SB 43: County health systems: County of San Mateo: dental care services.
- Session Year: 2017-2018
- House: Senate
- Latest Version Date: 2018-06-18
Existing law provides for the Medi-Cal program, which is administered by the State Department of Health Care Services and under which qualified low-income persons receive health care benefits. Existing law authorizes the County of San Mateo, and other counties electing to do so, to, by ordinance, establish a commission to arrange for the provision of health care services provided pursuant to the Medi-Cal program, and to provide health care delivery systems to other specified persons.
This bill would additionally authorize the County of San Mateo to arrange for the provision of dental care services provided pursuant to the Medi-Cal program. The bill would authorize the county to establish a 5-year pilot project to take any or all of certain activities relating to dental services, including, but not limited to, partnering with dental providers to deliver an integrated care approach to enrolled members, and establishing objectives for improving access to oral health care, including access to dental prevention services and pediatric dentistry.
This bill would make legislative findings and declarations as to the necessity of a special statute for the County of San Mateo.
Existing law establishes the State Department of Public Health and sets forth the powers and duties of the department. Existing law requires the department and general acute care hospitals to implement various measures relating to the prevention of health care associated infection, and requires that each general acute care hospital adopt and implement an antimicrobial stewardship policy, in accordance with guidelines established by the federal government and professional organizations, that includes a process to evaluate the judicious use of antibiotics, as specified. Existing law requires the department to establish a list of reportable communicable and noncommunicable diseases and conditions, including, but not limited to, diphtheria, listeria, salmonella, shigella, and streptococcal infection in food handlers or dairy workers, and typhoid. Existing law requires local health officers to report to the department any disease or condition on the list, as specified by the department. This bill would require specified general acute care hospitals and clinical laboratories to submit a report to the department, commencing July 1, 2019, and each July 1 thereafter, containing an antibiogram of the facility for the previous year. The bill would require the Antimicrobial Stewardship and Resistance Subcommittee of the Healthcare Associated Infections Advisory Committee of the department, on or before January 1, 2019, to develop and recommend to the department, the acceptable electronic format for the report and a method for the department to accurately estimate the number of deaths that result from antimicrobial resistant infections for specified types of antimicrobial infections. The bill would require the department, commencing January 1, 2020, and each January 1 thereafter, to publish and post on its Internet Web site a report that would include designated information relating to the incidence, type, and distribution of antimicrobial-resistant infections and the estimated number of deaths that result from antimicrobial resistant infections. The bill would prohibit data collected pursuant to the bill from being disclosed to the public on a facility-specific basis, but would allow for the disclosure of case-specific information, under prescribed circumstances.Existing law also establishes the State Department of Public Health and sets forth the powers and duties of the department. Existing law requires the State Department of Public Health department and general acute care hospitals to implement various measures relating to the prevention of health care associated infection, and requires that each general acute care hospital adopt and implement an antimicrobial stewardship policy, in accordance with guidelines established by the federal government and professional organizations, that includes a process to evaluate the judicious use of antibiotics, as specified.
Existing law requires the State Department of Public Health department to establish a list of reportable communicable and noncommunicable diseases and conditions, including, but not limited to, diphtheria, listeria, salmonella, shigella, and streptococcal infection in food handlers or dairy workers, and typhoid. Existing law requires local health officers to report to the department any disease or condition on the list, as specified by the department.
This bill would require specified general acute care hospitals and clinical laboratories to submit a report to the department, commencing July 1, 2018, 2019, and each July 1 thereafter, containing an antibiogram of the facility for the previous year. The bill would require the Antimicrobial Stewardship and Resistance Subcommittee of the Healthcare Associated Infections Advisory Committee of the department, on or before January 1, 2019, to develop and recommend to the department, the acceptable electronic format for the report and a method for the department to accurately estimate the number of deaths that result from antimicrobial resistant infections for specified types of antimicrobial infections. The bill would require the department, commencing January 1, 2019, 2020, and each January 1 thereafter, to publish and post on its Internet Web site a report, based on the data reported by hospitals and clinical laboratories, and from certificates of death, which report that would include designated information relating to the incidence, type, and distribution of antimicrobial-resistant infections and the estimated number of deaths for which that result from antimicrobial resistance is listed on the certificate of death as the disease or condition directly leading to death, an antecedent cause, or a significant condition contributing to death. resistant infections. The bill would prohibit data collected pursuant to the bill from being disclosed to the public on a facility-specific basis, but would allow for the disclosure of case-specific information, under prescribed circumstances.
(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 under the direction of the State Public Health Officer. Existing law sets forth the powers and duties of the State Public Health Officer, including, but not limited to, designation as the State Registrar of Vital Statistics, having supervisory powers over local registrars and responsibility for the uniform and thorough enforcement of laws relating to the registration of certain vital statistics.
Existing law designates the persons responsible for completing a certificate of death and the required contents of the certificate, including, but not limited to, the decedents name, sex, and birthplace, as well as the disease or conditions leading directly to death and antecedent causes. Existing law makes it a crime to refuse or fail to furnish correctly the information required to be included in a death certificate.
This bill would require the statement of the disease or conditions leading directly to death and antecedent causes on the certificate of death to include any occurrence of antimicrobial-resistant infection that was a factor in the death, in the professional judgment of the physician and surgeon last in attendance. By adding to the required contents of a certificate of death, this bill would expand the definition of existing crimes, thus imposing a state-mandated local program.
(2)Existing law also requires the State Department of Public Health and general acute care hospitals to implement various measures relating to the prevention of health care associated infection, and requires that each general acute care hospital adopt and implement an antimicrobial stewardship policy, in accordance with guidelines established by the federal government and professional organizations, that includes a process to evaluate the judicious use of antibiotics, as specified.
Existing law requires the State Department of Public Health to establish a list of reportable communicable and noncommunicable diseases and conditions, including, but not limited to, diphtheria, listeria, salmonella, shigella, and streptococcal infection in food handlers or dairy workers, and typhoid. Existing law requires local health officers to report to the department any disease or condition on the list, as specified by the department.
This bill would require general acute care hospitals and clinical laboratories to submit a report to the department, commencing July 1, 2018, and each July 1 thereafter, containing an antibiogram of the facility for the previous year. The bill would require the department, commencing January 1, 2019, and each January 1 thereafter, to publish and post on its Internet Web site a report, based on the data reported by hospitals and clinical laboratories, and from certificates of death, which would include designated information relating to the incidence, type, and distribution of antimicrobial-resistant infections, the type, level, and frequency of use of antimicrobial drugs, infections and the number of deaths for which antimicrobial resistance is listed on the certificate of death as the disease or condition directly leading to death, an antecedent cause, or a significant condition contributing to death. The bill would prohibit data collected pursuant to the bill from being disclosed to the public on a facility-specific basis, but would allow for the disclosure of case-specific information, under prescribed circumstances.
(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 under the direction of the State Public Health Officer. Existing law sets forth the powers and duties of the State Public Health Officer, including, but not limited to, designation as the State Registrar of Vital Statistics, having supervisory powers over local registrars and responsibility for the uniform and thorough enforcement of laws relating to the registration of certain vital statistics.
Existing law designates the persons responsible for completing a certificate of death and the required contents of the certificate, including, but not limited to, the decedents name, sex, and birthplace, as well as the disease or conditions leading directly to death and antecedent causes. Existing law makes it a crime to refuse or fail to furnish correctly the information required to be included in a death certificate.
This bill would require the statement of the disease or conditions leading directly to death and antecedent causes on the certificate of death to include any occurrence of antimicrobial-resistant infection that was a factor in the death, in the professional judgment of the physician and surgeon last in attendance. By adding to the required contents of a certificate of death, this bill would expand the definition of existing crimes, thus imposing a state-mandated local program.
(2)Existing law also requires the State Department of Public Health and general acute care hospitals to implement various measures relating to the prevention of health care associated infection, and requires that each general acute care hospital adopt and implement an antimicrobial stewardship policy, in accordance with guidelines established by the federal government and professional organizations, that includes a process to evaluate the judicious use of antibiotics, as specified.
Existing law requires the State Department of Public Health to establish a list of reportable communicable and noncommunicable diseases and conditions, including, but not limited to, diphtheria, listeria, salmonella, shigella, and streptococcal infection in food handlers or dairy workers, and typhoid. Existing law requires local health officers to report to the department any disease or condition on the list, as specified by the department.
This bill would require general acute care hospitals and clinical laboratories to submit a report to the department, commencing July 1, 2018, and each July 1 thereafter, containing an antibiogram of the facility for the previous year. The bill would require the department, commencing January 1, 2019, and each January 1 thereafter, to publish and post on its Internet Web site a report, based on the data reported by hospitals and clinical laboratories, and from certificates of death, which would include designated information relating to the incidence, type, and distribution of antimicrobial-resistant infections, the type, level, and frequency of use of antimicrobial drugs, and the number of deaths for which antimicrobial resistance is listed on the certificate of death as the disease or condition directly leading to death, an antecedent cause, or a significant condition contributing to death. The bill would prohibit data collected pursuant to the bill from being disclosed to the public on a facility-specific basis, but would allow for the disclosure of case-specific information, under prescribed circumstances.
(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 under the direction of the State Public Health Officer. Existing law sets forth the powers and duties of the State Public Health Officer, including, but not limited to, designation as the State Registrar of Vital Statistics, having supervisory powers over local registrars and responsibility for the uniform and thorough enforcement of laws relating to the registration of certain vital statistics.
Existing law designates the persons responsible for completing a certificate of death and the required contents of the certificate, including, but not limited to, the decedents name, sex, and birthplace, as well as the disease or conditions leading directly to death and antecedent causes. Existing law makes it a crime to refuse or fail to furnish correctly the information required to be included in a death certificate.
This bill would require the statement of the disease or conditions leading directly to death and antecedent causes on the certificate of death to include any occurrence of antimicrobial-resistant infection that was a factor in the death, in the professional judgment of the physician and surgeon last in attendance. By adding to the required contents of a certificate of death, this bill would expand the definition of existing crimes, thus imposing a state-mandated local program.
(2)Existing law also requires the State Department of Public Health and general acute care hospitals to implement various measures relating to the prevention of health care associated infection, and requires that each general acute care hospital adopt and implement an antimicrobial stewardship policy, in accordance with guidelines established by the federal government and professional organizations, that includes a process to evaluate the judicious use of antibiotics, as specified.
Existing law requires the State Department of Public Health to establish a list of reportable communicable and noncommunicable diseases and conditions, including, but not limited to, diphtheria, listeria, salmonella, shigella, and streptococcal infection in food handlers or dairy workers, and typhoid. Existing law requires local health officers to report to the department any disease or condition on the list, as specified by the department.
This bill would require general acute care hospitals and clinical laboratories to submit a report to the department, commencing July 1, 2018, and each July 1 thereafter, containing an antibiogram of the facility for the previous year. The bill would require the department, commencing January 1, 2019, and each January 1 thereafter, to publish and post on its Internet Web site a report, based on the data reported by hospitals and clinical laboratories, and from certificates of death, which would include designated information relating to the incidence, type, and distribution of antimicrobial-resistant infections, the type, level, and frequency of use of antimicrobial drugs, and the number of deaths for which antimicrobial resistance is listed on the certificate of death as the disease or condition directly leading to death, an antecedent cause, or a significant condition contributing to death. The bill would prohibit data collected pursuant to the bill from being disclosed to the public on a facility-specific basis, but would allow for the disclosure of case-specific information, under prescribed circumstances.
(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.
(a)It is necessary that a special commission be established in San Mateo County and in any other county designated by the California Medical Assistance Commission in order to meet the problems of the delivery of publicly assisted medical care in the counties and to demonstrate ways of promoting quality care and cost efficiency.
(b)The Board of Supervisors of San Mateo County and of the designated counties may, by ordinance, establish commissions to do any or all of the following:
(1)Negotiate the exclusive contracts specified in Section 14087.5 and to arrange for the provision of health care services provided pursuant to this chapter.
(2)Enter into contracts for the provision of health care services to subscribers in the Healthy Families Program.
(3)Enter into agreements under Chapter 5 (commencing with Section 6500) of Division 7 of Title 1 of the Government Code.
(4)With respect to the County of San Mateo only, arrange for the provision of dental care services provided pursuant to this chapter.
(c)In addition to the authority specified in subdivision (b), the Board of Supervisors of San Mateo County may, by ordinance, authorize the commission established pursuant to this section to provide health care delivery systems for any or all of the following persons:
(1)Persons who are eligible to receive medical benefits under this chapter in the county, including, but not limited to, persons who are eligible through federal waiver or a pilot project.
(2)Persons who are eligible to receive medical benefits under both Title 18 and Title 19 of the federal Social Security Act.
(3)Persons who are eligible to receive medical benefits under Title 18 of the federal Social Security Act.
(4)Persons who are eligible to receive medical benefits under publicly supported programs if the commission and participating providers acting pursuant to subcontracts with the commission agree to hold harmless the beneficiaries of the publicly supported programs if the contract between the sponsoring government agency and the commission does not ensure sufficient funding to cover program costs.
(5)Other individuals or groups in the service area, including, but not limited to, public agencies, private businesses, and uninsured or indigent persons. The commission shall not use any payment or reserve from the Medi-Cal program for purposes of this paragraph.
(d)Nothing in this section shall prohibit the commission established pursuant to this section from providing services pursuant to paragraph (5) of subdivision (c) in counties other than the commissions county if the commission is approved by the Department of Managed Health Care to provide services in those counties. The commission shall not use any payment or reserve from the Medi-Cal program for purposes of this subdivision.
(e)If the board of supervisors elects to enact an ordinance pursuant to this section, all rights, powers, duties, privileges, and immunities vested in a county by an article shall be vested in the county commission. Any reference in this article to county shall mean a commission established pursuant to this section.
(f)The enabling ordinance shall specify the membership of the county commission, the qualifications for individual members, and any other matters as the board of supervisors deems necessary or convenient for the conduct of the county commissions activities. A commission so established shall be considered a public entity for purposes of Division 3.6 (commencing with Section 810) of Title 1 of the Government Code. All commissioners shall be appointed by majority vote of the board of supervisors and shall serve at the pleasure thereof. The board of supervisors may appoint no more than two of its own members to serve on the commission.
(g)As an alternative to establishing a separate commission, the enabling ordinance may designate the board of supervisors itself as the commission authorized by this article.
(h)Nothing in this section shall This section shall not be construed to supersede Section 14093.06 or 14094.3.
SEC. 2.Section 14087.511 is added to the Welfare and Institutions Code, immediately following Section 14087.51, to read:14087.511.If the County of San Mateo elects to provide dental care services pursuant to this article, the county may establish a five-year pilot project to do any or all of the following:
(a)Partner with dental providers to deliver an integrated care approach to enrolled members.
(b)Establish objectives for improving dental utilization, as medically indicated.
(c)Establish objectives for improving access to oral health care, including access to dental prevention services and pediatric dentistry.
(d)Test innovative payment models to incentivize dental provider participation.
(e)Evaluate the medical cost impact of integrating dental care, such as reducing emergency room visits due to dental pain and performing dental procedures in a hospital setting.
SEC. 3.The Legislature finds and declares that a special statute is necessary and that a general statute cannot be made applicable within the meaning of Section 16 of Article IV of the California Constitution because of the unique circumstances applicable to publicly assisted medical care in the County of San Mateo.
SECTION 1.The Legislature finds and declares all of the following:(a)The epidemic of antibiotic resistance is a worldwide problem and is expected to grow. The federal Centers for Disease Control and Prevention (CDC) estimates that antibiotic-resistant infections kill at least 23,000 Americans each year and sicken two million. The Review on Antimicrobial Resistance, a study commissioned by the United Kingdom, estimates that by 2050, if nothing is done, 10 million people will die worldwide from antibiotic-resistant infections, surpassing the 8.5 million people who will die from cancer.(b)Antibiotic-resistant infections threaten modern medicine as we know it. If this epidemic is not curtailed, routine surgeries and minor infections may once again become life-threatening, jeopardizing the hard-won gains made battling infectious disease.(c)Many leading public health organizations and world leaders have sounded the alarm about antibiotic resistance. The World Health Organization (WHO) has labeled antibiotic resistance as one of the biggest threats to global health and the CDC identifies antibiotic resistance as one of our most serious health threats. In September 2016, the United Nations (UN) convened in New York and put forward a declaration to tackle antibiotic resistance. It was only the fourth time in history that the UN had met to tackle a global health problem, underscoring the significance of the problem.(d)Monitoring and tracking antibiotic resistance is a core component to combating antibiotic resistance, as specified by the CDC. With appropriate surveillance of antibiotic-resistant infections, public health leaders can develop appropriate protocols for prevention, control, and treatment, can monitor disease trends, assess effectiveness of prevention and control measures, identify populations or geographic areas at high risk, and more.(e)Despite the magnitude of this public health problem, the State Department of Public Health does not monitor or track the occurrence of antibiotic-resistant infections or deaths caused by those infections. Although the department is required by law to establish a list of reportable diseases, that list does not include the tracking and monitoring of antibiotic-resistant infections. The department also is mandated by existing law to track three antibiotic-resistant infections, but only when those infections are health care acquired and in a patients bloodstream.SEC. 2.Part 5.5 (commencing with Section 121565) is added to Division 105 of the Health and Safety Code, to read:5.5.ANTIMICROBIAL-RESISTANT INFECTION121565.The following definitions shall apply for purposes of this part:(a)Antibiogram means an annual summary of antimicrobial susceptibility of bacterial isolates, as defined by the Clinical and Laboratory Standards Institute (CLSI) M39 guidelines and subsequent updates.(b)Antimicrobial resistance means a bacterial infection caused by a bacterium that demonstrates in vitro a minimum antimicrobial inhibitory concentration that exceeds susceptibility breakpoints, using the most recent diagnostic test standards approved by the United States Food and Drug Administration pursuant to the Federal Food, Drug, and Cosmetic Act.(c)Clinical laboratory has the same meaning as defined in paragraph (8) of subdivision (a) of Section 1206 of the Business and Professions Code.(d)Department means the State Department of Public Health.(e)General acute care hospital has the same meaning as defined in subdivision (a) of Section 1250.(f)Subcommittee means the Antimicrobial Stewardship and Resistance Subcommittee of the Healthcare Associated Infections Advisory Committee of the State Department of Public Health.121566.(a)Commencing on July 1, 2019, and each July 1 thereafter, each general acute care hospital that operates a clinical laboratory that conducts tests for antimicrobial resistance and each clinical laboratory that is not part of a hospital and that conducts tests for antimicrobial resistance shall submit a report to the department, in an acceptable electronic format, containing an antibiogram of the facility for the previous year.(b)(1)On or before January 1, 2019, the subcommittee shall develop and recommend both of the following to the department:(A)The acceptable electronic format for the report. The format may be updated as the subcommittee or department deems necessary as new information or data on antimicrobial resistance becomes available. In developing the acceptable electronic format, the subcommittee shall select the types of antimicrobial resistance infections that should be included in the report, which may include, but not be limited to, antimicrobial resistant infections identified by the federal Centers for Disease Control and Prevention as urgent, serious, or concerning.(B)A method for the department to accurately estimate the number of deaths that result from antimicrobial resistant infections for the types of antimicrobial infections selected pursuant to subparagraph (A). The method may rely on data from certificates of death or other sources of data available to the subcommittee or department.(2)The subcommittee or department may consult with any subject matter experts or stakeholders for purposes of this subdivision.121567.(a)Commencing on January 1, 2020, and each January 1 thereafter, based on the data reported by general acute care hospitals and clinical laboratories pursuant to Section 121566, as well as from the information on deaths that result from antimicrobial resistant infections determined based on the method developed pursuant to Section 121566, the department shall publish and post on its Internet Web site a report that includes the following information:(1)The incidence, type, and distribution of antimicrobial-resistant infections statewide, and within regions of the state, as defined by the department, and by facility type.(2)The incidence, type, and distribution of the estimated number of deaths that result from antimicrobial resistant infections, and within regions of the state, as defined by the department, and by facility type.(b)The report shall not identify information specific to any one health facility or general acute care hospital. Data collected pursuant to this part shall not be disclosed to the public on a facility-specific basis, except that the department may release case-specific information to other facilities, physicians, and the public if the department determines, on a case-by-case basis, that the release of the information is necessary to protect persons in a public health emergency.The Legislature finds and declares all of the following:
(a)The epidemic of antibiotic resistance is a worldwide problem and is expected to grow. The federal Centers for Disease Control and Prevention (CDC) estimates that antibiotic-resistant infections kill at least 23,000 Americans each year and sicken two million. The Review on Antimicrobial Resistance, a study commissioned by the United Kingdom, estimates that by 2050, if nothing is done, 10 million people will die worldwide from antibiotic-resistant infections, surpassing the 8.5 million people who will die from cancer.
(b)Antibiotic-resistant infections threaten modern medicine as we know it. If this epidemic is not curtailed, routine surgeries and minor infections may once again become life-threatening, jeopardizing the hard-won gains made battling infectious disease.
(c)Many leading public health organizations and world leaders have sounded the alarm about antibiotic resistance. The World Health Organization (WHO) has labeled antibiotic resistance as one of the biggest threats to global health and the CDC identifies antibiotic resistance as one of our most serious health threats. In September 2016, the United Nations (UN) convened in New York and put forward a declaration to tackle antibiotic resistance. It was only the fourth time in history that the UN had met to tackle a global health problem, underscoring the significance of the problem.
(d)Monitoring and tracking antibiotic resistance is a core component to combating antibiotic resistance, as specified by the CDC. With appropriate surveillance of antibiotic-resistant infections, public health leaders can develop appropriate protocols for prevention, control, and treatment, can monitor disease trends, assess effectiveness of prevention and control measures, identify populations or geographic areas at high risk, and more.
(e)Despite the magnitude of this public health problem, the State Department of Public Health does not monitor or track the occurrence of antibiotic-resistant infections or deaths caused by those infections. Although the department is required by law to establish a list of reportable diseases, that list does not include the tracking and monitoring of antibiotic-resistant infections. The department also is mandated by existing law to track three antibiotic-resistant infections, but only when those infections are health care acquired and in a patients bloodstream.
(f)The department is the central repository of certificates of death, which it uses to calculate state mortality statistics. An attending physician is legally obligated to file a certificate of death, and to record the disease or condition directly leading to death, antecedent causes, and other significant conditions contributing to the death.(g)Although the department generally reports on mortality statistics for a wide range of diseases based on information it gathers through certificates of death, it currently does not report on antibiotic-resistant infections as a cause of death.SEC. 2.Section 102825 of the Health and Safety Code is amended to read:102825.(a)The physician and surgeon last in attendance, or in the case of a patient in a skilled nursing or intermediate care facility at the time of death, the physician and surgeon last in attendance or a licensed physician assistant under the supervision of the physician and surgeon last in attendance, on a deceased person shall state on the certificate of death the disease or condition directly leading to death, antecedent causes, other significant conditions contributing to death and any other medical and health section data as may be required on the certificate, including information regarding the presence of any antimicrobial-resistant infection, in accordance with paragraph (1) of subdivision (b) of Section 102875. He or she shall also specify the time in attendance, the time he or she last saw the deceased person alive, and the hour and day on which death occurred, except in deaths required to be investigated by the coroner. The physician and surgeon or physician assistant shall specifically indicate the existence of any cancer as defined in subdivision (h) of Section 103885, of which the physician and surgeon or physician assistant has actual knowledge.(b)A physician and surgeon may designate one or more other physicians and surgeons, who have access to the physician and surgeons records, to act as agent for the physician and surgeon for purposes of the performance of his or her duties under this section, provided that any person so designated acts in consultation with the physician and surgeon.SEC. 3.Section 102875 of the Health and Safety Code is amended to read:102875.The certificate of death shall be divided into two sections.(a)The first section shall contain those items necessary to establish the fact of the death, including all of the following and those other items as the State Registrar may designate:(1)(A)Personal data concerning decedent including full name, sex, color or race, marital status, name of spouse, date of birth and age at death, birthplace, usual residence, and occupation and industry or business.(B)Commencing July 1, 2015, a person completing the certificate shall record the decedents sex to reflect the decedents gender identity. The decedents gender identity shall be reported by the informant, unless the person completing the certificate is presented with a birth certificate, a drivers license, a social security record, a court order approving a name or gender change, a passport, an advanced health care directive, or proof of clinical treatment for gender transition, in which case the person completing the certificate shall record the decedents sex as that which corresponds to the decedents gender identity as indicated in that document. If none of these documents is presented and the person with the right, or a majority of persons who have equal rights, to control the disposition of the remains pursuant to Section 7100 is in disagreement with the gender identity reported by the informant, the gender identity of the decedent recorded on the death certificate shall be as reported by that person or majority of persons.(C)Commencing July 1, 2015, if a document specified in subparagraph (B) is not presented and a majority of persons who have equal rights to control the disposition of the remains pursuant to Section 7100 do not agree with the gender identity of the decedent as reported by the informant, any one of those persons may file a petition, in the superior court in the county where the decedent resided at the time of his or her death, or where the remains are located, naming as a party to the action those persons who otherwise have equal rights to control the disposition and seeking an order of the court determining, as appropriate, who among those parties shall determine the gender identity of the decedent.(D)Commencing July 1, 2015, a person completing the death certificate in compliance with subparagraph (B) is not liable for any damages or costs arising from claims related to the sex of the decedent as entered on the certificate of death.(E)Commencing July 1, 2015, a person completing the death certificate shall comply with the data and certification requirements described in Section 102800 by using the information available to him or her prior to the deadlines for completion specified in that section.(2)Date of death, including month, day, and year.(3)Place of death.(4)Full name of father and birthplace of father, and full maiden name of mother and birthplace of mother.(5)Informant.(6)Disposition of body information including signature and license number of embalmer if body embalmed or name of embalmer if affixed by attorney-in-fact; name of funeral director, or person acting as such; and date and place of interment or removal. Notwithstanding any other law to the contrary, an electronic signature substitute, or some other indicator of authenticity, approved by the State Registrar may be used in lieu of the actual signature of the embalmer.(7)Certification and signature of attending physician and surgeon or certification and signature of coroner when required to act by law. Notwithstanding any other law to the contrary, the person completing the portion of the certificate setting forth the cause of death may attest to its accuracy by use of an electronic signature substitute, or some other indicator of authenticity, approved by the State Registrar in lieu of a signature.(8)Date accepted for registration and signature of local registrar. Notwithstanding any other law to the contrary, the local registrar may elect to use an electronic signature substitute, or some other indicator of authenticity, approved by the State Registrar in lieu of a signature.(b)The second section shall contain those items relating to medical and health data, including all of the following and other items as the State Registrar may designate:(1)Disease or conditions leading directly to death and antecedent causes, including, in the professional judgment of the physician and surgeon last in attendance, the occurrence of any antimicrobial-resistant infection that was a factor in the death.(2)Operations and major findings thereof.(3)Accident and injury information.(4)Information indicating whether the decedent was pregnant at the time of death, or within the year prior to the death, if known, as determined by observation, autopsy, or review of the medical record. This paragraph shall not be interpreted to require the performance of a pregnancy test on a decedent, or to require a review of medical records in order to determine pregnancy.SEC. 4.SEC. 2.Part 5.5 (commencing with Section 121565) is added to Division 105 of the Health and Safety Code, to read:5.5.ANTIMICROBIAL-RESISTANT INFECTION121565.The following definitions shall apply for purposes of this part:
(a)Antibiogram means an annual summary of antimicrobial susceptibility of bacterial isolates, as defined by the Clinical and Laboratory Standards Institute (CLSI) M39 guidelines and subsequent updates.
(b)Antimicrobial resistance means a bacterial infection caused by a bacterium that demonstrates in vitro a minimum antimicrobial inhibitory concentration that exceeds susceptibility breakpoints, using the most recent diagnostic test standards approved by the United States Food and Drug Administration pursuant to the Federal Food, Drug, and Cosmetic Act.
(c)Clinical laboratory has the same meaning as defined in paragraph (8) of subdivision (a) of Section 1206 of the Business and Professions Code.
(d)Department means the State Department of Public Health.
(e)General acute care hospital has the same meaning as defined in subdivision (a) of Section 1250.
(f)Subcommittee means the Antimicrobial Stewardship and Resistance Subcommittee of the Healthcare Associated Infections Advisory Committee of the State Department of Public Health.
121566.(a)Commencing on July 1, 2018, 1, 2019, and each July 1 thereafter, each general acute care hospital that operates a clinical laboratory that conducts tests for antimicrobial resistance and each clinical laboratory that is not part of a hospital and that conducts tests for antimicrobial resistance shall submit a report to the department, in an acceptable electronic format, containing an antibiogram of the facility for the previous year.
(b)(1)On or before January 1, 2019, the subcommittee shall develop and recommend both of the following to the department:
(A)The acceptable electronic format for the report. The format may be updated as the subcommittee or department deems necessary as new information or data on antimicrobial resistance becomes available. In developing the acceptable electronic format, the subcommittee shall select the types of antimicrobial resistance infections that should be included in the report, which may include, but not be limited to, antimicrobial resistant infections identified by the federal Centers for Disease Control and Prevention as urgent, serious, or concerning.
(B)A method for the department to accurately estimate the number of deaths that result from antimicrobial resistant infections for the types of antimicrobial infections selected pursuant to subparagraph (A). The method may rely on data from certificates of death or other sources of data available to the subcommittee or department.
(2)The subcommittee or department may consult with any subject matter experts or stakeholders for purposes of this subdivision.
121567.(a)Commencing on January 1, 2019, 2020, and each January 1 thereafter, based on the data reported by general acute care hospitals and clinical laboratories pursuant to Section 121566, as well as from certificates of death, the information on deaths that result from antimicrobial resistant infections determined based on the method developed pursuant to Section 121566, the department shall publish and post on its Internet Web site a report that includes the following information:
(1)The incidence, type, and distribution of antimicrobial-resistant infections statewide, and within regions of the state, as defined by the department, and by facility type.
(2)The number of deaths for which antimicrobial resistance is listed on the certificate of death as the disease or condition directly leading to death, an antecedent cause, or a significant condition contributing to death. This shall include all of the following:(A)The number of deaths that may be attributed to each type of antimicrobial-resistant infection, as determined by the department.(B)The number of deaths, statewide and in each region of the state, as determined by the department.(C)The number of deaths, by facility type.(2)The incidence, type, and distribution of the estimated number of deaths that result from antimicrobial resistant infections, and within regions of the state, as defined by the department, and by facility type.
(b)The report shall not identify information specific to any one health facility or general acute care hospital. Data collected pursuant to this part shall not be disclosed to the public on a facility-specific basis, except that the department may release case-specific information to other facilities, physicians, and the public if the department determines, on a case-by-case basis, that the release of the information is necessary to protect persons in a public health emergency.
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 all of the following:
(a)The epidemic of antibiotic resistance is a worldwide problem and is expected to grow. The federal Centers for Disease Control and Prevention (CDC) estimates that antibiotic-resistant infections kill at least 23,000 Americans each year and sicken two million. The Review on Antimicrobial Resistance, a study commissioned by the United Kingdom, estimates that by 2050, if nothing is done, 10 million people will die worldwide from antibiotic-resistant infections, surpassing the 8.5 million people who will die from cancer.
(b)Antibiotic-resistant infections threaten modern medicine as we know it. If this epidemic is not curtailed, routine surgeries and minor infections may once again become life-threatening, jeopardizing the hard-won gains made battling infectious disease.
(c)Many leading public health organizations and world leaders have sounded the alarm about antibiotic resistance. The World Health Organization (WHO) has labeled antibiotic resistance as one of the biggest threats to global health and the CDC identifies antibiotic resistance as one of our most serious health threats. In September 2016, the United Nations (UN) convened in New York and put forward a declaration to tackle antibiotic resistance. It was only the fourth time in history that the UN had met to tackle a global health problem, underscoring the significance of the problem.
(d)Monitoring and tracking antibiotic resistance is a core component to combating antibiotic resistance, as specified by the CDC. With appropriate surveillance of antibiotic-resistant infections, public health leaders can develop appropriate protocols for prevention, control, and treatment, can monitor disease trends, assess effectiveness of prevention and control measures, identify populations or geographic areas at high risk, and more.
(e)Despite the magnitude of this public health problem, the State Department of Public Health does not monitor or track the occurrence of antibiotic-resistant infections or deaths caused by those infections. Although the department is required by law to establish a list of reportable diseases, that list does not include the tracking and monitoring of antibiotic-resistant infections. The department also is mandated by existing law to track three antibiotic-resistant infections, but only when those infections are health care acquired and in a patients bloodstream.
(f)The department is the central repository of certificates of death, which it uses to calculate state mortality statistics. An attending physician is legally obligated to file a certificate of death, and to record the disease or condition directly leading to death, antecedent causes, and other significant conditions contributing to the death.
(g)Although the department generally reports on mortality statistics for a wide range of diseases based on information it gathers through certificates of death, it currently does not report on antibiotic-resistant infections as a cause of death.
SEC. 2.Section 102825 of the Health and Safety Code is amended to read:102825.(a)The physician and surgeon last in attendance, or in the case of a patient in a skilled nursing or intermediate care facility at the time of death, the physician and surgeon last in attendance or a licensed physician assistant under the supervision of the physician and surgeon last in attendance, on a deceased person shall state on the certificate of death the disease or condition directly leading to death, antecedent causes, other significant conditions contributing to death and any other medical and health section data as may be required on the certificate, including information regarding the presence of any antimicrobial-resistant infection, in accordance with paragraph (1) of subdivision (b) of Section 102875. He or she shall also specify the time in attendance, the time he or she last saw the deceased person alive, and the hour and day on which death occurred, except in deaths required to be investigated by the coroner. The physician and surgeon or physician assistant shall specifically indicate the existence of any cancer as defined in subdivision (h) of Section 103885, of which the physician and surgeon or physician assistant has actual knowledge.
(b)A physician and surgeon may designate one or more other physicians and surgeons, who have access to the physician and surgeons records, to act as agent for the physician and surgeon for purposes of the performance of his or her duties under this section, provided that any person so designated acts in consultation with the physician and surgeon.
SEC. 3.Section 102875 of the Health and Safety Code is amended to read:102875.The certificate of death shall be divided into two sections.
(a)The first section shall contain those items necessary to establish the fact of the death, including all of the following and those other items as the State Registrar may designate:
(1)(A)Personal data concerning decedent including full name, sex, color or race, marital status, name of spouse, date of birth and age at death, birthplace, usual residence, and occupation and industry or business.
(B)Commencing July 1, 2015, a person completing the certificate shall record the decedents sex to reflect the decedents gender identity. The decedents gender identity shall be reported by the informant, unless the person completing the certificate is presented with a birth certificate, a drivers license, a social security record, a court order approving a name or gender change, a passport, an advanced health care directive, or proof of clinical treatment for gender transition, in which case the person completing the certificate shall record the decedents sex as that which corresponds to the decedents gender identity as indicated in that document. If none of these documents is presented and the person with the right, or a majority of persons who have equal rights, to control the disposition of the remains pursuant to Section 7100 is in disagreement with the gender identity reported by the informant, the gender identity of the decedent recorded on the death certificate shall be as reported by that person or majority of persons.
(C)Commencing July 1, 2015, if a document specified in subparagraph (B) is not presented and a majority of persons who have equal rights to control the disposition of the remains pursuant to Section 7100 do not agree with the gender identity of the decedent as reported by the informant, any one of those persons may file a petition, in the superior court in the county where the decedent resided at the time of his or her death, or where the remains are located, naming as a party to the action those persons who otherwise have equal rights to control the disposition and seeking an order of the court determining, as appropriate, who among those parties shall determine the gender identity of the decedent.
(D)Commencing July 1, 2015, a person completing the death certificate in compliance with subparagraph (B) is not liable for any damages or costs arising from claims related to the sex of the decedent as entered on the certificate of death.
(E)Commencing July 1, 2015, a person completing the death certificate shall comply with the data and certification requirements described in Section 102800 by using the information available to him or her prior to the deadlines for completion specified in that section.
(2)Date of death, including month, day, and year.
(3)Place of death.
(4)Full name of father and birthplace of father, and full maiden name of mother and birthplace of mother.
(5)Informant.
(6)Disposition of body information including signature and license number of embalmer if body embalmed or name of embalmer if affixed by attorney-in-fact; name of funeral director, or person acting as such; and date and place of interment or removal. Notwithstanding any other law to the contrary, an electronic signature substitute, or some other indicator of authenticity, approved by the State Registrar may be used in lieu of the actual signature of the embalmer.
(7)Certification and signature of attending physician and surgeon or certification and signature of coroner when required to act by law. Notwithstanding any other law to the contrary, the person completing the portion of the certificate setting forth the cause of death may attest to its accuracy by use of an electronic signature substitute, or some other indicator of authenticity, approved by the State Registrar in lieu of a signature.
(8)Date accepted for registration and signature of local registrar. Notwithstanding any other law to the contrary, the local registrar may elect to use an electronic signature substitute, or some other indicator of authenticity, approved by the State Registrar in lieu of a signature.
(b)The second section shall contain those items relating to medical and health data, including all of the following and other items as the State Registrar may designate:
(1)Disease or conditions leading directly to death and antecedent causes, including, in the professional judgment of the physician and surgeon last in attendance, the occurrence of any antimicrobial-resistant infection that was a factor in the death.
(2)Operations and major findings thereof.
(3)Accident and injury information.
(4)Information indicating whether the decedent was pregnant at the time of death, or within the year prior to the death, if known, as determined by observation, autopsy, or review of the medical record. This paragraph shall not be interpreted to require the performance of a pregnancy test on a decedent, or to require a review of medical records in order to determine pregnancy.
SEC. 4.Part 5.5 (commencing with Section 121565) is added to Division 105 of the Health and Safety Code, to read:5.5.ANTIMICROBIAL-RESISTANT INFECTION121565.The following definitions shall apply for purposes of this part:
(a)Antibiogram means an annual summary of antimicrobial susceptibility of bacterial isolates, as defined by the Clinical and Laboratory Standards Institute (CLSI) M39 guidelines and subsequent updates.
(b)Antimicrobial resistance means a bacterial infection caused by a bacterium that demonstrates in vitro a minimum antimicrobial inhibitory concentration that exceeds susceptibility breakpoints, using the most recent diagnostic test standards approved by the United States Food and Drug Administration pursuant to the Federal Food, Drug, and Cosmetic Act.
(c)Clinical laboratory has the same meaning as defined in paragraph (8) of subdivision (a) of Section 1206 of the Business and Professions Code.
(d)Department means the State Department of Public Health.
(e)General acute care hospital has the same meaning as defined in subdivision (a) of Section 1250.
121566.Commencing on July 1, 2018, and each July 1 thereafter, each general acute care hospital and each clinical laboratory shall submit a report to the department, in an acceptable electronic format, containing an antibiogram of the facility for the previous year.
121567.(a)Commencing on January 1, 2019, and each January 1 thereafter, based on the data reported by general acute care hospitals and clinical laboratories pursuant to Section 121566, as well as from certificates of death, the department shall publish and post on its Internet Web site a report that includes the following information:
(1)The incidence, type, and distribution of antimicrobial-resistant infections statewide, and within regions of the state, as defined by the department, and by facility type.
(2)The type, level, and frequency of use of antimicrobial drugs statewide, and within regions of the state, as determined by the department, and by facility type.(3)(2)The number of deaths for which antimicrobial resistance is listed on the certificate of death as the disease or condition directly leading to death, an antecedent cause, or a significant condition contributing to death. This shall include all of the following:
(A)The number of deaths that may be attributed to each type of antimicrobial resistant antimicrobial-resistant infection, as determined by the department.
(B)The number of deaths, statewide and in each region of the state, as determined by the department.
(C)The number of deaths, by facility type.
(b)The report shall not identify information specific to any one health facility or general acute care hospital. Data collected pursuant to this part shall not be disclosed to the public on a facility specific facility-specific basis, except that the department may release case-specific information to other facilities, physicians, and the public if the department determines, on a case-by-case basis, that the release of the information is necessary to protect persons in a public health emergency.
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 all of the following:
(a)The epidemic of antibiotic resistance is a worldwide problem and is expected to grow. The federal Centers for Disease Control and Prevention (CDC) estimates that antibiotic-resistant infections kill at least 23,000 Americans each year and sicken two million. The Review on Antimicrobial Resistance, a study commissioned by the United Kingdom, estimates that by 2050, if nothing is done, 10 million people will die worldwide from antibiotic resistant infections, surpassing the 8.5 million people who will die from cancer.
(b)Antibiotic-resistant infections threaten modern medicine as we know it. If this epidemic is not curtailed, routine surgeries and minor infections may once again become life-threatening, jeopardizing the hard-won gains made battling infectious disease.
(c)Many leading public health organizations and world leaders have sounded the alarm about antibiotic resistance. The World Health Organization (WHO) has labeled antibiotic resistance as one of the biggest threats to global health and the CDC identifies antibiotic resistance is as one of our most serious health threats. In September 2016, the United Nations (UN) convened in New York and put forward a declaration to tackle antibiotic resistance. It was only the fourth time in history that the UN had met to tackle a global health problem, underscoring the significance of the problem.
(d)Monitoring and tracking antibiotic resistance is a core component to combating antibiotic resistance, as specified by the CDC. With appropriate surveillance of antibiotic-resistant infections, public health leaders can develop appropriate protocols for prevention, control, and treatment, can monitor disease trends, assess effectiveness of prevention and control measures, identify populations or geographic areas at high risk, and more.
(e)Despite the magnitude of this public health problem, the State Department of Public Health does not monitor or track the occurrence of antibiotic-resistant infections or deaths caused by those infections. While Although the department is required by law to establish a list of reportable diseases, that list does not include the tracking and monitoring of antibiotic-resistant infections. The department also is mandated by existing law to track three antibiotic-resistant infections, but only when those infections are health care acquired and in a patients bloodstream.
(f)The department is the central repository of certificates of death, which it uses to calculate state mortality statistics. An attending physician is legally obligated to file a certificate of death, and to record the disease or condition directly leading to death, antecedent causes, and other significant conditions contributing to the death.
(g)While Although the department generally reports on mortality statistics for a wide range of diseases based on information it gathers through certificates of death, it currently does not report on antibiotic-resistant infections as a cause of death.
SEC. 2.Section 102825 of the Health and Safety Code is amended to read:102825.(a)The physician and surgeon last in attendance, or in the case of a patient in a skilled nursing or intermediate care facility at the time of death, the physician and surgeon last in attendance or a licensed physician assistant under the supervision of the physician and surgeon last in attendance, on a deceased person shall state on the certificate of death the disease or condition directly leading to death, antecedent causes, other significant conditions contributing to death and any other medical and health section data as may be required on the certificate, including information regarding the presence of any antimicrobial- resistant infection, in accordance with paragraph (1) of subdivision (b) of Section 102875. He or she shall also specify the time in attendance, the time he or she last saw the deceased person alive, and the hour and day on which death occurred, except in deaths required to be investigated by the coroner. The physician and surgeon or physician assistant shall specifically indicate the existence of any cancer as defined in subdivision (h) of Section 103885, of which the physician and surgeon or physician assistant has actual knowledge.
(b)A physician and surgeon may designate, designate one or more other physicians and surgeons surgeons, who have access to the physician and surgeons records, to act as agent for the physician and surgeon for purposes of the performance of his or her duties under this section, provided that any person so designated acts in consultation with the physician and surgeon.
SEC. 3.Section 102875 of the Health and Safety Code is amended to read:102875.The certificate of death shall be divided into two sections.
(a)The first section shall contain those items necessary to establish the fact of the death, including all of the following and those other items as the State Registrar may designate:
(1)(A)Personal data concerning decedent including full name, sex, color or race, marital status, name of spouse, date of birth and age at death, birthplace, usual residence, and occupation and industry or business.
(B)Commencing July 1, 2015, a person completing the certificate shall record the decedents sex to reflect the decedents gender identity. The decedents gender identity shall be reported by the informant, unless the person completing the certificate is presented with a birth certificate, a drivers license, a social security record, a court order approving a name or gender change, a passport, an advanced health care directive, or proof of clinical treatment for gender transition, in which case the person completing the certificate shall record the decedents sex as that which corresponds to the decedents gender identity as indicated in that document. If none of these documents is presented and the person with the right, or a majority of persons who have equal rights, to control the disposition of the remains pursuant to Section 7100 is in disagreement with the gender identity reported by the informant, the gender identity of the decedent recorded on the death certificate shall be as reported by that person or majority of persons.
(C)Commencing July 1, 2015, if a document specified in subparagraph (B) is not presented and a majority of persons who have equal rights to control the disposition of the remains pursuant to Section 7100 do not agree with the gender identity of the decedent as reported by the informant, any one of those persons may file a petition, in the superior court in the county where the decedent resided at the time of his or her death, or where the remains are located, naming as a party to the action those persons who otherwise have equal rights to control the disposition and seeking an order of the court determining, as appropriate, who among those parties shall determine the gender identity of the decedent.
(D)Commencing July 1, 2015, a person completing the death certificate in compliance with subparagraph (B) is not liable for any damages or costs arising from claims related to the sex of the decedent as entered on the certificate of death.
(E)Commencing July 1, 2015, a person completing the death certificate shall comply with the data and certification requirements described in Section 102800 by using the information available to him or her prior to the deadlines for completion specified in that section.
(2)Date of death, including month, day, and year.
(3)Place of death.
(4)Full name of father and birthplace of father, and full maiden name of mother and birthplace of mother.
(5)Informant.
(6)Disposition of body information including signature and license number of embalmer if body embalmed or name of embalmer if affixed by attorney-in-fact; name of funeral director, or person acting as such; and date and place of interment or removal. Notwithstanding any other law to the contrary, an electronic signature substitute, or some other indicator of authenticity, approved by the State Registrar may be used in lieu of the actual signature of the embalmer.
(7)Certification and signature of attending physician and surgeon or certification and signature of coroner when required to act by law. Notwithstanding any other law to the contrary, the person completing the portion of the certificate setting forth the cause of death may attest to its accuracy by use of an electronic signature substitute, or some other indicator of authenticity, approved by the State Registrar in lieu of a signature.
(8)Date accepted for registration and signature of local registrar. Notwithstanding any other law to the contrary, the local registrar may elect to use an electronic signature substitute, or some other indicator of authenticity, approved by the State Registrar in lieu of a signature.
(b)The second section shall contain those items relating to medical and health data, including all of the following and other items as the State Registrar may designate:
(1)Disease or conditions leading directly to death and antecedent causes, including, in the professional judgment of the physician and surgeon last in attendance, the occurrence of any antimicrobial-resistant infection that was a factor in the death.
(2)Operations and major findings thereof.
(3)Accident and injury information.
(4)Information indicating whether the decedent was pregnant at the time of death, or within the year prior to the death, if known, as determined by observation, autopsy, or review of the medical record. This paragraph shall not be interpreted to require the performance of a pregnancy test on a decedent, or to require a review of medical records in order to determine pregnancy.
SEC. 4.Part 5.5 (commencing with Section 121565) is added to Division 105 of the Health and Safety Code, to read:5.5.ANTIMICROBIAL-RESISTANT INFECTION121565.The following definitions shall apply for purposes of this part:
(a)Antibiogram means an annual summary of antimicrobial susceptibility of bacterial isolates, as defined by the Clinical and Laboratory Standards Institute (CLSI) M39 guidelines and subsequent updates.
(b)Antimicrobial resistance means a bacterial infection caused by a bacterium that demonstrates in vitro a minimum antimicrobial inhibitory concentration that exceeds susceptibility breakpoints, using the most recent diagnostic test standards approved by the United States Food and Drug Administration pursuant to the federal Food, Drug, and Cosmetic Act.
(c)Clinical laboratory has the same meaning as defined in paragraph (8) of subdivision (a) of Section 1206 of the Business and Professions Code.
(d)Department means the State Department of Public Health.
(e)General acute care hospital has the same meaning as defined in subdivision (a) of Section 1250.
121566.Commencing on July 1, 2018, and each July 1 thereafter, each general acute care hospital and clinical laboratory shall submit a report to the department, in an acceptable electronic format, containing an antibiogram of the facility for the previous year.
121567.(a)Commencing on January 1, 2019, and each January 1 thereafter, based on the data reported by general acute care hospitals and clinical laboratories pursuant to Section 121566, as well as from certificates of death, the department shall publish and post on its Internet Web site a report that includes the following information:
(1)The incidence, type, and distribution of antimicrobial-resistant infections statewide, and within regions of the state, as defined by the department, and by facility type.
(2)The type, level, and frequency of use of antimicrobial drugs statewide, and within regions of the state, as determined by the department, and by facility type.
(3)The number of deaths for which antimicrobial resistance is listed on the certificate of death as the disease or condition directly leading to death, an antecedent cause, or a significant condition contributing to death. This shall include all of the following:
(A)The number of deaths that may be attributed to each type of antimicrobial resistant infection, as determined by the department.
(B)The number of deaths, statewide and in each region of the state, as determined by the department.
(C)The number of deaths, by facility type.
(b)The report shall not identify information specific to any one health facility or general acute care hospital. Data collected pursuant to this part shall not be disclosed to the public on a facility specific basis, except that the department may release case-specific information to other facilities, physicians, and the public if the department determines, on a case-by-case basis, that the release of that the information is necessary to protect persons in a public health emergency.
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 all of the following:
(a)The epidemic of antibiotic resistance is a worldwide problem and is expected to grow. The federal Centers for Disease Control and Prevention (CDC) estimates that antibiotic-resistant infections kill at least 23,000 Americans each year and sicken two million. The Review on Antimicrobial Resistance, a study commissioned by the United Kingdom, estimates that by 2050, if nothing is done, 10 million people will die worldwide from antibiotic resistant infections, surpassing the 8.5 million people who will die from cancer.
(b)Antibiotic-resistant infections threaten modern medicine as we know it. If this epidemic is not curtailed, routine surgeries and minor infections may once again become life-threatening, jeopardizing the hard-won gains made battling infectious disease.
(c)Many leading public health organizations and world leaders have sounded the alarm about antibiotic resistance. The World Health Organization (WHO) has labeled antibiotic resistance as one of the biggest threats to global health and the CDC identifies antibiotic resistance is one of our most serious health threats. In September 2016, the United Nations (UN) convened in New York and put forward a declaration to tackle antibiotic resistance. It was only the fourth time in history that the UN had met to tackle a global health problem, underscoring the significance of the problem.
(d)Monitoring and tracking antibiotic resistance is a core component to combating antibiotic resistance, as specified by the CDC. With appropriate surveillance of antibiotic-resistant infections, public health leaders can develop appropriate protocols for prevention, control, and treatment, can monitor disease trends, assess effectiveness of prevention and control measures, identify populations or geographic areas at high risk, and more.
(e)Despite the magnitude of this public health problem, the State Department of Public Health does not monitor or track the occurrence of antibiotic-resistant infections or deaths caused by those infections. While the department is required by law to establish a list of reportable diseases, that list does not include the tracking and monitoring of antibiotic-resistant infections. The department also is mandated by existing law to track three antibiotic-resistant infections, but only when those infections are health care acquired and in a patients bloodstream.
(f)The department is the central repository of certificates of death, which it uses to calculate state mortality statistics. An attending physician is legally obligated to file a certificate of death, and to record the disease or condition directly leading to death, antecedent causes, and other significant conditions contributing to the death.
(g)While the department generally reports on mortality statistics for a wide range of diseases based on information it gathers through certificates of death, it currently does not report on antibiotic-resistant infections as a cause of death.
SEC. 2.Section 102825 of the Health and Safety Code is amended to read:102825.(a)The physician and surgeon last in attendance, or in the case of a patient in a skilled nursing or intermediate care facility at the time of death, the physician and surgeon last in attendance or a licensed physician assistant under the supervision of the physician and surgeon last in attendance, on a deceased person shall state on the certificate of death the disease or condition directly leading to death, antecedent causes, other significant conditions contributing to death and any other medical and health section data as may be required on the certificate; he certificate, including information regarding the presence of any antimicrobial- resistant infection, in accordance with paragraph (1) of subdivision (b) of Section 102875. He or she shall also specify the time in attendance, the time he or she last saw the deceased person alive, and the hour and day on which death occurred, except in deaths required to be investigated by the coroner. The physician and surgeon or physician assistant shall specifically indicate the existence of any cancer as defined in subdivision (h) of Section 103885, of which the physician and surgeon or physician assistant has actual knowledge.
(b)A physician and surgeon may designate, one or more other physicians and surgeons who have access to the physician and surgeons records, to act as agent for the physician and surgeon for purposes of the performance of his or her duties under this section, provided that any person so designated acts in consultation with the physician and surgeon.
SEC. 3.Section 102875 of the Health and Safety Code is amended to read:102875.The certificate of death shall be divided into two sections.
(a)The first section shall contain those items necessary to establish the fact of the death, including all of the following and those other items as the State Registrar may designate:
(1)(A)Personal data concerning decedent including full name, sex, color or race, marital status, name of spouse, date of birth and age at death, birthplace, usual residence, and occupation and industry or business.
(B)Commencing July 1, 2015, a person completing the certificate shall record the decedents sex to reflect the decedents gender identity. The decedents gender identity shall be reported by the informant, unless the person completing the certificate is presented with a birth certificate, a drivers license, a social security record, a court order approving a name or gender change, a passport, an advanced health care directive, or proof of clinical treatment for gender transition, in which case the person completing the certificate shall record the decedents sex as that which corresponds to the decedents gender identity as indicated in that document. If none of these documents are is presented and the person with the right, or a majority of persons who have equal rights, to control the disposition of the remains pursuant to Section 7100 is in disagreement with the gender identity reported by the informant, the gender identity of the decedent recorded on the death certificate shall be as reported by that person or majority of persons.
(C)Commencing July 1, 2015, if a document specified in subparagraph (B) is not presented and a majority of persons who have equal rights to control the disposition of the remains pursuant to Section 7100 do not agree with the gender identity of the decedent as reported by the informant, any one of those persons may file a petition, in the superior court in the county in which where the decedent resided at the time of his or her death, or in which where the remains are located, naming as a party to the action those persons who otherwise have equal rights to control the disposition and seeking an order of the court determining, as appropriate, who among those parties shall determine the gender identity of the decedent.
(D)Commencing July 1, 2015, a person completing the death certificate in compliance with subparagraph (B) is not liable for any damages or costs arising from claims related to the sex of the decedent as entered on the certificate of death.
(E)Commencing July 1, 2015, a person completing the death certificate shall comply with the data and certification requirements described in Section 102800 by using the information available to him or her prior to the deadlines for completion specified in that section.
(2)Date of death, including month, day, and year.
(3)Place of death.
(4)Full name of father and birthplace of father, and full maiden name of mother and birthplace of mother.
(5)Informant.
(6)Disposition of body information including signature and license number of embalmer if body embalmed or name of embalmer if affixed by attorney-in-fact; name of funeral director, or person acting as such; and date and place of interment or removal. Notwithstanding any other provision of law to the contrary, an electronic signature substitute, or some other indicator of authenticity, approved by the State Registrar may be used in lieu of the actual signature of the embalmer.
(7)Certification and signature of attending physician and surgeon or certification and signature of coroner when required to act by law. Notwithstanding any other provision of law to the contrary, the person completing the portion of the certificate setting forth the cause of death may attest to its accuracy by use of an electronic signature substitute, or some other indicator of authenticity, approved by the State Registrar in lieu of a signature.
(8)Date accepted for registration and signature of local registrar. Notwithstanding any other provision of law to the contrary, the local registrar may elect to use an electronic signature substitute, or some other indicator of authenticity, approved by the State Registrar in lieu of a signature.
(b)The second section shall contain those items relating to medical and health data, including all of the following and other items as the State Registrar may designate:
(1)Disease or conditions leading directly to death and antecedent causes. causes, including, in the professional judgment of the physician and surgeon last in attendance, the occurrence of any antimicrobial-resistant infection that was a factor in the death.
(2)Operations and major findings thereof.
(3)Accident and injury information.
(4)Information indicating whether the decedent was pregnant at the time of death, or within the year prior to the death, if known, as determined by observation, autopsy, or review of the medical record. This paragraph shall not be interpreted to require the performance of a pregnancy test on a decedent, or to require a review of medical records in order to determine pregnancy.
SEC. 4.Part 5.5 (commencing with Section 121565) is added to Division 105 of the Health and Safety Code, to read:5.5.ANTIMICROBIAL-RESISTANT INFECTION121565.The following definitions shall apply for purposes of this part:
(a)Antibiogram means an annual summary of antimicrobial susceptibility of bacterial isolates, as defined by the Clinical and Laboratory Standards Institute (CLSI) M39 guidelines and subsequent updates.
(b)Antimicrobial resistance means a bacterial infection caused by a bacterium that demonstrates in vitro a minimum antimicrobial inhibitory concentration that exceeds susceptibility breakpoints, using the most recent diagnostic test standards approved by the United States Food and Drug Administration pursuant to the federal Food, Drug, and Cosmetic Act.
(c)Clinical laboratory has the same meaning as defined in paragraph (8) of subdivision (a) of Section 1206 of the Business and Professions Code.
(d)Department means the State Department of Public Health.
(e)General acute care hospital has the same meaning as defined in subdivision (a) of Section 1250.
121566.Commencing on July 1, 2018, and each July 1 thereafter, each general acute care hospital and clinical laboratory shall submit a report to the department, in an acceptable electronic format, containing an antibiogram of the facility for the previous year.
121567.(a)Commencing on January 1, 2019, and each January 1 thereafter, based on the data reported by general acute care hospitals and clinical laboratories pursuant to Section 121566, as well as from certificates of death, the department shall publish and post on its Internet Web site a report that includes the following information:
(1)The incidence, type, and distribution of antimicrobial-resistant infections statewide, and within regions of the state, as defined by the department, and by facility type.
(2)The type, level, and frequency of use of antimicrobial drugs statewide, and within regions of the state, as determined by the department, and by facility type.
(3)The number of deaths for which antimicrobial resistance is listed on the certificate of death as the disease or condition directly leading to death, an antecedent cause, or a significant condition contributing to death. This shall include all of the following:
(A)The number of deaths that may be attributed to each type of antimicrobial resistant infection, as determined by the department.
(B)The number of deaths, statewide and in each region of the state, as determined by the department.
(C) The number of deaths, by facility type.
(b)The report shall not identify information specific to any one health facility or general acute care hospital. Data collected pursuant to this part shall not be disclosed to the public on a facility specific basis, except that the department may release case-specific information to other facilities, physicians, and the public if the department determines, on a case-by-case basis, that the release of that information is necessary to protect persons in a public health emergency.
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.
|
Date
|
Status
|
|---|---|
| Jun 26, 2018 | June 26 set for second hearing canceled at the request of author. |
| Jun 18, 2018 | From committee with author's amendments. Read second time and amended. Re-referred to Com. on HEALTH. |
| Jul 11, 2017 | July 11 set for first hearing canceled at the request of author. |
| Jun 8, 2017 | Referred to Com. on HEALTH. |
| May 31, 2017 | In Assembly. Read first time. Held at Desk. |
| May 30, 2017 | Read third time. Passed. (Ayes 40. Noes 0. Page 1263.) Ordered to the Assembly. |
| May 26, 2017 | Read second time. Ordered to third reading. |
| May 25, 2017 | From committee: Do pass. (Ayes 7. Noes 0. Page 1176.) (May 25). |
| May 19, 2017 | Set for hearing May 25. |
| May 15, 2017 | May 15 hearing: Placed on APPR. suspense file. |
| May 4, 2017 | Set for hearing May 15. |
| May 3, 2017 | May 8 hearing postponed by committee. |
| May 1, 2017 | Set for hearing May 8. |
| Apr 20, 2017 | From committee: Do pass and re-refer to Com. on APPR. (Ayes 9. Noes 0. Page 807.) (April 19). Re-referred to Com. on APPR. |
| Apr 5, 2017 | From committee with author's amendments. Read second time and amended. Re-referred to Com. on HEALTH. |
| Mar 31, 2017 | Set for hearing April 19. |
| Mar 30, 2017 | April 5 hearing postponed by committee. |
| Mar 28, 2017 | Set for hearing April 5. |
| Mar 27, 2017 | March 29 set for first hearing canceled at the request of author. |
| Mar 7, 2017 | Set for hearing March 29. |
| Jan 31, 2017 | From committee with author's amendments. Read second time and amended. Re-referred to Com. on HEALTH. |
| Jan 12, 2017 | From committee with author's amendments. Read second time and amended. Re-referred to Com. on HEALTH. |
| Jan 12, 2017 | Referred to Com. on HEALTH. |
| Dec 6, 2016 | From printer. May be acted upon on or after January 5. |
| Dec 5, 2016 | Introduced. Read first time. To Com. on RLS. for assignment. To print. |
|
Date
|
Description
|
Location
|
Votes
|
|
|---|---|---|---|---|
| May 30, 2017 | Senate 3rd Reading SB43 Hill et al. | Senate Floor |
Passed |
|
| May 25, 2017 | Do pass | Senate Standing Committee on Appropriations |
Passed |
|
| May 15, 2017 | Placed on suspense file | Senate Standing Committee on Appropriations |
Passed |
|
| Apr 19, 2017 | Do pass, but first be re-referred to the Committee on [Appropriations] | 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
|
|---|---|---|
| California Hospital Association | ** Against | May 27, 2017 |
| California Society Of Pathologists | * Support | Apr 19, 2017 |
| California State PTA | ** Support | May 27, 2017 |
| Consumer Attorneys Of California | ** Support | May 27, 2017 |
| Health Officers Association Of California | * Neutral | Apr 19, 2017 |
| Infectious Disease Association of California | ** Against | May 27, 2017 |
Office of Senate Floor Analyses (916) 651-1520 Fax: (916) 327-4478 | SB |
THIRD READING
Bill No: SB 43
:
SENATE HEALTH COMMITTEE: 9-0, 4/19/17
AYES: Hernandez, Nguyen, Atkins, Leyva, Mitchell, Monning, Newman, Nielsen, Roth
SENATE APPROPRIATIONS COMMITTEE: 7-0, 5/25/17
AYES: Lara, Bates, Beall, Bradford, Hill, Nielsen, Wiener
DIGEST:
This bill requires general acute care hospitals and laboratories to submit annual antibiograms to the California Department of Public Health (CDPH) after July 1, 2019. Requires CDPH to, commencing January 2019, develop an appropriate format for the antibiogram report and to develop a method of estimation of the number of deaths caused by antimicrobial resistant infections. Requires CDPH to publish, commencing January 1, 2020, on an annual basis, information on incidences in hospital and deaths caused by antimicrobial organisms resistance to drugs.
ANALYSIS:
Existing law:
- Requires CDPH to establish the Hospital Infectious Disease Control Program which implements various measures relating to disease surveillance and the prevention of healthcare-associated infection (HAI). Requires hospitals to appoint a Healthcare Associated Infection Advisory Committee (HAI-AC) that makes recommendations related to methods of reporting cases of hospital acquired infections in general acute care hospitals.
- Requires general acute care hospitals to prepare a written report every three years that examines the hospital’s quality and effectiveness in infection surveillance and prevention programs.
- Requires CDPH to establish the Ken Maddy California Cancer Registry (CCR) to collect and report information on incidences and mortalities of cancer.
This bill:
- Defines, for the purposes of this bill, the following:
- “Antibiogram” as an annual summary of antimicrobial susceptibility of bacterial isolates, defined by the Clinical and Laboratory Standards Institute M39 guidelines and subsequent updates;
- “Antimicrobial resistance” as a bacterial infection caused by a bacterium that demonstrates in vitro a minimum antimicrobial inhibitory concentration that exceeds susceptibility breakpoints, using the most recent diagnostic test standards approved by the United States Food and Drug Administration pursuant to the Federal Food, Drug, and Cosmetic Act; and,
- “Subcommittee” as the Antimicrobial Stewardship and Resistance Subcommittee of the Healthcare Associated Infections Advisory Committee of the CDPH.
- Requires each general acute care hospital that conducts tests for antimicrobial resistance, each clinical laboratory that conducts tests for antimicrobial resistance, and each clinical laboratory that is not part of a hospital and that conducts antimicrobial resistance to submit to CDPH an electronic report of an antibiogram of the facility for the previous year commencing on July 1, 2019, and each July 1 thereafter.
- Requires CDPH’s HAI Subcommittee, by January 1, 2019, to develop and recommend an electronic format for the submission of antibiogram reports from eligible hospitals and laboratories. This includes the types of antimicrobial resistant infections to be reported on, that may include, but are not limited to, the antimicrobial resistant infections identified by the Center for Disease Control and Prevention (CDC) as urgent, serious, or concerning.
- Requires CDPH’s HAI Subcommittee, by January 1, 2020, to develop and recommend a method of estimating the number of deaths that result from antimicrobial resistant infections as established by the Subcommittee. The method may rely on data from death certificates or other sources of data.
- Requires CDPH, commencing on January 1, 2019, and each January 1 thereafter, based on the data reported by hospitals and labs, as well as estimates of deaths from antimicrobial resistant infections, to publish and post on its Web site a report that includes the following information:
- Occurrence of antimicrobial-resistant infections statewide by type, incidence, and facility type; and,
- Estimated number of deaths that result from antimicrobial resistant infections.
- Prohibits the report from identifying information specific to any one health facility or hospital.
Comments
- Author’s statement. According to the author, disease surveillance is a basic function of public health departments. The CDPH currently tracks 80 communicable diseases such as typhoid, the flu and HIV, and also tracks deaths based on death certificates. But despite the catastrophic nature of the antibiotic resistance crisis, California and the federal government do not track antibiotic resistant infections or deaths associated with the infections. As a result, public health leaders cannot appropriately monitor and define the problem, put forward evidence based solutions, identify emerging trends and new threats, or measure the effectiveness of interventions. SB 43 fixes the knowledge gap on antibiotic resistance by establishing a first in the nation system to monitor and track antibiotic resistant infections and deaths. The CDC estimates that at least two million Americans are infected with – and at least 23,000 Americans die as a result of – antibiotic-resistant infections every year, resulting in at least $20 billion in direct health care costs and at least $35 billion in lost productivity in the United States. In California, CDPH estimates that antibiotic-resistant infections are responsible for at least 3,000 deaths and 260,000 illnesses every year. If left unchecked the problem will grow. A 2014 study commissioned by the United Kingdom determined that by 2050, more people will die from antibiotic-resistant infections worldwide than from cancer. Underscoring the threat to global health, the United Nations (UN) took action on the issue, marking only the fourth time in history that the UN convened to confront a health crisis. UN Secretary-General Ban Ki-moon called antimicrobial resistance “a fundamental, long-term threat to human health, sustainable food production and development.”
- The rise of a public health problem. Since the discovery of antibiotics and similar drugs in the 1940s, also known as antimicrobials, these drugs have greatly reduced illness and death from infectious diseases. However, antimicrobials have been used so widely and for so long that the infectious organisms the drugs are designed to kill have adapted to them, making the drugs less effective. The CDC estimates that over 20,000 Americans die and more than two million fall ill each year from antibiotic-resistant infections, leading to increased healthcare costs over the coming years as infections become more difficult if not impossible to treat.
According to the World Health Organization (WHO), antimicrobial resistance occurs due to the misuse of antimicrobials in a variety of ways. They are often administered when they are not needed, continued when they are no longer necessary, or prescribed at the wrong dose. A 2015 national study published by the National Institutes of Health showed that antimicrobials have also become among the most misused medicines of those available to the practicing physician. This clinical misuse, in addition to the patient overuse, has led to the emergence of resistant microbes, which in turn has created an ever-increasing need for new drugs and faster detection of antimicrobial resistance. In some cases these pathogens have been pan-resistant, meaning that they are resistant to all available antimicrobials.
In 2015, WHO characterized antibiotic resistance as a “crisis that has been building up over decades, so that today common and life-threatening infections are becoming difficult or even impossible to treat.” Resistant infections not only result in increased morbidity and mortality, but increased economic burdens. For example, studies have shown that antibiotic-resistant infections are associated with longer lengths of stay and increased mortality, both in the hospital and in intensive care units.
- Biggest threats. In 2013, the CDC published a report describing 18 antimicrobial resistant organisms that pose the biggest threats to Americans, categorizing them as urgent, serious, and concerning. The three urgent threats (C. difficile, Carbapenem-resistant Enterobacteriaceae (CRE), and drug-resistant Neisseria gonorrhoeae) were described as high-consequence antibiotic resistant microbes that could require urgent public health attention to identify infections and limit transmission. For example, a 2015 study published in the Journal of American Medical Association indicated that CRE affected approximately 3 in 100,000 people in the U.S. Of the 599 cases studied, 51 patients died due to the lack of antimicrobial treatment options. The next level of 12 antibiotic resistant microbes is described as “serious hazard” that could pose significant risk, which could become urgent without ongoing public health monitoring and prevention activities. The WHO has reported that individuals with Methicillin-resistant Staphylococcus aureus (MRSA), one of bacteria in this category, have a 64% greater chance of dying than people who contract the same infection in its nonresistant form. The “concerning” category consists of three bacteria for which the threat of antibiotic resistance is low, and/or there are multiple therapeutic options for resistant infections. There bacterial pathogens cause severe illness and require monitoring and in some cases, rapid incident and outbreak response. One of those three bacteria, Erythromycin-resistant Group A Streptococcus causes 1,300 illnesses annually in the U.S, and results in approximately 160 deaths.
- California’s antimicrobial stewardship program. In an attempt to track the state’s incidences of antimicrobial resistance in clinical facilitates, the CDPH HAI Program developed a statewide antimicrobial stewardship program initiative in February 2010. It strengthened and promoted optimization of antimicrobial utilization in California health care facilities. According to CDPH, the purpose of an antimicrobial stewardship program in a healthcare facility is to measure and promote the appropriate use of antimicrobials by selecting the appropriate agent, dose, duration, and route of administration in order to improve patient outcomes, while minimizing toxicity and the emergence of antimicrobial resistance. As part of the stewardship program, the California Antibiogram Project (CAP) was created to collect information on specific antimicrobial-organism combinations across California’s general acute care hospitals. The program collected and published antibiogram data from 85 hospitals in annual reports from 2008 to 2010 and was able to confirm that there was a rise in certain antimicrobial resistant bacteria such as MRSA.
Since CAP’s conclusion in 2010, the CDPH HAI Program has convened a California Antimicrobial Resistance Laboratory Network, through which they are requesting voluntary submissions of selected antimicrobial resistant laboratory data. This data is fed into a larger, national database administered by the National Antimicrobial Resistance Laboratory Network, which aims to collect and monitor national trends in antimicrobial resistant infections. However, antibiograms from statewide clinics and laboratories are no longer collected and analyzed by CDPH.
- Current local efforts. Los Angeles County Department of Public Health (LAC DPH) passed an order on January 17, 2017 that requires acute care hospitals and skilled nursing facilities to provide their annual antibiogram to the LAC DPH every year starting in 2018. It focuses especially on carbapenem-resistant Enterobaceriaceae (CRE), with the goal of guiding optimal antimicrobial treatment for patients with CRE or similar infections. LAC DPH has begun developing an antibiogram template to standardize collection, reporting, and aggregation of data.
- Reporting of cancer mortality. The CCR is a legally mandated, state-wide, population-based cancer registry that was implemented in 1988. It researches and collects data on the causes, controls, and cures of cancer by monitoring the incidence and mortality rates in California. CCR reports on mortality utilizing CDPH’s Center of Health Statistics, which bases its data on the underlying causes of death reported on death certificates. CCR publishes this information in annual reports, categorizing data based on state, regional, and county levels.
- Reporting cause of death. A physician in last attendance of a patient certifies the death certificate based on his or her knowledge and medical opinion. Uncertainty in determining the main and contributing factors of death for a patient can result in inconsistent data entry and collection. According to CDPH, doctors in California currently follow the CDC’s manual on the tenth revision of the International Statistical Classification of Diseases and Related Health Problems, which provides pre-established codes for hundreds of causes of death. The system has broad categories for infections, but does not allow for the reporting of specific antimicrobial resistant infections that can be coded for, and therefore collects and aggregates this data into a broad classification of infections.
- CDC reporting methods. Due to the possibility of inconsistency in reporting causes of death for specific diseases, the CDC does not solely rely on death certificates for mortality data. While national cancer data utilizes death certificate data, the CDC reports that fatality statistics for infectious diseases like HIV/AIDS are determined using state and national surveillance programs to estimate annual mortality numbers. When the number of deaths caused by HIV/AIDS as estimated by the national surveillance program was compared to the number of deaths due to HIV/AIDS reported on death certificates, the CDC found that HIV/AIDS was under-reported as the cause of death on death certificates.
FISCAL EFFECT: Appropriation: Fiscal Com.: Local:
According to the Senate Appropriations Committee:
- One-time costs of $615,000 over three fiscal years and ongoing costs of $90,000 per year for the development and operation of the information technology system needed to accept and process data from hospitals and clinics by the CDPH (Licensing and Certification Fund). Because the CDPH would be receiving detailed reports from over 1,000 reporting entities, it would need to develop a system for accepting the required data electronically and processing that data for reporting.
- One-time costs of $340,000 over three fiscal years for the development of regulations to specify the manner and requirements for reporting data by hospitals and laboratories by the CDPH (Licensing and Certification Fund).
- Ongoing costs of $280,000 per year to analyze the reported data and prepare the required reports by the CDPH (Licensing and Certification Fund).
- Ongoing costs of $100,000 per year for additional licensing and enforcement activities by the CDPH (Licensing and Certification Fund). As part of its ongoing licensing and enforcement program, the CDPH would incur additional workload to ensure that hospitals and clinics are complying with the reporting requirements of the bill.
California State PTA
Consumer Attorneys of California
OPPOSITION: (Verified 5/23/17)
California Hospital Association
Infectious Disease Association of California
ARGUMENTS IN SUPPORT: Supporters of this bill argue that this bill will increase patient safety by establishing a system to monitor and track antibiotic resistant infections and deaths related to those infections. A statewide public health surveillance system for tracking antibiotic resistant infections and deaths will encourage improved control of antimicrobial resistance and help save lives.
ARGUMENTS IN OPPOSITION: The Infections Disease Association of California and the California Hospital Association are opposed, unless amended based on a prior version of the bill, and it is unclear if the most recent amendments will remove this opposition. They state that mandating inclusion of cause of death associated with antimicrobial-resistant infections on death certificates alone may not represent a reliable way to determine causation of death and that the data may not be interpretable or actionable.
5/27/17 18:32:28
**** END ****
SENATE COMMITTEE ON
Senator Ricardo Lara, Chair
2017 - 2018 Regular Session
SB 43 (Hill) - Antimicrobial-resistant infection: reporting
Version: | Policy Vote: |
Urgency: | Mandate: |
Hearing Date: | Consultant: |
This bill meets the criteria for referral to the Suspense File.
Bill Summary:
SB 43 would require hospitals and clinical laboratories to submit information to the Department of Public Health regarding antimicrobial resistant infections. The bill would require the Department to report annually on this information and on the estimated annual mortality rate due to antimicrobial resistant infections.
Fiscal Impact:
- One-time costs of $615,000 over three fiscal years and ongoing costs of $90,000 per year for the development and operation of the information technology system needed to accept and process data from hospitals and clinics by the Department of Public Health (Licensing and Certification Fund). Because the Department would be receiving detailed reports from over 1,000 reporting entities, it would need to develop a system for accepting the required data electronically and processing that data for reporting. See staff comments below.
- One-time costs of $340,000 over three fiscal years for the development of regulations to specify the manner and requirements for reporting data by hospitals and laboratories by the Department of Public Health (Licensing and Certification Fund).
- Ongoing costs of $280,000 per year to analyze the reported data and prepare the required reports by the Department of Public Health (Licensing and Certification Fund).
- Ongoing costs of $100,000 per year for additional licensing and enforcement activities by the Department of Public Health (Licensing and Certification Fund). As part of its ongoing licensing and enforcement program, the Department would incur additional workload to ensure that hospitals and clinics are complying with the reporting requirements of the bill.
Background:
Under current law, the Department of Public Health operates the Hospital Infectious Disease Control Program. Under this Program, the Department collects data from hospitals on hospital acquired infections and prepares reports using that data. However, under current law, the requirements for reporting this data are less comprehensive than would be required under this bill. The Department estimates that there are about 80,000 hospital acquired infections each year in the state, whereas only about 20,000 of those infections are reported to the Department, under the current reporting requirements.
The Governor’s January budget proposal includes a request for $990,000 in additional funding for this Program to increase public education efforts and more closely track the incidence of hospital acquired infections.
Under current law, general acute care hospitals and skilled nursing facilities are required to implement antibiotic stewardship programs. The intention of those programs is to avoid anti-microbial resistant infections by avoiding unnecessary use of antibiotics and preventing infections. As part of those programs, hospitals and skilled nursing facilities usually track the levels of antimicrobial resistant infections (at least for infections of particular concern).
Proposed Law:
SB 43 would require hospitals and clinical laboratories to submit information to the Department of Public Health regarding antimicrobial resistant infections. The bill would require the Department to report annually on this information and on the estimated annual mortality rate due to antimicrobial resistant infections.
Specific provisions of the bill would:
- Commencing July 1, 2019 and each July 1 thereafter, require each general acute care hospital that operates a clinical laboratory and each clinical laboratory that is not part of a general acute care hospital to submit a report to the Department including a summary of the antimicrobial resistant infections found in the prior year;
- Require an existing advisory committee of the Department of Public Health to develop an electronic format for the report and a method for the Department to estimate the number of deaths that occur each year from antimicrobial resistant infections;
- Require the Department to report annually, beginning on January 1, 2020 using the data reported from hospitals and laboratories and the Department’s estimates of deaths due to antimicrobial resistant infections;
- Prohibit the report from identifying facility-specific data.
Staff Comments:
Antimicrobial resistant infections are a major and growing threat to public health. According to the Centers for Disease Control and Prevention, about 23,000 Americans die as a result of antimicrobial resistant infections each year. According to the Department of Public Health, antimicrobial resistant infections are responsible for at least 3,000 deaths in the state each year. Although an antimicrobial resistant infection can be acquired anywhere, a significant number of such infections are acquired in hospitals and other health facilities.
The Department of Public Health anticipates significant information technology costs to develop and operate systems to allow for electronic reporting by hospitals and laboratories. Given the large number of reporting entities and the potential for significant amounts of data coming from each entity, it is likely that a substantial information technology system will be necessary to implement the bill. As part of its estimate of the information technology needs under the bill, the Department indicates that it will need $90,000 per year for computer servers. The Department assumes it will have a continuous need for purchasing new servers and testing their operations. This cost seems excessive for an ongoing program.
-- END --
SENATE COMMITTEE ON HEALTH
Senator Ed Hernandez, O.D., Chair
BILL NO: SB 43
AUTHOR: | Hill | ||
VERSION: | April 5, 2017 | ||
HEARING DATE: | April 19, 2017 | ||
CONSULTANT: | Bao Nguyen | ||
SUBJECT: Antimicrobial-resistant infection: reporting
SUMMARY: Requires general acute care hospitals and laboratories to submit annual antibiograms to the California Department of Public Health (CDPH) after July 1, 2019. Requires CDPH to, commencing January 2019, develop an appropriate format for the antibiogram report and to develop a method of estimation of the number of deaths caused by antimicrobial resistant infections. Requires CDPH to publish, commencing January 1, 2020, on an annual basis, information on incidences in hospital and deaths caused by antimicrobial organisms resistance to drugs.
Existing law:
- Requires CDPH to establish the Hospital Infectious Disease Control Program which implements various measures relating to disease surveillance and the prevention of healthcare-associated infection (HAI). Requires hospitals to appoint a Healthcare Associated Infection Advisory Committee (HAI-AC) that makes recommendations related to methods of reporting cases of hospital acquired infections in general acute care hospitals.
- Requires general acute care hospitals to prepare a written report every three years that examines the hospital’s quality and effectiveness in infection surveillance and prevention programs.
- Requires CDPH to establish the Ken Maddy California Cancer Registry (CCR) to collect and report information on incidences and mortalities of cancer.
This bill:
- Defines, for the purposes of this bill, the following:
- “Antibiogram” as an annual summary of antimicrobial susceptibility of bacterial isolates, defined by the Clinical and Laboratory Standards Institute (CLSI) M39 guidelines and subsequent updates;
- “Antimicrobial resistance” as a bacterial infection caused by a bacterium that demonstrates in vitro a minimum antimicrobial inhibitory concentration that exceeds susceptibility breakpoints, using the most recent diagnostic test standards approved by the United States Food and Drug Administration pursuant to the Federal Food, Drug, and Cosmetic Act; and,
- “Subcommittee” as the Antimicrobial Stewardship and Resistance Subcommittee of the Healthcare Associated Infections Advisory Committee of the CDPH.
- Requires each general acute care hospital that conducts tests for antimicrobial resistance, each clinical laboratory that conducts tests for antimicrobial resistance, and each clinical laboratory that is not part of a hospital and that conducts antimicrobial resistance to submit to CDPH an electronic report of an antibiogram of the facility for the previous year commencing on July 1, 2019, and each July 1 thereafter.
- Requires CDPH’s HAI Subcommittee, by January 1, 2019, to develop and recommend an electronic format for the submission of antibiogram reports from eligible hospitals and laboratories. This includes the types of antimicrobial resistant infections to be reported on, that may include, but are not limited to, the antimicrobial resistant infections identified by the CDC as urgent, serious, or concerning.
- Requires CDPH’s HAI Subcommittee, by January 1, 2020 to develop and recommend a method of estimating the number of deaths that result from antimicrobial resistant infections as established by the Subcommittee. The method may rely on data from death certificates or other sources of data.
- Requires CDPH, commencing on January 1, 2019, and each January 1 thereafter, based on the data reported by hospitals and labs, as well as estimates of deaths from antimicrobial resistant infections, to publish and post on its website a report that includes the following information:
- Occurrence of antimicrobial-resistant infections statewide by type, incidence, and facility type; and,
- Estimated number of deaths that result from antimicrobial resistant infections.
- Prohibits the report from identifying information specific to any one health facility or hospital.
FISCAL EFFECT:
This bill has not been analyzed by a fiscal committee.
COMMENTS:
- Author’s statement. According to the author, disease surveillance is a basic function of public health departments. The CDPH currently tracks 80 communicable diseases such as typhoid, the flu and HIV, and also tracks deaths based on death certificates. But despite the catastrophic nature of the antibiotic resistance crisis, California and the federal government do not track antibiotic resistant infections or deaths associated with the infections. As a result, public health leaders cannot appropriately monitor and define the problem, put forward evidence based solutions, identify emerging trends and new threats, or measure the effectiveness of interventions. SB 43 fixes the knowledge gap on antibiotic resistance by establishing a first in the nation system to monitor and track antibiotic resistant infections and deaths. The Center for Disease Control and Prevention (CDC) estimates that at least 2 million Americans are infected with – and at least 23,000 Americans die as a result of – antibiotic-resistant infections every year, resulting in at least $20 billion in direct health care costs and at least $35 billion in lost productivity in the United States. In California, CDPH estimates that antibiotic-resistant infections are responsible for at least 3,000 deaths and 260,000 illnesses every year. If left unchecked the problem will grow. A 2014 study commissioned by the United Kingdom determined that by 2050, more people will die from antibiotic-resistant infections worldwide than from cancer. Underscoring the threat to global health, the United Nations took action on the issue, marking only the fourth time in history that the UN convened to confront a health crisis. UN Secretary-General Ban Ki-moon called antimicrobial resistance “a fundamental, long-term threat to human health, sustainable food production and development.”
- The rise of a public health problem. Since the discovery of antibiotics and similar drugs in the 1940s, also known as antimicrobials, these drugs have greatly reduced illness and death from infectious diseases. However, antimicrobials have been used so widely and for so long that the infectious organisms the drugs are designed to kill have adapted to them, making the drugs less effective. The CDC estimates that over 20,000 Americans die and more than two million fall ill each year from antibiotic-resistant infections, leading to increased healthcare costs over the coming years as infections become more difficult if not impossible to treat.
According to the World Health Organization (WHO), antimicrobial resistance occurs due to the misuse of antimicrobials in a variety of ways. They are often administered when they are not needed, continued when they are no longer necessary, or prescribed at the wrong dose. A 2015 national study published by the National Institute of Health (NIH) showed that antimicrobials have also become among the most misused medicines of those available to the practicing physician. This clinical misuse, in addition to the patient overuse, has led to the emergence of resistant microbes, which in turn has created an ever-increasing need for new drugs and faster detection of antimicrobial resistance. In some cases these pathogens have been pan-resistant, meaning that they are resistant to all available antimicrobials.
In 2015, WHO characterized antibiotic resistance as a “crisis that has been building up over decades, so that today common and life-threatening infections are becoming difficult or even impossible to treat.” Resistant infections not only result in increased morbidity and mortality, but increased economic burdens. For example, studies have shown that antibiotic-resistant infections are associated with longer lengths of stay and increased mortality, both in the hospital and in intensive care units.
- Biggest threats. In 2013, the CDC published a report describing 18 antimicrobial resistant organisms that pose the biggest threats to Americans, categorizing them as urgent, serious, and concerning. The three urgent threats (C. difficile, Carbapenem-resistant Enterobacteriaceae (CRE), and drug-resistant Neisseria gonorrhoeae) were described as high-consequence antibiotic resistant microbes that could require urgent public health attention to identify infections and limit transmission. For example, a 2015 study published in the Journal of American Medical Association (JAMA) indicated that CRE affected approximately 3 in 100,000 people in the U.S. Of the 599 cases studied, 51 patients died due to the lack of antimicrobial treatment options. The next level of 12 antibiotic resistant microbes is described as “serious hazard” that could pose significant risk, which could become urgent without ongoing public health monitoring and prevention activities. The WHO has reported that individuals with Methicillin-resistant Staphylococcus aureus (MRSA), one of bacteria in this category, have a 64% greater chance of dying than people who contract the same infection in its nonresistant form. The “concerning” category consists of three bacteria for which the threat of antibiotic resistance is low, and/or there are multiple therapeutic options for resistant infections. There bacterial pathogens cause severe illness and require monitoring and in some cases, rapid incident and outbreak response. One of those three bacteria, Erythromycin-resistant Group A Streptococcus causes 1,300 illnesses annually in the U.S, and results in approximately 160 deaths.
- California’s antimicrobial stewardship program. In an attempt to track the state’s incidences of antimicrobial resistance in clinical facilitates, the CDPH HAI Program developed a statewide antimicrobial stewardship program (ASP) initiative in February 2010. It strengthened and promoted optimization of antimicrobial utilization in California health care facilities. According to CDPH, the purpose of an antimicrobial stewardship program in a healthcare facility is to measure and promote the appropriate use of antimicrobials by selecting the appropriate agent, dose, duration, and route of administration in order to improve patient outcomes, while minimizing toxicity and the emergence of antimicrobial resistance. As part of the stewardship program, the California Antibiogram Project (CAP) was created to collect information on specific antimicrobial-organism combinations across California’s general acute care hospitals. The program collected and published antibiogram data from 85 hospitals in annual reports from 2008 to 2010 and was able to confirm that there was a rise in certain antimicrobial resistant bacteria such as MRSA.
Since CAP’s conclusion in 2010, the CDPH HAI Program has convened a California Antimicrobial Resistance Laboratory Network, through which they are requesting voluntary submissions of selected antimicrobial resistant laboratory data. This data is fed into a larger, national database administered by the National Antimicrobial Resistance Laboratory Network, which aims to collect and monitor national trends in antimicrobial resistant infections. However, antibiograms from statewide clinics and laboratories are no longer collected and analyzed by CDPH. - Current local efforts. Los Angeles County Department of Public Health (LAC DPH) passed an order on January 17, 2017 that requires acute care hospitals and skilled nursing facilities to provide their annual antibiogram to the LADPH every year starting in 2018. It focuses especially on carbapenem-resistant Enterobaceriaceae (CRE), with the goal of guiding optimal antimicrobial treatment for patients with CRE or similar infections. LAC DPH has begun developing an antibiogram template to standardize collection, reporting, and aggregation of data.
- Reporting of cancer mortality. The CCR is a legally mandated, state-wide, population-based cancer registry that was implemented in 1988. It researches and collects data on the causes, controls, and cures of cancer by monitoring the incidence and mortality rates in California. CCR reports on mortality utilizing CDPH’s Center of Health Statistics, which bases its data on the underlying causes of death reported on death certificates. CCR publishes this information in annual reports, categorizing data based on state, regional, and county levels.
- Reporting cause of death. A physician in last attendance of a patient certifies the death certificate based on his or her knowledge and medical opinion. Uncertainty in determining the main and contributing factors of death for a patient can result in inconsistent data entry and collection. According to CDPH, doctors in California currently follow the CDC’s manual on the tenth revision of the International Statistical Classification of Diseases and Related Health Problems (ICD), which provides pre-established codes for hundreds of causes of death. The system has broad categories for infections, but does not allow for the reporting of specific antimicrobial resistant infections that can be coded for, and therefore collects and aggregates this data into a broad classification of infections.
- CDC reporting methods. Due to the possibility of inconsistency in reporting causes of death for specific diseases, the CDC does not solely rely on death certificates for mortality data. While national cancer data utilizes death certificate data, the CDC reports that fatality statistics for infectious diseases like HIV/AIDS are determined using state and national surveillance programs to estimate annual mortality numbers. When the number of deaths caused by HIV/AIDS as estimated by the national surveillance program was compared to the number of deaths due to HIV/AIDS reported on death certificates, the CDC found that HIV/AIDS was under-reported as the cause of death on death certificates.
- Prior legislation. SB 994 (Hill) would have required antibiotic stewardship in outpatient doctors’ offices. SB 944 was subsequently amended to a different subject area in the Assembly.
SB 27 (Hill, Chapter 758, Statutes of 2015) restricts the use of medically important antimicrobial drugs in livestock for specified purposes, requires a veterinarian’s prescription or feed directive for use, and eliminates the over-the-counter availability of these drugs. Requires the California Department of Food and Agriculture (CDFA), in coordination with federal programs and agencies, to develop a program to track antimicrobial drug use in livestock and the emergence of antimicrobial-resistant bacteria; and requires CDFA to develop antimicrobial stewardship guidelines and best management practices on the proper use of these drugs.
SB 361 (Hill, Chapter 764, Statutes of 2015) requires antibiotic stewardship programs by January 1, 2017 in SNF consistent with guidelines provided by the CDC and the centers of Medicare and Medicaid Services (CMS). Requires antibiotic stewardship training every four years for veterinarians.
SB 1311 (Hill, Chapter 843, Statutes of 2014) requires all general acute care hospitals to adopt and implement an antimicrobial stewardship policy that includes a process to evaluate the judicious use of antibiotics.
SB 1058 (Alquist, Chapter 296, Statutes of 2008) enacts the Medical Facility Infection Control and Prevention Act. Requires hospitals to implement specified procedures for the screening, prevention, and reporting of specified health care associated infections. Requires hospitals to report positive MRSA and other healthcare associated infection test results to CDPH and requires CDPH to make specified information public on its website. Requires hospitals to designate an infection control officer who, in conjunction with the hospital infection control committee, must ensure implementation of the testing and reporting provisions and other hospital infection control efforts. Requires hospitals to report quarterly to CDPH all central line associated blood stream infections and total central line days. Requires each hospital to report quarterly to CDPH all health care associated surgical site infections of deep or organ space surgical sites, health care associated infections of orthopedic surgical sites, cardiac surgical sites, and gastrointestinal surgical sites designated as clean and clean-contaminated, and the number of surgeries involving deep or organ space, and orthopedic, cardiac, and gastrointestinal surgeries designated clean and clean-contaminated. Further revises existing hospital infection control policy requirements and CDPH’s licensing and certification requirements.
- Support. Supporters of this bill argue that this bill will increase patient safety by establishing a system to monitor and track antibiotic resistant infections and deaths related to those infections. A statewide public health surveillance system for tracking antibiotic resistant infections and deaths will encourage improved control of antimicrobial resistance and help save lives.
- Oppose unless amended. The Infections Disease Association of California (IDAC) and the California Hospital Association (CHA) state that mandating inclusion of cause of death associated with antimicrobial-resistant infections on death certificates alone may not represent a reliable way to determine causation of death and that the data may not be interpretable or actionable. It is unclear if the most recent amendments will remove this opposition.
SUPPORT AND OPPOSITION:
Support: California State PTA
Consumer Attorneys of California
Oppose: California Hospital Association (unless amended, previous version)
Infectious Disease Association of California (unless amended, previous version)
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Discussed in Hearing
1MIN
Senate Floor
48MIN
Senate Standing Committee on Appropriations
7MIN
Senate Standing Committee on Health
Bill Author
Bill Co-Author(s):
