2What is Point of CarePoint-of-Care Testing (POCT) is defined as diagnostic testing at or near the site of patient care. This testing is categorized as waived and non waived testing.Waived testing at Mount Auburn Hospital includes Glucose meters, Fecal Occult Blood, Urine dipstick, and Urine hCG.Non Waived testing at Mount Auburn Hospital includes Activated Clotting Times (ACT) and Oxyhemoglobin. Non Waived tests are more complex and cannot be performed by the consumer.
4RegulatoryAll Point of Care tests are subject to regulatory guidelines.The College of American Pathologists (CAP) regulates both Waived and Non Waived TestingThe Joint Commission regulates Waived Testing
6Five “Elements of Performance” WT Policies and ProceduresWT Testing and Supervising StaffWT CompetencyWT Quality ControlWT Documentation
7Standard WTThe Director named on the CLIA certificate approves a constant approach for when waived test results can be used for diagnosis and treatment and when follow up treatment is required.All procedures and policies are approved by the Director.Procedures and policies establish: usage and limitations, need for confirmatory testing, specimen type collection and identification/labeling and preservation, storage conditions for test components, reagent use (expiration), Quality control (frequency and type and remedial action) result reporting and equipment performance
8Standard WT (cont.)Current and complete policies and procedures are available to testing staff.Criteria for confirmatory testing is established and the use of results is consistent with the hospital’s policies and the manufacturers' recommendations for waived testing.
9Standard WTThe Director identifies staff responsible for performing and supervising waived testingResponsible staff may be employees of the hospital, contracted staff, or employees of a contracted service.Responsible staff may be identified within job descriptions, or by individual names.At Mount Auburn Hospital, the Director designates the Laboratory’s POC Technical Coordinator to monitor the testing and QC processes, according to regulatory standards.
10Standard WTStaff and licensed independent practitioners performing waived tests are competent.Training for POC testing is done at hospital orientation and/or on the Nursing Units, depending on the test. All training is documented.Competency assessment must include at least 2 methods of review and these may include performance of blind specimens (proficiency samples), direct observation of routine work, QC monitoring, and written testing. Competency is assessed initially and annually at a minimum.
11Standard WTThe organization performs quality control checks for waived testing on each procedure.Procedures establish written Quality Control Plans for each test based on: how the test is used, reagent stability, manufacturers’ recommendation, the hospitals experience with the test, and current acceptable guidelines.Each Point of Care Test has its own Quality Control guidelines written into the procedure.Quality Control data is reviewed and evaluated in keeping with CAP standards. Data is monitored in the Laboratory by the Director or designee.
12Standard WTThe Organization maintains records for waived testing.Quality Control results are documented either on a log,flow sheet or electronically.Example: Glucometer patient results and QC data flow electronically to the glucose meter computer system, maintained in the Laboratory. This system is interfaced with Meditech.Example: Occult Blood results are documented on flow sheets, paper or online. (Notations by physicians in the medical record are to be accompanied by QC results.)Individual tests results for all waived tests are associated with Quality Control Results.