MGH-MGPO Relocation Questionnaire: This questionnaire should be used to help plan for POCT program resources for your move or remodel.Mock Inspection Remedial Action Template.Feel free to use it to self check your Joint Commission readiness Mock Inspection Checklist: This checklist is used by the POCT program staff to assess site compliance.Great refresher for POCT Site Coordinators Joint Commission Preparation Checklist for POCT Site Coordinators: This list gives a broad overview to assist with compliance activities.Quality Control - Reagent Storage, Ordering and Documentation Guide.PPM KOH and Wet Prep Patient Result Log.PPM KOH, Wet Mount & Fern Blind Samples.PPM Competency Assessment Completion Guideline.PPM Competency Assessment Documentation.Billing, Insurance & Financial Assistance.Commutability limitations influence quality control results with different reagent lots. ![]() Clinical and Laboratory Standards Institute, Wayne, PA 2012. Verification of Comparability of Patient Results within One Healthcare System: Approved Guideline (Interim Revision). Arch Pathol Lab Med 2008 132:838-846Ĭlinical and Laboratory Standards Institute. State of the Art in Trueness and Inter-Laboratory Harmonization for 10 Analytes in General Clinical Chemistry. The accuracy of laboratory measurements in clinical chemistry: a study of eleven analytes in the College of American Pathologists Chemistry Survey with fresh frozen serum, definitive methods and reference methods. Clinical evaluation of the Accu-Chek Advantage blood glucose monitoring system. Medicare, Medicaid and CLIA programs CLIA fee collection correction and final rule. ✓ Records of comparability studies reflecting performance at least twice per year with appropriate specimen typesĭepartment of Health and Human Services, Centers for Medicare and Medicaid Services. ✓ Written procedure for performing instrument/method comparison AND antigen typing versus culture or detection of DNA versus a biochemical characteristic) designed to detect the same analyte. This checklist requirement does not apply to multiple analytical methods (e.g. multiple incubation and monitoring cells in a continuous monitoring blood culture instrument, two identical blood culture instruments connected to a single computer system, or multiple thermocycler cells in a real time polymerase chain reaction instrument). Two or more detectors or incubation cells connected to a single data collection, analysis and reporting computer need not be considered separate systems (e.g. Important: These materials are not an IQCP for your Abbott test systems. We are pleased to provide you with materials to support your IQCPs. If these are defined as separate tests, then this requirement does not apply unless each type of aPTT test is performed on more than one analyzer.įor Microbiology testing, this requirement applies when two instruments (same or different manufacturers) are used to detect the same analyte. The Clinical Laboratory Improvement Amendments (CLIA) program recently introduced the Individualized Quality Control Plan (IQCP) as a new quality control option for nonwaived testing. For example, some laboratories may use multiple aPTT reagents with variable sensitivity to the lupus anticoagulant. This requirement only applies when the instruments/reagents are producing the same reportable result. In cases when availability or pre-analytical stability of patient/client specimens is a limiting factor, alternative protocols based on QC or reference materials may be necessary but the materials used should be validated (when applicable) to have the same response as fresh human samples for the instruments/methods involved. The use of pooled patient samples is acceptable since there is no change in matrix. Otherwise, the use of human samples, rather than stabilized commercial controls, is preferred to avoid potential matrix effects. Quality control data may be used for this comparison for tests performed on the same instrument platform, with both control materials and reagents of the same manufacturer and lot number. This requirement is not applicable to calculated parameters. The laboratory must establish a written procedure for this check that includes acceptance criteria. This comparison is required only for nonwaived instruments/methods accredited under a single CAP number. ![]() ![]() The purpose of the requirement is to evaluate the relationship between test results using different methodologies, instruments, or testing sites. NOTE: This requirement applies to tests performed on the same or different instrument makes/models or by different methods. If the laboratory uses more than one nonwaived instrument/method to test for a given analyte, the instruments/methods are checked against each other at least twice a year for comparability of results.
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