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 (biopsy) slides, patient final testing report (medical records (MR), slide labeling and interview with a laboratory personnel, it was determined that from 01/07/2016 through 01/04/2018 for 1 out of 10 patients testing records reviewed, the laboratory failed to establish and follow written policies and procedures for specimen collection and labeling for each Mohs (biopsy) specimen source. The findings included: a. No patient Mohs slide(s) KB17-M299 (L. Lat Cheek) performed on 07/11/2017 could be retrieved at the time of the survey (01/11 /2018), it was discovered that the original Mohs slide(s) had been relabeled with the slide unique identifiers of another patient KB17-M303 (R Temple) performed on 07/25 /2017. It is the laboratory's policy to relabel the patient Mohs slides with addition unique identifiers from the original pencil transcription at the time of the Mohs surgical procedure. b. On 01/16/2018 (survey date, 12:00 AM), the laboratory personnel affirmed that the original patient Mohs slide unique identifiers did not match the relabeled patient's Mohs slide(s) label and was mislabeled with a different patient's information. c. Based on the laboratory's annual test volume declaration (01 /09/2018) the laboratory performed 560 Mohs surgical 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 --