CLIA Regulations require each laboratory that introduces a test system that will be used to report patient test results to establish a system to provide evidence of the accuracy, precision, and reportable range of test results prior to use of the results for clinical patient care. It is the responsibility of the laboratory director and clinical consultant of the Organization to assure that a verification method is conducted to assess and document performance specifications. The laboratory is required to conduct performance specification and validation for all of the following test systems to be used as part of clinical patient testing, including but not limited to: 1) an unmodified, FDA-cleared or approved test system; 2) modification of an FDA-cleared or approved test system; 3) introduction of a test system not subject to FDA clearance or approval, including methods developed in-house and standardized methods such as text book procedures; and 4) introduction of a test system in which performance specifications are not provided by the manufacturer.
The Organization has determined that activity undertaken to establish normal ranges for assays to be used clinically at JHM is part of clinical operations activities of the Organization. Validation steps taken to comply with CLIA regulations required for clinical operations of the laboratories at JHM are not human subjects research activities. IRB approval of clinical operations validation activities is not required. Activities for clinical operations may include, but are not limited to, assessing day-to-day, run-to-run, and within-run variation, as well as operator variance; repeat testing of known patient samples over time; testing material in duplicate and over time; repeat testing of calibration materials over time, testing reference materials or comparing results of tests performed using an established reference method; comparing split sample results with results obtained from a method shown to provide clinically valid results; obtaining new samples to establish a reference range that is appropriate for the laboratory’s patient population to reflect the type of specimen and demographic variables such as age and sex (as applicable); and retention of data on verification of performance specifications.
Laboratory testing undertaken with a commercial sponsor to develop a new laboratory test or test system, or any development activity that would collect data to be submitted to FDA for purposes of bringing a new test to market, is human subjects research for which IRB approval is required. Any questions regarding human subjects laboratory research as distinguished from clinical operations of JHM laboratories should be directed to office for Human Subjects Research and/or the IRB Counsel for Human Research.