BILL ANALYSIS Ó
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|SENATE RULES COMMITTEE | AB 940|
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THIRD READING
Bill No: AB 940
Author: Ridley-Thomas (D) and Waldron (R)
AmendedAmended:7/14/15 in Senate
Vote: 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 masters 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:
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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.
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
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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:
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.
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7)Authorizes a renewal fee for a clinical laboratory
toxicologist, clinical cytogeneticist, and clinical molecular
biologist.
8)Makes clarifying and technical amendments.
Background
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,
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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
lesser-credentialed individuals to be lab directors for labs
conducting high complexity tests. However, the DPH has
interpreted "substantially" to mean "fully." 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 Fiscal
Com.:YesLocal: No
SUPPORT: (Verified8/19/15)
California Clinical Laboratory Association (source)
American Association of Bioanalysts
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American Clinical Laboratory Association
California Association of Bioanalysts
California Society of Pathologists
Laboratory Corporation of America
OPPOSITION: (Verified8/19/15)
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."
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
AB 940
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