BILL ANALYSIS Ó
SENATE COMMITTEE ON
BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT
Senator Jerry Hill, Chair
2015 - 2016 Regular
Bill No: AB 757 Hearing Date: June 29,
2015
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|Author: |Gomez |
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|Version: |June 22, 2015 |
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|Urgency: |No |Fiscal: |Yes |
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|Consultant|Sarah Huchel |
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Subject: Healing arts: clinical laboratories.
SUMMARY:1) 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
(TPRT) in a licensed plasma collection facility.
Existing state law:
1)Provides for the licensure, registration, and regulation of
clinical laboratories and various clinical laboratory
personnel, including cytotechnologists, by the California
Department of Public Health (DPH). (Business and Professions
Code (BPC) §§ 1200-1327)
2)Authorizes the following individuals to perform clinical
laboratory tests or examinations classified as of moderate
complexity under the Clinical Laboratory Improvement
Amendments (CLIA) under the overall operation and
administration of the laboratory director:
a) A licensed physician and surgeon.
b) A licensed podiatrist or a licensed dentist if the
results of the tests can be lawfully utilized within his or
her practice.
c) A person licensed to engage in clinical laboratory
AB 757 (Gomez) Page 2
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practice or to direct a clinical laboratory.
d) A licensed physician assistant if authorized by a
supervising physician and surgeon.
e) A licensed nurse.
f) A perfusionist.
g) A respiratory care practitioner.
h) A person performing nuclear medicine technology.
i) A person certified or licensed as an "Emergency Medical
Technician II" or paramedic while providing prehospital
medical care, a person licensed as a psychiatric
technician, as a vocational nurse, or as a midwife, or
certified as a nurse assistant or a home health aide, who
provides direct patient care, if the person is performing
the test as an adjunct to the provision of direct patient
care by the person, is utilizing a point-of-care laboratory
testing device at a site for which a laboratory license or
registration has been issued, meets the minimum clinical
laboratory education, training, and experience requirements
set forth in regulations adopted by the department, and has
demonstrated to the satisfaction of the laboratory director
that he or she is competent in the operation of the
point-of-care laboratory testing device for each analyte to
be reported.
j) Any other person within a physician office laboratory if
the test is performed under the supervision of the
patient's physician and surgeon or podiatrist who shall be
accessible to the laboratory to provide onsite, telephone,
or electronic consultation as needed, and shall do both of
the following:
i) Ensure that the person is performing test methods as
required for accurate and reliable tests.
ii) Have personal knowledge of the results of the
clinical laboratory testing or examination performed by
that person before the test results are reported from the
laboratory.
AB 757 (Gomez) Page 3
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aa) A pharmacist. (BPC § 1206.5)
3)Declares Legislative intent to sustain the integrity of
California's laboratory standards, including its personnel
standards, and that changes in technology to increase the
efficiency of health care delivery be accommodated when the
providers of laboratory services utilizing technology remain
competent to provide accurate, reliable, and necessary test
results. (Uncodified language from SB 113 (Maddy) Chapter
510, Statutes of 1995)
Existing federal law:
1)Establishes conditions that laboratories must meet for
certification to perform testing on human specimens 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 an individual performing moderate complexity testing
to have a current license issued by the state in which the
laboratory is located, if such licensing is required; and
meets one of the following requirements:
a) Is a physician licensed to practice medicine in the
state in which the laboratory is located or have earned a
doctoral, master's, or bachelor's degree in a chemical,
physical, biological or clinical laboratory science, or
edical technology from an accredited institution.
b) Has earned an associate degree in a chemical, physical
or biological science or medical laboratory technology from
an accredited institution.
c) Is a high school graduate or equivalent and have
successfully completed an official military medical
laboratory procedures course of at least 50 weeks duration
and have held the military enlisted occupational specialty
of Medical Laboratory Specialist (Laboratory Technician).
d) Has earned a high school diploma or equivalent and
documentation of training appropriate for the testing
performed prior to analyzing patient specimens. Such
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training must ensure that the individual has:
i) Skills required for proper specimen collection,
including patient preparation, if applicable, labeling,
handling, preservation or fixation, processing or
preparation, transportation and storage of specimens.
ii) Skills required for implementing all standard
laboratory procedures.
iii) Skills required for performing each test method and
for proper instrument use.
iv) Skills required for preventive maintenance,
troubleshooting and calibration procedures related to
each test performed.
v) A working knowledge of reagent stability and
storage.
vi) The skills required to implement the quality control
policies and procedures of the laboratory.
vii) An awareness of the factors that influence test
results; and,
viii) The skills required to assess and verify the
validity of patient test results through the evaluation
of quality control sample values prior to reporting
patient test results. (42 CFR § 493.1423)
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 the personnel responsibilities described in
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this subpart;
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)States the intent of the Legislature to enact legislation to
identify who, and under which circumstances, may perform a
TPRT test using an automatic, button-operated refractometer
with a digital readout in a licensed plasma collection
facility in California.
2)Authorizes a person who meets standards equivalent to the
federal CLIA regulations for performing a moderate complexity
test to perform a TPRT using an automatic, button-operated
refractometer with a digital readout in a licensed plasma
collection facility in California if all of the following
conditions are met:
a) He or she has earned a high school diploma or
equivalent, as determined by the Centers for Medicare and
Medicaid Services pursuant to CLIA.
b) He or she performs the TPRT using an automatic,
button-operated refractometer with a digital readout in a
licensed plasma collection facility.
c) His or her training in the proper procedure to be
employed when performing a TPRT using an automatic,
button-operated refractometer with a digital readout has
been certified by a physician and surgeon licensed in this
state or by a licensed clinical laboratory director who is
in charge of the licensed plasma collection facility, or
their certified, trained designate. The instructor shall
document, and the plasma collection facility shall maintain
the documentation of the individual's successful completion
of training in the performance of the total protein
refractometer test using an automatic, button-operated
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refractometer with a digital readout.
d) He or she performs the TPRT using an automatic,
button-operated refractometer with a digital readout under
the direction and supervision of the physician and surgeon
or licensed clinical laboratory director.
e) He or she submits the test results to the physician and
surgeon or licensed clinical laboratory director under
whose direction and supervision he or she performed the
test using an automatic, button-operated refractometer with
a digital readout.
3)Sunsets the provisions of this bill on January 1, 2019.
FISCAL EFFECT: This bill is keyed "fiscal" by the Legislative
Counsel. According to the Assembly Appropriations Committee
analysis dated May 13, 2015, this bill has a negligible state
fiscal effect.
COMMENTS:
1.Purpose. This measure is sponsored by Grifols, Inc., a
company that, among other lines of business, owns and operates
147 plasma donor centers where plasma is collected to be used
in the company's protein therapies.
This bill would allow the company to employ a lesser skilled
individual than is currently required under California law to
perform TPRT, a test that screens potential plasma donors.
This change would be an exception to state law, but consistent
with federal law.
According to the Author's office, "California law authorizes
17 different categories of health care personnel ([including]
'any person' in a doctor's office) to conduct the total
protein refractometer test?.
"AB 757 will authorize a fully-trained and fully-supervised
employee, whose general training meets that required by
federal standards, followed by specific training to operate a
one-button, automated, total protein refractometer test in our
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licensed plasma collection centers in California. The bill
allows the highly qualified physicians, laboratory directors,
and other health care professionals on-site to serve more
plasma donors while continuing to supervise the operation of
the simple, almost entirely automated, total protein
refractometer test.
"This would not only ensure efficiency and better service
delivery at these licensed facilities, but would also allow
highly qualified physicians and surgeons to serve more
patients while continuing to supervise the administration of
this simple, almost entirely automated total protein
refractometer test analysis."
2.CLIA and California Law. 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. According to the sponsor,
California is one of 7 states that have developed more
rigorous lab personnel requirements. California defers to
CLIA in matters of determining test complexity, which dictates
who and under what circumstances, may perform a test.
The FDA categorizes diagnostic tests by their complexity-from
the least to the most complex: waived tests, moderate
complexity tests, and high complexity tests. Personnel
authorized to perform the tests are required to have skill and
training commensurate with the test level. Diagnostic tests
are categorized as waived if they are simple to use and there
is little chance the test will provide wrong information or
cause harm if it is performed incorrectly.
3.Total Protein Refractometer Test (TPRT). As part of
donor-screening and quality-assurance procedures, some plasma
donation centers perform screening tests on-site, and these
screening tests are considered "waived tests," with the
exception of the TPRT. While some centers use older, analog
refractometers to conduct the test, other centers use newer,
digital refractometers, like the instrument described in this
bill. FDA assigned TPRT to the moderate complexity category
under CLIA, regardless of type.
The Plasma Protein Therapeutics Association submitted to the
FDA, in an effort to get this instrument reclassified, that
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the experiences of one of their member centers that use
digital refractometers to perform TPRTs "demonstrate that the
test is a simple procedure with little health impact. The
intended users of digital refractometers are donation-center
employees who have prior training in blood borne pathogens,
also known as universal precautions; in the hands of these
test operators, the total protein test by digital
refractometer is a simple procedure?.
"While older, analog refractometers require water calibration
? digital refractometers offer accurate, simple, electronic,
water calibration at the push of a button. Digital
refractometers are battery-operated, portable, and automatic
and measure accurately, consistently from technician to
technician, and electronically the same scale as analog
refractometers. While older, analog refractometers require
trained operators with experience and knowledge of proper use,
simple operational software and interface-onscreen
instructions guide technicians through digital-refractometer
results."
The request for FDA reclassification of TPRT is still pending,
but the sponsors believe it will likely be completed by this
bill's sunset date of 2019.
4.Related Legislation. AB 940 (Ridley-Thomas) of 2015 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 CLIA requirements, and makes
other technical and conforming changes. Status : This bill is
scheduled to be heard in the Senate Committee on Business,
Professions, and Economic Development 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
currently in the Senate Committee on Appropriations.
5.Arguments in Support. The sponsor, Grifols, Inc. , writes,
"Currently, the total protein refractometer test unit is
categorized by federal CLIA as a 'moderate complexity test.'
California law authorizes 17 different categories of health
AB 757 (Gomez) Page 9
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care personnel, subject to varying levels of independence or
supervision, to conduct a moderate complexity test. This even
includes 'any person' if supervised in a physician's office.
In fact, a total protein refractometer test can be
administered in the overwhelming majority of states by an
employee trained to federal standards. However, California
law does not authorize this simple, almost entirely automated
test to be conducted by a highly trained and supervised
employee at a licensed plasma donation center, unless they are
covered by the current roster of license categories?.
AB 757 (a) allows a specially trained employee, (b) in the
unique and limited setting of a plasma donation facility, (c)
to operate a virtually automated test with the push of one
button, (d) under an array of supervisory, licensed health
care personnel - including the responsible physician and
surgeon and/or other licensed facility manager. The end goal
of this measure is to help our California Department of Public
Health-licensed plasma donation centers operate more
efficiently by authorizing a properly-trained employ to
perform this simple task as part of the donor intake process,
without diverting other employees from their primary
occupations."
Plasma Protein Therapeutics Association, Blood Centers of
California, KEDPlasma LLC and Octapharma Plasma are in support
of this bill because it will help their operations, as well.
6.Arguments in Opposition. The California Association for
Medical Laboratory Technology , the professional association
representing clinical laboratory scientists and other
laboratory personnel in California, oppose AB 757, writing,
"At issue are the safety of plasma donors and the competency
of personnel who test them for donor eligibility.
"AB 757 would allow lesser trained and educated persons than
currently permitted by law to perform a total protein
refractometer analysis, categorized as a moderately complex
test by the FDA, in a licensed plasma collection facility.
The primary function of the total protein analysis is to
provide an accurate and precise value in order to ensure donor
safety prior to donating plasma. An erroneously performed
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analysis, like a false negative result, which allows the
plasma center to proceed with the donation, could cause
significant donor harm. As a result, the regulatory agencies
have mandated that the individuals performing the total
protein test must have demonstrated a higher level of
education and training such as those individuals listed in BPC
section 1206.5 (b)."
"Plasma donors are paid. They can donate every two weeks if
their total protein is at least 6 g/dL. Many plasma
collection centers "bleed" their donors down to 6 g/dL of
protein regularly. If the protein refractometer test and/or
calibration is done incorrectly and the protein read is higher
than it actually is, there is a potential to over 'bleed' a
donor causing donor harm, such as death from untreated low
protein, immune deficiency, heart and respiratory problems,
bruising, insufficient blood clotting, muscle wasting and
reduced energy. In short, the current personnel standard
needs to be maintained."
The California Society of Pathologists and Engineers &
Scientists of California, IFPTE Local 20 also express concern
about patient safety and quality control with lesser-trained
individuals.
7.Policy Consideration. Although TPRT is classified as a
moderate complexity test under CLIA, the sponsors argue that
advances in technology have made the digital refractometer, an
instrument that performs the test, so simple that it should be
considered "waived." Were it classified as such, the sponsors
would have much more personnel latitude according to existing
California law and likely would not need this bill. However,
the FDA has not yet begun a reclassification process, though
there is a pending request for it to do so.
Uncodified language from the 1995 bill that incorporated CLIA
into California law declared Legislative intent "to sustain
the integrity of California's laboratory standards, including
its personnel standards, and that [any] changes in technology
to increase the efficiency of health care delivery be
accommodated when the providers of laboratory services
utilizing technology remain competent to provide accurate,
reliable, and necessary test results," SB 113 (Maddy, Chapter
510, Statutes of 1995.)
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This bill may be viewed as either a request to make an
exception to California's higher standards for personnel
performing moderate complexity tests or a premature move in
advance of FDA reclassification to streamline operator
requirements. The sponsors do not indicate a lack of
sufficient personnel under current law, but rather express
preference to better allocate skilled resources.
SUPPORT AND OPPOSITION:
Support:
Grifols, Inc. (Sponsor)
Blood Centers of California
KEDPlasma LLC
Octapharma Plasma, Inc.
Plasma Protein Therapeutics Association
Opposition:
California Association for Medical Laboratory Technology
California Society of Pathologists
Engineers & Scientists of California, IFPTE Local 20
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