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 biopsy slides, patient final electronic testing report (medical records (EMR), slide labeling and interview with a laboratory personnel and laboratory director, it was determined that from 07/19/2017 through 06/21/2018 for two (2) out of ten (10) patients 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) patient's unique identifier(s) (accession #) found on the histopathology biopsy slides were incorrectly transcribed in the final patient Mohs pathology report (EMR). Biopsy Date Slides # EMR # 06/09/2018 Ki18-62 Ki18-63 06/06/2018 Ki18-63 Ki18-62 b. On 06/28/2018, 11:45 AM (survey date), the laboratory director affirmed that the unique identifiers (Accession #) on biopsy slides and the patient final testing report (EMR) were incorrectly transcribed. c. Based on the laboratory's annual test volume declaration the laboratory performed 260 patient initial biopsies 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 --