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Based on interview and record review, the hospital failed to ensure an informed consent for the hypothermia care was obtained for one of two sampled patients (Patient 1) as per the hospital's P&P. This failure created the risk of the patient or the patient's family member not being allowed to make decisions about their health care.

Findings:

Review of the hospital's P&P titled Hypothermia Care, Post Cardiac Arrest, effective 12/4/24, showed the mechanisms responsible for brain damage after a cardiac arrest are multi-factorial. The lack of perfusion to the brain during arrest leads to ischemia and possible anoxic brain damage.

* Purpose: To establish the multidisciplinary approach and method for instituting immediate mild-moderate hypothermia (core temperature 33-36 degrees Celsius) in patients who meet inclusion criteria presenting in coma following cardiac arrest.

* Scope: All patients meeting eligibility after cardiac arrest.

* Responsibility: Physicians-ED /Intensivist/Cardiologist/Neurologist, Rapid Response Nurse, ED/CVU/ICU/Cath Lab Registered Nurse, Respiratory Therapists, and Pharmacists.

* Procedure:

- After full arrest review inclusion and exclusion criteria for patients with a return of spontaneous circulation following cardiac arrest.

- Physician assesses the patient inclusion and exclusion criteria and orders Hypothermia Intervention.

- Obtain Hypothermia Pre-printed Orders and informed consent per hospital policy...

On 4/30/25 at 0830 hours, Patient 1's closed medical record review was conducted with the CNO and Director of Quality Department.

Patient 1's closed medical record showed Patient 1 was admitted to the hospital on 2/24/25.

Review of the closed medical record showed the preprinted orders for Hypothermia After Cardiac Arrest dated 3/9/25 at 2130 hours.

Further review of Patient 1's medical record did not show an informed consent had been obtained for the hypothermia care.

On 4/30/25 at 1705 hours, the Director of Quality Department confirmed there was no documented evidence the care team had obtained an informed consent from the patient's family member for the hypothermia care as per the hospital's P&P.

Based on interview and record review, the hospital failed to ensure one of two sampled patients (Patient 1) received care in a safe setting as evidenced by:

1. There was no documented evidence of the Hypothermia Inclusion/Exclusion Criteria for Patient 1's hypothermia therapy as per the hospital's P&P.

2. The hospital failed to obtain a complete physician's order for ventilator settings and for IV FLUID maintenance.

3. The hospital failed to show documented evidence of monitoring the CVP for the IV FLUID target goal as per the Physician's order.

4. The hospital failed to show documented evidence of the size of the cooling pads used on Patient 1 for hypothermia therapy.

These failures created an unsafe environment for the patient receiving hypothermia therapy.

Findings:

Review of the hospital's P&P titled Hypothermia Care, Post Cardiac Arrest, effective 12/4/2024, showed the mechanisms responsible for brain damage after a cardiac arrest are multi-factorial. The lack of perfusion to the brain during arrest leads to ischemia and possible anoxic brain damage.

* Purpose:

- To establish the multidisciplinary approach and method for instituting immediate mild-moderate hypothermia (Core temperature 33-36 Celsius) in patients who meet inclusion criteria presenting in coma following cardiac arrest.

- To describe the methodology to induce hypothermia for up to 24 hours, and identifies specific steps used in the re-warming phase to bring the patients safely back to normothermia.

* Responsibility:

- Physicians-ED /Intensivist/Cardiologist/Neurologist, Rapid Response Nurses, ED/CVU/ICU/Cath Lab Registered Nurses, Respiratory Therapists, and Pharmacists.

* Policy:

- Patients post cardiac arrest with a return of spontaneous circulation (ROSC). The health care team will evaluate potential candidates for Hypothermia using the Inclusion/Exclusion Criteria Progress Note.

* Procedure:

- Physician assesses patient inclusion and exclusion criteria and orders Hypothermia Interventions.

- Obtain Hypothermia Pre-printed Orders...

- Assure that the following equipment is available...CVP and/or PA catheter to assess fluid volume/hemodynamic status.

- Assess the clinical status, prior to initiating hypothermia therapy:..assess respiratory rate and ventilatory function...

- Obtain physician order for initiation of sedation and analgesia for cooling...anticipate need for BP support...

- Use fluids to maintain euvolemia. Target CVP: 6-10 mm Hg...

Review of the hospital's P&P titled Physician Orders: Telephone, Verbal, and Written, effective 12/4/2024, showed verbal and telephone Orders...are e-signed by the prescriber within 48 hours...

On 4/30/25 at 0830 hours, Patient 1's closed medical record was reviewed with the CNO and the Director of Quality Department. Patient 1's closed medical record showed Patient 1 was admitted to the hospital on 2/24/25. Patient 1 expired on 4/3/25.

Review of the Cardiopulmonary Resuscitation Record dated 3/9/25, showed CPR started at 0959 hours and resuscitation event ended at 1023 hours. The Outcome section showed "Reason Resuscitation Ended: Return of Circulation (greater than 20 min.)." The hypothermia criteria showed the patient was identified as a candidate for hypothermia therapy. The patient was admitted to ICU.

On 4/30/25 at 1437 hours, ICU RN 1 was interviewed about hypothermia therapy. ICU RN 1 stated hypothermia therapy started with the physician's assessment for criteria. The assessment would be documented on the Hypothermia Inclusion/Exclusion Criteria Progress Note. The preprinted orders set for Hypothermia After Cardiac Arrest would be completed by the providers (ED physicians, Intensivist, Pulmonologists, Cardiologists, or Neurologists) by checking the boxes where there was a choice of orders or by filling in the blanks. The Therapeutic Hypothermia Nursing Worksheet was used to document the size of the cooling pad used on the patient and the monitoring of the patient's CVP during the hypothermia therapy.

On 4/30/25 at 1705 hours, Patient 1's closed medical record was reviewed with the Director of Quality Department. The Director of Quality Department confirmed the following findings:

* There was no documented evidence of the provider's assessment on the Hypothermia Inclusion/Exclusion Criteria Progress Note.

* The PREPRINTED ORDERS FOR: Hypothermia After Cardiac Arrest did not show orders for the ventilator settings; the Ventilator Mode, RR, TV, FiO2, PEEP, PS sections were left blank.

* The PREPRINTED ORDERS FOR: Hypothermia After Cardiac Arrest showed, "TORB (Telephone Order Read Back) by Dr.1" on 3/9/25 at 2130 hours, and was "Noted by RN" on 3/9/25 at 2135 hours. The orders showed Dr. 1 electronically signed the PREPRINTED ORDERS FOR: Hypothermia After Cardiac Arrest on 4/8/25 at 1447 hours.

* The medical record showed the patient had a CVP monitor line but there was no documentation showing the CVP reading during hypothermia therapy.

* The size of the cooling pad used on the patient was not documented on the Therapeutic Hypothermia Nursing Worksheet.