Summary:
Summary Statement of Deficiencies D2003 ENROLLMENT CFR(s): 493.801(a)(2)(ii) For those tests performed by the laboratory that are not included in subpart I of this part, a laboratory must establish and maintain the accuracy of its testing procedures, in accordance with 493.1236(c)(1) This STANDARD is not met as evidenced by: Based on review of 2020, 2021 and 2022 laboratory records and interview with laboratory director (LD) 10/26/22, the laboratory failed to verify the accuracy of the Mohs testing performed at least twice annually in 2020 and 2021 and at least once in 2022, a period of approximately 30 months in which a verification of accuracy was not performed. Findings: Review of 2020, 2021 and 2022 laboratory records revealed no documentation of a verification of accuracy for the Mohs testing. Interview with LD at approximately 12:00 p.m. confirmed the laboratory did not perform a verification of accuracy for the Mohs testing for approximately 30 months. The LD stated there was a large turn over in staff and sending slides for review was overlooked. 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 --