Training is required for all staff members performing POCT. Staff members performing POCT are not required to 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.
Before training for POCT, each staff member must have qualifications compliant 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 before initiation of testing as well as following any changes or updates in instrumentation, kits, or test methods. Initial training must be documented and completed before the user performs any patient testing. Competency must also be documented. The initial training must include direct observation, and be documented, and the documentation must be 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 before performing patient testing.
All training must be performed by a qualified individual or company representative and the competency of the tester verified before performing patient testing. A qualified trainer must have been trained and demonstrated competency in all methods for which training is being conducted.
