BILL ANALYSIS �
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|SENATE RULES COMMITTEE | SB 1481|
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UNFINISHED BUSINESS
Bill No: SB 1481
Author: Negrete McLeod (D)
Amended: 8/20/12
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
SENATE FLOOR : 36-0, 5/3/12
AYES: Alquist, Berryhill, Blakeslee, Calderon, Cannella,
Corbett, Correa, De Le�n, DeSaulnier, Dutton, Emmerson,
Evans, Fuller, Gaines, Hancock, Harman, Hernandez, Huff,
Kehoe, La Malfa, Leno, Lieu, Liu, Lowenthal, Negrete
McLeod, Pavley, Price, Rubio, Steinberg, Strickland,
Vargas, Walters, Wolk, Wright, Wyland, Yee
NO VOTE RECORDED: Anderson, Padilla, Runner, Simitian
ASSEMBLY FLOOR : Not available
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.
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Assembly Amendments (1) require the pharmacy notify the
public health officer of the county in which the pharmacy
is located that the pharmacy is performing those tests; (2)
require the test be approved by the federal Food and Drug
Administration (FDA) for sale to the public without a
prescription in the form of an over-the-counter test kit;
(3) require the test be performed by a pharmacist at a
community pharmacy upon customer request; (4) require the
pharmacy receive registration from the Department of
Public Health (DPH) pursuant to existing law; (5) specify
the registration issued to the community pharmacy be valid
for two years; and (6) add double-jointing language with AB
761 (Hernandez).
ANALYSIS :
Existing State Law:
1. Provides for the licensure and regulation of clinical
laboratories and personnel by the 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 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),
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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 (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 Section
101160 - 101165)
This bill:
1. Provides that statutes requiring CLIA waived tests to be
performed under the operation and administration of a
laboratory director, as specified, do not apply to a
pharmacist at a community pharmacy who, upon customer
request, performs only blood glucose, hemoglobin A1c
(blood sugar), or cholesterol tests classified as waived
under CLIA and are approved by the federal FDA for sale
to the public without a prescription in the form of an
over-the-counter test kit, provided that all of the
following requirements are satisfied:
A. The pharmacy obtains a valid CLIA certificate of
waiver and complies with all other requirements for
the performance of waived clinical laboratory tests
under applicable federal regulations. For purposes
of CLIA, the person identified as responsible for
directing and supervising testing oversight and
decision-making shall be the pharmacist-in-charge, as
specified;
B. The pharmacy obtains a registration from the DPH
pursuant to existing law, as specified; and,
C. The tests are performed only by a pharmacist, as
defined under the Pharmacy Law, in the course of
performing routine patient assessment procedures in
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compliance with their scope of practice as specified
under the Pharmacy Law.
2. Makes conforming and technical changes.
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
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))
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
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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
SUPPORT : (Verified 8/28/12)
California Pharmacists Association (source)
California Chronic Care Coalition
California Retailers Association
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California Society of Health System Pharmacists
Congress of California Seniors
National Association of Chain Drug Stores
Pharmacy Choice and Access Now
Remedy Pharm
Rite Aid Pharmacy
OPPOSITION : (Verified 8/28/12)
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.
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
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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:k 8/28/12 Senate Floor Analyses
SUPPORT/OPPOSITION: SEE ABOVE
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