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 proficiency testing review, policy and procedure review, medical record review and interview, the laboratory failed to perform twice annual verification for KOH in 2025. Findings include: 1. Review of CAP proficiency testing showed no results for FSM-A 2025, KOH testing samples in 2025. 2. Policy titled, "KOH Proficiency testing", written on 04/01/2016 stated, "Twice annually The College of American Pathologist will send KOH proficiency kits to test the physician ' s ability to diagnosis various fungal specimen types. The answer sheet will be faxed to CAP ... Results will be kept on file in the laboratory ..." 3. A KOH fungal sample was analyzed microscopically on the following patient: Patient Collection Date Reported Results P1 11/18/2025 Hyphae Present 4. In an interview on 04/29/2026 at 4:15 pm, E1 (Office Manager) confirmed the laboratory had completed twice annual verification only once for KOH testing in 2025. Legend: CAP-College of American Pathologist E-Employee FSM-Fungal Smear KOH-Potassium Hydroxide Preparation P-Patient 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 --