BILL ANALYSIS Ó
AB 940
Page 1
ASSEMBLY THIRD READING
AB
940 (Ridley-Thomas and Waldron)
As Amended April 23, 2015
Majority vote
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|Committee |Votes |Ayes |Noes |
| | | | |
| | | | |
|----------------+------+---------------------+---------------------|
|Business & |14-0 |Bonilla, Jones, | |
|Professions | |Baker, Bloom, | |
| | |Campos, Chang, Dodd, | |
| | |Eggman, Gatto, | |
| | |Holden, Mullin, | |
| | |Ting, Wilk, Wood | |
| | | | |
|----------------+------+---------------------+---------------------|
|Appropriations |17-0 |Gomez, Bigelow, | |
| | |Bonta, Calderon, | |
| | |Chang, Daly, Eggman, | |
| | |Gallagher, | |
| | | | |
| | | | |
| | |Eduardo Garcia, | |
| | |Gordon, Holden, | |
| | |Jones, Quirk, | |
| | |Rendon, Wagner, | |
| | |Weber, Wood | |
| | | | |
| | | | |
AB 940
Page 2
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SUMMARY: Adds the specialty of reproductive biology and the
subspecialty of biochemical genetics and makes conforming changes,
removes the requirement that clinical laboratory co-directors
substantially comply with federal Clinical Laboratory Improvement
Amendments (CLIA) requirements, and makes other technical and
conforming changes. Specifically, this bill:
1)Amends the definition of laboratory director to clarify that the
laboratory director on the laboratory's CLIA certificate meets
the qualifications under CLIA for the type and complexity of
tests being offered by the laboratory.
2)Amends the definition of laboratory director to allow a
scientist, licensed under state law to direct a laboratory
performing high complexity tests, such as a bioanalyst, to
become a co-director of a laboratory performing high complexity
tests without having to meet the CLIA requirements.
3)Amends the requirement for a bioanalyst license to allow an
applicant to obtain four years of experience as any kind of CLS
in any CLIA-approved laboratory instead of four years of
experience as a California-licensed CLS in laboratory approved
by the California Department of Public Health (CDPH).
4)Adds two new license categories: a) the specialty of
reproductive biology and b) the subspecialty of biochemical
genetics and makes conforming changes.
5)Authorizes CDPH to charge a renewal fee for the existing license
categories of clinical cytogeneticist and clinical molecular
biologist licenses.
AB 940
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6)Makes conforming changes.
FISCAL EFFECT: According to the Assembly Appropriations
Committee, this bill would result in the following costs and
revenues to the Clinical Laboratory Improvement Fund:
1)One-time costs of in the range of $400,000 over two years. This
includes modifying regulations, program development, creating
forms and related implementation activities.
2)Ongoing costs of under $100,000 to oversee additional licenses.
3)Projected ongoing fee revenue of approximately $90,000
associated with new licensure categories
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. This bill will allow a Bioanalyst with a
Master's Degree to serve as an additional laboratory director in a
laboratory performing high complexity testing and will allow an
applicant for a bioanalyst license to obtain the required four
years of experience in an out of state CLIA-approved laboratory.
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."
AB 940
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Background. This bill seeks to address clinical laboratory
workforce issues with two changes: 1) allowing qualified
licensees without doctorate or medical degrees, such as a
bioanalyst, to serve as laboratory co-directors and 2) providing
more career opportunities within the clinical laboratory field.
Clinical Lab Directors. Under federal law, all clinical
laboratories must have a laboratory director that complies with
the CLIA requirements. Among other things, CLIA requires that
laboratory directors for laboratories performing high complexity
tests must have, among other things, a medical or doctorate
degree. For medium complexity tests, the minimum requirement is a
bachelor's degree and a specific level of training. This bill
will allow a licensee without a medical or doctorate degree, who
can already perform high complexity tests, to serve as the
director of a clinical laboratory performing high complexity
tests.
Clinical Laboratory Bioanalyst Requirements. Under current law,
bioanalysts must complete four years of training in a CDPH
approved facility. 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 states other states. New York, Florida,
California, and about 10 other states and United States
territories have personnel licensing schemes that laboratories
must meet.
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.
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This bill seeks to increase employment in clinical laboratories by
providing more career opportunities for personnel.
Analysis Prepared by:
Vincent Chee / B. & P. / (916) 319-3301 FN:
0000683