CLIA stands for Clinical Laboratory Improvement Amendments of 1988. CLIA of 1988 is an amendment to the original Clinical Laboratory Improvement Act of 1967. The purpose of CLIA, 1988, is to provide accuracy, reliability, and timeliness of patient testing results. CLIA 1967 covered only Medicare, Medicaid, and interstate commerce; CLIA 1988 has a broader scope.
Sections of a CLIA Manual
There are several sections that must be included in a CLIA laboratory manual. These sections include a lab’s QA plan, specimen collection, specimen labeling, form completion, a panic value list, and guidelines for releasing the results. The Laboratory also needs to establish written procedures for specimen collection, handling and the referral. These include…show more content… These requirements are equal to or more intense than the CLIA condition-level requirements. The lab will authorize the approved accreditation organization program to release to the CMS all records and permit inspections. The laboratory that is seeking to meet the CLIA requirements must do all of the following: Obtain a certificate of accreditation/waiver, pay any fees required, meet proficiency testing requirements; it must authorize its proficiency testing organization to furnish the results of the lab’s participation in an approved PT program for monitoring the lab’s PT and for making the annual PT results. A lab that refuses to authorize the release of its results will no longer be deemed to meet the condition-level requirements, then will be under a full review by the CMS which could lead to a revocation of its…show more content… However, now the regulations allow the lab to reduce the frequency of testing external quality control materials, that are equivalent QC procedure, for certain test systems. The laboratory must document all of the control procedures, or again, it didn’t happen.
Comparison of test results
If the same test is performed by the lab using different methods and instruments, the lab must have a system that will evaluate/define the relationship between the test results using the said different methods and instruments and/or testing sites. The laboratory must identify and assess the patient’s test results that appear inconsistent with the relevant criteria, age, sex, and diagnosis of the patient. Again, you should document all results and their comparisons.
Corrective Actions
Policies for corrective actions should be readily available and followed as necessary to maintain the lab’s operations in a manner that will ensure the accuracy of all test results and reports. You should document all of the actions taken. The lab should take corrective action to ensure the reporting of accurate and reliable
