BILL ANALYSIS Ó
SENATE COMMITTEE ON
BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT
Senator Jerry Hill, Chair
2015 - 2016 Regular
Bill No: AB 940 Hearing Date: June 29,
2015
-----------------------------------------------------------------
|Author: |Ridley-Thomas |
|----------+------------------------------------------------------|
|Version: |April 23, 2015 |
-----------------------------------------------------------------
----------------------------------------------------------------
|Urgency: |No |Fiscal: |Yes |
----------------------------------------------------------------
-----------------------------------------------------------------
|Consultant|Sarah Huchel |
|: | |
-----------------------------------------------------------------
Subject: Clinical laboratories.
SUMMARY:1) Allows a master's level bioanalyst to be a laboratory
director for a high-complexity 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.
AB 940 (Ridley-Thomas) Page 2
of ?
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 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.
AB 940 (Ridley-Thomas) Page 3
of ?
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
ii)Be certified in anatomic or clinical pathology, or both,
by the American Board of Pathology or the American
AB 940 (Ridley-Thomas) Page 4
of ?
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
AB 940 (Ridley-Thomas) Page 5
of ?
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)
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
AB 940 (Ridley-Thomas) Page 6
of ?
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.
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:
AB 940 (Ridley-Thomas) Page 7
of ?
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
AB 940 (Ridley-Thomas) Page 8
of ?
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 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
AB 940 (Ridley-Thomas) Page 9
of ?
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 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.
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
AB 940 (Ridley-Thomas) Page 10
of ?
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.
AB 940 (Ridley-Thomas) Page 11
of ?
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.
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,"
AB 940 (Ridley-Thomas) Page 12
of ?
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.
-- END --