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Based on review of the hospital policies and procedures, medical record reviews and staff and physician interviews, nursing staff failed to ensure an informed consent for the administration of blood was obtained for 1 out of 3 sampled patients (Patient #15).

The findings include:

Review of the hospital's policy "Blood and Blood Components, Administration of" with an effective date of 08/29/2020 revealed "... Informed consent must be completed by the provider in accordance with the Informed Consent policy prior to administration of blood or blood components; emergent transfusions will be noted on consent ... 2. Non -Emergent Transfusion ... d. For inpatient units, the consent is valid for the patient's entire hospitalization until discharge ..."

Review of the Hospital A's "Medical and Dental Staff Bylaws" dated May 2018 revealed no indication that a consent for blood transfusion was valid at both Hospital A and Hospital B.

Medical record review on 10/16/2020 Patient #15 revealed a 28-year-old male admitted to Hospital A on 08/08/2020 at 0045 for Sepsis (potentially life-threatening condition caused by the body's response to an infection). Review of the H&P (history and physical) note dated 08/07/2020 at 2138 revealed Patient #15's past medical history of "Polysubstance abuse" and "Hep C (hepatitis C - infection caused by a virus attacks the liver)." Review of a Discharge Summary note dated 08/11/2020 at 2019 revealed Patient #15 had a rapid response team (group of doctors and nurses called to provide critical care expertise at a patient's bedside when condition is deteriorating) intervention on 08/11/2020 at 1840 related to worsening mental status and absence of movement in the left upper and lower extremities. Record review revealed a "CT (computerized tomography) scan (series of x-ray images taken from different angles to produce a cross-sectional images) dated 08/11/2020 at 1929 revealed "Emergent basilar artery occlusion ... recommended for transfer to Hospital B for mechanical thrombectomy ..."

Review of a Physician order dated 09/21/2020 at 0313 revealed an order to transfuse a unit of blood. Review revealed the patient received the unit of blood on 09/21/2020 at 0750. Review of a physician's order dated 09/22/2020 at 0838 revealed an order to transfuse one unit of blood. Review revealed the patient received the unit of blood on 09/22/2020 at 1400. Review of a physician's order dated 10/14/2020 at 0449 revealed an order to transfuse one unit of blood. Review revealed the patient received the unit of blood on 10/14/2020 at 1027. Review of a physician's order dated 10/14/2020 at 1308 revealed an order to transfuse one unit of Cryoprecipitate (a precipitate such as factor VIII, that is formed by cooling a solution, such as blood plasma). Review revealed the patient received the unit of cryoprecipitate on 10/14/2020 at 1844. Review revealed no consent for the blood was obtained during Patient #15's hospitalization from 09/18/2020, the day of re-admission to Hospital A, through 10/14/2020. Review revealed a transfusion consent was signed by the patient on 08/30/2020 for blood administration at Hospital B. Review of a H&P note dated 09/18/2020 at 1850 revealed "28 years old male with PMH (past medical history) of hepatitis C, IV drug abuse, polysubstance abuse, admitted from Hospital B on 09/18/2020 for continuation of care ..." Record review revealed a Physician order dated 09/21/2020 at 0313 for "Transfuse Red Blood Cells ... Order Details Transfuse 001 unit 1 occurrence Routine ... Indication Hematocrit LESS THAN 21% (Hgb [Hemoglobin] LESS THAN 7 g/dL [grams/deciLiter]) ... Date Consent For Blood Obtained 08/25/2020 ..." Review of Blood Transfusion Flowsheet revealed a unit of red blood cells was started 09/21/2020 at 0454 and finished at 0750 ... Review revealed a Physician order dated 09/22/2020 at 0838 for "Transfuse Red Blood Cells ..." Review of Blood Transfusion Flowsheet revealed a unit of red blood cells was started 09/22/2020 at 1218 and finished at 1400. Review of a Physician order dated 10/14/2020 at 0449 revealed "Transfuse Red Blood Cells ..." Review of the Blood Transfusion Flowsheet revealed a unit of red blood cells was started 10/14/2020 at 0722 and finished at 1027. Review of the medical record for Patient #15 revealed no consent for blood administration at Hospital A had been completed.

Interview on 10/16/2020 at 1635 with MD (Medical Doctor) #2 revealed the blood consent form obtained at Hospital B (a distinct certified facility) can be used at Hospital A (a separate distinct certified facility because they are part of the same health care system. Interview revealed patients were transferred to Hospital B for procedures were not performed at Hospital A. Interview revealed Patient #15 was transferred to Hospital B in August 2020, not discharged from Hospital A, and re-admitted from Hospital B to Hospital A in September 2020. Interview revealed Hospital A's bylaws did not address whether blood consent obtained at Hospital B could be used at Hospital A.

Based on video review, medical record review and staff interviews, the hospital staff failed to promote patient safety by not ensuring the Emergency Department (ED) support staff notified the clinical staff of a patient in distress while in the patient waiting area for 1 of 1 patient (Patient #16).

Findings included:

Video review on October 14, 2020 at 11:55 AM revealed, on September 29, 2020 at:
1. 11:50 AM, Patient #16 presented to the ED patient entrance in a wheelchair. ED screener assisted the patient from the ED entrance area to the ED registration desk. After placing the patient at the registration desk, ED screener went, obtained, and provided the patient a blue barf bag.
2. 11:51 AM, while at the ED Registration desk, Patient #16 demonstrated distress as indicated by using the blue barf bag while the ED Registrar initiated and continued with the registration process.
3. 11:56/11:57 AM, as the registration process continued, a female staff member dressed in blue scrubs walked through the registration area and entered the triage room. Registration process completed as indicated by the ED Registrar locating Patient #16 away from the registration desk to a space within the ED patient waiting area.
4. 11:58 AM, Patient #16 was down on the waiting area floor. ED staff, all females, 2-dressed in blue scrubs and 2-dressed in gray scrubs, tended to the patient. ED staff assist patient back into wheelchair and took the patient back to the ED patient care area.
Review revealed, Patient #16 was in distress upon entrance and while located in the ED waiting area.

Closed medical record review on October 14, 2020 revealed on September 29, 2020 at 11:51 AM, Patient #16 presented the ED with complaints of weakness and abdominal pain. While in the ED patient care area, the patient received care and was deemed stable for discharge. Review revealed at 4:49 PM, the patient was discharged to home with discharge instructions.

Interview on October 14, 2020 at 2:30 PM with the ED Registrar revealed, while Patient #16 was at the registration desk, ED RN #1 walked through the waiting area when coming back from lunch. At that time, ED RN #1 acknowledged the condition of the patient by stating, "he didn't look good" and with that verbal acknowledgement, the Registrar was under the perception the condition of the patient was being addressed. Interview revealed, a clinical staff member acknowledged the condition of the patient.

Interview on October 14, 2020 at 2:45 PM with the ED Clinical Nurse Manager and after video review revealed, upon arrival, Patient #16 could have been taken directly back to the ED patient care area.

Interview on October 14, 2020 at 3:10 PM with ED RN #1, ED RN #2, ED CNA #1, and ED CNA #2 revealed, everyone worked dayshift on September 29, 2020, tended to and recalled the waiting room situation with Patient #16. As for ED RN #1 revealed, working in the triage area and while coming back from lunch, the nurse walked thru the ED waiting area, and saw the patient. The patient looked uncomfortably but did not appear in immediate distress. As for ED RN #2 revealed, working as the Charge Nurse and felt the ED Registrar should have notified the ED clinical staff sooner because, once they saw the patient, the patient experienced respiratory distress and abdominal pain. As for ED CNA #1 revealed, functioned as the ED greeter for that day and was away from the waiting area when Patient #16 presented to the ED due to escorting an interviewee to an interview location. As for ED CNA #2 revealed, working in the triage area and failed to recall ED CNA #1 reporting as leaving the ED waiting area. Interview revealed, all staff believed Patient #16 experience could had been better; in that, Registrar could have reported to the ED Clinical staff sooner, ED CNA #1, the greeter, could have reported off to ED CNA #2, so that a clinical staff could have been present in the ED waiting area, and ED RN #1 could have assisted the patient sooner when coming back from lunch.

Interview on October 15, 2020 at about 8:30 AM with the Regulatory Service Coordinator revealed, there was no policy/procedure or guideline for non-clinical staff, working in the ED, on what to do when a patient present in distress.

Interview on October 16, 2020 at about 11:00AM revealed with the ED Patient Access Manager revealed, the Registrar should have notified the clinical staff of the patient in acute distress; however, there was no formalize training for the non-clinical staff working in the ED. Interview revealed, going forward, non-clinical staff, working in the ED, would receive EMTALA training as to what steps to take when a patient presents to the ED in distress.


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