All laboratory testing, whether performed within the central laboratory, or at the point of care, must abide by Federal regulations as proposed by Clinical Laboratory Improvement Ammendments (CLIA).  All testing sites must operate under one of  three CLIA Certificates (Waived PPMP, or moderately complex) depending on the level of testing performed.  Most Point of Care Testing within the UTMB enterprise will fall under either a waived or PPMP certificate.

    The Point of Care Testing (POCT) program at UTMB has been developed by a multidisciplinary CPI team comprised of physicians, nursing, outpatient clinic, and Pathology personnel.  The process as designed by the team requires that any new testing, provided a CLIA Certificate is already existent and current, be initiated by the Medical Director and Practice (Area) Manager by filling out and submitting POCT Forms BST 09I and BST 09CA  Information on these forms that is especially critical includes  approximate cost involved, justification for POCT over routine central laboratory testing, and how the POC test will enhance patient outcome.  Forms are then forwarded to the Director of Point of Care.  After all information is submitted, it is reviewed and a decision is relayed to the requestor(s) upon review. For further information on compliance and quality control related issues refer to Hospital Policy 9.13.4 Governance of Point of Care Testing.
   

Once a request is granted, employee validation process is implemented prior to beginninng performance of the approved POC test .  Employees must read the SOP,  pass the appropriate online test as well as successfully perform  unknown samples.
For questions about  Employee Validation e-mail our Director of Point of Care