Summary:
Summary Statement of Deficiencies D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. This STANDARD is not met as evidenced by: Based on observation of the Cryostat (Antartica Inc CTD-1, serial number 33673920) and Microscope (Leica DM100, serial number 412516), review of laboratory records and Mohs slides from April 2022 to February 2026, and interview with Laboratory Assistant-1 (LAB116 Laboratory Personnel Report, 2/26/26), it was determined the laboratory failed to have a written policy/procedure and established ongoing practice to monitor laboratory records for accuracy, identify errors, and apply corrections as applicable. Findings included: 1. Mohs cases from 2022 to 2026, were selected from the Mohs Log books for review, including the Mohs surgery notes and photos in the patient's chart, Mohs map, and Mohs slides. Two out of 19 records had errors, as follows: a. Case # 25-100. Date of service: 8/12/25. Mohs Surgeon/Testing Person-1 i. Mohs surgery notes identified the site as Left distal posterior upper arm. ii. The Mohs Log, photos, Mohs map, and Mohs slides identified the site as Right distal posterior upper arm. b. Case # 26-029. Date of service: 2/24/26. Mohs Surgeon/Testing Person- 1 i. Mohs surgery notes, photos, Mohs map, and 10 out of 13 Mohs slides identified the site as Right clavicular neck. ii. The Mohs Log and 3 out of 13 slides identified the site as Left clavicular neck. 2. Laboratory Assistant-1 affirmed (3/09/26 at 4:30 PM) the aforementioned findings of errors in the laboratory Mohs records and the lack of an established ongoing review process to ensure their accuracy and quality. . 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 --