BILL ANALYSIS Ó
AB 757
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Date of Hearing: May 13, 2015
ASSEMBLY COMMITTEE ON APPROPRIATIONS
Jimmy Gomez, Chair
AB
757 (Gomez) - As Amended April 30, 2015
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Urgency: No State Mandated Local Program: YesReimbursable: No
SUMMARY:
This bill carves out a narrow exemption from rules governing
which laboratory personnel can perform moderate complexity tests,
to authorize a medical assistant who meets specified criteria to
perform a total protein refractometer test analysis in a licensed
AB 757
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plasma collection facility in this state.
FISCAL EFFECT:
Negligible state fiscal effect.
COMMENTS:
1)Purpose. The author states this bill will help promote
efficiencies, where appropriate, in the biomedical industry
while continuing to prioritize patient health and safety. He
contends the test addressed in this bill is a standard, mostly
automated procedure performed during donor intake and
assessment to determine donor eligibility for plasma donation.
2)Background. Federal and state law jointly govern the provision
of laboratory services, and California Department of Public
Health regulates laboratories on behalf of the state and
federal government. The statute Clinical Laboratory
Improvement Amendments (CLIA), is the federal framework for
laboratory oversight. Under federal CLIA, tests are classified
as either waived, moderate-complexity, or high-complexity.
Waived tests are simple and low-risk, while moderate- and
high-complexity tests are subject to more stringent regulation.
Existing law authorizes certain exceptions from normal rules
governing which professionals can conduct certain tests.
Medical assistants are not licensed, although they are
supervised on-site by physicians and can be certified by
private agencies approved by the Medical Board of California.
3)Support. According to Grifols, Inc., the sponsor of this
measure, a total protein refractometer test can be administered
in 48 states by a trained healthcare professional equivalent to
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what California defines as a medical assistant. The Blood
Centers of California are also in support.
4)Opposition. California Association for Medical Laboratory
Technology, California Society of Pathologists, and Engineers &
Scientists of California, IFPTE Local 20 oppose this bill,
arguing exemptions undermine test result integrity and
protection for patients. They explain that although the test
may be simple, calibration needs to be conducted by qualified
personnel.
Analysis Prepared by:Lisa Murawski / APPR. / (916)
319-2081