Training Requirements for POCT

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Training Requirements for POCT

Training is required for all staff members performing POCT. Staff members performing POCT may not be laboratory testing personnel. These persons may lack previous laboratory experience and training to apply to the testing process and regulatory compliance for the POCT methods.
Prior to training for POCT, each staff member must have qualifications verified with federal and state requirements and accreditation agencies, if appropriate. For institutions performing POCT utilizing waived or non-waived testing, CLIA regulations require a high school diploma or equivalency. Some state regulating agencies require a license and/or a specific level of professional qualifications for persons performing laboratory testing in any setting, including point-of-care.
Each qualified POCT user must complete initial training and orientation on each test method prior to initiation of testing and following any changes or update in instrumentation, kits, or test methods. Initial training must be completed prior to the user performing any patient testing, and competence must be documented. This initial training must include direct observation. be documented, and the documentation retained in the individual's training record.
Following any changes or updates in methodology, training of personnel in the new methodology must occur and be documented prior to performing patient testing.
All training must be performed by a qualified individual or company representative and competency of the tester verified prior to performing patient testing. A qualified trainer must have been trained and demonstrated competency for all methods for which training is being conducted.