Summary:
Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to perform and document activities used to verify the accuracy of a Microbiology test procedure at least twice annually in 2018. Findings are as follows: 1. The laboratory performed the Tzanck Microscopic Examination for viruses under the specialty of Microbiology as confirmed by the Site Manager (SM) during a tour of the laboratory at 1:05 p.m. on 10/23/19. 2. Documentation of the Tzanck twice annual verification of accuracy was not found for 2018 during review of laboratory records. The laboratory was unable to provide the verification documentation upon request. 3. Laboratory records indicated five patients received Tzanck testing in 2018. 4. In an interview at 2:15 p.m. on 10/23/19, the SM confirmed the above finding. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --