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 test record review, lack of documentation, and interview with staff, the laboratory failed to verify potassium hydroxide (KOH) and dermatophyte culture test accuracy at least twice annually for two of two years of testing reviewed, (2017 and 2018). The laboratory performed approximately 240 KOH preparations and 15 cultures for growth or no growth of dermatophyte. Findings include: 1. Patient test records review included documentation the laboratory performed KOH and dermatophyte culture testing. 2. The laboratory failed to document they verified the accuracy of KOH and dermatophyte culture testing twice annually in 2017 and 2018. 3. In an interview by email on 01/14/2019 the laboratory manager confirmed after moving to an electronic record system the laboratory lost the documentation method they used to capture the dates and specimens they used to meet the requirement for accuracy verification for both KOH preparations and dermatophyte cultures. 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 --