Summary:
Summary Statement of Deficiencies D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to retain 2021 microscopic examination verification of accuracy records for at least two years. Findings are as follows: 1. The laboratory performed fungal and parasite microscopic examinations as confirmed by Histotechnician 1 (HT1) during a tour of the laboratory at 1:05 p.m. on 05/24/23. 2. The laboratory performed fungal accuracy check via peer review at least twice annually as established in a memo found in the KOH Testing Accuracy Validation Log manual. Accuracy checks for parasites were also completed at least twice annually via peer review as established in the Scabies Scraping Procedure. 3. The KOH Testing Accuracy Validation Logs reviewed on date of survey did not include documentation for the time period of 08/23/18 to 10 /16/22. The log in progress included accuracy verifications dated 10/17/22 - 04/11/23. The last accuracy verification entry on the previous log was 08/23/18. 4. In an interview on at 2:45 p.m., HT1 confirmed the above findings. 5. The laboratory was given an opportunity to provide the missing documentation within two business days. 6. In an email received at 2:09 p.m. on 05/25/23, the Clinic Manager (CM) indicated 53 patients received fungal testing and 7 patients received parasite testing in 2021 as indicated in an internal report. 7. In an email received at 12:21 p.m. on 05/31/23, the CM confirmed the testing accuracy log from 08/23/18 - 10/16/22 was not found. 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 --