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 record review and interview with laboratory staff, the laboratory did not ensure that histology reagents, solutions, and other supplies are not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. Findings: 1. Record review showed that the "Slide Grid List" which lists the sequence numbers of prepared histology slides had a label on the top right of the page which documented the lot numbers of the hematoxylin and eosin (H&E) stains used for staining. The expiration dates were not documented on the label. 2. During an interview on 07/10/2023 at 12:40 PM, laboratory staff confirmed that the expiration dates for the H&E stains were not documented and stated that the laboratory did not record the lot numbers and expiration dates for the other histology reagents including "Penfix," 95% and 100% alcohol, xylene, and paraffin. D5781