Notification to Laboratories in the CAP’s Reproductive Laboratory Program

To College of American Pathologists (CAP) Accredited Reproductive Laboratories:

As a service to CAP-accredited laboratories, the CAP is providing clarification on 1) the reporting of laboratory director and Clinical Laboratory Improvement Amendments (CLIA) certificate information to the CAP and 2) laboratory director qualifications.

Reporting Requirements:

Laboratories possessing a CLIA Certificate of Accreditation or Registration that have selected the CAP as their accreditor must:

• Ensure that the name of the laboratory director reported to the CAP matches the name on the CLIA certificate and
• Report all testing performed under CLIA to the CAP.

Laboratories performing clinical laboratory testing (eg, semen analysis, hormone analysis) and embryology procedures may designate a separate embryology laboratory director (section director) for the embryology services; however, the overall laboratory director listed for the CAP must be the person listed on the CLIA certificate.

Laboratory Director Qualifications:

Laboratory directors must meet the qualifications defined in the CAP checklists, as well as any applicable state-specific requirements, such as state personnel licensure.

• High-complexity laboratory director qualifications are defined in TLC.10100 in the Director Assessment Checklist.
• Embryology laboratory director qualifications are defined in RLM.10166 in the Reproductive Laboratory Medicine Checklist.

The state of California requires laboratories with a California Clinical Laboratory license to be directed by a: 1) California-licensed physician; 2) California-licensed doctoral scientist in the specialty of testing performed; or 3) California-licensed bioanalyst. The state does not recognize High-Complexity Laboratory Director (HCLD) certification by the American Board of Bioanalysis in lieu of state licensing. If the individual listed as the laboratory director on the CLIA certificate does not qualify to direct embryology, a separate embryology laboratory director must be separately defined and reported to the CAP.

Does my laboratory need to take any action?

Laboratories need to contact the CAP and correct laboratory information if any of the following apply:

• Laboratory director names on the laboratory’s CLIA certificate and CAP certificate do not match
• Laboratory director does not meet the CAP or state-specific qualifications
• Incorrect CLIA certificate information was reported to the CAP
• Testing performed by another laboratory (separate CLIA certificate) was incorrectly reported to the CAP

How do I correct my laboratory information?

Go to cap.org and log into e-LAB Solutions Suite to make changes in Laboratory Data Maintenance to your CAP information for laboratory director names, CLIA certificate information, and test/activity menu changes.

Thank you for your participation in the CAP’s Reproductive Laboratory Accreditation Program.

Questions? Contact us at 800-323-4040 or email accred@cap.org.