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Running head: ALARM SAFETY DURING RECONFIGURATION 1

Alarm Safety During the Reconfiguration of a Patient Care Unit

Thomas A Kane

Ferris State University

ALARM SAFETY DURING RECONFIGURATION 2

Abstract

There are many aspects to alarm safety and management. This paper reviews the

background of the reconfiguration of a patient care unit due to changes in hospital designation

and the need to address alarm safety and management issues due to the unit’s reconfiguration.

The Joint Commission has been at the forefront of alarm safety and management most recently

with the designation of alarm issues in one of six patient safety goals in 2003, subsequently

issuing a sentinel event alert in April of 2013 and then designating a National Patient Safety Goal

related to management of alarms in July of 2013. For alarm management to be effective, an

organization is best served to have both a just culture and a culture of safety, and the nurse must

follow ethical philosophies as suggested by the American Nurses Association Standards of

Practice. Several large studies show the value of alarm management in the reduction of

unnecessary alarms resulting in the reduction of alarm burden and alarm fatigue improving

patient care. The patient care unit reviewed utilized an alarm risk assessment tool to stratify the

alarm risk to determine the priority of alarm management. Urgent alarm management needs

were addressed utilizing a rapid cycle change approach. Alarm management improvement

processes utilize a LEAN approach and the PDCA method to insure ongoing improvements for

the units alarm management initiative and patient safety.


Alarm management and safety is a vital component of safe patient care. Responding to

alarms negatively affects patient care workflow due to staff interruptions, responding to alarms

affects staff performance due to alarm fatigue and affects patient satisfaction due to the

decreased availability of staff secondary to answering equipment alarms (Bonafide et al., 2015).

This paper will explore the background of alarm safety and management, and the challenges of

appropriately managing alarms on one organization’s recently reconfigured patient care unit.

Original research related to alarm management; alarm fatigue and staff response to alarms will

be reviewed and discussed. This paper will also discuss potential causation linkages of nursing

sensitive indicators (NSI) such as nursing hours per patient day, voluntary turnover, and nurse

vacancy rate to alarm management. A review of the organization’s efforts to define the

organizations alarm risk, manage alarms effectively and quality improvement efforts related to

alarms are discussed. The purpose of this paper is to explore the concepts of alarm management

and safety including alarm burden, fatigue, alarm audibility and response to alarms as well as the

applicability to a reconfigured unit and the use of standardization, error prevention, and risk

assessment to improve patient safety.

Background

The organization discussed in this paper is an acute care hospital licensed for forty-five

beds in a rural setting. The hospital had been licensed as a critical access hospital (CAH) until

December of 2013 when the federal government revoked the hospitals critical access status and

the hospital was forced to return to acute care status. During the time the hospital was under

critical access status, a decision was made to relinquish The Joint Commission (TJC)

accreditation status and be licensed under the annual Centers for Medicare and Medicaid


Services (CMS) annual review process. This period without TJC accreditation was

approximately nine years. Prior to the return to acute care status, the hospital had a six-bed

intensive care unit (ICU) and twelve inpatient adult and pediatric medical surgical beds. Due to

the change from critical access, status to acute care status the reimbursement schema changed

from a cost plus under critical access to traditional diagnostic related group (DRG)

reimbursement resulting in significantly lower projected reimbursement and cash flow.

In an effort to achieve economies of scale under the acute care licensure model, the

licensed inpatient beds were reconfigured with a general medical unit designated with a

progressive care unit (PCU) embedded within the newly reconfigured adult-pediatric inpatient

unit (APIU). The philosophy was to bring the treatment to the patient verses moving the patient

from unit to unit for care. All of the former ICU staff and equipment was relocated to the

reconfigured APIU-PCU patient care area. As the newly configured PCU, rooms were private

rooms; some challenges were noted regarding visualization of the rarely admitted ICU patient.

At the same time, the hospital reconfigured the physical location and layout of the APIU-

PCU area a hospitalist program was instituted in an effort to stabilize medical provider staff and

improve continuity of patient care. With the initiation of the hospitalist program, the hospital

noted a change in the acuity level of the patients in the PCU. Previous to the reconfiguration,

there was rarely a patient requiring invasive or non-invasive mechanical ventilation, indwelling

hemodynamic monitoring lines or critical care intravenous medications. As the patient acuity

increased, the nursing staff noted several safety issues due to the higher patient acuity that

required additional treatment, monitoring or life support devices including the inability to hear

ventilator or BiPAP alarms, the inability to readily visualize cardiac and hemodynamic monitors

in various parts of the unit away from the centralized PCU and difficulty in differentiating APIU


alarms and alerts from the PCU alarms and alerts due to the physical proximity of the tracker

boards, alarm stations and monitoring boards. The hospital, recognizing the potential for patient

safety issues embarked on a process to identify the potential alarms involved, risk assess the

alarms identified and begin a process to improve patient safety and care.

Alarm Safety, Management, and Fatigue

The Joint Commission alarm publications

In recognition of patient safety issues, TJC issued six patient safety goals in 2003

(Richardson, 2004). Richardson noted that goal six included “improving the effectiveness of

clinical alarm systems” (p. 280). The expectation of the goal is that alarms are regularly tested

with respect to trigger settings, audibility in competition with other auditory competition and

appropriateness of settings. Richardson noted that if there are barriers to sound transmission

such as walls, doors or other physical components the effectiveness of the alarm may be

compromised. Similarly, competing audible alerts will decrease the effectiveness of the alarm

and increase the distractions of the staff.

In April of 2013, The Joint Commission issued a sentinel event alert: Medical device

alarm safety in hospitals (The Joint Commission, 2013, April). The sentinel event alert was in

response to TJC data base analysis that showed between January of 2009 and January of 2012,

hospitals self-reported, “ninety eight alarm events, eighty resulted in death, thirteen in permanent

loss of function and five in unexpected additional care” (p.1). This sentinel event alert also noted

that between 85 and 99 percent of alarms are non-actionable and often this is due to improper

setting of the alarm.


The alert (The Joint Commission, 2013, April), noted that there are several factors

contributing to alarm safety issues including; alarm settings not matching the patients clinical

status, lack of staff to respond, non-integration with appropriate devices such as phones or hand

held devices, inadequate training, equipment malfunctions and alarm fatigue. In an effort to

impart urgency to the issue of alarm management and safety and improve patient safety, TJC

added alarm safety to the National Patient Safety Goals (NPSG) effective January 2014 (The

Joint Commission, 2013, July) and labeled the goal NPSG.06.01.01. There are four main

elements of performance that are established under this NPSG. The elements defined by TJC

include, making alarm system safety an organizational priority, identify the most important

alarms to manage, ensure policies and procedures are in place and educate staff about the proper

use and response to alarms.

Alarm Fatigue

Alarm burden and the associated alarm fatigue has been identified in the literature as one

of the leading causes of decreased response times to alarms, patient injuries and a staff dis-

satisfier which may result in voluntary staff turnover, in turn causing a decrease in nursing hours

per patient day and a higher nursing vacancy rate, all concerns identified as structural NSI

(Montalvo, 2007). A study by Drew et al. (2014) in five intensive care units ICU’s) over 31 days

encompassing 461 patients representing 48,173 monitoring hours noted 2,558,760 alarms, or an

average of 525 alarms per hour. The alarm burden was calculated as the number of audible

alarms per bed per day calculated in the study as 187 alarms per bed per day. The high number

of alarms noted in this study contributes significantly to alarm fatigue. Alarm fatigue is defined

as “when clinicians are desensitized by numerous alarms, many of which are false or clinically

irrelevant” (Drew et al., 2014, p.2). This study focused on correcting alarm fatigue through


technical improvements and correct alarm management. The authors suggested that alarm

burden would be significantly reduced from cardiac monitors through a program of regular

replacement of ECG monitor electrodes and staff education related to appropriate setting of

alarm parameters.

Alarms are often put into three categories, false alarms or those that are due to equipment

malfunction such as poor electrode contact, patient movement, or broken lead wires. Non-

actionable alarms or those that are a true alarm but require no intervention and actionable alarms

or those, which are a true alarm and require some patient intervention (Welch, 2012). A

relationship between exposure to nonactionable alarms was the subject of a study by Bonafide et

al., (2015). The setting for the study was a pediatric ICU where 36 nurses were observed via a

video system over a total of 210 hours. During the period of the study, of 5070 alarms observed,

87.1% were nonactionable. The study found that the higher the number of non-actionable alarms

that occurred in the previous 120 minutes the longer the response time was. A non-actionable

alarm rate of 80 or greater per hour in the previous 120 minutes had a direct correlation with

increased alarm response time. The study reported a Hawthorne like effect occurred as four of

the nurses in this study reported that they answered the alarms faster because they knew they

were being observed. The results of the study in the pediatric ICU found the median response

time if there were 0 to 29 alarms in the previous 120 minutes was 1.6 minutes, if there were 30 to

79 alarms in the previous 120 minutes the median response time was 6.3 minutes and if there

were more than 80 alarms the median response time was 16 minutes (p. 350). The results of this

study show that as alarm burden increases there is an increase in alarm fatigue and longer alarm

to response time potentially compromising patient care.


One methodology to combat alarm fatigue suggested by Nix (2015) was the use of an

interdisciplinary team to assess the unit. In the Nix article, the unit studied had an average of

5300 alarms per day 95% of which were false alarms. The study suggested utilization of a

standardized methodology for patients on a cardiac monitor including daily setting of

parameters, replacement of the electrodes and criteria to remove patients that were not

appropriate to be monitored. The simple steps reviewed in this study resulted in a decrease of

alarms from 180 to 40 per patient per day and false alarms were reduced from 95% to 50%.

On the patient care unit, relocation of all patient care monitors in close proximity created

an environment where there was a significant increase in auditory stimulation. The combination

of additional staff on the reconfigured unit in conjunction with a melding of cultures and

additional stimulation caused significant emotional stress in the work environment. Before the

device issues could be addressed, it was noted that there were voluntary resignations resulting in

a reduction in the nurses hours per available and initially the number of hours per patient day.

The admission ability of the unit was altered to account for the change in available staffing.

These are nursing sensitive indicators that had a direct effect on patient care.

Alarm management

The FDA reported 566 alarm related deaths for 2005 to 2008 (Funk, Clark, Bauld, Ott, &

Coss, 2014). Although there has been significant attention to alarm safety and management by

THJ, Funk et al. (2014) noted that nurses have functionally reduced many alarm notifications to

white noise and thus many are ignored. In the Funk study, responses to a survey done in 2005-

2006 were compared to the same survey repeated in 2011. The results in 2011 showed that the

respondents felt there were less nuisance alarms than the 2005-2006 respondents did; however,


the 2011 respondents felt that policies had less of an impact on alarm management and safety the

study reported this was likely due to the increasing number of clinical devices with alarms.

Creighton and Cvach (2010) performed a study on a 15-bed medical progressive care unit

beginning with an analysis of alarm types. The authors identified the types of alarms and

categorized them into four types, “crisis, warning, advisory, and message” (p. 30). An advisory

task force was formed that tested interventions to reduce the types of alarms, including, setting

alarm parameters, staff training, revision of default parameters and elimination of duplicate

alarms. The result of this study’s management initiative was a reduction in the total number of

alarms by 43%. There were four items that the study by Creighton and Cvach recommended in

addition to the management of the alarm itself, they were standard practice of staff analyzing

alarm parameters, setting alarms to actionable levels only, and staff training in device use and

organization wide policies for device management.

A component of alarm management that is often over looked it alarm informativeness.

Alarm informativeness is “the discrimination power of an alarm system to detect abnormalities”

(Rayo and Bruce, 2015, p.283). The concept of informativeness is one of whether the device can

actually monitor the parameter the user desires and if it cannot does the lack of informativeness

create a scenario whereby there are unnecessary alarms that contribute to alarm fatigue. Rayo

and Bruce categorized informativeness into six areas; sensory; the ability to detect, information;

the ability to convey what the device detected, attention: the ability to attract user attention,

cognitive; the ability to sort true alarms from false, workload, the ability to sort or triage

detections and advisory; the ability to cross check future actions. Utilizing this information

device users would be able to assess device capabilities and optimize the use of the device to

reduce alarms.


Alarm management on the unit is in need of standardization. Each nurse sets alarm

parameters on vital sign and cardiac monitors based on their past experiences with alarm burden

and comfort level of the alarm parameters in relation to patient condition. The organizations

biomedical engineering department is a contracted entity and performs required checks to ensure

that the alarm functions to the manufacturers specifications. However to date there has been

little or no interaction with the biomedical technician regarding standardization of setting alarm

parameters.

Organizational Culture

Ethics and Culture

Culture can be defined as “a shared set of beliefs and values about how people work

individually and in teams” (Phillips, 2006, p. 147). Nursing has a culture of ethical behavior as

the patient’s advocate to insure that the patient receives the best and safest care possible. The

American Nurses Association (ANA) Standards of Professional Performance, Standard 7 –

Ethics (2010) competencies states in part;

Takes appropriate action regarding instances of illegal, unethical, or inappropriate

behavior that can endanger or jeopardize the best interests of the consumer or

situation.

Speaks up when appropriate to question healthcare practice when necessary for

safety and quality improvement. (The American Nurses Association, 2010, p. 47)

In an organization with a just culture, i.e. one in which a nurse can bring issues to the

attention of the organizations management for the betterment of patient care and safety without

fear of reprisal, the nurse must report safety issues so that the device, process or issue can be


resolved. Nurses have an ethical responsibility to report patient safety issues although many do

not for fear of reprisal.

A culture of safety is one in which safety issues are anticipated and acted on proactively

whenever possible to prevent the event from occurring. In regard to alarm safety and

management, Phillips (2006) notes that every nurse is responsible for every alarm helping to

insure patients are safe and decreasing the over alarm burden of the individual nurse. A culture

of safety can be cultivated utilizing LEAN principals for standardizing practices and

implementing error proofing of process to insure patient safety.

When the unit was reconfigured, the nurses at the bedside exercised their ethical

responsibility and notified the hospitals management team about safety concerns related to

availability of monitors where they could be readily viewed in alternate areas to the central

nurses’ station citing lack of ability to view information crucial to patient safety. The nursing

staff also voiced concerns about the initial placement of the monitors and the ability to discern

one unit’s information from another as well as the lack of ability to consistently hear audible

alarms on life support devices. The culture of the organization for many years was one of

divisiveness and retribution and the nurses did not feel there was a just culture. As a new

management team has entered the organization attempts are being made at improving

communication, daily executive rounding with the nurses to discuss issues of concern and patient

safety as well as implementing suggestions from the nurses to improve patient care. The

implications to nursing are improved communications between staff and management that will

improve communication of goals, expectations, and changes. Improvements in communication

will improve patient care as the organization can begin standardizing not only communication

but also the resulting process and patient care.


Patient Safety and Alarm Management

One of the tenants of alarm safety is to have an adequate number of individuals to

monitor the alarms in a safe manner. This monitoring also known as surveillance was studied by

Voepel-Lewis, Pechlavanidis, Burke, & Talsma, (2013) to correlate the relationship of patient

adverse events to staffing and to correlate surveillance with staffing. The study reviewed the

ability to monitor patients for adverse events on a pediatric unit and the change in probability of

an adverse event. The study included 256 patients divided in to two groups, one with traditional

nurse staffing and one with enhanced nurse staffing. The results of the study by Vopel-Lewis et

al. (2013) were that one additional RN hour correlated with a 73% reduction in adverse patient

events. This study is one of the articles utilized the organization utilized to begin defining

evidenced based practice and the need to standardize alarm management.

The organization recognized the need to improve its alarm management practices. A

multidisciplinary team was assembled to begin the process of addressing alarm management.

The team consisted of representatives from nursing, respiratory care, performance improvement,

C-suite, human resources and risk management. The team, based on a review of literature began

by performing an alarm assessment (Table 1) and identifying alarms critical to patient safety.

The next steps the team will perform are defining the process for alarm management for each of

the alarms and standardize the processes of patient application, setting of parameters, adjustment

of parameters based on change in patient status and utilization of the device. As an example in

this organization, patients are often unnecessarily placed on telemetry adding to the non-

actionable alarm burden and alarm fatigue. Through the process of standardization, the team will

attempt to error proof the processes surrounding alarm management. Graban (2012) reviewed

three types of error proofing; make it impossible to create the error, make the error obvious, and


make the system tolerant of the error. While making it impossible to create an error in alarm

management, standardization of the patient-device interface and setting of alarm parameters will

reduce the error. During the review, the team may find that internal adjustment of alarm ranges

may improve the management where appropriate. Making the error obvious may take on the

simplicity of dating electrodes prior to application so staff knows if they need to be changed to

improve the contact, signal, and reduce the error. In the case of making the system error tolerant,

if one were to consider the barriers to hearing alarms, utilization of technology to send an alarm

to a device such as a smart phone or tablet carried by the staff this would make the system

tolerant to the error. A significant challenge to becoming a high reliability organization in

relation to alarm management and safety will be change of the culture so that every individual

proactively monitors and is involved with all monitors and alarms. Utilizing real time peer

mentoring to effect cultural change and standardizing alarm management will improve patient

safety, decrease alarm burden and improve the nursing work environment.

Conclusion

Alarm management and alarm safety must be addressed on an ongoing basis in every

organization in order to assure patient safety and reduce nurse burnout related to alarm fatigue.

Nurse burnout due to the environment they work in is a significant contributor to voluntary

turnover and nurse vacancy rates, which directly impact the hours per patient day of nursing that,

is available to provide patient care. The organization in this paper recognized the staff nurses’

ethical responsibility to insure that there were appropriate devices and the alarms were set and

could be heard in order to respond in a timely fashion. The organization conducted an alarm risk

assessment to determine the alarms that needed to be addressed urgently such as cardiac

monitors and CPAP/BiPAP units as shown in Table 1. In some cases such as the CPAP/BiPAP


units and the cardiac monitors, immediate steps were taken utilizing a rapid cycle change

approach to improve patient safety. Studies reviewed in the paper noted that application of

standardized processes reduce the number of alarms , reducing the alarm burden and the alarm

fatigue. Reduction of alarm fatigue is a nurse work environment satisfier with the potential of

reducing voluntary turnover and decreasing the negative impact of turnover on available nursing

hours for patient care. The organizations unit has taken steps to identify and stratify alarm risks.

There is literature review being done by the organization to implement best practices and the

organization is utilizing a LEAN approach with PDCA follow up to standardize alarm

management. The conclusion of this paper is that the organization has begun the process of

standardizing alarm management; however, there are still inconsistencies that may affect patient

care. Pronovost et al. (2013) discussed four components of a conceptual model utilized at The

Johns Hopkins Hospitals. The components discussed included, communication and clarification

of goals, building capacity utilizing Lean, transparent reporting and sustaining the process.

The organization reviewed in this paper has begun the process of alarm management,

with the formation of an interdisciplinary team, agreement to utilize LEAN principles, completed

an alarm assessment and begun literature review for best practices related to alarm management.

Seven alarms were identified as critical and all of the alarms identified played a role in

alarm fatigue. LEAN principals were discussed to identify the gaps in process related to use of

devices with alarms, purchasing process for integration of devices for reduction in alarms as well

as identification of waste. Waste identified included time waste dues to response to non-

actionable alarms, personnel waste due to voluntary resignations, and financial waste due to the

limiting factor of nursing staffing on admissions. The group embraced the themes of the World

Health Organization regarding Interprofessional Education and Collaborative Practice


(Sherwood & Barnsteiner, 2012) including teamwork, roles and responsibilities, communication,

ethics and attitude, and patient centered care. In a collaborative manner, utilizing information

from the alarm assessment and direct observation on the unit the group determined that there is a

lack of alarm management standardization, waste was identified in the alarm management

processes, and a plan to sustain the process of alarm management needs to be developed.


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Table 1ALARM RISK ASSESSMENT OF A RECONFIGURED UNIT

Necessary or unnecessary? Does it contribute to alarm fatigue

Severity Rating (Risk to patient if alarm not

heard)

Probability of an improper staff

response to the alarm

Potential for harm based on history

Scoring criteria based on history 5 = Lifesaving alarm 5 = Death 5 = Almost certain 3 = Frequently Alarm Risk4 = Prevents injury 4 = Permanent injury 4 = Probable 2 = Occasionally = Critical >753 = Assists with monitoring 3 = Long term injury 3 = Possible 1 = Never = Moderate 74 - 252 = Acts as a reminder 2 = Minor injury 2 = Very unlikely = Low <251 = Adds convenience 1 = No injury 1 = Will not occur

(Scoring provided by Coverys Insurance, Risk Management Department 2015)

A B C D

AlarmNecessary or unnecessary

(Does the alarm contribute to alarm/ noise fatigue

Severity Rating (Risk to patient if alarm not heard)

Probability of an improper

response to alarm

Potential for harm based on history

Total Score (A x B xC x D)

Scores > 75 are critical alarms (Critical ? Yes

or No)Cardiac monitor 5 5 4 2 200 YESBiPAP/CPAP unit 5 5 4 2 200 YESPulse oximetry 5 5 4 2 200 YESNurse call 4 4 5 2 160 YESVentilator 5 5 2 2 100 YESBed alarms 4 4 3 2 96 YESHemodynamic monitors 4 4 3 2 96 YESBathroom emergency call 4 3 3 2 72 NOChair occupancy alarm 4 3 3 2 72 NOIV Pump 2 3 5 2 60 NOPneumatic tourniquet 4 4 2 1 32 NOBlood Warmer 2 3 2 2 24 NOFeeding pump 3 2 3 1 18 NOSequential Compression Device 1 2 4 2 16 NOMedical gas alarm 2 3 2 1 12 NODefibrillator 1 5 2 1 10 NOFree standing vital sign machine 1 3 2 1 6 NONegative pressure room 2 3 1 1 6 NOAED 2 3 1 1 6 NOMedication Refrigerator 5 1 1 1 5 NODoor alarms on unit 1 1 1 1 1 NO

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