Summary:
Summary Statement of Deficiencies D0000 An initial certification survey was conducted on January 3, 2022. Blue Ocean Dermatology LLC clinical laboratory was not in compliance with 42 CFR 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 staff interview, the laboratory failed to verify the accuracy of the reading and interpretation of the Hematoxylin and Eosin (H&E) stain for one of two of the required twice annual verification for two of two (A, B) Mohs surgeons in 2021. Findings: The laboratory used peer review to verify the accuracy of the reading and interpretation of H&E stain for their Mohs surgery slides. Review of the peer review log for Mohs Surgeon A showed peer review was completed on 12/15 /21 with patient cases from 02/26/2021 to 07/16/2021. Review of the peer review log for Mohs Surgeon B showed peer review was completed on 12/16/21 with patient cases from 06/18/2021 to 11/05/2021. On 01/03/2022 at 1:30 PM, the Nurse Practitioner stated peer review was performed only once on each of the Mohs surgeons. 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 --