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 review of accuracy assessments, patient logs, and interview, the laboratory failed to verify the accuracy of dermatopathology interpretations of its frozen sections at least twice annually for 2 of 2 years reviewed in 2019, 2020, and 2021. Findings follow. Accuracy assessments for dermatopathology interpretations of frozen sections were requested on June 29, 2021 at 1150 hours but not provided. Review of the Frozen Section Biopsy Log showed from 07/22/19 - 01/20/2021 there were 71 cases /patients reported. Interview with the Laboratory Director on June 29, 2021 at 1150 hours in the breakroom confirmed accuracy assessments for frozens were not performed this survey cycle. D6116 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(3) The technical supervisor is responsible for enrollment and participation in an HHS approved proficiency testing program commensurate with the services offered. This STANDARD is not met as evidenced by: Based on review of accuracy assessments, patient logs, and interview, the technical supervisor failed to perform proficiency testing, or another means of verifying accuracy for the dermatopathology interpretations of its frozen sections for 2 of 2 years reviewed in 2019, 2020, and 2021. Refer to D5217. 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 --