BILL ANALYSIS �
AB 1215
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Date of Hearing: April 30, 2013
ASSEMBLY COMMITTEE ON HEALTH
Richard Pan, Chair
AB 1215 (Hagman and Holden) - As Amended: April 9, 2013
SUBJECT : Clinical laboratories.
SUMMARY : Expands the definition of laboratory director for
purposes of a clinical laboratory test or examination classified
as waived to include a licensed clinical laboratory scientist
(CLS) and limited CLS (LCLS). Authorizes a person licensed as a
CLS, as specified, and qualified under the federal Clinical
Laboratory Improvement Amendments (CLIA) to additionally perform
the duties and responsibilities of a waived clinical laboratory
director, as specified.
EXISTING LAW :
1)Establishes in federal law, CLIA, which regulates
laboratories when performing testing on human specimens,
and includes laboratory standards for proficiency
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
federal 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)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
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(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.
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
waived, is a duly licensed naturopathic doctor, is an
optometrist, as specified, 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
kits, on their own bodies, or on their minor children or
legal wards, and certified emergency medical technicians
and licensed paramedics providing basic life support
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services, as specified.
9)Requires DPH to issue a CLS and LCLS license to a person
who has a baccalaureate or an equivalent or higher
degree, as specified. Authorizes a CLS/LCLS to engage in
clinical laboratory practice under the overall operation
and administration of a laboratory director. Authorizes
a CLS/LCLS who is qualified under CLIA to perform
clinical laboratory tests or examinations classified as
of high complexity, waived, or of moderate complexity
under CLIA.
FISCAL EFFECT : None
COMMENTS :
1)PURPOSE OF THIS BILL . According to the author, the
implementation of the Patient Protection and Affordable Care
Act (ACA) will extend health benefits to an estimated seven
million uninsured Californians by 2018. The newly insured
will increase the demand for care and auxiliary services such
as clinical laboratory testing. 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 are not directors of laboratories
conducting waived tests. Currently, there is a shortage of
clinical laboratory personnel. According to the sponsors,
allowing CLS's to be laboratory directors would alleviate the
need for simple tests (like urine dip stick) to be done at a
high complexity labs, freeing the lab to process the tests it
is more appropriately equipped to do and allows the CLS to
focus on higher complexity testing rather than being
distracted to do simpler waived testing. Additionally, many
CLS's are of retirement age. Keeping them in the workforce
longer as waived lab director consultants allows other
practitioners to do simple testing and ensures that the CLS
training and experience are not lost from the workforce. This
role is not as stressful or physical, so retirees who are
weary of the stress and physicality of a standard lab could
remain in the workforce longer, without having to contend with
complicated machinery and the running of samples and results
here and there. Instead, they can fill the waived testing lab
director gap, freeing CLS's in labs to focus on other testing.
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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 the
only 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
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).
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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.
c) Workforce Shortage . According to a report published by
the Center for the Health Professions at the University of
California, San Francisco entitled "California's Health
Care Workforce: Readiness for the ACA Era," California's
employment of CLS has been stagnant since 2001, while
national CLS employment has grown 15%. California's per
capita supply of CLS is much lower than the nation's: 35
CLS per 100,000 population in California compared to 54.4
per 100,000 in the U.S. overall. From 1980 - 2005, the
number of CLS licensure candidates dropped significantly
from 2,515 to 724. The report points out that California's
hospitals are concerned about the supply of clinical lab
professionals, as vacancies in these areas have a
significant impact on care delivery and hospital
efficiency.
3)SUPPORT . The American Federation of State, County, and
Municipal Employees, Blood Centers of California, Engineers
and Scientists of California and the California Association
for Medical Laboratory Technology state that this bill will
assist in addressing the likely increased demand for
laboratory tests and will result in greater access to safe,
simple, and economical tests.
4)PREVIOUS LEGISLATION .
a) SB 1481 (Negrete McLeod), Chapter 874, Statutes of 2012,
allows pharmacists to perform specific CLIA waived tests
without the supervision of a laboratory director under
specific conditions.
b) AB 761 (Roger Hern�ndez), Chapter 714, Statutes of 2012,
includes a licensed optometrist in the definition of
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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.
c) 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.
d) AB 1442 (Feuer) of 2007 would have required 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.
e) 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 levels of
supervision required when unlicensed personnel perform
them. AB 185 was held in the Assembly Business and
Professions Committee.
f) AB 1370 (Matthews) of 2005 would have included a
pharmacist within the definition of laboratory director if
the clinical laboratory test or examination is a routine
patient assessment procedure, as defined. AB 1370 was held
in Assembly Business and Professions Committee.
g) AB 433 (Nava) of 2005 would have exempted 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.
h) 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.
5)DOUBLE REFERRAL . This bill is double referred. It was heard
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on April 16, 2013 in the Assembly Business Professions and
Consumer Protections Committee and passed out on a 13-0 vote.
REGISTERED SUPPORT / OPPOSITION :
Support
California Association for Medical Laboratory Technology
(cosponsor)
Engineers & Scientists of California, IFPTE (cosponsor)
United Nurses Association of California/Union of Health Care
Professionals (cosponsor)
Western States Council of the United Food & Commercial Workers
(cosponsor)
American Federation of State, County and Municipal Employees,
AFL-CIO
Blood Centers of California
California Society of Pathologists
Opposition
None on file.
Analysis Prepared by : Rosielyn Pulmano / HEALTH / (916)
319-2097