Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Minars Dermatology Llc on 6/12/2019. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level 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 record review and interview with Testing Personnel (TP) # 2, the laboratory failed to ensure the twice a year accuracy verification testing for Mycology for 2 (#6 and #3) in 2018 and 1 (#6) for 2017 out of 5 TP of the KOH test, subspecialty of Mycology; for 2 out of 2 (2017 and 2018) years reviewed. Findings include: Review of Proficiency Testing records, revealed: - No documentation of the peer review for KOH Test, Mycology for TP # 6 for 2017 and 2018. - No documentation of 2017 peer review for KOH test, Mycology for TP # 3 for 2018 During an interview on 06/12 /2019 at 2:30 PM, the TP # 2 confirmed that the laboratory had no documentation of the accuracy verification for the TP of reference during the years listed above. 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 --