BILL ANALYSIS
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|SENATE RULES COMMITTEE | SB 744|
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THIRD READING
Bill No: SB 744
Author: Strickland (R)
Amended: 5/21/09
Vote: 27 - Urgency
SENATE HEALTH COMMITTEE : 11-0, 4/15/09
AYES: Alquist, Strickland, Aanestad, Cedillo, Cox,
DeSaulnier, Leno, Maldonado, Negrete McLeod, Pavley, Wolk
SENATE BUS., PROF. & ECON. DEVEL. COMMITTEE : 6-1, 4/27/09
AYES: Wyland, Aanestad, Oropeza, Romero, Walters, Yee
NOES: Correa
NO VOTE RECORDED: Negrete McLeod, Corbett, Florez
SENATE APPROPRIATIONS COMMITTEE : 13-0, 5/26/09
AYES: Kehoe, Cox, Corbett, Denham, DeSaulnier, Hancock,
Leno, Oropeza, Runner, Walters, Wolk, Wyland, Yee
SUBJECT : Clinical laboratories: public health
laboratories
SOURCE : Department of Public Health
DIGEST : This bill increases licensing fees on clinical
laboratories and their personnel, as administered by the
Laboratory Field Services within the Department of Health.
ANALYSIS :
Existing law:
CONTINUED
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1. Establishes in federal law, the Clinical Laboratory
Improvement Amendments of 1988 (CLIA), regulates
laboratories when performing testing on human specimens
and includes laboratory standards for proficiency
testing, facility administration, personnel
qualifications, and quality control and applies
standards to all settings, including commercial,
hospital, or physician office laboratories.
2. Establishes within the Department of Public Health (DPH)
the Laboratory Field Services (LFS) which provides for
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," or that perform provider-performed microscopy
(PPM), which is microscopic analysis of a specimen by a
health care provider such as a physician, to be
registered, rather than licensed, by DPH, and requires a
laboratory that operates multiple locations, to obtain a
separate license or registration for each laboratory
location.
4. 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.
5. Allows the DPH to certify a clinical laboratory that is
accredited by a private, nonprofit organization as
having met state licensure or registration requirements,
provided that the accrediting organization is federally
approved under CLIA, has accreditation standards that
are equal to, or more stringent than, state licensure
and registration requirements, and allows DPH to
randomly inspect its accredited clinical laboratories
for compliance with state law. Specifies certification
requirements for accredited laboratories, including
allowing the accrediting organization to provide any
records or other information about the laboratory
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required by DPH.
6. Requires clinical laboratories to pay fees, as
specified, to DPH for the purposes of initial and
renewal licensure, registration, or certification.
7. Establishes the Clinical Laboratory Improvement Fund
(CLIF), into which fees collected by DPH from clinical
laboratories are deposited and used for the purpose of
licensing, registration, certification, inspection, or
other activities relating to the regulation of clinical
laboratories.
8. Requires the services of a public health laboratory to
be available to city or county local public health
departments for the purpose of examining suspected cases
of infectious and environmental diseases, and to assist
in community disease surveillance. Requires any city or
county public health laboratory, and specified personnel
to be approved by DPH, and to comply with all applicable
CLIA requirements. Under existing law, public health
laboratories are exempt from licensure and certification
fees.
9. Requires an unlicensed person employed by a clinical
laboratory whose job is to withdraw blood from a patient
to be certified as a phlebotomy technician. Existing
law requires an individual seeking phlebotomy technician
certification to pay a fee of $25 to DPH upon initial
application and annual renewal.
This bill increases the certification and biennial renewal
fee of a phlebotomy technician from $25 to $100. The
current fee generates approximately $1 million annually.
Preliminary analysis indicates that this fee will generate
approximately $2 million in revenues, or $1 million net,
from licensing 36,000 - 40,000 phlebotomists each year.
This bill increases fees on various clinical personnel in
specified amounts.
This bill requires clinical laboratories that perform tests
classified as moderate to high complexity under CLIA that
will be applying for licensure or annual renewal to pay a
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fee based on the number of tests performed at the
laboratory, which will be capped at 15 million tests per
facility annually. The current fees generated
approximately $1.8 million in FY 2007-2008. It is
estimated that revenues will be $4 million in FY 2009-2010
and $5 million ongoing, or $2 million net in FY 2009-2010
and $3 million net ongoing.
This bill increases the annual fee for the clinical
laboratories registered by the DPH that perform tests
waived by CLIA and/or provider-performed microscopy. The
current fee generates approximately $500,000 annually.
This fee increase will generate approximately $1 million in
FY 2009-2010 and $1.5 million ongoing, or $500,000 net in
FY 2009-2010 and $1 million net ongoing.
This bill prohibits the total fees collected from exceeding
the costs incurred by the department for licensing,
certification, inspection, or other activities related to
the regulation of clinical laboratories.
This bill provides that the costs of the DPH to conduct a
reinspection of a laboratory applying for initial licensure
would be paid by the laboratory in the amount of the
initial application fee unless the reinspection was due to
an error or omission by the department. This bill requires
a clinical laboratory to pay a delinquency fee equal to 25
percent of the annual renewal fee if its license or
registration is not renewed before the expiration date.
FISCAL EFFECT : Appropriation: No Fiscal Com.: Yes
Local: Yes
According to the Senate Appropriations Committee:
Fiscal Impact (in thousands)
Major Provisions 2009-10 2010-11
2011-12 Fund
Clinical laboratory ($3,000)
($5,000)($5,000)Special*
licensing, registration,
and laboratory staff
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fee revenue
*Clinical Laboratory Improvement Fund
SUPPORT : (Verified 5/27/09)
California Department of Public Health (source)
Blood Centers of California
California Association of Public Health Laboratory
Directors
ARGUMENTS IN SUPPORT : According to the DPH, the Sponsor
of this bill, DPH is currently unable to adequately enforce
state laws and regulations regarding licensing,
certification and registration of clinical laboratories,
because of insufficient funding. DPH points out that this
funding shortage has resulted in an inability for LFS to
conduct inspections, investigate complaints, promptly
process licensure applications, and take enforcement action
when needed. It states that the provisions in this bill
will help address this problem, by adjusting and imposing
new fees for facility and personnel licensure and
certification, charging for re-inspections of laboratories,
fining for delinquent laboratory license renewals, and
charging fees for licensure of multiple laboratory
locations. DPH also indicates that in order to improve LFS
inspection activities, this bill implements a
recommendation by the California State Auditor to leverage
accrediting organizations for the purposes of clinical
laboratory inspections. A strong clinical laboratory
oversight program is necessary to protect public health,
and that this bill provides additional resources for the
laboratory oversight program within DPH.
CTW:do 5/28/09 Senate Floor Analyses
SUPPORT/OPPOSITION: SEE ABOVE
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