Congress passed the Clinical Laboratory Improvement Amendments (CLIA) act in 1988 to establish quality standards for all non-research laboratory testing:
- Performed on specimens derived from humans; and
- For providing information for the diagnosis, prevention, and treatment of disease or impairment, or assessment of health.
The objective of the CLIA program is to ensure quality in laboratory testing procedures and specifically to establish quality standards to ensure the accuracy, reliability, and timeliness of the patient’s test results. The CLIA Quality System Regulations became effective on April 24, 2003. Now the laboratory is required to check (verify) the manufacturer’s performance specifications provided in the package insert for:
- Accuracy: If test results for previously tested samples fall within the stated acceptable limits, accuracy is verified
- Precision: Can the results be repeated mulitple times on the same day and on different days by different operators.
- Reportable range: Use known samples to confirm the upper and lower limits of the test.
- Also: Reference range or interval: Do the reference ranges provided by the test system’s manufacturer fit your patient population?
The number of samples needs to be established for every test, 20 samples are seen as a “rule of thumb”.
The FDA defines a Laboratory Developed Test (LDT) as an in vitro diagnostic test that is manufactured by and used within a single laboratory (i.e. a laboratory with a single CLIA certificate). LDTs are also sometimes called in-house developed tests, or “home brew” tests. Similar to other in vitro diagnostic tests, LDTs are considered “devices,” as defined by the FFDCA, and are therefore subject to regulatory oversight by FDA.
Sources:Centers for Medicare & Medicaid Services, Genohub