If not available, make your selection based upon the cartridge type and lot number. Note 2: For creatinine results, select IDMS-Traceable Calibration, if available. When reporting results, look for a separate peer group for these cartridge lots. Note 1: ph and PCO 2 results from EC8+ cartridge lots with prefix letters F, G, H, J, and K will not agree with ph and PCO 2 results from other cartridges. Therefore, it is important for troubleshooting purposes to record the cartridge type and lot number used to report PT results. We are working with the PT providers to prevent unnecessary PT failures and will continue to work with customers and providers when we suspect failures are due to miscoding or inappropriate peer groups. APOC recognizes that it may be difficult for PT providers and customers to ensure proper coding. Furthermore, miscoding may cause inaccurate peer group means, resulting in unnecessary failures for some participants. Continued PT failures may result in the loss of your permission to report results. Miscoding your results can cause PT failures. Cartridge generations are identified by the prefix letter preceeding the cartridge lot number. Periodically, Abbott Point of Care (APOC) makes cartridge manufacturing changes which may affect the results for non whole-blood samples, such as proficiency testing (PT) material. The information below should be used to select the correct code(s). CODING i-stat RESULTS Proficiency Testing providers use different methods for coding results. Other venous whole blood samples, capillary, and/ or arterial samples tested using these same cartridges on the i-stat 1 System are categorized by the FDA as moderate complexity. Date: 10-Mar-16Ģ With the i-stat 1 System, the FDA has categorized the tests included on the i-stat G, Crea, E3+, EC4+, 6+, and CHEM8+ cartridges as waived when testing is performed using venous whole blood samples collected in sodium or lithium heparin evacuated tubes. 100 & 200 Abbott Park Road Abbott Park, IL USA Art: AF Rev. Check with your state regulatory agency for state requirements. The College of American Pathologists (CAP) requires proficiency testing for waived tests. COLA recommends PT testing and will issue an educational citation for noncompliance. Waived Tests Proficiency Testing for waived tests is not a CLIA requirement nor is it a requirement from The Joint Commission. Laboratories must comply with the CLIA requirements and those of their accrediting organization when testing PT samples. For CLIA regulated analytes, proficiency testing (PT) programs must provide three separate shipments during the year that include five challenges for each analyte or test. The i-stat System may be a primary testing system when: A hospital has separate CLIA certificates for the main laboratory and point of care testing A hospital owns a clinic, same-day surgery, kidney dialysis unit, etc., which requires a separate CLIA certificate The i-stat System is the hospital s primary laboratory testing system or The i-stat System is the main testing system in a physician s office, skilled nursing facility, unaffiliated patient transport service, home healthcare agency, etc. A primary testing system is defined as the only method or the primary method for performing and reporting tests under a CLIA certificate. The laboratory must participate successfully as defined by the criteria defined in Subpart I Proficiency Testing Programs. CLIA REQUIREMENTS FOR PROFICIENCY TESTING Moderate Complexity Tests CLIA regulation Subpart H Participation in Proficiency Testing requires a laboratory to enroll in a proficiency testing program approved by the Centers for Medicare and Medicaid Services (CMS) for its primary test system or that system used at its primary site. Peer performance is enhanced by following the instructions of the manufacturer. The use of inter-laboratory comparison, provided by PT, allows laboratories to ensure that their instruments are performing at a level comparable to their peers. Proficiency testing provides a snapshot in time of the analytic performance for a given test. Pay special attention to the Coding i-stat Results section since coding information may change periodically. 1 i-stat TECHNICAL BULLETIN Proficiency Testing on the i-stat System Please read this Technical Bulletin in its entirety before participating in a Proficiency Testing (PT) event as there are reminders and helpful information to enhance your probability of successful performance.
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