The Clinical Laboratory Improvement Amendments of 1988, require biennial inspections for clinical laboratories. This is why most laboratory inspections are based on CLIA regulations. However, laboratories may be inspected by a myriad of other agencies, including the Occupational Safety and Health Administration (OSHA) and the COLA. Surveyors usually notify laboratories up to two weeks in advance of an inspection, but they have the authority to enter and inspect the laboratory at any time. All OSHA inspections are conducted without notice. That is why it’s a good idea to have a clinical lab consulting guide you on how to make your laboratory inspection-ready.
Documents for the inspection
The outcome of an inspection is based on the laboratory's condition and documentation. Documents that a compliant laboratory must have prepared for an inspection by its accrediting agency include:
Pre-survey information: CLIA or the accrediting agency will request certain basic information, including the laboratory's business hours, test menu, test volumes, and directions to the facility. To make your survey go more smoothly, provide the requested information immediately.
Personnel files (paper or electronic): These must be available for everyone working in the laboratory. For the physician director, this includes the license to practice medicine in the state where the laboratory is located and documentation of experience or training to serve as a director. For the technical consultant college degree, proof of experience, and a performance evaluation should suffice. For testing personnel, files must contain laboratory-specific training records, an annual competency evaluation, and documentation of the highest level of formal education.
Previous survey reports and corrective actions: Inspectors might not see the previous report, but must review the corrective actions and all associated documentation, so it’s important to have that material ready to present when requested.
Manuals and installation records
Test procedures and manuals must be current, comprehensive, and signed by the laboratory manager or director. Installation records should be readily available for all instruments acquired since the most recent inspection. They must show that your testing personnel participated in the calibrations and validation studies. A professional at a clinical lab consulting can further assist you with details on what kind of test procedures the inspector might ask for.
Other things to consider for your laboratory to be inspection ready include calibration verification, maintenance records, service reports, and quality controls records organized by test, by specialty, or by date. If you are a lab manager or owner be sure to contact a professional at a clinical lab consulting like Click on Lab to guide you with lab inspection matters.