Summary:
Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on direct observation, temperature record review, and interview with the Laboratory Director (LD), the laboratory failed to monitor and document temperature conditions in laboratory draw room 128 where 104 blood collection tubes were stored. Findings: 1. During inspection of laboratory draw room 128 on July 24, 2025 at approximately 10:00 AM, the following blood collection tubes were observed: a. BD Vacutainer EDTA - 50 tubes Lot# 5015996 b. BD Vacutainer SST - 24 tubes Lot #5031305 c. Greiner Bio-One Red Top - 30 tubes Lot# C2411359 All tubes displayed manufacturer-printed storage temperature requirement of 4-25C (40-77F) on packaging. 2. Record review of room temperatures revealed no evidence the laboratory documented temperatures in draw room 128. 3. Interview with the LD on July 24, 2025 at approximately 11:00 AM confirmed that temperature monitoring and documentation procedures were not implemented for laboratory draw room 128. D5781