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AB 940
THIRD READING
Bill No:
Author:
Amended:
Vote:
AB 940
Ridley-Thomas (D) and Waldron (R)
7/14/15 in Senate
21
SENATE BUS, PROF. & ECON. DEV. COMMITTEE: 8-0, 6/29/15
AYES: Hill, Bates, Block, Galgiani, Hernandez, Jackson, Mendoza, Wieckowski
NO VOTE RECORDED: Berryhill
SENATE APPROPRIATIONS COMMITTEE: Senate Rule 28.8
ASSEMBLY FLOOR: 79-0, 6/1/15 - See last page for vote
SUBJECT: Clinical laboratories
SOURCE: California Clinical Laboratory Association
DIGEST: This bill allows a master’s level clinical laboratory bioanalyst who is
not the Clinical Laboratory Improvement Amendments (CLIA) lab director to be a
laboratory director for a high-complexity lab, allows a bioanalyst to gain
experience in a clinical laboratory certified by CLIA, and makes other
modifications to existing law.
ANALYSIS: Existing federal law establishes conditions that laboratories must
meet to perform testing on human specimens for certification under CLIA. (Title
42, Code of Federal Regulations (CFR) § 493.1)
Existing state law:
1) Authorizes a person licensed as a clinical laboratory bioanalyst or bioanalyst to:
a) If qualified under CLIA, to perform clinical laboratory tests or examinations
classified as of high complexity under CLIA.
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b) Perform the duties and responsibilities of a laboratory director, technical
consultant, clinical consultant, technical supervisor, and general supervisor,
as specified under CLIA, in the specialties of histocompatibility,
microbiology, diagnostic immunology, chemistry, hematology,
immunohematology, genetics, or other specialty or subspecialty specified in
regulations adopted by the Department of Public Health (DPH).
c) To perform any clinical laboratory test or examination classified as waived
or of moderate complexity under CLIA. (Business and Professions Code
(BPC) § 1203)
2) Defines the term “laboratory director” to means any person who is:
a) A duly licensed physician and surgeon.
b) Only for purposes of a clinical laboratory test or examination classified as
waived:
i) A licensed clinical laboratory scientist.
ii) A licensed limited clinical laboratory scientist.
iii) A licensed naturopathic doctor.
iv) A licensed optometrist serving as the director of a laboratory which only
performs specified clinical laboratory tests.
c) Licensed to direct a clinical laboratory under existing law and who
substantially meets the laboratory director qualifications under CLIA for the
type and complexity of tests being offered by the laboratory. (BPC § 1209
(a))
3) Allows a clinical laboratory to have multiple laboratory directors. (BPC §
1265)
This bill:
1) Authorizes a master’s level licensed clinical laboratory bioanalyst or bioanalyst
who is not the CLIA lab director to perform all of the following:
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a) Clinical laboratory tests or examinations classified as of high complexity
under CLIA.
b) The duties and responsibilities of a laboratory director in the specialties of
histocompatibility, microbiology, diagnostic immunology, chemistry,
hematology, immunohematology, genetics, or other specialty or subspecialty
specified in DPH regulations.
2) Defines “CLIA laboratory director” as the person identified on the CLIA
certificate issued to the laboratory by the federal Centers for Medicare and
Medicaid Services (CMS).
3) Deletes requirements that specify a laboratory director must substantially meet
the requirements under CLIA.
4) Requires that the following individuals who are identified as the CLIA
laboratory director of a laboratory that performs clinical laboratory tests
classified as moderate or high complexity to meet the laboratory director
qualifications under CLIA for the type and complexity of tests being offered by
the laboratory:
a) A duly licensed physician and surgeon.
b) A person licensed by DPH to direct a clinical laboratory.
5) Strikes reference to the requirement that an applicant for a clinical bioanalyst
license have four years’ experience as a “licensed” clinical laboratory scientist.
6) Replaces the requirement that an applicant for a clinical bioanalyst license have
experience in a clinical laboratory approved by the DPH and is certified under
CLIA.
7) Authorizes a renewal fee for a clinical laboratory toxicologist, clinical
cytogeneticist, and clinical molecular biologist.
8) Makes clarifying and technical amendments.
Background
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Laboratory Personnel Shortage. According to the Healthcare Laboratory
Workforce Initiative, a collaboration of the Hospital Council of Northern and
Central California in conjunction with the California Hospital Association,
California is experiencing a serious shortage of laboratory personnel. It reports
that the number of clinical laboratory scientists declined in California between
1999 and 2001 from 36,000 to 26,000, and, as of several years ago, California
ranks among the seven lowest states in the ratio of clinical laboratory scientists per
100,000 people. The report further indicates that, “While these numbers appear
small, in fact their impact on patient care and hospital operations is great. The
average age of a CLS in California is above 50.”
Several factors contribute to the shrinking clinical laboratory workforce:
1) Low visibility of the profession, resulting in a lack of recognition and public
understanding of laboratory careers.
2) The growth of industries such as biotech and laboratory manufacturers has
increased the demand for skilled workers.
3) A lack of career development opportunities has discouraged potential recruits
and made it difficult to retain qualified professionals.
This bill is designed to create more professional opportunities for individuals
interested in a clinical laboratory career and make it easier for professionals in
other states to meet California training requirements towards state licensure.
Bioanalysts. The federal CLIA laws set the regulatory floor for laboratory testing;
states are free to develop higher standards, and laboratories must follow whichever
law is more stringent. In most cases, California law is stricter than CLIA.
However, CLIA has higher requirements for a bioanalyst to become the director of
a lab conducting high complexity tests than California. CLIA requires the lab
director for high complexity testing to have, among other qualifications, a medical
or doctorate degree. California law permits a lab directors to “substantially meet”
CLIA requirements.
According the author, the purpose of the term “substantially” was to allow for
variation in case California sought full CLIA exemption, which it has not, nor does
it plan to. Inclusion of the word “substantially” was intended to allow lessercredentialed individuals to be lab directors for labs conducting high complexity
tests. However, the DPH has interpreted “substantially” to mean “fully.”
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Therefore, under state law, all laboratory directors must meet all CLIA
requirements.
This bill revises current law to allow a master’s level bioanalyst to be a lab director
for a high complexity lab, contrary to CLIA requirements. The Author’s office
argues this is not in direct conflict with federal law because California law allows
for multiple lab directors, and CLIA requires only one; as long as a lab has one
CLIA lab director responsible for the direction of the lab and personnel, there may
be other lab directors performing lab director duties, but without the full
responsibility and liability associated with the CLIA lab director. DPH has not
opined on validity of this proposal and whether using the term “lab director” for
both individuals who are, and are not CLIA qualified would cause undue
confusion.
This bill also allows a bioanalyst to qualify for California licensure in facilities that
are not California Department of Public Health approved, but rather CLIA
certified. The author’s office argues that this would allow more flexibility for
bioanalysts coming from out of state to qualify for state licensure.
FISCAL EFFECT: Appropriation: No
SUPPORT: (Verified
Fiscal Com.:
Yes
Local: No
8/19/15)
California Clinical Laboratory Association (source)
American Association of Bioanalysts
American Clinical Laboratory Association
California Association of Bioanalysts
California Society of Pathologists
Laboratory Corporation of America
OPPOSITION: (Verified 8/19/15)
None received
ARGUMENTS IN SUPPORT: The sponsor, California Clinical Laboratory
Association, the American Association of Bioanalysts, and the California
Association of Bioanalysts write, “This bill proposes to re-establish a career ladder
for clinical laboratory personnel…. AB 940 is necessary because the bill allows
for California to continue being a competitive state in the clinical laboratory
business that attracts new individuals in this field.”
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California Society of Pathologists write, “Clinical laboratories still have shortages
of multiple types of personnel. We believe that AB 940 will help create a career
ladder to allow lab personnel to enter and provide services in these specialty areas
with requisite training and experience.”
ASSEMBLY FLOOR: 79-0, 6/1/15
AYES: Achadjian, Alejo, Travis Allen, Baker, Bigelow, Bloom, Bonilla, Bonta,
Brown, Burke, Calderon, Campos, Chang, Chau, Chávez, Chiu, Chu, Cooley,
Cooper, Dababneh, Dahle, Daly, Dodd, Eggman, Frazier, Beth Gaines,
Gallagher, Cristina Garcia, Eduardo Garcia, Gatto, Gipson, Gomez, Gonzalez,
Gordon, Gray, Grove, Hadley, Harper, Roger Hernández, Holden, Irwin, Jones,
Jones-Sawyer, Kim, Lackey, Levine, Linder, Lopez, Low, Maienschein, Mathis,
Mayes, McCarty, Medina, Melendez, Mullin, Nazarian, Obernolte, O'Donnell,
Olsen, Patterson, Perea, Quirk, Rendon, Ridley-Thomas, Rodriguez, Salas,
Santiago, Steinorth, Mark Stone, Thurmond, Ting, Wagner, Waldron, Weber,
Wilk, Williams, Wood, Atkins
NO VOTE RECORDED: Brough
Prepared by: Sarah Huchel / B., P. & E.D. / (916) 651-4104
8/19/15 20:48:52
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