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Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §482.13, Patient Rights, was out of compliance.

A-0144 The patient has the right to receive care in a safe setting. The facility failed to ensure patients received care in a safe setting. Specifically, the facility failed to ensure two of four patients on telemetry (remote patient monitoring) for cardiac or respiratory concerns were monitored according to facility policies. Based on interviews and document review, the facility failed to ensure patients received care in a safe setting. Specifically, the facility failed to ensure two of four patients reviewed who were on telemetry (remote patient monitoring) for cardiac or respiratory concerns were monitored according to facility policy.

Based on interviews and document review, the facility failed to ensure patients received care in a safe setting. Specifically, the facility failed to ensure two of four patients reviewed who were on telemetry (remote patient monitoring) for cardiac or respiratory concerns were monitored according to facility policy. (Patient #1 and #5).

Findings include:

Facility policies:

According to the Assessment and Reassessment Nursing Documentation policy, focused reassessments by a registered nurse occur as necessary based on the patient's acuity level, care plan, or changes in the patient's condition. Reassessments may be based on the patient's diagnosis, desire for care, treatment, and services, response to previous care, treatment, and services, and discharge planning needs.

According to the Telemetry, End-Tidal Carbon Dioxide Monitoring, and Pulse Oximetry Monitoring policy, cardiac monitoring enables continuous observation of the heart's electrical activity in patients with conduction disturbances or in those at risk for life-threatening arrhythmias. Telemetry may also be used for continuous pulse oximetry monitoring. The Virtual Health Center Tech (VHC) tech documents the interpretation of rhythm at admission, and charts all incoming and outgoing pulse oximetry and cardiac in the electronic health record (EHR) including rhythm changes, saturation levels, and periods off the monitor. The VHC tech will document communication regarding who was contacted and any comments in the EHR. Communication of telemetry monitoring alarms and response to alarms will occur based on the classification of alarms. Non-emergent/crisis/yellow alarms include oxygen saturation under 85% and heart rate under 50. A yellow response requires prompt assessment of the patient. After assessing the patient, the RN will collaborate with the VHC tech to determine if the alarm is clinically significant.

References:

According to the registered nurse (RN) job description for the neurology and cardiac units, the RN provides direct patient care, at a proficient level, using the nursing process and the policies, values, and mission of the organization. Plans, implements, and evaluates patient care plans based on patient assessment to optimize outcomes. Monitors, records, and communicates patient condition. Collaborates as needed across disciplines to coordinate patient care.

According to the Virtual Health Technician job description, the telemetry technician (teletech) monitors patients on telemetry devices. The tech performs surveillance of multiple patients, recognizes abnormal findings, and reports and documents findings. The tech recognizes, intervenes, and documents abnormal findings during monitoring and also maintains charting documentation in the EHR.

According to the Telemetry Notification Algorithm, crisis alarms include a pause over three seconds, non-sustained ventricular tachycardia (VTach) (an accelerated heartbeat) over two seconds but under six seconds, a change in heart rhythm if new or worsening, ST changes (change in the electrocardiogram), the pacer not capturing data, heart rate (HR) over 140 or under 50, and oxygen saturation under 85%. The tele-tech calls the primary RN. If there is no answer, the teletech calls the charge nurse (CN). If no answer, the teletech calls the Red Phone. The teletech charts the event and calls in the patient's medical record.

1. The facility failed to ensure patients on telemetry for cardiac or respiratory concerns were monitored according to facility policy.

A. Document review

i. A review of Patient #1's medical record and an incident report revealed Patient #1 experienced an event on 3/3/24 at 2:23 p.m. while on telemetry in which their oxygen saturation decreased below normal limits but staff were unaware until a family member alerted an RN to a change in Patient #1's condition.

a. Patient #1's medical record revealed Patient #1 was admitted to the facility on 2/23/24 for weakness. Patient #1 had a history of chronic progressive cognitive decline, Parkinson's disease (brain disorder causing uncontrollable movements), and failure to thrive (state of decline caused by chronic concurrent diseases). On 3/3/24, Patient #1 was on cardiac and oxygen monitoring in the neurology unit. On 3/3/24 at 2:23 p.m., nursing notes from the rapid response team (RRT) revealed Patient #1's oxygen saturation had decreased, however, no initial value was documented, and the patient's blood pressure (BP) was 182/80 (normal was 120/80). The medical record revealed on 3/3/24 at 3:06 p.m., Patient #1 was transferred from the neurology unit to the progressive care unit (PCU) (step-down unit for patients who required frequent care and monitoring) to receive a higher level of care. On 3/4/24, the physician's note revealed Patient #1 had experienced increased oxygen needs on 3/3/24 and had required bilevel positive airway pressure (BiPAP) (machine to help with breathing).

On 3/3/24, the telemetry monitoring notes failed to reveal the teletech had observed a change in heart rate, rhythm, or oxygen saturation after an event earlier that day at 10:59 a.m. and additionally, did not contain documentation of RN communication after 10:59 a.m.

b. An incident report for Patient #1 revealed on 3/3/24, a rapid response team was called to the patient's bedside due to an increased need for oxygen and decreased oxygen saturation around 50% (normal was 95-100%). The incident report revealed the teletetch had not notified the RN of the patient's low oxygen status and it was Patient #1's family member who had alerted the nursing staff.

This lack of communication between telemetry and nursing staff during a change in a patient's health status was in contrast to the Telemetry, End-Tidal Carbon Dioxide Monitoring, and Pulse Oximetry Monitoring policy and the Telemetry Notification Algorithm which read, the telemetry technician charted all pulse oximetry readings in the EHR including oxygen saturation levels. A yellow alarm included an oxygen saturation measurement under 85% and required the telemetry technician to call the primary RN for a prompt assessment of the patient by the nursing staff.

ii. A review of Patient #5's medical record revealed Patient #5 experienced an event on 11/21/23 at 12:28 which was observed by telemetry and communicated to nursing staff but was not acted upon until family members became concerned.

a. Patient #5's medical record revealed Patient #5 was admitted to the facility on 11/17/23 for a Non-ST-Elevation Myocardial Infarction (NSTEMI) (a type of heart attack). Patient #5 had a history of kidney cancer, had only one kidney, and now had an acute kidney injury as well. On 11/21/23 at 12:35 a.m., a nursing note revealed Patient #5's family member alerted nursing staff that Patient #5 was not breathing and their lips were blue. The nursing note documented Patient #5's HR was in the 30s (normal was 60-100) and BP was not detectable. Patient #5 passed away shortly thereafter. On 11/21/23 at 12:35 a.m., a second nursing note revealed the family had expressed concern for the patient, and the patient was found with a heart rate in the 40s (in contrast to the HR documented in the first nursing note), and breathing slowly, which then progressed to asystole (lack of heart activity). The nursing note revealed the patient passed away on 11/21/23 at 12:46 a.m.

On 11/21/23 at 12:28 a.m., the telemetry monitoring notes revealed the teletech had observed Patient #5's heart rate was 36 and had notified the RN of the change. Ten minutes later, at 12:38 a.m., the teletech observed a heart rate of 33 and again, notified the RN.

The nurse's lack of response to a telemetry notification regarding an urgent change in health status was in contrast to the Telemetry, End-Tidal Carbon Dioxide Monitoring, and Pulse Oximetry Monitoring policy, the Telemetry Notification Algorithm, and the Assessment and Reassessment Nursing Documentation policy which read, cardiac monitoring enabled continuous observation of the heart's electrical activity. A yellow response included a heart rate reading under 50 and required prompt assessment of the patient by the nursing staff. Focused reassessments by an RN occurred as necessary based on changes in the patient's condition.

B. Interviews

i. On 3/28/24 at 12:13 p.m., an interview was conducted with telemetry technician (Tech) #1. Tech #1 stated they monitored patients on telemonitoring and followed the telemetry algorithm in response to changes in rate, rhythm, and oxygen saturation. They stated they called nursing staff when there was a change in patient status and remained on the phone until the RN was in the room with the patient. Tech #1 also stated they documented all events in the patients' medical records, including the RN notifications. This was in contrast to Patient #1's medical record which did not reveal documentation or communication with nursing staff regarding telemetry changes. Tech #1 stated this process of monitoring patients and communicating with nursing staff was important for patient safety and providing the best patient care.

ii. On 3/28/24 at 12:00 p.m., an interview was conducted with lead telemetry technician (Tech) #2. Tech #2 stated they gave nurses 10 minutes to address concerns observed and communicated by teletechs or the technicians would call back to re-address the concerns. They stated it was important for teletechs to follow the telemetry algorithm, collaborate with nursing staff, and document all patient events and communication with floor staff to ensure patient safety.

iii. On 3/28/24 at 9:06 a.m., an interview was conducted with RN #3. RN #3 stated patients were placed on telemonitoring when they had chest tubes (surgical drains to release fluid or air), changes in heart rhythm or rate, or chronic obstructive pulmonary disease (COPD). They stated nurses were required to respond to calls from telemetry technicians. RN #3 stated if they were free and received a telemetry call, RN #3 immediately went into the patient's room to assess for a change in condition and if they were engaged in other patient care duties, the charge nurse assisted. This statement was in contrast to Patient #5's medical record which did not reveal nursing staff had assessed Patient #5 after being notified of a change in condition.

RN #3 stated nurses were required to verify the patient's data and document their patient assessment after a telemetry notification. RN #3 stated it was important for patients to be monitored by telemetry and nursing staff to ensure the patients' safety. They stated in the past, a notification from telemetry about a change in a patient's health condition had allowed RN #3 to call a code (emergency response) to help deliver better patient care. RN #3 stated the risk of not responding quickly to telemetry notifications was a potentially poor patient outcome.

iv. On 3/28/24 at 8:12 a.m., an interview was conducted with RN #4. RN #4 stated telemetry technicians contacted nursing staff in response to changes in patients' heart rate, rhythm, or oxygen status after which the nurse would then assess the patient. This was in contrast to the medical records for both Patient #1 and #5 in which family members alerted staff to patient changes in condition. RN #4 stated performing a patient assessment in response to the telemetry staff's notification was important as there could otherwise be negative health outcomes for the patient.

v. On 3/28/24 at 11:26 a.m., an interview was conducted with chief nursing officer (CNO) #5. CNO #5 stated they oversaw the virtual health center and all of the telemonitoring. They stated telemetry techs followed the telemetry algorithm and all communication between the virtual health center and nursing staff was documented in the medical record. CNO #5 stated the role of telemetry in providing patient care was of the utmost importance.

CNO #5 stated the teletech responsible for monitoring Patient #1 should have called the nursing staff after observing the decrease in oxygen saturation. They stated for Patient #5, the teletech did notify the RN and CNO #5 had not observed a process gap on their end. CNO #5 stated there were many sick patients being monitored on telemetry and if there was a gap in monitoring or communication, this posed a risk to patient safety.

vi. On 3/28/24 at 9:57 a.m. an interview was conducted with chief medical officer (CMO) #7. CMO #7 stated the VHC had an escalation pattern for calling nursing staff for patient concerns, including dead batteries in the monitoring equipment. They stated issues like this may not have appeared to be an emergency but were, as ill patients were not monitored. CMO #7 stated teletechs called the RN following the telemetry algorithm, after which the RN had 10 minutes to fix the concern or a code would be called. CMO #7 stated telemetry was very important in patient care for patients who required extra monitoring.

Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §482.21 Quality Assessment and Performance Improvement Program was out of compliance.

A-0283 Quality Improvement Activities §§482.21(b)(2)(ii), 482.21(c)(1) & 482.21 (c)(3) §482.21(b)(2) Standard: Program Data The hospital must use the data collected to-- ... (ii) Identify opportunities for improvement and changes that will lead to improvement. §482.21(c) Standard: Program Activities (1) The hospital must set priorities for its performance improvement activities that-- (i) Focus on high-risk, high-volume, or problem-prone areas; (ii) Consider the incidence, prevalence, and severity of problems in those areas; and (iii) Affect health outcomes, patient safety, and quality of care. (3) The hospital must take actions aimed at performance improvement and, after implementing those actions, the hospital must measure its success, and track performance to ensure that improvements are sustained. Based on observations, interviews, and document review, the facility failed to ensure the quality assurance and performance improvement (QAPI) program reviewed and analyzed safety events and then implemented follow-up improvement activities. This failure affected nursing services and patient rights.

Based on observations, interviews, and document review, the facility failed to ensure the quality assurance and performance improvement (QAPI) program reviewed and analyzed safety events and then implemented follow-up improvement activities. This failure affected nursing services and patient rights. (Cross reference A-0144 and A-0405).

Findings include:

Facility policies:

According to the facility Improvement Plan policy, the goal is to provide a framework to support the continual improvement of patient care outcomes, patient safety, and performance excellence. This is done through a systematic approach to the design, monitoring, assessment, and improvement of management, clinical, and support processes. The facility has established the following performance improvement (PI) objectives, to promote a leader-driven system for performance improvement, to integrate and coordinate performance improvement activities throughout the facility, to identify and/or resolve process problems utilizing PI concepts and techniques, to facilitate communication, to ensure that the facility monitors and sustains performance improvement using indicators, to utilize external comparative databases to monitor performance and to assist in setting priorities for improving performance, to shift the primary focus from the performance of individuals to the performance of the processes and systems, while continuing to recognize the importance of the individual competence of staff members, to maintain current written guidelines or standards of professional practice and related policies and procedures that demonstrate compliance with both internally and externally established standards and regulations, to measure and maintain competency by monitoring the staff through the use of performance-based standards, to proactively identify and reduce the risk of patient harm, and enhancing a culture of safety.

The Quality Improvement Council (QIC) includes senior management and medical staff leadership and coordinates and oversees clinical Pl efforts including, but not limited to: Assuring clinical quality and applying Pl principles to poorly performing metrics, reviewing aggregate data to detect trends, patterns, and opportunities for improvement that may relate to systems or processes, including but not limited to patient safety, clinical quality, infection control, nursing quality, risk management occurrence report summaries, and annually assisting leadership in setting organizational priorities for improvement activities related to clinical care.

According to the Patient Rights and Responsibilities policy, patients have the right to receive care from competent personnel that is respectful and safe and to be free from abuse, neglect, and harassment.

According to the Telemetry, End-Tidal Carbon Dioxide Monitoring, and Pulse Oximetry Monitoring policy, cardiac monitoring enables continuous observation of the heart's electrical activity in patients with conduction disturbances or in those at risk for life-threatening arrhythmias. Telemetry may also be used for continuous pulse oximetry monitoring. The Virtual Health Center Tech (VHC) tech documents the interpretation of rhythm at admission, and charts all incoming and outgoing pulse oximetry and cardiac in the electronic health record (EHR) including rhythm changes, saturation levels, and periods off the monitor. The VHC tech will document communication regarding who was contacted and any comments in the EHR. Communication of telemetry monitoring alarms and response to alarms will occur based on the classification of alarms. Non-emergent/crisis/yellow alarms include oxygen saturation under 85% and heart rate under 50. A yellow response requires prompt assessment of the patient by nursing staff.

References:

According to the Safety Event Classification (SEC) and Serious Safety Event Rate (SSER) Patient Safety Measurement System for Healthcare, the SEC provides common definitions and an algorithm for the classification of safety events. The classification is based on the degree of harm that results from a deviation from expected performance or standard of care. The SEC serves as the foundation for the calculation of the SSER, a measure of events resulting in moderate to severe harm, including death. Together, the SEC and SSER provide a consistent methodology for measuring patient harm and improvement in reducing patient harm.

Identifying deviations consists of comparing expected performance with actual performance. Wherever a difference exists between expected and actual performance, a deviation exists. Consideration of performance standards should include external as well as internal sources of information such as established policies, procedures, and protocols; nationally recognized best practices and standards of care; industry-imposed practice mandates and requirements; implied professional practice standards; and objective clinical review by other experts. Standards rise over time and what is considered a performance standard today may be a deficiency in care. A direct cause-and-effect relationship between the deviation and the outcome to the patient is the another consideration in the SEC. While deviations from performance standards may coincide with a serious outcome, a direct cause-and-effect relationship between deviations and outcome may be difficult to determine. This may be the case when a patient is in critical condition or has other complications or co-morbidities. In such a case, the organization may be reluctant to declare a safety event or tend to downgrade the safety event classification. The ultimate goal of safety event classification and cause analysis is the identification and correction of root causes to prevent future events of harm. The organization can safeguard against safety event under-classification by considering its obligation to do everything possible to provide an uncompromised, safe experience - did the organization best protect the patient from harm, regardless of the ability to prove a direct cause-and-effect relationship. Once a deviation from generally accepted performance standards is identified, the third level of assessment assesses the level of harm experienced by the patient and determines the safety event classification. A Serious Safety Event results in harm that ranges from moderate to severe patient harm or death. A Precursor Safety Event results in minimal harm, no detectable harm, or no harm. In a Near Miss Safety Event, the initiating error is caught before it reaches the patient by either a detection barrier built into the process or by chance.

According to the Management of Event Reports workflow, staff run the risk report daily. The Clinical Quality and Safety Specialist (CQSS) team ensures that all event reports are reviewed on the first business day after they are reported. CQSS shall review unresolved event reports, with the expectations as follows: initial response is three business days from the reported date and follow-up response is five business days for the first investigation. Each follow-up question is three business days for responses. When event reports have not met the timeliness standard, CQSS shall send out a reminder e-mail to leadership. When repeat reminders are needed, the reminder shall be sent to the unit manager and senior director of clinical quality and risk management. Through review of the event report and patient record, CQSS shall determine and document the severity level of each event. CQSS shall task the event report to all appropriate leaders for follow-up. CQSS shall conduct an investigation with the involved units/departments. Event reports will remain open until an investigation is complete and all necessary information has been added. CQSS and unit leadership shall document follow-up in the event report. When all investigation is complete and all questions and follow-up have been addressed, CQSS will assign a final harm score and mark the event as resolved.

Precursor Safety Event include the following: PSE4 is no harm: an adverse event that reaches the patient yet results in no harm, with sufficient information to determine that no harm occurred. PSE3 is no detectable harm: an adverse event that reaches the patient yet without ability to determine the existence or fact of harm, yet harm may exist. This includes events where the onset of harm may occur later. PSE2 is minimal temporary harm: an adverse event resulting in minor harm lasting for a limited time only which requires little or no intervention. PSE1 is minimal permanent harm: an adverse event resulting in minor harm with no expected change in clinical status which requires little or no intervention.

Serious Safety Event include the following: SSE5 is moderate temporary harm: an adverse event resulting in significant harm lasting for a limited time. It requires a higher level of care/monitoring or an additional minor procedure or treatment to resolve the condition. SSE4 is severe temporary harm: an adverse event resulting in critical, potentially life-changing harm yet lasting for a limited time with no permanent residual. It requires prolonged transfer to a higher level of care or monitoring, transfer to a higher level of care for a life-threatening condition, or an additional major surgery, procedure, or treatment to resolve the condition. SSE3 is moderate permanent harm: an adverse event resulting in significant harm with no expected change in clinical condition, yet not sufficiently severe to impact activities of daily living or business function. This includes events that result in a permanent reduction in physiologic reserve, disfiguration, and impairment or aided sense or function. SSE2 is severe permanent harm: an adverse event resulting in critical, life-changing harm with no expected change in clinical status. This includes events resulting in permanent loss of organ, limb, or vital physiologic or neurologic function. SSE1 is an adverse event resulting in death.

According to the Telemetry Notification Algorithm, crisis alarms include a pause over three seconds, non-sustained ventricular tachycardia (VTach) (an accelerated heartbeat) over two seconds but under six seconds, a change in heart rhythm if new or worsening, ST changes (change in the electrocardiogram), the pacer not capturing data, heart rate (HR) over 140 or under 50, and oxygen saturation under 85%. The tele-tech calls the primary RN. If there is no answer, the telemetry technician (teletech) calls the charge nurse. If no answer, the teletech calls the Red Phone. The teletech charts the event and calls in the patient's medical record.

1. The facility failed to ensure the QAPI program identified performance improvement opportunities impacting patient safety and nursing services according to facility policy.

A. Telemetry medical record and event reports review

i. A review of medical records for Patient #1 and Patient #5 revealed telemetry and nursing staff failed to monitor patients while on continuous monitoring for changes in condition.

a. Patient #1's medical record revealed Patient #1 was admitted to the facility on 2/23/24 for weakness. During their stay, Patient #1 experienced a decrease in oxygen saturation which was not documented in the medical record and the patient's blood pressure (BP) was 182/80 (normal was 120/80). Telemetry notes did not reveal the teletech had observed these changes or notified the RN. After the event, Patient #1 was transferred to the progressive care unit (PCU) (step-down unit for patients who required frequent care and monitoring) to receive a higher level of care and bilevel positive airway pressure (BiPAP) (machine to help with breathing).

An event report for Patient #1 revealed on 3/3/24, a rapid response team was called to the patient's bedside due to an increased need for oxygen and decreased oxygen saturation around 50% (normal was 95-100%). The incident report revealed the teletetch had not notified the RN of the patient's low oxygen status and it was Patient #1's family member who had alerted the nursing staff. The follow-up to the event did not reveal a harm score although during an interview with regulatory standards manager (Manager) #13 on 4/1/24 at 10:39 a.m. revealed it had been scored PSE3, indicating no detectable harm.

This lack of communication between telemetry and nursing staff during a change in a patient's health status was in contrast to the Improvement Plan which read, the facility supported improving patient care outcomes and patient safety through monitoring, assessment, and improvement of clinical processes. The facility proactively identified and reduced the risk of patient harm, monitored performance improvement using indicators, and shifted the primary focus from the performance of individuals to the performance of the processes and systems, while recognizing the importance of individual competence, enhancing a culture of safety.

b. Patient #5's medical record revealed Patient #5 was admitted to the facility on 11/17/23 for a Non-ST-Elevation Myocardial Infarction (NSTEMI) (a type of heart attack). During their stay, the medical record revealed the patient's family alerted the RN that Patient #5 had their HR drop into the 30s (normal was 60-100), was breathing slowly, and had an undetectable blood pressure (BP). Patient #5 passed away shortly thereafter. The telemetry monitoring notes revealed the RN was notified of the change in condition by the teletech although the nursing notes did not reflect an assessment.

The event report for Patient #5 revealed no evidence the RN was in the room after the teletech notification. This event was scored PSE3, which indicated no detectable harm to the patient.

The nurse's lack of response to a telemetry notification regarding an urgent change in health status was in contrast to the Improvement Plan which read, the facility supported improving patient care outcomes and patient safety through monitoring, assessment, and improvement of clinical processes. The facility proactively identified and reduced the risk of patient harm and shifted the primary focus from the performance of individuals to the performance of the processes and systems.

ii. A review of event reports revealed additional examples of telemetry and nursing staff failing to monitor patients while on continuous monitoring for changes in condition between 8/7/23 to 1/5/24, which were all scored by CQSS staff as PSE3 (no detectable harm) or PSE4 (no harm to the patient), including:

a. An event report from 1/5/24 revealed a patient on telemetry to assess heart and oxygen status experienced a decrease in oxygen saturation to 74% then 67% within a short period. The patient also experienced ventricular tachycardia (VTach) (irregular heartbeat) and was then transferred to a higher level of care requiring BiPAP. The event stated the RN was not notified of these changes and a physician in the room with the patient happened to notice the abnormal oxygen saturation. Follow-up to the event revealed the RN was notified by telemetry multiple times. The event was given a rating of PSE4.

b. An event report from 9/23/23 revealed a teletech notified a patient's certified nursing assistant (CNA) of the patient in VTach although their documentation did not state the role of the staff member notified of this change in heart rhythm. The event follow-up revealed the CNA did not notify the RN after speaking with the teletech as the CNA lacked the clinical ability to understand the importance of the health change. This event was given a rating of PSE4.

c. An event report from 11/1/23 revealed a patient experienced atrial fibrillation (AFib) (irregular heartbeat) with a HR in the 140s without any notification to the RN. The follow-up revealed the teletech was coached on reviewing the rhythm from the previous shift and no other opportunities for staff were identified. This event was given a rating of PSE3.

d. On 8/7/23, an incident report revealed a patient had experienced an increased need for oxygen and was weaned down to less oxygen after treatment. After this occurred, a nurse saw from the electronic health record (EHR) the patient had had an oxygen saturation under 88% (normal was 95-100%) for approximately 40 minutes. During this time, the teletech charted an abnormal heart rate and rhythm but the bedside RN stated they had not been made aware. The follow-up to the event revealed the tech had appropriately notified the RN of low oxygen saturation (under 85%) towards the end of this event, but the event did not reveal any follow-up to the lack of communication regarding the abnormal heart rate and rhythm. This event was given a rating of PSE3.

This review of telemetry event reports which were all addressed individually with staff members and given ratings of PSE3 or PSE4 was in contrast to the SEC and SSER Patient Safety Measurement System for Healthcare which read, the ultimate goal of safety event classification was the identification and correction of root causes to prevent future events of harm. In cases where deviations coincided with serious outcomes and the direct cause-and-effect relationship was difficult to determine, the facility safeguarded against safety event under-classification by considering its obligation to do everything possible to provide an uncompromised, safe experience, asking if the organization best protected the patient from harm, regardless of the ability to definitively prove a direct cause-and-effect relationship.

This review of telemetry event reports was also in contrast to the Improvement Plan which read, the facility supported improving patient care outcomes and patient safety through monitoring, assessment, and improvement of clinical processes. The facility proactively identified and reduced the risk of patient harm and shifted the primary focus from the performance of individuals to the performance of the processes and systems.

B. Observations and document review of hand hygiene

i. Observations on 3/27/24 between 8:01 a.m. and 12:09 p.m. on the fourth floor revealed multiple missed opportunities for hand hygiene. These included:

a. A nurse dropped discarded supplies onto the floor, picked them up with gloved hands, used those same gloves to touch a patient's skin and administer injectable medication, and then typed on the computer with the same gloves.

b. A nurse typed on the computer with gloved hands, administered injectable medications, then typed again on the computer, all without changing gloves or performing hand hygiene.

c. A nurse dropped a medication syringe on the floor, picked it up, and walked with it out of the medication room. The observation did not reveal the nurse had redrawn the medication or discarded the now contaminated syringe.

These observations were in contrast to the Improvement Plan which read, the facility supported improving patient care outcomes and patient safety through monitoring, assessment, and improvement of clinical processes. The facility monitored performance improvement using indicators and performance improvement projects were monitored and sustained.

ii. A review of the document Hand Hygiene Compliance produced by Quality revealed the facility was auditing hand hygiene. The trend report revealed a target of 93% compliance with a 98% observed compliance rate. The Hand Hygiene Compliance report was in contrast to observations which revealed multiple opportunities for hand hygiene compliance.

C. Interviews

i. On 3/28/24 at 11:26 a.m. an interview was conducted with CNO #5. CNO #5 stated if opportunities for improvement were found as a result of event reports, they assessed whether the failure was due to a compliance gap or an education gap. CNO #5 stated VHC staff would be coached after missed opportunities and this education provided was tailored to the staff member's individual needs. CNO #5 stated they had not observed a trend in the event reports relating to telemetry and added, if trends were observed, they would implement education across the entire VHC team. CNO #5 stated the continuous patient monitoring provided by the VHC was of utmost importance for ensuring safe patient care.

This interview was in contrast to Patient #1 and Patient #5's medical records as well as the event reports about telemetry and changes in patient condition.

ii. On 03/27/24 at 4:07 p.m. and 3/28/24 at 2:46 p.m., interviews were conducted with CNO #6. CNO #6 stated they were part of the quality improvement team, including the quality improvement committee (QIC) and service line quality committee (SLQC). They stated quality tracked metrics to improve lives and patient safety. CNO #6 stated quality looked for fallouts and trends. They stated events were tracked and trended based on the assessment of potential harm from those events. CNO #6 stated observing trends helped prevent or reduce the risk those same incidents would happen again in the future. CNO #6 stated trends observed through the event reporting and follow-up process required systemic changes, necessitating more than individualized education to staff members. However, CNO #6 stated event follow-up followed a just culture model in which employees were coached by their managers and disciplinary action would be taken if needed.

CNO #6 stated quality looked at established metrics to evaluate the success of performance improvement (PI) projects. They stated choosing metrics associated with PI projects helped the quality team stay true to their ethical compass and provide safe patient care. CNO #6 stated quality was auditing hand hygiene across the facility and tracked these metrics. They stated if projects were not achieving results, for example, if improvements were not seen, the quality team needed to go back and identify the failure. This was in contrast to observations of hand hygiene, in which multiple opportunities were seen for improvement, and which had not been identified by the facility. CNO #6 stated there was a risk to patients if quality did not evaluate areas of opportunity to provide better patient care and improve patient outcomes.

iii. On 3/28/24 at 9:57 a.m. an interview was conducted with chief medical officer (CMO) #7. CMO #7 stated they reviewed event reports frequently. They stated they had not seen an issue with telemetry and remote patient monitoring which was in contrast to the medical records for Patient #1 and 5 and the event reports around telemetry. CMO #7 stated the VHC had an escalation pattern for calling nursing staff related to patient concerns, including dead batteries in the monitoring equipment, which may not have appeared to be an emergency but were, as ill patients were not monitored in that time. CMO #7 stated telemetry was very important in patient care for patients who required extra monitoring.

CMO #7 stated the facility had a strong history of process improvement. They stated they were currently engaged in a patient deterioration project aimed at catching patients deteriorating while inside the facility using information from the EHR and involving frequent vital signs, although this project was not based on concerns with telemetry and communication with the nursing staff. CMO #7 stated the motivation behind this project was improved patient care and patient-centered care. CMO #7 stated the facility wanted to provide the best care, not just what was acceptable care.

CMO #7 stated systemic causes were responsible for most safety events and generally could not be attributed to one staff member's failures. They stated they wanted to support nursing staff and physicians at the facility by improving systemic processes.

iv. On 3/28/24 at 2:46 p.m. and 4/1/24 at 8:58 a.m., an interview was conducted with regulatory standards manager (Manager) #13. Manager #13 stated quality's role was to identify patient safety concerns and trends and address these quickly to decrease any risk to the patient. They stated the quality team ensured the facility delivered the best and safest care, in part through data collection and response to events. This was in contrast to medical records for Patient #1 and #5 and event reports which did not reveal telemetry was identified as a concern by quality and thereafter, tracked and trended.

Manager #13 stated the CQSS staff scored event reports, investigated event reports, and assessed the adequacy of the information provided by involved staff before closing out the event report. Manager #13 stated the CQSS staff was responsible for assessing harm to patients in event reporting, with more patient harm leading to a higher severity score. They stated the CQSS staff looked for high-risk, low-volume event reports as well as those that also required further analysis. Manager #13 stated the harm score gave more information about how the event was to be reviewed. They stated if personnel were identified as the issue behind the event report, the unit manager was responsible for providing education and feedback to that staff member. This was in contrast to the Improvement Plan which read, the facility proactively identified and reduced the risk of patient harm and shifted the primary focus from the performance of individuals to the performance of the processes and systems.

v. On 4/1/24 at 9:40 a.m. an interview was conducted with senior director of quality and safety (Director) #12. Director #12 stated they oversaw Manager #13 and CQSS staff in their role. Director #12 stated quality and event reporting was necessary to keep patients safe and identify processes that improved patient care. They stated telemetry events were tracked and trended by clinical leadership as well as others. Director #12 stated safety events and trends were reviewed daily. They stated if trends were seen, the quality team reviewed individual event reports. Director #12 stated in the past, the facility tracked and trended communication between the VHC and nursing staff when the VHC first came on board however, the facility culture improved and nurses recognized the importance of virtual monitoring in their ability to focus on patient care.

Director #12 stated the CQSS role required the clinical skill of event prioritization, identifying themes and opportunities for improvement, and bringing events forward for further review. They stated the CQSS role was task-oriented and as such, the staff was trained to investigate and close out events. Director #12 stated one of the CQSS staff had previously been mentored and they recognized upon review of the event reports requested during the recent survey, more education was needed for the CQSS staff and they had observed an opportunity for the CQSS role to be less task-oriented to improve the event reporting process. Direcor #12 stated more management and investment in the CQSS staff was necessary to improve CQSS staff's efficacy and aptitude when following up on event reports. They stated the goal of quality and event reporting was zero harm to the patients.

Based on interviews and document review, the facility failed to provide nursing care in accordance with facility policies in one of five medical records reviewed. (Patient #2)

Findings include:

References:

According to the Lippincott Procedures Tub baths and showers guidance, provided by the facility, showers provide personal hygiene, stimulate circulation, and reduce tension for a patient. Showers also allow close observation of the condition of a patient, including the assessment of joint mobility and muscle strength.

According to the Lippincott Procedures Bed baths guidance, provided by the facility, performing a bed bath not only cleans a patient's skin, but also stimulates circulation, provides mild exercise, and promotes comfort. Bed baths also enable assessment of the condition of the patient's skin as well as muscle strength. Daily bathing can help prevent hospital-acquired infections.


1. The facility failed to ensure patients were offered the opportunity to bathe during hospital admission.

A. Record review

i. A review of Patient #2's medical record revealed on 1/28/24 the patient was admitted from the emergency department to the surgical care unit for diagnoses of small bowel obstruction (a partial or complete blockage of the small or large intestine) and malignant neoplasm (a cancerous tumor made up of cells that grow, multiply, and spread to other parts of the body) of the right colon.

A review of physical therapy and occupational therapy notes on 1/30/24 revealed Patient #2 had decreased independence in functional mobility. Patient #2 required total help with toileting and a lot of help with bathing.

A review of the CNA Vitals and I/O flowsheet revealed Patient #2 declined bathing on 2/4/24. There was no evidence Patient #2 was offered a shower or bathing option from 1/28/24 until 2/4/24 (six days).

B. Interviews

i. An interview was conducted on 3/26/24 at 11:17 a.m. with registered nurse (RN) #8. RN #8 stated patients should have been offered a bath every other day while admitted. RN #8 stated bathing was important because bacteria could cause problems. RN #8 stated bathing was a part of caring for the whole patient with respect. RN #8 stated bathing could prevent disease processes.

This interview was in contrast to the record review which revealed Patient #2 was not offered a bath for a period of six days.

ii. An interview was conducted on 3/28/24 at 8:12 a.m. with RN #4. RN #4 stated all patients should have been offered an opportunity to bathe every other day. RN #4 stated bathing patients was important to help patients feel better and to improve mobility. RN #4 stated the risk of not bathing patients or offering the opportunity to bathe would be skin issues or a yeast infection.

iii. An interview was conducted on 3/27/24 at 1:12 p.m. with the nurse manager on the surgical unit (Manager) #9. Manager #9 stated the expectation was for patients to be offered a shower, bath, or CHG wipes( disposable cloths that contain chlorhexadine gluconate (CHG) to kill germs on the skin) every other day. Manager #9 stated if a patient would have declined an opportunity to bathe, the expectation was for staff to have documented the offer and refusal by the patient.

iv. An interview was conducted on 3/28/24 at 1:15 p.m. with CNO #6. CNO #6 stated the expectation for the facility staff was to offer patients an opportunity to bathe every other day.

Based on interviews and document review, the facility failed to ensure medications were prepared and administered in accordance with facility policies and national guidelines. Specifically, the facility failed to ensure staff preparing and administering medications performed hand hygiene according to facility policy in four out of five observations of medication preparation and administration.

Findings include:

Facility policy:

According to the Hand Hygiene policy, hand hygiene is the single most effective way of preventing the transmission of infection. Staff should perform hand hygiene in the following situations: before entry into an occupied patient room and/or before touching a patient or a patient's surroundings; before performing a clean/aseptic procedure (e.g., before inserting or accessing invasive devices); after touching a patient or patient's surroundings and/or upon exit from an occupied patient room; after contact with fluids, excretions, mucous membranes, non-intact skin or wound dressings; after doffing gloves and PPE (personal protective equipment), and after using the restroom.

Reference:

According to the Centers for Disease Control and Prevention (CDC) Hand Hygiene in Healthcare Settings guidance, retrieved at https://www.cdc.gov/handhygiene/providers/index.html and last reviewed on 1/8/21, hand hygiene reduces the spread of potentially dangerous germs to patients. Multiple opportunities for hand hygiene occur during a single care episode. Clinical indications for hand hygiene include: immediately before touching a patient; when hands are visibly soiled; before performing an aseptic task or handling invasive medical devices; before moving from work on a soiled body site to a clean body site on the same patient; after touching the patient or the patient's immediate environment; after contact with blood, body fluids, or contaminated surfaces; and immediately after glove removal.

1. The facility failed to ensure hand hygiene was performed according to facility policies and national guidelines.

A. Observations

i. Observations conducted on 3/27/24 at 12:11 p.m. revealed a registered nurse (RN) drew up a syringe of medication from a vial. The RN then dropped the medication-filled syringe onto the floor. The RN picked up the syringe off the floor and exited the medication room. The RN did not waste the medication dropped on the floor. Additionally, the RN did not wash their hands after they touched the floor.

ii. Observations conducted on 3/27/24 at 8:11 a.m. revealed RN #10 washed their hands upon entering the patient room. RN #10 then applied gloves and used computer equipment to scan the patient's wristband. After administering an IV medication, RN #10 used gloved hands to pick up items off the floor of the patient's room and discard them into the trash. Without changing gloves, or performing hand hygiene, RN #10 used the same gloves that had touched the floor to administer a subcutaneous (administered under the skin) injection to the patient.

iii. Observations conducted on 3/27/24 at 12:09 p.m. revealed RN #11 entered the medication room and approached the Pyxis without performing hand hygiene. RN #11 removed a multi-dose insulin vial from the Pyxis and drew up a syringe of insulin from the vial without performing hand hygiene.

iv. Observations conducted on 3/27/24 at 12:14 revealed RN #11 washed their hands when entering the patient's room. RN #11 applied gloves, and then typed on the computer with gloved hands. Using the same gloves, RN #11 approached the patient, placed a gloved hand on the patient's abdomen, and administered two subcutaneous medications. RN #11 then approached the computer wearing the same gloves that had been in contact with the patient's skin, and RN #11 typed on the computer without removing the gloves or performing hand hygiene.

B. Interviews

i. An interview was conducted on 3/28/24 at 8:12 a.m. with RN #4. RN #4 stated if a medication, or medication syringe, fell to the ground, the item should have been wasted, and a new medication should be obtained for the patient. RN #4 stated when administering medications, nurses should have performed hand hygiene prior to entering a patient's room. RN#4 stated nurses should have scanned the medications, and then performed hand hygiene after touching the surface of the computer and scanning device. RN #4 stated after performing hand hygiene in the patient room, nurses should have applied gloves before administering medications to the patient. RN #4 stated the nurses should have removed gloves after administering medications and performed hand hygiene again. RN #4 stated hand hygiene was important to stop the spread of germs and would keep patients safe. RN #4 stated the risk of not performing hand hygiene would be transferring germs and disease.

ii. An interview was conducted on 3/28/24 at 9:06 a.m. with RN #3. RN #3 stated hand hygiene protects both patients and nurses. RN #3 stated hand hygiene should have been performed every time coming into or out of a patient's room, and upon entering the medication room. RN #3 stated performing hand hygiene upon entering the medication room would make medication administration safer, and it was important to wash hands before drawing up medication because there was a risk of infection with intravenous medication (administered into a vein) administration and intramuscular (administered into a muscle) medication administration. Additionally, RN #3 stated when administering medication to a patient, nurses should have washed their hands before entering the patient's room. RN #3 stated nurses should have used the computer to scan medication, then should have applied gloves before administering medication to patients.

RN #3 stated the risk of not performing hand hygiene correctly would be the deterioration of sick patients, including risk of bacteria exposure leading to sepsis (a serious medical condition resulting from the presence of microorganisms in blood or tissue, potentially leading to organ malfunction, shock, and death).