for Family Health- Women, Infants, and Children	2	0	1
Center for Health Care Quality- Licensing and Certification	30	8	7
Office of the State Public Health Laboratory	7	3	0
Center for Infectious Diseases- Communicable Disease Control	2	1	5
Center for Infectious Diseases-Office of AIDS	1	1	4
Other Divisions or Branches with no identified regs at this time, but with completed regs.			7
Total	66	25	32

7. Support. DPH, the sponsor of this bill, contends that in order to remain compliant with up-to-date clinical practices instead of being errantly held to antiquated practices in state regulations, facilities must request program flexibility from DPH, and this additional step creates hurdles for health facilities and clinics. DPH concludes that this bill will eliminate the need to revise regulations simply to update references to the most recent standards of practice. The California Long-Term Care Ombudsman Association supports this bill because it helps to create a more efficient and cost effective method for ensuring skilled nursing facilities are referencing standards and providing care that is consistent with the most current nationally recognized professional standards.

8. Policy comment. There are numerous instances in which a regulated entity cannot operate effectively because factors in today’s world conflict with regulations that have not been updated by DPH in 20 to 30 years. This problem has affected health care facilities, labs, pharmacies, and narcotic treatment facilities, among others. There have been a number of bills that have come through this Committee to work around outdated regulations, without leaving facilities unregulated entirely. Those bills have been drafted to address specific instances in which an outdated regulation was limiting the ability of providers to practice in the most effective manner. For example, federal regulations were amended in 2001 to allow for Sunday or holiday closure of methadone clinics in certain cases while state regulations have not been updated for over 20 years and require methadone clinics to be open seven days a week. There are take-home doses of methadone available that are safe to use, ensuring that patients do not have a break in treatment if a facility were closed one day a week. Another bill heard by this Committee permits pharmacy technicians, rather than pharmacists, to check expiration dates on the labels of drugs in a hospital pharmacy – something currently prohibited by a regulation not updated since its promulgation in 1986. While this Committee has approved a piecemeal approach to the problem of outdated regulations, the longstanding reluctance of DPH to utilize the standard rulemaking process is troubling. It is encouraging that DPH is currently engaged in an effort to update Title 22 regs. DPH should also examine what the barriers have been to using the APA process in an effort to make that a more routine part of their role as a regulator.

SUPPORT AND OPPOSITION:

Support: California State Department of Public Health (sponsor)

American Federation of State, County and Municipal Employees

Arc and United Cerebral Palsy California Collaboration

California Commission on Aging

California Senior Legislature

Congress of California Seniors

Oppose: None received.

-- END --

Date of Hearing: April 29, 2015

ASSEMBLY COMMITTEE ON APPROPRIATIONS

Jimmy Gomez, Chair

ABPCA Bill Id:AB 614

Author:(Brown) – As Amended Ver:April 16, 2015

Urgency: No State Mandated Local Program: No Reimbursable: No

SUMMARY:

This bill authorizes the California Department of Public Health (CDPH) to use a streamlined administrative process to update regulatory references to health care standards of practice adopted by a state or national association when outdated standards are referenced in the California Code of Regulations (CCR). It also requires, if there is public comment in opposition to the proposed update, CDPH to use the normal regulatory process.

FISCAL EFFECT:

Negligible state fiscal effect.

COMMENTS:

1. Purpose. According to the author, this bill will eliminate the need to revise regulations simply to update references to the most recent standards of practice when applicable. The author states that this will result in an efficient and cost-effective method for ensuring that health facilities and CDPH are referencing standards and providing care that is consistent with the most current nationally recognized professional standards, improving the quality of patient care provided in licensed health facilities. The bill is sponsored by CDPH.

2. Background. The Administrative Procedures Act (APA) governs the regulatory process, and the Office of Administrative Law (OAL) enforces its provisions. Pursuant to APA, new regulations, as well as updates to existing regulations, must go through a public comment and review process. Many references in CDPH's regulations governing quality of care in health facilities make reference to guidance developed by professional societies. These references tend to require updating more regularly than the regulations in which they are embedded.

3. Staff Comment. A number of recent bills have addressed the alleged failure of CDPH to promulgate regulations, including bills last session addressing standards for forensic alcohol laboratory tests and tissue banks and, in this session, cytology and pediatric day health and respite care facilities. This bill appears to offer a reasonable way to update some specific regulatory references that relate to standards of practice, but it does not address the larger issue of many other regulations that may be decades out of date, or regulations that were never promulgated.

Analysis Prepared by: Lisa Murawski / APPR. / (916) 319-2081

Date of Hearing: April 14, 2015

ASSEMBLY COMMITTEE ON HEALTH

Rob Bonta, Chair

ABPCA Bill Id:AB 614

Author:(Brown) – As Introduced Ver:February 24, 2015

SUBJECT: Health care standards of practice.

SUMMARY: Authorizes the California Department of Public Health (DPH) to use a streamlined administrative process to update regulatory references to health care standards of practice adopted by a state or national association when outdated standards are referenced in the California Code of Regulations (CCR). Specifically, this bill:

1. Requires DPH, when updating regulatory references to health care standards in the CCR to:

   1. Post the name of the state or national association, the title of the health care standards of practice, and the version of the updated health care standards of practice to be adopted on DPH's Internet Website;

   2. Post notice of DPH's proposed adoption of the state or national association's health care standards of practice on it's on its Internet Website for at least 45 days;

   3. Notify stakeholders that the proposed standards have been posted on DPH's Internet Website by issuing a mailing to the most recent stakeholder list on file with DPH's Office of Regulations; and,

   4. Accept public comment for at least 30 days after the conclusion of the 45-day posting period.

2. Requires DPH to hold a public hearing during the public comment period if a member of the public requests one, and to consider comments prior to the adoption of the standards.

3. Specifies that written responses to public comments are not required of DPH.

4. Specifies that if comments in opposition to the adoption of the proposed standards are received, DPH cannot use the streamlined process, and must instead seek adoption of the standards using the regulatory process established in the Administrative Procedures Act (APA).

EXISTING LAW: Establishes DPH to license health facilities and requires DPH to adopt, amend or repeal, as specified, any reasonable rules and regulations as may be necessary or proper to carry out the exercise of its power. Establishes, under the APA, a process for adopting, amending, or repealing regulations.

FISCAL EFFECT: This bill has not been analyzed by a fiscal committee.

COMMENTS:

1. PURPOSE OF THE BILL. According to the author, this bill will eliminate the need to revise regulations simply to update references to the most recent standards of practice when applicable. The author states that this will result in an efficient and cost effective method for ensuring that health facilities and DPH are referencing standards and providing care that is consistent with the most current nationally recognized professional standards, improving the quality of patient care provided in licensed health facilities.

2. BACKGROUND.

   1. Regulatory Process. The regulatory process, governed by the APA and enforced by the Office of Administrative Law (OAL) is designed to provide the public with a meaningful opportunity to participate in the adoption of regulations or rules that have the force of law and to ensure the creation of an adequate record for the public, OAL, and judicial review.
      
      Generally, there are two types of rulemaking procedures that a state agency can pursue: regular or emergency. The regular rulemaking process requires that a state agency meet certain public hearing and notice requirements. The emergency rulemaking process has different requirements, which generally include a brief public notice period, a finding of emergency, a brief public comment period, review by OAL and an OAL decision. For the regular rulemaking process, once a state agency decides to conduct a rulemaking action, it develops four documents required during the preliminary stage: a) the proposed text; b) the Initial Statement of Reasons; c) the Fiscal Impact Statement; and, d) the Notice of Proposed Regulatory Action (notice).
      
      To initiate a rulemaking action, an agency issues a notice by having it published in the California Regulatory Notice Register (Register), by mailing the notice to those persons who have filed a request for notice of regulatory action, and by posting the notice, text, and Initial Statement of Reasons on the agency's Website. Once the notice is published in the Register, the APA rulemaking process is officially started and the agency has one year within which to complete the rulemaking and submit the rulemaking file to OAL.

The APA requires at a minimum a 45-day opportunity to comment to the agency, in writing, on the proposed regulation. An agency has the option as to whether it will hold a public hearing on a proposed rulemaking action. However, if an agency does not schedule a public hearing, any interested person can submit a written request within a specified timeframe requesting one to be held, and the agency must then give notice and hold a public hearing.

After the initial public comment period, a rulemaking agency may decide to change its initial proposal either in response to public comments received or on its own initiative. The agency must then decide whether a change is: a) nonsubstantial; b) substantial and sufficiently related; or, c) substantial and not sufficiently related. A rulemaking agency must make each substantial, sufficiently related change to its initial proposal available for public comment for at least 15 days before adopting such a change. Thus, before a rulemaking agency adopts such a change, it must mail a notice of opportunity to comment on proposed modifications along with a copy of the text of the proposed changes to each person who has submitted written comments on the proposal, testified at the public hearing, or asked to receive a notice of proposed modifications. The agency must also post the notice on its Website. No public hearing is required. The public may comment on the proposed modification in writing. The agency must then consider the comments received during the 15-day comment period which are specifically directed to the proposed modifications. An agency may conduct more than one 15-day opportunity to comment on modifications.

A rulemaking agency must summarize and respond on the record to timely comments that are directed at the proposal or at the procedures followed by the agency during the regulatory action. With each comment, the agency must either: a) explain how it has amended the proposal to accommodate the comment; or, b) explain the reasons for making no change to the proposal. The summary and response to comments is included as part of the rulemaking file in the Final Statement of Reasons.

Finally, a rulemaking agency must transmit a rulemaking action to OAL for review within one year from the date that the notice was published in the Regulatory Notice Register. OAL then has 30 working days to conduct its review. OAL must review the rulemaking record to determine whether it demonstrates that the rulemaking agency satisfied the procedural requirement of the APA, and review the proposed regulations for compliance with the six legal standards set forth in the APA: Authority; Reference; Consistency; Clarity; Nonduplication; and, Necessity. OAL may not substitute its judgment for that of the rulemaking agency with regard to the substantive content of the regulations.

According to DPH, their experience is that a relatively simple regulation packet could move through the process in as few as 15-18 months, regulations pertaining to more complicated subject matter can sometimes take several years, depending on the volume of public comments.

2. Health care standards of practice. Nationally recognized professional organizations use industry expertise, information gathered through research, patient outcomes, and best practices to develop standards that are accepted in various medical professions for providing the highest quality of care possible. For example, the American Academy of Pediatrics publishes a wide variety of clinical practice guidelines on a range of subjects including: The Diagnosis, Management, and Prevention of Bronchiolitis, Management of Newly Diagnosed Type 2 Diabetes Mellitus in Children and Adolescents, and Treatment of the School-Aged Child With Attention-Deficit/Hyperactivity Disorder, to name a few.

3. Obsolete references to standards of practice in CCR. There are approximately 30 references to outdated standards of practice in Title 22 of the CCR (which apply to various health facilities, including clinics, and general acute care hospitals), some of which are referenced in more than one place, and dating as far back as 1961. The American Dietetic Association standards of practice referenced for educational programs for dietetic service staff in general acute care hospitals were adopted in June 1974. DPH is currently in the process of updating Title 22. Some of the regulatory packets could be completed later this year, other more complex packets will take several years to complete, and due to the volume (Title 22 effects up to 30 different types of health facilities) DPH estimates that the entire update will not be complete until sometime in 2025. Currently, health facilities affected by regulations which reference outdated standards of practice are requesting program flexibility from DPH to allow them to operate using more current medical standards.

1. SUPPORT. DPH is the sponsor of this bill and notes they are the enforcement and regulatory agency for approximately 30 different types of health care facilities and clinics, and they have a backlog of regulations that are subject to the APA. DPH contends that in order to remain compliant with up-to-date clinical practices instead of being errantly held to antiquated practices in state regulations, facilities must request program flexibility from DPH, and this additional step creates hurdles for health facilities and clinics. DPH concludes that this bill will eliminate the need to revise regulations simply to update references to the most recent standards of practice.

The California Long-Term Care Ombudsman Association supports this bill because it helps to create a more efficient and cost effective method for ensuring skilled nursing facilities are referencing standards and providing care that is consistent with the most current nationally recognized professional standards.

4. PREVIOUS LEGISLATION.

   1. AB 1312 (Brown) of 2013 would have authorized DPH to, without taking any regulatory action, update references in the CCR to health care standards of practice adopted by a recognized state or national association when the same state or national association and its outdated standards are already named in the CCR. AB 1312 was held in Assembly Health Committee.

   2. AB 1487 (Hill), Chapter 444, Statutes of 2010, allows DPH to adopt initial regulations based on the “Guidelines for Reducing Risk of Viral Transmission During Fertility Treatment” using a streamlined process.

5. SUGGESTED AMENDMENTS. In order to insure that stakeholders and the public are kept apprised of which professional standards are being updated in CCR, this bill should be amended to clarify and strengthen the manner in which DPH notifies the public in advance of any proposed update by requiring DPH to include the name of the state or national association, the title of the health care standards of practice, and the version of the updated health care standards of practice to be adopted. This bill should also be amended to require DPH to publish a notice in the Register when updating references to standards of practice in CCR.

This bill should be amended to clarify that if the state or national association whose standards of practice are currently referenced no longer exists, DPH must adopt new standards pursuant to the full regulatory process, and to clarify that if no opposition is received by DPH, the Website must be updated to notify the public that the standard has been adopted and the effective date of that standard.

REGISTERED SUPPORT / OPPOSITION:

Support
California Department of Public Health (sponsor)
California Long-Term Care Ombudsman Association

Opposition
None on file.

Analysis Prepared by: Lara Flynn / HEALTH / (916) 319-2097