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101 E VALENCIA MESA DRIVE

FULLERTON, CA 92835

BLOOD TRANSFUSIONS AND IV MEDICATIONS

Tag No.: A0410

Based on interview and record review, the hospital failed to ensure the nursing staff followed the hospital's P&P for the administration of blood and blood products for three of four sampled patients (Patients 1, 2, and 3) as evidenced by:

1. For Patient 1, the physician's order to transfuse Red Blood Cells (PRBC) over one hour was not followed, and complete vital signs were not assessed and documented during the blood transfusion.

2. For Patient 2, there was no documentation to show if the patient had any suspected transfusion reaction, and complete vital signs were not assessed and documented during the blood transfusion.

3. For Patient 3, the transfusion was not started within 30 minutes from the time the unit of blood was issued from the blood bank.

This posed the risk of potential complications, including undetected changes in the patient's condition, delayed interventions, and overall compromised patient safety during the blood transfusion process.

Findings:

Review of the hospital's P&P titled Transfusion Reaction dated April 2024 showed patients are to be observed frequently during the transfusion, including monitoring of vital signs and temperature. Vital signs should be taken prior to starting the transfusion, 15 minutes after starting the transfusion, every hour thereafter and at the end of the transfusion, and documented on the transfusion record. Signs or symptoms of a possible adverse effect include fever (rise of 1 degree Celsius or 2 degrees Fahrenheit).

Review of the hospital's P&P titled Transfusion Therapy dated April 2025 showed transfusion must be started within 30 minutes from the time the unit of blood was issued from the blood bank.

Review of the hospital's Transfusion Service Scope of Practice and Clinical Service Agreement showed the blood bank provides optimal storage conditions for each type of blood component, according to regulatory requirements. Prolonged storage outside of these limitations compromises the safety, purity, and the potency of the blood product. A transfusion must either be started, or the blood returned to the blood bank within 30 minutes of issue.

1a. On 5/15/25 at 1022 hours, medical record review for Patient 1 was conducted with the Accreditation Program Manager.

Patient 1's medical record showed the patient was admitted to the hospital on 2/7/25.

Review of the physician's order dated 5/8/25 at 0751 hours, showed to transfuse one unit of PRBC over one hour.

However, review of Patient 1's Blood Administration Flowsheet showed the one unit of PRBC was transfused on 5/8/25 at 1048 hours and completed at 1342 hours, over approximately three hours instead of the rate ordered by the physician.

b. Further review of Patient 1's medical record showed there was no documented evidence Patient 1's temperature was assessed on 5/8/25 at 1300 hours.

On 5/15/25, during the interview and concurrent record review, the Accreditation Program Manager verified the findings.

2a. On 5/15/25 at 1117 hours, medical record review for Patient 2 was conducted with the Accreditation Program Manager.

Patient 2's medical record showed the patient was admitted to the hospital on 5/7/25.

Review of the physician's order dated 5/8/25 at 0352 hours, showed to transfuse two units of PRBC to Patient 2.

Review of Patient 2's Blood Administration Flowsheet showed the first unit of PRBC was transfused from 5/8/25 at 0445 hours to 0759 hours, with no suspected transfusion reaction. The second unit of PRBC was transfused from 5/8/25 at 1115 hours to 1323 hours; however, there was no documentation to show if the patient had any suspected transfusion reaction.

On 5/15/25 at 1411 hours, an interview was conducted with Nurse Manager 1 who stated the nurses were supposed to document whether or not the patient had a suspected reaction to the blood transfusion at the end of the transfusion.

b. Further review of Patient 2's medical record showed that there was no documented evidence Patient 2's temperature was assessed on 5/8/25 at 0700 (hourly) and 0759 hours (at the end of the transfusion of the first unit), and vital signs were not assessed and documented on 5/8/25 at 1323 hours, at the end of the transfusion of the second unit.

On 5/15/25, during the interview and concurrent record review, the Accreditation Program Manager verified the findings.

3. On 5/15/25 at 1303 hours, medical record review for Patient 3 was conducted with the Accreditation Program Manager.

Patient 3's medical record showed the patient was admitted to the hospital on 5/11/25.

On 5/15/25 at 1055 hours, an interview was conducted with the Blood Bank Supervisor who stated once a type and screen then crossmatch was completed, the unit of blood was released to the nurse who signed a copy of the order, and that order or requisition form was time stamped by the blood bank to indicate the date and time the blood was released to the nurse.

Review of the physician's order dated 5/11/25 at 2105 hours, showed to transfuse one unit of PRBC to Patient 3.

Review of the copy of the blood transfusion order signed by the nurse showed the unit of PRBC was released to the nurse on 5/11/25 at 2242 hours.

However, review of Patient 3's Blood Administration Flowsheet showed the unit of PRBC was started on 5/11/25 at 2325 hours, not within 30 minutes of issuance by the blood bank.

On 5/15/25 at 1411 hours, an interview was conducted with Nurse Manger 1 who stated blood transfusion must be started within 30 minutes from the time the unit of blood was issued from the blood bank, and the nurse must contact the blood bank for further instructions if they were unable to start the transfusion within the 30 minutes.

On 5/15/25, during the interview and concurrent record review, the Accreditation Program Manager verified the findings.