BILL ANALYSIS Ó
AB 757
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CONCURRENCE IN SENATE AMENDMENTS
AB
757 (Gomez)
As Amended June 22, 2015
Majority vote
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|ASSEMBLY: | 74-0 | (May 22, |SENATE: |39-0 | (August 24, |
| | |2015) | | |2015) |
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Original Committee Reference: B. & P.
SUMMARY: Authorizes a person, who meets specified criteria, to
perform a total protein refractometer test using an automatic,
button-operated refractometer with a digital readout in a
licensed plasma collection facility in this state.
Specifically, this bill:
1)Authorizes a person whose qualifications are at least the
equivalent of those specified in Code of Federal Regulations
Title 42, Section 493.1423(b)(4) to perform a total protein
refractometer test using an automatic, button-operated
refractometer with a digital readout in a licensed plasma
collection facility in this state if all of the following
conditions are met:
a) The person has earned a high school diploma or
equivalent, as determined by the Centers for Medicare and
Medicaid Services (CMS) pursuant to the federal Clinical
Laboratory Improvement Amendments of 1998 (CLIA) (42 United
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States Code Section 263a);
b) The person performs the total protein refractometer test
using an automatic, button-operated refractometer with a
digital readout in a licensed plasma collection facility;
c) The person's training in the proper procedure to be
employed when performing a total protein refractometer test
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 must document, and the plasma collection
facility must 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) The person performs the total protein refractometer test
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; and,
e) The person submits the test results for interpretation
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.
2)States that no reimbursement is required pursuant to
California Constitution Article XIII B, Section 6, as
specified.
The Senate amendments increase the required qualifications to
perform the test (a moderate complexity test) from a medical
assistant to a person qualified to perform the test under
federal law.
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FISCAL EFFECT: According to the Senate Appropriations
Committee, pursuant to Senate Rule 28.8, negligible state costs.
COMMENTS:
Purpose. This bill is sponsored by Grifols, Inc. According to
the author, "Plasma donation centers are critical to ensuring
the availability of therapies that treat rate, chronic, and
sometimes life-threatening diseases. AB 757 would authorize a
medical assistant who meets specified criteria to perform a
total protein refractometer test analysis - a standard, mostly
automated procedure performed during donor intake and assessment
to determine donor eligibility - in state licensed plasma
collection facility in California. This will help promote
efficiencies, where appropriate, in the biomedical industry
while continuing to prioritize patient health and safety."
Background. In California, only licensed or certified
individuals may perform moderate complexity tests. This bill
would create an exception to the requirement under state law
for a total protein refractometer test, which is a moderate
complexity test. However, it will still require the person to
meet the qualifications required under federal law to perform
a moderate complexity test, including having earned a high
school diploma or equivalent and having documentation of
training appropriate for the testing performed prior to
analyzing patient specimens. The training must ensure that
the individual has:
1)The skills required for proper specimen collection, including
patient preparation, if applicable, labeling, handling,
preservation or fixation, processing or preparation,
transportation and storage of specimens;
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2)The skills required for implementing all standard laboratory
procedures;
3)The skills required for performing each test method and for
proper instrument use;
4)The skills required for performing preventive maintenance,
troubleshooting and calibration procedures related to each
test performed;
5)A working knowledge of reagent stability and storage;
6)The skills required to implement the quality control policies
and procedures of the laboratory;
7)An awareness of the factors that influence test results; and,
8)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.
Total Protein Refractometer Test. The measurement of total
protein uses an instrument called a refractometer. A
refractometer is a device that shines a beam of light through
a sample of liquid. The device measures the amount of light
that is refracted (bent) due to the solids in the sample. In
blood, protein causes light to bend. The greater the amount
of protein, the more light is bent from the light path.
According to the sponsors, Grifols measures a potential plasma
donor's total protein levels as part of the initial screening
process.
Analysis Prepared by:
Vincent Chee / B. & P. / (916) 319-3301 FN: 0001303
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