BILL ANALYSIS Ó
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|SENATE RULES COMMITTEE | AB 757|
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THIRD READING
Bill No: AB 757
Author: Gomez (D)
Amended: 6/22/15 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: 74-0, 5/22/15 (Consent) - See last page for
vote
SUBJECT: Healing arts: clinical laboratories
SOURCE: Grifols, Inc.
DIGEST: This bill 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.
ANALYSIS:
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)
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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 or have earned a doctoral, master's, or
bachelor's degree in a chemical, physical, biological or
clinical laboratory science, or medical 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.
d) Has earned a high school diploma or equivalent and
documentation of training appropriate for the testing
performed prior to analyzing patient specimens. (42 CFR §
493.1423)
Existing state law:
1)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
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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, 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, as specified.
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.
aa) A pharmacist. (Business and Professions Code § 1206.5)
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
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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
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.
Background
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
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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.
This bill would allow the source of this bill 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.
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 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 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.
FISCAL EFFECT: Appropriation: No Fiscal
Com.:YesLocal: Yes
SUPPORT: (Verified7/14/15)
Grifols, Inc. (source)
Blood Centers of California
KEDPlasma LLC
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Octapharma Plasma, Inc.
Plasma Protein Therapeutics Association
OPPOSITION: (Verified7/14/15)
California Association for Medical Laboratory Technology
California Society of Pathologists
Engineers & Scientists of California, IFPTE Local 20
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 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. ...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.
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, "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
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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.
ASSEMBLY FLOOR: 74-0, 5/22/15
AYES: Achadjian, Travis Allen, Baker, Bigelow, Bloom, Bonilla,
Bonta, Brough, 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-Sawyer, Kim, Lackey, Levine, Linder, Lopez, Low,
Maienschein, Mathis, Mayes, McCarty, Medina, Melendez, Mullin,
Nazarian, Obernolte, Patterson, Perea, Quirk, Rendon,
Ridley-Thomas, Rodriguez, Salas, Santiago, Steinorth, Mark
Stone, Thurmond, Ting, Wagner, Wilk, Williams, Wood, Atkins
NO VOTE RECORDED: Alejo, Jones, O'Donnell, Olsen, Waldron,
Weber
Prepared by:Sarah Huchel / B., P. & E.D. / (916) 651-4104
7/14/15 19:27:51
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