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A. Based on document review and interview, it was determined that for 2 of 5 patients' (Pts. #1 and #3) clinical records reviewed for blood transfusions, the hospital failed to ensure that assessments for vital signs were documented in accordance with approved policies and procedures.

Findings include:

1. On 03/09/2025, the hospital's policy titled, " Routine Administration of Blood and Blood Components" (effective 07/2024) was reviewed and included, "...J. Check the blood pressure, pulse, respirations, oxygen saturation (pulse oximeter) and temperature pre-transfusion, 15-20 minutes after initiating the infusion and at one, two, three hours, and post-transfusion"

2. The clinical record of Pt. #1 was reviewed on 03/10/2025. Pt. #1 was admitted on 04/01/2024 with diagnoses of hepatic (liver) abscess and septic shock. The clinical record indicated that Pt. #1 received the following blood products:

- On 4/1/2024, a unit of FFP (fresh frozen plasma) was administered at 8:00 PM. There were no vital signs (i.e., temperature, respiratory rate, pulse rate, blood pressure, and oxygen saturation) taken 15 minutes after initiation of the transfusion.
- Multiple additional units of FFP were administered on 4/2/2024, where vitals were not taken before and/or 15 minutes after initiation of the transfusion.
- On 4/2/2024, a unit of RBC (red blood cells) was administered at 10:25 PM. There was no temperature taken before initiation of the transfusion. There were also no vital signs taken 15 minutes after initiation of the blood transfusion.
- On 4/3/2024, a unit of RBC was administered at 4:57 AM. There were no vital signs taken 15 minutes after initiation of the transfusion.
- On 4/3/2024, a unit of RBC was administered at 10:28 AM. There were no vital signs taken 15 minutes
- On 4/3/2024, another unit of FFP was administered at 12:27 PM. There were no vital signs taken 15 minutes after initiation of the transfusion.

3. On 03/10/2025, the clinical record for Pt. #3 was reviewed. Pt. #3 was admitted on 2/25/2025 due to cardiac arrest. The clinical record indicated that Pt. #3 had a blood transfusion on 3/9/2025 at 08:59 AM. Pt. #3's clinical record lacked the initial temperature in the flowsheet at 08:59 AM.

4. An interview was conducted on 03/10/2025, at approximately 1:30 PM, with the Clinical Nurse Educator (E#8). E #8 stated that there should be documentation of Pt. #3's initial vital signs including temperature, pulse, respirations, oxygen saturation, and blood pressure.

5. On 3/10/2024 from 1:00 PM through 3:00 PM, clinical record review of administration of blood products was conducted with E #3 (Clinical Nurse Manager). Findings of the review was also discussed with E #3. E #3 stated a complete set of vital signs, i.e., temperature, blood pressure, respiratory rate, pulse rate, and oxygen saturation should be taken before and 15 minutes after initiation of transfusion.



B. Based on document review and interview, it was determined that for 2 of 5 patients' (Pts.#1 and #3) clinical records reviewed for blood transfusion, the hospital failed to ensure that stop time, infusion rate, and blood volume were documented in accordance with approved policies and procedures.

Findings include:

1. On 03/09/2025 the hospital's policies titled, " Routine Administration of Blood and Blood Components" (revised 06/2021 and 07/2024) were reviewed and included"... The date transfused and the transfusion start and stop times must be completed in the appropriate electronic medical record (EPIC) Blood Product Administration Module...1. Set the infusion rate so that transfusion will be completed within the physician order time... Record the volume infused..."

2. On 3/10/2025, the clinical record of Pt. #1 was reviewed. Pt. #1 was admitted on 04/01/2024 with diagnoses of hepatic (liver) abscess and septic shock. The clinical record indicated that on 04/01/2024, Pt. #1 was administered a unit of FFP (fresh frozen plasma) at 8:00 PM. The record lacked documentation of the time the transfusion was completed.

3. On 03/10/2025, the clinical record for Pt. #3 was reviewed. Pt.#3 was admitted on 02/25/2025 due to cardiac arrest. The clinical record indicated that Pt. #3 had a blood transfusion on 3/9/2025 at 08:59 AM. Pt. #3's clinical record lacked documentation of the stop time, infusion rate, and blood volume administered during the transfusion.

4. An interview was conducted on 03/10/2025 at approximately 1:30 PM with the Clinical Nurse Educator (E#8). E #8 stated that there should be documentation of the transfusion infusion rate, blood volume, and stop time in EPIC.


C. Based on document review and interview, it was determined that for 2 of 5 patients' (Pts. #1 and #8) clinical records reviewed for blood transfusions, the hospital failed to ensure that potential signs and symptoms of a blood transfusion reaction were reported immediately to the physician and blood bank.

Findings include:

1. On 03/10/2025, the hospital's policy titled, "Routine Administration of Blood and Blood Components" (effective 07/2024) was reviewed and included, "...Observe the patient frequently during the entire infusion. Be alert for any adverse events possibly due to transfusion reaction..."

2. On 03/10/2025, the hospital's policy titled, "Transfusion Reaction Management" (effective 12/2023) was reviewed and included, "...All adverse consequences of transfusion ('Transfusion Reaction') will be reported to the blood bank as soon as recognized. Transfusion reaction evaluation is ordered and reaction manifestations are documented in EPIC [electronic medical record]. Transfusion Reaction: includes any adverse consequences of transfusion, immediate or delayed...Symptoms of a transfusion reaction include but are not limited to: ...hypoxemia [low oxygen saturation]... blood pressure changes, usually acute, either hypertension [high blood pressure] or hypotension [low blood pressure]...Notify the patient's physician of any possible transfusion reaction... Initiate and order a transfusion reaction work-up [notifies the blood bank of potential reaction]..."

3. On 03/11/2025, the hospital's policy titled, " Routine Care, Assessment and Vital Signs Guidelines" (effective 10/2023) was reviewed and included,"Blood Administration, abnormal vital signs are reported to the physician by the RN [registered nurse] promptly and notification documented..."

4. The clinical record of Pt. #1 was reviewed on 03/10/2025. Pt. #1 was admitted on 04/01/2024 with diagnoses of hepatic (liver) abscess and septic shock. The clinical record indicated that on 04/02/2024, Pt. #1 was administered a unit of FFP (fresh frozen plasma) between 3:30 PM and 4:00 PM. At 4:00 PM, Pt. #1's oxygen saturation went down to 88% (normal level above 92%). There was no documentation that the physician and/or blood bank were notified regarding changes in Pt. #1's clinical condition following administration of blood product.

5. On 03/10/2025, the clinical record for Pt. #8 was reviewed. Pt. #8 was admitted on 2/4/2025 due to shock. The clinical record indicated that Pt. #8 had a blood transfusion on 2/9/2025 at 12:15 PM. The physician's order on 2/9/2025 at 11:46 AM to transfuse blood includes, "Notify physician if signs of transfusion reaction (e.g. temp increase greater than 2F [Fahrenheit] or 1 centigrade, other significant change in vital signs, rash or pain. If patient reacts, stop transfusion, document reaction in document flowsheet, and place transfusion reaction evaluation order). The record indicated that Pt. #8's blood pressure on 2/9/2025 at 12:30 PM (during transfusion) was 92/54. The next vitals at 12:45 PM indicated that the blood pressure rose to 142/71 (indicates hypertension if greater than 120/90). The record lacked documentation that the increase in blood pressure was noticed and that the physician and blood bank were notified.

6. An interview was conducted on 03/10/2025 at approximately 1:30 PM with the Clinical Nurse Educator (E#8). E#8 stated that if the vitals change and/or are out of range, the expectation would be to retake the vitals to see if there was an error. E#8 stated that if the vitals remained out of range or concerning, then the physician should be notified immediately.

7. On 3/10/2024 from 1:00 PM through 3:00 PM, the clinical record review of administration of blood products was conducted with E #3 (Clinical Nurse Manager). E #3 stated that there should be documentation when a physician was notified regarding change in patient's clinical condition.


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D. Based on document review and interview, it was determined that for 1 of 5 (Pt. #3) clinical records reviewed for blood transfusions, the hospital failed to ensure that verification of the blood product to recipient was completed by two qualified individuals prior to starting the transfusion.

Findings include:

1. The hospital's policy titled, "Routine Administration of Blood and Blood Components" (revised 07/2024), was reviewed and required, "...The identity of the recipient must be established at his or her bedside prior to transfusion by two individuals, who are qualified to participate in this process (i.e. registered nurse(s)..) ...This includes comparison of both the patient's full name and date of birth or medical record number on the 'compatibility tag' and the patient's identification band... This check must be documented in [the electronic medical record]..."

2. The clinical record of Pt. #3 was reviewed on 03/10/2025. Pt. #3 was admitted on 02/25/2025 due to cardiac arrest. The record indicated that Pt. #3 had a blood transfusion initiated on 03/09/2025 at 8:59 AM. The record lacked documentation that identity of the recipient was completed by two individuals prior to starting the transfusion.

3. An interview was conducted with the Clinical Nurse Educator (E#8) on 03/10/2025 at approximately 1:30 PM. E#8 stated that the verification screen pops-up when the nurse enters a new bag for transfusion. E#8 stated that the computer will then prompt for another nurse to sign in and verify the patient and blood product. E#8 stated that E#8 was unsure how the nurse entered a start time for the transfusion but did not complete the next steps to verify. E#8 stated that two nurses are required to verify the correct patient and blood product before every transfusion.