Assessment of test performance on external proficiency testing samples, internal blind unknowns or previously analyzed samples, Assessment of problem solving skills (42 CFR 493.1413 (b)(8) and 493.1451(b)(8)). Competency Testing for personnel will include competency testing of all lab processes that employee performs. Competency assessment of waived methods is not required for CLIA compliance, but may be required for compliance with state or accreditation agency regulations. Selected elements of competency assessment include but are not limited to the six elements required for non-waived testing A laboratory must evaluate and document the competency of all testing Competency assessment A successful training program incorporates comprehensive initial training and emphasizes competency assessment. Healthcare facilities can use point of care testing (POCT) devices to improve healthcare delivery. Use of a written test specific to the test assessed (i.e. Outline guidelines for competency assessment as applied to POCT. Assessment of problem-solving skills; If any problems with competency assessment are noted they should be documented and corrected through the laboratory’s QA process. If the POCT is non-waived or moderately complex, competency assessment must be performed and documented. 2 Competency assessments may be performed and comprise data created throughout the competency assessment time period. Outline specific parameters to be included in the competency assessment program for employees performing POCT. Competency assessment is required (§493.1445(e)(13) of the CLIA regulations) twice the first year that an individual engages in testing and annually thereafter. Competency Test in Waived Testing CHC Waived Testing Requirements. SUBJECT: WAIVED TESTING REFERENCE #13001 PAGE: 2 DEPARTMENT: HOME HEALTH OF: 7 EFFECTIVE: APPROVED BY: REVISED: Successful completion of competency evaluation on specific test, for which the individual will perform waived testing Successful completion of competency for an instrument that is used for a test; staff The six elements include: Direct observation of routine patient test performance, including patient preparation, if applicable, and specimen collection, handling, processing and testing*. Personnel training, competency assessment, and the potential need for additional personnel. In recent years, however, more facilities have moved toward moderate complexity testing such as troponin cardiac biomarker, blood gasses, prothrombin time, and bilirubin. Personnel training and periodic competency assessment must also be documented. The requirement for an annual competency assessment applies to everyone who actually performs testing, Yost emphasized, including pathologists and doctoral-level personnel. It’s important to note that peer reviews among testing personnel are NOT acceptable for regulatory personnel competency assessment. The session will cover how forms should be standardized to reflect the required 6 elements, as well as competency for waived testing. Responsibilities related to the six elements of competency required for assessment of non-waived tests (moderate and high complexity) can be found in the standards for the laboratory’s Technical Consultant (CFR §493.1413) and Technical Supervisor (§493.1451). Proficiency Testing including competency of your testing personnel. Documentation is essential to assure quality waived testing. B. Competency Testing will be completed by all employees that participate in performing any type of lab test. 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