Summary:
Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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: (1) Water quality. (2) Temperature. (3) Humidity. (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: Observation, review of temperature records, lack of documentation and interview demonstrated that 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 11/7 /24 at 12:34 p.m., the surveyor observed two rooms (laboratory and office/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 office/storage room for the period of April 2024 to the date of the survey. C) During a tour of the laboratory on 11/7/24 at 02:15 p.m. the surveyor observed 2 boxes of Medonic M-Series Pack with a storage temperature requirement of 4 degrees to 35 degrees Centigrade (C) lot # 2408-006, expiration date 2027-03-31, in the office/storage room. D) Upon request, the laboratory could not present the temperature records for the office/storage room in which the supplies identified above were stored. E) In an interview on 11/7/24 at 02:35 p.m., the laboratory staff member (# 4 on form CMS 209) confirmed that temperature records for the office/storage room were not recorded. D5783