Lab Documents
Requirements
- Current Lab Certification (e.g. CLIA, CAP)
- Normal Lab/Reference Values
Tips / Additional Information
- Keep updated lab documents to document the competency of all lab facilities being utilized, and to support the reliability of test results.
- If lab documents are filed electronically or separately, include a signed and dated note to file indicating the location.
- Research laboratories typically do not have lab certifications (e.g. CLIA, CAP). In the case of research laboratories, ensure that the research lab reference values are on file.
- CLIA and all other licensure for all UCLA labs can be found here: UCLA Clinical Laboratories Licensing & Accreditation Documents
- You will also need the CV of the lab manager for your regulatory binder. Please contact UCLA Pathology & Laboratory Medicine to obtain a copy.
- Reference values: UCLA Health Laboratory Test Directory
Applicable GCP Sections: