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Technical Updates & Information

2003 CLIA Crosswalk (PDF)

The 2003 CLIA Crosswalk was published in the California Regulatory Notice Register on October 7, 2016 and became effective by operation of law 60 days after publication. The Crosswalk lists subparts of 2003 CLIA determined to be equivalent to or more stringent than California law.

Medical Laboratory Technician Scope of Practice (B&PC Ā§ 1260.3)

As of January 1, 2019, AB 2281 takes effect. This bill amends the California Business and Professions Code subsection 1260.3(b) to expand the duties authorized for licensed MLTs in California.

EQC and IQCP in California (PDF)

Notice regarding EQC and IQCP in California.

ASM-CDC Sentinel Laboratory Survey (PDF)

The American Society for Microbiology (ASM) and the Centers for Disease Control and Prevention (CDC) are working together to conduct a baseline survey of all members of the state Laboratory Response Network on awareness and use of laboratory practice guidelines related to the collection, storage, and preservation of urine for microbiological culture.

Non-Compliance Inducement Letter (PDF)

Notice regarding non-compliance inducement in physiciansā€™ offices will be presented at the May 2018 CLTAC meeting.

Issues Specific to California Clinical Laboratory Law - 2017 (PDF)

Issues specific to California law pertaining to clinical laboratory science.

Magellan Diagnostics Safety Communication ā€“ May 17, 2017 (PDF)

Magellan Diagnostics has issued a notification to facilities regarding LeadCareĀ® Blood Lead Testing Systems and changes to existing LeadCareĀ® product usage and labeling.

CDCā€™s Health Advisory ā€“ May 17, 2017

A CDC health advisory has been issued May 17, 2017 regarding: Potential for Falsely Low Blood Lead Test
Results from LeadCareĀ® Analyzers.

FDA advises testing for Zika virus in all donated blood and blood components in the US

On August 26, 2016, the U.S. Food and Drug Administration issued a revised guidance recommending universal testing of donated Whole Blood and blood components for Zika virus in the U.S. and its territories.

Zika, Dengue, and Chikungunya Viruses Information Supplement (PDF)

A supplement to AABB Association Bulletin #16-04 providing additional information on Zika virus.

Communications Regarding Zika Virus Positive Blood Donors (PDF)

Guidance for communication by the California Department of Public Health to California blood collection centers regarding local Zika virus transmission, reporting Zika virus-positive blood donors, and blood center notification for local Zika virus transmission.

Tissue Bank Exemption Letter (PDF)

Information about Assembly Bill 2750, which was signed into law by the Governor on September 9, 2016. This bill creates an exemption from current California tissue bank licensing laws regarding the storage of allograft tissue under certain conditions. The new exemption becomes effective on January 1, 2017.

Notice Regarding Storage of Allograft Tissue (PDF)

Notice regarding change to requirements for tissue bank license when storing allograft tissue.

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