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 information obtained during the entrance tour, a review of the Procedure Manual and "Independent Case Review" documentation (used for accuracy verification of Histopathology testing), and an interview with the Technical Consultant, the surveyor determined the Laboratory Director failed to document his assessment and comparison of the peer groups' results with the laboratory's results. This was noted on four out of four accuracy verification activities reviewed. The findings include: 1. During the entrance interview and tour of the laboratory at approximately 11:30 AM on 3/6/2018, the Technical Consultant stated the new Laboratory Director had added the specialty of Histopathology to the menu in late 2016. The Director performed on-site reading of slides from his patients' prostate biopsies which are processed and stained at another laboratory. 2. A review of the procedure manual revealed the new policy, "Independent Case Review", which stated the laboratory would send out slides from two cases semi-annually for independent review. 3. A review of the "Independent Case Review" documentation revealed the laboratory had sent out slides from two cases in March 2017 and two cases in October 2017. The in-house results reports were attached to each of the corresponding peer group reports. The surveyor observed the Laboratory Director's signature on each of the peer group reports, however there was no indication of whether the results were comparable with the in-house laboratory results. There was no record of a comparison indicating there were no discrepancies, minor discrepancies with no effect on patient care, or major discrepancies which would require documentation of