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Based on observation, interview, medical record, and Policy and Procedure review, it was determined that the hospital failed to:
1.) Assure direct involvement by the Medical Director of Respiratory Services in the direction and supervision of respiratory services staff (see Tag A 1153);
2.) Assure that the hospital had a data-driven Quality Assurance/Process Improvement Plan that included quality indicators for Respiratory Services (see Tag A 283); and
3.) Assure follow-up on the adverse event/adverse incident which involved Patient #1 (see Tag A 286).

The cumulative effect of these systemic problems placed all patients in need of respiratory services at risk for not receiving care in a safe setting.

Based on interview and review of policies and procedures and hospital documents, it was determined that the hospital failed to set priorities for performance improvement activities that focused on issues affecting the care of patients who received Respiratory Services. The hospital's failure to do so potentially placed all patients who received respiratory services at risk for harm.

Findings include:

On March 11, 2014, the Quality Assurance/Process Improvement (QAPI) manager was interviewed. S/he stated that there was not an individual QAPI plan for Respiratory Care Services and that the hospital-wide plan did not specifically include indicators for Respiratory Care Services. S/he stated that quality indicators were set by the system-wide Swedish Hospital Quality Council. Each individual hospital was to include those indicators as well as develop additional indicators specific to the needs of the individual hospital.

The QAPI manager stated that up to the present time, the Swedish-Edmonds campus had had a "home-grown" system, but the campus was currently in the process of integrating into the larger Swedish system.

The Swedish Health Services "Quality and Patient Safety Program Quality Assurance Improvement Plan", approved June 12, 2013, was reviewed. The plan was found to contain the following statements:

"Key functions of the Quality and Patient Safety Program...
Priorities for performance improvement activities that:
-Focus on high-risk, high volume or problem-prone areas.
-Consider the incidence, prevalence and severity of the problems in those areas.
-Affect health outcomes, patient safety and quality of care.
-Track medical errors...analyze their causes and implement preventive actions...
-Take action aimed at performance improvement, implement those actions, measure success and track performance to ensure that improvements are sustained.
-Create and support a culture of reliability and safety."

The proposed: CRITICAL CARE INDICATORS - 2014 for ICU/PCU had not been approved as of March 12, 2014.

Based on interview, observation, review of medical records and review of hospital documents, it was determined that the hospital failed to track medical errors, analyze their causes and implement preventive actions and mechanisms to assure that clear expectations for safety were established and implemented. The hospital's failure to do so resulted in a medical error relating to Patient #1 that was not analyzed, and subsequent preventive actions were not implemented to establish safe practices related to all patients who received respiratory services throughout the hospital.

Finding 1:
Patient #1 was an 81-year old individual who had been brought to the hospital's Emergency Department by medics after 911 was called on 12/10/2011. The patient had a 2 to 3-day history of worsening dyspnea [difficulty breathing], which had increased just prior to the patient's admission. The patient also had known coronary artery disease, atrial fibrillation [irregular heartbeats], an abdominal aortic aneurysm [a bulging area in the large artery in the abdomen] and a chronic kidney condition. It was initially believed that the patient ' s symptomology was cardiac in nature and the patient was admitted to the cardiology service, but on 12/14/2011, the patient was transferred to the Intensive Care Unit [ICU] because of her/his increased dyspnea and hypoxemia (low oxygen levels in the blood).

In the ICU, the Patient #1 was intubated and placed on a ventilator. The patient continued to have difficulty breathing and required significant ventilator assistance. On 12/19/2011, the patient was diagnosed with respiratory failure and on 12/20/2011, a tracheostomy (a surgical opening into the neck for placement of a breathing tube) was performed.
On 12/20/2011, Physician #3, an intensivist (physician who cares for patients in ICU) assumed care of the patient. The physician documented that the patient required " fairly high levels of PEEP (positive end expiratory pressure ventilator assistance) to maintain adequate oxygenation ... " The physician documented " ...over the next several days, [the patient] had severe difficulty maintaining adequate oxygenation. With virtually any movement [s/he] would desaturate [oxygen blood levels would decrease] ...on the morning of 12/24/2011 [s/he] continued to be unstable " .
Physician #2, a hospitalist (a physician who cares for acutely ill hospitalized patients) assumed care of Patient #1 on 12/24/2011 until the morning of 12/25/2011. On 12/24/2011, Physician #2 gave a verbal order for a change in the ventilator setting and authenticated it [confirmed by written signature that the order was correct]. During the March 18, 2014 interview with Physician #2, Physician #2 confirmed s/he had issued the incorrect ventilator setting order on 12/24/2011 and had not realized the error at the time. The ventilator setting order for APRV (airway pressure release ventilation, a pressure control mode of mechanical ventilation) had the " high " and " low " settings for the ventilator transposed on the order.

Respiratory therapy (RT) and nursing staff assigned to Patient #1 on 12/24/2011 until the morning of 12/25/2011, had not questioned or identified the incorrect ventilator setting order.

On the morning of 12/25/2011, Physician #1 and Physician #3 came to the ICU and documented " ...felt that [the patient ' s] ventilator setting were inappropriate...made changes ...and this resulted in a bump up in [the patient ' s] oxygen saturation into the mid 90 ' s. Unfortunately, with these changes there was some increase in airway pressure, although in general gas exchange did improve " .

On March 17, 2014, Physician #1, an intensivist, who had been the attending physician for Patient #1 was interviewed. He/she identified the incorrect ventilator setting for Patient #1 the morning of 12/25/2011 and had reported the incident in writing to the Manager of Quality Management and Regulatory Compliance (QMRC). He/she also spoke with Physician #2, who ordered the ventilator settings.

Physician #4, the Medical Director of Respiratory Therapy, stated that s/he had not been formally informed of the event regarding the 12/24/2011 incorrect ventilator settings for Patient #1. S/he stated that s/he had not been asked to participate in any quality assurance/process improvement discussions regarding the event. The physician stated s/he had done her/his own investigation of the incident and found that a hospitalist had been covering [providing medical care to the patients] in the ICU that night.

During the March 6, 2014 interview with the QMRC manager, s/he stated that s/he had done the RCA (root cause analysis) for this event. The QMRC manager also stated that the RCA was incomplete and that a complete evaluation of the situation, and the events leading up to it, had not occurred. The QMRC manager stated that the hospital's internal investigation confirmed that the ventilator had been set incorrectly for 31 hours. The hospital's investigation included a " cause and effect " analysis which identified 3 contributing main causes for this event: People, policies and procedures, and methods. All three categories listed verbal orders as a contributing cause resulting in incorrect ventilator settings. The following actions were taken:

1. The RCA "action plan" stated that verbal orders would be addressed at the next staff meeting for RNs and RTs. The QMRC manager stated s/he did not know if that had been accomplished.

2. The ICU nurse manager provided documentation of an inservice, provided to the RT staff on January 4, 2012. The inservice was provided by the vendor of the ventilator used for Patient #1 and was attended by RT staff and the nurse manager. There was no documentation of any training for the RNs.

3. The QMRC manager stated that, after recognition of the incorrect ventilator setting, the hospital "immediately" conducted an inservice on ventilator settings, taught by Physician #1. The inservice was for the ICU RNs and RTs. Further interviews revealed that the inservice provided had included only the RTs and the ICU nurse manager.

4. On March 12, 2014, the QMRC manager, the Nurse Manager for ICU/PCU and the QAPI manager all stated that Physician #1 had subsequently gone to a meeting of the hospitalists and discussed ventilator settings, specifically the APRV. No documentation of that meeting was available.

5. The QMRC manager also stated that the case had been reviewed by the hospital's Peer Review process. The QMRC manager was unable to provide documentation of the inservice or the peer review.

6. On March 6, 2014, the nurse manager of the ICU/PCU stated that after the event, s/he had immediately counseled the 3 RTs who had provided care to the patient while the ventilator was set incorrectly. The manager was unable to provide documentation of the counseling sessions. When asked if the 3 RNs who had also provided care to the patient had been counseled, the manager stated that s/he did not know.

Finding 2:

On 3/12/2014, at 12:50 PM, a portion of the ICU was toured in the company of the RT assigned to work in the ICU that day. Patients #2 and #3 were identified as being the only patients in the ICU who were on ventilators and those rooms were entered.

The RT stated that the physician order in the computer for the ventilator settings for Patient #3 was not the same as the actual setting on the ventilator. S/he stated that s/he had taken a verbal order from the intensivist earlier in the day but had not yet entered the new order into the computer.

The intensivist on duty in the ICU, Physician #5, was interviewed in the company of the RT and the verbal order was discussed. The Physician #5 and the RT discussed the verbal order for the ventilator setting change, including what time the order had been given. Physician #5 was asked if there had been some emergent situation occurring at the time the verbal order was given which may have prevented her/him from entering the order in the computer directly. S/he stated that there was not.

On 3/17/2014, Physician #1 stated that it was her/his practice to use verbal orders. The physician stated that it was "hard not to use" verbal orders because often there were several things going on at the same time which made writing orders difficult.

Finding 3:

On March 12, 2014, the manager of QAPI stated that the hospital had not defined the qualifications for hospitalists who provided care to ICU patients when intensivists were not on duty. S/he stated that the hospital had not defined whether or if specific additional training for the hospitals was required. S/he stated that the hospital had not put in writing which physicians in-house were to provide backup to the hospitalists, and if so, what that backup would consist of. S/he stated that the intensivists were always available for calls, but the hospital had not defined in writing what the expectation was about availability, including response times to phone calls or requests for the intensivists to come to the hospital.

Based on interview, review of hospital's policies and procedures and document review, it was determined that the hospital failed to define and implement acceptable standards of respiratory care. The hospital's failure to do so resulted in potential risk to all patients in the Intensive Care Unit, who were on ventilators and also potentially placed all patients who were in need of respiratory care throughout the hospital, at risk for harm. The cumulative effect of these systemic problems resulted in the hospital's failure to protect the safety of Patient #1 and failure to implement corrective measures where necessary to assure the safety of all patients in the hospital who required respiratory services.

Failure to provide appropriate, per hospital position descriptions, leadership and supervision to the Respiratory Therapists, who provided hospital-wide services. (See Tag A 1153)

Failure to develop and implement adequate policies and procedures, in accordance with medical staff directives, to guide the practice of respiratory services. (See Tag A 1160)

Failure to define the qualifications of respiratory services staff and practitioners who worked in the Intensive Care Unit and throughout the hospital. (See Tag A 1161)

Failure to develop and implement position descriptions and an organizational structure that was consistent with State regulations and the hospital's own requirements. (See Tag A 1161)

Based on interview and review of hospital documents, it was determined that the hospital failed to organize respiratory care services appropriate to the scope and complexity of the respiratory therapy (RT) services offered.
The hospital's failure to do so resulted in missing and/or outdated policies and procedures; policies and procedures that did not have documented involvement of the medical staff; and a lack of defined standards for the qualifications and supervision of the RT staff.

The hospital's failure to do so resulted in a lack of RT supervision by qualified staff (as defined by Revised Code of Washington and by the hospital); and a lack of defined organization and defined qualifications and staffing of the RT staff.

The hospital's failure to organize the RT service and to provide written guidance to the RT service, with input and approval from the medical staff, placed all patients of the hospital at risk for incomplete, inaccurate and inconsistent care and service from the RT service, with a subsequent risk to patient health and safety.

Based on interview and review of hospital documents, it was determined that the hospital failed to appoint a service director who was a doctor of medicine or osteopathy, to supervise and administer the respiratory service. The hospital's failure to do so placed all patients who required respiratory services at risk for incomplete, incorrect and/or inconsistently administered respiratory services.
Findings include:

On March 6, 2014, the Director of ICU/PCU, Med/Surg [intensive care unit, post coronary unit, medical and surgical units] was interviewed. S/he stated that the person who supervised the respiratory therapists (RTs) was the nurse manager of the ICU/PCU. The Director stated that the nurse manager in turn reported to her/him, the Director.

The Director stated that the ICU/PCU nurse manager provided daily clinical supervision to the RTs. S/he also stated that the RT's "self-monitored." The Director stated that there was a "system-wide" [referring to multiple hospitals within the Swedish hospital system] resource person who was an RT. The plan was for this person to be at the Swedish-Edmonds campus to provide director supervision to the RTs for 1 shift per week, but that plan had not yet been implemented.

The Medical Director for Respiratory Therapy and Sleep Laboratory (also referred to as the Medical Director for Respiratory Therapy, Medical Director Pulmonologist, and Medical Director of Respiratory and Pulmonary Function) was interviewed by telephone on March 21, 2014. S/he stated that s/he had been the Medical Director for Respiratory Therapy at the hospital for more than 20 years but did not provide supervision or direction to the hospital RTs but at times the RTs did come to her/him with questions or concerns.
Review of the Respiratory Scope of Services statement dated January 2011, revealed a schematic which showed that the certified and registered respiratory therapists who provided hospital-wide services, reported to the manager of ICU/PCU (respiratory/cardiology/neurology). A dotted line, signifying communication, connected the manager to the Medical Director Pulmonologist.

Review of all policies and procedures for the Respiratory Therapy Service revealed no documentation of authorship or approval from the Medical Director or any other medical staff member.

The Nurse Manager for the ICU/PCU was interviewed on 3/11, 3/12 and 3/18/2014. S/he stated that a physician was the Medical Director of Respiratory and Pulmonary Function. S/he stated that s/he met with the physician once a month for approximately an hour to discuss issues related to respiratory therapy.

The Nurse Manager for ICU/PCU stated that the RTs provided respiratory services throughout the hospital and were not confined to the ICU/PCU where s/he was the manager. When asked to describe how it was determined which RT had which assignment and what calls took priority, the manager stated that s/he made a schedule for each shift and designated a lead RT for each shift. The manager stated that when s/he was out of the hospital, the RTs "decide in the moment for themselves" how to shift assignments and how to prioritize patient care issues . S/he stated that the RTs could call her/him at home and then if s/he had further questions, s/he could call the system-wide resource RT.

When asked to describe her/his qualifications to supervise the Respiratory Therapists, the Nurse Manager stated that s/he had a background in critical care nursing and had experience with ventilators. S/he stated that there was one person who was an RT resource for all Swedish Hospital campuses, did not work at the hospital on a regular or predictable basis and had no defined role at the Swedish Edmonds campus.

Review of the Nurse Manager's position description revealed the following:
"Title: Clinical Nurse Manager
Department: Critical Care, Respiratory Care, Pulmonary Function, EEG, EKG, Echocardiography and Vascular Studies...
Managerial/Supervisory Responsibilities: All department/unit staff.
Qualifications: Education/Training. RN with Bachelor's Degree in Nursing required. Masters Degree in Nursing required..."

The Nurse Manager confirmed that s/he was not an advanced practice nurse and stated that s/he had received "on the job training" relative to respiratory therapy.

Based on interview and review of hospital documents, it was determined that the hospital failed to develop and implement adequate policies and procedures, in accordance with medical staff directives, to guide the practice of respiratory services practitioners. The hospital's failure to do so placed all patients who received respiratory services at risk for incomplete and/or incorrect care and service with a subsequent risk to health and safety.

Findings include:
The Intensive Care Unit (ICU) Nurse Manager was requested to provide all policies and procedures pertaining to respiratory services. S/he provided a 3-ring binder which s/he stated contained all policies and procedures (P&P) pertaining to respiratory services. The notebook was labeled "Respiratory Therapy Policies and Procedures".
Review of the policy and procedure (P&P) manual revealed the following missing or outdated P&P's:

1. Procedures to follow in the advent of adverse reactions to treatments or interventions: No P&P was provided for the advent of adverse reactions to respiratory treatments or intervention.

2. Pulmonary function testing: No P&P was provided that described pulmonary function testing.

3. Therapeutic percussion and vibration: The P&P Chest Physiotherapy/Postural Drainage was in the manual, but had expired as of 10/16/2011.

4. Bronchopulmonary drainage: The P&P "Chest Physiotherapy/Postural Drainage was in the manual, but had expired as of 10/16/2011.

5. Mechanical ventilation and oxygenation support: The only P&P that addressed mechanical ventilation and oxygen support was "In-Hospital Transport of Mechanically Ventilated Patient". The policy stated that a RT was to accompany patients during transport, that all "transport ventilators can be used for transporting mechanically ventilated patients for procedures except MRI...". The policy noted which type of ventilator was to be used for MRI procedures and then listed supplies that were to include, but were not limited to "Laerdal no -rebreathing valve, HME [not defined], E-cylinder oxygen tank, monitor [type of monitor was not specified] and PPE [not defined] "if needed". When a PPE would be needed was not defined.

6. The process for actual mechanical ventilation and oxygenation of patients was not defined. The policy had expired as of 10/14/2011.

7. Aerosol, humidification, and therapeutic gas administration: The P&Ps which addressed aerosol, humidification and therapeutic gas administration were: "Continuous Nebulized Bronchodilator Therapy: (P&P expired 3/14/2014), "Heliox administration [heliox is a mixture of helium and oxygen] (P&P expired 11/5/2013),"Humidification during Mechanical Ventilation" (P&P expired 10/14/2013), and "Inhaled Bronchodilator Therapy: Small-Volume Nebulizer" (P&P expired 3/14/2014). No policy was provided for the administration of pure oxygen.

Based on interview and review of hospital documents, it was determined that the hospital failed to designate in writing the qualifications and amount of supervision required for personnel to carry out specific procedures. The hospital's failure to do so placed all hospital patients who required respiratory services at risk for incomplete, inaccurate or inconsistent respiratory care and services.
Findings include:

On March 6, 2014, the Chief Nurse Executive (CNO) was interviewed. S/he was asked if the hospital had defined the level of education and/or experience required for a respiratory therapist (RT) to work in specific areas of the hospital. Specifically discussed was the issue of certified respiratory therapists and registered respiratory therapists. The CNO stated that there was no specific requirement for RTs, other than current licensure.

On March 12, 2014, the ICU/PCU Nurse Manager, who supervised the respiratory therapists (RTs), was interviewed. S/he was asked to describe the respiratory service and stated the following:
-There were never less than 2 RTs on duty in the hospital.
-RTs all responded to any Rapid Response Team call [rapid response teams were called when the patient's clinical situation did not appear to warrant a code blue]. S/he stated that the RTs were also expected to respond to any code blue call in the hospital. [A code blue signified that a patient was in significant distress and may have a cardiopulmonary arrest].
-If the RTs left the Intensive Care Unit (ICU) they were to notify the ICU registered nurses. The RTs were available for call by pager and phone when they were not physically present in the ICU.

The ICU/PCU Nurse Manager stated that the initial assignments for RTs were made by the lead or charge RT for the next shift. When asked how it was determined that staffing changes might need to be made due to changes in census or patient needs, the manager stated that the "charge RT" made those decisions. The manager stated that s/he made the schedule for the RTs and designated who was to be the charge RT for each shift. When asked how prioritization or changes in responsibilities were made during a shift, such as in a case where 2 emergent situations occurred simultaneously, the manager stated that the RTs made those decisions "in the moment". S/he stated that the RTs could call her/him at home and s/he in turn could call the system-wide resource RT if s/he had questions.

The ICU/PCU Nurse Manager stated that none of the above processes had been defined in writing.

Position descriptions for "Respiratory Care Practitioner (Therapist) were reviewed. The position description stated that the RTs were to report to the Director, Respiratory Care. The "position Summary" stated: "Performs Respiratory Care procedures on patients of all ages (neonates, infants, pediatric, adult, geriatric) in all areas of the hospital".

"Qualifications: Education/Training: Prefer RRT. Must have education and training sufficient to qualify for licensure in Washington State...current Washington State Respiratory Care Practitioner License...BLS [basic life support] certification. ACLS [advanced certification life support] within 6 months of hire. NRP [neonatal resuscitation program] certification within 6 months of hire."

The Nurse Manager stated that the RTs covered all areas of the hospital including labor and delivery, newborn nursery and the Emergency Department. Review of the position description revealed that no specialized training was required for the RTs, who could be called on to work in any area of the hospital, and were required to respond to all calls for Rapid Response Teams and codes blue, as well.

The hospital's "Scope of Service" for Respiratory Services stated:
"I. Department Description
a.) Patient population served: "Respiratory Care provides inpatient and ER services to patients of all ages.

b.) Hours of operation (include accessibility after hours) 24 hours per day, 7 days a week...

II. Department Purpose (treatments/activities or services performed)
-Mechanical ventilation management (invasive and non-invasive), troubleshooting, and maintenance
-Artificial airway care...
-Therapeutic gases (oxygen and helium/oxygen)...
-Bronchopulmonary hygiene...
-Humidity and aerosol therapy...
-Transport of critically ventilated patients...
-Perform disgnostic [sic] testing...may assist with bedside bronchoscopies and cardioversion
-Respond to all emergency sitation [sic]: cardiopulmonary resuscitation, rapid response team..."

Physician #2, a hospitalist who was on duty the night of 12/24/2011, was asked to describe the supervision of the hospital's RTs. The physician stated that the RTs report to the ICU attending physicians on day shifts. S/he stated that during evenings and night shifts, the RTs reported to the hospitalists.

The Medical Director for Respiratory Therapy stated that s/he had seen the Scope of Services in the past, but was unaware of the schematic that described a communication-only status between the Medical Director and the Nurse Manager. S/he stated that the Nurse Manager, to whom the RTs reported, was too busy to spend much time with her/him, but the Medical Director had requested a monthly meeting which usually lasted about an hour.

The hospital had not defined in writing the acceptable staffing mix for RTs; for example, if all Certified Respiratory Therapists on a shift was acceptable or if a minimum number of RTs per shift were required to have a minimum level of experience. The hospital had not defined in writing how patient safety was to be assured if RT staff had not yet completed their ACLS and/or NRP certifications. The hospital had not defined in writing how many staff had to have specialized training in age-specific RT services. The hospital had not defined in writing how RT staff was to manage competing priorities or who the resource person was for the RT staff.

Four RTs were interviewed about supervision and resources available to them.

RT #1 stated s/he reported directly to the Nurse Manager of the ICU. The RT stated that s/he felt comfortable with her/his own skill set but sometimes asked other RTs for input. S/he stated that there was a RT at another hospital campus s/he could call with questions. S/he stated that s/he did not report to the physicians, but used them as a resource.

RT #2 stated that s/he reported directly to the Nurse Manager of the ICU. S/he stated that s/he also reported to the "charge therapist", which on 3/12/2014 was RT #1. RT #2 stated that if s/he had questions about equipment or orders s/he would seek out a more experienced RT to clarify. When asked if s/he had a RT resource, s/he replied "not really". S/he stated that s/he usually went to RT #1 because RT #1 had more experience with neonates. The RT stated that the nurse manager was not able to assist with respiratory issues, so would go to the ICU "docs".

RT #3 stated that s/he reported directly to the nurse manager of the ICU. When asked who s/he went to for clarification or for support on clinical issues specific to respiratory therapy, the RT stated that the RTs got support "from each other" and from the intensivists.

Based on interview, observation, review of medical records and review of hospital documents, it was determined that the hospital failed to track medical errors, analyze their causes and implement preventive actions and mechanisms to assure that clear expectations for safety were established and implemented. The hospital's failure to do so resulted in a medical error relating to Patient #1 that was not analyzed, and subsequent preventive actions were not implemented to establish safe practices related to all patients who received respiratory services throughout the hospital.

Finding 1:
Patient #1 was an 81-year old individual who had been brought to the hospital's Emergency Department by medics after 911 was called on 12/10/2011. The patient had a 2 to 3-day history of worsening dyspnea [difficulty breathing], which had increased just prior to the patient's admission. The patient also had known coronary artery disease, atrial fibrillation [irregular heartbeats], an abdominal aortic aneurysm [a bulging area in the large artery in the abdomen] and a chronic kidney condition. It was initially believed that the patient ' s symptomology was cardiac in nature and the patient was admitted to the cardiology service, but on 12/14/2011, the patient was transferred to the Intensive Care Unit [ICU] because of her/his increased dyspnea and hypoxemia (low oxygen levels in the blood).

In the ICU, the Patient #1 was intubated and placed on a ventilator. The patient continued to have difficulty breathing and required significant ventilator assistance. On 12/19/2011, the patient was diagnosed with respiratory failure and on 12/20/2011, a tracheostomy (a surgical opening into the neck for placement of a breathing tube) was performed.
On 12/20/2011, Physician #3, an intensivist (physician who cares for patients in ICU) assumed care of the patient. The physician documented that the patient required " fairly high levels of PEEP (positive end expiratory pressure ventilator assistance) to maintain adequate oxygenation ... " The physician documented " ...over the next several days, [the patient] had severe difficulty maintaining adequate oxygenation. With virtually any movement [s/he] would desaturate [oxygen blood levels would decrease] ...on the morning of 12/24/2011 [s/he] continued to be unstable " .
Physician #2, a hospitalist (a physician who cares for acutely ill hospitalized patients) assumed care of Patient #1 on 12/24/2011 until the morning of 12/25/2011. On 12/24/2011, Physician #2 gave a verbal order for a change in the ventilator setting and authenticated it [confirmed by written signature that the order was correct]. During the March 18, 2014 interview with Physician #2, Physician #2 confirmed s/he had issued the incorrect ventilator setting order on 12/24/2011 and had not realized the error at the time. The ventilator setting order for APRV (airway pressure release ventilation, a pressure control mode of mechanical ventilation) had the " high " and " low " settings for the ventilator transposed on the order.

Respiratory therapy (RT) and nursing staff assigned to Patient #1 on 12/24/2011 until the morning of 12/25/2011, had not questioned or identified the incorrect ventilator setting order.

On the morning of 12/25/2011, Physician #1 and Physician #3 came to the ICU and documented " ...felt that [the patient ' s] ventilator setting were inappropriate...made changes ...and this resulted in a bump up in [the patient ' s] oxygen saturation into the mid 90 ' s. Unfortunately, with these changes there was some increase in airway pressure, although in general gas exchange did improve " .

On March 17, 2014, Physician #1, an intensivist, who had been the attending physician for Patient #1 was interviewed. He/she identified the incorrect ventilator setting for Patient #1 the morning of 12/25/2011 and had reported the incident in writing to the Manager of Quality Management and Regulatory Compliance (QMRC). He/she also spoke with Physician #2, who ordered the ventilator settings.

Physician #4, the Medical Director of Respiratory Therapy, stated that s/he had not been formally informed of the event regarding the 12/24/2011 incorrect ventilator settings for Patient #1. S/he stated that s/he had not been asked to participate in any quality assurance/process improvement discussions regarding the event. The physician stated s/he had done her/his own investigation of the incident and found that a hospitalist had been covering [providing medical care to the patients] in the ICU that night.

During the March 6, 2014 interview with the QMRC manager, s/he stated that s/he had done the RCA (root cause analysis) for this event. The QMRC manager also stated that the RCA was incomplete and that a complete evaluation of the situation, and the events leading up to it, had not occurred. The QMRC manager stated that the hospital's internal investigation confirmed that the ventilator had been set incorrectly for 31 hours. The hospital's investigation included a " cause and effect " analysis which identified 3 contributing main causes for this event: People, policies and procedures, and methods. All three categories listed verbal orders as a contributing cause resulting in incorrect ventilator settings. The following actions were taken:

1. The RCA "action plan" stated that verbal orders would be addressed at the next staff meeting for RNs and RTs. The QMRC manager stated s/he did not know if that had been accomplished.

2. The ICU nurse manager provided documentation of an inservice, provided to the RT staff on January 4, 2012. The inservice was provided by the vendor of the ventilator used for Patient #1 and was attended by RT staff and the nurse manager. There was no documentation of any training for the RNs.

3. The QMRC manager stated that, after recognition of the incorrect ventilator setting, the hospital "immediately" conducted an inservice on ventilator settings, taught by Physician #1. The inservice was for the ICU RNs and RTs. Further interviews revealed that the inservice provided had included only the RTs and the ICU nurse manager.

4. On March 12, 2014, the QMRC manager, the Nurse Manager for ICU/PCU and the QAPI manager all stated that Physician #1 had subsequently gone to a meeting of the hospitalists and discussed ventilator settings, specifically the APRV. No documentation of that meeting was available.

5. The QMRC manager also stated that the case had been reviewed by the hospital's Peer Review process. The QMRC manager was unable to provide documentation of the inservice or the peer review.

6. On March 6, 2014, the nurse manager of the ICU/PCU stated that after the event, s/he had immediately counseled the 3 RTs who had provided care to the patient while the ventilator was set incorrectly. The manager was unable to provide documentation of the counseling sessions. When asked if the 3 RNs who had also provided care to the patient had been counseled, the manager stated that s/he did not know.

Finding 2:

On 3/12/2014, at 12:50 PM, a portion of the ICU was toured in the company of the RT assigned to work in the ICU that day. Patients #2 and #3 were identified as being the only patients in the ICU who were on ventilators and those rooms were entered.

The RT stated that the physician order in the computer for the ventilator settings for Patient #3 was not the same as the actual setting on the ventilator. S/he stated that s/he had taken a verbal order from the intensivist earlier in the day but had not yet entered the new order into the computer.

The intensivist on duty in the ICU, Physician #5, was interviewed in the company of the RT and the verbal order was discussed. The Physician #5 and the RT discussed the verbal order for the ventilator setting change, including what time the order had been given. Physician #5 was asked if there had been some emergent situation occurring at the time the verbal order was given which may have prevented her/him from entering the order in the computer directly. S/he stated that there was not.

On 3/17/2014, Physician #1 stated that it was her/his practice to use verbal orders. The physic