BILL ANALYSIS
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|SENATE RULES COMMITTEE | SB 744|
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UNFINISHED BUSINESS
Bill No: SB 744
Author: Strickland (R)
Amended: 7/14/09
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 BUSINESS, PROF. & ECON. DEVELOP. COMM. : 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
SENATE FLOOR : 39-0, 6/1/09
AYES: Aanestad, Alquist, Ashburn, Benoit, Calderon,
Cedillo, Cogdill, Corbett, Correa, Cox, Denham,
DeSaulnier, Ducheny, Dutton, Florez, Hancock, Harman,
Hollingsworth, Huff, Kehoe, Leno, Liu, Lowenthal,
Maldonado, Negrete McLeod, Oropeza, Padilla, Pavley,
Romero, Runner, Simitian, Steinberg, Strickland, Walters,
Wiggins, Wolk, Wright, Wyland, Yee
ASSEMBLY FLOOR : 70-3, 9/2/09 - See last page for vote
SUBJECT : Clinical laboratories: public health
CONTINUED
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laboratories
SOURCE : Department of Public Health
DIGEST : This bill revises licensing and certification
requirements for clinical laboratories by recognizing
accreditation of clinical laboratories by private,
nonprofit organizations (PNOs), as specified, revises
license fees according to the number of tests performed,
and makes other administrative changes
Assembly Amendments delete the requirement for PNOs provide
the Department of Health Services (DHS) procedures for
making proficiency testing information available upon
request of any person, delete the requirement for PNOs to
agrees to permit the Department to conduct random
inspections of clinical laboratories accredited by it in
order to validate compliance with California law, and
require DHS to begin accepting applications for
certificates of deemed status, in a form and manner
prescribed by DHS, by January 1, 2011.
ANALYSIS :
Existing law:
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
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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
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
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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:
1. Requires the State Department of Health Services
(DHS) to issue a certificate of deemed status to
laboratories accredited by PNOs that they deem meet
state licensure or registration requirements, provided
that the following conditions are met:
A. The PNO meets all of the following
requirements:
(i) Is approved by the federal
Center for Medicare and Medicaid Services
as an accreditation body under the federal
Clinical Laboratory Improvement Amendments
of 1988 (CLIA) and provides the Department
with the following information:
(1) A detailed comparison of
the individual accreditation or approval
requirements, with the comparable
condition-level requirements;
(2) A detailed description
of its inspection process, including all
of the following:
a. Frequency
of inspections;
b. Copies of
inspection forms;
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c.
Instructions and guidelines;
d. A
description of the review and decision
making process of inspections;
e. A statement
concerning whether inspections are
announced or unannounced; and,
f. A
description of the steps taken to monitor
the correction of deficiencies.
(3) A description of the
process for monitoring proficiency testing
performance, including action to be taken
in response to unsuccessful participation;
and,
(4) A list of all of its
current California licensed or registered
laboratories and the expiration date of
their accreditation, licensure, or
registration, as applicable.
(ii) Is approved by DHS as having
accreditation standards that are equal to,
or more stringent than, state requirements
for licensure and registration;
(iii) Conducts inspections of
clinical laboratories in a manner that will
determine compliance with federal standards
and California laws to the extent that
California laws provide greater protection
to residents, or are more stringent than
federal standards, as determined by DHS.
Permits DHS to, without taking regulatory
action, implement or interpret this section
by means of an All Clinical Laboratories
Letter (ACLL), as specified.
(iv) Is approved by DHS as meeting the
requirements of this bill. Requires DHS to
begin accepting applications for approval,
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in a form and manner prescribed by DHS, by
January 1, 2011. Requires DHS to make a
determination on an application submitted
pursuant to this subparagraph within 180
days of receiving the application.
B. The laboratory meets all of the following
requirements:
(i) Meets the accreditation standards
of the PNO;
(ii) Agrees to permit the PNO to
provide any records or other information to
DHS, its agents, or contractors, as DHS may
require;
(iii) Pays fees, as specified;
(iv) Authorizes its proficiency testing
organization to furnish to DHS and the PNO
the results of the laboratory's
participation in an approved proficiency
testing program, as specified, for the
purpose of monitoring the laboratory's
proficiency testing, along with explanatory
information needed to interpret the
proficiency testing results, upon request of
DHS;
(v) Authorizes the PNO to release to
DHS a notification of every violation of
condition-level requirements, including the
actions taken by the organization as a
result of the violation, within 30 days of
the initiation of the action; and,
(vi) Authorizes the PNO to give notice
to DHS of any withdrawal of the laboratory's
accreditation.
2. States that if the PNO has withdrawn or revoked its
accreditation of a laboratory, the laboratory shall
retain its certificate of deemed status for 45 days
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after it receives notice of the withdrawal or
revocation of the accreditation, or the effective date
of any action taken by DHS, whichever is earlier.
3. Requires a certificate of deemed status issued to be
renewed annually provided that the conditions for
issuance are still met. Except as otherwise
authorized, DHS shall not conduct routine inspections
of a laboratory issued a certificate of deemed status.
Each application for a certificate of deemed status
and each request for renewal of that certificate shall
be accompanied by fees, as specified.
4. Requires the total of the certificate application and
renewal fees collected by DHS to be sufficient to
cover the cost of issuing the certificate. If DHS
determines that those certificate fees do not fully
support the costs of these activities, it shall report
that determination to the Legislature.
5. Specifies that this bill should not be construed to
prohibit the exercise of DHS's authority to conduct
complaint investigations, sample validation
inspections, or require submission of proficiency
testing results to DHS to ensure compliance of any
clinical laboratory with state standards.
6. Requires DHS to charge fees for the application and
renewal of the certificate of no more than $100 for a
two-year period.
7. Requires a clinical laboratory applying for a license
to perform tests or examinations classified as of
moderate or of high complexity under CLIA and a
clinical laboratory applying for certification to pay
an application fee for that license or certification
based on the number of tests it performs or expects to
perform in a year, as follows:
A. Fewer than 2,001 tests: $270;
B. Between 2,001 and 10,000, inclusive,
tests: $820;
C. Between 10,001 and 25,000, inclusive,
tests: $1,315;
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D. Between 25,001 and 50,000, inclusive,
tests: $1,580;
E. Between 50,001 and 75,000, inclusive,
tests: $1,960;
F. Between 75,001 and 100,000, inclusive,
tests: $2,340;
G. Between 100,001 and 500,000, inclusive,
tests: $2,740;
H. Between 500,001 and 1,000,000, inclusive,
tests: $4,910; and,
I. More than 1,000,000 tests: $5,260, plus
$350 for every 500,000 tests over 1,000,000, up
to a maximum of 15,000,000 tests.
8. Requires a clinical laboratory performing tests or
examinations classified as of moderate or of high
complexity under CLIA and a clinical laboratory with a
certificate as described above to pay an annual
renewal fee based on the number of tests it performed
in the preceding calendar year, as follows:
A. Fewer than 2,001 tests: $170;
B. Between 2,001 and 10,000, inclusive,
tests: $720;
C. Between 10,001 and 25,000, inclusive,
tests: $1,115;
D. Between 25,001 and 50,000, inclusive,
tests: $1,380;
E. Between 50,001 and 75,000, inclusive,
tests: $1,760;
F. Between 75,001 and 100,000, inclusive,
tests: $2,040;
G. Between 100,001 and 500,000, inclusive,
tests: $2,440;
H. Between 500,001 and 1,000,000, inclusive,
tests: $4,610; and,
I. More than 1,000,000 tests per year:
$4,960, plus $350 for every 500,000 tests over
1,000,000, up to a maximum of 15,000,000 tests.
9. States that the personnel licensing delinquency fee
is equal to the annual renewal fee.
10. Requires a clinical laboratory subject to
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registration, as specified, and performing only those
clinical laboratory tests or examinations considered
waived under CLIA to pay an annual fee of $100.
11. Requires a clinical laboratory subject to
registration, as specified, and performing only
provider-performed microscopy, as defined under CLIA,
to pay an annual fee of $150.
12. Requires a clinical laboratory performing both waived
and provider-performed microscopy to pay an annual
registration fee of $150.
13. Requires the costs of DHS to conduct any
reinspections to ensure compliance of a laboratory
applying for initial licensure to be paid by the
laboratory. This additional cost for each visit shall
be equal to the initial application fee and shall be
paid by the laboratory prior to issuance of a license.
DHS shall not charge a reinspection fee if the
reinspection is due to error or omission on the part
of DHS.
14. Requires a fee of $25 to be assessed for approval of
each additional authorized location.
15. Requires DHS, by July 1, 2013, to report to the
Legislature during the annual legislative budget
hearing process the extent to which the state
oversight program meets or exceeds federal oversight
standards and the extent to which the federal
Department of Health and Human Services is accepting
exemption applications and the potential cost to the
state for an exemption.
16. Prohibits the total fees collected under this chapter
from exceeding the costs incurred by DHS for
licensing, certification, inspection, or other
activities relating to the regulation of clinical
laboratories and their personnel.
17. Requires the annual renewal fee for a clinical
laboratory license or registration to be paid during
the 30-day period before the expiration date of the
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license or registration.
18. Requires that if the license or registration is not
renewed before the expiration date, the licensee or
registrant, as a condition precedent to renewal, must
pay a delinquency fee equal to 25% of the annual
renewal fee for up to 60 days after the expiration
date, in addition to the annual renewal fee in effect
on the last preceding regular renewal date. Failure to
pay the annual renewal fee in advance during the time
the license or registration remains in force shall
result in the forfeiture of the license or
registration after a period of 60 days from the
expiration date of the license or registration.
19. Requires all fees and interest to be deposited and
maintained in the Clinical Laboratory Improvement Fund
(CLIF) and to be used for the purpose of administering
the regulation of clinical laboratories only, as
specified.
20. Adds an urgency statute, stating that in order to
protect the public health by providing strong clinical
laboratory oversight as soon as possible, it is
necessary that this bill take effect immediately.
21. Makes legislative findings and declarations.
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
fee revenue
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*Clinical Laboratory Improvement Fund
SUPPORT : (Verified 9/3/09)
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.
ASSEMBLY FLOOR :
AYES: Adams, Ammiano, Arambula, Beall, Bill Berryhill,
Blakeslee, Block, Blumenfield, Brownley, Caballero,
Charles Calderon, Carter, Chesbro, Conway, Cook, Coto,
Davis, De La Torre, De Leon, DeVore, Emmerson, Eng,
Evans, Feuer, Fletcher, Fong, Fuentes, Fuller, Furutani,
Gaines, Galgiani, Garrick, Gilmore, Harkey, Hayashi,
Hernandez, Hill, Huber, Huffman, Jeffries, Jones,
Krekorian, Lieu, Bonnie Lowenthal, Ma, Mendoza, Monning,
Nava, Nestande, Niello, Nielsen, John A. Perez, V. Manuel
Perez, Portantino, Ruskin, Salas, Saldana, Silva,
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Skinner, Smyth, Solorio, Audra Strickland, Swanson,
Torlakson, Torres, Torrico, Tran, Villines, Yamada, Bass
NOES: Anderson, Tom Berryhill, Knight
NO VOTE RECORDED: Buchanan, Duvall, Hagman, Hall, Logue,
Miller,
CTW:do 9/3/09 Senate Floor Analyses
SUPPORT/OPPOSITION: SEE ABOVE
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