What is proficiency testing under Clinical Laboratory Improvement Amendments of 1988 (CLIA) and why is it important?
Proficiency testing PT is a process which is mandated under CLIA to evaluate the accuracy of non-waived medical laboratory testing. This is accomplished by distributing samples designed to mimic the patient samples a laboratory might receive; having the laboratories test them; and then having the results scored by the PT provider. Microbiology samples test the laboratory’s ability to identify organisms that would commonly be included in patient specimens or determine the presence or absence of particular organisms. Why and how did these proficiency testing samples come to contain influenza A (H2N2) virus, and where did the samples originate? Apparently, Meridian Bioscience, Inc., acting contractually on behalf of four PT providers, selected the H2N2 strain of influenza A virus. It is our understanding that Meridian obtained the H2N2 sample from a supplier of biological specimens and kept the sample under storage since approximately 2000. In most circumstances, contractors who provide P
Related Questions
- Since I perform only a few simple tests in my office, do Clinical Laboratory Improvement Amendments (CLIA) regulations apply to my practice?
- What is proficiency testing under Clinical Laboratory Improvement Amendments of 1988 (CLIA) and why is it important?
- What are the Clinical Laboratory Improvement Amendments of 1988 (CLIA 88)?
