What Is Waived Testing?

By Author: Mary Rusk
Total Articles: 5
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The FDA defines "Waived" tests as those that are simple to use with a low risk for error, and therefore need adhere to a less strict version of the Clinical Laboratory Improvement Amendments (CLIA), which regulates all laboratory testing facilities performing tests on human specimens, whether for the treatment, prevention, diagnosis, or assessment of disease. Although the the common view is that waived tests are foolproof, they aren't, so care should be taken to follow the manufacturer's instructions and testing personnel must be familiar with everything involving the test system.


Some waived tests may be performed in physician's office lab (POL), such as fecal occult blood testing and dipstick urinalysis. To qualify for office testing, a physician's office must have the CLIA certificate of waiver on file, explicitly follow the instructions from the manufacturer, and have paid the certificate fees.


Laboratories that perform waived tests do so exclusively. A laboratory facility that perform complex tests is subject to requirements regarding personnel, proficiency testing, and regular inspections. ...
... Labs performing waived tests are not, although that does not mean the POL or laboratory doesn't have any specific regulatory criteria they must follow. They do. Here are the criteria and requirements a POL or waived lab must meet.


Labs must use the current manufacturer's instructions, which come with every lot of testing kits. Write the date received on the instructions from the most recent shipment and keep it on file. Sometimes instructions change from lot to lot, so it's necessary to always be follow the most recent instructions.


Along with the instructions, testing kit manufacturers will sometimes specify calibration and/or quality control measures, which labs must diligently follow. Quality control documentation must be retained by waived testing labs for two years.


There can be a tendency to alter reagent strips by cutting them in half to test double the amount of samples. This can lead to errors. It is a requirement that test kits/reagents are not to be altered. Use them just as they are received.


Among other information, the manufacturer's instructions include guidelines and requirements for handling and storing the test kits. POLs and waived testing labs must handle and store kits exactly according to the directions. Any reagents that are outdated must be removed and disposed of in the recommended manner.


Keep documentation of all testing personnel's training in their personnel file. Every waived test and every test method requires that the personnel performing the test be trained in that test or method. If a test method or manufacturer changes, train employees in the new method, document it, and place it in the personnel file.


POLs surveying agency must be informed of any change in lab status, such as if there's a change in personnel or the name of the practice changes. Refrigerator and room temperatures must be monitored. The POL must also follow all OSHA regulations for lab testing, such as Bloodborne Pathogens regulations.


Mary Rusk is a freelance writer for COLA Central, a Waived testing and Medical laboratory Accreditation Company. Interested in finding out more about CLIA requirements by COLA.org? Visit our website today for more information.