BILL ANALYSIS �
AB 1215
Page 1
Date of Hearing: April 16, 2013
ASSEMBLY COMMITTEE ON BUSINESS, PROFESSIONS AND CONSUMER
PROTECTION
Richard S. Gordon, Chair
AB 1215 (Hagman and Holden) - As Amended: April 9, 2013
SUBJECT : Clinical laboratories.
SUMMARY : Redefines the term "laboratory director" to allow a
licensed clinical laboratory scientist (CLS) to operate as the
director of a clinical laboratory when performing simple tests
exempted from the federal Clinical Laboratory Improvements
Amendments (CLIA) of 1988.
EXISTING STATE LAW :
1)Provides for the licensure and regulation of clinical
laboratories and their personnel by the California Department
of Public Health, and requires clinical laboratories to be
operated under the supervision of a laboratory director, as
specified. (Business and Professions Code [BPC] Section 1260
et seq.; California Code of Regulations, Title 17, Division 1,
Chapter 2)
2)Prohibits the performance of a clinical laboratory test or
examination classified as waived under the federal CLIA of
1988 unless the test or examination is performed under the
overall operation and administration of a laboratory director,
as defined, and is performed by specified persons, including
certain health care personnel. (BPC 1209)
3)Defines the following terms:
a) "Clinical laboratory scientist" shall mean any person
other than a licensed clinical laboratory bioanalyst or
trainee who is licensed to engage in clinical laboratory
practice under the supervision of a laboratory director. A
licensed CLS may perform clinical laboratory tests or
examinations classified as of high complexity under CLIA
and the duties and responsibilities of a technical
consultant, clinical consultant, technical supervisor, and
general supervisor, as specified under CLIA, in the
specialties of histocompatibility, microbiology, diagnostic
immunology, chemistry, hematology, immunohematology,
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genetics, or other specialty or subspecialty specified by
regulation adopted by the department. A licensed CLS may
perform any clinical laboratory test or examination
classified as waived or of moderate complexity under CLIA;
(BPC 1204) and,
b) "Laboratory director" shall 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. (BPC 1209)
EXISTING FEDERAL LAW :
1)Establishes CLIA under federal law, which regulates clinical
laboratories that perform tests on human specimens and sets
standards for facility administration, personnel
qualifications and quality control. These standards apply to
all settings, including commercial, hospital or physician
office laboratories. (Title 42 of the Code of Federal
Regulations [CFR], Part 493)
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 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. (42
CFR 493)
FISCAL EFFECT : None. This bill is keyed non-fiscal by the
Legislative Counsel.
COMMENTS :
1)Purpose of this bill . This bill would allow CLSs to operate
as laboratory directors overseeing clinical laboratories
performing less complex CLIA-waived tests, thereby expanding
the pool of individuals qualified to fill such positions. As
federal law already authorizes CLSs to become laboratory
directors but California does not, AB 1215 would conform state
law to federal law. This bill is sponsored by the California
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Association of Medical Laboratory Technology and multiple
labor organizations.
2)Author's statement . According to the author's office,
"Current law prohibits the performance of a clinical
laboratory test or examination classified as waived by the
CLIA, unless the test or examination is performed under the
overall operation and administration of a laboratory director.
Securing a laboratory director in California is a complex and
expensive task that precludes other healthcare providers from
being able to provide waived testing services to their
patients. In recent years, bills have passed expanding who
can be a laboratory director, but the most highly trained
people, who actually work in the laboratories, cannot."
3)Clinical laboratory oversight . California clinical
laboratories are subject to both federal and state oversight.
The federal CLIA regulates clinical labs based on the
complexity (low, moderate or high) of the tests offered.
Congress passed CLIA in 1988, which established quality
standards for all laboratory testing to ensure the accuracy,
reliability and timeliness of patient test results regardless
of where the test was performed.
State oversight of clinical labs is administered by the
California Department of Public Health's (DPH's) Laboratory
Field Services (LFS), which regulates about 19,000 clinical
labs and their personnel statewide, monitors proficiency
testing, investigates complaints, and sanctions labs that
violate the law or regulations. LFS provides licensing,
registration, and certification services for clinical
laboratory facilities, blood banks, tissue banks and the
testing personnel who perform professional pre-analytical,
analytical, and post analytical testing services for these
facilities.
In conformity with CLIA, DPH licenses or registers clinical
labs according to the complexity of the tests 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.
This bill deals specifically with tests that are 'waived', or
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exempt from regulatory oversight, because they are approved by
the FDA for home use, utilize simple and accurate methods that
make the possibility of error negligible, or pose no
significant risk of harm to the patient if incorrectly
performed. Any person can purchase these tests from
pharmacies, drugstores, supermarkets, or retail stores and
conveniently perform the test at home. Examples of these
tests include: dipstick or tablet reagent urinalysis, stool
sampling, ovulation tests, urine pregnancy tests, and certain
tests of a small amount of blood obtained by skin prick or
blood draw.
4)Clinical laboratory director requirements and duties . A
laboratory 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
laboratory. Under federal CLIA, CLSs can be waived laboratory
directors. Under state law, for the purposes of waived tests,
a laboratory director can also include a licensed naturopathic
doctor, an optometrist or a person 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. In recent years,
state legislation has expanded the definition of who can
become a lab director for waived labs (naturopaths,
optometrists, and pharmacists), and this bill would add a CLS
to that list.
A laboratory director of a clinical laboratory performing
waived tests is responsible for the overall operation and
administration of the waived laboratory, including: ensuring
that testing personnel are competent to perform test
procedures; recording and reporting test results promptly,
accurately, and proficiently; and assuring compliance with the
applicable regulations relating to the state laboratory law
and the federal CLIA. While the laboratory director may
delegate such duties to persons who meet appropriate
qualifications, the laboratory director is responsible for
ensuring that all assigned duties and testing are properly
performed. The lab director would also be accessible to the
laboratory to provide onsite, telephone, or electronic
consultation as needed.
5)Clinical Laboratory Scientist . A CLS holds, at the minimum, a
bachelors of science degree with specific coursework in
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laboratory disciplines such as hematology, medical
microbiology, clinical chemistry, immunology,
immunohematology, statistics, mathematics, quality assurance,
instrumentation, and/or laboratory administration. In
addition, CLSs must complete 52 weeks of clinical laboratory
training in a DPH-approved laboratory and pass an approved
licensure examination. A CLS may perform all three levels of
CLIA tests - waived, moderate, and high complexity testing,
including analyzing body fluids, cells, and tissue samples.
Some of a CLS's duties include supervising unlicensed staff,
phlebotomists, and medical laboratory technicians, managing
daily activities and directing quality assurance, finances,
and technological improvements in the laboratory.
6)Effects of this bill . By including CLSs in the definition of
a "laboratory director," this bill would effectively allow
CLSs to independently perform waived tests without supervision
by another lab director. This would also allow a CLS who
wishes to work part-time to operate a clinical laboratory
performing CLIA-waived tests.
CLSs are already licensed to perform the highest category of
tests and are specifically trained in laboratory science and
can ensure that tests are being performed properly and
specimen procurement and handling are in accordance with
protocols. Therefore, CLSs are presumably capable of
performing the duties of a waived laboratory director, and may
allow healthcare providers to hire CLSs more affordably than a
physician or surgeon.
7)Arguments in Support . According to the lead sponsor, the
California Association for Medical Laboratory Technology,
"This bill permits licensed CLSs to serve as laboratory
directors for waived laboratories, ensuring that the very
individuals educated to do so function at the level of their
training and license.
"Federal law requires a clinical laboratory test to be
performed under the overall supervision of a laboratory
director. Federal law also allows CLSs to be directors of a
waived laboratory. However, California law permits only
physicians, surgeons, naturopaths, and to a more limited
extent, optometrists and pharmacists, to be a director of a
waived laboratory. It seems appropriate and in the public
interest [that] the very profession training in clinical
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laboratory science should service in this capacity [as a
director of a waived laboratory] in California."
8)Related Legislation . AB 399 (Fox) of 2013 would authorize the
DPH to establish application and license renewal fees for new
license categories that exceed the costs for implementation.
This bill is pending in the Assembly Business, Professions and
Consumer Protection Committee.
AB 830 (Holden) of 2013 would require DPH to promulgate
regulations by January 1, 2015, requiring any facility
operating a clinical laboratory to provide specified training
to CLSs, medical laboratory technicians, and any individuals
who are charged with direct and responsible supervision of
either a CLS or a medical laboratory technician This bill is
pending in Assembly Business, Professions and Consumer
Protection Committee.
9)Previous Legislation . AB 761 (Hern�ndez), Chapter 714,
Statutes of 2012, allows optometrists to independently perform
waived clinical laboratory tests necessary for the diagnosis
of conditions and diseases of the eye.
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 would have required clinical
laboratories that perform tests to screen 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 would have expanded the duties that
unlicensed personnel are authorized to perform in a clinical
laboratory and would have revised the level of supervision
required when unlicensed personnel perform them. AB 185 was
held in Assembly Business and Professions Committee.
AB 1370 (Matthews) of 2005 would have included a pharmacist
within the definition of laboratory director if the clinical
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laboratory test or examination is a routine patient assessment
procedure, as defined. AB 1370 was held in Assembly Business
and Professions Committee.
AB 433 (Nava) of 2005 would have exempted physician office
laboratories from licensure and regulatory requirements
governing clinical laboratories and their personnel by the
Department of Health Services. AB 433 was held in Assembly
Health Committee.
10)Double-referral . This bill is double-referred, and if passed
by this committee will be referred to the Assembly Health
Committee.
REGISTERED SUPPORT / OPPOSITION :
Support
California Association of Medical Laboratory Technology
(sponsor)
Engineers and Scientists of California, Local 20 of the
International Federation of Professional and Technical
Engineers (sponsor)
United Nurses Associations of California/Union of Health Care
Professionals (sponsor)
Western States Council of the United Food & Commercial Workers
(sponsor)
Blood Centers of California
California Society of Pathologists
Opposition
None on file.
Analysis Prepared by : Joanna Gin / B.,P. & C.P. / (916)
319-3301