Summary:
Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (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 observation of the laboratory, a review of the laboratory procedure, reagent logs, patient test logs, and staff interviews, the laboratory failed to ensure that personnel did not use the Scott's Bluing reagent beyond the manufacturer's expiration date for micrographically oriented histographic surgery (MOHS) histopathology patient testing for 14 days in 2025. The findings include: 1. Observation of the laboratory on 07/28/2025 at 9:45 a.m. revealed a Linistat auto stainer and reagents used to process patient tissue specimens from MOHS procedures for histopathology testing. 2. A review of the "Mohs South Staining Protocol" laboratory procedure revealed that Scott's Bluing reagent was step six of 14. 3. A review of the laboratory's reagent log titled "Mohs Stain Expiration Log" for 2025 revealed the following: Scott's Bluing reagent lot number 233420 was opened on 08/20/2024, expired on 12/19 /2024, and was empty on 04/08/2025. Scott's Bluing reagent lot number 2424318 was opened on 04/08/2025 with an expiration date of 09/11/2025. 4. A review of the laboratory patient logs titled "Mohs Patient Daily Log" from December 2024 through April 2025 revealed that the laboratory used the expired Scott's Bluing reagent lot number 233420 for 136 patient tissue slides from 01/07/2025 through 04/01/2025. 5. An interview with the practice manager on 07/28/2025 at 11:00 a.m. confirmed the survey findings. D5779