“High Complexity Tests

This category includes those tests that are modified by the laboratory, developed by a laboratory, or a test classified as high complexity under CLIA. Laboratories under CLIA and COLA also must comply with Section §493.1201 (general QC): The laboratory must establish and follow written QC procedures for monitoring and evaluating the quality of the analytical testing process of each method to assure the accuracy and reliability of patient test results and reports. Section §493.1202 states for each test of high complexity performed, the laboratory must meet all applicable standards of this subpart (subpart K). For statistical QC, laboratories must be in compliance with the following sections:

§493.1218: Control procedures are performed on a routine basis to monitor the stability of the method or test system; control and calibration materials provide a means to indirectly assess accuracy and precision of patient test results. Control procedures must be performed as defined in this section unless otherwise specified in sections §493.1223 through §493.1285 (these state specific QC requirements for blood gases, hematology, etc.).

§493.1218(b) for each method that is developed in-house, is a modification of the manufacturer’s test procedure, or is a method that has not been cleared by the FDA as meeting the CLIA requirements for general QC (all highly complex methods), the laboratory must evaluate instrument and reagent stability and operator variance in determining the number, type, frequency of testing calibration or control materials and establish criteria for acceptability used to monitor test performance during a run of patient specimen(s).

§493.1218(d)(1) The stated values of an assayed control material may be used as the target values provided the stated values correspond to the methodology and instrument employed by the laboratory and are verified by the laboratory.

§493.1218(d)(2) Statistical parameters for unassayed materials must be established over time by the laboratory through concurrent testing with calibration materials or control materials having previously determined statistical parameters. (The statistical parameters, e.g. mean and SD, for each lot number must be determined through repetitive testing).

§493.1218(e) Control results must meet the laboratory’s criteria for acceptability prior to reporting patient test results. Laboratory criteria for acceptability refers to the particular control limits or control rules chosen by the laboratory.”

The issue is being able to document the controls in order to be in compliance with §493.1218(d)(2) and §493.1218(e) at the bare minimum because the control data is considered proprietary and unavailable to the lab.

Reference
U.S. Department of Health and Human Services. Medicare, Medicaid and CLIA programs: Regulations implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA). Final rule. Fed Regist 1992; 57:7002-186.

U.S. Department of Health and Human Services. Medicare, Medicaid and CLIA programs: Regulations implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and Clinical Laboratory Act program fee collection. Fed Regist 1993:58:5215-37.