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 patient Mohs surgical procedures slides on 08/11/2021 10:30 a.m., patient final testing reports (medical records/operative notes), slide labeling and interview with the laboratory personnel, it was determined that from 06/12/2019 through 06/16/2021 for one (4) out of ten (10) random patients' testing records reviewed, the laboratory failed to follow written policies and procedures for specimen collection, labeling and Mohs surgery reports for each Mohs specimen. The findings included: 1. Review of four (4) Mohs patient slides, the unique identifiers (accession number) did not match the unique identifiers found on the final patient testing reports (map and operative report). Duplicate unique identifiers were assigned to different patient slides and final reports as well as a transcription error on the operative report Mohs Case Number M405-20 for patient MRN 030904 for accession number M407- 20. Surgical Date Accession # Patient MRN 12/09/2020 M406-20 002094 12/09/2021 M406-20 002995 12/09/2020 M407-20 030904 12/09/2020 M407-20 021031 2. On 08 /11/2021 12:30 (survey date), the laboratory personnel affirmed that the unique slide identifiers reported on the four different patient final testing reports were duplicate accession numbers. 3. Based on the laboratory's annual test volume declaration (08/05 /2021) the laboratory performed 7,082 histopathological Mohs surgical procedures tests annually. 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 --