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. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on the review of the blood bank refrigerator alarm check records performed on 8/19/24 and interview with general supervisor (GS) #1, the laboratory failed to maintain an adequate temperature alarm system for the storage of blood products. Findings: 1. Review of monitoring records found a 24 hour monitoring system was in place with paper graphs for temperature records. 2. The hospital, including the laboratory, relocated to a new building on 7/8/24. Review of Hi/Lo alarm check records performed on 8/19/24 revealed the secondary monitoring process (laboratory was not staffed 24 hours a day, 7 days a week) was nonfunctional for the secondary notification to the nursing station. 3. Review of patient records found no patient received blood products from 7/8/24 to the date of survey. 4. Interview with the GS #1on 8/21/24 at 12:03 p.m. confirmed, the laboratory failed to maintain an adequate temperature alarm system for the storage of blood products. 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 --