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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 §482.12 Governing Body was out of compliance.

A-0083 The governing body must be responsible for services furnished in the hospital whether or not they are furnished under contracts. The governing body must ensure that a contractor of services (including one for shared services and joint ventures) furnishes services that permit the hospital to comply with all applicable conditions of participation and standards for the contracted services. Based on observations, document reviews, and interviews, the governing board failed to provide oversight for services furnished in the facility. Specifically, the governing board failed to ensure the facility maintained an adequate number of telemetry boxes (battery-operated devices used to track the heart's electrical activity) to monitor all patients with a telemetry order. (Cross-reference A-0144, A-0273)

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's Rights was out of compliance.

A0114 - The patient has the right to receive care in a safe setting. Based on observations, document reviews, and interviews the facility failed to ensure patients received care in a safe setting. Specifically, the facility failed to ensure an adequate number of telemetry boxes (battery-operated devices used to monitor the heart's electrical activity) were available to monitor patients according to providers' (physician or physician's assistant) orders, facility policy, and national guidelines in one of one medical record reviewed for patients with telemetry orders (Patient #1). (Cross-reference A-0273, A-0083)

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-0273 - The hospital must measure, analyze, and track quality indicators ...and other aspects of performance that assess processes of care, hospital service and operations. Based on observations, document reviews, and interviews, the facility's quality assessment and performance improvement (QAPI) program failed to measure, analyze, and track quality indicators to assess processes of care and hospital services. Specifically, the facility failed to measure, analyze, and track incidents where staff was unable to complete providers' (physicians and physician assistants) orders for telemetry monitoring (a system to monitor the electrical activity of the heart) due to an inadequate number of available telemetry boxes (battery-operated devices used to monitor the heart's electrical activity). (Cross-reference A-0144, A-0083)

Based on observations, document reviews, and interviews, the governing board failed to provide oversight for services furnished in the facility. Specifically, the governing board failed to ensure the facility maintained an adequate number of telemetry boxes (battery-operated devices used to track the heart's electrical activity) to monitor all patients with a telemetry order. (Cross-reference A-0144, A-0273)

Findings include:

Facility policies:

The Telemetry Monitoring (a system to monitor the electrical activity of the heart) policy read, purpose: To apply best practice standards to telemetry monitoring to ensure prompt detection of changes in heart rate or rhythm. Telemetry monitoring personnel is responsible for reporting to the physician or designee incidents of life-threatening cardiac arrhythmias (irregular heartbeats) and initiating appropriate actions for significant changes in cardiac rate or rhythm and new or unexpected changes in the cardiac rate, rhythm, or clinical status.

The Incident Reports policy read, an incident report will be completed on any incident deemed to be inconsistent with the desired operation of the facility or the care of patients. An incident report must be completed when any event occurs that is not a natural consequence of a patient's disease or procedure.

Reference:

The Governing Board Bylaws read, the governing board is legally responsible for the operations of the facility and has such duties conferred to it herein and as further required by the laws and accreditation standards. The governing board shall oversee the physical resources and personnel required to meet the needs of the patients.

The governing board shall require implementation of a hospital-wide quality assessment and performance improvement (QAPI) plan that reports on the activities and mechanisms for monitoring and evaluating the quality and safety of patient care. The QAPI plan shall identify opportunities to improve patient care and shall identify and resolve problems including but not limited to monitoring and auditing of departments and service lines. The governing board shall support these activities.

1. The governing board failed to provide oversight of resources to fulfill providers' (physician or physician's assistants) orders for telemetry monitoring.

A. Observations, interviews, and document review revealed the facility owned an inadequate number of telemetry boxes for nurses and telemetry technicians (staff trained in abnormal heart rhythms) to monitor patients' heart rhythms per providers' orders and facility policy.

i. On 8/22/23 at 8:16 a.m., observations were conducted at the facility's telemetry monitoring station (a workstation continuously monitored by staff trained in cardiac rhythms). Observations revealed 53 hospital beds that could admit patients with orders requiring a telemetry box. The telemetry technicians (staff with advanced training in cardiac rhythms) stored one telemetry box at the monitoring station. Observations of the cardiac rhythm monitor revealed telemetry technician (Tech) #1 monitored one patient using an additional telemetry box, for a total of two functional telemetry boxes in the facility.

Further observations conducted throughout the facility did not reveal additional, functional telemetry boxes.

ii. A review of Patient #1's medical record revealed he was admitted to the facility on 8/2/23 for acute respiratory failure with hypoxia (difficulty breathing with insufficient oxygen throughout the body tissues.) On 8/2/23 physician's assistant (PA) #2 wrote in the medical record that Patient #1 required telemetry monitoring to track his prolonged QT interval (electricity moved through the lower part of the heart too slowly).

The review of Patient #1's medical record further revealed providers did not place an order for telemetry until 8/4/23. The medical record did not reveal evidence of telemetry monitoring until 8/7/23. The findings in Patient #1's medical record were in contrast to the Telemetry Monitoring policy which instructed to apply best practice standards to telemetry monitoring to ensure prompt detection of changes in heart rate or rhythm. Telemetry monitoring personnel was responsible for reporting to the physician or designee incidents of life-threatening cardiac arrhythmias (irregular heartbeats) and initiating appropriate actions for significant changes in cardiac rate or rhythm and new or unexpected changes in the cardiac rate, rhythm, or clinical status.

iii. On 8/22/23 at 10:32 a.m., an interview was conducted with physician's assistant (PA) #6. PA #6 said when she ordered telemetry she spoke with nursing staff to avoid delay in initiating telemetry, because the medical concern that prompted the telemetry order required immediate monitoring. PA #6 stated without telemetry patients could decompensate (deterioration of a previously stable system) without staff and providers noticing. PA #6 further stated this decompensation could include unnoticed, abnormal heart rhythms, abnormal vital signs, fast or slow heart rates, increased need for oxygen, and unstable blood pressure.

PA #6 stated the facility had a limited number of telemetry boxes. She explained if both telemetry boxes were in use and an admission later in the day required telemetry, providers would have to make a decision on which patient received the telemetry box. PA #6 said she wanted all patients who required telemetry to have access to monitoring, as without telemetry some patients would be watched less closely.

B. The facility was unable to provide evidence the QAPI committee measured, analyzed, and tracked the lack of telemetry boxes according to policy.

i. Review of the facility's incident reports from 11/15/22 to 8/21/23 revealed no evidence staff entered a report when they were unable to fulfill the provider's order for telemetry monitoring.

The lack of incident reports was in contrast to the Incident Reports policy which instructed an incident report to be completed on any outcome deemed to be inconsistent with the desired care of patients. The policy also instructed an incident report to be completed when any event occurred which was not a natural consequence of a patient's disease or procedure.

ii. On 8/23/23 at 4:46 p.m., an interview was conducted with director of quality (Director) #13. Director #13 indicated she was aware the facility's chief nursing officer (CNO) #12 made capital expenditure requests, dated 6/30/23 and 7/25/23, to purchase more telemetry boxes. Director #13 said she had not received any incident reports regarding the lack of telemetry boxes. Director #13 also said she was unsure why staff had not entered incident reports when they were unable to complete telemetry orders, but staff should have entered these events into the reporting system to allow tracking of adverse events, near misses, or any outcomes related to the lack of telemetry monitoring.

Director #13 explained the facility used incident reports to track unexpected occurrences and to monitor trends. Director #13 said incident reports prompted the QAPI committee to analyze the cause of an incident, discuss issues with the corporation that owned the facility, and track patient harm.

The lack of incident reports and subsequent failure to address trends related to patient harm was in contrast to the Governing Board Bylaws, which instructed the governing board to implement a hospital-wide QAPI plan that reported on the mechanisms for monitoring the quality and safety of patient care. The Bylaws required the governing board to support the QAPI committee in improving patient care and resolving problems.

C. Review of the governing board meeting minutes from 12/15/22, 5/3/23, and 8/8/23 revealed no evidence the governing board discussed the facility's inadequate number of available telemetry boxes. The governing board meeting minutes also did not provide evidence of oversight to the QAPI committee on identifying the opportunity to improve patient care presented by the lack of telemetry boxes.

The lack of oversight regarding the inadequate number of telemetry boxes was in contrast to the Governing Board Bylaws, which instructed the governing board to oversee the physical resources required to meet the needs of the patients.

D. On 8/24/23 at 11:41 a.m., an interview was conducted with chief medical officer (CMO) #17. CMO #17 stated he attended governing board meetings. CMO #17 said the QAPI committee, medical executive committee (MEC, a meeting of the facility's providers that made key leadership decisions for policies and procedures, with an emphasis on quality control and quality improvement activities), and governing board all met once a quarter on the same day. He explained the intent of the meetings and the reason they were scheduled on the same day was to encourage discussion of abnormal occurrences and to find solutions to problems.

CMO #17 said the governing board had not discussed the facility's lack of telemetry boxes. He stated given the possible consequences to patients, the issue should have been discussed at QAPI, MEC, and the governing board meetings. CMO #17 said leadership used the governing board meetings as a mechanism to communicate with the facility's corporate owner. He stated the purpose of the governing board was to advocate for supplies or process changes that increased patient safety.

CMO #17 explained the QAPI, MEC, and governing board meetings provided opportunities for leadership from different departments in the facility to identify, analyze, and resolve all issues that affected patient care. CMO #17 stated if the MEC or QAPI committees concluded the facility needed funds to purchase telemetry boxes, the issue would have been forwarded to the governing board. The governing board would then advocate for the funds with the facility's corporate owner. He said the purpose of the governing board was to advocate for the facility if the regular communication channels did not provide the needed results. CMO #17 further said the governing board acted to capture the attention of decision-makers to accomplish goals.

Based on observations, document reviews, and interviews the facility failed to ensure patients received care in a safe setting. Specifically, the facility failed to ensure an adequate number of telemetry boxes (battery-operated devices used to monitor the heart's electrical activity) were available to monitor patients according to providers' (physician or physician's assistant) orders, facility policy, and national guidelines in one of one medical record reviewed for patients with telemetry orders. (Patient #1) (Cross-reference A-0273, A-0083)

Findings include:

Facility policy:

The Telemetry Monitoring (a system to monitor the electrical activity of the heart) policy read, purpose: To apply best practice standards to telemetry monitoring to ensure prompt detection of changes in heart rate or rhythm. Telemetry monitoring personnel is responsible for reporting to the physician or designee incidents of life-threatening cardiac arrhythmias (irregular heartbeats) and initiating appropriate actions for significant changes in cardiac rate or rhythm and new or unexpected changes in the cardiac rate, rhythm, or clinical status.

References:

The Lippincott Procedures - Cardiac Monitoring guideline provided by the facility read, cardiac monitoring enables continuous observation of the heart's electrical activity in patients with conduction disturbances (abnormal movement of electricity through the heart) and in those at risk for life-threatening arrhythmias. In telemetry, a small transmitter connected to the patient sends electrical signals to another location, where they are displayed on a monitor. Telemetry is especially useful for monitoring arrhythmias that occur during sleep, rest, exercise, and stressful situations.

Continually monitor the electrocardiogram (ECG, a recording of the heart's electrical activity used to diagnose arrhythmias) pattern for arrhythmias along with the patient's response to any rhythm or heart rate change and intervene appropriately. Obtain a rhythm strip when a rhythm change occurs.

In patients at high risk for torsades de pointes (a fast arrhythmia from the lower part of the heart), a QTc (a measurement of the time electricity takes to reset in the bottom of the heart, adjusted for heart rate to increase accuracy) greater than 0.5 seconds is dangerously prolonged.

1. The facility failed to ensure an adequate number of telemetry boxes to monitor patients when ordered by providers.

a. Observations

i. On 8/22/23 at 8:16 a.m., observations were conducted at the facility's telemetry monitoring station (a workstation continuously monitored by staff trained in cardiac arrhythmias). Observations revealed 53 hospital beds that could admit patients with orders requiring a telemetry box. The telemetry technicians (staff trained in cardiac arrhythmias) stored one telemetry box at the monitoring station. Observations of the cardiac rhythm monitor revealed telemetry technician (Tech) #1 monitored one patient using an additional telemetry box, for a total of two functional telemetry boxes in the facility.

Further observations conducted throughout the facility did not reveal additional, functional telemetry boxes.

b. Document review

i. A review of Patient #1's medical record revealed he was admitted to the facility on 8/2/23 for acute respiratory failure with hypoxia (difficulty breathing with insufficient oxygen throughout the body tissues.) Patient #1's medical record indicated he had an extensive cardiac medical history, including a history of emergency surgery on 5/9/23 to repair an abdominal aortic aneurysm (the lower part of the body's main artery became weakened and started to bulge), heart failure with reduced ejection fraction (the heart was weakened and pumped less blood throughout the body), and a prolonged QT interval (electricity moved through the lower part of the heart too slowly.)

The medical record review further revealed on 8/2/23, physician's assistant (PA) #2 wrote in Patient #1's history and physical (a document written by providers to communicate a patient's medical history, physical exam, and medical plan of care) that the patient needed telemetry to monitor his QTc. However, review of the medical record did not reveal a provider's order for telemetry monitoring dated 8/2/23. On 8/2/23 PA #2 did order an ECG test (a test where a snapshot recording is taken of the electrical signals in the heart).

Patient #1's first ECG test, dated 8/3/23, showed a QTc of 529 milliseconds (msec). The Lippincott Procedures Cardiac Monitoring guideline read, in patients at high risk for torsades de pointes, a QTc greater than 500 msec seconds was dangerously prolonged.

On 8/2/23, registered nurse (RN) #4 wrote in the medical record that Patient #1 was admitted to a floor that required a telemetry box for cardiac monitoring and that he had a cardiac history. RN #4 wrote she had called PA #2 for telemetry monitoring orders but did not reach him, therefore she left a voicemail asking for a return call. On 8/3/23, RN #4 wrote in the medical record Patient #1 had a new order for telemetry, but the charge RN (a nurse who provided oversight for the daily operations of the facility) said no telemetry boxes were available. Patient #1's medical record did not include a provider's order for telemetry until Physician #3 entered one on 8/4/23.

On 8/5/23, RN #5 wrote in Patient #1's medical record that his heart rate increased, his blood pressure dropped, and he was becoming confused so she contacted PA #6 for orders. RN #5 further wrote Patient #1 required telemetry due to his cardiac history. PA #6 entered a second telemetry order on 8/5/23. However, RN #5 wrote Charge RN #9 again stated no telemetry boxes were available.

On 8/6/23 and 8/7/23, RN #7 wrote in Patient #1 medical record that he was not on telemetry. Further, on 8/7/23 RN #7 wrote she assessed a new onset of irregular heartbeat in Patient #1. In the 8/7/23 note RN #7 documented Patient #1 had an order for telemetry monitoring, no telemetry box was available, and he continued to be monitored on pulse oximetry (a device used to measure the oxygen level of the blood that also monitors heart rate, but not the heart rhythm).

The medical record review revealed the first telemetry strip (a printout of the electrical activity in the heart) on 8/7/23 at 8:24 p.m. This indicated the facility initiated telemetry five days after PA #2 first wrote the patient needed telemetry for QTc monitoring and three days after Physician #3 ordered telemetry for the first time.

Patient #1's medical record indicated on 8/13/23 he experienced decreased mental status, cardiac arrhythmias, and bleeding from his nose and throat. Providers elected to emergently transfer him to a higher level of care at a different facility. According to the county coroner report, Patient #1 subsequently died at that facility.

The medical record review was in contrast to the Lippincott Procedures Cardiac Monitoring guideline which read, cardiac monitoring enabled continuous observation of the heart's electrical activity in patients with conduction disturbances and in those at risk for life-threatening arrhythmias. The Lippincott guideline instructed to continually monitor the ECG pattern for arrhythmias along with the patient's response to any rhythm or heart rate change, and to intervene appropriately.

The record review for Patient #1 was also in contrast to the Telemetry Monitoring policy which read, the purpose of the policy was to apply best practice standards to telemetry monitoring which ensured prompt detection of changes in heart rate or rhythm. The policy instructed telemetry monitoring personnel to report to the physician or designee incidents of life-threatening cardiac arrhythmias, significant changes in cardiac rate or rhythm, and new or unexpected changes in the cardiac rate, rhythm, or clinical status.

ii. The facility provided two Capital Equipment Request forms, dated 6/30/23 and 7/25/23. On both of these forms chief nursing officer (CNO) #12 requested funds to purchase additional telemetry boxes. CNO #12 indicated on the form that telemetry boxes were life-saving monitoring equipment. CNO #12 wrote staff lacked the capacity to monitor patients if the facility did not purchase the telemetry boxes.

c. Interviews

i. On 8/22/23 at 7:37 a.m., an interview was conducted with Tech #1. Tech #1 stated telemetry monitoring allowed staff to respond to the patient's heart rhythm. Tech #1 explained she continuously monitored telemetry so she could immediately notify nursing and medical staff if a patient required transfer to a higher level of care. Tech #1 further explained the facility did not have the capacity to perform surgical procedures or cardiac interventions such as placing a stent in a heart (a procedure performed under x-ray that used wire mesh to increase blood flow to the heart.)

Tech #1 said the standard of care in her job was to respond to heart rhythm changes within two minutes, and that lack of response could lead to the patient's death. She stated part of the monitoring process included measuring electrical intervals in the heart, such as the QT interval. Tech #1 said if an interval changed she would notify the nursing staff to assess the patient. Tech #1 further said if the patient assessment warranted further intervention, the nursing staff would contact the medical provider for orders. Tech #1 explained telemetry monitoring across time helped providers understand cardiac variables when making care decisions.

Tech #1 said torsades de pointes as a result of prolonged QTc could have led to a patient experiencing a heart attack or cardiac death. She also said in the case of a heart attack, telemetry allowed early intervention so medical and nursing staff could stabilize patients prior to sending them to a higher level of care. Tech #1 said she regularly measured QT intervals to allow staff to perform early intervention, which prevented this chain of events from occurring.

ii. On 8/21/23 at 9:22 a.m., an interview was conducted with RN #8. RN #8 said the facility used telemetry for patient safety and early detection of heart arrhythmias. She stated telemetry allowed staff to care for patients in a more timely way. RN #8 explained the patient population served by the facility had many comorbidities (multiple diseases or medical conditions experienced by one patient). RN #8 explained patients with multiple comorbidities were at risk for a domino effect where one event led to another event, causing the patient to decompensate (deterioration of a previously stable system). RN #8 further explained telemetry allowed early intervention to prevent cardiac decompensation.

iii. On 8/22/23 at 8:42 a.m., an interview was conducted with RN #5. RN #5 explained a prolonged QT interval could have led to torsades de pointes, which would lead to the patient not effectively circulating blood through his or her body. She said torsades de pointes could circulate some blood, which meant without a telemetry strip or ECG staff could assess the arrhythmia to be a regular heart rhythm. RN #5 further explained patient symptoms included low blood pressure, high pulse rate, confusion, and a drop in the blood oxygen level.

RN #5 said if a provider ordered telemetry monitoring on the medical-surgical floor she frequently was unable to place a telemetry box on the patient due to lack of resources. RN #5 stated telemetry should have been placed on patients immediately, particularly in patients with an extensive cardiac history who were at risk for arrhythmias.

RN #5 explained as an alternative to telemetry, patients had sometimes been placed on continuous pulse oximetry monitoring. RN #5 further said continuous pulse oximetry would provide staff with information on blood oxygen levels and heart rate, but would not provide a heart rhythm. RN #5 said telemetry monitoring was specifically designed to display the heart rhythm. RN #5 said without a monitoring a heart rhythm, the patient could have been in a dangerous arrhythmia and staff would not know until the patient decompensated.

RN #5 stated she remembered caring for Patient #1. She further stated due to her assessment of his physical condition she was not comfortable caring for him on a medical-surgical floor without telemetry monitoring. RN #5 explained after contacting PA #6 and Charge RN #9, the decision was made to monitor Patient #1 via continuous pulse oximetry. RN #5 stated this situation was unsafe for Patient #1, as pulse oximetry was not a replacement for telemetry and the patient could have experienced a deadly cardiac event.

iv. On 8/21/21 at 9:59 a.m., an interview was conducted with RN #10. RN #10 explained he frequently assisted the telemetry technicians with monitoring patients. He further explained due to the lack of telemetry boxes, if a provider ordered telemetry the staff and medical team would prioritize which patient was monitored on telemetry based on acuity (a measurement of the severity of a patient's illness).

RN #10 stated telemetry orders from providers indicated the patient had a critical need and therefore needed the monitoring. He said nurses and telemetry technicians used telemetry as a quick reference and to catch early indications of problems requiring intervention. RN #10 stated if providers ordered telemetry and staff could not place a telemetry box on the patient, the facility had failed to use every available resource to intervene in potentially life-threatening situations.

v. On 8/22/23 at 12:12 p.m., an interview was conducted with Charge RN #11. Charge RN #11 stated the lack of telemetry boxes had been difficult for staff, and had been occurring over the last several years as telemetry boxes were lost or broken. She stated when she began employment with the facility in 2012 the facility owned 23 telemetry boxes and currently the level was the lowest it had ever been with only two available telemetry boxes. Charge RN #11 explained if a provider ordered telemetry and a telemetry box was not available, staff would have to move two or more patients in the facility to allow admission into the intensive care unit (ICU), which had built-in telemetry monitoring and did not require a telemetry box. She further explained this sometimes was not possible if no patients could be moved from the ICU.

Charge RN #11 explained not following a provider order for telemetry was not safe for patients because staff did not know the cardiac rhythm. She further explained nurses had a responsibility to execute patient care ordered by the provider. Charge RN #11 stated patients could die due to the lack of telemetry boxes, and pulse oximetry was not a telemetry replacement as it only provided oxygenation and heart rate information.

vi. On 8/22/23 at 10:32 a.m., an interview was conducted with PA #6. PA #6 said when she ordered telemetry she spoke with nursing staff to avoid lag time, because the medical concern that prompted the telemetry order required immediate monitoring. PA #6 stated without telemetry patients could decompensate without staff and providers noticing. PA #6 further stated this decompensation could include unnoticed, abnormal heart rhythms, abnormal vital signs, fast or slow heart rates, increased need for oxygen, and unstable blood pressure.

PA #6 stated the facility had a limited number of telemetry boxes. She explained if both telemetry boxes were in use and an admission later in the day required telemetry, providers would have to make a decision on which patient received the telemetry box. PA #6 said she wanted all patients who required telemetry to have access to monitoring, as without telemetry some patients would be watched less closely.

vii. On 8/23/23 at 1:36 p.m., an interview was conducted with director of quality (Director) #13. Director #13 said the purpose of telemetry monitoring was to track a patient's cardiac condition, especially if they had a cardiac medical history or were receiving electrolytes (substances in the body which naturally have a positive or negative charge, such as potassium) which could change the heart rhythm. She explained telemetry helped track the progress of different disease processes. Director #13 explained telemetry gave staff and providers information that contributed to the patient's overall health assessment. Director #13 said the request for funding for additional telemetry boxes had not yet been addressed by the corporation that owned the facility.

Based on observations, document reviews, and interviews, the facility's quality assessment and performance improvement (QAPI) program failed to measure, analyze, and track quality indicators to assess processes of care and hospital services. Specifically, the facility failed to measure, analyze, implement interventions, and track incidents where staff was unable to complete providers' (physicians and physician assistants) orders for telemetry monitoring (a system to monitor the electrical activity of the heart) due to an inadequate number of available telemetry boxes (battery-operated devices used to monitor the heart's electrical activity). (Cross-reference A-0144, A-0083)

Findings include:

Facility policies:

The Telemetry Monitoring policy read, purpose: To apply best practice standards to telemetry monitoring to ensure prompt detection of changes in heart rate or rhythm. Telemetry monitoring personnel is responsible for reporting to the physician or designee incidents of life-threatening cardiac arrhythmias (irregular heartbeats) and initiating appropriate actions for significant changes in cardiac rate or rhythm and new or unexpected changes in the cardiac rate, rhythm, or clinical status.

The Incident Reports policy read, an incident report will be completed on any incident deemed to be inconsistent with the desired operation of the hospital or the care of patients. An incident report must be completed when any event occurs that is not a natural consequence of a patient's disease or procedure.

Incident report rationale: To provide a record of the incident and document facts, to provide a factual document for further internal investigation, for purposes of statistical analysis, and to improve the facility's services.

Reference:

The QAPI Plan read, the purpose of the facility's QAPI plan is to ensure the hospital demonstrates a consistent endeavor to deliver optimal care in an environment of minimal risk. The QAPI plan allows for a systemic, coordinated, and continuous approach to improving performance by focusing on processes and mechanisms that address these values.

This plan will monitor every aspect of patient care as it relates to the treatment of disease and disability in order to identify and resolve any breakdowns that may result in suboptimal patient care and safety. The overall objectives of the QAPI plan are to collect data to monitor the hospital's performance, compile and analyze the data, and improve performance on an ongoing basis.

Functions of the QAPI committee: review, assess, and analyze data in order to assist in setting priorities for hospital-wide process improvement activities that are designed to improve patient care, process outcomes, and patient safety. Working to create a culture of safety and continuous performance improvement. Receiving, evaluating, and coordinating all reports submitted relating to the monitoring of the quality of care and patient safety. Acting expeditiously to remove barriers when improvement suggestions have been made.

1. The QAPI program failed to ensure incidents of a lack of available telemetry boxes were analyzed to ensure the facility had enough telemetry boxes to meet the needs of patients.

A. Observations, document reviews, and interviews revealed the facility owned an inadequate number of telemetry boxes for nurses and telemetry technicians (staff trained in abnormal heart rhythms) to monitor patients' heart rhythms per providers' orders and facility policy.

i. On 8/22/23 at 8:16 a.m., observations were conducted at the facility's telemetry monitoring station (a workstation continuously monitored by staff trained in cardiac arrhythmias). Observations revealed 53 hospital beds that could admit patients with orders requiring a telemetry box. The telemetry technicians (staff trained in cardiac arrhythmias) stored one telemetry box at the monitoring station. Observations of the cardiac rhythm monitor revealed telemetry technician (Tech) #1 monitored one patient using an additional telemetry box, for a total of two functional telemetry boxes in the facility.

Further observations conducted throughout the facility did not reveal additional, functional telemetry boxes.

ii. A review of Patient #1's medical record revealed he was admitted to the facility on 8/2/23 for acute respiratory failure with hypoxia (difficulty breathing with insufficient oxygen throughout the body tissues.) On 8/2/23 physician's assistant (PA) #2 wrote in the medical record that Patient #1 required telemetry monitoring to track his prolonged QT interval (electricity moved through the lower part of the heart too slowly.)

The review of Patient #1's medical record further revealed providers did not place an order for telemetry until 8/4/23. The medical record did not reveal evidence of telemetry monitoring until 8/7/23. The findings in Patient #1's medical record were in contrast to the Telemetry Monitoring policy which instructed to apply best practice standards to telemetry monitoring to ensure prompt detection of changes in heart rate or rhythm. Telemetry monitoring personnel was responsible for reporting to the physician or designee incidents of life-threatening cardiac arrhythmias (irregular heartbeats) and initiating appropriate actions for significant changes in cardiac rate or rhythm and new or unexpected changes in the cardiac rate, rhythm, or clinical status.

iii. On 8/22/23 at 10:32 a.m., an interview was conducted with PA #6. PA #6 said when she ordered telemetry she spoke with nursing staff to avoid delay in initiating telemetry, because the medical concern that prompted the telemetry order required immediate monitoring. PA #6 stated without telemetry patients could decompensate (deterioration of a previously stable system) without staff and providers noticing. PA #6 further stated this decompensation could include unnoticed, abnormal heart rhythms, abnormal vital signs, fast or slow heart rates, increased need for oxygen, and unstable blood pressure.

PA #6 stated the facility had a limited number of telemetry boxes. She explained if both telemetry boxes were in use and an admission later in the day required telemetry, providers would have to make a decision on which patient received the telemetry box. PA #6 said she wanted all patients who required telemetry to have access to monitoring, as without telemetry some patients would be watched less closely.

B. Document review and interviews revealed the facility was unable to provide evidence the QAPI committee measured, analyzed, and tracked the lack of telemetry boxes according to policy.

i. Review of the facility's incident reports from 11/15/22 to 8/21/23 revealed no evidence staff entered a report when they were unable to fulfill the provider's order for telemetry monitoring.

The lack of incident reports was in contrast to the Incident Reports policy which instructed an incident report to be completed on any outcome deemed to be inconsistent with the desired care of patients. The policy also instructed an incident report to be completed when any event occurred which was not a natural consequence of a patient's disease or procedure. The Incident Report policy rationale read, incident reports recorded the incident and documented facts, provided a basis for internal investigation and statistical analysis, and improved the facility's services.

ii. Review of the facility's QAPI meeting minutes from 11/3/22, 3/26/23, and 7/25/23 revealed no evidence the QAPI committee addressed the facility's insufficient telemetry monitoring capability.

The QAPI committee's failure to address the insufficient supply of telemetry boxes was in contrast to the QAPI Plan which instructed the program to ensure the facility demonstrated optimal care in an environment of minimal risk. The QAPI Plan instructed to monitor every aspect of patient care related to the treatment of disease and disability in order to identify and resolve any breakdowns that resulted in suboptimal patient care and safety.

iii. Interviews

a. On 8/24/23 at 6:39 a.m., an interview was conducted with charge registered nurse (Charge RN) #14 (a nurse who provided oversight for the daily operations of the facility). Charge RN #14 said after considering the years of workarounds charge nurses and providers performed to monitor patients with an insufficient number of telemetry boxes, staff should have entered incident reports when a telemetry box was not available. She explained the lack of telemetry boxes was common enough that it had become a normal routine for staff, so they did not consider entering an incident report when it occurred.

Charge RN #14 said telemetry technicians, nurses, and providers would "shuffle" patients through the facility to provide the sickest patients with telemetry, and as a result, telemetry boxes would be taken from one patient for the benefit of another. She explained the lack of telemetry boxes had been noticeable for at least the prior two years. Charge RN #14 stated the facility had started with an adequate supply of telemetry boxes but these were lost or broken over time until only two remained. Charge RN #14 said the lack of telemetry boxes could have led to a patient's death.

b. On 8/23/23 at 5:15 p.m., an interview was conducted with assistant chief nursing officer (ACNO) #16. ACNO #16 stated if staff was unable to follow the provider's orders for telemetry monitoring they should have completed an incident report. She explained this formal reporting method tracked staff notifications to providers when the facility was unable to accommodate the expected level of care. ACNO #16 said incident reports would also have tracked when a provider made the decision the patient did not need the telemetry monitoring, or if the patient had to be transferred to a higher level of care due to the lack of telemetry boxes.

c. On 8/24/23 at 11:25 a.m., an interview was conducted with the director of respiratory therapy, radiology, and laboratory (Director) #15. Director #15 stated in hindsight she would have pushed harder two years ago for the purchase of additional telemetry boxes. She explained she would have taken measures to understand who needed to be informed of the lack of telemetry boxes. Director #15 said she should have worked to move the lack of telemetry boxes forward so patients received the monitoring they needed.

d. On 8/23/23 at 4:46 p.m., an interview was conducted with director of quality (Director) #13. Director #13 indicated she was aware the facility's chief nursing officer (CNO) #12 made capital expenditure requests, dated 6/30/23 and 7/25/23, to purchase more telemetry boxes. Director #13 said she had not received any incident reports regarding the lack of telemetry boxes. Director #13 also said she was unsure why staff had not entered incident reports when they were unable to complete telemetry orders, but staff should have entered these events into the reporting system to allow tracking of adverse events, near misses, or any outcomes related to the lack of telemetry monitoring.

Director #13 explained the facility used incident reports to track unexpected occurrences and to monitor trends. Director #13 said incident reports prompted the QAPI committee to analyze the cause of an incident, discuss issues with the corporation that owned the facility, and track patient harm.

Director #13 stated past QAPI projects tracked through incident reports resulted in the facility proactively following revised policy and procedures to ensure patients received expected care. She explained incident reports tracked and trended problems to support QAPI investigations. Director #13 said incident reporting interrupted the ripple effect that diminished patient safety.

e. On 8/24/23 at 11:41 a.m., an interview was conducted with chief medical officer (CMO) #17. CMO #17 said he participated in the QAPI committee meetings but he was unaware of how severe the lack of telemetry boxes had become. CMO #17 stated the lack of telemetry boxes should have been a formal discussion in QAPI and medical executive meetings (a meeting of the facility's providers that made key leadership decisions for policies and procedures, with an emphasis on quality control and quality improvement activities). He also stated he should have been made more aware of the lack of telemetry boxes because it became a medical issue due to the lack of patient monitoring. CMO #17 stated he needed to know about trends that affected patient quality of care and outcomes.