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 Mohs test records and Frozen Biopsy test records and interview with the facility personnel, the laboratory failed to ensure positive identification on two out of six dermatopathology specimens from the time of collection of the specimen through completion of testing and reporting of test results. Findings include: 1. The laboratory performs Mohs, Frozen biopsy testing and Frozen Excision testing under the subspecialty of Histopathology, with an annual reported test volume of 2,107. 2. Review of the Mohs test records and the Frozen Biopsy test records for patient D.L. from 5-08-2024 indicated each separate specimen was labeled with the same accession number (2024-JT-678). 3. The laboratory failed to ensure positive identification of a patient's specimen from the time of collection through the completion of testing and reporting of results for 2 out of 6 dermatopathology specimens, as evidenced above. 4. The facility personnel interviewed on 7/12/24 at 10: 20 AM acknowledged that the laboratory used the same accession number for two separate dermatopathology specimens. 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 --