This notification impacts all College of American Pathologists (CAP)-accredited laboratories with California laboratory licensure.
On January 1, 2019, the California Department of Public Health modified Business and Professions Code BPC.1260.3 for medical laboratory technicians (MLTs) performing moderate complexity testing to allow MLTs to perform additional types of testing as listed below. Effective immediately, the CAP is allowing laboratories to implement changes relating to the regulation for expanded MLT duties.
The amended law now authorizes the work scope of California licensed MLTs who perform clinical laboratory tests classified as moderately complex to also include the following testing:
- Microscopic urinalysis
- Blood typing, such as automated ABO/Rh testing and automated antibody screen testing
- Blood smear reviews other than manual leukocyte differentials
MLTs in the state of California may NOT perform:
- Any other microscopic analysis or immunohematology procedures
- Any manual leukocyte differentials
- Blood typing performed to determine donor/recipient compatibility, such as:
- Recipient & donor ABO group/D(Rho) type
- Antigen typing
- Direct antiglobulin test
- Tests for unexpected antibody detection and identification
- Crossmatch procedures
- Any high-complexity tests, including high-complexity immunohematology procedures
More information on the revised law can be found on the California Department of Public Health website, California Business and Professionals Code (BPC), subsection 1260.3.
GEN.78250 (Personnel Qualifications and Licensure) will be revised in the 2019 CAP accreditation checklist edition, scheduled for release in the late summer of 2019, to expand the duties of California licensed MLTs for moderate complex testing.
Who is affected by this change?
- Laboratories in California with clinical laboratory licensure or registration.
- Laboratories outside of California that perform testing on specimens originating from California.
- CAP inspectors who may inspect a laboratory with a California clinical laboratory license, including inspectors originating from other states.
Test classification can be accessed on the FDA website at CLIA Database by Complexity.
Please retain this notification for your files.