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 lack of accuracy verification documentation for the microscopic interpretation of Frozen Biopsy specimens and interview with the facility personnel on 10/08/25 at 1:39 PM, the laboratory failed to verify the accuracy of testing performed under the subspecialty of Histopathology at least twice annually during 2024. Findings include: 1. No documentation was presented for review to indicate the laboratory verified the accuracy of the microscopic interpretation of Frozen Biopsy specimens at least twice annually during 2024. 2. The facility personnel interviewed on 10/08/25 at 1:39 PM confirmed the laboratory failed to verify the accuracy of histopathology testing at least twice annually during 2024. 3. The laboratory performed 4 frozen biopsies in 2024. 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. 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 -- This STANDARD is not met as evidenced by: Based on review of final test result information for Mohs maintained in the Electronic Health Record (EHR) and interview with the facility personnel on October 8, 2025 at 1:16 PM, the laboratory failed to accurately report Mohs test results in the patient's EHR for one out of three patient records reviewed during the survey. Findings include: 1. Patient-specific data and the final test result information for Mohs is manually transcribed by laboratory personnel into the patient's EHR. 2. One out of three Mohs cases reviewed (# MSP24-844) failed to include the correct test result for Mohs in the patient's EHR. The Mohs test result information maintained in the EHR stated, "Stage 1: Frozen section analysis showed: residual tumor seen." The Mohs map, patient's slides, and the laboratory's Mohs log indicated the total number of Mohs stages as 2. No documentation of Stage 2 findings was indicated in the patient's EHR, including the final test result showing the tumor was cleared at Stage 2 (as indicated on the Mohs map). 3. The facility personnel interviewed on 10/08/25 at 1:16 PM confirmed the final test result for Stage 2 was not entered into the EHR for the Mohs case referenced above. 4. The laboratory performs testing in the subspecialty of Histopathology with a reported annual test volume of 1,379. -- 2 of 2 --