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Based on medical record review, document review, and interview, in one of one medical records, it was determined that nursing staff failed to implement a physician order for a bedside sitter (in-person, constant observation), but instead implemented a virtual (remote) patient safety monitoring observation sitter for Patient #2. (A0144).

Cross Reference:
482.13(c)(2) Patient Rights: Care in Safe Setting

Based on policy review, medical record review, document review, and interview, in one of one medical record reviewed, it was determined that the facility failed to ensure that all patients receive care in a safe setting for one patient (Patient #2), as evident by:
1. Nursing staff failed to implement a physician order for a bedside sitter (in-person, constant observation) for Patient #2, but instead implemented a virtual (remote) patient safety monitoring observation sitter. Patient #2 was able to dislodge their tracheostomy tube (breathing tube in neck) three times in four months (11/23/23, 12/17/23, and 01/02/24) and their gastric feeding tube (used for nutrition) four times in two months (11/08/23, 11/15/23, 12/11/23, and 12/31/23). Failure to implement physician orders and appropriate safety interventions resulted in additional surgical procedures to replace the tracheostomy and gastric tube.
2. Nursing staff were unable to review documentation of hourly observations by the virtual (remote) patient safety monitoring observation sitter in the medical record for Patient #2. Failure to have access to all patient information prohibits a full assessment of a patient's condition/needs by the nursing staff and has the potential for an adverse patient event.
3.On 12/17/23, the virtual (remote) patient safety monitoring observation sitter failed to notify in-person nursing staff of Patient #2 dislodging their tracheostomy. This failure of notification has the potential for a delay in care and/or a patient adverse event.

Findings #1:

Review of the policy "Virtual Patient Safety Observation Procedure", last revised 07/20/22, revealed all 1:1 (in-person, constant observation) sitter requests (physician orders) made by a provider must be clarified with the provider if the registered nurse believes the patient is suitable for virtual (remote) patient safety monitoring observer monitoring. The registered nurse should document the conversation with the provider in the medical record and request that the provider order be discontinued.

Review of the medical record from 10/08/23 to 01/09/24 revealed nursing staff failed to execute physician order for a bedside (in-person) sitter and failed to implement additional and/or changes to safety interventions after the multiple dislodgments of the tracheostomy tube (breathing tube) and gastric tube (feeding tube), to prevent further adverse events as evidenced by the following:
-On 10/08/23 at 02:23 PM, Patient #2 was admitted to the medical intensive care unit for accidental drug overdose, respiratory failure, electrolyte abnormalities, underlying infection, and aspiration.
-From 10/08/23 to 01/09/24, nursing staff assessed Patient #2 for safe environment and implemented fall precautions.
-From 10/08/23 to 01/09/24, nursing staff documented that Patient #2 was impulsive, had poor judgement, had poor safety awareness, and had poor attention/concentration with intermittent agitation including trying to get out of bed and pulling at lines.
-On 10/20/23 at 11:33 AM, a tracheostomy tube (tube placed in small opening in neck to assist breathing) was inserted. On 11/07/23, a gastric feeding tube (tube inserted in the stomach for nutrition) was placed.
-From to 11/07/23 to 11/08/23 and 11/10/23 to 01/09/24, an abdominal binder was applied to prevent gastric tube dislodgement.
-On 11/08/23 at 08:12 AM, Staff (UUU), Critical Care Physician, documented that Patient #2 pulled out their gastric feeding tube the previous night due to agitation. A foley catheter was placed in the gastric tube tract to keep the tract from closing. At 10:51 AM, the gastric tube was replaced by interventional radiology (procedure using x-ray guidance).
-On 11/15/23 at 09:57 PM, Staff (SSS), Licensed Practical Nurse, documented that Patient #2 pulled out their gastric feeding tube. The provider was notified.
-On 11/16/23 at 02:00 PM, interventional radiology (procedure using x-ray guidance) procedure to replace the gastric tube was attempted and not successful. At 08:58 PM, the gastric tube was replaced in the operating room via a laparoscopic gastrostomy tube (a surgeon makes two small incisions in the abdomen, one for the gastric tube and one for a camera, allowing the surgeon to see the stomach and other organs) placement.
-From 11/16/23 to 11/18/23, and 11/20/23 to 12/11/23, the physician ordered bilateral soft wrist restraints due to Patient #2's inability to fully comply with directions and for pulling at lines.
-On 11/22/23 at 10:06 AM, Staff (HHH) Physician, ordered a bedside in-person, constant observation sitter.
-From 11/22/23 to 01/09/24, nursing staff documented that a virtual (remote) patient safety monitoring observer was in place for continuous monitoring of Patient #2 (no evidence was found to indicate the use of virtual (remote) patient safety monitoring was discussed/approved by the physician and/or that a bedside, in-person sitter was utilized during the entire hospitalization).
-On 11/23/23 at 01:36 PM, Staff (UU), Registered Nurse, documented Patient #2 received 50 milligrams of Benadryl (sedating medication to decrease agitation) at 10:00 AM with no effect. At 11:30 AM, while in the medical rehabilitation gym, Patient #2 pulled out their tracheostomy tube.
-On 11/23/23 at 05:21 PM, the tracheostomy tube was initially replaced by the respiratory therapist but was not replaced into the proper position. Staff (VVV) Ear/Nose/Throat Physician placed a new tracheostomy tube via a flexible scope with a camera to verify placement.
-On 12/11/23 at 07:57 PM, Staff (TTT) Registered Nurse, documented Patient #2's gastric feeding tube was found to be dislodged from their abdomen. Patient #2 had both mitts and bilateral soft wrist restraints on. The trauma surgery provider attempted to replace the gastric feeding tube three times without success. A foley catheter was inserted by the provider into gastric tube tract and was secured with tape and an abdominal binder.
-On 12/11/23 at 09:21 PM, Staff (VV) Physician replaced the gastric tube at the bedside.
-From 12/12/23 to 12/17/23, the physician ordered bilateral soft wrist and soft ankle restraints due to Patient #2's inability to fully comply with directions to maintain personal safety.
-On 12/17/23 at 03:36 PM, Staff (W), Registered Nurse, documented Patient #2 pulled out the tracheostomy tube at 10:45 AM while in the medical rehabilitation unit. Patient #2 had on bilateral soft wrist and ankle restraints and was on the virtual (remote) patient safety monitoring. The respiratory therapist inserted a new tracheostomy tube without difficulty and the provider assessed Patient #2.
-From 12/18/23 to 12/19/23, bilateral soft wrist and a left ankle restraints were ordered daily for Patient #2's confusion/disorientation, inability to fully comply with directions, and for pulling at lines.
-From 12/21/23 to 01/09/24, bilateral soft wrist restraints were ordered due to Patient #2's inability to fully comply with directions and for pulling at lines.
-On 12/31/23 at 07:05 PM, Staff (PPP) Registered Nurse, documented Patient #2 was found in bed with their legs hanging over the side rail. The gastric feeding tube was lying next to them with the balloon still inflated and extension tubing still connected.
-On 12/31/23 at 06:03 PM, Staff (VV) Physician replated the gastric tube at the bedside.
-On 01/02/24 at 02:38 PM, Staff (RRR) Registered Nurse documented Patient #2's tracheostomy was dislodged while in the gym with physical therapy. At 03:58 PM, the tracheostomy tube was replaced by Staff (SS) Respiratory Therapist, at the bedside.
-On 01/09/24, the provider discontinued the bedside in-person, constant observation sitter.

Review of the staff assignment sheets dated 11/08/23, 11/23/23, 12/11/23, 12/17/23, 12/31/23, and 01/02/24 (dates Patient #2 pulled out their tracheostomy or gastric tube) revealed no evidence that Patient #2 had a bedside (in-person, constant observation) sitter assigned to their care.

Interview on 05/21/24 at 01:52 PM with Staff (UU), Registered Nurse revealed Patient #2 had their feeding tube and tracheostomy tube dislodged multiple times. Patient #2 always had an abdominal binder on to help keep the feeding tube in place. Additional interventions implemented to prevent tube dislodgment were a virtual (remote) patient safety monitoring observer, mitts, restraints, and being placed close to the nurse's station for faster interventions. Patient #2 had music therapy and other recreational therapies to help keep them calm. Staff (UU) felt Patient #2 warranted a bedside (in-person, constant observation) sitter, however a sitter is generally not available.

Interview on 05/22/24 at 09:00 AM with Staff (VV), General Surgeon revealed they were called three times for dislodgement of Patient #2's feeding tube. The third time, Staff (VV) inserted a red rubber catheter to keep the tract open until another feeding tube could be placed (replaced on 12/31/23). Staff (VV) does not recall if any adjunctive therapy was in place such as an abdominal binder. Any patient that has a feeding tube is at risk of dislodgment.

Interview on 05/22/24 at 12:00 PM with Staff (W), Registered Nurse, revealed Patient #2 had a virtual (remote) patient safety monitoring observer the whole admission and did not recall ever seeing an in-person, constant sitter at the bedside. Patient #2 would have benefited from a bedside (in-person, constant observation) sitter, not just having someone watching (remotely) Patient #2 remove their tubes.

Interview on 05/23/24 at 09:00 AM with Staff (BBB), Physician and Staff (DDD), Resident Physician revealed on 11/15/23 Staff (DDD) was notified of the dislodgement of Patient #2's gastric tube. A foley catheter was inserted through the abdominal stoma to prevent the hole from closing until the gastric tube could be replaced (replaced on 12/31/23). Medications were changed. A bedside (in-person, constant observation) sitter would have been a reasonable request for Patient #2. Staffing is very challenging. Physicians must think about using restraints for patients due to bedside (in-person, constant observation) sitters not being available. On 12/31/23, Patient #2 removed their feeding tube. General surgery was notified, and the feeding tube was reinserted at the bedside. On 12/31/23, Patient #2 was in bilateral wrist restraints and an abdominal binder on prior to dislodging the gastric tube.

Interview on 05/23/24 at 12:27 PM with Staff (HHH), Physician revealed on 12/11/23, Patient #2 pulled out their gastric feeding tube. A foley catheter was inserted into the stoma to keep it open. On 11/22/23, a bedside (in-person, constant observation) sitter was ordered to keep the Patient #2 safe and help to prevent additional tube dislodgements. Patient #2 was difficult to redirect and unable to follow commands due to decreased cognitive function. It was not possible to have a meaningful dialogue with Patient #2. The virtual (remote) patient safety monitoring observer was not ideal but was the best option available at the time. Interventions that were used to prevent tube dislodgements were an abdominal binder, redirection, insertion of a low-profile gastric tube, medications (for anxiety), restraints, and bolus (one time) feedings instead of continuous.

Interview on 05/29/24 at 11:57 AM with Staff (B), Assistant Director of Nursing Quality Officer confirmed Patient #2 had a virtual (remote) patient safety monitoring observer, not a bedside (in-person) sitter, and that there is no documentation in the medical record of a conversation between the provider and nurse for the use of a virtual (remote) sitter instead of a bedside (in-person, constant observation) sitter.

Interview on 05/29/24 at 06:30 PM with Staff (A) Associate Quality Officer, Staff (B) Assistant Director of Nursing, Staff (F) Assistant Quality Officer, verified these findings.

Findings #2:

Review of the policy "Virtual Patient Safety Observation Procedure", last revised 07/20/22, revealed the registered nurse would assess patient safety and ongoing need for a virtual (remote) patient safety monitoring observation sitter and document every shift. (The virtual patient safety monitoring observation sitter documentation was not a part of the electronic medical record).

Review of the medical record for Patient #2 from 11/22/23 to 01/09/24 revealed no evidence of virtual (remote) patient safety monitoring observation documentation or registered nurse shift assessments related to patient safety/ongoing need for the virtual (remote) patient safety monitoring observation sitter, in the medical record.

Interview on 05/29/24 at 11:52 with Staff (V), Geriatric Psychiatric Specialist Manager, revealed the virtual (remote) patient safety monitoring observation sitter documents their observations on paper forms remotely, but the information is not included in the patient's electronic medical record. Bedside caregivers and nursing staff cannot visualize any virtual (remote) patient safety monitoring observation sitter documentation.

Findings #3:

Review of the policy "Virtual Patient Safety Observation Procedure", last revised 07/20/22, revealed the virtual (remote) patient safety observer will verbally interact with the patient to divert from potentially unsafe behaviors and/or activities using various diversional tactics, including the possible activation of an alarm at the bedside to inform all available staff to respond when a patient is thought to be in imminent danger. When necessary, the virtual (remote) patient safety observer will communicate observations and patient needs to the appropriate bedside care provider assigned to the patient.

Review of the virtual (remote) patient safety monitoring observation form (not part of the medical record) for Patient #2, dated 12/17/23, revealed at 11:00 AM, Patient #2 was awake, in bed, and had visitors. The virtual (remote) patient safety monitoring observer documented that Patient #2 pulled their tracheostomy out and no other action was needed. (No evidence was found to indicate that the virtual (remote) patient safety monitoring observer contacted the hospital caregiver/nursing staff.)

Interview on 05/29/24 at 11:37 AM with Staff (III), Virtual (remote) Patient Safety Monitoring Observation Sitter revealed on 12/17/23, Patient #2's virtual sitter camera was in privacy mode when they heard Patient #2's father calling for help. Staff (III) did not see Patient #2 dislodge their tracheostomy and could not recall notifying the hospital bedside caregiver/nursing staff that Patient #2 removed their tracheostomy.

Based on policy review, medical record review, document review, and interview, the hospital failed to ensure the Quality Assurance and Performance Improvement Program involved all departments/services and focused on indicators to improve health outcomes and prevent/reduce medical errors as evidenced by: the Quality Assurance and Performance Improvement Program does not monitor the effectiveness, safety, and quality of care related to the virtual (remote) patient safety monitoring observation program (A0273). The Quality Assurance and Performance Improvement Program failed to identify, analyze, and track adverse events for Patient #2 related to the dislodgement of the gastric feeding tube three out of four times and tracheostomy three out of three times (A0286).

Cross Reference:
482.21(a), (b)(1), (b)(2)(i), (b)(3)- Data Collection & Analysis
482.21(a), (c)(2), (e)(3)- Patient Safety

Based on medical record review, policy review, interviews, and document review, the Quality Assurance and Performance Improvement Program did not monitor the effectiveness, safety of services, and quality of care provided by the virtual (remote) patient safety monitoring observation program.

Findings include:

Review of the policy "Quality Assessment and Performance Improvement Plan", last revised on 03/29/23, revealed quality and safety in the organization is monitored by review of data for identified performance measures. Performance measures are chosen based on management plan goals; quality councils and quality improvement coordinating groups performance improvement plans and initiatives; requirements/recommendations; quality assessment and performance improvement plan; evidence-based practice and system level performance indicators, and the ability to track results against benchmarks. Each departmental quality program is responsible for providing the resources and oversight for quality assurance and performance improvement activities within their department, with oversight by the hospital quality program. Each department head is responsible for quality monitoring, evaluation, and improvement of all aspects of care and services delivered by the department. Quality of care and services are assessed by regular evaluation of quality and utilization data, case reviews, and systems issues. Quality is improved by regular self-assessment against established quality criteria and compliance with external standards. Departments are responsible for quality across the continuum of care.

Review of the "Quality Asurance and Performance Improvement Committee Minutes and Reports," from 01/2023 to 01/29/24, revealed no evidence that the Quality Assurance and Performance Improvement program is monitoring the virtual (remote) patient safety monitoring observation program to evaluate effectiveness, safety of services, and the quality of care, including the care received by Patient #2. No data and/or indicators were listed in the documentation.

Interview on 05/29/24 at 10:47 AM with Staff (A), Associate Quality Officer, Staff (G), Associate Quality Officer and Staff (V), Director of the Virtual (remote) Patient Safety Monitoring program revealed Staff (V) does not participate in quality assurance and performance improvement and no data is collected from the virtual (remote) patient safety monitoring observation sitter or from the department. The program was implemented in April of 2023. Due to lack of staffing and a 60% staffing vacancy rate, the team (Geriatric Specialist Team responsible for assigning a bedside or virtual sitter) has been unable to accommodate requests for a bedside (in-person, constant observation) sitter. The unit the patient is on is then responsible for providing a bedside (in-person, constant observation) sitter. Patient #2 had an order on 11/22/23 for a bedside (in person, constant observation) sitter. The team was unable to provide the bedside sitter, only a virtual (remote) patient safety monitoring observation sitter.

Interview on 05/29/24 at 11:30 AM with Staff (A), Associate Quality Officer, verified the findings.

Based on policy review, medical record review, and interview, the Quality Assurance and Performance Improvement Program failed to ensure an adverse patient event report was submitted for the multiple dislodgments of the gastric feeding tube (11/08/23, 11/15/23, and 12/11/23) and tracheostomy (11/23/23, 12/17/23, and 01/02/24) for Patient #2. Failure to report adverse events prevents the analysis of events to identify potential trends/issues and the implementation of preventative actions to reduce medical errors and adverse patient events.

Findings include:

Review of the policy "Reporting Adverse Events, Near Miss and Unsafe Conditions - Patients and Visitors Policy," last revised 07/10/23, revealed an event is an adverse occurrence related to the care and services provided to patients and their visitors. Serious events, including those with an adverse effect on patient outcome, must be reported immediately to area leadership, the office of counsel to the medical center, and/or the quality assurance office. In all cases where an event/adverse outcome, near-miss or close call has occurred, the event must be reported by the end of the shift in which the event occurred, was first discovered, or by the end of the next workday. Staff should report actual or potential patient safety or quality of care events as soon as it can safely be done after the event, via the event reporting system.

Review of the medical record for Patient #2 revealed Patient #2 was admitted to the medical intensive care unit for accidental drug overdose, respiratory failure, electrolyte abnormalities, underlying infection, and aspiration. On 10/20/23 at 11:33 AM, a tracheostomy tube was inserted. From 11/22/23 to 01/09/24, a physician order was written for bedside (in-person, constant observation) observation due to agitation and pulling at lines, however, nursing staff instead implemented virtual (remote) patient safety monitoring observation. No documentation was found to indicate the physician agreed with the use of virtual (remote) monitoring. No documentation was found in the medical record of the virtual patient safety monitoring observer observations required to be documented every hour. Patient #2 was able to dislodge their tracheostomy on 11/23/23, 12/17/23, and 01/02/24 and dislodged their gastric tube on 11/08/23, 11/15/23, 12/11/23, and 12/31/23, that required replacement and/or surgical intervention. After each dislodgement event, nursing staff failed to implement interventions to prevent future adverse events.

Review of event reporting documentation from 11/08/23 to 01/09/24 revealed the facility provided an adverse event report for the 12/31/23 dislodgement of a gastric tube. No evidence was found of event reports for the gastric tube dislodgements on 11/08/23, 11/15/23, and 12/11/23 and the tracheostomy dislodgements on 11/23/23, 12/17/23, and 01/02/24.

Interview on 05/30/24 at 12:30 PM with Staff (A), Associate Quality Officer, revealed that not every tube removal occurrence would need an event report to be submitted. If the removal caused harm, it would be expected that an event report would be submitted. A tracheostomy replacement would not be considered harm, therefore would not need an event report. A simple exchange of a feeding tube would not need an event report. On 11/15/23 when the feeding tube was removed and an abdominal exploratory laparotomy was needed, an event report should have been submitted.