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 2016 -2017 Log Book for Mohs procedures, patients reports, and laboratory documents verifying the accuracy of histopathology testing; the lack of laboratory documents, and interview with laboratory personnel, the laboratory failed to at least twice annually verify the accuracy of pathologies reported for fresh, frozen biopsy specimen during Mohs procedures. Findings include: a. The Mohs Log for 2016 - 2017 included the collection of fresh, frozen biopsy specimen. Patients records revealed the Mohs surgeon read the biopsy slides and reported the pathology. b. Review of laboratory documents verifying the accuracy of testing revealed only slides for Mohs procedures were selected. No slides for frozen biopsies were included. c. Laboratory personnel affirmed (3/12/18) the failure to include frozen biopsy slides to verify pathologies reported. d. The reliability and quality of pathology reports for frozen biopsies could not be assured : 1) Number of frozen biopsies 2016 ..............................24 2017.................................7 2018 (only to 3/12/18)......2 2) A few examples are as follows: Date ID Sites ----------------------------------------------------- 1 /20/16 P H, J L. upper nose 5/03/16 J, P L .upper eyelid 5/18/16 R, M R. nostril 8/15 /16 S, P anterior neck 11/15/16 T, S L. cheek " " L. medial cheek 3/30/17 C, K R. upper nose 6/13/17 A, A L. nostril 9/26/17 R, H Mid upper nose " " Mid nose 1/04/18 B, A L. upper forehead 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 --