Summary:
Summary Statement of Deficiencies D2003 ENROLLMENT CFR(s): 493.801(a)(2)(ii) (2)(ii) For those tests performed by the laboratory that are not included in subpart I of this part, a laboratory must establish and maintain the accuracy of its testing procedures, in accordance with 493.1236(c)(1). This STANDARD is not met as evidenced by: Based on review of policies and procedures, a lack of testing records, and an interview with the laboratory director, the laboratory failed to establish a process to verify the accuracy of Potassium Hydroxide (KOH) microscopy since patient testing began on 8 /29/2025. Findings include: 1. A review of the laboratory policies and procedures revealed that there was no process for verifying the accuracy of KOH testing twice annually. 2. A review of testing records revealed that no biannual verification records for KOH were available. 3. An interview on 4/8/2026 at 1100 AM with the laboratory director confirmed the laboratory did not have a process for verification of KOH test results. 4. The laboratory reports performing 50 KOH tests annually. 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 --