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 laboratory test records for Mohs procedures and Frozen Biopsy, the lack of laboratory documents, and interview with laboratory administrative personnel, the laboratory failed to at least twice annually verify the accuracy of pathology reported for Frozen Biopsy specimens in 2017 - 2018. Findings included: a. The laboratory Mohs log documented Frozen Biopsy slides prepared onsite with pathology reported by the Mohs Surgeon in 2017 and 2018. b. The laboratory provided documents titled "proficiency testing" for reviewing Mohs slides to verify the final stage of clearing. Documents for 2017 included one Frozen Biopsy slide reviewed for accuracy of pathology reported by the Mohs Surgeon. Documents for 2018 did not include any reviews of Frozen Biopsy slides. c. Laboratory administrative personnel were unable to provide documents reviewing Frozen Biopsy slides at least one other time in 2017, and at least twice in 2018; and thus, the laboratory failed to have a Policy and practice to at least twice annually verify the accuracy of Frozen Biopsy pathology. d. The reliability and quality of pathology reported for Frozen Biopsy could not be assured in the absence of verifying accuracy at least twice annually. e. The Laboratory administrative person affirmed (4/16/19 at 4: 39pm) the Mohs Surgeon reported 38 Frozen Biopsies in 2017, and 28 FBX in 2018. 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 --