Abbott i-STAT 1 System Manual - Technical Bulletin

Abbott Point of Care Inc. • Abbott Park, IL 60064 • USA

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 

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.  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 

tests under a CLIA certificate.  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.

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.  Laboratories must comply with the 

CLIA requirements and those of their accrediting organization when testing PT samples. 

Waived Tests

Proficiency Testing for waived tests is not a CLIA requirement or a requirement from the Joint Commission 

or COLA.  However, the College of American Pathologists (CAP) requires proficiency testing for waived tests.  

Check with your state regulatory agency for state requirements.

With the i-STAT 1 System, the FDA has categorized the tests included on the i-STAT G, Crea, E3+, EC4+,