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 observation, review of manufacturer's instructions, review of the laboratory's 2023 and 2024 temperature logs, and interview with testing personnel (TP #1) on 2/21/25, the laboratory failed to define an acceptable temperature range for the refrigerator used to store immunohistochemical (IHC) reagents. Findings: During a tour of the laboratory at approximately 12:05 p.m., surveyors observed IHC reagents stored in a refrigerator in a room outside the laboratory. Review of manufacturer's instructions for the Bio SB TintoFast MART-1 and Cytokeratin AE1/AE3 IHC stains revealed storage requirements of 2 to 8 degrees Celsius (35.6 to 46.4 degrees Fahrenheit). Review of the 2023 and 2024 refrigerator logs revealed the logs did not include an acceptable range. During an interview at approximately 12:15 pm, TP #1 confirmed other laboratory logs included acceptable temperature ranges but this one refrigerator log did not. D5785