BILL ANALYSIS Ó AB 761 Page 1 Date of Hearing: January 10, 2012 ASSEMBLY COMMITTEE ON BUSINESS, PROFESSIONS AND CONSUMER PROTECTION Mary Hayashi, Chair AB 761 (Roger Hernandez) - As Amended: January 4, 2012 SUBJECT : Optometrists SUMMARY : Allows optometrists to independently perform waived clinical laboratory tests necessary for the diagnosis of conditions and diseases of the eye. Specifically, this bill : 1)Adds licensed optometrists to the list of persons who are authorized under current law to perform a clinical laboratory test or examination classified as waived under the federal Clinical Laboratory Improvement Amendments (CLIA) of 1988. 2)Includes licensed optometrists in the definition of "laboratory director" for purposes of a clinical laboratory test or examination classified as waived. 3)Allows optometrists who are certified to use therapeutic pharmaceutical agents (TPAs) to perform a clinical laboratory test or examination classified as waived under CLIA necessary for the diagnosis of conditions and diseases of the eye or adnexa, or if otherwise specifically authorized by the Optometry Practice Act. EXISTING LAW 1)Establishes CLIA under federal law, which regulates clinical laboratories that perform tests on human specimens and sets standards for facility administration, personnel qualifications and quality control. These standards apply to all settings, including commercial, hospital or physician office laboratories. 2)Defines CLIA waived tests as simple laboratory examinations and procedures that are approved by the Food and Drug Administration (FDA) for home use, employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible, or pose no reasonable risk of harm to the patient if the test is performed incorrectly. AB 761 Page 2 3)Provides for the licensure and regulation of clinical laboratories and their personnel by the State Department of Health Services (now the Department of Public Health (DPH)), and requires clinical laboratories to be operated under the supervision of a laboratory director, as specified. 4)Defines "laboratory director" to mean any person who is a duly licensed physician and surgeon, or, only for purposes of a clinical laboratory test or examination classified as waived, is a duly licensed naturopathic doctor, or is licensed to direct a clinical laboratory and who substantially meets the laboratory director qualifications under CLIA for the type and complexity of tests being offered by the laboratory. 5)Prohibits anyone from performing a clinical laboratory test or examination classified as waived under CLIA unless the clinical laboratory test or examination is performed under the overall operation and administration of the laboratory director and the test is performed by specified health care practitioners for specified purposes. 6)Establishes the Optometry Practice Act, administered by the State Board of Optometry (Board), to regulate the practice of optometry. 7)Defines the practice of optometry to include the prevention and diagnosis of disorders and dysfunctions of the visual system, and the treatment and management of certain disorders and dysfunctions of the visual system, as well as the provision of rehabilitative optometric services. 8)Requires optometrists to apply for a certificate from the Board and meet specified requirements in order to be certified to use TPAs and authorized to treat specified conditions. FISCAL EFFECT : Unknown COMMENTS : Purpose of this bill . According to the author, "State law prohibits the performance of a clinical laboratory test or examination classified as waived under the federal CLIA law unless the test or examination is performed under the overall operation and administration of a AB 761 Page 3 laboratory director...Optometrists are not considered or classified as a laboratory director, therefore cannot administer these simple CLIA waived tests related to the eye. "AB 761 will allow optometrists to administer simple CLIA waived tests that are already within their scope of their practice. This legislation will designate optometrists as lab directors for CLIA waived tests only and not for other more complex types of testing?This will not expand the type or the number of tests that would be considered CLIA waved." Background . California clinical laboratories are subject to both federal and state oversight. Federal oversight falls under CLIA, which is administered by the Centers for Medicare and Medicaid Services (CMS) within the U.S. Department of Health and Human Services. CLIA regulates clinical labs based on the complexity of tests the lab offers. "Waived" tests are approved by FDA for home use, use simple and accurate methods that make the possibility of error negligible, or pose no significant risk of harm to the patient if incorrectly performed. Clinical labs performing only "waived" tests must register with the CLIA program, pay biennial certificate fees, allow inspections, and perform tests according to manufacturers' instructions. "Moderate" or "high" tests, which are more complex, may be performed by clinical labs that pay higher fees, undergo biennial inspections, and meet tougher standards for personnel, supervision, quality assurance and proficiency testing. State oversight of clinical labs is administered by DPH, which regulates about 19,000 clinical labs and their personnel statewide, monitors proficiency testing, investigates complaints, and sanctions labs that violate the law or regulations. In conformance with CLIA, DPH licenses or registers clinical labs according to the complexity of testing they perform. Labs must be licensed for moderately or highly complex procedures, and registered for low complexity. About 3,000 clinical labs are licensed for moderate and/or high complexity testing. The remaining are registered labs performing waived tests and/or AB 761 Page 4 provider-performed microscopy. Waived tests can be performed under the supervision of a lab director and other specific conditions by a number of health care practitioners, including physicians, podiatrists, dentists, naturopathic doctors, physician assistants, nurses, respiratory care practitioners, and others. This bill adds licensed optometrists to this list. A lab director must be a licensed physician and surgeon or meet other licensure requirements, and is responsible for overseeing the overall operation and administration of the lab. For purposed of waived tests, a lab director can also include a licensed naturopathic doctor or a person licensed to direct a clinical laboratory and who substantially meets the laboratory director qualifications under CLIA for the type and complexity of tests being offered by the laboratory. This bill includes optometrists in this definition, thereby allowing optometrists to independently perform waived tests without supervision by a separate lab director. The CMS issued a memo in September of 2006 to provide clarification regarding optometrists serving as laboratory directors of moderate complexity testing under CLIA. The memo states, "The Doctor of Optometry (OD) degree is suitable to meet the personnel qualifications for laboratory director of moderate complexity testing provided the testing is limited to tests related to the medical specialty of optometry." This bill allows optometrists to serve as a lab director for waived tests, which are simpler than the moderate complexity testing that the CMS memo allows. Many states, including California, require additional certification for optometrists who wish to administer, prescribe, and dispense medications or "TPAs." In California, this certification requires additional education, examination and experience. Current law allows optometrists who are certified to use TPAs to perform a number of procedures, such as blood draws for patients suspected of having diabetes, suture removal with prior approval of the treating physician, and use of an auto-injector to counter allergic reaction. This bill allows optometrists who are certified to use TPAs to also perform waived tests or AB 761 Page 5 examinations that are necessary for the diagnosis of conditions and diseases of the eye or its appendages. Support . The California Optometric Association states, "Currently, patient safety is compromised because optometrists cannot legally perform (CLIA waived) tests during an office visit. For example, the RPS Adeno Detector can diagnose viral conjunctivitis while the patient is still in the office, which allows the doctor to make an accurate diagnosis and limit spread of disease while simultaneously reducing ocular antibiotic resistance. This legislation would designate optometrists as lab directors for CLIA waived tests only (not for more complex tests). Specifically, it adds optometrists to the category of lab directors that currently includes medical doctors, osteopaths and naturopaths. The bill does not expand the type or number of tests that would be considered waived." Opposition . The California Association for Medical Laboratory Technology (CAMLT) states, "CAMLT recognizes the ability of optometrists to perform certain waived tests limited to their scope of practice pertaining to the eye, but had concerns about the broad range of testing that the bill's sponsors have indicated interest in, such blood and urine tests or those relating to conditions, such as diabetes and infections, not treatable by optometrists. CAMLT?feels that a technical, clarifying amendment?is still in order. "As previously stated, of greater concern is whether or not optometrists receive the proper education and training to perform as a laboratory director and those attendant functions outlined in Section 1209 of the Business and Professions Code. A review of Section 1209, designed to protect patient health and safety, clearly defines and outlines the many duties and significant responsibilities required to direct a clinical laboratory in California." Previous legislation . SB 1246 (Negrete McLeod), Chapter 523, Statutes of 2010 includes naturopathic doctors in the list of health care practitioners who can perform a clinical laboratory test or examination classified as waived under CLIA, and designates naturopathic doctors as clinical laboratory directors for CLIA waived tests only. AB 761 Page 6 AB 1442 (Feuer) of 2007 requires clinical laboratories that perform tests to screen for human immunodeficiency virus (HIV) that are classified as waived under CLIA to enroll in a proficiency testing program and to obtain the appropriate license or registration from DPH, as specified. This bill was held on the Assembly Floor. AB 185 (Dymally) of 2007 expands the duties that unlicensed personnel are authorized to perform in a clinical laboratory and revises the levels of supervision required when unlicensed personnel perform them. This bill was held in Assembly Business and Professions Committee. AB 1370 (Matthews) of 2005 includes a pharmacist within the definition of laboratory director if the clinical laboratory test or examination is a routine patient assessment procedure, as defined. This bill was held in Assembly Business and Professions Committee. AB 433 (Nava) of 2005 exempts physician office laboratories from licensure and regulatory requirements governing clinical laboratories and their personnel by the Department of Health Services. This bill was held in Assembly Health Committee. Double referred . This bill is double-referred to Assembly Health Committee. REGISTERED SUPPORT / OPPOSITION : Support California Optometric Association (sponsor) California Academy of Eye Physicians and Surgeons California State Board of Optometry Opposition California Clinical Laboratory Association (CCLA) California Association for Medical Laboratory Technology Analysis Prepared by : Angela Mapp / B.,P. & C.P. / (916) 319-3301 AB 761 Page 7