Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Water's Edge Dermatology on 07/10/2019. The laboratory was not in compliance with Code of Federal Regulations (CFR), Part 493, requirements for clinical laboratories. 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 laboratory personnel, the laboratory did not verify the accuracy of mycology testing twice annually. Findings include: Review of verifications of potassium hydroxide (KOH) preparations on 07/10/2019 revealed that the laboratory verified the accuracy of KOH preps only once in 2018. During an interview with the laboratory histotechnologist at 9:45 a.m. on 07/10/2019, she confirmed that they must have skipped one verification. 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 --