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SB-43 Antimicrobial-resistant infection: reporting.(2017-2018)

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Date Published: 04/06/2017 04:00 AM
SB43:v96#DOCUMENT

Amended  IN  Senate  April 05, 2017
Amended  IN  Senate  January 31, 2017
Amended  IN  Senate  January 12, 2017

CALIFORNIA LEGISLATURE— 2017–2018 REGULAR SESSION

Senate Bill No. 43


Introduced by Senator Hill
(Coauthors: Senators Allen, Dodd, and Skinner)
(Coauthors: Assembly Members Cristina Garcia and Maienschein)

December 05, 2016


An act to amend Sections 102825 and 102875 of, and to add Part 5.5 (commencing with Section 121565) to Division 105 of, of the Health and Safety Code, relating to public health.


LEGISLATIVE COUNSEL'S DIGEST


SB 43, as amended, Hill. Antimicrobial-resistant infection: reporting.

(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 decedent’s 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

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.

Vote: MAJORITY   Appropriation: NO   Fiscal Committee: YES   Local Program: YESNO  

The people of the State of California do enact as follows:


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 patient’s 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 surgeon’s 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 decedent’s sex to reflect the decedent’s gender identity. The decedent’s gender identity shall be reported by the informant, unless the person completing the certificate is presented with a birth certificate, a driver’s 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 decedent’s sex as that which corresponds to the decedent’s 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:

PART 5.5. ANTIMICROBIAL-RESISTANT INFECTION

121565.
 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 XIII B 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 XIII B of the California Constitution.