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Defining the Scope of TJC's NPSG on Clinical Alarms

What is alarm fatigue?

Alarm fatigue occurs when staff members are exposed to an excessive number of medical device alarms, which can result in sensory overload desensitizing them to the noise.

What patient safety risks are associated with alarm fatigue?

Alarm desensitization can result in delayed alarm responses or missed alarms indicating a true sentinel event.

What are some factors contributing to alarm fatigue?

Some factors contributing to alarm fatigue include "leads off" apathy, unit noise, communication breakdowns, lack of alarm escalation capabilities, and competing priorities.

What is the scope of the alarm problem?

The ECRI Institute has consistently listed alarm hazards at or near the top of its annual top 10 Health Technology Hazards as well as its top 10 Patient Safety Concerns for Healthcare Organizations. The Joint Commission's Sentinel Event database includes reports of 98 alarm-related events between January 2009 and June 2012; 80 resulted in death and 13 in permanent loss of function. In 2013, The Joint Commission issued a new National Patient Safety Goal aimed at improving clinical alarm safety that is required for all accrediting hospitals by January 1, 2016. The AAMI Foundation organized The National Coalition for Alarm Management Safety to bring together stakeholders for the purposes of knowledge-sharing and information distribution. Beyond medical device alarms there are a number of clinical events creating noise and interruptions including overhead paging, phones ringing, and non-medical device alerts such as nurse call alerts.

Alarm complexity diagram
What is the difference between an alarm and an alert?

Both alarms and alerts interrupt clinicians and can be a source of distraction that leads to critical errors. Even though they are often used interchangeably, they have different purposes and require different levels of federal oversight depending on their risk to a patient.

Alerts can come from many different sources, including the EMR/EHR, lab systems, CPOE, medication administration software, imaging systems, nurse call systems, and various other sources. Almost any system in the clinical environment can generate an alert. A nurse's phone that receives alerts or can process text messages can also generate alerts (i.e. via a beep or vibrate) that let the nurse know when a new message has arrived. Alerts are not usually associated with medical devices and are not always immediately time sensitive – a delay of 30 seconds or even several minutes is often acceptable unlike with a patient monitoring alarm.

Alarms are typically derived from medical devices and often communicate an event requiring immediate intervention. By way of example, consider the level of urgency to respond to a V-Fib or asystole alarm from a patient monitor. Alarms are always more time-sensitive and a delay of a few seconds may matter to the safety of the patient. Alarms are almost always intended for nurses or respiratory therapists (i.e. non-physicians). Physicians do not deal with alarm response – nurses and other clinicians on the floor respond to alarms.

Furthermore, alarms are always regulated by the FDA from both the medical device side (alarm generation) and from the perspective of an alarm management middleware. The FDA regulates alarm management middleware vendors through the 510k process. As a result, only a few vendors can offer an alarm notification capability.

The Joint Commission (TJC) issued its R3 Rationale report in response to its NPSG.06.01.01 for alarm system safety. A key statement in this report outlines clinical alarms as being more critical and a higher threat to patient safety as compared to "alerts." In fact, the report explicitly states that the NPSG does not address "items such as nurse call systems, alerts from computerized provider order entry (CPOE), or other information technology (IT) systems." Clearly, TJC believes the best starting point is with an evaluation of medical device alarms. Extension, however, feels strongly that patients could be at risk if distractions from other systems are not properly managed; therefore, all systems generating noise should be considered part of a comprehensive strategy to reduce interruptions.

How should a clinical interruption be defined?

Clinical interruptions are anything that distracts a clinician from the task at hand and have the potential to increase patient safety risks. These include medical device alarms as well as nurse call events, overhead pages, phones, EHR alerts, lab notifications, and other clinical systems generating messages. A recent study reported that RNs were interrupted about 12 times per hour, or once every 5 minutes.

What are some of the risks associated with clinical interruptions?

Experimental studies suggest that interruptions produce negative impacts on memory by requiring individuals to switch attention from one task to another. Returning to a disrupted task requires completion of the interrupting task and then regaining the context of the original task. One study reported that each interruption was associated with a 12.1 percent increase in procedural failures and a 12.7 percent increase in clinical errors.

How often do nurses experience a clinical interruption?

In one recent (2015) baseline interruptions study completed by Extension Healthcare at a hospital in the northeast US, it was determined that nurses heard over 1 million audible interruptions. This was compiled from a 31-day Extension Evaluate study of 6 departments simply reviewing nurse call alerts and patient monitor alarms collected from 129 beds. It was determined that patients produced an audible alarm once every 6 minutes and nurses averaging 3 patients each had to respond to an audible alert or alarm every 2 minutes.

How did clinical event notifications evolve from decreasing patient safety risks to increasing them?

The earliest paging systems for physicians were launched in 1950. As recently as 15 years ago, first generation alarm management middleware vendors connected medical devices with these paging systems and later, VoIP phones, to deliver critical alarms directly to clinicians. These secondary alarm notifications ensured that a possible sentinel event was received if a clinician was not within earshot of the medical device and allowed them to more freely move about the unit.

They were so effective at delivering alarms that they were expanded to different departments, but their growth lacked the corresponding training necessary for nurses to manage these medical devices at the bedside. Hospitals defaulted to a "better safe than sorry" strategy choosing to deliver every single alarm generated, which resulted in a lot of false alarms. In addition, new medical devices and clinical systems aiming to leverage the rapid response workflow soon increased the number of alarms and alerts being delivered to nurses generating a neverending parade of chimes to dissect, prioritize, and act upon. The cognitive taxation that results is what is commonly referred to as "alarm fatigue" although "interruption fatigue" would be more generally applicable.

Is alarm safety a product or a process – is technology necessary to manage alarms?

Alarm safety requires both technology and well-defined processes. The AAMI Foundation's Healthcare Technology Safety Institute (HTSI) outlined 9 steps that hospitals should follow to pursue a proactive risk assessment approach to improving alarm management:

  1. Assemble a multidisciplinary team
  2. Review recent events and near misses
  3. Observe alarm coverage processes and ask nurses and other staff about their concerns
  4. Review entire alarm coverage system
  5. Identify patient safety vulnerabilities and potential failures
  6. Determine underlying causes of potential failures
  7. Develop realistic, implementable strategies to address underlying causes
  8. Implement strategies and evaluate their effectiveness
  9. Monitor effectiveness of strategies and provide feedback to staff

HTSI also recommends 8 technology areas for hospitals to evaluate:

  1. Monitoring modalities and capabilities
  2. Configuration
  3. Ancillary alarm technologies, which includes the following:
  4. Alarm integration system
  5. Non-interactive remote displays
  6. Interactive remote displays
  7. Enunciators
  8. Notification/communication devices
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Leveraging Alarm Safety Middleware to Reduce Clinical Interruptions

What should a hospital look for in an alarm safety system vendor?

There are only few vendors that can provide an enterprise-class alarm safety and event response platform that meets the highest standards. The following reasons explain the supply shortage:

  • Heavy investment and 3 to 5 years necessary to produce a capable platform
  • Many inputs needed to support most hospitals (an input is a source system integration to systems such as the EHR, physiological monitors, pumps, ventilators, security systems, RFID, etc.)
  • Many outputs needed to support most hospitals that often have mixed communications devices (an output is usually a device such as a VoIP phone, smartphone, pager, or a medium such as the ability to make a phone call or send a text message.)
  • Regulated environment (viable vendors require a 510k clearance from the FDA to operate in this space)
  • Clinical, technical, and market domain expertise are required to develop the right solution for today and future markets because of rapidly changing technology and user requirements.

These points corroborate why an EHR cannot provide an alarm safety and event response solution – there is a lot that goes into providing a capable platform. The following list will help you make a better decision on vendor credibility as it relates to delivering an enterprise alarm safety and event response solution:

  • Connectors/adaptors/integrations to support most name-brand input systems including all EHR systems, medical devices, and nurse call systems
  • Supports all common end points today including VoIP devices (Cisco, Spectralink, Ascom, Vocera) and smartphones
    • Beware of any solution that does not support VoIP devices as this likely means it is a newer company without much experience or many installations.
    • Based on your specific requirements and migration plans, it often makes sense to look for a solution that offers interoperability between various types of phones and vendors.
  • >100 hospital installations
  • A 510k Class II medical device clearance specific to secondary alarm notifications
  • Pricing that is easy to understand
  • Utilizes formal project management best practices and hires PMP-certified project managers
  • Exclusive to healthcare – many vendors serve other markets outside healthcare and this offers no direct benefit to your hospital
  • Company based in the United States (regulatory, staffing, and other issues lead to the recommendation of a US-based vendor)
  • Multiple clinicians on staff including:
    • A CNO that your CNO can relate to
    • Pre-sales staff
    • Implementation staff
    • Training and go-live support
  • Industry sponsorships and relationships (ECRI, AAMI, HIMSS, ACCE, AONE, etc.)
  • More than 1 reference site
  • Platform capable of handling context
  • Advanced or complex alarming support
  • Extensible platform that can be expanded without additional adaptor or connector pricing

With approximately 200 customers Extension has proven to be the new leader in alarm management. To be a valuable partner to you, Extension strives to equip your team with the information needed to make an educated buying decision. Regardless of the final vendor decision, the organization is making an investment in patient safety. The reality is that there are only a couple of complete enterprise-capable platforms on the market. If Extension has not heard of a vendor under consideration, we will quickly and kindly inform you; caveat emptor (buyer beware). We truly want you to make the best decision for your organization.

What are the major components of an alarm safety solution?

The many components that comprise an enterprise alarm safety solution can be grouped into three main categories – (1) Alerts and Alarms, (2) Patient-Centric Messaging and Voice Communications, and (3) Advanced Rules, Context, and Presence. At the intersection of these major components is the essence of what an ideal solution looks like – one that enables more effective communication and collaboration among the care team in response to critical patient events. This includes being able to aggregate and store data "on the fly" so that advanced rules and clinical context can be applied to aid in reducing interruptions and optimizing event response.

Based on the reliable adage that you cannot manage what you cannot measure, gaining control of the clinical event environment requires an ability to recognize and manage a range of different clinical events. Hospitals must ensure that any solution evaluated includes the ability to manage and prioritize both alerts and alarms. Be aware that some vendors make claims that they provide "alerting" capabilities, but this is much different than being able to "manage alarms".

One key mistake that hospitals often make is confusing the tactical deployment of a secure messaging app with solving the problem of addressing clinical communications. There are a large number of physician groups, specialist groups, and hospital departments feeling the pressure to make a tactical decision on a secure messaging smartphone app, largely to address the problem of hospital staff sending PHI in violation of HIPAA regulations.

For hospitals that have already implemented a secure messaging app, it may not "feel" like it's a limited strategy; after all, the software works for the clinicians and it gives them the ability to text back and forth just as they do in their personal lives. It also protects the data (i.e. it adheres to HIPAA guidelines) and there may even be some basic integration into scheduling or lab results. The issue arises when this "accidental architecture" is confused with a unified clinical communications solution. This approach has the following drawbacks:

  1. Disjointed solutions require many vendors and time consuming oversight. This includes assisting ongoing integration between vendors.
  2. Multiple vendors decrease the likelihood of your success.
  3. A multi-vendor approach not only increases costs for hospitals but also increases potential points of failure.
  4. It is difficult to maintain a hybrid device environment while ensuring compatibility and interoperability between newer smartphones and traditional VoIP phones (i.e. Cisco, Spectralink, etc.).
  5. With an "accidental architecture" hospitals face potential regulatory issues and must consider which vendors carry an FDA 510k clearance and which do not.
  6. Multiple systems can contribute to alarm fatigue if not managed properly. Studies have shown that simply providing phones to nurses to enable communications can increase interruptions and add to the problem of alarm fatigue.
Extension enterprise overview diagram
What are the benefits of an alarm safety solution or "alarm middleware"?

An alarm safety system helps healthcare organizations reduce the dangers of traditional medical alerting processes, including alarm fatigue. The benefits of an alarm safety system can be categorized into the following 5 groups:

  1. Managing and prioritizing the clinical alarm and notification delivery process improves staff responsiveness by providing a streamlined workflow.
  2. Receiving contextual alarm notifications at the point-of-care facilitates situational awareness and enhances patient surveillance.
  3. Preventing workflow interruptions increases staff efficiency and productivity.
  4. Enabling care team members with advanced event response options improves care team collaboration and care coordination.
  5. Delivering alarms to caregiver phones reduces overhead noise and creates a better environment for healing and recovery.

One example proof point can be taken from a study at a VA medical center in Florida. Extension performed a "before and after" alarm interruption study after implementing a specific monitor technician workflow and escalation process. The hospital was able to reduce the nursing nuisance alarms and interruptions 55% by using an advanced alarm middleware.

Another internal time-motion study conducted by the Battle Creek Medical Center in Michigan determined their alarm safety system is saving 700 FTE nursing hours per unit, per year. This is based simply on the nursing time saved by sending physician orders and nurse call alerts directly to a nurse's Cisco VoIP phone.

Another important benefit of alarm management systems is the impact on patient and staff experiences. With the industry focus on HCAHPS (Hospital Consumer Assessment of Healthcare Providers and Systems) scores for customer satisfaction, a "quiet" and responsive environment is critical. One private medical center in Florida reduced telemetry alarms by 76% (over 7 days) and achieved the highest patient satisfaction scores in the history of the facility after implementing an advanced alarm safety system.

How does an alarm safety system facilitate care collaboration?

Many hospitals continue to use relatively antiquated folder-based email messaging services that burden first generation mobile devices and desktop messaging. A next generation view of secure messaging facilitates the most perfect form of clinician collaboration – the care team assembled around the patient's bed reviewing a diagnosis, a care plan, or a discharge plan. This level of frictionless collaboration is not contained in a feature set or a menu bar - it is a unified user interface binding a next-generation seamless messaging solution to the alarm or alert notification.

With traditional texting solutions clinicians and staff can individually message one another or groups, maintain a favorites list, and initiate a voice call, but workflow research has shown that the majority of texting between caregivers is tied to a specific patient or clinical event. The purpose-built design of an advanced middleware solution with integrated event response (i.e. secure texting and voice) removes the friction that holds back that easy collaboration for every conversation.

What is the difference between first and next generation alarm safety systems?

First generation systems are focused solely on the notification component of alarm management. They fail to address the importance of what should happen after caregivers receive the alarm or event. Outdated notification systems simply send alarms or alerts from the source to the assigned caregiver with an indicator about what the event is and the room number to respond to.

With first generation systems, each alarm is received one at a time and a simple rule is applied to determine if the alarm should be sent to the primary assigned caregiver or not. Caregivers cannot do anything with the event other than accept, reject, or ignore the message. There is no method provided to manage or coordinate the event response that needs to include how clinicians communicate and collaborate in response to critical events. In this case, the "intelligence" is equivalent to that of what a pager offers. When it comes to communication and collaboration – first generation systems are limited in their event response options and typically only facilitate a call back to the patient room.

All other patient-related communications are ad hoc and uncoordinated - and the ease of use is highly dependent on the types of phone devices used and the ability to easily find the person(s) that a caregiver needs to call or message. In addition, there is no contextual data provided and presence information is often limited – both of which are valuable to enhance the notification and event response workflow. In sharp contrast to first generation systems, next generation systems enable improved event response workflow and communications.

Next generation alarm safety systems are designed entirely different from the first generation systems that preceded. Next generation systems begin collecting data and building a temporary patient record as soon as the patient is admitted to provide the alarm, patient, and caregiver context. This context comes from many different systems including ADT, EMR, staff assignments, presence, location data from RTLS, and more.

Using all of this data, advanced rules are applied in order to intelligently notify the caregiver that can best respond, and not bother those caregivers unable to effectively respond. In comparison to the first generation sample alert, a next generation system like Extension Engage provides a rich user experience that offers context, presence, and an automatically generated care team list based on the patient and the event type.

Consider a primary assigned nurse that is in an isolation room; Extension knows that nurse is unable to respond because of their location as determined by the RTLS system. Extension can automatically bypass the primary nurse and notify the backup caregiver. Even this simple use case reduces interruptions and helps address alarm fatigue.

Bed rail down alert on a first generation application vs a next generation application
What is clinical event response and how does it relate to alarm safety?

The first step hospitals should take to address alarm issues is to review alarm management policies and procedures including practices for setting and changing alarm limits on the medical device itself. However, alarm safety is more than just managing alarms and routing clinical alert notifications to caregivers. It's also what the caregiver does with the alert (how they respond to the patient event) that has an impact on outcomes in their facilities.

Other problems that contribute to alarm-related safety events are the number of nursing interruptions coupled with the inability of clinicians to effectively collaborate in response to meaningful alarms. How you manage the "clinical event response" and the workflow are vital factors to evaluate in order to achieve a complete alarm safety solution.

The functionality of most systems stops at delivering the alarm to the assigned caregiver. Next generation alarm safety systems leverage the power of an enterprise platform and data model with context, presence, and advanced rules to enable a "methodical and managed event response." The Extension Engage platform automatically manages the care team list based on the type of event and the current shift's role-based assignments. Clinicians are freed from the repetitive administrative task of searching for additional care team members to include in the event response.

From the Engage Mobile user's perspective, the list of people you likely need to call or interact with is automatically generated, prioritized, and populated into the application; thus, the person(s) you most likely need to contact is at the top of the list. This eliminates the need to search through a sizeable directory to find the right person(s), which saves time and expedites intervention.

 Next generation alarm safety and event response on an iPhone
What is situational awareness and how do hospitals leverage it?

Situational awareness is the perception of environmental elements with respect to time and/or space, the comprehension of their meaning, and the projection of their status after some variable has changed, such as time, or some predetermined event. Situational awareness involves being aware of what is happening in the vicinity in order to understand how information, events, and one's own actions will impact goals and objectives, both immediately and in the near future.

One with an adept sense of situational awareness generally has a high degree of knowledge with respect to inputs and outputs of a system, i.e. an innate "feel" for situations, people, and events that play out due to variables the subject can control. Inadequate or absent situational awareness have been identified as primary factors in accidents attributed to human error including in healthcare environments. Thus, situational awareness is especially important in a highly complex care environment where the information flow can be excessive and poor decisions can lead to sentinel events.

Team situational awareness is the degree to which the team members know which information needs to be shared, or has already been shared, including their higher level assessments and projections (which are usually not otherwise available to fellow team members), and information on team members' task status (availability), current capabilities, and location (which can be useful to help determine availability).

Context is key to enabling situational awareness. When context is combined with the ability to easily communicate and collaborate among care team members, a higher degree of situational awareness can be realized. In the care environment, communication and the ability to collaborate among the care team is enabled with both text messaging and voice communications deployed via the hospital infrastructure and mobile devices. Both text and voice capabilities are required in order to sufficiently address the issue. Ideally, the text messaging component of a solution can leverage the context provided; meaning, text messages will be automatically linked to the relevant patient events and ensuing conversations.

How does Extension Engage leverage context to reduce clinical interruptions?

Context provides the missing links. It is required to enable complex rules processing and to provide clinicians with supplemental information that will assist them with both the alarm notification process as well as the event response workflow. There are many types of context that are derived or processed from external sources by the Extension Engage platform.

Alarm context refers to supplemental details or data about the specific alarm or event. For example, this could be the current blood pressure, respiratory rate and SpO2 readings from the patient monitor when a high heart rate alarm is received. Having multiple data points provides for better decision-making in response to the alarm.

Patient context refers to details about the patient and this is derived from a real-time interface to ADT (Admit, Discharge, and Transfer) or a system such as the EMR/EHR. For example, when nurses receive an alarm, they can respond more appropriately if they have the patient's last set of vital signs or most recent lab values included in the message when received on the phone.

Location context is important because the physical location of a caregiver helps determine availability. As an example, if the nurse happens to be in an isolation room, then the Extension Engage rules engine can use their current location to determine that the nurse is not able to accept a critical alarm. Location context is determined via an interface to common RFID or real-time location systems (RTLS).

Proximity context can be very important when trying to locate a nurse in close proximity to an event as compared to other caregivers and is determined via RFID/RTLS systems.

Presence context refers to the status of the nurse's communication device such as whether their phone is "on" and registered on the system. Additional presence context is contained in the messaging layer of a unified communications system. Most corporate desktop environments are limited to "Available", "Busy", and "Do Not Disturb". Specialized UC systems optimized for use in healthcare environments may be configured to utilize presence status for a variety of clinical and hospital staff roles ("On transport"; "Medications Room"; "Off Unit-Radiology", etc.).

Expanded partnerships and integrations with real-time location systems will be critical to implement more efficient workflows. Automatically applying specific rules based upon proximity, location or workflow is an opportunity for saving steps and increasing user adoption.

Nurses rely heavily on the use of presence to facilitate more efficient alarm and event workflows, freeing clinicians to focus on patient care. For instance, if the primary nurse is involved at the patient bedside with a post-surgical abdominal dressing change and cannot break the sterile field, she should not be interrupted. Consequently, by marking herself "unavailable" all future notifications would be automatically routed to the alternate available nurse.

How does Extension Engage use advanced rules to reduce clinical interruptions?

Many alarm management/middleware solutions will evangelize their rules engine. Most boast about having advanced rules that will send the right alarm to the right caregiver at the right time. Although this claim is relatively valid in most cases, many still lack the ability to develop truly complex or advanced rules. For example, most middleware solutions can route messages based on a nurse-to-patient association (assignment). They can even ensure the alarms and alerts are routed appropriately based on caregiver role. They can develop rules to escalate at varying time thresholds and some can even ensure a preset number of people/roles accept the alert, as in a code situation.

What is lacking from the first generation alarm management solutions is the ability to develop rules based on variables from multiple sources whether or not the variables are contained in the originating alarm message. Clinically, this leaves the caregiver with less than optimal information to make a decision and in most cases this type of alerting is actually contributing to alarm fatigue. For example:

First generation alarm management:

  • Bed rail down alert is triggered – This is a preconfigured alert and is sent out the same way every time, regardless of any patient condition.

Next generation alarm management:

  • Bed rail alert is triggered – This can be configured using advanced rules to send a high priority alert if the patient fall risk is =/>51 and/or patient is on pain relievers.
  • Bed rail alert is triggered – This can be configured using advanced rules to send a medium priority alert if the patient fall risk is 25-50.
  • Bed rail alert is triggered – This can be configured using advanced rules to send (or not) a notification for patients whose fall risk is <25.

More importantly than sending alarms is the ability to use complex rules taking into account variables from multiple sources to determine when not to send an alarm to the mobile device. For example, data shows 85% of low SpO2 alarms self-correct in less than 8 seconds. Most middleware solutions can delay an alarm to dispatch based on a time threshold. However, they cannot take into account the value of the SpO2 to determine if it should be delayed to dispatch. Using advanced rules hospitals can decide to 'hold' the SpO2 alarm if <88% allowing time to self-correct, or send immediately if <=87%.

Bed rail down alert on a first generation application vs a next generation application
Can an alarm safety platform consider multiple parameters before triggering an alarm?

Ask any clinician and they will tell you that a single symptom or single data point rarely tells the story; a qualified diagnosis requires a trend or a pattern. This is especially true when you are dealing in high acuity environments where patient conditions can change rapidly. For example, understanding that a patient's pulse is increasing is extremely important (especially with a cardiac patient) but understanding that this is occurring coincident with a low potassium lab value is even more important as it could cause a run of premature ventricular contractions in a condition called Ventricular Tachycardia (Vtach).

Complex alarms and events involve applying advanced rules to multiple sources of data that help paint a picture of what is actually happening to a patient and to empower caregivers with the tools to intervene. In another common example, an advanced alarm safety platform like Extension Engage maintains awareness of the respiration rate (information received from a ventilator or nursing observation), current lab results (information received from the EHR or LIS system), and demographic information (from the EHR) and can provide the ability to send alarms conditional on certain correlating physiological events being met.

The clinical correlated signals originate from multiple sources and are aggregated by an intelligent, next generation alarm safety platform, like Extension.

What is the smartphone "app belt" and how does Extension streamline different workflows into one application?

As more and more software vendors are developing applications for smartphones, end users are finding themselves thrown back in time to the days where there was a separate device for handling different tasks. The common term for this is the "nursing tool belt." In a similar way, Extension has coined the phrase "app belt" as a way of highlighting the problem created by users that will have many apps running on their smartphones with no apparent way to make the user experience seamless and easy.

Hospitals must seek vendors that can integrate outside of their own application while holding the context of the patient and the security rights of the user across multiple systems. If caregivers are expected to log in and out of multiple apps, the efficiency gains desired will be lost and in some instances, the apps designed to help them will become burdensome.

One simple example is the Extension programming interface to seamlessly integrate with other mobile applications. This interface was developed directly for Extension users. This partnering and open architecture concept enables nurses using Engage Mobile to access third-party applications such as AirstripOne within a "single touch." Engage Mobile users have the ability to select the "waveform icon" in the upper right corner of the cardiac alarm notification opening the AirstripOne application with the accurate patient/time context.

Extension Engage's message queue on an iPhone
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Regulatory Directives Related to Alarm Safety

What are the existing regulatory directives related to alarm safety?

The Joint Commission (TJC) is an independent, not-for-profit organization that accredits and certifies more than 20,500 health care organizations and programs in the United States. Joint Commission accreditation and certification is recognized nationwide as a symbol of quality that reflects an organization's commitment to meeting certain performance standards.

The Joint Commission National Patient Safety Goal on Alarms (NPSG.06.01.01): Initiated in 2014, NPSG.06.01.01 addresses patient safety risks associated with clinical alarm systems. The NPSG focusing on safe clinical alarm management for hospitals and critical access hospitals includes a phased implementation with a full compliance date of January 1, 2016.

Hospitals had until July 1, 2014, to comply with Phase One of NPSG.06.01.01 by establishing alarm system safety as a hospital priority and identifying the most important alarm signals to manage. Hospitals have until January 1, 2016 to establish policies and procedures for managing the alarms identified and to educate staff and independent practitioners about the purpose and proper operation of alarm systems for which they are responsible.

NPSG.06.01.01 addresses clinical alarms that can compromise patient safety if they are not properly managed. This includes alarms from equipment such as cardiac monitors, IV machines, and ventilators that have visual and/or auditory components. In general, this does not include items such as nurse call systems, alerts from computerized provider order entry (CPOE), or other information technology (IT) systems.

The four Elements of Performance (EP) related to this prioritized safety goal include:

  • Input from a multidisciplinary team, comprised of nursing leadership, quality and patient safety leadership, physician leadership, biomedical and clinical engineering, and information technology. A senior administrator, such as a chief nursing officer or a chief medical officer should lead this effort.
  • Identification of alarms that put the patient most at risk if the signal is not attended to or malfunctions.
  • Establishing the alarm signals that most contribute to the overall alarm noise (causing a syndrome called 'alarm-fatigue'), and decide if these alarms are necessary at all. Appropriate documentation will be needed to demonstrate compliance when TJC does its survey.
  • Educate staff and licensed independent practitioners about the purpose and proper operation of alarm systems for which they are responsible.
What alarm safety trends have emerged in response to NPSG.06.01.01?

Recent discussions among the AAMI Foundation's HTSI Alarms System Steering Committee have changed the possible focus of the 2016 NPSG to expand beyond the definition and scope that currently includes only clinical alarms. The new scope may include events that cause "nursing interruptions". This is an acknowledgement that the scope of the problem is larger than just clinical or medical device alarms and suggests a more comprehensive plan should be established.

What are the risks of failing to comply with the NPSG for clinical alarms?

Healthcare organizations cannot afford to lose Joint Commission accreditation. Losing accreditation means the following to most hospitals:

  • Increased difficulty gaining a competitive edge in the marketplace.
  • Liability insurance costs will likely increase.
  • Staff recruitment and development is compromised making it easier to attract qualified personnel who prefer to serve in an accredited organization.
  • Negative recognition by insurers and other third parties; in some markets, accreditation is a prerequisite to eligibility for insurance reimbursement.
  • Potential need to undergo additional surveys and inspections.
Why do some solutions have an FDA 510k clearance and is it a requirement?

FDA 510k clearance is necessary for any alarm safety system that a hospital plans to integrate with medical devices, patient monitors, and ventilators. There is a notable distinction between "alerts" and "alarms" (refer to the "Alarms vs. Alerts" section of this document). Don't be fooled by vendors that only offer "alerting" and are reliant on third-party partnerships that have FDA 510k clearance for "alarm" management.

What are the existing regulatory directives related to event response?

The Joint Commission National Patient Safety Goal on Staff Communication (NPSG.02.03.01) addresses the need to report critical results of tests and diagnostic procedures on a timely basis to improve the effectiveness of communication among caregivers.

Given the complexity and sophistication of the caregiver role in today's hospital setting, safety demands that systems and processes be in place in order that critical information is not missed, and that it is communicated promptly and accurately.

Vital physiological changes, critical test results, and diagnostic procedures, which fall significantly outside of the normal range, may indicate a life-threatening situation. The intent is to provide a licensed caregiver these results within the established timeframe so that the patient can be promptly treated.

The Elements of Performance necessary to meet this goal require that each hospital must:

1. Develop written policies and procedures for the following:

  • Define the normal limits of vital patient physiological parameters.
  • Provide a definition of what constitutes a critical test or procedure.
  • Decide and define by whom these critical results (be it a physiological alarm, a critical test or diagnostic procedure) are reported.
  • Define what the acceptable length of time is between the availability of the result and the time it is reported.

2. Implement procedures for managing these critical results of alarms, alerts, critical tests, or diagnostic procedures.

3. Evaluate the timeliness of reporting the critical results

The multidisciplinary clinical staff is mobile, and so is communication between teams. To achieve and maintain optimal integrity of communication involving the patient, a holistic privacy strategy must be implemented when it comes to the use of mobile phone devices. When communicating the elements of physiological alarms, alerts, text messaging, critical diagnostic tests, and laboratory procedures, it is ideal when this communication takes place on one platform, rather than issuing this data in fragmented communication silos.

The Joint Commission National Patient Safety Goal to Identify Patients Correctly (NPSG.01.01.01) requires at least two patient identifiers when providing care, treatment, and services.

Human error is bound to ensue considering the amount of interruptions that occur during the course of a clinician's shift. These errors can have dire results for the patient. Therefore, at least two patient identifiers must be used when providing care, treatment, services, or written communication. The intent of this goal is twofold; 1) to reliably identify the individual as the person for whom the service, treatment, or communication is intended, and 2) to match the service, treatment, or communication to that individual.

The elements of acceptable patient identifiers may include:

  • Patient name
  • Assigned identification number
  • Telephone number
  • Date of birth
  • Or other person-specific identifier

Note that the patient's room number or physical location may not be used as an identifier.

What effect do alarms have on patients?

A noisy hospital is not an optimal healing environment for patients requiring rest. In addition, nurses report patient frustration at the bedside when their phone is ringing with other patient alarms and events. As a result, patient satisfaction can suffer if alarms, alerts, and messages are not properly managed.

The Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) is a standardized survey instrument and data collection methodology that is used to measure patients' perspective of hospital care. This national standard is used for collecting and public reporting information that enables valid, uniform comparisons to be made across hospitals to support consumer choice.

Three broad goals exist as the basis that shape the survey:

  • The survey is designed to produce meaningful consumer comparison of data among hospitals on topics that are important to the consumer/patient-family.
  • The sole action of publicizing reported data is to create incentives for hospitals to improve the quality of care.
  • The hospital HCAHPS score is associated with federal Medicare/Medicaid reimbursement. A higher score translates to a higher patient-family satisfaction of care and services provided. The higher the patient-family satisfaction of services and care - the higher the financial reimbursement.

When these concepts are applied to mobile technology of alarms, alerts and critical messaging, it is theorized, if used correctly, the caregiver will experience less interruptions, and have more time to spend at the patient's bedside. For example, using RTLS technology, Extension Engage can automatically escalate an alarm or alert if the primary recipient is with another patient, which reduces bedside interruptions. The attention to the patient-family results in better HCAHPS scores.

Does an alarm safety and event response platform comply with HIPAA security requirements?

Another communication directive concerning hospitals relates to security. The Health Insurance Portability and Accountability Act (HIPAA) is a federal Rule requiring hospitals protect patient information. The HIPAA Privacy Rule establishes national standards to protect individuals' medical records and other personal health information, and applies to health plans, health care clearinghouses, and health care organizations that conduct certain health care transactions electronically. The Rule requires appropriate safeguards to protect the privacy of personal health information, and sets limits and conditions on the uses and disclosures that may be made of such information without patient authorization.

Individuals, organizations, and agencies that meet the definition of a covered entity under HIPAA must comply with the Rule's requirements to protect the privacy and security of health information and must provide individuals with certain rights with respect to their health information. A 'Covered Entity' includes entities that process nonstandard health information they receive from another entity into a standard (i.e., standard electronic format or data content), or vice versa. If a covered entity engages a business associate to help it carry out its health care activities and functions, the covered entity must have a written business associate contract or other arrangement with the business associate that establishes specifically what the business associate has been engaged to do and requires the business associate to comply with the Rule's requirements to protect the privacy and security of protected health information. In addition to these contractual obligations, business associates are directly liable for compliance with certain provisions of the HIPAA Rules.

When applied to the concept of mobile technology of health communication, the privacy and safeguard of the information is paramount. Disparate systems may create room for error. A best practice is to maintain the integrity of patient data on one unified platform.

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Best Practices for Alarm Safety and Clinical Systems Integration

Why is patient monitor integration with an alarm safety system the best place for hospitals to begin?

Integration with patient monitoring is a basic requirement for an alarm safety system. Hospitals have realized their largest gains in addressing the alarm safety problem by ensuring that patient monitoring alarms are managed via a central platfom.

In most high acuity patient care areas, patient monitors are typically the largest contributors to the sheer volume of alarms. Patient monitoring is a challenging process; depending on the individual configuration of the monitor many will alarm for non-critically actionable events. While the information that is being provided to the clinician is "needed knowledge," it may not be contextually relevant to have an emergent action assigned to it.

At a large academic institution in the Northeast, Extension's research and analysis showed 91 percent of alarms were non-critical, and many non-actionable. Most alarms simply provided "knowledge" to the nurse. The nurse was able to maintain mobility (and vigilance of other patients) with a quick review of the alarm and context on his/her phone versus having to go to the patient room to check on the alarm situation.

An alarm safety system serves as a single source for alarm distribution by proactively coordinating alarms and notifications from numerous sources including patient monitors. This workflow eliminates alarm and notification conflicts and ensures communications are routed to personnel based on bed/patient assignments and a clinician's proximity (i.e. proximity context). Beyond that, notifications can be routed based on a clinician's licensure or specialized skill sets (i.e. care team context). Consider this example: the intelligent alarm capabilities of an alarm safety system can help implement a best practices alarm fatigue reduction initiative by sending the third "leads-off" alarms in a defined time period to a telemetry technician or nurse specialist trained in and dedicated to daily cardiac electrode changes.

Integration to patient monitoring always requires an FDA 510k clearance from your alarm safety vendor.

Medical device alarm notification diagram
How does an alarm safety program support a hospital's "War Room" for remote patient monitoring?

Hospitals have experimented with a variety of solutions to determine the validity of a patient monitoring alarm over the past few decades – utilizing remote monitoring 'war rooms' is just one of those tried solutions. The monitoring techs have in view a number (24-60) of patient monitoring displays and their role is to determine whether or not an alarm is legitimate, and to contact the nurse responsible for the patient in the event that it is real.

The primary advantage of such an environment is the reduction in alarm fatigue for the primary caregiver. This type of initiative can also improve the response time and eliminate the failure to respond. The monitor watcher approach does not alleviate the need for secondary alarm notification solutions as part of an overall alarm management and mobility strategy. In fact, by automating the process, next generation alarm management platforms in conjunction with monitor watchers have proven to reduce the number of alarms reaching the caregiver by 55-70% over first generation alarm management platforms alone. The combination of automatic escalation with the process also increases the response time to life critical events without relying on a series of phone calls.

However, this type of solution has its own set of challenges including costs and lack of trained techs/high staff turnover. Tim Gee, Principal at Medical Connectivity, has provided a comprehensive summary, which includes comments from industry leaders such as Maria Cvach at Johns Hopkins.

If hospitals decide to leverage alarm management platforms as a replacement of monitor watchers, it is imperative they choose a company that has a deep understanding of clinical workflows, patient monitoring systems capabilities, deep understanding of alarm fatigue issues, and overall sound clinical judgment.

Why is nurse call system integration necessary for any comprehensive alarm safety program?

Integration with nurse call systems is a popular starting point for most alarm safety projects. By definition, nurse call is designed to interrupt the nurse to get their attention so the nursing staff can service the patient request or respond to a patient initiated crisis such as chest pain or shortness of breath. In accordance with AAMI and ECRI guidelines, interruptions and alarms need to be managed using a unified approach otherwise alarm collisions will occur as the nurse tries to make sense of everything coming at them at once.

While basic nurse call systems can assist in improving patient care, an advanced alarm safety solution enables a comprehensive clinical event response workflow that intelligently regulates alerts (like nurse call alerts) and alarms (like patient monitoring alarms) and facilitates care team communications from a single system. Implementing a comprehensive solution establishes a central point of management for hospital-wide clinician and staff alarm notifications, and would avoid redundant, silo-based investments in additional systems to address gaps in both patient care and care team communication.

Nurse call vendors have more recently moved in the direction of offering features similar to alarm safety systems but the biggest limitation of nurse call vendors is that they do not carry an FDA 510k clearance and are not able to provide comprehensive message-based interfaces to key medical devices such as patient monitors, ventilators, IV pumps, and pulse oximeters. At best, they provide a "dry-contact" style interface that simply provides an indication that some type of alarm has been triggered but cannot provide the detailed data and context about the alarm or event.

Nurse call alert diagram
How is EHR data leveraged by an alarm safety system?

Most hospitals have made a substantial investment in an enterprise EHR. EHRs are great at capturing and storing data but "mobilizing" this information has been a challenge for many EHR vendors. Alerts generated from most EHRs are made available to users that are logged into the EHR system and all EHR work requires that a clinician be logged in. EHRs are not designed to automatically "push" notifications to clinician's mobile devices. For example, the availability of a critical lab result would not automatically notify the intended recipient. Clinicians often wait at a computer refreshing the screen over and over again to see if a lab result has been entered.

An advanced alarm safety system offers the ability to consider the most important EHR "signals" and delivers them to the most appropriate caregiver on their mobile phone along with necessary event context. In the case of a lab result, the message could also include information about the patient's recent labs or trending enzyme levels.

In order to achieve a greater degree of situational awareness it is recommended that an advanced alarm safety system integrate bi-directionally with all EHRs to aid in the clinical documentation compliance process. Nurses are required to provide documented evidence of consultation as needed between the RN and physician such as progress notes, countersignatures of physicians, use of consultation forms, chart notes, and copies of letters requesting consult. In any of these cases, the audit trail of communications can be automatically integrated into the patient's chart. The primary interface to EHRs is via the HL7 protocol.

EHR extension diagram
How is the assignment managed in the current system? (i.e. Nurse Call or EMR)

Your alarm safety system should support the importing or synchronization of staff assignments from multiple systems such as nurse call or your EHR. The best practice calls for a hospital to breakdown system "silos" and utilize a unified staff assignment client and standard integrations between different vendors as necessary. Commonly supported vendors that provide a staff assignment synchronization function include Rauland-Borg ResponderSync, Hill-Rom Navicare, West-Call, and CareLogistics. Extension can work with you to reduce the hospital's reliance on a fixed staff assignment model.

The staff assignment process has changed over the years. The legacy first generation concept of simply assigning a device to a nurse with an escalation path no longer applies or requires too much maintenance. Today, we think more about clinical roles, assignments and mobility.

Can this work with our existing phone systems?

The alarm safety system should be able to leverage the considerable investments your hospital has made into an enterprise Unified Communications (UC) system.

While text messaging is a separate and distinct function on most in-house wireless devices (different messaging protocols than those used for voice connectivity), the appropriate response to the alarm event may be a voice call to another care team member or the patient and the alarm safety system needs to be integrated seamlessly with the voice capabilities of the caregiver's wireless device.

Can an alarm safety and event response platform integrate hospital wifi devices as well as BYOD smartphones?

Many healthcare facilities have struggled to find a single phone or end point device that works for all roles and use cases within their organization. The desired type of end point device varies significantly from site to site. For example, some organizations require their environmental services department to take a picture of the room to document room readiness while others provide pagers due to their durability.

The overall trend in healthcare is rapidly moving to providing smartphone devices for direct care providers, especially as more healthcare software vendors develop applications related to patient care. It is unlikely that all staff members will have smartphone devices or that any single device will work for all members of the care team. The ability to communicate via voice and text messaging across hybrid phones and end point environments is vital to care team collaboration.

Extension Engage is the only alarm safety and event response platform that enables bidirectional communication between hospital-distributed wifi phones and BYOD smartphones.

Group of phones
Can an alarm safety system integrate with a Medical Device Connectivity Integrator?

Medical Device Connectivity vendors such as Capsule Technologies, Nuvon, and NantHealth (iSirona) aggregate data into their own central Medical Device Connectivity (MDC) server from many different medical devices across all care areas for the purposes of automating clinical documentation. These capabilities are often described as "feeding streams of data to the EHR." MDC vendors write either standard or proprietary device drivers in order to communicate with each of the medical devices directly or they communicate via vendor-specific device gateways such as a Philips monitoring server or ventilator.

When these device drivers are developed, tested, and validated, the driver typically collects all data from the devices including alarm data. The alarm data can be separated into a separate data stream at the central MDC server and then sent to the alarm safety system via the HL7 protocol. An alarm safety system should be able to take data from any of the MDC vendors. Another important point about MDC vendors, although no longer required by the FDA, they typically have secured either a class I or class II FDA 510k clearance and therefore they require general controls, which sufficiently manages the risk for these classes of systems.

How many alarms should a nurse or other caregiver receive during a shift?

Studies show that in a typical critical care unit there are up to 700 alarms per patient, per day and between 85 and 99% of these alarms do not require a clinical intervention. It goes without saying that clinicians – while incredibly intelligent and organized – do not have the cognitive ability to effectively process all of these incoming alarms, nor should they be expected to as most of these do not require action.

In another study published in Anesthesiology focused on a general care setting at Dartmouth Hitchcock Medical Center (NH), nurses answering the question "how many alarms are tolerable from a human factors standpoint to avoid alarm fatigue?" responded that two to four alarms per patient per day was the limit.

Can a secure text messaging company perform the necessary functions of an alarm safety platform?

The key is to ensure that your hospital's text messaging strategy is aligned with your clinical workflow objectives. Vendors that offer just secure text messaging or "HIPAA-compliant messaging" typically do not have the ability to integrate with many devices and systems, they do not carry an FDA 510k clearance, they cannot provide important contextual data, and they do not have an intelligent workflow and advanced rules engine.

Nurses receive alarms, alerts and messages from different sources and systems. Without a unified system to manage the alerts, alarms and messaging, all of these will be received in an uncoordinated way – which results in alarm collisions. Users will experience different fonts and screen presentations, even different apps – usually without important context. Nurses must then sort through all of the messages and alerts and perform their own prioritization and organization of the information on the device. Spending time organizing a high volume of alerts and messages takes away time the nurse could be spending at the bedside.

It is also worth a strategic check to ensure that your hospital's text messaging strategy is aligned with your current infrastructure investments. Your long-term goals for facilitating healthcare delivery collaboration cannot happen on an island of smartphones – much of the benefits of mobile clinical communications will be enhanced through enterprise integration with the range of unified communications services and devices used by both mobile and desktop users in non-clinical workgroups throughout the enterprise. A common platform for provisioning, directory and security services will have a measurable benefit in the total cost of ownership.

An alarm safety system enables you to configure all alarms, alerts, and messaging to be managed by a single platform. Information can be coordinated and prioritized properly based on advanced rules that control the flow and volume of information to the nurse. Not all messages are critical in nature, and alarms (e.g. vent alarms) should be more important than most alerts (e.g. low level nurse call requests). Text messaging should be properly integrated into a hospital's alarm management strategy so that it helps solves the combination of clinical workflow problems and also enhances care team communications. If these systems are not managed properly and carefully coordinated in a hospital, the more dangerous it is for patients. The last thing anyone wants is finger pointing to other systems or "it's not my responsibility." If all these disparate systems are brought together there is a significant risk to patients that must be mitigated and understood. This becomes much easier when it is only one vendor or solution.

How long will it take to fully implement an alarm safety program?

The overall timeline is directly correlated to the project scope and the hospital's resource availability. A good rule of thumb for a 300-bed hospital with 3 workflows is roughly 16 weeks. Workflows typically include integration to a specific system such and nurse call, patient monitoring or EMR. For example, a Medical/Surgical acute care unit with nurse call integration is a workflow; a CCU/MICU and SICU with patient monitoring and nurse call integration is another workflow. The expected 16-week duration begins when the Statement of Work (SOW) is finalized and the customer kick-off is conducted. A generic project implementation and customer lifecycle timeline is represented the below figure.

Accredited hospitals have until January 1, 2016 to comply with The Joint Commission's NPSG on alarm safety, which includes continuing education and illustrating progress on their alarm safety programs. However, alarm safety programs are not one-time events. The specific process improvements will vary by hospital, but initiatives should be ongoing to measure progress and revise as necessary. A successful alarm safety program will require patience as stakeholders work to identify and measure the relevant clinical systems and medical devices in each department.

Organizations are always finding new uses for notification and communication systems. Extension encourages expanding the utilization of its platform. However, any implementation should be tailored and deployed in manageable pieces. Additions and changes should go through an internal change control process to evaluate the benefits and costs of any additional workflows and/or advanced rules.

As long as there is good documentation of the use cases, configuration, and intended benefits, the rules will remain manageable. It's a matter of being able to manage the deployment and ensure the rules and workflows that are being added are providing benefit and not contributing to notification fatigue.

Can we add more improvements and workflows over time?

Best practices support integrating workflows or use cases over time. Extension recommends starting out with standard, simple use cases such as nurse call and patient monitoring because of high and immediate impact on nursing workflow and reductions in interruptions. As the clinical staff becomes comfortable receiving secondary notifications to their mobile devices your hospital should consider adding additional use cases and more complex rules.

Extension clinical and technical consultants will work with your project team(s) over time to identify ways to optimize the utilization of the Extension Engage alarm management and event response platform. Optimization will include adding additional workflows, adding rules to current workflows, and moving beyond traditional alarm management methodologies. Your technical system administrator or the Extension technical consultant can make any additional configuration changes required. The Extension platform does not require custom scripting to obtain advanced workflows or complex rules.

Do I need an alarm safety committee if my hospital is not accredited by The Joint Commission?

Any hospital concerned with patient safety, staff retention, and patient satisfaction should be addressing the alarm and interruption problem, regardless of an accreditation requirement.

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Deployment and Maintenance of an Alarm Safety System

What are the objectives of a successful alarm safety management deployment?
  1. A decrease in response times to alarms
  2. An increase staff communication efficiency and satisfaction
  3. A measurable increase in patient safety and satisfaction
  4. A reduction in alarm fatigue/noise/interruption fatigue
  5. Provide comprehensive data for reporting and analytics necessary for process improvement and tracking progress.
What criteria should be followed to establish a successful alarm safety management deployment?

Resources – Project resources, clinical, technical, and project sponsors are clearly established during the initial stages of a project and are engaged and committed throughout the implementation lifecycle.

Scope of Work – Projects have a tendency to fail when the specific deliverables are not clearly defined early on during the sales process. It is critical to agree upon the scope of a project and stick with it. Changes typically require additional effort and costs. Changing direction midstream should be avoided at all costs. When changes are required, they should be thoroughly discussed and follow a change management process

Project Execution – The saying goes "Failing to plan, is planning to fail." Underestimating the required effort of a communication project may have a devastating effect. Faster doesn't necessarily help you realize your goals sooner. Developing a well thought out plan and sticking to it typically results in a better experience. A project has a greater opportunity for success when it is executed properly, the first time; as opposed to fixing the damage created by a poor project experience.

Project Sponsorship – One of the primary reasons projects do not succeed is a lack of executive sponsorship and management oversight. The primary responsibilities of the project sponsors are to provide clear direction for the project, to secure necessary resources as well as to ensure that the project is on time, budget, and stays within the intended scope. This is different than the project manager whose primary responsibility is simply project execution.

Key Stakeholders – Projects require the necessary representation from key business groups that are all committed to project success. Key stakeholders include resources from departments including but not limited to project management, nursing, clinical engineering, and IT.

Flexibility – Being slightly flexible and open to change is important to a success. Professional service resources typically have years of clinical experience implementing alarm management best practices. Hospitals should be willing to listen, and understand the reasons and best practices, and then review opportunities to apply them to their specific situations. Trying to fit a new solution into current may not help hospitals realize your operational goals.

Change Management – It is not uncommon for the scope of a project to change after the project has begun. It is important, however, to recognize that it is in everyone's best interest to manage changes properly and to establish the process at the beginning of an engagement. Changes must be fully vetted and approved by all parties. The change request will clearly state the additional effort, time, and associated costs, if any.

What leadership roles should be involved in deploying an alarm safety management system?

In a project of this magnitude and the criticality of an alarm safety program in the hospital, it is important to have "buy-in" and accountability from all relevant departments. Depending on the size of project some of these may be combined but important specific roles are defined below:

Executives – Executives sponsor the project and ultimately have responsibility for the success of the project. Executives ensure that project stakeholders are identified and committed to the project.

Clinical Leaders – Alarm management solutions are highly configurable. Clinical leads are responsible for the clinical design of the alarm and alert management solution.

Biomedical/Clinical Engineering Leaders – These resources assist in medical device communication, necessary configurations, troubleshooting, and testing specific device connectivity.

Technical Leaders

  • HL7 Engineer – This role is required to support the integration of various input systems with the Extension solution.
  • Systems Analyst – This individual assist in planning, configuration, workflow analysis, and hospital communication.

Project Managers – Project managers keep resources, tasks, and timelines in check and ensure that project deliverables are met.

Telecom – The role supports configuration of the communication solution to all planned endpoints (Wireless VOIP, Smartphones, badges, etc.).

What are the phases of implementation?

Once a hospital commits to using advanced alarm middleware and unified communication to improve alarm safety processes they should consider these resources, milestones, deliverables and best practices to facilitate a cohesive partnership. With Phase 1 the sales cycle ends and there is a transition to professional services and an assigned project manager takes over.

Discovery Phase: The Extension deployment team is assigned and begins to collaborate with the sales team to ensure there is a full understanding of the engagement, Scope of Work (SOW), and customer needs. At this time a kick-off date is scheduled.

Initiate Phase: A kick-off call is held with the customer and key partners. The SOW is reviewed to validate the work to be delivered and to set expectations. The technical pre-requisites are discussed and a project timeline is established.

Design Phase: A clinical workflow assessment is conducted with the customer's clinical staff to assess the current processes and desired state. An impact review is achieved with key stakeholders and new workflows are finalized as well as a detailed project timeline.

Deploy Phase: The Extension appliance is installed and the solution is configured as defined by the clinical workflow assessment. User acceptance is then completed to ensure the solutions delivered are as expected. At this time, Extension training is conducted and the system goes live.

Activation Phase: The fifth phase is one of the most rewarding project phases. The system is almost ready for clinical use and clinicians will begin to see the results of their hard work. During this phase key milestones are completed such as the User Acceptance Testing (UAT), mobile readiness assessment, user training, and the go-live plan is finalized.

Closure Phase: The deployment team and customer conduct a "lessons learned" session and any outstanding items are addressed. During this step a project closure document is signed by both parties.

Post Implementation: Both a 30 and 60-day "wellness check" is conducted to analyze the system and support status. Also, at this stage Extension tracks and reports on staff utilization and addresses potential customer requested workflow changes. Additional functionality is explored during this stage as requested by the customer.

What are the hospital's resource commitments?

The time commitments of the implementation team will vary over the course of the project; however, Extension does not anticipate any one individual spending more than 0.25 FTE on this project at any given time.

Does the hospital need to hire a project manager?

Typically project managers are dedicated to the implementation team for about 0.25 FTE for the duration of the project. Some sites retain the project manager at a 0.15 FTE long-term to manage change control process as sites add additional workflows, change or add rules, change or add units, etc.

What ongoing resources will be required after the project is complete?

IT departments typically assign a System Administrator to support, troubleshoot, and help with ongoing system maintenance as necessary. Depending on the size of the hospital this is typically up to .25 FTE.

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Quantifying the Value of an Alarm Safety System

What are some ROI considerations for an alarm safety system?

There are many areas hospitals that realize a return on their alarm safety investment. Some of the considerations are as follows:

  • Improved clinical communications, care team collaboration, and care coordination
  • Reduction in clinical errors such as medication preparation and administration
  • Reduction in patient misidentification
  • Improved physician satisfaction and physician referrals
  • Reduction in order/lab delays and repeat orders/labs
  • Greater patient throughput
  • Improved bed management
  • Greater return on investment of existing IT and clinical systems
  • Reduction in IT cost and administration
  • Increase HCAHPS scores
  • Less risk of HIPAA violation
  • Greater likelihood of compliance with TJC NPSG.02.03.01
  • Reduction in nursing steps and physical and mental stress
  • Reduction in nursing overtime costs
  • Less risk for adverse events, reducing alarms floods
  • Real-time data that can be used to reduce risk and improve clinical workflow.

The exact dollar value saved for each hospital will vary given different organizational objectives and by what specifically is measured. For example what is the ROI for a 25% increase in HCAHPS scores? This highlights significant value of an alarm and event management and event response solution that may not be measured in dollars. Extension is constantly working with customers to show these value metrics.

The total cost of ownership (TCO) varies by hospital or by hospital system. Below are some general items to consider as you explore your options. Extension's goal is to educate, inform, and arm you with information to share with others at your hospitals.

For most alarm safety and event response solutions there are several areas of cost that contribute to the TCO:

  • Licensing
  • Adaptor or connector licensing
  • Professional Services
  • Training
  • Project Management
  • Maintenance
  • Whole-version upgrades
  • Hardware and computer servers
  • Adequate network and wireless infrastructure – coverage, capacity, and security
  • End devices such as phones, pagers, accessories (e.g. charging stations)

Extension believes that keeping things simple is best for the customer; therefore, Extension bundles costs into 3 categories:

Licensing – A perpetual license to utilize the Engage platform based on the number of clinical workflows you want to implement including expansion of new use cases and workflows. Extension Healthcare charges licensing on a per-bed basis but not all vendors charge this way. Options are available for an unlimited number of workflows and also for enterprise software licenses that cover all licensed beds.

Professional Services – This item includes all of the services needed to get your system working to your expectations including technical implementation, project management, planning, scoping, workflow design, training, customer user acceptance testing, go-live support, and scheduled wellness checks after go-live. It is important to note that clinical leaders should be involved in every phase of an implementation. See the graphics below showing a nurse in every phase of the project.

Maintenance – This is called "Extension Assurance" and covers all support needs (24/7/365), maintenance including in-version and whole-version software upgrades, bug fixes, third party adapter updates and hardware replacement in the event one of your appliances fail (for those customers not using a virtual machine environment).

Additional internal costs should also be considered for a hospital. This answer varies from hospital to hospital since it depends on the size of the hospital and the number of alarm and event response workflows the hospital is utilizing. Extension Healthcare - as part of the maintenance program - provides many of the resources needed to maintain the system; a common scenario is for a resource in IT or applications to be trained as an administrator of Extension Engage. This person can then handle most of the simple administration needed to maintain day-to-day operations.

Assuming a multi-workflow or enterprise license is purchased, we do not charge extra licensing when you implement additional workflows or adapters aimed at achieving greater value from your alarm safety and event response platform. When expanding your deployment there will be professional services fees based on the scope of work.

How much of your investment can be attributed to compliance with The Joint Commission NPSG's?

If you are an accredited facility by The Joint Commission, in theory, all of your investment can be attributed to compliance. Described in greater detail below in the Departmental Budgets section, an alarm safety platform solves many diverse problems allowing the costs to be allocated to many different departments including:

  • Nursing
  • Application
  • IT/Telecom
  • Bio-Med/Facilities
  • Safety and Compliance

The Joint Commission National Patient Safety Goals are having a big impact on the alarm safety and event response space. Extension's team can help you decide how the budget can be allocated, TCO, long-term costs, and more.

What is the value of having clinicians on staff?

An alarm safety and event response platform involves clinical systems, clinical workflow, and is most used by nurses. Therefore, the clinical design and workflow best practices are a critical component of the "right" product being created, sold, and implemented in the "right" clinical situation. A few of the areas where Extension has found clinical staff to be invaluable contributors include the executive level (CNO or CNE) as well as clinical solution architects (pre-sale), clinical implementers (post-sale), clinical product managers (product design), and clinical trainers (implementation).

A conundrum in the alarm safety space, and health information technology space as a whole, is that healthcare is becoming more technologically and software-driven. Many software companies rely on software developers to design the solutions, but clinical software, for the most part, should be designed for clinicians, by clinicians. While software developers must be part of the process, companies that do not have clinicians heavily involved are likely to miss the salient aspects in creating great software for clinicians. This is especially true for alarms and alerts as they typically originate from a patient event – often serious in nature.

It is important that clinicians be an integral part of all processes including software and product design, sales, implementation, and training. If the vendor you are working with does not have clinicians involved, ask why and make sure you are comfortable with the alternative.

Why are costs not operationalized?

The trend of operationalizing costs does not apply to advanced enterprise alarm safety and event response platforms. There are many reasons for this including the cost of regulation, the cost of maintaining compliance, changing market dynamics, and changing technologies such as medical devices and mobile smartphones. After many years of selling enterprise platforms to US hospital systems, Extension has come to realize that most prefer to own a license to the software as opposed to an operational model.

Extension Engage is an FDA Class II regulated medical device requiring Extension Healthcare to follow strict software development and product development processes and to incorporate advanced quality assurance measures. The benefit to the hospital is that the system has been developed to meet these high standards and quality is much higher than it would be otherwise. The substantial investment in quality assurance and regulatory compliance makes offering a model that is funded month-to-month increasingly difficult for any solution provider.

Hospitals must also differentiate SaaS from a hosted model. Extension Engage can be centrally hosted but is not delivered, from a cost perspective, as a service. It is sold and delivered as a perpetual license meaning the hospital system owns a license to use the software as they see fit and they own this for life (some restrictions apply). Extension does not charge additionally for whole-version upgrades if the hospital is an active Extension Assurance customer. As a result of the regulatory impact, nearly all of our customers pay for annual maintenance to ensure compliance, version upgrades to the core software, and updates to adapters.

What departmental budget pays for an alarm safety solution (Clinical, Applications, Biomed, Facilities, IT, Telecom)?

There is a saying in healthcare, "If you've seen one hospital, you've seen one hospital". No two hospitals are alike. When it comes to alarm safety, Extension has seen budgets come from every department in a hospital including applications, nursing, IT, telecom, biomed, and facilities. One way to help understand is to ask, "What is the motivation for solving our alarm safety, event response, and messaging problems?"

If the answer is "safety", then nursing, compliance and regulatory budgets could be the right answer. Adding to this possibility is The Joint Commission National Patient Safety Goal 06.01.01 on alarm safety. Since 83% of acute care hospitals in the US are accredited by TJC, we anticipate that many of those hospitals and systems will use regulatory budgets for an alarm safety and event response platform.

As a software platform, funding for the Extension solution may also come from the software application budget. Similarly, some hospitals have utilized their IT and telecom budgets (as the solution typically involves sending alarms and alerts to telephones and other mobile devices).

Finally, more budget dollars are coming from biomedical engineering and facilities especially with new hospital builds. Clinical engineering/bio-med is increasingly responsible for devices outside of physiological monitors, pumps, and ventilators including beds, bed management, and nurse call systems, resulting in some budgetary dollars to aid in solving issues related to alarm safety and event response.

In general, budgets for an alarm safety and event response platform come from:

  • Nursing
  • Application
  • IT/Telecom
  • Bio-Med/Facilities
  • Safety and Compliance

Regardless of where your budget originates, our team can help you and your decision-makers determine the best use of limited funds to drive compliance for National Patient Safety Goals, improve safety, and improve satisfaction and communication among valued caregivers.

Should I be purchasing for future needs?

Yes, as healthcare technology changes frequently and legislative and regulatory mandates also remain dynamic it is crucial to purchase a solution that can grow with your hospital's needs over time. Many hospitals begin with a single or several workflows, or use cases, and then quickly realize the benefit of an alarm safety and event response platform for satisfying their full range of needs. Some progressive hospital systems will find new and creative ways to use a flexible and extensible platform such as Extension Engage. Hospitals often realize that it makes sense to approach alarm safety from an enterprise perspective and they elect to purchase all licenses up front so that they can proactively build out their infrastructure to support an enterprise-wide alarm safety system.

A good example of changing regulatory needs is The Joint Commission National Patient Safety Goal on alarm safety (NPSG.06.01.01). While the first phase mandates that hospitals address the issue of alarm fatigue as it relates to physiological monitors and ventilators, subsequent phases are expected to include all nurse interruptions. It is important to select a platform that not only meets the immediate needs of the 2016 National Patient Safety Goal, but all nursing interruptions that come from other sources such as nurse call systems, lab systems and the EHR.

The Joint Commission also issued a complimentary R3 Report that explicitly describes the alarms that are targeted in the initial phase of the National Patient Safety Goal. Again, Extension believes – as do other industry groups, forums and advisory boards – that more industry guidance and regulation is forthcoming. Extension is actively participating in alarm safety industry forums and is helping to shape the future for how alarms, alerts, and clinical interruptions will be managed.

Alarm safety solutions improve clinical and patient workflow. If you have served in an acute care setting for any period of time, you recognize that workflow can always be improved and there are always new problems to solve. A flexible alarm safety platform can do just that – solve problems that might not exist today. By implementing an alarm safety solution you may soon recognize that the problems you thought did not have a solution now do – that is the magic of a well-designed, flexible and extensible alarm safety and event response solution. The number and type of problems that can be solved are limited only to your creativity in solving workflow challenges.

Extension Healthcare's clinical and technical teams are available to discuss your specific hospital situation and assist to understand the evolving needs of an alarm safety solution, as well as the current and future regulatory environment. The team can describe compelling use cases that Extension's 200+ hospital sites are using today as well as future solutions that are on the horizon. Some of these workflows and use cases solve problems that cannot be resolved by first generation solutions.

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Staying Ahead Of The Curve - The Future Of Alarm Safety

What should we be planning for now?

Alarm safety and event response has emerged as a distinct and dynamic market segment – quickly changing due to evolving technologies that impact patient safety, enterprise communications and collaboration, clinical workflows, the regulatory environment as well as facilitating new ways to use existing technology never previously considered. It seems like these changes happen weekly – preparing for them is a wise investment strategy.

Currently, the goals outlined by NPSG.06.01.01 focus all eyes on medical device alarms, patient monitoring, ventilators and IV pumps. This should be a continuous and measurable process that extends beyond the TJC January 1, 2016 deadline. With new reports published monthly on other interruptions and real-life incidents, what do hospitals focus on next? Orders (CPOE events), lab results, overhead paging, and text messaging are nursing interruptions that could directly impact patient care and the overall patient experience.

Many hospitals are focusing narrowly on a single challenge such as secure texting or alarm data collection when a comprehensive strategy for solving both challenges is more appropriate. While recognizing the importance of rapidly addressing current user needs, Extension encourages hospital leaders to take a step back and look at the bigger picture; managing alarms, alerts, and other disruptive occurrences as they are inextricably linked with the ability to respond and collaborate in a meaningful way with other caregivers.

How will context evolve to support next generation clinical integration?

Context will continue to drive future architecture and the evolution of Extension's interoperability partner initiatives. The vision extends beyond the tactical competitive need to maintain an advantage over alternative solutions. In early work to graft contextual data sources into the central rules engine, Extension sought to overcome the dangerous limitations of first generation alarm management where too many non-actionable, non-specific alarms lacking context presented inherent risks to patient safety.

Context-enriched clinical alerts advise the clinician's response. By enabling a more rapid processing of priorities, context can have an enduring effect on the productivity and efficacy of front-line clinicians. As it relates to middleware, or alarm safety and event response solutions, context is one difference between first generation and next generation platforms.

An example of a first generation (i.e. basic) alarm is a notification to a clinician that an event has occurred in room 201. While it is good to know that an event is taking place the clinician may not have any other information about the event - who the patient is, their acuity level, special needs, why they were admitted, or the criticality of the event.

For many traditional alerting vendors, context has become a "me-too" or a way to check a box based on nothing more than an ADT feed. The next area for further development will be to expand on the use of context to take direct aim at the "specificity problem" in alarm notifications. Extension will work more closely with customers to develop conditional rules to improve specificity of selected notifications.

This builds on Extension's central design principle that the best thing we can do is not send an alarm unless it is actionable; otherwise it is an unwarranted nursing interruption. Extension works with hospitals and its interoperability partners (i.e. third-party technologies) to design hospital-specific solutions that reduce alarms and alerts. This means Extension is open to acquiring and referencing more, richer sources of data to deliver more intelligent alarms and alert notifications.

The most tangible and valuable clinical deliverable Extension can drive from its technical architecture (the rules engine, dynamic datasets and data aggregation capabilities) is the ability to take a patient monitor alarm and qualify or disqualify based on all other information available. The continued refinement of the rules engine is central to this next phase of Extension's evolution.

PVC alarms are a good example of how advanced rules can further assist caregivers. If there was a lab result earlier in the day that indicated low Potassium level (K<2.5 mEq/L), and then PVC alarms changed to non-sustained Vtach alarms, a nurse would want to be notified; otherwise, PVC alarms are a major source of nursing "alarm fatigue. The use of timely clinical context with labs, vitals and arrhythmia’s along with flexible customizations for advanced rules would significantly reduce non-actionable alarms.

Are multivariate alarm notifications on Extension's roadmap?

One system enhancement to the Extension Engage platform under exploration is to leverage multivariate alarm notifications. An example is the specificity of multi-lead ECG monitoring for ST elevation changes that may indicate serious injury to the heart muscle, setting off a life-threatening cardiac alarm. One specific scenario would be a multivariate ST alarm notification, enabled by analyzing data from a physiological patient monitor. Using the ECG diagnostic parameter(s), one can measure signal changes from the multiple views of the heart, such as inferior, anterior, and lateral walls.

Findings from several clinical studies specifically point to this unmet need (i.e. multi-lead monitoring). A report by a clinical cardiology task force summarized it this way: Technologies that can operate across multiple vendor systems to dynamically monitor and correlate alarm signals from these multiple sources aid in meeting an American Heart Association recommendation. It references an ECG patient monitor recommendation that "...monitors should be capable of simultaneously displaying and analyzing two and preferably three or more leads."

The benefits of multi-lead monitoring include discrimination of noise and artifact from true beats, reducing false and non-actionable alarms; and improved clinical system resiliency for uninterrupted monitoring even in the presence of electrode contact failure.

How can an alarm safety system faciliate clinical decision support?

The term Clinical Decision Support (CDS) is used over such a wide spectrum of clinical applications that it's definition is frustratingly imprecise. CDS systems may be used to generate symptom-based orders sets, identify potential drug-drug interactions, signal a pattern in cardiac rhythms, and even recommend optimal reimbursement codes. Extension's future opportunities within the CDS category suit its goal of reducing the frequency of non-actionable interruptions by improving the specificity of common event notifications. This may be enabled through two broad categories: advanced context and policy changes (e.g. Specific SpO2 or vitals alarm notification policies for patients receiving opiates); and multivariate alarm notifications.

The current challenge is quickly updating these decision systems with the most current data from multiple systems. These are the same input systems and analytical requirements that an alarm safety and event response platform requires to manage complex alarms. Since clinical decision support systems are managed in parallel to complex alarm safety systems, a shared knowledge base would be appropriate. With many common system requirements, a complimentary solution seems reasonable to quickly change treatment plans based on the most current observations.

How will clinicians use smartphones to support patient care in the future?

Both nurses and physicians value the same advantages that smartphones offer consumers – the ability to run a suite of specialized productivity applications on a single device without experiencing the interruptive friction of moving from one app to another. A frictionless user experience will improve the performance of common daily activities. Clinical users expect:

  • Simple access with single sign-on where clinical context is preserved.
  • Multiple best-in-class apps operating seamlessly on one device/screen.
  • A mobile tool with immediate access to all necessary information.

The need starts with unified sign-on but requires a deeper level of shared application context. If a patient is selected in one application, the application context must persist throughout a clinical workflow (physician or nurse). This level of context must consider the dimension of time and care modality (e.g. Cardiac; Orthopedic, etc.).

For example, a nurse who is managing multiple patients by focusing primarily on the most current vitals and alarms as well as also diagnostic care plan requirements, physician orders, and labs. Mobile devices are the most effective and efficient tools, and access to these tools will facilitate faster user adoption.

Consider physician patient assignments: associating themselves with their assigned patient list including the ability to maintain patient assignments, order entry tools, current vitals, procedure scheduling, waveform strips, referral/consult management, reference tools and other diagnostic tools requires a deep-level application integration and vendor collaboration to connect everything seamlessly. At the center of the mobile clinician's digital communication strategy is an alarm safety platform capable of this type of integration.

Can an alarm safety system perform predictive modeling functions?

One of the central user interface design considerations of the current Extension platform is that it does not wait for a user to explicitly ask for information. Instead, with knowledge of the patient and clinical event type, it uses its underlying predictive model to identify information that is most likely to be relevant at each decision point. The Extension Engage platform works continuously in the background to proactively find and refresh this information - from across the unit or from a centralized EMR database.

As a key component of any application that attempts to understand task sequence and domain workflow, predictive modeling will continue to be leveraged to extract meaning from ambient clinical events, physiological values, location and proximity data, trends, and conversations. Most of us have observed these statistical techniques can be far from perfect, but there are advantages gained by limiting focus to event response in hospital and care delivery environments. These capabilities will help optimize clinicians' time and reduce delays in the delivery of patient care. The immediate value of this unique anticipatory computing environment also benefits and improves adoption by front-line event response staff.

Can an alarm safety system provide reports to measure the frequency, location, and types of alarms generated?

Retrospective interruption reports are typically the most requested type of reporting. They are mainly used for policy review and analysis and are usually analyzed over certain increments of time (weeks, months, years). There are three common use cases for these types of reports:

Alarm Baseline – Safety committees and/or Biomedical Engineers need to establish a baseline alarm assessment for The Joint Commission. Reports like this are commonly collected for a 30-day duration and for several departments within the hospital. These reports help answer questions like:

  • What alarm data are we or should we be collecting?
  • Can we or should we collect it again?

Impact Assessment – Patient safety and/or quality committees use these reports to review interruption types and compare alarm safety and interruption progress. These reports help answer questions like:

  • Are policy changes working?
  • Are nurses reacting to more or less interruptions since certain workflow changes were implemented?
  • What should we do about interruptions from the nurse call, CPOE, lab systems, etc.?

Root Cause Analysis – These reports provide a root cause analysis for specific patient incidents and episodes and a thorough understanding of why something happened.

  • Did a nurse receive the first alarm? Were there subsequent alarms? How long did it take?
  • What was the clinical response to an event?
  • Were there other alerts or alarms that would have impacted the response time?

Currently Extension provides basic reports but will offer more advanced retrospective reporting in the near future.

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Additional Alarm Safety Resources

At a national level, there is intense focus on problems related to patient safety especially alarm fatigue. In this report you will find educational material created by authoritative resources addressing the causes of alarm-related incidents and the implications hospitals and patients incur when alarm notifications and event responses as well as other nursing interruptions are not properly managed.

The Joint Commission

AAMI Foundation HTSI

AACN

ECRI

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