BILL ANALYSIS Ó
SB 1481
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Date of Hearing: July 3, 2012
ASSEMBLY COMMITTEE ON HEALTH
William W. Monning, Chair
SB 1481 (Negrete McLeod) - As Amended: June 13, 2012
SENATE VOTE : 36-0
SUBJECT : Clinical laboratories: community pharmacies.
SUMMARY : Exempts from existing clinical laboratory requirements
and regulations a community pharmacy that provides blood
glucose, hemoglobin A1c, or cholesterol tests, as specified, if
certain requirements are met. Specifically, this bill :
1)Exempts from existing clinical laboratory requirements and
regulations a community pharmacy that provides blood glucose,
hemoglobin A1c, or cholesterol tests, which are classified as
waived under the Clinical Laboratory Improvement Amendments of
1988 (CLIA) and 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 if
the following requirements are met:
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;
b) The tests are performed by a pharmacist in the course of
performing routine patient assessment procedures, as
specified; and,
c) The pharmacy notifies the public health officer of the
county in which the pharmacy is located that the pharmacy
is performing one or more of the tests identified.
2)Authorizes a pharmacist to perform skin puncture in the course
of performing 1) b) above.
EXISTING LAW :
1)Establishes in federal law, CLIA, which regulates
laboratories when performing testing on human specimens,
and includes laboratory standards for proficiency
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testing, facility administration, personnel
qualifications, and quality control. Applies standards
to all settings, including commercial, hospital, or
physician office laboratories.
2)Defines under CLIA waived tests as simple laboratory
examinations and procedures that are cleared by the 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.
3)Establishes within the Department of Public Health (DPH)
the Laboratory Field Services which provides for
licensing and registration services for clinical
laboratories, as specified.
4)Requires a clinical laboratory that performs tests that
are of moderate or high complexity to be licensed by DPH.
Requires a clinical laboratory that performs tests that
are of low complexity, also referred to as "waived
tests," or that perform provider-performed microscopy
(PPM), which is a microscopic analysis of a specimen by a
health care provider such as a physician, to be
registered, rather than licensed, by DPH.
5)Defines a clinical laboratory as any establishment or
institution operated for the performance of clinical
laboratory tests or examinations, or the practical
application of clinical laboratory sciences. Requires
clinical laboratories to pay DPH specified fees,
including initial and renewal licensure, registration, or
certification fees.
6)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 persons, including physicians and surgeons,
podiatrists, dentists, physician assistants, or
respiratory care practitioners.
7)Defines a laboratory director as any person who is a duly
licensed physician and surgeon, or only for purposes of a
clinical laboratory test or examination classified as
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waived, is a duly licensed naturopathic doctor, or is
licensed to direct a clinical laboratory and who meets
specified qualifications under CLIA for the type and
complexity of tests being offered by the laboratory.
States that the laboratory director is responsible for
the overall operation and administration of a clinical
laboratory, as specified.
8)Exempts certain clinical laboratories or persons
performing clinical laboratory tests or examinations from
clinical laboratory regulations, including the following:
clinical laboratories that are owned and operated by the
United States government; public health laboratories, as
specified; laboratories that perform clinical laboratory
tests or examinations for forensic purposes; individuals
who perform clinical laboratory tests or examinations
approved by the FDA for sale to the public without a
prescription in the form of an over-the-counter test kit,
on their own bodies or on their minor children or legal
wards, and certified emergency medical technicians and
licensed paramedics providing basic life support
services, as specified.
9)Establishes the Board of Pharmacy for the regulation and
licensing of pharmacists.
10)Authorizes a pharmacist to perform skin puncture in the
course of performing routine patient assessment
procedures, as specified. Defines routine patient
assessment procedures as procedures that a patient could,
with or without a prescription, perform for himself or
herself, or clinical laboratory tests that are classified
as waived.
FISCAL EFFECT : According to the Senate Appropriations
Committee, pursuant to Senate Rule 28.8, negligible state costs.
COMMENTS :
1)PURPOSE OF THIS BILL . The California Pharmacists Association
is the sponsor of this bill. According to the author, this
bill is intended to remove burdensome and unnecessary
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government regulations to improve efficiency in the
health-care delivery system. Specifically, this bill would
allow pharmacists to perform specific over-the-counter
laboratory tests, such as glucose level or cholesterol tests,
without the need to hire a laboratory director. Pharmacies
are not interested in becoming laboratories, and this bill
would allow pharmacists to perform only specific tests that
are already recognized by the law as safe to be performed with
little or no oversight. According to the author, this bill
will result in easier access to safe, simple, and economical
tests especially for low income individuals, less crowding in
physicians' offices, and an improved ability of pharmacists to
provide meaningful feedback to their patients when providing
drug consultations required by law. As California readies
itself to implement federal health care reform, the State must
improve efficiencies in the health care delivery system. Part
of this means improving treatment, and eliminating unnecessary
administrative burdens on health care providers.
2)BACKGROUND .
a) CLIA Waived Tests . CLIA defines waived tests as simple
laboratory examinations and procedures that are cleared by
the 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.
Waived tests include dipstick or Tablet reagent urinalysis
(used to test glucose, hemoglobin, and protein among other
things); Fecal occult blood; Ovulation tests; Urine
pregnancy tests; Erythrocyte sedimentation
rate-non-automated; and, Blood glucose by glucose
monitoring devices cleared by the FDA specifically for home
use. Amendments adopted for CLIA states that tests
approved by the FDA for home use automatically qualify for
CLIA waiver. Professional use versions of home use tests
are not automatically waived. However, such professional
versions do qualify for expedited waiver review since only
the differences between the home use and professional use
versions need to be examined to determine whether the
professional version qualifies for waiver.
b) Clinical Laboratories . There are currently
approximately 19,000 clinical laboratories in California,
3,000 of which are licensed laboratories performing
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moderate and/or high complexity testing. The remaining
12,000 are registered labs performing waived tests and/or
provider-performed microscopy. California clinical
laboratories are subject to both federal and state
oversight.
Federal CLIA requirements establish standards for
laboratories to ensure the accuracy, reliability, and
timeliness of patient test results, and specify numerous
quality standards, including those for facility
administration, personnel qualifications, quality control,
and proficiency testing, a process used by laboratories to
verify the accuracy and reliability of their test results.
CLIA standards apply to laboratory testing in all states,
and in all settings, including commercial, hospital, or
physician office laboratories. CLIA standards are based on
the complexity of the testing (waived, moderate, or high
complexity).
A clinical laboratory performing clinical laboratory tests or
examinations subject to a certificate of waiver or a
certificate of PPM under CLIA is required to register with
DPH. DPH requires that an application for a clinical
laboratory license or registration must include certain
information, including the name of the owner, the name of
the laboratory director, name and location of the
laboratory, a list of the clinical laboratory tests or
examinations performed by the laboratory by name, and total
number of test procedures and examinations performed
annually. Since this bill exempts a community pharmacy
from all clinical laboratory requirements, DPH will have no
regulatory authority over these pharmacies even when
performing waived tests.
c) Other States . According to the sponsor, there are 35
states that currently allow pharmacists to perform CLIA
waived testing, and 15 that do not, including California.
3)SUPPORT . The Congress of California Seniors indicates that
many frail seniors and others could benefit from having the
assistance of a pharmacist who knows their ongoing condition
and needs, and this is especially important to seniors who
take multiple medications and suffer from many adverse health
conditions. The California Pharmacists Association indicates
that this bill would improve the ability of pharmacists to
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provide meaningful feedback to their patients when providing
drug consultations. Patients that receive suboptimal drug
therapy or who do not take their medications as they should,
cost the health care system hundreds of billions of dollars
every year, and data show that more in-depth pharmacist
consultations leads to a marked improvement in patient
outcomes. The California Society of Health-System Pharmacists
indicates that this bill would result in easier access to
safe, accurate, and economically sound tests, especially for
the uninsured and underinsured individuals. Rite Aid points
out that pharmacists are the most accessible health care
professionals in most communities and their expertise should
be used more extensively to improve the overall health of our
society.
4)OPPOSITION . In opposition, the California Association for
Medical Laboratory Technology (CAMLT) indicates that this bill
would permit pharmacists to conduct three clinical laboratory
tests without any additional training or supervision and
without being subject to California laboratory law and
oversight, including the federal and state requirement that
requires a laboratory director to be designated and
responsible. CAMLT indicates that pharmacists should be
subject to the same oversight as any other discipline that
wants to do clinical laboratory testing, and should be willing
to take the responsibility of being the lab director. Lab
directors function to ensure that the manufacturer's
instructions are followed in doing the waived test. Of major
concern to CAMLT is that a pharmacy could make personnel with
no medical, scientific, or laboratory experience (cashier,
pharmacy tech, or administrative person) responsible for the
test without oversight from DPH. The California Clinical
Laboratory Association indicates that at the very least this
bill should be amended to require that a pharmacist be
designated as a laboratory director and to require oversight
by DPH.
The Western States Council of the United Food and Commercial
Worker, and the Engineers and Scientists of California state
that clinical laboratory regulations protect the public from
health risks when tests are performed incorrectly. The
California Association of Bioanalysts indicates that allowing
a community pharmacist who is not trained in clinical
laboratory to perform waived tests will create a false sense
of security for patients who may have a pharmacist do the
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testing where there is an incorrect result, and this could
lead to delayed medical care, increased pain and suffering,
and increased costs to the healthcare system.
5)RELATED LEGISLATION . AB 761 (Roger Hernández) includes a
licensed optometrist in the definition of laboratory director
and authorizes a licensed optometrist to perform CLIA waived
test as necessary for the diagnosis of conditions and disease
of the eye, as specified. AB 761 is pending in Senate
Appropriations Committee. AB 1328 (Pan) allows DPH to issue a
clinical laboratory scientist's license to an applicant who
completes at least two years of full-time employment as a
clinical laboratory scientist at a CLIA certified laboratory,
who possesses a baccalaureate or an equivalent or higher
degree from an accredited institution, and who passes a
national examination approved by DPH, subject to the payment
of a licensing fee. AB 1328 was held in the Assembly
Business, Professions and Consumer Protection Committee.
6)PREVIOUS LEGISLATION .
a) 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.
b) AB 1442 (Feuer) of 2007 requires clinical laboratories
that perform tests for human immunodeficiency virus 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. AB 1442
was held on the Assembly Floor.
c) 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. AB 185
was held in the Assembly Business and Professions
Committee.
d) 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
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assessment procedure, as defined. AB 1370 was held in
Assembly Business and Professions Committee.
e) AB 433 (Nava) of 2005 exempts physician office
laboratories from licensure and regulatory requirements
governing clinical laboratories and their personnel by DPH.
AB 433 was held in the Assembly Health Committee.
f) SB 1174 (Polanco), Chapter 640, Statutes of 2001,
exempts certified emergency medical technicians and
licensed paramedics providing life support who perform only
CLIA-waived blood glucose tests from state law governing
the licensure and regulation of clinical laboratories, as
specified.
7)DOUBLE REFERRAL . This bill is double-referred. It was heard
and passed out of the Assembly Business, Professions and
Consumer Protection Committee by a vote of 9-0 on June 12,
2012.
8)AMENDMENTS . In an effort to address concerns raised by
Committee staff, the author intends to amend this bill as
follows:
a) Exemption . Instead of exempting a community pharmacy
that provides the three tests from clinical laboratory
amendments, the author is proposing to instead exempt a
pharmacist at a community pharmacy, where the pharmacist,
upon customer request, performs only the three tests
specified above.
b) DPH registration . To address concerns for the lack of
regulatory authority of community pharmacies where the
three waived tests are performed, the author is proposing
to amend this bill to require community pharmacies where
the three waived tests are performed by pharmacists, to
register with DPH, with the registration valid for two
years.
9)PRECEDENT SETTING . This bill sets a precedent. It exempts
community pharmacies from all CLIA regulations that are
enforced by DPH. The sponsors indicate that the three tests
that will be performed at community pharmacies will be
performed by pharmacists, are available over-the-counter, and
are so simple that consumers already perform them on their own
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without any assistance. However, health care providers that
are authorized to perform waived tests are defined as clinical
laboratory directors. Inclusion of these health care
providers in the definition of laboratory directors ensures
DPH's oversight over the tests and practitioners.
Additionally, the current exemptions from clinical laboratory
requirements generally apply to non-profit laboratories as
opposed to businesses and individuals for personal use (those
owned and operated by the US government, public health
laboratories, forensic laboratories, laboratories that perform
tests or examinations for research and testing purposes,
clinics certified by the National Institutes on Drug Abuse,
clinics that monitor minor children diagnosed with diabetes,
individuals who use the test kit on their own bodies or on
their minor children or legal wards, and emergency medical
technicians and licensed paramedics providing basic or
advanced life support services, as specified). If this bill
is passed, it is likely that other types of retailers, or
facilities that employ health care providers, will seek an
exemption from all clinical laboratory requirements when
performing over-the-counter waived tests.
REGISTERED SUPPORT / OPPOSITION :
Support
California Pharmacists Association (sponsor)
California Society of Health-System Pharmacists
California Retailers Association
Congress of California Seniors
National Association of Chain Drug Stores
Pharmacy Choice and Access Now
Rite Aid
Individual pharmacists
Opposition
California Association of Bioanalysts
California Association for Medical Laboratory Technology
California Clinical Laboratory Association
Engineers & Scientists of California, IFPTE
Analysis Prepared by: Rosielyn Pulmano / HEALTH / (916)
319-2097
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