Summary:
Summary Statement of Deficiencies D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on record review and an interview with Testing Personnel (TP) #2, the laboratory failed to document all evaluations of test accuracy verification (TAV) activities for the MOHs and frozen section tissue biopsy interpretations performed in the subspecialty of Histopathology. All 3,080 patient tissue biopsy slide interpretation procedures performed from 03/10/2021 to 07/25/2023 had the potential to be affected by this deficient practice. Findings Include: 1. Review of the laboratory's "2.4 Peer Review Policy" policy and procedure, provided on the date of the inspection, approved via signature and date by the Laboratory Director on 03/08/2021, did not find instructions for the second physician to blindly document their interpretation of the MOHs and frozen section tissue biopsy examinations, however found the following items were available to the second physician. "The histology technician will retrieve a blind MOHs case from the a previous month and prepare all necessary components for the review. -Copy current MOHs map report that shows clear margins. -Blank MOHs map with only patient information -Case slides" 2. Review of two out of two tissue biopsy cases (one MOHs and one frozen section) sent for TAV in 2023 revealed the blank MOHs map with only the patient information and the mapping of Stage 1 for both cases did not have any indication of the second physician's interpretation. 3. Review of the laboratory's 2023 peer review forms for two out of two cases sent for TAV revealed the case date, the accession number, the patient name, the diagnosis, the number of stages/pieces/slides and the tech initials were documented prior to sending for re-interpretation. The second physician circled the quality (Excellent/Good/Fair/Poor), the disposition (agree/disagree), the comment sections were left blank, and they provided their signature and date. 4. The Inspector requested the laboratory's TAV blind tissue biopsy interpretation activities as Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- documented by the second physician for the one MOHs case and one frozen section case sent for TAV on 06/21/23 from TP#2. TP#2 confirmed the blank MOHs maps provided to the physician for their interpretive documentation of TAV cases were not completed and were left blank. TP#2 further confirmed that TP#2 was with the second physician at a double-headed scope during the re-interpretation and based on their verbal conversation, TP#2 indicated the quality and disposition sections on the peer review forms. TP#2 was unable to provide the requested documentation of the tissue biopsy interpretation of the second physician on the date of the inspection. The interview occurred on 07/25/2023 at 10:45 AM. -- 2 of 2 --