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 the laboratory's policies, quality assurance records from 2016 through 2018 and staff interview, it was revealed the laboratory failed to have documentation of performing twice annual accuracy assessment for MOHS testing in 2017. Findings included: 1. A review of the laboratory's policy titled Protocol for Quality Review of Microscopic Slides found " it is the policy of [name omitted] to send slides out twice a year to fellow MOHS surgeons for review to determine the quality and accuracy of the slide. " 2. A review of the laboratory's MOHS testing accuracy assessment records from 2016 through 2018 revealed the laboratory performed two accuracy assessments in 2016, one accuracy assessment in July 2017 and one accuracy assessment performed on March 27, 2018. The laboratory recorded that 2 cases were sent to a fellow MOHS surgeon on 10/30/2017, however there was no evaluation of the cases sent for review. 3. Interview of the histotechnician conducted on September 11, 2018 at 9:53 AM confirmed that the slides had been sent, but the reviews were not returned. She stated that she called the reviewing MOHS surgeons office when preparing for the inspection and they could not provide her with a copy of the review or find that the review was done. D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of