BILL ANALYSIS Ó
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|SENATE RULES COMMITTEE | SB 1481|
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THIRD READING
Bill No: SB 1481
Author: Negrete McLeod (D)
Amended: As introduced
Vote: 21
SENATE BUSINESS, PROF. & ECON. DEV.COMM. : 8-0, 4/9/12
AYES: Price, Emmerson, Corbett, Correa, Hernandez, Negrete
McLeod, Strickland, Wyland
NO VOTE RECORDED: Vargas
SENATE APPROPRIATIONS COMMITTEE : Senate Rule 28.8
SUBJECT : Clinical laboratories: community pharmacies
SOURCE : California Pharmacists Association
DIGEST : This bill allows pharmacists to perform specific
Clinical Laboratory Improvement Amendments (CLIA) waived
tests without the supervision of a laboratory director.
ANALYSIS :
Existing State Law:
1. Provides for the licensure and regulation of clinical
laboratories and personnel by the Department of Public
Health (DPH). (Division 2, Chapter 3, Articles 4-7,
Section 1260 et seq. of the Business and Professions
Code ÝBPC]; California Code of Regulations ÝCCR] Title
17, Division 1, Chapter 2. Often referred to as the
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"CLIA Law.")
2. The Pharmacy Law provides for the licensure and
regulation of pharmacists by the California Board of
Pharmacy. (BPC Section 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 Section 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 Section
1265(a)(1))
5. Requires all laboratories to include on the application
for licensure or registration, the name and location of
the laboratory, 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 Section 1265(b))
Existing Federal Law:
1. Governs the surveys and inspections of non-accredited
clinical laboratories. (Federal Social Security Act
Section 1864 and Federal Regulations ÝFR] 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 Section
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
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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.
Background
Federal CLIA of 1988 . 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 FR
493.15, CLIA-waived tests are test systems that are simple
laboratory examinations and procedures which are cleared by
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.
Federal Oversight of the CLIA Program . Center for Medicare
and Medicaid Services (CMS) regulates all laboratory
testing (except research) performed on humans in the United
States 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
"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))
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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 Section
353).
Additionally qualifications include:
1. Minimal scientific and technical knowledge is required
to perform the tests.
2. The knowledge required to perform the tests may be
obtained through on-the-job instruction.
3. 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 BPC
irrespective of whether the clinical laboratory is operated
under a CLIA certificate or under a state license or
registration. (CCR Title 17 Section 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
Section 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.
FISCAL EFFECT : Appropriation: No Fiscal Com.: Yes
Local: No
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SUPPORT : (Verified 4/30/12)
California Pharmacists Association (source)
California Retailers Association
California Society of Health System Pharmacists
National Association of Chain Drug Stores
Pharmacy Choice and Access Now
Remedy Pharm
Rite Aid Pharmacy
OPPOSITION : (Verified 4/30/12)
California Association for Medical Laboratory Technology
California Association of Bioanalysts
Engineers and Scientists of California
ARGUMENTS IN SUPPORT : The author's office indicates that
the intention of this bill 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 FDA for sale to the public without a
prescription in the form of an over-the-counter kit.
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's office, 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 bill allows 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's
office also states that this bill will result in both
insured and uninsured patients having easier access to
safe, simple and economic tests.
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ARGUMENTS IN OPPOSITION : The California Association for
Medical Laboratory Technology opposes this bill citing that
by allowing unqualified pharmacists to perform laboratory
tests, it will 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.
JJA:kc 4/30/2012 Senate Floor Analyses
SUPPORT/OPPOSITION: SEE ABOVE
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