Changes in QC blood gas requirements under the Final CLIA Rule Method validation Most of Subpart K centers on the analytical phase of testing and introduces a new term, “nonwaived testing.” Nonwaived replaces the former and differing QC requirements for the moderate- and high-complexity test categories with a single set of QC requirements for both. To ensure that test sites focus their quality efforts on all phases of the testing process, this new subpart adopts a quality systems approach and is organized to reflect the flow of a patient specimen through the laboratory. In this rule, the former quality practices described in Subparts K (Quality Control), J (Patient Test Management), and P (Quality Assurance) for tests of moderate and high complexity were updated and combined into a new Subpart K (Quality Systems for Nonwaived Testing). The basic QC requirements changed on Januwith the publication of the CLIA “Final Rule”. These as well as other mandated quality practices were discussed previously. When CLIA’s requirements were first promulgated, electronic quality control was unknown.Įventually CLIA allowed electronic controls to fulfill the daily QC requirement provided the manufacturer specified their use. The initial minimum QC standards for blood gas testing, described in the FebruFederal Register, included: following manufacturers' directions having a procedure manual that specifies how to perform tests and report results performing and documenting calibration procedures (or verifying calibration) at least once every six months assaying at least one QC sample every eight hours of testing and including a calibrator or control in each run unless the instrument is calibrated or self-calibrates at least every 30 minutes performing and documenting remedial actions and maintaining records of all quality control activities for two years. Currently, blood gas instrumentation used for POCT as well as that used in the central laboratory is classified as moderately complex. ![]() All are based on test method complexity or difficulty to perform the testing. ![]() The QC and calibration requirements of CLIA have been in effect for over 10 years.
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