Summary:
Summary Statement of Deficiencies D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on review of the patients' Mohs map, review of patient slides, review of the electronic test report, review of the laboratory's Mohs log and interview with the technical supervisor, the laboratory failed to follow established procedures to ensure positive identification of patient's dermatopathology specimens throughout the test reporting process. Findings include: 1. The laboratory began Mohs testing under the sub-specialty of histopathology in June 2020, with an approximate annual test volume of 350. It is the practice of the laboratory to assign a unique case number to each patient's Mohs specimen. The unique case number is included on the laboratory's Mohs log, the patient's Mohs map, the patient's slide(s) and the patient's electronic test report. 2. The laboratory failed to ensure positive identification of the patient's Mohs specimens for patient J.B. from testing performed on 8/14/2021 as evidenced by the following: - For the site, Left Lateral Zygoma, the Mohs log listed case# 21-127, and the electronic test report listed the case# as 21-114. - For the site, Left Preauricular Cheek, the Mohs log listed case# 21-129, and the electronic test report listed the case# as 21-116. 3. At approximately 11:20am on 9/22/2022, the technical supervisor interviewed during the survey confirmed that the case numbers listed on the Mohs log did not match the case numbers indicated on the final test report for the patient referenced above. D5801 TEST REPORT CFR(s): 493.1291(a) 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 -- 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 review of patient test reports and interview with the technical supervisor, the laboratory failed to have a system in place to ensure the accuracy of test results that are manually entered into the electronic medical record (EMR) Findings include: 1. The laboratory began Mohs testing under the sub-specialty of histopathology in June 2020, with an approximate annual test volume of 350. 2. It is the practice of the laboratory to manually transcribe the Mohs test information into the patients' EMR, including but not limited to, the Mohs case number, specimen site, number of stages, final test result and other pertinent information. 3. No documentation was presented for review during the survey conducted on September 22, 2022 to indicate the laboratory has a system in place to ensure the accuracy of patient test results that are manually entered into the EMR. 4. The technical supervisor interviewed on 9/22/22 at approximately 11:50am confirmed that the laboratory did not have a system in place to verify the accuracy of the patient test results that are manually entered into the EMR. -- 2 of 2 --