Framework for Quality Assurance in Molecular Diagnostics

Abstract

A framework for ensuring laboratory quality was laid down by Congress in the Clinical Laboratory Improvement Act of 1967. Because of public concerns about the quality of clinical laboratory testing in the United States, Congress passed the Clinical Laboratory Improvement Amendments of 1988 (CLIa88) setting forth uniform quality standards for all labora– tories performing tests for health purposes on human specimens. Laboratories must register with the Department of Health and Human Services (HHS) to obtain and maintain a current CLIA certificate regardless of whether they receive payment from Medicare or Medicaid programs. The Centers for Medicare & Medicaid Services (CMS), formerly the Health Care Financing Administration (HCFA), is a federal agency within HHS and is charged with the implementation of the CLIAa88 regulations. CMS working with the Public Health Services (PHS), specifi- cally the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA), developed standards for laboratory certification and set forth criteria for categorizing tests based on the level of complexity to perform the test. Tests, therefore, are categorized as waived, moderate complexity including the subcategory of provider-performed microscopy, or high complexity. Waived tests employ methods that are simple and are assumed to pose no risk or harm to the patient if the test is not performed correctly. L a boratories performing waived tests must follow manufacturers’ instructions for test performance and are not subject to routine inspections. Tests categorized as mod- erate and high complexity must meet such CLIa88 require– ments as: (1) maintaining optimal patient specimen integrity and identification throughout the testing process, (2) specifying the responsibilities and qualification for personnel performing the test, (3) establishing and following written Quality Control pro- cedures and (4) having a comprehensive Quality Assurance pro- gram in place. The laboratories performing moderate- and high-complexity testing must participate in a proficiency testing program for each specialty, analyte, or test for which they are certified and are subject to inspections by CMS or other pri- vate accrediting organizations. The major differences between moderate- and high-complexity testing are in the quality control and personnel standards. On February 29, 1992, these revised CLIA’88 regulations were published in the Federal Register (1) and it is recommended that each laboratory have a copy. On January 24, 2003, almost 11 yr later, CMS and the CDC published a final rule in the Federal Register (2) revising the quality control and personnel standards for laboratory services and changing the consensus requirements for grading proficiency tests. The rule specifies a common set of quality control (QC) standards for both moderate and high complexity testing (now known as nonwaived testing) and reduces the frequency with which QC is to be done in most specialty and subspecialty areas. Under the new rules, agencies providing proficiency testing programs must grade a laboratory’s sample in cases where there is 80%, not the current 90%, agreement among the participants or referee laboratories. This will ensure that more laboratories will be graded and ultimately improve the accuracy of laboratory testing. The CLIA rules now put the onus on the laboratory to review and validate nongraded samples, especially when the results do not agree with the intended response. Another change in the regulations is that directors of highcomplexity testing are to be board certified unless they are eligible to be grandfathered under the phase-in requirements.