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 Mohs and interview with the facility personnel, the laboratory failed to verify the accuracy of testing performed under the subspecialty of Histopathology at least twice annually during 2022 and 2023. Findings include: 1. No documentation was presented for review to indicate the laboratory verified the accuracy of Mohs testing at least twice annually during 2022 and 2023. 2. The facility personnel interviewed on 7/23/24 at 11:55 AM confirmed the laboratory failed to verify the accuracy of Mohs testing testing at least twice annually during 2022 and 2023. 3. The laboratory's reported annual test volume is 1,575. D5801 TEST REPORT CFR(s): 493.1291(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 patient test results maintained in the electronic medical record (EMR), review of the Mohs map, review of patient slides and interview with the facility personnel, the laboratory failed to accurately report the Mohs test result for one out of three patient records reviewed. Findings include: 1. The laboratory performs Mohs testing in the sub-specialty of Histopathology, with an approximate annual test volume of 1,565. 2. The laboratory utilizes an electronic medical record (EMR) system to document the Mohs test procedure and Mohs test result. The final test result information is manually transcribed by laboratory personnel into the patient's EMR. 3. The laboratory failed to correctly enter (manually transcribe) the number of Mohs stages in the EMR for one out of three patient records reviewed during the survey, case# 21872. The patient's slides and Mohs map indicated a total of 3 stages, and the operative note (final test result) entered in the EMR indicated a total of 2 stages. 4. The facility personnel interviewed on 7/23/2024 at 11:25 AM confirmed that the laboratory failed to accurately report the final test result in the EMR for the patient indicated above. -- 2 of 2 --