BILL ANALYSIS Ó
SB 1481
Page 1
Date of Hearing: June 12, 2012
ASSEMBLY COMMITTEE ON BUSINESS, PROFESSIONS AND CONSUMER
PROTECTION
Mary Hayashi, Chair
SB 1481 (Negrete McLeod) - As Amended: June 6, 2012
SENATE VOTE : 36-0
SUBJECT : Clinical laboratories: community pharmacies.
SUMMARY : Exempts community pharmacies performing only
specified waived tests from state law governing the licensure
and regulation of clinical laboratories. Specifically, this
bill :
1)Exempts a community pharmacy that is providing only blood
glucose, hemoglobin A1c (blood sugar), or cholesterol tests
classified as waived under the federal Clinical Laboratory
Improvement Amendments (CLIA) of 1988 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;
b) The tests are performed by a licensed 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 in 1),
above.
2)Clarifies that a pharmacist may perform skin puncture in the
course of performing the procedures identified in 1), above.
3)Makes conforming changes.
EXISTING LAW
1)Establishes CLIA under federal law, which regulates clinical
laboratories that perform tests on human specimens and sets
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standards for facility administration, personnel
qualifications and quality control. These standards apply to
all settings, including commercial, hospital or physician
office laboratories.
2)Defines CLIA waived tests as simple laboratory examinations
and procedures that are approved by the 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.
3)Provides for the licensure and regulation of clinical
laboratories and their personnel by the California Department
of Public Health (DPH), and requires clinical laboratories to
be operated under the supervision of a laboratory director, as
specified.
4)Defines "laboratory director" to mean any person who is a duly
licensed physician and surgeon, or, only for purposes of a
clinical laboratory test or examination classified as waived,
is a duly licensed naturopathic doctor, or is licensed to
direct a clinical laboratory and who substantially meets the
laboratory director qualifications under CLIA for the type and
complexity of tests being offered by the laboratory.
5)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 health care
practitioners for specified purposes.
6)Exempts a number of clinical laboratories or persons
performing tests in specified laboratories from state law
governing the licensure and regulation of clinical
laboratories, including labs owned and operated by the federal
government, public health labs, forensic labs, research and
teaching labs, labs that register with DPH to perform blood
glucose monitoring for children with diabetes, persons who use
over-the-counter (OTC) test kits on themselves or their
children, and certified emergency medical technicians (EMTs)
and licensed paramedics providing life support who perform
only CLIA-waived blood glucose tests, as specified.
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7)Provides for the licensure and regulation of pharmacists by
the California Board of Pharmacy.
8)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.
FISCAL EFFECT : Unknown
COMMENTS :
Purpose of this bill . According to the author, "This bill is
intended to remove burdensome and unnecessary 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. Passage of
this legislation will result in easier access to safe, simple,
and economic 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.
"Although federal law subjects facilities performing only
CLIA-waived tests to a lesser level of regulation, California
law still requires facilities to comply with a number of
regulations, including the requirement to have a lab director
(which must be a physician) oversee all tests. Securing a lab
director is a complex and often expensive task that precludes
many pharmacies from being able to register with DPH. In the
nearly 20 years since state laboratory statutes were enacted,
the technology behind these tests has evolved greatly. The law
hasn't kept up, and now someone with a four-year doctorate
degree can't provide OTC laboratory tests without going through
unnecessary steps of contracting with a lab director and paying
fees to the state.
"There is a growing need for consumers to have access to routine
patient assessment tests related to medication therapy. The New
England Healthcare Institute states that 'poor medication
adherence is exacting a heavy toll in the form of unnecessary
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illness, disability and premature mortality, particularly among
the burgeoning number of chronically ill patients in the U.S.
Poor medication adherence in all its manifestations costs the
U.S. upwards of $290 billion per year in unnecessary health care
spending.' Medication non-adherence occurs among patients for a
number of reasons, many of which involve sub-optimal therapy.
"There are many commercially available tests that can help
patients and their pharmacists monitor therapy and disease.
With the results of these tests, appropriate adjustments to
treatment can be made in a timely manner, helping to improve
medication adherence and overall treatment. This is especially
important in treating chronic illnesses, which afflict
significant numbers of patients and account for an overwhelming
proportion of healthcare costs. With 90% of chronic conditions
requiring medication as a first-line treatment, improving
medication therapy is essential.
"As California readies itself to implement federal healthcare
reform, the state must improve efficiencies in the healthcare
delivery system. Part of this means improving treatment, and
part of it means eliminating unnecessary administrative burdens
on healthcare providers. This bill will help to address both of
these areas."
Background . California clinical laboratories are subject to
both federal and state oversight. Federal oversight falls under
CLIA, which is administered by the Centers for Medicare and
Medicaid Services (CMS) within the U.S. Department of Health and
Human Services. CLIA regulates clinical labs based on the
complexity of tests the lab offers.
"Waived" tests are approved by FDA for home use, use simple and
accurate methods that make the possibility of error negligible,
or pose no significant risk of harm to the patient if
incorrectly performed. Clinical labs performing only "waived"
tests must register with the CLIA program, pay biennial
certificate fees, allow inspections, and perform tests according
to manufacturers' instructions.
"Moderate" or "high" tests, which are more complex, may be
performed by clinical labs that pay higher fees, undergo
biennial inspections, and meet tougher standards for personnel,
supervision, quality assurance and proficiency testing.
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DPH regulates about 19,000 clinical labs and their personnel
statewide, monitors proficiency testing, investigates
complaints, and sanctions labs that violate the law or
regulations. DPH licenses or registers clinical labs according
to the complexity of testing they perform. Labs must be
licensed for moderately or highly complex procedures, and
registered for low complexity. About 3,000 clinical labs are
licensed for moderate and/or high complexity testing. The
remaining are registered labs performing waived tests and/or
provider-performed microscopy.
Waived tests can be performed under the supervision of a lab
director by a number of health care practitioners, including
physicians, podiatrists, dentists, pharmacists, naturopathic
doctors, physician assistants, nurses, respiratory care
practitioners, and others. A lab director must be a licensed
physician and surgeon or meet other licensure requirements, and
is responsible for overseeing the overall operation and
administration of the lab.
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.
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. A certificate of waiver also requires
that: minimal scientific and technical knowledge is required to
perform the tests; the knowledge required to perform the tests
may be obtained through on-the-job instruction; and, the
individual who administers the test must follow the
manufacturer's instructions.
The California Laboratory Field Services 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 more than 800 laboratories each
year. The program is also responsible for inspection of more
than 200 laboratories with a CLIA certificate of waiver.
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Support . The California Pharmacists Association writes, "This
bill does not expand pharmacists' scope of practice. The tests
this bill addresses are 'finger prick' style glucose tests,
cholesterol tests, and hemoglobin A1c (blood sugar) tests.
Pharmacists are trained to perform these tests in pharmacy
school and regularly perform them in practice - if the pharmacy
has $100,000 to contract with a 'laboratory director.'
Pharmacies are currently licensed by the California Board of
Pharmacy, and are not interested in becoming laboratories.
Rather than allow them to act as 'laboratory directors,' this
bill would simply allow pharmacists to perform OTC tests without
an additional level of state regulation."
Opposition . The California Association for Medical Laboratory
Technology (CAMLT) states, "California's licensure law for
Clinical Laboratory Scientists has long been recognized for its
high standards and unparalleled commitment to establishing
quality standards to protect its patients. Under the proposed
bill, allowing unqualified pharmacists to perform laboratory
testing would place these individuals outside the state's
oversight on clinical laboratory law, effectively weakening the
essential licensure standards in the state of California. SB
1481 would exempt pharmacists from requirements that were
enacted to protect patients and deliver reliable results. CAMLT
does not believe that allowing individuals to direct
laboratories and perform laboratory tests without meeting
educational and training standards is in the best interest of
the profession or the patients who seek reliable, quality
assured results."
Previous legislation .
AB 761 (Roger Hernández) of 2011 allows optometrists to
independently perform waived clinical laboratory tests if the
results can be used within the optometrist's scope of practice,
as specified. This bill was held in Assembly Business,
Professions and Consumer Protection Committee.
AB 1328 (Pan) of 2011 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. This bill was held in
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Assembly Business, Professions and Consumer Protection
Committee.
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.
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. This bill was held on the
Assembly Floor.
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. This bill was held in Assembly Business
and Professions Committee.
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 assessment procedure,
as defined. This bill was held in Assembly Business and
Professions Committee.
AB 433 (Nava) of 2005 exempts physician office laboratories from
licensure and regulatory requirements governing clinical
laboratories and their personnel by DPH. This bill was held in
Assembly Health Committee.
SB 1174 (Polanco), Chapter 640, Statutes of 2001, exempts
certified EMTs 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.
Double referred . This bill is double-referred to Assembly
Health Committee.
REGISTERED SUPPORT / OPPOSITION :
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Support
California Pharmacists Association (sponsor)
California Retailers Association
California Society of Health-System Pharmacists
California State Board of Pharmacy
Meiji Pharmacy
National Association of Chain Drug Stores
Pharmacy Choice and Access Now
Rite Aid
The Remedy Pharm
Two individuals
Opposition
California Association for Medical Laboratory Technology
California Association of Bioanalysts
California Clinical Laboratory Association
Engineers and Scientists of California, IFPTE
Western States Council of the United Food and Commercial Workers
Analysis Prepared by : Angela Mapp / B.,P. & C.P. / (916)
319-3301