BILL ANALYSIS Ó
AB 940
Page 1
Date of Hearing: April 21, 2015
ASSEMBLY COMMITTEE ON BUSINESS AND PROFESSIONS
Susan Bonilla, Chair
AB 940
(Ridley-Thomas and Waldron) - As Amended March 23, 2015
SUBJECT: Clinical laboratories.
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 substantive and non-substantive changes.
EXISTING LAW:
Federal Clinical Laboratory Improvement Act of 1988 (CLIA)
1)Requires clinical laboratories that perform tests on human
specimens to apply for certification with the Centers for
Medicaid and Medicare Services (CMS). (Title 42 of the Code of
Federal Regulations (CFR) § 493.3)
2)Sets standards for facility administration, personnel
qualifications, and quality control. The standards apply to
all settings, including commercial, hospital or physician
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office laboratories. The standards vary depending on the
complexity of the tests performed by the laboratory. (42 CFR
§§ 493.15-493.1495)
3)Classifies the complexity of the tests performed by a
laboratory as waived, moderate-complexity, or high-complexity.
(42 CFR § 493.5)
4)Defines waived tests as simple laboratory examinations and
procedures that are approved by the Food and Drug
Administration (FDA) for home use, employ methodologies that
are simple and accurate as to render the likelihood of
erroneous results negligible or pose no reasonable risk of
harm to the patient if the test is performed incorrectly. (42
CFR § 493)
5)Establishes a set of criteria to establish the complexity of
lab tests. Each criteria is rated from 1-3, and a total score
of less 12 is a moderate-complexity test, while higher than 12
is a high-complexity test. (42 CFR §493.17)
6)Requires a laboratory, as specified, to have a director who
meets specified qualifications and provides overall management
and direction. (42 CFR §§ 493.1403, 493.1441)
7)Requires a clinical laboratory director of a laboratory
performing medium complexity tests to have a medical degree, a
Ph.D., a master's degree, or bachelor's degree in a specified
field. (42 CFR § 493.1405)
8)Requires clinical laboratory directors of laboratories
performing high complexity tests to either have a medical
degree or a Ph.D. in a specified field with varying amounts of
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experience. (42 CFR §493.1443)
State Law
1)Provides for the licensure and regulation of clinical
laboratories and their personnel by the California Department
of Public Health (CDPH) and requires clinical laboratories to
be operated under the supervision of a laboratory director.
(Business and Professions Code (BPC) § 1260-1327; Title 17
California Code of Regulations (CCR) § 950-1230)
2)Defines a "laboratory director" as any person who is a duly
licensed physician and surgeon or is licensed to direct a
clinical laboratory and who substantially meets the laboratory
director qualifications under CLIA for the type and complexity
of tests being offered by the laboratory. (BPC § 1209)
3)Defines a "clinical laboratory bioanalyst" or "bioanalyst" as
any person licensed by the CDPH to engage in clinical
laboratory practice and direct a clinical laboratory. (BPC §
1203)
4)Specifies that a licensed bioanalyst that is qualified under
CLIA may perform the duties and responsibilities of a
laboratory director, 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 CDPH. (BPC § 1203)
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5)A licensed bioanalyst may perform any clinical laboratory test
or examination classified as waived or of moderate complexity
under CLIA. (BPC § 1203)
6)Defines "clinical laboratory scientist" (CLS) as any person,
other than a licensed clinical laboratory bioanalyst or
trainee, who is licensed to engage in clinical laboratory
practice under the supervision of a laboratory director. (BPC
§ 1204)
7)Specifies that a licensed CLS that is qualified under CLIA may
perform clinical laboratory tests or examinations classified
as of high complexity under CLIA and the duties and
responsibilities of a 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 by regulation adopted by
the department. (BPC § 1204)
8)Specifies that a licensed CLS may perform any clinical
laboratory test or examination classified as waived or of
moderate complexity under CLIA. (BPC § 1204)
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
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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 a CDPH-approved
laboratory.
4)Adds two new license categories: 1) the specialty of
reproductive biology and 2) the subspecialty of biochemical
genetics and makes conforming changes, including:
a) Authorizes a licensed clinical reproductive biologist
and a licensed clinical biochemical geneticist, limited to
the new subspecialty, to: 1) work in laboratory practice;
2) supervise others; 3) and direct a clinical laboratory,
or the portion limited to the subspecialty.
b) Authorizes a licensed CLS, under the additional
subspecialty of reproductive biology, to perform: 1)
laboratory tests classified as high complexity under CLIA;
2) the duties of a waived laboratory director; 3) the
duties of technical consultant; 4) the duties of clinical
consultant; 5) the duties of technical supervisor; and 6)
the duties general supervisor.
c) Authorizes a licensed trainee, if licensed in the
specialty or subspecialty, to work under the supervision of
a biochemical geneticist scientist and clinical
reproductive biologist scientist.
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d) Authorizes CDPH to issue limited clinical laboratory
scientist licenses for reproductive biology and biochemical
genetics (which limits them to tests of their specialty).
e) Defines the subspecialty of a licensed biochemical
geneticist scientist as biochemical genetics within the
specialty of genetics.
f) Defines the specialty of a licensed reproductive
biologist scientist as reproductive biology.
g) Allows CDPH to charge a fee for licensing and renewal of
clinical reproductive biologists and clinical biochemical
geneticists.
5)Authorizes CDPH to charge a renewal fee for the existing
license categories of clinical cytogeneticist and clinical
molecular biologist licenses.
6)Makes other technical changes.
FISCAL EFFECT: Unknown. This bill is keyed fiscal by the
Legislative Counsel.
COMMENTS:
1)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
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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."
2)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. At the federal level, unless the state
obtained exemption, clinical laboratories that perform
diagnostic and medical tests on human specimens must be CLIA
certified. CLIA requires laboratories performing moderate and
high complexity testing to meet certain procedural and
personnel standards. For laboratories performing waived
testing, the laboratories receive a certificate of waiver.
At the state level, the California Laboratory Field Services
(LFS), under the CDPH, ensures compliance with state law and
CLIA by performing bi-annual onsite inspections of
laboratories to ensure accuracy and reliability of laboratory
test results. The LFS performs routine inspections of over
800 laboratories each year.
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
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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.
In California, laboratories are permitted to have more than
one lab director and all laboratory directors must
"substantially meet" CLIA requirements. However, the CDPH has
not promulgated rules defining "substantially." According the
CDPH, the purpose of the term "substantially" was to allow for
variation in case CDPH sought CLIA exemption, which it has
not. Therefore, under state law, all laboratory directors
must meet all CLIA requirements.
Because at least one laboratory director must meet CLIA, the
removal of the term "substantially" would remove the
requirement that the co-directors meet CLIA requirements.
Instead, there will be one CLIA identified laboratory
director, and the co-directors will only need to meet the CDPH
licensing requirements (master's degree). It is unclear how
the supervision of laboratories is divided up between
laboratory directors.
According to the sponsor, there is no need for all laboratory
directors of laboratories performing high complexity tests to
have a medical or doctorate degree, particularly since there
will always be a CLIA identified laboratory director that has
either a medical degree or doctorate degree. In support, the
sponsor cites two studies commissioned by the U.S. Department
of Health and Human Services (HHS) and one doctoral
dissertation:
a) Kenney, Michael L., "Laboratory Quality and Director
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Qualifications: An Empirical Assessment of the Medicare
Requirement that Directors of Independent Clinical
Laboratories Possess Earned Doctorates," Ph.D.
dissertation, University of California, Berkeley, 1984.
b) Kenney, Michael L., "Laboratory Performance and
Regulatory Requirements: An Empirical Assessment of the
Quality Assurance Effects of Selected Regulatory
Requirements on the Performance of Clinical Laboratories,"
prepared for Technology, Evaluation and Assistance
Division, Laboratory Program Office, Centers for Disease
Control, United States Department of Health and Human
Services, 1985.
c) Kenney, Michael L. and Greenberg, Don P., "Final Report
on Assessment of Clinical Laboratory Regulations," prepared
for Office of Assistant Secretary for Planning and
Education, United States Department of Health and Human
Services, 1986.
While useful, it is important to note that the studies are
approximately 30 years old and may not take into account the
new changes in technology and medicine. Further, they were
all written by the same author so it is difficult to confirm a
lack of bias. However, there are also no studies indicating
otherwise.
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.
For laboratory approval, CLIA recognizes the personnel
requirements of states that have licensing schemes personnel,
such as New York, Florida, California, and about 10 other
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states and US territories, and requires that laboratories meet
the state's personnel license requirements.
By amending the state requirements, this bill will allow an
applicant for a bioanalyst license to obtain the required
experience out of state.
Workforce Shortages. In 2005, the federal Health Resources
and Services Administration (HRSA), working with the
University of California, San Francisco and the American
Society for Clinical Pathology (ASCP) published a clinical lab
scientist and technician workforce study. The study was done
in response to growing concerns over laboratory personnel
shortages.
The study utilized data from the 2002 federal Bureau of Labor
Statistics workforce study, which was used to make comparisons
between states (California was 76 percent lower than the
national average). The study also cited data from a 2002 ASCP
wage and vacancy survey. In the end, the study found
conflicting evidence and methodological variables and was
unable to conclude that there was a national workforce
shortage.
More recent statistics from the Bureau of Labor Statistics
show that, for clinical lab technicians (entry level clinical
lab personnel), California has stayed close to the national
average, between 91-93 percent from 2010 to 2014. For
clinical lab technologists (higher level, such as scientists
and bioanalysts), California has declined from 64 to 56
percent of the national average from 2010 to 2014.
The Bureau also projects that California's employment of
clinical lab technicians will increase 28% between 2012 and
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2022, while nationally it will grow 30%. Clinical lab
technologists will increase 12% between 2012 and 2022, while
nationally it will grow 14%. As of 2014, California employs
approximately 15,750 clinical lab technicians, and
approximately 10,210 clinical lab technologists.
The most recent vacancy survey (2012) by the ASCP, the same
survey used in the HRSA study, suggested that laboratory
vacancy rates have decreased since 2010, a 2% decrease in
laboratory staff and supervisor vacancies, except for the
field of cytology. However, ASCP noted, based on the data it
collected, it expects that there may be a future shortage.
Both the ASCP 2012 survey and the 2011 California Hospital
Association Allied Workforce report point to an aging
workforce; limitations on courses offered by colleges and
universities; laboratory training program closures resulting
in limited space in existing train programs; and, low
professional salaries for graduates as possible contributors
to a national shortage of qualified clinical laboratory
scientists and other laboratory personnel.
In addition, a 2014 Advance Healthcare Network survey indicates
that approximately 35% of laboratory workers are 50-59 years
old, with approximately 17% over the age of 60. Based on the
above data, it is currently 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.
Reproductive Biology and Biochemical Genetics. Current law
allows the CDPH to issue licenses and limited licenses in
various scientific specialties and subspecialties. It does
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not currently allow licenses for reproductive biology or
biochemical genetics.
According to the Johns Hopkins Bloomberg School of Public
Health, reproductive biology is the study of the biochemistry,
physiology, endocrinology, cell biology, genetics, and
molecular biology of a wide range of biological processes
involved in reproduction.
According to the Mayo Clinic, clinical biochemical genetics
deals with the evaluation and diagnosis of patients and
families with inherited metabolic disease, monitoring of
treatment, and distinguishing heterozygous carriers from
non-carriers by metabolite and enzymatic analysis of
physiological fluids and tissues. This bill will allow the
CDPH to issue licenses in the two fields.
3)Previous Legislation. AB 1215 (Hagman and Holden), Chapter
199, Statutes of 2013, expanded the definition of "laboratory
director" to include a duly licensed clinical laboratory
scientist and a duly licensed limited clinical laboratory
scientist and authorizes these individuals to perform the
duties and responsibilities of a waived laboratory director
under CLIA.
AB 830 (Holden) of 2013, would have required CDPH to
promulgate regulations by January 1, 2015, requiring any
facility operating a clinical laboratory to provide specified
training to CLSs, medical laboratory technicians, and any
individuals who are charged with direct and responsible
supervision of either a CLS or a medical laboratory
technician. NOTE: This bill was held in the Assembly Business
and Professions Committee.
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AB 761 (Hernández), Chapter 714, Statutes of 2012, allowed
optometrists to independently perform waived clinical
laboratory tests necessary for the diagnosis of conditions and
diseases of the eye.
SB 1481 (Negrete McLeod), Chapter 874, Statutes of 2012,
eliminated the requirement that only allowed a laboratory
director to perform CLIA waived tests and permitted
pharmacists to administer certain tests that were approved by
the federal Food and Drug Administration for sale to the
public without a prescription in the form of an
over-the-counter test kit upon customer request, provided that
the pharmacy obtained a CLIA certificate of waiver and a
registration from the CDPH and comply with all other
requirements governing clinical laboratories, as specified.
SB 1246 (Negrete McLeod), Chapter 523, Statutes of 2010,
included naturopathic doctors in the list of health care
practitioners who can perform a clinical laboratory test or
examination classified as waived under CLIA and designated
naturopathic doctors as clinical laboratory directors for
CLIA-waived tests only.
AB 1442 (Feuer) of 2007, would have required clinical
laboratories that perform tests to screen for human
immunodeficiency virus that are classified as waived under
CLIA to enroll in a proficiency testing program and to obtain
the appropriate license or registration from DPH, as
specified. NOTE: This bill failed passage on the Assembly
Floor.
AB 185 (Dymally) of 2007, would have expanded the duties that
unlicensed personnel are authorized to perform in a clinical
laboratory and would have revised the level of supervision
required when unlicensed personnel perform them. NOTE: AB 185
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failed passage in the Assembly Committee on Business and
Professions.
AB 1370 (Matthews) of 2005, would have included a pharmacist
within the definition of laboratory director if the clinical
laboratory test or examination is a routine patient assessment
procedure, as defined. NOTE: AB 1370 failed passage in the
Assembly Committee on Business and Professions.
AB 433 (Nava) of 2005, would have exempted physician office
laboratories from licensure and regulatory requirements
governing clinical laboratories and their personnel by the
Department of Health Services. NOTE: AB 433 failed passage in
the Assembly Health Committee.
ARGUMENTS IN SUPPORT:
According to the sponsor, "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. For these reasons, we thank you for authoring AB
940 (Ridley-Thomas)."
ARGUMENTS IN OPPOSITION:
None on file.
IMPLEMENTATION ISSUES:
According to CDPH, "substantially meets CLIA" in BPC § 1209 is
in conflict with another provision of law, BPC § 1207, states
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that a person licensed under BPC § 1264, and who supervises
others engaged in specified laboratory duties, must be also
qualified under CLIA. It is also in conflict with the
provisions of BPC §1209.1, which states that, in order to
perform high complexity tests, a histocompatibility laboratory
director needs to both be licensed under BPC §1260.1 and qualify
under CLIA. Therefore, these professions would need to meet
CLIA requirements regardless.
Because of the possible conflicts between the new laboratory
director definition this bill would create and the individual
sections defining the licensees and their requirements (such as
the bioanalyst in BPC § 1203), the author may wish to amend the
individual licensing provisions to make conforming changes.
REGISTERED SUPPORT:
California Clinical Laboratories Association (sponsor)
California Association of Bioanalysts
LabCorp
American Association of Bioanalysts
American Clinical Laboratory Association
REGISTERED OPPOSITION:
None on file.
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Analysis Prepared by:Vincent Chee / B. & P. / (916) 319-3301