SENATE COMMITTEE ON
BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT
Senator Jerry Hill, Chair
2015 - 2016 Regular
Bill No:
Author:
Version:
Urgency:
Consultant:
AB 940
Ridley-Thomas
April 23, 2015
No
Sarah Huchel
Hearing Date:
June 29, 2015
Fiscal:
Yes
Subject: Clinical laboratories.
SUMMARY: Allows a master’s level bioanalyst to be a laboratory director for a highcomplexity lab, creates licenses for a clinical reproductive biologist and clinical
biochemical geneticist, and makes other modifications to existing law.
Existing state law:
1) Provides for the licensure, registration, and regulation of clinical laboratories and
various clinical laboratory personnel by the California Department of Public Health
(DPH). (Business and Professions Code (BPC) §§ 1200-1327)
2) Defines a “clinical laboratory bioanalyst” or “bioanalyst” to mean a person licensed to
engage in clinical laboratory practice and direction of a clinical laboratory. (BPC §
1203)
3) Authorizes a person licensed as a clinical laboratory bioanalyst or bioanalyst to:
a) If qualified under Clinical Laboratory Improvement Amendments (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 DPH.
c) To perform any clinical laboratory test or examination classified as waived or of
moderate complexity under CLIA. (BPC § 1203)
4) Authorizes a person licensed to engage in clinical laboratory practice or to direct a
clinical laboratory to perform high complexity CLIA tests if the test is performed
under the overall operation and administration of the laboratory director, and if the
test or examination is within a specialty or subspecialty authorized by the person’s
licensure. (BPC § 1206.5 (c)(3))
5) Requires DPH, if it determines that a new category of license is necessary to direct a
laboratory or to perform clinical laboratory tests or examinations in specific
specialties or subspecialties, to adopt regulations identifying the license category or
modification, the education, training, and examination necessary to obtain the
AB 940 (Ridley-Thomas)
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license, and the specialty or subspecialty, or both, included within the new license
category, or within the existing category as modified. (BPC § 1208 (a))
6) 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))
7) Allows a clinical laboratory to have multiple laboratory directors. (BPC § 1265)
8) Requires an applicant for a clinical laboratory bioanalyst license to obtain experience
at a clinical laboratory approved by DPH. (BPC § 1260)
Existing federal law:
1) 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)
2) Classifies laboratory tests using three categories: “waived,” “moderate complexity,”
or “high complexity.” (42 CFR § 493.5)
3) Requires the laboratory director to be qualified to manage and direct the laboratory
personnel and performance of high complexity tests and must be eligible to be an
operator of a laboratory, as specified.
a) Requires the laboratory director to possess a current license as a laboratory
director issued by the State in which the laboratory is located, if such licensing is
required; and
b) Requires the laboratory director to:
i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine
or osteopathy in the State in which the laboratory is located; and
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ii) Be certified in anatomic or clinical pathology, or both, by the American Board
of Pathology or the American Osteopathic Board of Pathology or possess
qualifications that are equivalent to those required for such certification; or
c) Be a doctor of medicine, a doctor of osteopathy or doctor of podiatric medicine
licensed to practice medicine, osteopathy or podiatry in the State in which the
laboratory is located; and
i) Have at least one year of laboratory training during medical residency; or
ii) Have at least 2 years of experience directing or supervising high complexity
testing; or
d) Hold an earned doctoral degree in a chemical, physical, biological, or clinical
laboratory science from an accredited institution, and
i) Be certified and continue to be certified by a board approved by the United
States Health and Human Services Agency; or
ii) Before February 24, 2003, must have served or be serving as a director of a
laboratory performing high complexity testing and must have at least—
(1) Two years of laboratory training or experience, or both; and
(2) Two years of laboratory experience directing or supervising high
complexity testing.
e) Be serving as a laboratory director and must have previously qualified or could
have qualified as a laboratory director, as specified, on or before February 28,
1992; or
f) On or before February 28, 1992, be qualified under State law to direct a
laboratory in the State in which the laboratory is located. (42 CFR § 493.1443)
4) Requires the laboratory director to be responsible for the overall operation and
administration of the laboratory, including the employment of personnel who are
competent to perform test procedures, and record and report test results promptly,
accurate, and proficiently and for assuring compliance with the applicable
regulations. Among other duties, the laboratory director is required to:
a) Employ a sufficient number of laboratory personnel with the appropriate
education and either experience or training to provide appropriate consultation,
properly supervise and accurately perform tests, and report test results in
accordance with personnel responsibilities.
b) Ensure that prior to testing patients' specimens, all personnel have the
appropriate education and experience, receive the appropriate training for the
type and complexity of the services offered, and have demonstrated that they
can perform all testing operations reliably to provide and report accurate results.
(42 CFR § 493.1407)
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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) Establishes the following for a “clinical reproductive biologist” and “clinical
biochemical geneticist:”
a) Adds them to the list of persons authorized to be licensed by DPH to engage in,
or supervise others engaged in, clinical laboratory practice, that is limited to his
or her area of specialization.
b) Authorizes them to perform any clinical laboratory test or examination classified
as waived or of moderate complexity under CLIA.
c) Authorizes them to perform the duties and responsibilities of a laboratory
director, who is not the CLIA laboratory director, limited to his or her area of
specialty or subspecialty and are permitted only direct a clinical laboratory
providing service within those specialties or subspecialties.
d) Authorizes them, if qualified under CLIA, to perform clinical laboratory tests or
examinations classified as of high complexity under CLIA, and the duties and
responsibilities of a CLIA lab director, technical consultant, clinical consultant,
technical supervisor, and general supervisor, as specified.
e) Authorizes them to direct clinical laboratories specializing in biochemical genetics
within the specialty of genetics and reproductive biology, respectively, or other
specialty or subspecialty specified by DPH in regulation.
f) Makes them eligible for a limited clinical laboratory scientist license.
g) Adds them to the list of individuals who may supervise a trainee for the purpose
of receiving comprehensive practical experience and instruction in clinical
laboratory procedures.
3) 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).
4) Deletes requirements that specify a laboratory director must substantially meet the
requirements under CLIA.
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5) 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.
6) Strikes reference to the requirement that an applicant for a clinical bioanalyst license
have four years’ experience as a “licensed” clinical laboratory scientist.
7) 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.
8) Makes clarifying and technical amendments.
FISCAL EFFECT: This bill is keyed “fiscal” by the Legislative Counsel. According to
the Assembly Appropriations Committee analysis dated May 4, 2015, this bill will have
the following impact 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:
1. Purpose. This bill is sponsored by the California Clinical Laboratory Association.
According to the Author’s office, “There is a critical and growing shortage of licensed
clinical laboratory personnel in California. AB 940 will re-instate a true career ladder
for laboratory personnel by allowing a Bioanalyst to serve as the co-director of a high
complexity laboratory.” This bill will also permit experience toward a bioanalyst
license to be obtained at a CLIA-certified laboratory, instead of just a DPH-approved
laboratory, and creates licensure categories for clinical reproductive biologists and
clinical biochemical geneticists.
2. 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
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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:
a) Low visibility of the profession, resulting in a lack of recognition and public
understanding of laboratory careers.
b) The growth of industries such as biotech and laboratory manufacturers has
increased the demand for skilled workers.
c) 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.
3. 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.” 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 DPH 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.
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4. Reproductive Biology and Biochemical Genetics. Current law allows the DPH to
issue licenses and limited licenses in various scientific specialties and
subspecialties. Current law also requires DPH, if it determines that a new category
of license is necessary, to direct a laboratory or to perform clinical laboratory tests or
examinations in specific specialties or subspecialties; to adopt regulations identifying
the license category, the education, training, and examination necessary to obtain
the license, and the specialty or subspecialty, or both, included within the new
license category, or within the existing category as modified.
It does not appear that DPH has begun the regulatory process to recognize the new
specialties and licenses authorized in this bill; reproductive biology and clinical
biochemical genetics. It is unclear whether DPH has determined that these
categories are unnecessary or is failing to act to reflect market needs.
5. Related legislation this year. AB 757 (Gomez) of 2015, makes an exception to
California law to allow an individual who meets standards equivalent to federally
requirements to perform a particular type of total protein refractometer test in a
licensed plasma collection facility. (Status: This bill is scheduled to be heard in this
committee on June 29, 2015.)
AB 599 (Bonilla) of 2015, expands the scope of practice for a licensed
cytotechnologist by authorizing the performance of all tests and procedures
pertaining to cytology under the supervision of a laboratory director. (Status: This
bill is pending on the Senate Floor.)
6. Prior related 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. (Status: This bill was held in the Assembly Business and
Professions Committee.)
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 DPH and comply
with all other requirements governing clinical laboratories, as specified.
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7. 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.”
8. Recommended Technical Amendment. BPC 1205 is currently one continuous
sentence and is not clear as to its purpose. The following amendment would clarify
that the professions listed are those authorized to provide training to a trainee.
On page 4, line 18, place a period after “science” and insert “The training provided to
a trainee shall be provided”
On page 4, line 19, insert “any of the following individuals” before “a person”
On page 4, line 20, insert “a” after “chapter,”
SUPPORT AND OPPOSITION:
Support:
California Clinical Laboratory Association (Sponsor)
American Association of Bioanalysts
American Clinical Laboratory Association
California Association of Bioanalysts
California Society of Pathologists
Laboratory Corporation of America
Opposition:
None on file as of June 23, 2015.
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