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 the tour of the laboratory and an interview with the Testing Personnel (TP), the laboratory utilized expired materials for the Complete Blood Count (CBC) and Fecal Occult Blood (FOB) testing. This was noted for the expiration dates on the material packages to the current date of the survey. The findings include: 1. During the laboratory tour with the TP, the laboratory revealed the following expired materials were utilized for the CBC and FOB testing. A) RM Scientific Safe-T-Fill Micro Capillary Blood Collection (MCBC), Lot number 22C4507 with expiration of 3-31-2024. The package holds 50 MCBC and 25 were left. B) Consult Diagnostics FOB slides, Lot 0120101 with expiration date of 9-30-2023. The box holds 100 FOB and 6 were left. 2. A further review of these materials revealed no open dates were written on the package or box. 3. TC confirmed the above findings during the exit conference on 11-20-2024 at 1:15 PM. 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 --