Clarice Balconi Lamica 500Technology within hospitals has changed dramatically over the years; new devices with countless bells and whistles have appeared on our ward floors and within our treatment areas. Besides the new challenges of interoperability and device integration, the actual bells and whistles themselves have become a top concern for clinical engineering and hospital management. In recognition of the risk of rampant, unmanaged alarms in the clinical environment, within the past 9 years ECRI Institute has named alarms its top health technology hazard six times—and the number two hazard three times.

In 2013, The Joint Commission addressed the importance and significance of alarm management by instituting National Patient Safety Goal (NPSG) 06.01.01 to improve the safety of clinical alarm systems. This NPSG included four Elements of Performance (EP). The first two were implemented by deemed status hospitals in 2014; the final two go into effect on January 1, 2016.

In order to “establish alarm system safety as a hospital priority,” (EP 1) leadership at the Greater Los Angeles (GLA) Veterans Affairs Medical Center chartered a multidisciplinary team in 2013 to perform a proactive risk assessment, or healthcare failure modes and effects analysis (HFMEA) on medical device alarm safety. With representation from the nursing, quality management, patient safety, logistics, and biomedical engineering departments, the group had an extensive breadth of knowledge and experience.

However, due to the team’s size and respective authority of its members, a straightforward process was difficult to draft and evaluate. After several months, the team regrouped with fewer members, and was able to complete a cohesive draft of the process and begin analyzing it for possible failure modes.

With input from clinical staff, nurses were identified as the key contributors to and enactors of medical device alarm safety (and the ones most susceptible to/affected by alarm fatigue, alongside patients themselves). The assessment revealed that the onboarding and orientation process for Nursing Service was incomplete: nursing preceptors were not equally prepared to teach novel staff, and overall, there was insufficient material specifically covering alarm safety.

The team established that nursing preparation would need to cover, but not be limited to: alarm sound identification by tone, volume, and frequency; implications of alarm severities, including correct actions to take in various scenarios; simple strategies to decrease alarm fatigue, such as tailoring alarm settings to each patient; and allowing new nurses to experience infrequent, high-risk alarm situations through simulated environments when a real-time clinical example was unavailable. Comprehensive training needed to be unit-specific, developed with major Nursing Service participation to increase relevancy. Through development of the simulation environment and orientation guidelines, the hospital identified the most important alarm signals to manage (EP 2).

In 2015, GLA leadership worked to establish specific policies and procedures for managing the significant alarms (EP 3) by instituting a clinical alarms management committee. As the draft charter was created, a small core group from the original HFMEA team (Nursing, Biomedical Engineering, and Quality Management) worked to produce a survey to study the alarm presence in the hospital.

The team made a list of the most common equipment that alarms in the hospital, grouped by area. A tick sheet was designed to manually count alarm events over 24 hours and determine whether each event was clinically relevant (ie, actionable) or not, both at the bedside and central station. (An automated middleware solution that could calculate the same data was unfortunately unavailable, as it had been purchased by the hospital but not implemented.) Results from the “Alarms-per-Bed Day” event are currently being tabulated, and will provide a baseline from which to judge the effectiveness of new alarm policies.

Shortly after the alarms counting event, nursing managers were also surveyed to gauge responses and attitudes towards alarms. These replies will assist the committee in creating education tailored to staff. Using the results as a starting point, the committee will share proper examples of alarm management in order to teach clinicians about “the purpose and proper operation of alarm systems for which they are responsible” (EP 4).

The first order of business of the alarms committee is to create an enterprise-wide standard operating procedure for medical device alarms. That procedure has been drafted and awaits the committee’s review. The committee will also review existing policies for critical care areas that address how to determine clinically appropriate alarm parameters per patient situation, when the parameters can be changed, and when, if at all, alarms can be disabled (EP 3).

Meeting Phase I of the Joint Commission guidance (EPs 1 and 2) was simple after the proactive risk assessment team was trimmed down to a core, decisive group. Having too many people provide input was harmful to development. In order to avoid a similar challenge in the clinical alarms management committee, roles and responsibilities will be clearly defined when a member joins.

There are 167 VA hospitals throughout the country, and though each is unique in its device census, it can be useful to share best practices across the enterprise. While developing the clinical alarms standard operating procedure, GLA reached out to several other VA hospitals in order to review and adopt portions of their procedures. Utilizing a network of peers was very beneficial.

As 2016 approaches, VA Greater Los Angeles looks forward to improving patient safety and experience through successful management of alarms.

Clarice M. Balconi-Lamica is a biomedical engineer with the VA Greater Los Angeles Healthcare System. For more information, contact chief editor Jenny Lower at [email protected]