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 record review and interview, the laboratory failed to verify twice annually the accuracy of its Mohs Surgery slides for 2020 and four of nine patients (PT#1 and PT#7-PT#9) reviewed with testing performed in 2020. Findings include: 1. On 12/16 /2021 at 1:12 pm, upon request for 2020 Mohs twice-annual verification for proficiency testing, SP3 confirmed that no slide exchanges occurred for review by an independent laboratory in 2020. 2. Review of the "Quality Assurance Plan", dated February 2010 that was reviewed and signed by the laboratory director, indicated that proficiency specimens are sent out to an independent reference laboratory "on a bi- annual basis (every six months)" to "insure [sic] concurrence in diagnoses". 3. Review of nine medical records indicated that the following patients had Mohs surgery performed in 2020 without twice-annual verification to assure the accuracy of the Mohs Surgery performed. PT#1 on 2/11/2020 PT#7 on 7/30/2020 PT#8 on 8/26/2020 PT#9 on 9/14/2020 4. The annual test volume for Mohs testing is approximately 5060. 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 --