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 upon observation, review of temperature records, lack of documentation and interview the laboratory failed to monitor the temperature on each day of operation in one of two rooms in which supplies with storage temperature requirements were stored. . Findings follow: A) During a tour of the laboratory on 2/18/25 at 09:00 a..m., the surveyor observed two rooms (laboratory and storage ) containing laboratory items with a temperature storage requirement. B) A review of the laboratory's temperature records revealed that no room temperatures were recorded for the storage room for the calendar year 2024. C) During a tour of the laboratory on 2/18/25 at 09: 00 a..m. the surveyor observed 5 boxes of Sofia Flu A&B testing reagents with a storage temperature requirement of 15 degrees to 30 degrees Centigrade (C) lot # 709216, expiration date 2025-09-25, and BD Veritor Flu A&B testing reagents with a storage temperature requirement of 2 degrees to 30 degrees C lot # 2287216 expiration date 2025-10-06 in the storage room. D) Upon request, the laboratory could not present the temperature records for the storage room in which the supplies identified above were stored. E) In an interview on 2/18/25 at 10:20 a..m., the laboratory staff member (# 2 on form CMS 209) confirmed that temperature records for the storage room were not recorded. 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 --