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 a review of the laboratory's proficiency testing (PT) documents from the American Association of Bioanalysts (AAB), peer review documents and an interview with the laboratory director on 4/17/2024, the laboratory failed to verify the accuracy of potassium hydroxide (KOH) slide examinations and Mohs slide examinations in 2023 and 2024. The findings include: 1. A review of the laboratory's PT documents from AAB identified that the laboratory failed to perform biannual verification of test performance for KOH slide examinations once in 2024. 2. A review of the laboratory's Mohs peer review documents identified that the laboratory failed to perform biannual verification of test performance for Mohs slide examinations once in 2023. 3. An interview with the laboratory director on 4/17/2024 at 2:29 pm confirmed the above findings. 4. The laboratory reports performing 10 KOH slide examinations and 3000 Mohs slide examinations annually. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Based on a review of laboratory polices and procedures and an interview with the laboratory director on 4/17/2024, the laboratory failed to have a potassium hydroxide (KOH) slide examination procedure to ensure accurate and reliable test results. The findings include: 1. A review of the laboratory policies and procedures identified that the laboratory failed to have a KOH slide examination procedure that included step by step instructions. 2. An interview with laboratory director on 4/17/2024 at 2:29 pm confirmed that the laboratory failed to have a KOH testing procedure. 3. The laboratory reports performing 10 KOH slide examinations annually. -- 2 of 2 --