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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