HospitalInspections.org

Facility staff failed to include a consent for blood administration in the medical record for two of four patient records reviewed who received a blood transfusion (Patient # 2 and #10).

The findings included:

Review of the policy "Informed Consent" revised date 03/2020 revealed, "... 3) Scope: All (Named Facility) employees, faculty and staff are responsible for complying ...4) It is the policy of (Named Health Facility) to obtain informed consent from patients or their authorized representative prior to surgical operations and/or invasive procedures ...5) ...B ....4. Receipt of blood/blood components ..."

Review of the hospital policy titled "Blood and Blood Components, Administration of " effective date 06/02/2021 revealed "...PURPOSE The purpose of this policy is to the process for administering blood and blood products ...POLICY GUIDELINES Informed consent must be completed by the provider in accordance with the Informed Consent policy prior to administration of blood or blood components ..."

1. Closed medical record review on 11/16/2021 revealed Patient #2 was a 57-year old female who presented to the hospital on 06/26/2021 with a chief complaint of Motor Vehicle Crash. Medical record review of the History and Physical (H&P) revealed Patient #2 was admitted on 06/26/2021 through 07/09/2021 with a diagnosis of Right pubic Fracture documented by (Medical Doctor) MD #1. Record review revealed Patient #2 was medically treated and did not require surgery. Record review revealed on 07/01/2021 Patient #2 had a hemoglobin result of 6.2 (12.0 to 15.5 grams per deciliter). Record review revealed on 07/01/2021 at 0813, MD #2 ordered "Transfuse Red Blood Cells, one occurrence ..." Record review revealed on 07/01/2021 at 1147, (Registered Nurse) RN #3 administered a blood transfusion to Patient #2. Record review revealed on 07/01/2021 at 1651, Patient #2 was ordered a second unit of blood by MD #7. Review of the medical record revealed no evidence a consent for blood administration was obtained prior to administration of blood products for Patient #2.

Interview with RN #3 on 11/17/2021 at 1015 revealed as per policy the Medical Provider "(MD) would obtain the formal consent from Patient #2 for the ordered Blood transfusion ..." Interview revealed the RN would look in the record to assure the consent was obtained. The blood transfusion process required two RN verification in which both RN's reviewed the written consent and both RN's confirmed with a verbal from the patient. While the patient is on the unit the written consent would be in the patient's binder ..." Interview revealed RN #3 felt that she had reviewed the consent for blood administration for Patient #2. Interview revealed RN #3 felt the form was possibly misplaced away from the intended binder. Interview revealed the signed consent forms were kept in a binder on the unit assigned to the patient until the patient was discharged, whereby the consent forms would be scanned into the electronic medical record. Interview revealed there was no evidence of a signed consent form related to blood administration scanned into the electronic medical record of Patient #2.

Telephone interview with MD #2 on 11/19/2021 revealed she was the MD who ordered the blood transfusion on 07/01/2021 at 0813. Interview revealed the MD reviewed the record prior to the interview and did not see evidence of a signed consent for Patient #2. Interview revealed, " ...I looked thru the record and did not see one (consent) for blood ...The policy is for the ordering provider to get blood consent from the patient ...It would be the expectation that I get the patients consent for blood administration ..." Interview failed to reveal evidence of a signed consent form related to blood administration scanned into the electronic medical record of Patient #2.



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2. Review of the medical record on 11/18/2021 revealed Patient #10 was a 31-year-old male admitted directly through the emergency department (ED) to an intensive care unit (ICU) at the facility from a skilled nursing facility (SNF) on 11/11/2021 at 1054 after he developed altered mental status (AMS) and was noted to be unresponsive. Review of the admission History and Physical (H&P) revealed Patient #10's history included traumatic brain injury (TBI), epilepsy that required seven medications to control symptoms, left temporal lobe resection in 2012, percutaneous endoscopic gastrostomy (PEG-surgically implanted long term feeding tube placed through the abdominal wall into the stomach) tube insertion in March 2021, he was non-ambulatory and resided in a skilled nursing facility. Review revealed Patient #10's admission diagnosis was "urosepsis" (systemic infection which originates in the urine system) and he required mechanical ventilator support by 11/12/2021 at 2120. Medical record review revealed a red blood cell transfusion was started for Patient #10 on 11/14/2021 at 0525 and stopped at 0545 after approximately 25 milliliters had infused because of hypotension and concern for a transfusion reaction. Review of a physician's review of post transfusion data indicated "unlikely transfusion reaction" and the recommendation that future transfusions for Patient #10 be infused at a slower rate. Review revealed a second unit of blood was initiated by staff on 11/14/2021 at 1629 and the unit was completed at 2024. Record review revealed vital sign documentation by staff was consistent with facility policy during each administration. Review of the medical record revealed no evidence a consent for blood administration was obtained prior to administration of blood products for Patient #10.

Interview on 11/18/2021 at 1630 with a respiratory therapy staff member (RT #8) during electronic record review revealed there was no evidence of consent for blood administration in the electronic record. The staff member stated that a paper blood administration consent would likely be on Patient #10's inpatient unit where he was currently receiving treatment and a request for the document was made.

Interview on at 11/18/2021 at 1755 with the Director of Quality Improvement revealed no electronic or paper record of consent for blood products at the facility had been located for Patient #10 during the current admission.

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