Summary:
Summary Statement of Deficiencies D5555 IMMUNOHEMATOLOGY CFR(s): 493.1271(c)(f) (c) Blood and blood products storage. Blood and blood products must be stored under appropriate conditions that include an adequate temperature alarm system that is regularly inspected. (c)(1) An audible alarm system must monitor proper blood and blood product storage temperature over a 24-hour period. (c)(2) Inspections of the alarm system must be documented. This STANDARD is not met as evidenced by: Based on surveyor review of the laboratory's immunohematology policy, blood bank system alarm check records, and confirmed by interview with the laboratory manager the laboratory failed to inspect, perform, and document biannual blood bank refrigerator alarm system checks for four out of five time periods from 6/17/2024 - 7 /22/2026. Findings are: 1. The laboratory's Routine Maintenance for Transfusion Services policy stated that the alarm for the blood bank refrigerator would be checked biannually and to "record temperature from the thermometer when the alarm sounds." 2. The blood bank refrigerator alarm check records showed refrigerator alarm check performed on 6/17/2024 and no alarm checks performed during 2nd half of 2024, 1st half of 2025, 2nd half of 2025, and 1st half of 2026. 3. Interview with the laboratory manager on 7/22/2026 at 11:07 am, confirmed the laboratory failed to perform biannual blood bank refrigerator alarm checks for 2nd half of 2024, 1st half of 2025, 2nd half of 2025, and 1st half of 2026. 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 --