Summary:
Summary Statement of Deficiencies D0000 A recertification survey conducted from 03/06/2024 to 03/12/2024 found the GARY L CURSON DPM PA PODIATRY FOOT & ANKLE SURGERY clinical laboratory not in compliance with 42 CFR Part 493, Requirements for Laboratories. 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 record review and laboratory consultant interview, the laboratory failed to ensure that one out of two testing personnel (TP) participated in the twice a year accuracy verification for histopathology testing for one out of two years reviewed. Findings included: - Review of FORM CMS 209 Laboratory Personnel Report dated and signed by the Laboratory Director on 03/06/2024 revealed that the Laboratory Director, Technical Supervisor, General Supervisor and TP#A was the same person and that the laboratory had two TP (TP#A and TP#B). -Patient log review revealed that TP#B performed testing on 07/06/2022 and 11/09/2022 -Peer review records revealed that the laboratory failed to have records of peer review for TP#B for the year 2022. -During an interview on 03/06/2023 at 11:30 AM, the laboratory consultant confirmed that the laboratory failed to perform accuracy verification histopathology testing for TP#B during 2022. 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 --