Summary:
Summary Statement of Deficiencies D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of Quality Assessment policies and records and interview with the facility personnel, the laboratory failed to review and evaluate the results obtained from accuracy verification procedures conducted by the laboratory. Findings include: 1. The laboratory performs Mohs testing under the sub-specialty of Histopathology, with an approximate annual test volume of 200. The laboratory performs accuracy verification for non-regulated testing (Mohs testing) that is not included under subpart I. 2. The laboratory's established policy titled, "Proficiency Testing Policy" states, "Two cases will be evaluated by another Mohs physician per year to confirm and monitor accuracy of histopathology cases performed in house. A practicing Mohs physician shall confirm accuracy of the slides and the cases that were previously observed and diagnosed by the clinical director". 3. No documentation was presented for review to indicate the laboratory reviewed and evaluated the accuracy verfication results from 2017 to determine whether or not the results of the review were acceptable or if