To obtain your CLIA License, based on the lab directors experience, you will need a technical consultant. POLS can provide your lab with the correct technical consultant who can answer you lab staff question and insure that the lab is running correctly.
- Customized Laboratory Administrative documents required for moderate /high complexity laboratories.
- Preparation of a customized Quality Management Plan to address training and competency, quality control, process management, proficiency testing and patient documentation.
- Selection of test methodology appropriate for the clinical use of the test results.
- Verification of the test procedures performed and the establishment of the laboratory's test performance characteristics, including the precision and accuracy of each test and test system.
- Assure enrollment and participation in an HHS approved proficiency testing program commensurate with the services offered.
- Establishing a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results.
- Resolving technical problems and ensuring that remedial actions are taken whenever test systems deviate from the laboratory's established performance specifications.
- Ensuring that patient test results are not reported until all corrective actions have been taken and the test system is functioning properly.
- Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed.
- Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. The procedures for evaluation of the competency of the staff must include, but are not limited to:Evaluating and documenting the performance of individuals responsible for moderate/high complexity testing at least semiannually during the first year the individual tests patient specimens. Thereafter, evaluations must be performed at least annually unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's(a dangling thought).