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Based on staff interview, and policy and procedure review, the facility failed to ensure policies and procedures were followed regarding possible adverse transfusion reactions. This affected one (Patient #8) of 20 patients whose medical records were reviewed. This systemic effect of this deficient practice had the potential to affect all patients who received blood product transfusions from the facility.

The hospital census was 512 at the time of the survey.

Findings include:

Review of the medical record for Patient #8 was started on 11/06/13 at 12:00 PM and completed on 11/07/13 at 10:30 AM. Patient #8 arrived in the emergency department on 08/18/13 at 5:08 AM due to an open left ankle fracture that occurred approximately one week prior to this visit.

Patient #8 was scheduled to have corrective surgery for the left ankle fracture and was transferred to the surgical unit on 08/18/13 at 8:48 AM. Fresh frozen plasma (FFP) was ordered before surgery due to an INR of 1.9. INR stands for International Normalized Ratio and measures blood coagulation to determine the clotting tendency in the patient's blood.

Patient #8 received the FFP in the pre-operative area, where one unit was transfused successfully. Half way through the second unit, the patient started to develop respiratory distress. Staff H, the anesthesiologist who administered the FFP, stopped the transfusion, and the patient was taken to the operating room at 10:46 AM for airway management. The patient was intubated (placement of a flexible plastic tube into the windpipe), and placed on a ventilator (a machine that supports breathing) by the anesthesia team. Patient #8 was transferred to the surgical intensive care unit and expired at 2:42 PM.

An interview was conducted with Staff B (blood bank technical specialist) on 11/05/13 at 9:55 AM, and copies of the blood transfusion committee meeting minutes were requested for July, August, and September. Review of the September meeting minutes revealed Patient #8's case was discussed as a possible transfusion related acute lung injury after the trauma performance improvement committee's investigation. The final coroner's report as to the cause of the death was not yet available for review. A letter summarizing the facility's action regarding the death of Patient #8 was requested from Staff B, and was provided for review.

An interview conducted, on 11/06/13 at 11:00 AM, with Staff E (transfusion medical director) revealed the cause of death had not yet been determined a transfusion reaction. The letter summarizing the facility's actions regarding the death of Patient #8, was reviewed with Staff E during this interview, and revealed the trauma performance improvement committee sent an inquiry to the blood bank on 09/16/13, 20 days after Patient's #8 death, requesting the blood bank and the medical director to review the case to determine whether a transfusion related acute lung injury could have been a factor. The letter revealed a transfusion reaction test was not reported until 09/16/13 and a reaction test was not ordered until 09/17/13.

The review of the hospital's policy and procedure titled: Administration of Blood and Blood Products: Whole Blood, Packed Cells, Platelets, Plasma, Leukocytes, Cryoprecipitate, File: NC-F-6.1, was conducted on 11/05/13 starting at 11:30 AM, and revealed "If you suspect that any undesirable or unexpected effect due to or likely to be due to the administration of blood components had occurred, a transfusion reaction investigation should be initiated". The same policy and procedure also revealed, "In the event of a transfusion reaction: Notify the Blood Bank and obtain Transfusion Reaction Report".

Patient #8's medical record lacked evidence Staff H had notified the blood bank after the cessation of the transfusion as a possible transfusion reaction.

An interview was conducted with Staff H on 11/07/13 at 9:55 AM. Staff H stated he/she did not notify the blood bank of a possible transfusion reaction and confirmed the hospital had a policy to do so. Staff H stated, " we were short staffed that day, it was chaotic at the time, and under normal circumstances I would have notified the blood bank of a possible transfusion reaction, but at the time I used my clinical judgment, and I suspected pulmonary embolism for the patient, therefore, a possible transfusion reaction to the plasma was low on my list".

A second interview with Staff H along with Staff A (legal nurse consultant regulatory compliance), Staff B, Staff D (assistant chief nursing officer), and Staff E was completed on 11/07/13 at 12:25 PM. Staff H stated a suspected pulmonary embolism was at the top of the list for the cause of the patient's symptoms and a transfusion reaction was low on his/her list of possible causes of death for Patient #8. The interview revealed all considerations were taken, but the blood bank was not notified nor was a transfusion reaction report completed in accordance with the hospital's policy by Staff H or any of the staff working with Staff H on the day of the patient's death.