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 medical records (MR), biopsy slide labeling, and interview with a laboratory personnel, it was determined that from 11/30/2017 through 03/01 /2019 for two (2) out of eleven (11) random patient testing records reviewed, the laboratory failed to establish and follow written policies and procedures for specimen collection and labeling for each biopsy specimen source. The findings included: a. Review of two (2) biopsy slides Patient ID MM19-00076 (right wrist) collected: 02/11 /2019 and Patient ID MM19-00067(Posterior left shoulder) collected: 02/06/2019 were both assigned the same unique identifier (MM10-0076) on the final patient histopathology reports, yet the patient names on the final patient histology reports were different. b. On 06/13/2019 15:00 (survey date), the laboratory personnel confirmed that the patients' initial biopsies performed on 02/11/2019 and 02/06/2019 were noted on the final patient histopathology report with the same unique identifier (MM19-0007, yet the patient names were different. c. Based on the laboratory's annual test volume declaration (06/01/20190) the laboratory performed 850 patient pathology tests. 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 --