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Point of Care Testing

Point of Care Testing Procedure Manual

LifeBridge Health - Department of Pathology

Point-Of-Care Testing Procedure Manual


Waived Testing:
(Tests that meet the Clinical Laboratory Amendments of 1988 (CLIA "88) requirements for waived tests, are cleared by the Food and Drug Administration for home use, employ methodologies that are simple and accurate that the likelihood of erroneous results is negligible, or pose no risk of harm to the resident if the test is performed incorrectly.
 Blood Glucose Monitoring (BGM) ACCU-CHEK inform
 Gastroccult
 Hemoccult
 Quick Vue In-Line Strep A
 Quick Vue One-Step Urine hCG Pregnancy Test
 Quintimetrix Dropper Plus Urine Controls
 Urine Dip Stick (Bayer Multistix 10 SG)
 Coagu Chek XS Pro
   

Moderate Complex Test:
(A test that meets Clinical Laboratory Improvement Amendments of 1988 (CLIA "88) requirements based on knowledge required to performed the test; minimal training and limited experience required to perform the test; reagents and materials that are generally table and reliable; or require no special handling, precautions, or storage conditions; operational steps that are either automatically executed or are easily controlled; and stable and readily available calibration, quality control, and proficiency testing materials. Test system troubleshooting is automatic or self-correcting, or is clearly described or requires minimal judgment. Equipment maintenance provided by the manufacturer is seldom needed or can easily be performed. Minimal interpretation and judgment are required to perform pre-analytic, analytic and post-analytic processes, and the resolution of problems requires limited independent interpretation and judgment.

 
 Hemochron Signature Elite (ACT)
 SH i-STAT ONE
 Critical Values for i-STAT
 Act Kaolin(Activated Clotting Time) I-STAT

Required Forms
1. Request for Barcode
2. REPORTING POCT ERRORS RELATED TO PATIENT IDENTIFICATION
3. Request for POCT Form