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 histopathology and Mohs surgical procedures slides, patient final testing reports (medical records), slide labeling and an interview with the laboratory personnel, it was determined that from 02/05/2019 through 09/19/2020 for one (1) out of fourteen (14) random patients' testing records reviewed, the laboratory failed to follow written policies and procedures for specimen collection, labeling and Mohs surgery reports for each biopsy specimen. The findings included: 1. Review of three (3) Mohs patient slides biopsied on 01/30/2020 for specimens ID 520-273 (L Mid dorsal hand), 520-274 (L post foreman) and 520-275 (R ant forearm), the slide's unique identifier S520-275 (R ant forearm) found on the Mohs surgical slide did not match the unique identifier S20-276 (R ant forearm) found in the final patient's testing report. 2. On 11/30/2020 12:30 p. m. (survey date), the laboratory personnel affirmed that the unique slide identifier (ID ) 520-275 (R ant forearm) did not match the unique slide identifier S20-276 (R ant forearm) reported in the patient's final testing report. 3. Based on the laboratory's annual test volume declaration (02/25/2020) the laboratory performed 4,402 histopathology and (Mohs) 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 --