Summary:
Summary Statement of Deficiencies D0000 An announced validation survey was performed from February 6, 2024 to Feburary 7, 2024. The laboratory was found out of compliance with the CLIA regulations. The condition not met was: D6063 - 42 C.F.R. 493.1421 Condition: Laboratories performing moderate complexity testing; testing personnel D2077 GENERAL IMMUNOLOGY CFR(s): 493.837(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on the review of API proficiency testing Policy, API proficiency testing records in 2023, and confirmed in an interview, the laboratory failed to have documentation of self-evaluation for not participating for one of one regulated analyte, Infectious mononucleosis, in 2023 Immunology/Immunohematology - 2nd Event. The findings were: 1. Review of API Proficiency Testing Performance Evaluation page revealed "Laboratories are responsible for documenting and performing