BILL ANALYSIS Ó
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|Hearing Date:June 11, 2012 |Bill No:AB |
| |761 |
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SENATE COMMITTEE ON BUSINESS, PROFESSIONS
AND ECONOMIC DEVELOPMENT
Senator Curren D. Price, Jr., Chair
Bill No: AB 761 Author: Roger Hernandez
As Amended: June 4, 2012 Fiscal: Yes
SUBJECT: Optometrists.
SUMMARY: Provides that a laboratory director may include a licensed
optometrist and authorizes an optometrist to perform certain clinical
laboratory tests or examinations classified as waived under the
Clinical Laboratory Improvement Act (CLIA).
Existing law:
1) Provides for the licensure and regulation of optometrists by the
Board of Optometry (Board). (BPC § 3010)
2) Requires certification by the Board for a licensed optometrist to
use therapeutic pharmaceutical agents. (BPC § 3041.3)
3) Authorizes a licensed optometrist certified to use therapeutic
pharmaceutical agents to diagnose and treat specific conditions.
(BPC § 3041(a)(5); § 3041(b)(2)(c) et seq)
4) Provides for the licensure and regulation of clinical laboratories
and personnel by the California Department of Public Health (DPH).
(Division 2, Chapter 3, Articles 4-7, Section 1260 et seq. of the
Business and Professions Code (BPC); California Code of Regulations
(CCR) Title 17, Division 1, Chapter 2. Often referred to as the
"CLIA Law.")
5) Prohibits the performance of a clinical laboratory test or
examination classified as waived under the federal CLIA of 1988
unless the test or examination is performed under the overall
operation and administration of a laboratory director, as defined,
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and is performed by specified persons, including certain health
care personnel.
This bill:
1. Expands the category of persons who may perform CLIA waived tests
to include licensed optometrists if the results of the tests can be
lawfully utilized within their practice.
2. Provides that a laboratory director may include a licensed
optometrist serving as the director of a laboratory which only
performs specified CLIA waived tests including the Rapid Pathogen
Screening (RPS) Adeno Detector and Tear Osmolarity Test (TOT).
3. Authorizes a licensed optometrist certified to use therapeutic
pharmaceutical agents to additionally perform specified CLIA waived
tests and examinations that are necessary for the diagnosis of
conditions and diseases of the eye or ocular adnexa defined as the
adjacent structures of the eye including the extraocular muscles
and the eyelids, eyelashes, eyebrows and the conjunctiva.
FISCAL EFFECT: According to the Assembly Appropriation Committee
analysis dated January 19, 2012, this bill results in additional
fee-supported workload at the Department of Public Health in the range
of $150,000 annually.
COMMENTS:
1. Purpose. The California Optometric Association is the sponsor of
the bill. According to the Author, optometrist may order
diagnostic tests from a lab. The problem is that the patient and
doctor must wait for the test results, which can unnecessarily
delay appropriate diagnosis and treatment. Additionally, the
patient is often inconvenienced by having to go to a separate
location to get a test done that can be sold over the counter.
2. Background. Federal Clinical Laboratory Improvement Amendments of
1988 (CLIA). CLIA law specified that laboratory requirements be
based on the complexity of the test performed. It also established
provisions for categorizing a test as waived. Tests may be waived
from regulatory oversight if they meet certain requirements
established by the statute. On February 28, 1992, regulations were
published to implement CLIA.
Federal Definition of CLIA Waived Tests. According to Federal
Regulation 493.15, CLIA-waived tests are test systems that are
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simple laboratory examinations and procedures which are cleared by
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.
California Clinical Laboratory Personnel Requirements. All persons
performing, supervising, consulting on, or directing clinical
laboratory tests or examinations in California must meet the
requirements outlined in the Business and Professions Code
irrespective of whether the clinical laboratory is operated under a
CLIA certificate or under a state license or registration. (CCR
Title 17 § 1039.2 (a))
Currently, optometrists are certified 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 epinephrine auto-injector to counteract
anaphylactic reaction.
Center for Medicaid Services (CMS). 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 would allow optometrists to administer tests of simple
complexity including the RPS Adeno Detector and TOT.
RPS Adeno Detector. The RPS Adeno Detector quickly detects the
presence of adenovirus in the tear fluid. Adenoviral
conjunctivitis, such as "pink eye," represents the most common
external ocular infection. This in-office test allows for the
rapid detection of Adenoviral antigens directly from human eye
fluid on the lower conjunctiva. RPS Adeno Detector kits do not
require additional equipment to administer or interpret. Results
are achieved in
10 minutes allowing the optometrist to provide a diagnosis and
implement a treatment plan before patients leave the office.
TOT. Dry eye disease is a common condition in which the eye does
not produce enough tears to keep the surface of the eye
sufficiently lubricated. The TOT, produced by TearLab Corporation,
requires less than 50 nanoliters of tear fluid in order to measure
tear osmolarity or fluid of the eye. The TOT can produce a sample
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and test result in less than 30 seconds.
3. Current Related Legislation. SB 1481 (Negrete McLeod, 2012).
Exempts a community pharmacy, which solely provides CLIA-waived
tests, from the clinical laboratory regulations requiring that the
pharmacy hire a laboratory director who is a licensed physician.
Requires that the CLIA-waived test be administered by a pharmacist
in the course of performing routine patient assessment procedures.
Requires the pharmacy to obtain a Certificate of Waiver from the
DPH and comply with all CLIA requirements. Exempts a pharmacist
from state laboratory licensing requirements if the pharmacist only
performs CLIA-waived tests. This measure is currently awaiting a
hearing in Assembly Business, Professions and Consumer Protection
Committee.
4. Prior Related Legislation. SB 1246 (Negrete McLeod, Chapter 523,
Statutes of 2010) expanded the category of persons who may perform
clinical laboratory tests or examinations that are classified as
waived to include licensed naturopathic doctors if the results of
the tests can be lawfully utilized within their practice, and
expanded the definition of laboratory director to include
naturopathic doctors, as specified, for purposes of waived
examinations.
SB 1174 (Polanco, Chapter 640, Statutes of 2001) exempted those
certified emergency medical technicians and licensed paramedics,
providing basic life support services or advanced life support
services, who perform only blood glucose tests that are classified
as waived clinical laboratory tests under the federal CLIA of
1988, from the laws regulating clinical laboratories. Required the
provider of those services to obtain a valid Certificate of Waiver
and comply with all other requirements for the performance of
waived clinical laboratory tests under applicable federal
regulations.
SB 585 (Chesbro, Chapter 70, Statutes of 1999) permitted a
certified nurse midwife, a licensed nurse practitioner, a licensed
physician assistant acting under the supervision of a licensed
physician, or a licensed dentist to perform clinical laboratory
examinations classified as provider-performed microscopy under the
federal CLIA of 1988.
SB 366 (Maddy, Chapter 1141, Statutes of 1994) extended the
exemption from state clinical laboratory laws to facilities owned
and operated by a partnership or professional corporation of five
or fewer physicians and surgeons or podiatrists. The exemption
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applies only if the clinical laboratory tests or examinations are
performed for the patients of the physician, podiatrist,
partnership or professional corporation. This law repealed the
exemption upon U.S. Department of Health and Human Services
recognition of California's conformity with the requirements of
federal CLIA of 1988.
5. Arguments in Support. The Sponsor asserts that the bill will allow
optometrists to provide better care to their patients. Currently,
patient safety is compromised because optometrists cannot legally
perform these 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.
The American Federation of State, County and Municipal Employees
and the United Nurses Associations of California/Union of Health
Care Professionals also support the bill stating that the current
practice of sending tests to a laboratory unnecessarily delays
appropriate diagnosis and treatment.
The California Board of Optometry notes that optometrists can
already perform waived tests in a lab under the supervision of a
laboratory director. This bill will improve patient care and
public health by allowing optometrists to perform tests
independently.
TearLab Corporation indicates that the bill will have a direct
impact on the optometrists and their patients who depend on their
product to diagnose and manage dry eye disease. Specifically, the
measurement of tear fluid osmolarity for the diagnosis of dry eye
disease has been well vetted in peer reviewed clinical studies for
over 30 years. They also indicate that the TOT can only be
performed at the doctor's office, as tear fluid is a fragile sample
with insufficient volume to allow for collection and transfer to a
reference laboratory for analysis.
SUPPORT AND OPPOSITION:
Support:
California Optometric Association (Sponsor)
American Federation of State, County and Municipal Employees
California Board of Optometry
TearLab Corporation
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United Nurses Associations of California/Union of Health Care
Professionals
Opposition:
None received as of June 4, 2012.
Consultant:Le Ondra Clark