BILL ANALYSIS Ó
AB 940
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CONCURRENCE IN SENATE AMENDMENTS
AB
940 (Ridley-Thomas and Waldron)
As Amended August 20, 2015
Majority vote
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|ASSEMBLY: |79-0 |(June 1, 2015) |SENATE: |40- |(August 31, |
| | | | | |2015) |
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Original Committee Reference: B. & P.
SUMMARY: Clarifies that a qualified licensed bioanalyst may act
as a laboratory director, allows an applicant for a bioanalyst
license to obtain four years of experience in any laboratory
approved under the federal Clinical Laboratory Improvement
Amendments (CLIA), and authorizes the California Department of
Public Health (CDPH) to charge a renewal fee for specified
licenses. Specifically, this bill:
1)Defines "CLIA laboratory director" as the person identified as
the laboratory director on the CLIA certificate issued to the
laboratory by the federal Centers for Medicare and Medicaid
Services (CMS).
2)Clarifies that the laboratory director on the laboratory's
AB 940
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CLIA certificate must meet the qualifications under CLIA for
the type and complexity of tests being offered by the
laboratory.
3)Clarifies that a licensed bioanalyst may, if qualified under
CLIA, act as the CLIA laboratory director or co-director of a
laboratory performing high complexity tests.
4)Allows a clinical laboratory scientist that is not licensed in
this state, who is applying for a bioanalyst license, to
obtain four years of experience in a CLIA-approved laboratory,
rather than a laboratory inspected by the CDPH.
5)Authorizes the CDPH to charge a renewal fee for the existing
license categories of clinical cytogeneticist and clinical
molecular biologist licenses.
6)Makes other conforming changes.
The Senate amendments:
1)Clarify that a licensed bioanalyst, if qualified under CLIA,
may act as a CLIA laboratory director or as a co-laboratory
director.
2)Delete the two new license categories of reproductive biology
and biochemical genetics.
3)Rename the license for clinical molecular biologist to the
license for clinical genetic molecular biologist.
4)Make conforming changes.
AB 940
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FISCAL EFFECT: According to the Senate Appropriations
Committee, pursuant to Senate Rule 28.8, negligible state costs.
COMMENTS:
Purpose. This bill is sponsored by the California Clinical
Laboratory Association. According to the author, "[this bill]
will reestablish a true career ladder in the California clinical
laboratory field. Without this bill, the growing shortage of
licensed clinical laboratory personnel in California will
continue. To meet the healthcare demands of the California
population, increased numbers of licensed clinical laboratory
personnel are needed."
Background. Under federal law, all clinical laboratories must
have a laboratory director that complies with the CLIA
requirements. This bill will clarify the distinction between a
CLIA laboratory director and a co-laboratory director. It will
also allow a licensed bioanalyst who is qualified under CLIA to
serve as either the CLIA laboratory director or the co-director.
Bioanalyst Experience Requirement. Under current law,
bioanalysts must complete four years of training in a CDPH
approved facility as a California licensed clinical laboratory
scientist. When approving laboratories, CDPH performs an onsite
survey and requires ownership information prior to issuing a
laboratory a state license.
This bill will allow an applicant for a bioanalyst license to
use experience acquired in CLIA-approved laboratories in other
states, without being licensed as a clinical laboratory
scientist in this state. California, New York, Florida, and
about 10 other states have state personnel licensing schemes
that are in addition to the federal CLIA requirements.
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Workforce Shortages. At this time, it is unclear whether there
is a current laboratory personnel shortage. However, California
is behind the national average in clinical laboratory
technologists. This bill seeks to increase employment in
clinical laboratories by providing more career opportunities for
personnel.
Clinical Genetic Molecular Biologist Name Change. Existing CDPH
regulations describe the clinical molecular biologist license as
the clinical genetic molecular biologist license (California
Code of Regulations, Title 17, Section 1031.3). This bill
amends the statute to match the regulations.
Analysis Prepared by:
Vincent Chee / B. & P. / (916) 319-3301 FN: 0001552