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Based on policy review, document review, and staff interviews, it was determined the facility failed to ensure grievance policy and procedures were followed in one (1) out of five (5) grievances reviewed, filed on behalf of patient 1. This failure has the potential to negatively impact all patients receiving care at the facility.

Findings include:

A review was conducted of the policy titled, "Customer (Patient/Family/Visitor) Concern/Complaints/Grievance Process," last revised 03/12/21. The policy states in part, "...Procedure ...C.Grievances: 1. When a grievance is filed, initiate actions to achieve resolution involving other members of medical team as appropriate. a. Acknowledge receiving the grievance by a face to face visit to the patient or his/her representative if he or she is in the facility or by a telephone call or letter if the complaint is received after discharge. b. Make face to face visits to patient and family members with permission. c. Interview the complaint and document the interview. d. Confer with the nursing staff, social worker, physician, or other medical team members involved with the complaint. e. Review the necessary documents. f. If applicable, discuss a potential solution with a complaint and other parties involved. g. Attempt to reach a resolution to the complaint that is satisfactory to all parties involved. h. Conduct necessary follow-up and document in the grievance file. 2. Situations or practices that place the patient in immediate danger are to be promptly referred to the VP [Vice President] of Medical Affairs or VP of Patient Services. After hours, these should be referred to the Patient Care Coordinator who may contact the Administrator On Call. 3. Complete the appropriate documentation and forward to the Patient Advocate. 4. Management will, in coordination with a Patient Advocate, write a formal letter within 7 [seven] business days of receipt of the grievance to inform the appropriate individual of follow-up action and closure. If investigation is not complete within 7 [seven] business days, the response should inform the complaint the medical center is still working to resolve the complaint and that a written resolution is forthcoming. 5. Copies of all grievances will be forwarded to the Patient Advocate to assure acknowledgement to the complainant, appropriate communication to all departments involved, investigation by all departments, communication to the complaint of solution and closure ..."

A review was conducted of the grievance filed on behalf of patient (pt) 1 on 03/05/25. The grievance was reported in person to staff 4. The grievance, in summary, explains how information as to what happened with pt 1 was not communicated timely to the family, and they had questions as to what happened during the procedure. They also inquired if a sentinel event was reported, and the ICU physician was "negative." A comment on 03/13/25 at 10:21 a.m. states, "Reviewed. Awaiting additional information. Will review and discuss with [staff 6]." A letter was sent to pt 1 on 03/14/25 and states in part, "...I apologize for the delay in getting a response to you; however, it is important to us that we review your concerns thoroughly prior to sharing our results with you. You should expect a response by letter within 30 days of this letter ..."

A comment on 03/31/25 at 5:29 p.m. by staff 5 states, "Aware of situation. [Staff 3] documented air embolism in report. [Staff 3] will need to respond to the questions being asked of by the family. I am not aware of anything missing, and I will discuss staff conversations over patients and families." A comment on 04/07/25 at 12:06 p.m. states, "Reviewed and discussed reported event with [staff 6] on 03/31/25."

May it be noted, no further documentation was provided in response to the grievance. There is no evidence anyone had any additional conversations with the family, or notified staff 3 of the questions being asked.

An interview was conducted with staff 4 on 04/07/25 at 2:45 p.m. Regarding the grievance filed on behalf of pt 1, staff 4 states, "The grievance was just closed today, about an hour ago. I will send out a letter on behalf of the patient to the healthcare surrogate. I initially received the grievance in person from the family a day after the procedure, when the patient was here in the hospital. If the patient's [adult child] would have asked to talk to the doctor, I would have gotten [her/him] to speak with [her/him]. [She/he] basically just wanted the situation investigated. [She/he] asked about Sentinel events and sentinel events are kept confidential from me, so I would not know if that was filed. About four (4) to five (5) days after the grievance was filed, I went to check on the patient, and the patient's [spouse] was sleeping in the room, and the patient was unconscious. I never had any further contact with the patient or the family. I didn't receive any further complaints from the family."

An interview was conducted with staff 5 on 04/08/25 at 9:47 a.m. Regarding pt 1, staff 5 states in part, "...I didn't know that the family complained and filed a grievance the day after. I did not see that the grievance appeared in my Midas (grievance reporting and response) system to respond to until the end of March. I do rounding on patients in my department, and if I knew about this grievance, I could have gone over and talked to the patient. We could have let the doctor know, and [she/he] would have spoken to the patient and family as well. This doctor is very personable, and if they would have relayed to [her/him] what the family was complaining about, [she/he] would have been happy to speak to them ..."

A telephone interview was conducted with staff 3 on 04/08/25 at 11:27 a.m. Regarding pt 1, staff 3 states in part, "...I would have spoken to the family if they had any additional questions but no one told me they had any and they did not express any to me when I spoke with them. Part of my routine rounding is to always ask the family or patients if they have any questions about the care. I always updated the family on the whole situation and all the information I've obtained from the whole team taking care of the patient. I would even be happy to speak with them now if they called me and had any questions about what had happened ...The family never asked me about that. I would have been happy to explain it to them ..."

An interview was conducted with staff 13 on 04/08/25 at 1:00 p.m. Regarding pt 1, staff 13 states, "I remember this patient very well. The patient had issues during their procedure. The youngest [adult child] was here during the procedure. The doctors had spoken to [her/him] but [she/he] wasn't medical and didn't quite understand all the information that was given to [her/him] when [she/he] relayed it to the rest of the family. The rest of the family felt every time a new doctor came in, they were given conflicting information. The one (1) [adult child] who was a nurse, was upset. [She/he] requested to speak with someone because they weren't being told things clearly. [She/he] said [she/he] wanted to speak with the advocate. I called the advocate and they came up. The advocate, after they spoke with the family, they didn't tell me anything that was said. They didn't complain after that to me. I know the situation was hard and there were a lot of physicians involved in the case."

An interview was conducted with staff 14 on 04/08/25 at 1:34 p.m. Regarding pt 1, staff 14 states, "I remember the patient. I was not aware of a situation with the patient's family until after all the events occurred. When the patient's family filed a grievance, the patient advocate put it in the system and then I could see it and respond to it. I did not get this grievance."

An interview was conducted on 04/09/25 at 10:51 a.m. with staff 6. Regarding the grievance filed on behalf of pt 1, staff 6 states, "The situation was assigned to peer review regarding the air embolism during the procedure. It would be assigned for another EP provider to review it. It would be presented at quality. This is a risk associated with the procedure, so what we look at is the percentage of occurrences and does this provider fall out of the benchmark for the percentage. Usually a peer review takes thirty [30] to ninety [90] days. This one is scheduled for next Wednesday. Since this outcome was outside of standard, it should have been entered into Midas. The staff is not shy about bringing outcomes forward. Since this patient was a death after a procedure, those are all looked into. I was notified within hours of the air emboli and I sent it to the medical staff review coordinator immediately to make sure it was on the list for peer review. We can then put it in the Midas system if it's not there."

An interview was conducted with staff 17 on 04/09/25 at 1:33 p.m. Regarding Nursing peer review, staff 17 states in part, "...I was only asked to review the ketamine situation. I did not know the family filed a grievance on behalf of the patient and I was not asked to review anything regarding that."

An interview was conducted with staff 20 on 04/09/25 at 2:30 p.m. Regarding the grievance filed on behalf of pt 1, staff 20 states, "The patient advocate [staff 4] received the grievance. [She/he] pushed it to the provider side for communication. There was a piece of the grievance that was a provider issue. All the grievances would go through the grievance committee which meets bi-weekly. The advocate team puts everything together in a synopsis and then we review the grievance. This would probably be reviewed this week since it just was closed out. [Staff 4] reviews when [she/he] forwards everyone the information in the grievance system to make sure everyone is responding. We push everyone to get them done in seven (7) days. I agree that the nurse manager of the unit should have been aware of the situation even though there were no direct complaints from the ICU. I'm assuming the nurse manager didn't get it because there were no complaints on this particular unit. There's obvious opportunities for improvement for real-time communication. I will bring this up in the grievance committee meeting tomorrow."

Based on policy reviews, medical record reviews, and staff interviews, it was determined the facility failed to follow the policy and procedures for reporting patient safety events in three (3) out of three (3) events involving patient (pt) 1. This failure has the potential to negatively impact all patients receiving care at the facility.

Findings include:

A review was conducted of the policy titled, "Patient Safety Event, including Adverse and Sentinel Reportable Events," last revised 01/21. The policy states in part, "Policy: St Mary's Medical Center (SMMC) has a procedure for the notification, investigation, and action plan follow-up regarding patient safety events. Definitions: Patient safety event: an event, incident, or condition that could have resulted or did result in harm to a patient. This could be, but is not necessarily, the result of a defective system or process design, a system breakdown, equipment failure, or human error ...1. Adverse event: A patient safety event that resulted in harm to a patient ...5. Sentinel event: A patient safety event (not primarily related to the natural course of the patient's illness or underlying condition) that reaches a patient and results in death, permanent harm, or severe temporary harm. These events are called sentinel because they signal the need for immediate full investigation and response ...Procedure: 1. Identification A. Any persons performing work for SMMC who is aware of an event that may be an adverse or sentinel event is responsible for notifying leadership via the nursing/patient care or medical staff chain of command, as soon as possible. B. The event is to be reported to the Director of Quality and Accreditation as soon as possible, who is responsible to compare the reported event against the Sentinel event criteria. C. The Director of Risk management, Director of Quality and Accreditation, and/or their designee shall report any potential sentinel event to Medical Center Administration. D. The Director of Risk Management, or designee, will notify accounting to place the bill on hold for any event being investigated as sentinel. II. Immediate Response to an Adverse or Sentinel Event ...G. A risk event report should also be completed that includes a brief summary of the event specifying who, what, when, and where of the occurrence ...VI. Disclosure A. Patients and, when appropriate, their family/support person shall be informed about the unanticipated outcomes of care, treatment, and services related to adverse or Sentinel events ..."

A review was conducted of a policy titled, "Risk Event Reporting and Management Process," last revised 08/18. The policy states in part, "Policy: Patient/family/visitor accidents/incidents are to be reported as soon as possible after the event occurs. Definitions: a risk event ('event') is any occurrence or situation that is outside the expected course of delivery of hospital care. An event can involve an inpatient, outpatient, visitor, volunteer, employee or other person and may result in loss, damage, or violation of rights. A risk event may result when any of these people perceive, rightly or wrongly, that they have been slighted, neglected, mistreated, or injured. Procedure:1.The person involved in an event, witnessing an event, or the first to arrive at an event will initiate the appropriate internal communication process. The on-line computer form, 'Risk Event Reporting', is to be used for events involving patients and visitors. The on-line computer form 'Employee Injury Report/First Report of Injury' is to be used to report staff injuries.2. Risk management is responsible for coordinating internal notification of an event for appropriate review and event closure. The severity of an event and immediate needs of the patient or visitor are to be evaluated by the charge nurse, patient care coordinator, and any supervisory personnel. Follow up is to begin immediately on serious events per policy 'Patient Safety Event, Including Adverse and Sentinel Reportable Events'. If the on-line computer forms are not available, plain white paper is to be used for recording the event and forwarded to Risk Management before leaving duty. If the event occurs on an off shift, holiday, or weekend, the risk event report is to be given to the patient care coordinator who will forward the documentation to the Risk Management office. 3. Documentation in the medical record should reflect what occurred. It should not state that a 'risk event report' was completed or that risk management or quality was notified. 4. The risk event reporting form and any follow-up investigation are not part of the patient's medical record ..."

A medical record review was conducted for patient (pt) 1. The pt presented to the facility on 03/04/25 for a Watchman ' s procedure by staff 3. A "Watchman Implant Procedure" note by staff 3 states in part, "...Procedure Note:...During the exchange of the wire into the pigtail catheter, the patient developed a cough, with clear signs of air embolism observed on fluoroscopy. The patient subsequently experienced low blood pressure and ST [ST segment in an ECG (Electrocardiogram)] elevation. Blood was suctioned via the sheath, and high pacing from the pacemaker was initiated. A 4 [four] Fr [French] sheath was placed in the right femoral artery for blood pressure monitoring. Intracardiac echocardiography (ICE) revealed no evidence of pericardial effusion. Blood pressure and heart rate begin to stabilize. However, oxygen saturation remained low, and the patient was intubated. The patient remained clinically stable with normalized ECG changes, stable blood pressure, and improved oxygen saturation. The patient was extubated shortly after. Upon extubation, facial asymmetry and slight changes in pupil size were noted, prompting a stroke alert and an urgent CT [Computed Tomography] scan of the head. The family was notified ..."
The "Electrophysiology (EP) Device Report" was reviewed and revealed a stroke alert was called 12:32 p.m., and the stroke team arrived at 12:34 p.m. The pt was transported to CT from the EP lab at 12:37 p.m. The pt time of death was 03/18/25 at 10:48 p.m. The "Certificate of Death" lists the "Cause of Death" as 1. Air embolism, 2. PEA [pulseless electrical activity] arrest, 3. Kidney failure.

An interview was conducted with staff 5 on 04/08/25 at 9:47 a.m. Regarding pt 1, staff 5 states in part, "The patient had a Watchman's procedure. During the procedure, the doctor thought [he/she] visualized an air embolism. After the patient was extubated, the patient had signs and symptoms of a stroke. They called a stroke alert. The stroke team came to the EP lab. The stroke alert team is trained in assessment. They immediately started the assessment and took the patient straight to the CT scanner and then to the ED. All patients go to the ED to be evaluated if an unexpected outcome happens after the procedure, especially signs and symptoms of a stroke ...I did not file any incident report based on what happened during the procedure or after."

A telephone interview was conducted with staff 3 on 04/08/25 at 11:27 a.m. Regarding pt 1, staff 3 states in part, "The patient presented for a Watchman procedure. During the procedure, the patient had a big cough and became unstable. I visualized what was a possible air embolism. I aborted the procedure, and initiated supportive management. [She/he] stabilized and was extubated. After [she/he] was off anesthesia, there was a concern for the patient not responding appropriately. We called a stroke alert, and the stroke team took over care ..."

An interview was conducted on 04/09/25 at 10:51 a.m. with staff 6. Regarding pt 1, staff 6 states in part, "...Since this outcome was outside of standard, it should have been entered into Midas (patient safety event reporting system). The staff is not shy about bringing outcomes forward. Since this patient was a death after a procedure, those are all looked into. I was notified within hours of the air emboli and I sent it to the medical staff review coordinator immediately to make sure it was on the list for peer review. We can then put it in the Midas system if it's not there."

An interview was conducted with staff 1 on 04/09/25 at 3:20 p.m. Staff 1 confirmed there was no incident report or safety event report filed on behalf of pt 1 having an aborted procedure, having a potential air embolus during their procedure or having stroke-like symptoms post procedure.