BILL ANALYSIS Ó
SENATE COMMITTEE ON HEALTH
Senator Ed Hernandez, O.D., Chair
BILL NO: AB 1215
AUTHOR: Hagman and Holden
AMENDED: April 9, 2013
HEARING DATE: July 3, 2013
CONSULTANT: Moreno
SUBJECT : Clinical laboratories.
SUMMARY : Expands the definition of a "laboratory director" to
include a duly licensed clinical laboratory scientist and a duly
licensed limited clinical laboratory scientist and authorizes
these individuals to perform the duties and responsibilities of
a waived laboratory director, as specified, under the federal
Clinical Laboratory Improvement Amendments of 1988 (CLIA).
Existing law:
1.Establishes Clinical Laboratory Improvement Amendments of 1988
(CLIA) for the regulation of laboratories in performing
testing on human specimens, and includes laboratory standards
for proficiency testing, facility administration, personnel
qualifications, and quality control.
2.Establishes the Laboratory Field Services within the
Department of Public Health (DPH), for the licensing and
registration services for clinical laboratories, as specified.
3.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," to be
registered, rather than licensed, by DPH.
4.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.
5.Defines a "laboratory director" as any person who is a duly
licensed physician and surgeon, or for purposes of a clinical
laboratory test or examination classified as waived, is a duly
Continued---
AB 1215 | Page 2
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. Requires
the laboratory director to be responsible for the overall
operation and administration of a clinical laboratory, as
specified.
This bill: Expands the definition of a "laboratory director" to
include a duly licensed clinical laboratory scientist and a duly
licensed limited clinical laboratory scientist and authorizes
these individuals to perform the duties and responsibilities of
a waived laboratory director, as specified, under CLIA.
FISCAL EFFECT : This bill has been keyed non-fiscal.
PRIOR VOTES :
Assembly Business, Professions and Consumer Protections:13- 0
Assembly Health: 19- 0
Assembly Floor: 76- 0
Senate Business, Professions and Economic Development:10- 0
COMMENTS :
1.Author's statement. Ensuring greater access to care is
absolutely essential. Allowing Clinical Laboratory Scientists
(CLS) to act as laboratory directors for waived tests will
result in greater access to safe, simple, and economical tests
that will play a crucial role in meeting future demands for
clinical laboratory testing.
2.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
AB 1215 | Page
3
differences between the home use and professional use versions
need to be examined to determine whether the professional
version qualifies for waiver.
3.Clinical laboratories. There are 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.
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).
4.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 percent. 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 to 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.
5.Double referral. This bill was heard in the Senate Business,
Professions and Economic Development Committee on June 17,
2011, and passed with a 10-0 vote.
6.Prior legislation. SB 1481 (Negrete McLeod), Chapter 874,
Statutes of 2012, allows pharmacists to perform specific CLIA
waived tests without the supervision of a laboratory director
AB 1215 | Page 4
under specific conditions.
AB 761 (Roger Hernández), Chapter 714, Statutes of 2012,
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.
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 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.
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.
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.
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.
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.Support. The American Federation of State, County, and
AB 1215 | Page
5
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.
SUPPORT AND OPPOSITION :
Support: California Association for Medical Laboratory
Technology (co-sponsor)
American Federation of State, County and Municipal
Employees, AFL-CIO
Blood Centers of California
Engineers and Scientists of California, IFPTE
Western States Council of the United Food & Commercial
Workers
United Nurses Associations of California/Union of
Health Care Professionals
Oppose: None received
-- END --