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 records review, manual, and an interview with the testing personnel (TP), the laboratory failed to verify the accuracy of the Histopathology procedure the laboratory performs for the years of 2018 and 2019. Findings include: 1. American Society For Mohs Surgery (ASMS) Peer reviews, patients' test reports, and laboratory manual were reviewed. 2. The patients' test reports showed that the laboratory had been performing Mohs surgery procedures during the years of 2018 and 2019. 3. The documentation revealed that the laboratory no longer participated in the ASMS Peer Review to verify the accuracy of the Mohs surgery procedures performed during the above years. 4. The laboratory failed to establish and implement an alternative process to verify the accuracy of its Mohs procedure, since it no longer uses the ASMS peer review board to perform this function. 5. The laboratory failed to verify the accuracy of its Mohs procedure, at least twice annually, for the years of 2018 and 2019. 6. On a Recertification survey conducted on 02/11/2020 at 11:45 AM, the TP confirmed the above findings. 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 --