You operate a CLIA-waived lab, using waived test systems. Kits shipped to your location have been approved by the FDA, so quality control (QC) shouldn’t be an issue. Right?
Well, not exactly. QC is still critical to lab testing because it ensures your results are precise and accurate—and therefore, patients receive optimum care. Waived test systems might have left the manufacturer in perfect condition, but shipping variables, your internal receiving and storing practices, and patient demand for a given test can affect the reliability and accuracy of test results. Here’s why your lab needs to perform QC on waived tests.
“Waived” Doesn’t Mean “Home Free”
Any facility in the United States that performs laboratory testing on human specimens for health assessment or the diagnosis, prevention, or treatment of disease are regulated under the Clinical Laboratory Improvement Amendments of 1988 (CLIA).
Lab tests are classified as waived, moderately complex, or highly complex, depending on the type of test and the expertise required to successfully performing it. Waived tests include test systems cleared by the FDA for home use or approved under CLIA criteria for being simple and having a low risk of erroneous results. Common waived tests include urinalysis reagent strip, urine pregnancy, glucose, INR, and Strep A.
Waived labs have a CLIA Certificate of Waiver, which allows them to perform waived tests. According to the CLIA update from July 2018, 74% of CLIA-certified labs (186,746 labs) are waived labs and of that number, 78,369 labs are Physician Office Labs.
Use FDA-Approved Waived Kits
Using waived test systems does not mean that waived tests are completely error-proof or that you can use any kit designed to provide the test. Kits must be FDA approved to perform in the waived category. You can find the current list of approved kits at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/analyteswaived.cfm.
Follow Manufacturers’ Recommendations to the Letter
CLIA compliance requires labs to precisely follow all manufacturers’ instructions provided on package inserts—from “intended use” to “limitations of the procedure.” Simply relying on “quick reference” sections is not sufficient. Manufacturers might change test parameters, reagents, or other element of a test kit for many reasons—to accelerate results, achieve higher efficacy, or reduce kit costs. A lab can’t assume that test instructions will be identical from shipment to shipment.
Staff Proficiency is Key
When lab staff isn’t familiar with all aspects of the test system, or if they make a mistake in other steps of the test process, such as sample collection, errors can affect results. If a CLIA inspection finds that test kit directions are not being followed per manufacturers’ recommendations, that test, for that lab, becomes a high-complexity, nonwaived test. Nonwaived testing must meet additional inspection and high quality standards. These include staff proficiency testing, quality control and assessment, and additional lab personnel requirements. Without the right staff and processes, the lab can’t perform the test—losing revenue at the very least and potentially facing a shutdown.
This scenario played out in a lab at Wake Forest Baptist Medical Center in February, 2018. CMS inspectors found deficiencies ranging from hiring unqualified staff to improper training procedures and misdiagnosed cases. Lab staff also failed to validate new equipment properly—either because they had no validation process in place or they ignored the manufacturer’s recommendations. As a result, the Medical Center had to review more than 9,000 pathology cases for cancer misdiagnoses and placed its Medicare contract in jeopardy.
Take Charge of Waived Test Quality Control
Labs that perform QC on test systems can more easily identify any anomalies. For example, many waived tests are immunology-based, relying on antibodies. These proteins are sensitive to temperature changes. If test systems were subject to extreme heat or cold during shipping, test results can be affected. A solid external QC process can identify potential problems before they affect patients and avoid deficiencies during CLIA inspections:
- Document all shipments and lot numbers received.
- Document each time staff performs QC on shipments.
- Monitor test systems based on manufacturers’ recommendations. If tests have a shelf life of 30 days, have a process for tracking expiration dates and removing expired kits.
- Track when and for whom each kit is used, so that you can document that it was used within the manufacturer’s recommended timeframe.
- Ensure that new lab personnel and operators are properly trained and follow QC procedures.
- Make documentation easy to find and follow for quick reference by lab personnel or inspectors.
Procedural quality control is also critical. For each new shipment and lot, these steps are good laboratory practice:
- Be sure the product insert is current for the test system in use. If there is any question, visit the manufacturer’s product website to validate the most current insert.
- Read the entire product insert before you begin testing.
- Verify that the correct specimen type is used.
- Verify that proper reagents are added in the correct order.
- Verify that the test is performed according to the step-by-step procedure outlined in the product insert.
Applied Becker Consulting can help you assess your current waived test QC controls and strengthen them if necessary. If your lab has no formal QC measures in place, we can tailor a QC process and staff training to your lab’s needs. Don’t be caught without documentation! Contact us today.
 Center for Disease Control and Prevention, CLIA/Waived Tests https://wwwn.cdc.gov/clia/Resources/TestComplexities.aspx
 CLIA Laboratories by CLIA Certificate Type (Non-exempt only), CLIA Update, July 2018
 Wake Forest Baptist Lab’s Path Errors Teach Lessons, The Dark Intelligence Group, May 7, 2018