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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
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