HospitalInspections.org

Based on interview and document review, it was determined the facility nursing staff failed to transfuse blood components in accordance with facility policies and procedures by:

Not performing vital signs as indicated for two (2) out of three (3) patients sampled.

Not verifying the presence of an informed consent for one (1) of three (3) patients sampled.

The finding include:

On 09/19/23 at 8:55 am, the surveyor sampled three (3) patients who had recently received blood components for medical record review (Patient #9, Patient #10, Patient #11).

On 09/19/23 at 11:15 am, the surveyor reviewed the medical records of Patient # (9-11) -to include the blood component transfusion records-with the assistance of Staff Member #14 (Clinical Nurse Specialist).

The surveyor identified the following concerns during the medical record review:

Patient #9

Patient #9 was ordered to receive a total of four (4) units of packed red blood cells by the provider on 09/08/23 and 09/09/23. The surveyor identified that nursing staff did not perform vital signs consistent with blood component transfusion protocol for two (2) out of the four (4) transfusions.

Patient #9 received a blood transfusion which was initiated on 09/08/23 at 9:05 pm and was completed on 09/09/23 at 12:06 am. The surveyor identified that the only times in which the patient's temperature was documented was prior to, and at the initiation, of the blood transfusion.

The surveyor received confirmation by Staff Member #14 that temperature checks should be included in vital signs and is critical in the monitoring of a patient for a transfusion-related reaction during the administration of blood components.

The surveyor confirmed with Staff Member #14 that the patient did not have documentation of a temperature during the transfusion of the blood product administered on 09/08/23 at the following times: fifteen (15) minutes post initiation, thirty (30) minutes post initiation, one (1) hour post initiation, and one (1) hour post completion.

Patient #9 received a blood transfusion which was initiated on 09/09/23 at 2:20 am and was completed on 09/09/23 at 6:08 am. The surveyor identified that the only times in which the patient's temperature was documented was during the initiation and thirty (30)-minutes post initiation of the transfusion.

The surveyor confirmed with Staff Member #14 that the patient did not have documentation of a temperature during the transfusion of the blood product administered on 09/09/23 at the following times: pre-initiation, fifteen (15) minutes post initiation, one (1) hour post initiation, and one (1) hour post completion.

Patient #10

The surveyor identified that Patient #10 was ordered one (1) unit of packed red blood cells on 09/08/23. The transfusion record documentation indicated that the transfusion was initiated on 09/08/23 at 4:37 pm and had completed on 09/08/23 at 7:52 pm.

The surveyor identified that there was no documentation of any vital signs being performed (to include blood pressure, pulse, temperature, and pulse oximetry) upon both the initiation and thirty (30) minute post-initiation transfusion timeframes.

Additionally, in the afternoon of 09/19/23, the surveyor conducted an interview with Staff Member #14, and confirmed that there was no evidence of an informed consent related to the administration of blood components being present in the medical record of Patient #10.

An informed consent for the administration of blood components was not present within the medical record of Patient #10 despite the presence of a provider order specifically requesting verification by nursing.

The order, which was made by the attending physician on 09/08/23 at 10:47 am, reads, "Transfusion Consent ...Nursing Verification of Patient Consent Form". The electronic medical record (EMR) revealed that the order was acknowledged by nursing staff on 09/08/23 at 10:53 am.

The surveyor confirmed with Staff Member #14 during interview that a witnessed informed consent for the transfusion of blood components, to include packed red blood cells, is required prior to the administration of blood products.

Staff Member #14 added that the informed consent process also serves to provide the patient with blood component-related education to include the risks and benefits of the transfusion.

Patient #11

Patient #11 was ordered to receive one (1) unit of packed red blood cells by the provider on 09/15/23. The documentation revealed that the transfusion was initiated on 09/15/23 at 11:58 am and was completed on 09/15/23 at 2:45 pm. The surveyor confirmed with Staff Member #14 that no vital signs were documented at the one-hour post completion transfusion time frame.


At approximately 2:00 pm on 09/19/23, the surveyor reviewed the facility nursing policy titled, "Blood and Blood Component Administration for Inpatient and Outpatient" (with last revision date of 06/15/21), as well as the accompanying facility nursing procedure titled, "Blood and Blood Component Administration for Inpatient and Outpatient (Adult)" (with last revision date of 06/15/21).

The nursing policy states, in part, "3. Informed consent of the patient or a legally authorized representative shall be obtained ...prior to the administration of blood and blood components and shall be documented in the patient's permanent medical record".

The same policy continues to read, "4. In the event that the risks and benefits for blood have been discussed by the physician/APC but no blood consent has been initiated, the nurse can initiate the blood consent, sign the consent as a telephone order and have the patient sign to avoid delays in transfusing the patient".

The aforementioned blood component transfusion procedures states, in part, "2. Ensure physician (or designee) has obtained informed consent prior to administration of elective transfusions".

The same facility procedure states that obtaining complete sets of vital signs at the required transfusion timeframes are an important step for appropriately monitoring for transfusion-related reactions by nursing.

The "Blood and Blood Component Administration" policy continues to read, "6. Obtain baseline assessment and vital signs, no more than 30 minutes prior to obtaining blood, blood component or blood derivative", and to "assess vital signs (blood pressure, pulse, respirations and temperature)" and to "notify physician or designee of baseline temperature that is equal to or greater than 101.3 F (38.5 C), elevated BP or pulse, shortness of breath, we respirations or rales", and to "document in the transfusion doc [document] flowsheet" (sic).

In addition to obtaining vital signs prior to the start of a transfusion, the document adds that nursing staff are expected by facility protocol to monitor for vital signs, at a minimum, at the start of the transfusion, fifteen (15) minute post initiation, thirty (30) minute post initiation, one (1) hour post initiation, at the completion, and one (1) hour post completion of each blood component transfusion.

The surveyor disseminated the survey findings to staff on 09/19/23 at 3:00 pm during exit conference without further questions or concerns.