BILL ANALYSIS �
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CONSENT
Bill No: AB 1215
Author: Hagman (R) and Holden (D)
Amended: 4/9/13 in Assembly
Vote: 21
SENATE BUSINESS, PROF. & ECON. DEVELOP. COMM. : 10-0, 6/17/13
AYES: Lieu, Emmerson, Block, Corbett, Galgiani, Hernandez,
Hill, Padilla, Wyland, Yee
SENATE HEALTH COMMITTEE : 9-0, 7/3/13
AYES: Hernandez, Anderson, Beall, De Le�n, DeSaulnier, Monning,
Nielsen, Pavley, Wolk
ASSEMBLY FLOOR : 76-0, 5/6/13 - See last page for vote
SUBJECT : Clinical laboratories
SOURCE : California Association for Medical Laboratory
Technology
Engineers and Scientists of California Local 20 of
the IFPTE
United Nurses Associations of California/Union of
Health Care
Professionals
Western States Council of the United Food &
Commercial Workers
DIGEST : This bill expands the definition of laboratory
director to include a duly licensed clinical laboratory
scientist and a duly licensed limited clinical laboratory
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scientist and authorizes these individuals to perform the duties
and responsibilities of a waived laboratory director, as
specified, under the Clinical Laboratory Improvement Amendments
of 1988 (CLIA).
ANALYSIS :
Existing federal law:
1.Establishes CLIA, 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.
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.
Existing state law:
1.Provides for the licensure and regulation of clinical
laboratories and their personnel by the Department of Public
Health and requires clinical laboratories to be operated under
the supervision of a laboratory director.
2.Prohibits the performance of a clinical laboratory test or
examination classified as waived under the federal CLIA unless
the test or examination is performed under the overall
operation and administration of a laboratory director and is
performed by specified persons, including certain health care
personnel.
3.Defines "clinical laboratory scientist" (CLS) as 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.
4.Specifies that 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
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consultant, clinical consultant, technical supervisor and
general supervisor, as specified under CLIA, in the
specialties of histocompatibility, microbiology, diagnostic
immunology, chemistry, hematology, immunohematology, 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.
5.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 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.
This bill:
1.Expands the definition of "laboratory director" for purposes
of a clinical laboratory test or examination classified as
waived to include a duly licensed CLS and a duly licensed
limited clinical laboratory scientist (LCLS).
2.Indicates that a person licensed as a CLS and LCLS qualified
under CLIA may perform tests and the duties and
responsibilities of a waived laboratory director as specified
under CLIA.
Background
Federal CLIA . 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 Federal
Regulation 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
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the test is performed incorrectly.
Federal oversight of the CLIA Program . The Center for Medicare
and Medicaid Services (CMS) regulates all laboratory testing
(except research) performed on humans in the U.S. through 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. 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.
Additionally, qualifications include: 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.
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 Business and Professions
Code irrespective of whether the clinical laboratory is operated
under a CLIA certificate or under a state license or
registration.
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 bi-annual 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.
Both CLSs and LCLSs as laboratory directors. Both CLSs and LCLS
are regulated by the Department of Public Health. An LCLS is
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an individual who is duly licensed as a clinical chemist,
clinical microbiologist or clinical toxicologist scientist.
Both CLSs and LCLSs may perform clinical laboratory tests or
examinations classified as waived, moderate or high complexity
under CLIA. These tests generally fall within the specialty
areas of histocompatibility, microbiology, diagnostic
immunology, chemistry, hematology, immunohematology, genetics or
other specialty as specified in statute. Currently, a CLS or
LCLS is able to engage in clinical laboratory practice under the
overall operation and administration of a laboratory director.
This bill will allow a CLS or LCLS to serve as a director of a
waived laboratory.
Comments
According to the author, "The implementation of the Affordable
Care Act will extend health benefits to an estimated 7 million
uninsured Californians by 2018. The newly insured will increase
the demand for care and auxiliary services such as clinical
laboratory testing. Therefore, access to clinical laboratory
tests must be improved without compromising testing accuracy and
quality or patient safety. Under California law, the very
practitioners specifically trained and licensed in clinical
laboratory science cannot be directors of laboratories
conducting "waived" tests?Currently, there is a shortage of
clinical laboratory personnel. If more waived tests could be
performed by non laboratory personnel at the point of contact
with their healthcare providers, this would reduce the demand
for waived testing at high complexity laboratories."
FISCAL EFFECT : Appropriation: No Fiscal Com.: No Local:
No
SUPPORT : (Verified 7/8/13)
California Association for Medical Laboratory Technology
(co-source)
Engineers and Scientists of California - Local 20 of the IFPTE
(co-source)
United Nurses Associations of California/Union of Health Care
Professionals (co-source)
Western States Council of the United Food & Commercial Workers
(co-source)
AFSCME
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Blood Centers of California
California Society of Pathologists
ARGUMENTS IN SUPPORT : The United Nurses Associations of
California/ Union of Health Care Professionals (sponsor) and
AFSCME state, "CLSs perform waived, moderate and high complexity
laboratory testing, including analyzing body fluids, cells and
tissue samples. CLSs maintain instruments to assure the highest
level of accuracy. They supervise unlicensed staff. ?No other
healthcare professionals possess these unique qualifications.
This is far more education and training in clinical laboratory
practice than anyone currently allowed to direct a waived
laboratory except a pathologist. ?AB 1215 will ultimately help
alleviate shortages of clinical laboratory personnel, thus
resulting in greater access to safe, simple and economical tests
that will play a crucial role in meeting future demands for
clinical laboratory testing."
The Western States Council of the United Food & Commercial
Workers and the Engineers and Scientists of California - Local
20 of the IFPTE (sponsors) state, "Given that it is the CLS,
unlike the other professions?who is specifically educated,
trained and licensed in the field of clinical laboratory science
it makes sense to extend this statutory authorization to them as
well. This is especially true as we begin to implement the
Affordable Care Act, extending access to healthcare to millions
more Californians."
The California Association for Medical Laboratory Technology
(sponsor) notes, "With the implementation of the Affordable Care
Act, which will extend health benefits to some 4.7 million
Californians, there will be greater demand for care and
ancillary services such as clinical laboratory testing. Hence,
access to clinical laboratory tests must be improved without
compromising testing accuracy and quality or patient safety."
The California Society of Pathologists indicates, "With the
upcoming implementation of the ACA there will be and influx of
new patients who will need to access clinical lab testing for
diagnostic purposes. The use of CLSs in this capacity will
improve availability and access to these services."
The Blood Centers of California state, "Only Clinical Laboratory
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Scientists once licensed are allowed to perform the highly
complex and sophisticated tests performed in our laboratories.
We currently have a shortage of licensed health care personnel
and with the full implementation of health care reform, we can
anticipate an increase of patients and their need for laboratory
tests as well. To expand the definition of 'laboratory
director' will increase access to clinical tests including
waived tests."
ASSEMBLY FLOOR : 76-0, 5/6/13
AYES: Achadjian, Alejo, Allen, Ammiano, Atkins, Bigelow, Bloom,
Blumenfield, Bocanegra, Bonilla, Bonta, Bradford, Brown,
Buchanan, Ian Calderon, Campos, Chau, Ch�vez, Chesbro, Conway,
Cooley, Dahle, Daly, Dickinson, Donnelly, Eggman, Fong, Fox,
Frazier, Beth Gaines, Garcia, Gatto, Gomez, Gordon, Gorell,
Gray, Grove, Hagman, Harkey, Roger Hern�ndez, Jones,
Jones-Sawyer, Levine, Linder, Logue, Lowenthal, Maienschein,
Mansoor, Medina, Melendez, Morrell, Mullin, Muratsuchi,
Nazarian, Nestande, Olsen, Pan, Patterson, Perea, V. Manuel
P�rez, Quirk, Quirk-Silva, Rendon, Salas, Skinner, Stone,
Ting, Torres, Wagner, Waldron, Weber, Wieckowski, Wilk,
Williams, Yamada, John A. P�rez
NO VOTE RECORDED: Hall, Holden, Mitchell, Vacancy
MW:nl 7/9/13 Senate Floor Analyses
SUPPORT/OPPOSITION: SEE ABOVE
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