BILL ANALYSIS Ó ------------------------------------------------------------ |SENATE RULES COMMITTEE | SB 594| |Office of Senate Floor Analyses | | |1020 N Street, Suite 524 | | |(916) 651-1520 Fax: (916) | | |327-4478 | | ------------------------------------------------------------ THIRD READING Bill No: SB 594 Author: Wolk (D) Amended: 5/11/11 Vote: 21 SENATE HEALTH COMMITTEE : 6-3, 05/04/11 AYES: Hernandez, Alquist, De León, DeSaulnier, Rubio, Wolk NOES: Strickland, Anderson, Blakeslee SENATE APPROPRIATIONS COMMITTEE : 6-3, 05/23/11 AYES: Kehoe, Alquist, Lieu, Pavley, Price, Steinberg NOES: Walters, Emmerson, Runner SUBJECT : Local public health laboratories SOURCE : California Association of Public Health Laboratory Directors DIGEST : This bill requires the California Department of Public Health (CDPH) to promulgate regulations by January 1, 2013, that establishes minimum requirements for laboratories that train public health microbiologist-trainees, approve of and monitor a program of continuing education for public health microbiologists, and to require continuing education for public health microbiologists as a condition for renewal of a certificate issued by CDPH. The bill also requires CDPH to develop an examination in consultation with California Association of Public Health Laboratory Directors, make minor changes to laws related to the relationship between local health CONTINUED SB 594 Page 2 departments and public health laboratories and would codify various definitions existing in regulation related to public health laboratory staff. ANALYSIS : Existing federal law: Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), establishes various conditions that laboratories must meet in order to be certified to perform testing on human specimens. Laboratory standards established under CLIA include standards for proficiency testing, facility administration, personnel qualifications, and quality control. Existing federal regulations: Establish qualifications for directors of labs performing high complexity tests that include being licensed as a laboratory director and either licensed to practice medicine, hold a doctoral degree in specified fields, or be serving on or before February, 1992 as a lab director and meet qualifications for lab directors that existed in 1990. Existing state law: 1.Requires the local health department to have available the services of a public health laboratory (PHL) to examine specimens from suspected cases of infectious and environmental diseases and to assist in community disease surveillance. 2.Requires any city or county PHL and its personnel to be approved by CDPH and comply with CLIA. 3.Defines a "clinical laboratory" as any establishment or institution operated for the performance of clinical laboratory tests or examinations, or the practical application of clinical laboratory sciences. Requires a clinical laboratory that performs tests that are of moderate or high complexity to be licensed by CDPH. Existing state regulations: CONTINUED SB 594 Page 3 1.Require certificates of approval received from CDPH after inspection to be on display in every PHL. Prohibit a laboratory from operating without a certificate from CDPH. 2.Designate the laboratory of CDPH as the PHL for all local health jurisdictions that are not covered by local PHL service. 3.Allow written or oral, or both written and oral, examinations for the certificate of PHM to be held as needed and where designated by CDPH, under CDPH's supervision. 4.Describe PHM-trainee as a person receiving professional training required for certification as a PHM. 5.State that CDPH will establish minimum requirements for laboratories that train PHM-trainees and laboratories which accept personnel for training, must be specifically approved to provide training by CDPH. 6.Allow a health officer of a municipality or county to designate any laboratory as an official PHL to perform any of the basic services as defined in regulation, subject to the same requirements as an official public lab. Basic services include those deemed necessary for the various programs of the health department, and consultation and reference services to further the development of improved procedures and practices. This bill: 1.Requires the public health laboratory director to be responsible to the appropriate local health officer; 2.Permits a local health department, after consulting with the local health officer, to contract with any official city or county public health laboratory or with the laboratories of CDPH to provide services; 3.Designates the laboratories of CDPH as the public health laboratory for all local health department jurisdictions that do not otherwise have access to local public health CONTINUED SB 594 Page 4 laboratory service; 4.Requires any city or county public health laboratory to be certified by CDPH and to comply with specified California regulations; 5.Codifies the definitions of "public health laboratory director," "public health microbiologist," and "public health microbiologist-trainee"; 6.Requires the examination for public health microbiologists to be developed by CDPH in consultation with the California Association of Public Health Laboratory Directors; 7.Requires CDPH to adopt regulations by January 1, 2013, to establish minimum requirements for laboratories that train public health microbiologist-trainees, would require CDPH to approve of and monitor a program of continuing education for public health microbiologists, and would require continuing education for public health microbiologists. This bill codifies a requirement in regulation for CDPH to establish minimum requirements for laboratories that train public health microbiologist-trainees that has been in existence since the 1970s. It is unclear whether or not CDPH has developed such minimum requirements. The costs to CDPH to promulgate regulations to set minimum requirements and to approve and monitor a program of continuing education would be approximately $180,000 from the Clinical Laboratory Improvement Fund. Background There are currently 38 PHLs in California that are administered locally by city or county public health departments. Local PHLs provide services relating to the examination of specimens from suspected cases of infectious and environmental diseases, including specimens from humans, milk, water, food, vectors, and the environment. These labs also screen newborns for various genetic and congenital disorders; watch for disease-producing agents in food, humans, and animals; and test for new threats like CONTINUED SB 594 Page 5 West Nile virus, Severe Acute Respiratory Syndrome (SARS), avian influenza, and bioterrorism. While public health laboratories may conduct patient diagnostic testing, they differ from clinical laboratories in that the scope of their work, including their patient diagnostic testing, revolves around the prevention and control of communicable disease, community surveillance of infectious or communicable disease, and promoting and maintaining public health. Local PHLs are approved by CDPH, meaning that they are certified to meet state and federal law and regulations. All of the laboratories meet CLIA standards for conducting high-complexity lab tests. CDPH also certifies PHMs and PHL directors to ensure that they meet all educational and training requirements required by state regulations. Existing state regulations set forth specific requirements and standards that PHLs must meet, including requirements pertaining to personnel, reporting, and safety procedures and precautions. FISCAL EFFECT : Appropriation: No Fiscal Com.: Yes Local: Yes According to the Senate Appropriations Committee: Major Provisions 2011-12 2012-13 2013-14 Fund CDPH start-up costs $15 $180 $0 Special* and regulations * Clinical Laboratory Improvement Fund SUPPORT : (Verified 5/24/11) California Association of Public Health Laboratory Directors (source) Napa-Solano County Public Health Laboratory Mosquito and Vector Control Association of California OPPOSITION : (Verified 5/24/11) California Association for Medical Laboratory Technology California State Association of Counties CONTINUED SB 594 Page 6 City and County of San Francisco County Health Executives Association of California County of Nevada County of San Bernardino County of Santa Clara Board of Supervisors Los Angeles County Board of Supervisors Orange County Board of Supervisors Placer County Board of Supervisors Regional Council of Rural Counties San Joaquin County Board of Supervisors Urban Counties Caucus Ventura County Board of Supervisors ARGUMENTS IN SUPPORT : CAPHLD is sponsoring this bill to ensure quality PHL services are sufficiently available statewide to protect local communities from communicable disease threats like H1N1, tuberculosis, HIV, SARS and foodborne and waterborne outbreaks, and to respond to emergencies and security threats like biological and chemical terrorist attacks, like the anthrax scares following the September 11 attacks. CAPHLD mentions incidences when PHL directors have had to carry out medically-oriented duties that CAPHLD claims were not in accord with public health, based on instructions from non-medical government personnel. CAPHLD also believes that due to the technical nature of a public health microbiologist's duties and its importance to the protection of the public, certification tests should be developed with sufficient stakeholder input, which CAPHLD can provide. ARGUMENTS IN OPPOSITION : The County Health Executives Association of California (CHEAC) is opposed to SB 594 because they believe the bill would limit county flexibility in how PHL services could be provided. They are particularly concerned about the provisions of the bill that require a local health department's designated PHL to be operated by a city or county and would dictate the types of laboratory services that must be performed only by a county or city's designated PHL. CHEAC has asked for specific amendments to remove several provisions of the bill. The California Association for Medical Laboratory CONTINUED SB 594 Page 7 Technology (CAMLT) acknowledges that areas of practice and responsibility of the certified PHM may be significantly different in some areas from Limited License Microbiologist /Clinical Laboratory Scientist (LLM/CLS). CAMLT says that the two professions share in their analysis of human specimens and that CLS/LLM must successfully complete a year-long post baccalaureate program and pass a state licensing exam for the exact breadth and scope of function for human testing. CAMLT claims that SB 594 allows PHMs to do many of the same tasks that LLM/CLS can do, but with only six months of training. This six-month program would not only include human specimen testing, but also cover all the other functions that the PHM is required to perform: testing on milk, dairy products, air, water, sewage, animals, insects and other vector sources. CAMLT believes that if PHMs are to perform the exact same function as the CLS with regard to human testing, then education and training should be equivalent. CTW:nl 5/25/11 Senate Floor Analyses SUPPORT/OPPOSITION: SEE ABOVE **** END **** CONTINUED