Summary:
Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on record review and staff interview, laboratory (lab) personnel performing proficiency testing (PT) and the Laboratory Director (LD) failed to sign the PT attestation form for 6 out of 6 PT events in 2023 and 2024. Findings include: 1. Review on 3/6/2025 of the lab's PT records revealed 3 PT events in 2023 and 3 PT events in 2024 and the attestation forms for the 6 of 6 PT events were not signed by the testing personnel and LD. 2. Interview on 3/6/2025 at 10:30 a.m. with the Practice Manager confirmed the above finding. 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 and staff interview, the laboratory (lab) failed to review and evaluate potassium hydroxide slide examination (KOH) proficiency testing (PT) results for 3 of 5 PT events with unacceptable scores in 2023 and 2024. Findings include: 1. Review on 3/6/2025 of the lab's PT records revealed the lab obtained unacceptable results for KOH testing in 5 of 6 PT events from 2023 through 2024. PT scores for KOH are as follows: 2023 Event 1 - 100% 2023 Event 2 - 50% 2023 Event Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- 3 - 0% 2024 Event 1 - 0% 2024 Event 2 - 0% 2024 Event 3 - 50% Further review of the 5 events with unacceptable results revealed the lab documented review and evaluation for 2 of the 5 events. The evaluation form for 2024 Event 3 documented the slides were reevaluated and obtained acceptable results and the KOH protocol was reviewed by the Laboratory Director; this evaluation form was not signed by the Laboratory Director and did not include documentation of the results obtained during reevaluation. A PT "