Summary:
Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on review of 2021, 2022, and 2023 DTM (dermatophyte test medium) patient records and interview with the clinical manager 1/23/23, the laboratory failed to discard expired DTM media and the media was used for patient testing. Review of DTM patient records revealed: 1. DTM lot #X15-477938 with expiration date 7/21/21 was used to test patient #549312, set up 7/28/21. 2. DTM lot #X15-482919 with expiration date 10/10/21 was used to test the following patients: a. patient #545194, set up 10/27/21; b. patient #9958, set up 11/9/21; c. patient #32671, set up 2/23/22; d. patient #553580, set up 7/18/22. During interview at approximately 1:25 p.m., the clinical manager stated the DTM lot number might not have been documented correctly on the patient log. She stated the new lot number of DTM (lot #X15-491957, expiration date 3/9/22) should have been used for patients set up on 10/27/21, 11/9/21, and 2/23/22. D6091 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iii) The laboratory director must ensure all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require