CLIA Regulations: Competency, Proficiency Testing (PT), and Inspections. Exam Questions With Verified Answers.

CLIA Regulations: Competency, Proficiency Testing (PT), and Inspections. Exam Questions With Verified Answers. To ensure good lab practices, a lab must adhere to many quality measures - answer-the goal of all measures is to provide safe, efficient health care Competency - answer-the ability to accomplish a task successfully -in the lab, this means testing the right sample in the correct way to produce the best result possible for patient care -must encompass all phases of testing: pre-analytic, analytic, and post-analytic -it is ok for a lab to develop an effective competency program -don't at least twice a year during the 1st year the individual performs patient testing and annually thereafter -if a new test method or a change in instrumentation, all testing personnel must be reevaluated before reporting patient results Per CLIA - answer-The goal of these regulatory and certifying standards is to "ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results." 6 requirements for competency - answer1. direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing, and testing 2. Monitoring the recording and reporting of test results (post-analytical phase) - answer-can be accomplished by reviewing patient records in a lab information system (LIS), hard copy reports, or patient medical records -specific elements, such as critical value documentation, accurate RR, corrected reports, and accurate patient demographics are important to the quality of patient data and should be monitored 3. Review of intermediate test results or worksheets, QC records, PT results, and preventive maintenance (PM) records - answer-a method to document the review of the elements mentioned in the standard must be used to ensure that all staff are maintaining quality in the lab 4. Direct observation of performance of instrument maintenance and function checks - answer-in addition to the review of documentation, a specified individual is also responsible to watch staff perform instrument maintenance and function checks, which are critical to analyzer performance - ensures that all steps are performed according to the writing procedures 5. Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external PT samples - answer-this requires the assessor to prepare unknown samples to be incorporated into the daily workload 6. Assessment of problem solving skills - answer-problems encountered include inadequate or mislabeled specimens, troubleshooting instrumentation or reagent performances, and customer complaints Director's role - answer-lab director is ultimately responsible for the oversight of competency; the director authorizes specific responsibilities and duties of supervisors and consultants, and ultimately, of all staff who are involved in all phases of testing -ensuring that policies and procedures are established for monitoring individuals Supervisor's role - answer-while they policy may be developed and/or approved by the lab director, a supervisor is the individual responsible for assessing and documenting competency -they ID training needs and assure that each individual performing tests receives regular in- service training and education appropriate for the type and complexity of the lab services performed Test systems to be assessed: - answer-any non-waived test system must be addressed in a competency program -waived testing is not considered a test system that requires annual competency assessment Any non-waived test system must be addressed in a competency program - answer-this includes PPM and moderate- and high- complexity testing Waived testing is not considered a test system that requires annual competency assessment - answer-it is essential to patient care that testing personnel are properly trained and perform testing according to the manufacturer's instructions to provide accurate results Proficiency Testing (PT) - answer-CLIA requires labs to take ongoing measures to verify the accuracy of tests and procedures -the "gold standard" for doing this is through PT programs