Sprinkled throughout the CLIA regulation are requirements for policies and procedures. All policies and procedures must be approved, signed, and dated by the laboratory director when they are implemented and whenever any changes are made. It’s important to note each policy and procedure must be individually signed by the laboratory director. The laboratory director cannot
CLIA regulations require proficiency testing on “regulated analytes”. These analytes are outlined under the proficiency testing section of the CLIA regulations. Proficiency testing for each regulated analyte is required three times a year. Samples must be tested in the same manner as patient samples and must be integrated with routing patient specimens. Typically, five proficiency
CLIA has specific requirements for personnel, depending on the complexity of testing performed. Laboratory testing is classified in three different categories: waived, moderate, and high. Laboratories performing only waived testing have no personnel requirements, according to CLIA. Moderate complexity testing requires the laboratory to have a Laboratory Director and one or more of the following:
The goal of quality assurance (QA) in the laboratory setting is to recognize and correct problems identified in laboratory testing in order to provide accurate and reliable laboratory results. A quality assurance program must be written and must indicate what QA activities take place and when the laboratory performs those activities. The written quality assurance
Amid concerns about the reliability of PAP smear testing and false negative results leading to patient deaths, Congress passed the Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88). The CLIA regulations govern every laboratory, including small physician offices. The definition of a laboratory, according to CLIA regulations, is: “a facility for the biological, microbiological, serological,
There are several different types of CLIA certificates. The most simple is a “Certificate of Waiver” (or COW). Under this certificate, a laboratory may only performed tests classified as “waived” by the Food and Drug Administration (FDA). Additionally, a COW must follow manufacturer’s instructions for the tests that are performed. This type of certificate is