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25 POCONO ROAD

DENVILLE, NJ 07834

PATIENT SAFETY

Tag No.: A0286

Based on the review of one of one medical record (MR1), staff interviews, and review of facility documents, it was determined the facility failed to ensure that a Risk Incident Report was generated after an adverse patient event in the Emergency Department.

Findings include:

Facility document titled, "Patient Safety Plan" (Reviewed/Revised 1/2025) stated, " ...IV. Definition: ... Patient Safety Event: Any identified defect, error, medical accident, near miss, sentinel event, medication error, significant procedural variance, or other threat to safety that could result in patient injury ...VI. Reporting Medical/Healthcare Errors: A. Reporting Policy: ... To promote openness, the organization shall ensure that all reported mistakes be handled without threat of punitive action. ... All incidents, especially clinical errors, must be reported immediately. B. Unusual Occurrence / Risk Incident Reporting: ... When a medical / healthcare error is identified, the patient care provider will immediately: ... Complete a Risk Incident Report in addition to reporting the error to the immediate Director of Manager as appropriate."

A review of the medical record for Patient (P)1, revealed that Patient (P)1 arrived at the ED on 04/04/25 at 7:40 AM. The patient's arrival complaint was documented as "sob (short of breath) asthma attack."

A review of the ED Timeline revealed the following:

On 04/04/25 at 14:10 (2:10 PM) Orders Placed: Respiratory Care-Intubation

In the ED Course Note dated 04/04/25 at 1708 (5:08 PM) written by S17 (ED Physician) it stated, "I was called to the room by staff due to a difficult intubation. Entering the room the patient had blood from the left side of [his/her] mouth and [he/she] was not paralyzed. [He/She] was being ventilated with BVM (Bag Valve Mask). [BVM is a manual resuscitator used to provide rescue ventilation to patients who are not breathing or are having difficulty breathing.] ... oral pharynx was visualized with glide scope. Focal [sic] cords were not visible due to blood in oropharynx and apparent trauma from previous intubation attempts ...There were no additional attempts to pass endotracheal tube through non-visualized vocal cords. [He/She] was continued to be ventilated with the BVM with supplemental oxygen. ... non-rebreather mask was applied maintaining oxygen saturation. Anesthesia was called to re-evaluate nonemergent intubation. Shortly after the incident pulmonologist [S31] was available for consultation. [He/She] agreed that intubation was not emergent, and [he/she] attempted to optimize with medication. [The patient] was transferred to the ICU (intensive care unit). Incident discussed with ICU attendings."

In a Procedure Note written on 04/04/25 at 5:30 PM by S21 (Physician Assistant, Critical Care) it stated, "Intubation: Date/Time: 04/04/25 2:03 PM; Performed by: [S21]; ... The procedure was performed in an emergent situation. Verbal consent obtained. ... Attempted intubation was performed due to worsening respiratory failure secondary to asthma exacerbation. Patient was unable to be intubated after 1 (one) attempt. Following the attempt, patient was stabilized and subsequently intubated by anesthesiology in the ICU."

On 04/17/25 at 10:00 AM, interviews were conducted in the presence of S2, S6 (Chief Medical Officer), S19 (MD [Medical Doctor], ICU [Intensive Care Unit] Director), S20 (Assistant Program Director), and S22 (Manager of Quality/Performance Improvement). During the interview, S19 stated, "On 4/4/25, the midlevel provider (Physician Assistant) attempted to intubate [P1] twice and 'failed' both times. Following the incident, the patient had an X-Ray completed. The patient was stabilized in the emergency department (ED), and successfully intubated by S23 (Anesthesiologist) in the ICU." S19 further stated that the incident was verbally reported to him/her and is currently under peer review.

During the interview, S2 confirmed that the failed intubation on 04/04/25 was classified as a "Patient Safety Event," and an incident report should have been completed on 04/04/25, in accordance with the facility's "Patient Safety Plan." On 04/17/25 at 10:14 AM, S2 confirmed that there was no incident report generated for this event.