Abbott Point of Care Inc.
Art: 714262-00AA Rev. Date: 17-Mar-11
Technical BulleTin
i-STAT
®
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. Pay special attention to the “Coding i-STAT Results” section since
coding information may change periodically.
Proficiency testing provides a snapshot in time of the analytic performance for a given test.
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. Peer performance is
enhanced by following the instructions of the manufacturer.
CLIA REQUIREMENTS FOR PROFICIENCY TESTING
Moderate Complexity Tests
CLIA regulation Subpart H – Participation in Proficiency Testing requires a laboratory to enroll in a proficiency
system or that system used at its primary site. The laboratory must participate successfully as defined by
the criteria defined in Subpart I – Proficiency Testing Programs.
A primary testing system is defined as the only method or the primary method for performing and reporting
unaffiliated patient transport service, home healthcare agency, etc.
during the year that include five challenges for each analyte or test. Laboratories must
Waived Tests
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