Summary:
Summary Statement of Deficiencies D5801 TEST REPORT CFR(s): 493.1291(a) (a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: Based on direct observation, laboratory records, patient test reports, and interview with laboratory representative (LR) and the Laboratory director (LD); the laboratory failed to have a reliable system in place to ensure test results, including the number of Mohs histopathology surgical stages, were accurately transferred to the final report for one of five patients reviewed. Findings include: 1. Review of laboratory records revealed the Mohs histopathology map for patient 366964 with case number NV25- 023, which indicated margins were clear after III stages from the right upper cutaneous lip. 2. Direct observation of Mohs histopathology slides for case number NV25-023, tested on 01/31/2025, revealed a total of nine patient slides for I, II and III Mohs surgical stages. 3. Review of the patient test report for patient 366964 with Case number NV25-023, from 01/31/2025, under "Operative Procedure details" stated "There was no evidence of residual tumor at the wound margins after 1 Mohs micrographic surgery stages" and failed to document findings for stages II and III. 4. Interview with the LR and the LD on 10/30/2025, at 11:15 am, established the Mohs surgical map was accurate for patient 366964 with case number NV25-023 having clear margins after III Mohs surgical stages. The LR and LD confirmed laboratory failed to have a reliable system in place to ensure test results, including the number of Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Mohs histopathology surgical stages, were accurately transferred to the final report for one of five patients reviewed. -- 2 of 2 --