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, patient final testing reports (medical records), slide labeling and interview with the laboratory director, it was determined that from 07/25/2018 through 07/17/2019 for one (1) 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 operative reports for each biopsy specimen. The findings included: a. Review of patient (6) slides, specimen ID H.K (l. temple) 08/22/2018, the slide unique identifier [(site) (l. Temple)] found on the Mohs slides did not match the unique identifier [(site) (right forehead)] found on the final patient's testing report. b. On 07/25/2019 11:30 AM (survey date), the laboratory director confirmed that the unique slide identifier [(site) (l. Temple)] found on the Mohs (5) slides did not match the unique slide identifier [(site) (right forehead)] reported in the patient's final testing report. d. Based on the laboratory's annual test volume declaration (07/19/2019) the laboratory performed 250 histopathology (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 --