With all the preparations required to ready a clinical laboratory for regulatory inspection, it can be easy to overlook offsite testing locations, especially those performing CLIA-waived tests. Hospital laboratories with a CLIA Certificate of Compliance or Certificate of Accreditation may also oversee waived testing sites, and it is important to remember that those locations have as much potential for citations as the larger testing departments.
Here are five key areas that require special attention during inspection preparation:
Regulations require a testing site be able to provide proof that an order (either written or electronic) is in place prior to the performance of the test and contains all the necessary components to be considered a valid order. These components include:
- Patient name
- Patient date of birth
- Lab test(s) requested
- Physician name
- Physician signature
- Date of the order
The validation process also applies to standing orders. Organize these orders so they are easily retrievable from storage.
CLIA requires personnel who perform waived tests to follow the manufacturer's instructions for a testing procedure; however, a separate standard operating procedure (SOP) may be written.
- If there is a separate SOP in place, have the CLIA director listed on the certificate review and sign it prior to placing the test into use.
- Review the package insert of the manufacturer’s instructions with each new shipment to verify that nothing has changed with the testing procedure. If there are changes noted, then modify the SOP (if applicable) and have it signed again by the director.
- Mark procedures that are no longer used with the date range of use and file for retrieval during the inspection process.
- Do not make any changes to the parameters of testing described in the manufacturer’s instructions. Modifications can cause the test to fall under more stringent CLIA requirements for non-waived tests.
There are numerous records to maintain pertaining to the test performance itself. Review this data regularly to ensure reliable conditions and testing results. Components include:
- Daily temperatures for refrigerators, freezers, and the ambient testing area.
- Daily humidity readings in the ambient testing area.
- Date of test, lot numbers used, and expiration dates.
- Date and time of equipment function checks, calibration, and/or maintenance.
- Discard any expired reagents, test cartridges, or quality control material.
- Any manufacturer’s notices related to product recalls or warnings regarding specific lot numbers.
- Corrective action taken in response to unacceptable quality control results.
Maintain accurate records of patient test results and include:
- Sufficient patient identifiers, the lot numbers of testing material, reagent, and quality control.
- Quantitative and qualitative results that are documented appropriately according to the manufacturer’s instructions.
- Test results that are not acceptable or require repeat testing should be noted and the corrective actions documented.
- When waived test results require follow-up or confirmatory testing, there should be written policies outlining the correct steps for personnel to take, including the names of the additional tests, examples of completed forms, and contact information for the referring laboratory.
Training and competency
Personnel should be trained and competent in each test they perform with supporting documentation completed by both trainer and trainee.
- Initial training must occur before the employee performs the test.
- Competencies take place at six months and then annually thereafter.
- Include topics such as the use of universal precautions and Health Insurance Portability and Accountability Act (HIPAA) laws in an employee’s initial training and then document it annually, though these are often part of a health system’s annual education.
- Keep a copy of the in-date waived CLIA certificate ready to show an inspector upon request. For easier access, retain documentation near the testing area or machine location.
- Ensure off-site locations are not mistakenly performing non-waived (moderate or high- complexity) testing without proper training, personnel, or supporting documentation. Verify the test kits, instruments, and procedures used are licensed as CLIA-waived.
- Verify that locations are not performing microscopy. If they are, there must be a separate CLIA certificate depending on the level of personnel performing the procedure. If it is providers only, the location requires a Certificate for Provider-Performed Microscopy. If location staff (non-providers) are performing the procedure, that location needs a CLIA certificate for non-waived tests.
Most importantly, it is up to laboratory leadership to ensure that all state and local requirements for testing are met. These requirements might be more or less stringent than federal requirements. When state or local regulations governing laboratory testing are more stringent than the federal CLIA requirements, they supersede what is required under CLIA.
Please refer to the appropriate specific regulatory agency for their requirements. This document is intended for guidance only.