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: Based on a review of temperature logs, a review of the contents of the laboratory refigerator, and interviews with Testing Personnel #1 and the Lab Supervisor, the laboratory failed to record the refrigerator temperatures three months in 2021, and failed to ensure the refrigerator maintained temperatures required for the storage of items therein as per manufacturer's specifications for more than two months. The findings include: 1. A review of the refrigerator temperatures revealed the laboratory failed to record the temperatures in April, May and June 2021. The surveyor further noted 2-8 degrees Celsius (C) was documented as the acceptable ranges for the refrigerator, however temperatures were below this range from 10/7 thru 12/21/2021 (two and a half month out of range). 2. On 12/21/2021 at 12/20 PM the surveyor reviewed the contents of the refrigerator with Testing Personnel #1. Contents included the Medonic Hematology quality controls (QC), the DCA Vantage Urine Microalbumin/Creatinine QC, and the Immunocard Mycoplasma kit. A review of the manufacturer's storage requirements for these items revealed a required temperature range of 2-8 degrees C. 3. During the exit summation on 12/21/2021 at 2:30 PM, the above noted findings were reviewed and confirmed with the Lab Supervisor. . D5781