California Senate Bill SB594 Amended / Bill

 BILL NUMBER: SB 594AMENDED BILL TEXT AMENDED IN SENATE APRIL 28, 2011 INTRODUCED BY Senator Wolk FEBRUARY 17, 2011 An act to amend Sections 101150 and 101160 of, and to add Sections 101161 and 101162 to, the Health and Safety Code, relating to public health. LEGISLATIVE COUNSEL'S DIGEST SB 594, as amended, Wolk. Local public health laboratories. Existing law establishes the State Department of Public Health and sets forth its powers and duties relating to the prevention and control of disease  ,  including, but not limited to  ,  the duty to approve local public health laboratories. This bill would recast those provisions to specify the duties of the local public health laboratories, to require the department to develop and administer written examinations for the certificate of public health microbiologist for public health laboratories, to require the department to adopt regulations related to certification and approval of training programs and continuing education requirements, and to define related terms. The bill would preclude the assessment of related fees for certificates or continuing education. By requiring that local agencies comply with these requirements, this bill would impose a state-mandated local program. The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement. This bill would provide that, if the Commission on State Mandates determines that the bill contains costs mandated by the state, reimbursement for those costs shall be made pursuant to these statutory provisions. Vote: majority. Appropriation: no. Fiscal committee: yes. State-mandated local program: yes. THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS: SECTION 1. Section 101150 of the Health and Safety Code is amended to read: 101150. (a) For the purpose of protecting the community and the public health, the local health department of a city or county shall have available the services of a city or county public health laboratory for the examination of specimens from suspected cases of infectious and environmental diseases, that may include, but need not be limited to, the examination of specimens from milk, milk products, waters, food products, vectors, and the environment. (b) The public health laboratory shall provide laboratory services necessary for the  various   examination of specimens from suspected cases of infectious and environmental diseases to support the communicable disease and environmental health  programs of the local health department.  The public health laboratory may support other programs of the local health department or other departments.  The public health laboratory shall also provide the analyses required to assist in community disease surveillance and to meet the responsibilities and support the programs of the local health department. (c) In matters concerning the public's health, the public health laboratory director shall be responsible to the local health officer whose duty it is to enforce the law in accordance with Section 101030, 101375, 101460, or 101470.  This   subdivision does not preclude the local health department from requiring the public health laboratory director to be administratively responsible to other local health department personnel.  (d) The public health laboratory shall provide consultation and reference services to further the development of improved laboratory procedures and practices related to the identification, prevention, control, and surveillance of human disease in the community. (e)  A local health officer   After consulting with the health officer and the public health laboratory director, a local health department  may contract with any official city or county public health laboratory or with the laboratories of the State Department of Public Health to provide the services required by this chapter. (f) The laboratories of the State Department of Public Health are hereby designated as the public health laboratory for all local health department jurisdictions that do not otherwise have access to local public health laboratory service. SEC. 2. Section 101160 of the Health and Safety Code is amended to read: 101160. (a) Any city or county public health laboratory established for the purposes set forth in this chapter and its personnel shall be approved by the State Department of Public Health and shall comply with the requirements of CLIA. (b) For purposes of this article, the following terms have the following meanings: (1) "CLIA" means the federal Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. Sec. 263a;  P.L.   Public Law  100-578) and the regulations adopted thereunder by the federal Health Care Financing Administration and effective on January 1, 1994, or any later date, when adopted in California pursuant to subdivision (b) of Section 1208 of the Business and Professions Code. (2) "Approved"  or "approval"  means certified by the State Department of Public Health to be in compliance with state and federal  statutory or  regulatory requirements pertaining to municipal and county public health laboratories and public health laboratory personnel. (3) "Certificate" means a certificate of approval issued by the State Department of Public Health to a city or county facility or an individual after the department's determination that the city or county facility personnel, or training program qualifications, are in conformity with the requirements of this article. (4) "Public health laboratory" means a laboratory that is operated by a city or county  , or pursuant to a joint exercise of powers agreement entered into pursuant to the Joint Exercise of Powers Act (Chapter 5 (commencing with Section 6500) of Division 7 of Title 1 of the Government Code),  in conformity with this article. (5) "Public health laboratory director" means a person who meets the CLIA requirements for laboratory director and who is authorized to direct a public health laboratory certified under this article. (6) "Public health microbiologist" means a person who meets the CLIA requirements for testing personnel  in a high complexity laboratory  and who is authorized to perform  high complexity tests limited to the specialties of microbiology and diagnostic immunology and waived and moderate complexity tests in any specialty or subspecialty   laboratory tests or analyses  pursuant to a certificate issued under this article. (7) "Public health microbiologist-trainee" means a person meeting the academic qualifications and approved by the State Department of Public Health to train in an approved public health laboratory leading to examination and certification as a public health microbiologist under this article.  (8) "Specialty" means histocompatibility, microbiology, diagnostic immunology, chemistry, hematology, immunohematology, pathology, genetics, or other specialty or subspecialty specified by regulation adopted by the State Department of Public Health.   (9) "Subspecialty" means any of the following:   (A) For purposes of microbiology, it means bacteriology, mycobacteriology, mycology, parasitology, virology, molecular biology, and serology for diagnosis of infectious diseases, or other subspecialty specified by regulation adopted by the State Department of Public Health.   (B) For purposes of diagnostic immunology, it means syphilis serology, general immunology, or other subspecialty specified by regulation adopted by the State Department of Public Health.   (C) For purposes of chemistry, it means routine chemistry, clinical microscopy, endocrinology, toxicology, or other subspecialty specified by regulation adopted by the State Department of Public Health.   (D) For purposes of immunohematology, it means ABO / Rh Type and Group, antibody detection for transfusion, antibody detection nontransfusion, antibody identification, compatibility, or other subspecialty specified by regulation adopted by the State Department of Public Health.   (E) For purposes of pathology, it means tissue pathology, oral pathology, diagnostic cytology, or other subspecialty specified by regulation adopted by the State Department of Public Health.   (F) For purposes of genetics, it means molecular biology related to the diagnosis of human genetic abnormalities, cytogenetics, or other subspecialty specified by regulation adopted by the State Department of Public Health.  SEC. 3. Section 101161 is added to the Health and Safety Code, to read: 101161. The State Department of Public Health shall develop and administer the written examinations for the certificate of public health microbiologist for public health laboratories. The examination shall be developed in consultation with the California Association of Public Health Laboratory Directors. The examination shall be held as needed and where designated by the State Department of Public Health. There shall be no fee levied upon individuals for the examinations. SEC. 4. Section 101162 is added to the Health and Safety Code, to read: 101162. (a) The State Department of Public Health, by January 1, 2013, shall adopt regulations, in consultation with the California Association of Public Health Laboratory Directors, to do all of the following: (1) Establish minimum requirements for training laboratories that train public health microbiologist-trainees, and require that training laboratories that accept those personnel for the purposes of this article be approved and certified by the State Department of Public Health. (2) Initiate, administer, and monitor a program of continuing education for public health microbiologists certified pursuant to this article. (3) Require a maximum of 12 hours of continuing education completed within a 12-month period, or 24 hours of continuing education completed within a 24-month period, as a condition for renewal of a certificate issued under this article. (b) Fees shall not be levied upon county or municipal public health laboratories or public health laboratory personnel for approval or renewal of any certificates or maintaining the continuing education program pursuant to this article. SEC. 5. If the Commission on State Mandates determines that this act contains costs mandated by the state, reimbursement to local agencies and school districts for those costs shall be made pursuant to Part 7 (commencing with Section 17500) of Division 4 of Title 2 of the Government Code.