One last topic to discuss, and this will help to bring all of the previously discussed quality control terms and tools into focus - as they are utilized in the packages of validation and verification. (For an example of how this information may be represented, review any laboratory test method package insert, and you should find detailed information on how the test method was validated for use.)
Validation versus verification
The process of validation of test methods falls upon the initial manufacturer of the test system/method. Laboratory-developed tests may also be required under law to provide detailed documentation of new test validations. Once a new test has been validated, the verification process is required by the end user. Each laboratory must verify that the test system/method meets the manufacturer's specifications.
The U.S. Clinical Laboratory Improvement Amendments (CLIA) require laboratory users of nonwaived, unmodified, FDA-cleared or approved test systems to perform the following before reporting patient test results:
- Demonstrate that the test system is capable of obtaining performance specifications comparable to those established by the manufacturer for the following performance characteristics:
- Accuracy
- Precision
- Reportable range of test results for the test system
- Verify that the manufacturer's reference ranges (normal values) are appropriate for the laboratory's patient population.
