Summary:
Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the Dermatologic Surgery Center laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. . 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, the laboratory failed to maintain documentation to verify, at least twice annually, procedures it performs that are not included in subpart I of this part as evidenced by the following: The laboratory's procedure for peer review of pathology cases was to pull eight (8) cases (four (4) skin biopsy and four (4) MOHS cases) every six months and re-examined by another pathologist to verify the the accuracy of the diagnoses. A review of calendar years 2016 and 2017 quality assessment records for case review revealed that, for some records, there was no date of review indicated (2016: case numbers for MOHS 16-50, 16-100, 16-156, 16-208, 16-243 and biopsy case numbers BXF16-51, BXF16-99, and BXF16-134; 2017: case numbers for MOHS 17-50, 17-100, 17-148, 17-200 and biopsy case number BXF17-50) making it impossible to determine whether the reviews were performed at least twice annually or all on the same date. The laboratory director interviewed on 1/18/18 at 9:12 am verified that the dates the case reviews for skin biopsy and MOHS cases were performed was not available. 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 --