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Based on record review, and interview, the facility failed to provide care in a safe setting; the hospital did not have a procedure to report a possible blood transfusion reaction, to the facility's hospital-wide quality assessment and performance improvement program as recommended by the CAP (College of American Pathologist) and AABB (Association for the Advancement of Blood and Biotherapies) guidelines. Patient #6 died, within one hour, following a transfusion of Fresh Frozen Plasma and the facility did not review the possibility of a death due to a blood transfusion reaction. This failure to conduct post-transfusion quality surveillance monitoring places current and future patients at risk of a possible adverse transfusion reaction and death.

Findings:

Review of Patient #6's medical records reflected a 59-year-old-male admitted on 3/23/23 with a complaint of a rapid heart rate and shortness of breath. Patient #6 was diagnosed with a Pericardial Effusion (fluid around the heart). The patient was to receive a pericardiocentesis (tapping the pericardial sac to remove the fluid). Patient #6 had a known history of Factor 5 Leiden deficiency (a bleeding disorder that thickens the blood). The laboratory results indicated his blood was too thin; an order was placed to transfuse plasma, to decrease the risk of the patient bleeding during the procedure.

Patient #6 received 2 units of FFP (fresh frozen plasma) on 3/25/23. The infusion started at 8:44 pm and finished at 9:21 pm. CPR (Cardiopulmonary Resuscitation) was started at 10:00 pm, 39 minutes after the completion of the transfusions. CPR stopped at 10:40 pm.

During an interview on 02/05/24 at 2:00 pm in an admin office, Staff #1, Medical Director when asked how the laboratory is notified of a death following a blood product transfusion stated, "If the clinician doesn't report a possible reaction, the pathologist does not know about it. The physician must order a workup."

During a telephone interview, on 02/06/24 at 11:00 am, when asked if Patient #6's death, following a blood product infusion, was reported to the Laboratory to review as a possible blood transfusion reaction, Staff #3, Cardiologist stated, "We only reviewed the cardiology care. I don't know what quality did."

When asked what is the timeline for considering a blood transfusion reaction after receiving a blood transfusion Staff #1 stated, "Clinically I would like 24 hours. A patient can have TACO (Transfusion-associated circulatory overload) or TRALI (Transfusion- related acute lung injury) between 24- 48 hours later. We follow the CAP (College of American Pathologist) and AABB (Association for the Advancement of Blood and Biotherapies) guidelines.
There should have been a work-up."

Review of the facility provided AABB (American Association of Blood and Biotherapies) Technical Manual, 20th edition, page 634 reflected, "Acute or immediate transfusion reactions occur within 24 hours of the administration of a component and often during the transfusion ...The clinical significance of an acute transfusion reaction often cannot be determined by the patient's clinical history or signs and symptoms alone but requires laboratory evaluation."