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CA AB613
Bill
Status
9/27/2018
Primary Sponsor
Adrin Nazarian
Click for details
AI Summary
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Authorizes persons with a high school diploma or equivalent and five hours of training to perform total protein tests using a digital refractometer in licensed plasma collection centers until January 1, 2021.
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Requires training certification by a moderate complexity laboratory technical consultant, physician, or licensed clinical laboratory director, and mandates that a qualified supervisor remain physically onsite during testing.
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Specifies that digital refractometers must be used within 30 feet of the donor, classified as waived or moderate complexity under federal CLIA standards, and require competency evaluation before initial testing and every six months thereafter.
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Requires test results to be recorded in an FDA 510k-approved blood establishment computer system through electronic records, verified entry, timestamped photographs, or double blind entry systems.
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Makes information collected to assess competency and performance of test personnel confidential and exempt from the California Public Records Act.
Legislative Description
Healing arts: clinical laboratories.
Last Action
Chaptered by Secretary of State - Chapter 799, Statutes of 2018.
9/27/2018