Summary:
Summary Statement of Deficiencies D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on record review, lack of documents, and interview, the laboratory failed to verify the accuracy of the Potassium Hydroxide (KOH) procedure it performs, affecting 110 patients' tests. Findings include: 1. The American Proficiency Institute (API) proficiency testing (PT) program records for 2020 and 2021, KOH patient test log, and procedures manual were reviewed. 2. The manual stated the laboratory would enroll in API's "Microscopy - KOH Preparation, (glass slide)" PT program as the method to verify the accuracy of its KOH procedure. 3. The API-PT reports revealed the laboratory received the following scores: EVENT SCORE 2020 1st 100% 2020 2nd Failure to Participate 2020 3rd 0% - Unsatisfactory Performance 2021 1st 0% - Unsatisfactory Performance 2021 2nd 50% - Unsuccessful 2021 3rd 50% - Unsuccessful 4. Further review of the documents showed the laboratory investigated one (Event 2021 3rd) out of five PT failed events. The laboratory failed to provide any other documentation that verified the accuracy of its KOH procedures when receiving continuous failures. 5. Review of the patients' KOH logs from 02/2020 to 02/2021 revealed 110 patients were tested and reported. 6. On a Recertification survey conducted on 02/28/2022 at 12:50 PM, office staff and laboratory manager confirmed the above findings. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform 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 -- test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require