BILL ANALYSIS Ó
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|Hearing Date:April 9, 2012 |Bill No:SB |
| |1481 |
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SENATE COMMITTEE ON BUSINESS, PROFESSIONS
AND ECONOMIC DEVELOPMENT
Senator Curren D. Price, Jr., Chair
Bill No: SB 1481Author:Negrete McLeod
As Introduced: February 24, 2012 Fiscal: Yes
SUBJECT: Clinical laboratories: community pharmacies.
SUMMARY: Allows pharmacists to perform specific Clinical Laboratory
Improvement Amendments (CLIA) waived tests without the supervision of
a laboratory director.
Existing California Law:
1) 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.")
2) The Pharmacy Law provides for the licensure and regulation of
pharmacists by the California Board of Pharmacy. (BPC § 4000)
3) Authorizes a pharmacist to perform skin puncture in the course of
performing CLIA-waived tests while under the supervision of a
laboratory director who is a licensed physician.
(BPC § 1206.5, 1209)
4) Classifies licensed laboratories as those that perform examinations
classified as moderate to high complexity under CLIA and classified
registered laboratories as those that perform only CLIA-waived
tests. (BPC § 1265(a)(1))
5) Requires all laboratories to include on the application for
licensure or registration, the name and location of the laboratory,
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the name of the laboratory director(s), a list of the laboratory
tests performed by the laboratory, and the total number of tests
performed annually.
(BPC § 1265(b))
Existing Federal Law:
1)Governs the surveys and inspections of non-accredited clinical
laboratories. (Federal Social Security Act § 1864 and Federal
Regulations (FR) Title 42 commencing with Section 493.1)
2)Governs municipal and county laboratories and their compliance with
CLIA. (California Health and Safety Code Division 101, Part 3,
Chapter 2, Article 5 § 101160 - 101165)
This bill:
1) 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.
2) Requires that the CLIA-waived test be administered by a pharmacist
in the course of performing routine patient assessment procedures.
3) Requires the pharmacy to obtain a Certificate of Waiver from the
DPH and comply with all CLIA requirements.
4) Exempts a pharmacist from state laboratory licensing requirements
if the pharmacist only performs CLIA-waived tests.
FISCAL EFFECT: Unknown. This bill has been keyed "fiscal" by
Legislative Counsel.
COMMENTS:
1. Purpose. This bill is sponsored by the California Pharmacists
Association (Sponsor) . The Author indicates that the intention of
SB 1481 is to remove burdensome state government regulations in
order to allow pharmacists to perform CLIA-waived tests, including
glucose meters, cholesterol tests and dip stick style tests to
monitor diabetes or kidney function. These tests are approved by
the federal Food and Drug Administration for sale to the public
without a prescription in the form of an over-the-counter kit.
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Under state regulations, facilities are required to hire a
laboratory director, who is a licensed physician, to oversee the
administration of these tests. However, under federal regulations,
facilities that only perform CLIA-waived tests are not required to
have a laboratory director who is a licensed physician.
According to the Author, securing a lab director is an expensive
task that precludes many pharmacies from being able to register
with the DPH. Furthermore, the Author states that this legislation
would allow pharmacists to utilize over-the-counter tests, thereby
allowing pharmacists to make appropriate adjustments to medication
therapy in order to improve adherence and overall treatment. The
Author also states that this legislation would result in both
insured and uninsured patients having easier access to safe, simple
and economic tests.
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
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.
Federal Oversight of the CLIA Program. Center for Medicare and
Medicaid Services (CMS) regulates all laboratory testing (except
research) performed on humans in the U.S. through the CLIA. In
total, CLIA covers approximately 175,000 laboratory entities. The
Division of Laboratory Services, within the Survey and
Certification Group, under the CMS has the responsibility for
implementing the CLIA Program.
Federal Certificate of Waiver. Under federal CLIA law, a
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"Certificate of Waiver" is defined as a certificate issued or
reissued to a laboratory. The primary obligation of the holder of
a Certificate of Waiver is to ensure that the manufacturer's
directions for giving the test are followed. (FR 493.2(5))
A laboratory may qualify for a Certificate of Waiver if it
restricts the tests that it performs to certain tests or
examinations such as dipstick tests, ovulation tests, urine
pregnancy tests and blood glucose monitoring by FDA devices
approved for home use (Public Health Service Act § 353).
Additionally qualifications include:
a) Minimal scientific and technical knowledge is required to
perform the tests.
b) The knowledge required to perform the tests may be obtained
through on-the-job instruction.
c) The individual who administers the test must follow the
manufacturer's instructions.
(FR 493.17 1(i)(A)(B))
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))
Additionally, California law authorizes pharmacists to perform
CLIA-waived tests under the supervision of a laboratory director
who is a licensed physician. (BPC § 4052.1)
California Oversight of the CLIA Program. The California
Laboratory Field Services (LFS) ensures compliance with state and
federal clinical laboratory laws and regulations by performing
biannual onsite inspections of laboratories to ensure accuracy and
reliability of laboratory test results. LFS performs routine
inspections of over 800 laboratories each year. The program is
also responsible for inspection of over 200 laboratories with a
CLIA Certificate of Waiver.
3. Related Legislation. AB 761 (Hernandez, 2011) expands the category
of persons who may perform clinical laboratory tests or
examinations that are classified as waived to include licensed
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optometrists if the results of the tests can be lawfully utilized
within their practice, and provides that a laboratory director may
include a licensed optometrist serving as the director of a
laboratory which only performs specified clinical laboratory
testing, for purposes of waived examinations. Authorizes a
licensed optometrist certified to use therapeutic pharmaceutical
agents to additionally perform specified clinical laboratory tests
or examinations classified as waived that are necessary for the
diagnosis of conditions and diseases of the eye or adnexa, which
the bill would define to mean ocular adnexa. This measure is a
two-year bill and is currently in this Committee to be heard.
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
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
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recognition of California's conformity with the requirements of
federal CLIA of 1988.
4. Arguments in Support. Supporters of the bill, including Rite Aid
Pharmacy , indicate that in approximately 40 other states,
pharmacists are permitted to assist patients by performing
CLIA-waived tests. They state that pharmacists are often the most
accessible health care professionals in many communities.
The California Society of Health-System Pharmacists indicates that
pharmacists are trained to perform these tests during pharmacy
school.
Other supporters note that the bill would allow trained pharmacists
to administer simple tests in order to detect illnesses in
patients. Additionally, patients may have difficulty utilizing
over-the-counter tests and this bill would permit pharmacists to
assist patients in learning to use their test over-the-counter
tests appropriately.
Supporters also note that this bill is critical to lowering the
skyrocketing costs of health care which in part result from
patients not appropriately adhering to their medications.
Supporters indicate that if pharmacists are able to perform
CLIA-waived tests, they will be armed with better information in
order to help patients manage their medications.
5. Arguments in Opposition. The California Association for Medical
Laboratory Technology opposes the bill citing that by allowing
unqualified pharmacists to perform laboratory tests, it would place
these individuals outside of the state's oversight, and effectively
weaken the state's licensure standards. They also assert that
pharmacists are not medical doctors that prescribe, treat or
diagnose and lack the proper education, training and credentials
which increases the possibility of testing errors and misdiagnosis.
The California Association of Bioanalysts and the California
Clinical Laboratory Association note that having a community
pharmacist who is not trained in the clinical laboratory field will
create a false sense of security for patients who elect to have a
pharmacist conduct their test if there is an incorrect result.
The Western States Council of the United Food & Commercial Workers
and the Engineers and Scientists of California both indicate that
that they see no rationale for allowing pharmacists to not adhere
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to current law.
SUPPORT AND OPPOSITION:
Support:
California Pharmacists Association (Sponsor)
California Society of Health system Pharmacists
Rite Aid Pharmacy
2 individuals
Opposition:
California Association for Medical Laboratory Technology
California Association of Bioanalysts
California Clinical Laboratory Association
Engineers and Scientists of California
Western States Council of the United Food & Commercial Workers
Consultant:Le Ondra Clark