clinical alarm systems testing—a program assessment model

Home Study Program AUGUST 2004, VOL 80, NO 2

Home Study Program Clinical alarm systems tes t ing -

A program a s s e s s m e n t model ‘ he article ”Clinical alarm systems testing-A program assessment model” is the basis for this AORN Journal independent study. The behavioral objectives and examination for this program were prepared with consultation from Susan Bakewell, RN, MS, BC, education program pro- fessional, Center for Perioperative Education.

Participants receive feedback on incorrect answers. Each applicant who suc- cessfully completes this study will receive a certificate of completion. The deadline for submitting this study is August 31,2007.

Complete the examination answer sheet and learner evaluation found on pages 293-294 and mail with appropriate fee to

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2170 S Parker Rd, Suite 300 Denver, CO 80231-5711

or fax the information with a credit card number to (303) 750-3212.

You also may access this Home Study via AORN Online at http://www.aorn.orgy’journal/homestudy/default.htm.

BEHAVIORAL OBJECTIVES After reading and studying the article on clinical alarm systems testing, nurses

will be able to

1. define the Joint Commission on Accreditation of Healthcare Organizations’ patient safety goal related to clinical alarm systems,

2. identify the elements of a clinical alarm system,

3. discuss the steps for creating a clinical alarm systems testing program,

4. describe how to implement a clinical alarm systems testing program, and

5. explain the implications of a clinical alarm systems testing program for the perioperative area.

MANAGEMENT

This

P W m m meets criteria far CNOR and CRNFA recertifico- tion, as well as other continuing education requirements.

A minimum scare of 70% on the multi- ple-choice examination is necessary to earn 2.4 con- tact hours far this independent study.

Purpose/Goal: To educate perioperative nurses about clinical alarm systems and testing pra- grams far clinical alarms.

AORN JOURNAL 279

Home Study Program Clinical alarm systems testing- A program assessment model

MANAGEMENT Wesley Richardson, RN The Joint Commission’s goal is

n July 2002, the Joint Commission on Accreditation of Healthcare Organi- I zations (JCAHO) approved six

national patient safety goals to be implemented in 2003.’ Goal six is to “improve the effectiveness of clinical alarm systems.” This goal was developed as a result of ventilator-related sentinel events.’ The Joint Commission reviewed 23 reports of deaths or injuries (ie, 19 deaths, four comas) related to long-term ventilation. Sixty-five percent of these cases were related to malfunc- tion or misuse of an alarm or an inade- quate alarm.’

A clinical alarm is defined as

any alarm that‘s intended to protect the individual receiving care or alert the staf that the individual is at increased risk and needs immediate assistance.3

ABSTRACT ONE HEALTH CARE SYSTEM developed a

clinical alarm systems testing program in an effort to meet the Joint Commission on Accreditation of Healthcare Organizations’ national patient safety goal related to improving the effectiveness of clinical alarm systems.

IT IS IMPERATIVE that all staff members are aware of the importance of clinical alarms and are prepared to deal with an alarm that is sounding.

THIS ARTICLE DEFINES clinical alarms and clinical alarm systems, provides recommendations for developing and designing a clinical alarm systems testing program, and presents a format for a clinical alarm systems testing program. AORN J 80 (August 2004) 280-288.

relevant to the full spectrum of alarm systems that are triggered by physical or physiologic monitoring of the individual, by variation in measured parameter of medical equipment directly applied to the individual, or selfactivated by the individual.’

The Joint Commission’s expectation is that organizations will implement and document regular preventive maintenance and testing of clinical alarm systems, ensure alarms are activated with appropriate settings, and ensure clinical alarms are audible with respect to distances and competing noise within each unit.’ One way to do this is to develop and implement a clinical alarm system testing program that involves all staff members.

ELEMENTS OF A CLINICAL ALARM SYSTEM The perioperative area has numer-

ous and varied clinical alarms, and it is extremely important to identify and test all of them. All perioperative areas, including preoperative holding, the OR, and postoperative areas, must be assessed. One problem is that the many alarms in these areas may be viewed as nuisances and ignored or dismissed as unimportant. For example, some alarms, such as pneumatic pump stocking alarms, anti-throm- bolytic compression boot alarms, and electronic cooling pad device alarms, may be considered minor and may not prompt an appropriate reaction. Although these alarms are not considered as important as holding area, OR, or postanesthesia care unit patient monitors, if they are not attended to, it may negatively affect patient care.

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Richardson AUGUST 2004, VOL 80, NO 2

To date, there are few published rec- ommended strategies for meeting JCAHOs goal regarding clinical alarm systems. Although JCAHO offers sug- gestions for meeting the goal, it does not dictate any specific strategies or guide- lines for developing and designing a clinical alarm systems testing program.

One way to develop a clinical alarm systems testing program involves using a fishbone diagram to investigate the causes of an ineffective clinical alarm system (Figure l).' The elements that make up a clinical alarm system include equipment, staff members, the environment, and other dynamics specific to a unit or type of equipment.' The interaction between these fundamental elements is used to determine the efficacy of a clinical alarm system.

EQUIPMENT EVALUATION. When evaluating equipment, managers first must determine whether a particular piece of equipment is included in a preventive maintenance program and is scheduled regularly for service. This usually is a fuiction of an institu- tion's biomedical services department, so to remain abreast of equipment status, unit managers may have to request preventive maintenance service records from that department. Nurse managers can del- egate the responsibility for observing the clinical alarm test along with the responsibility for alerting the biomedical services department about new items; old, common items; or items with a known history of mal- functions or alarm volume controls that go to "off" inappropriately.

STAFF MEMBERS. Everyone

associated with a particular piece of equipment must be familiar with it and competent to use it correctly. Competency should include the ability to adjust and tailor alarm settings to individual patients. To get an appropriate response, each staff member must be able to identify and understand the meaning of all clinical alarms. Assessing how a given alarm is per- ceived by all personnel is extremely important for developing an effective clinical alarm system. For example, if an equipment alarm triggers frequently, staff members may view that alarm as a nuisance and either ignore it or not respond immediately. All staff members must be aware of personal or individual clinical alarm response behaviors and be encouraged to adjust their practices accordingly when needed.

PERJOPERATIVE ENVIRONMENT. Periopera- tive nurses may become so accus- tomed to a high ambient noise level (eg, surgical equipment, radios, loud talking) that alarms may not be

Figure 1 The fishbone diagram illustrates variables that may result i n an ineffective clinical alarm system.

Technical Staff members unfamiliar

Known or historical

Lack of understanding of alarm identification

Unaware of "alarm on/oW' Ineffective clinical alarm

Concerns unique t o the facility or device

Presence of sound- blocking walls or doors

Use of similar-sounding Other

Environment ~~

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Ricliardson AUGUST 2004, VOL 80, NO 2

noticed immediately. If there are physical barriers, such as sound-blocking walls or doors or equipment with similar-sounding alarms, the clinical alarm system may be compromised. The proximity of a clinical alarm to staff members also is a consideration. Some alarms might be ignored by the circulating nurse because they usually are monitored directly by the anesthe- sia care provider; it is assumed this person will respond to the alarm. In addition, an alarm that is triggered rarely has a high potential of being compromised because staff members may not be familiar with it, which may result in their inability to respond to the alarm. Assessing staff member knowledge is paramount to ensure everyone knows how to respond appropriately to all alarms. A flaw in any of these variables contributes to an ineffective clinical alarm system.

OTHER DYNAMICS. There may be addi- tional characteristics related to a clinical alarm system that are specific or unique to a facility, a unit, or a piece of equipment. Managers and staff members must seek out these unique characteristics, report them to the biomedical services and facilities management departments, and determine ways to mini- mize any potential negative effects on the clinical alarm system.

ASSESSING A CLINICAL ALARM SYSTEMS TESTING PROGRAM

Using the patient clinical alarm systems assessment wheel model (Figure 2) as a guide can be the first step in designing a clinical alarm systems testing program. This model includes several lay- ers starting with the patient who is at the center of the model. The next layer is the testing ring layer, which includes 0 equipment (ie, items needed to pro-

vide the service) that may contain clinical alarms that alert clinicians of a patient in need;

0 staff member preparedness, which ensures a clinician is ready to take appropriate action, is competent regarding the meaning of the clinical alarm, and can respond in a timely and appropriate fashion; and

0 environment (ie, the setting or conditions under which clinicians operate and respond to a clinical alarm, how these conditions affect the clinical alarm system). The next layer is the organizational

ring. Several components are part of this ring, including

policy, 0 clinical division protocols, and 0 system-wide education.

POLICY. The policy provides guidance on clinical alarms and clinical alarm systems testing. It supports establishment of clinical division protocols and education plans.

CLINICAL DIVISION PROTOCOLS. Clinical division protocols are a set of specific norms for responding to clinical alarms on a particular unit. Establishing these protocols can improve responses, espe- cially on units with unique variables that may affect staff member responses negatively.

SYSTEM-WIDE EDUCATION. An education plan must be implemented and main- tained to ensure competency as well as appropriate staff member response. The best-case scenario is that all hospital staff members are involved and knowledgeable about appropriate responses. Staff members must respond either passively or actively. This method pro- motes a multidisciplinary approach and ensures that all staff members understand that it is not just nurses who respond to clinical alarms.

After the organizational and testing rings are in place, the outermost ring, which represents a sound clinical alarm systems testing program, will be implemented. This ensures that patients will be well protected. .

282 AORN JOURNAL


Figure 2 The patient clinical alarm systems assessment wheel can be a first step in

developing a testing program.

THE TESTING PROGRAM Investigating strategies

implemented by other organizations revealed that thc most common strategy was an initial clinical alarm systems test with no follow-up testing unless staff member, equipment, or en\ 'ironmen- + tal changes occurrcd. Thc primary goal for this project was tci dcvelop a ongoing program that would raise staff member awareness about cl inica I alarms, promote patient safety, and, ultimately, protect patients from harm or death. The program needed to demonstrate continuity, so managers drafted a policy outlining the definition of a clinical alarm; the procedures for risk assessment, maintenance and testing, and evaluating user knowledge and response; and the purpose of the project, which was to ensure patient safety through an effective clinical alarm system.

The program identified and outlined maintenance and testing responsibili- ties on the part of the biomedical services department and the equipment user, as well as user knowledge assess- ments related to competencies. The "alarms" acronym was used to help staff members respond appropriately to a triggered clinical alarm (Table 1). Finally, a clinical alarm testing process was developed that was designed to evaluate the efficacy o f the clinical alarm system (Figure 3).

The clinical alarm systems testing program requires testing two clinical alarm systems each month. These tests are scheduled on the clinical alarm systems observation calendar. All equipment that has a clinical alarm is included on this calendar. Each month, the two scheduled clinical alarm systems being tested are announced in the

organization's safety newsletter and in the monthly environmental checklist packet. Maintaining a schedule for clinical alarm systems testing demonstrates an ongoing clinical alarm systems testing program, which is what the Joint Commission wants to see. Testing is scheduled for the busiest times in the clinical area in an effort to maximize capture of potential clinical alarm systems flaws. If a unit does not contain the items being tested, it does not have to perform a clinical alarm systems observation that month.

Of the two items selected monthly, one ~ ~~

TABLE 1 The Alarms Acronym

A Always physically enter the room during an alarm. L Look at the patient. A Alarms should be audible over competing noises. R Reason-Evaluate the reason for the alarm. M Make sure to check the alarm before and during a

surgical procedure. S Stop tum-off capabilities; do not deactivate.

Reprinted with permission from Methodist Healthcare System, Sun Antonio.

~~~~~

AORN J O U R N A I . 283


management departments perform clinical alarm systems observation on one of the

Observe the interac- t ion between the

pment, environment, staff members.

clinical alarm systems observation of one of the items. Test only one item of the

identified nomenclature. For example, test only one infusion pump, not a l l 20 pumps

items according t o

observation form t o the director of biomedical services.

Submit action plan if required as well. Keep a copy of the clinical alarm systems form

NOTE The biomedical services and facilities management departments wi l l continue regularly scheduled preventive maintenance checks on al l equipment with clinical alarms.

A Observation should

4.. .... . . . . . . . .

( i n your unit. ,’

During the semiannual safety walk, the surveyor

wil l ask the manager for the clinical alarm systems file. The observation form with

the highest risk assessment score wi l l be chosen t o be

tested immediately.

is a unit-based item (eg, infusion pump) that is observed by the unit manager. The other is a hospital-wide item or alarm (eg, fire alarm, infant abduction alarm). Staff members from the biomedical or facilities management departments conduct observation of hospital- wide alarms. Units that have more than one of the machine being tested (eg, 20 infusion pumps) only conduct the test or observation on one machine, because results are likely to be the same, regard- less if one or 20 machines are tested.

CLINICAL ALARM SYSTEMS OBSERVATION FORM

Observers use the clinical alarm systems observation form when perform- ing a clinical alarm systems test (Table 2). This form has three sections: 0 equipment demographics, 0 staff member response, and 0 risk assessment. It is imperative to conduct clinical

alarm systems tests and use the observation forms during the busiest unit or department times. This ensures getting the best evaluation of the interaction among equipment, staff members, and the environment. process

EQUIPMENT DEMOGRAPHICS. As the name implies, the equipment demographics area requires information on equipment nomenclature. This part of the form also includes the date and time the test was performed and the physical location of the test.

STAFF MEMBER RESPONSE. This part of the form also is self-explanatory. Th~s section asks some of the following questions. 0 Can staff members hear the clinical

0 Did staff members respond in a time-

0 Did staff members respond appro-

Thirty seconds or less was determined to be an appropriate initial response

Figure 3 Flowchart of the clinical alarm systems testing

alarm?

ly fashion?

priately?

AORN JOURNAL 285

AUGUST 2004, VOL 80, NO 2 Richardson

Frequency of alarm 1 pt Alarm activates 1 to 7 times per week 2 pt Alarm activates less than once per week, more than once per month 3 pt Alarm activates less than once per month 4 pt False alarms are frequent and cause staff members not to respond (action plan required)

Staff member preparedness 1 pt Alarm is routine, and all staff members are knowledgeable 2 pt Alarm is occasional but is part of an annual competency program 3 pt Alarm is rare, and few staff members are knowledgeable (action plan required) 4 pt Staff members did not respond promptly and appropriately (action plan required)

Other observations:

Observer’s name (print): Signature:

* Submit action plan ifstaff member response is greuter than 30 seconds. ** Submit action plan if answer is ‘’no.’’ Adapted with permission from the Methodist Healthcare System, Sun Antonio. 1

TABLE 2

0 Barrier exists between alarm and caregiver 0 False alarms are frequent and cause staff members

0 Alarm is rare, and few staff members are knowledgeable 0 Staff members did not respond promptly and appropriately

not to respond

Clinical Alarm System Observation Form

Submit action plan

Facility score Date: Day/time: Unit /department: Physical location/room: Type of equipment: Model: Manufacturer: Preventive maintenance #

Staff response Type of alarm: Time between alarm and initial response by staff members: Is remote monitoring (eg, command station) in place? Yes No Time to alarm resolution: (minutes) Was alarm clearly audible to staff members? Yes No** If no, why not?

Barrier Volume decreased High ambient noise level Alarm off Similar sounding alarms Other:-- Did staff members respond promptly? Yes No** Was the cause of the alarm clearly identified by staff members? NO**

(minutesy

Yes

Risk assessment (add all circled items below to score risk assessment) Low risk score (ie, less than 6) Medium risk score (ie, 6 to 8)

1 No action required. Continue scheduled alarm systems tests. I No action recluired. Continue scheduled alarm svstems tests and

286 AORN JOURNAL


time to an alarm. An initial response is the act of physically going to assess the patient, not a total resolution of the triggered alarm, which could take more than 30 seconds.

Nurses are not the only staff members expected to respond to alarms. This program calls for all disciplines and staff members to respond when a clinical alarm is heard. There are two types of responses, active and passive. An active response is the act of physically assessing the patient and resolving the triggered clinical alarm. A passive response is the act of alerting nursing staff members about a triggered clinical alarm, provided that they are not already aware. For example, an employee, such as a janitor, cannot ignore a triggered clinical alarm in an ambulatory surgery center. Instead, he or she must alert a nurse about the alarm so the patient receives attention immediately.

RISK ASSESSMENT. Risk assessment determines potential hazards to patient safety by evaluating the interaction between the environment, equipment, and personnel. Areas assessed include proximity of the alarm to staff members, frequency of the alarm, and staff member preparedness. Proximity of the alarm to staff members seeks to answer the question, “Are there any environmental factors that negatively affect staff members’ ability to respond in a timely and appropriate fashion to a triggered clinical alarm?” The frequency of alarm assessment helps identify and determine potential nuisance alarms. If a clinical alarm goes off frequently, nurses may be slow to respond. In this case, education and establishment of department or unit norms will help alleviate the problem. The staff preparedness assessment evaluates the interaction between the alarm and staff members with regard to knowledge and competency.

Scoring for the clinical alarm system observation form is simple and quick. One item is circled for each area, and the sum of all three circled items yields a risk assessment score. The proximity of alarm to staff category descriptors are scored one to four, as are the frequency of alarm and staff member prepared-

ness. Depending on what the observer witnesses, he or she will circle only one number for each category. The three circled numbers are added to yield a total risk assessment score.

A score of eight or greater requires an action plan aimed at reducing the risk assessment score. There are specific items within the three areas that, if circled, require an action plan. Failures in staff member response and risk assessment areas require that an action plan be submitted to the director of biomedical services for review. When clinical Action plans specifically outline a resolution for alarm is heard, the failed items on the observation form. For all disciplines example, if the equip-

away from the user, the number one is circled. Next, if the alarm is one

which potentially could cause staff members to ignore it or not respond, the number four would be circled. Finally, if the

everyone is knowledgeable about it, the number one is circled for the section. The sum of these circled numbers is six. Alone, a risk assessment score of six requires that no action plan is drafted; however, the number four was circled for the frequency of alarm category, indicating that staff members may view this particular alarm as a nuisance and subse- quently choose not to respond to it immediately. In this case, an action plan is required that is aimed at rais- ing awareness and changing the per- ception that the clinical alarm basical- ly is a nuisance and, therefore, can be ignored.

ment is less than 5 ft and staff members should

that triggers frequently, respond actively O r PaSSiVelY. It should not be

alarm is routine and lefi up to nursing Staff

members Only*

IMPLICATIONS FOR PERIOPERATIVE AREAS There are various types of person-

nel in the perioperative area, so a multidisciplinary approach to increasing awareness of the importance of clinical

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AUGUST 2004, VOL 80, NO 2 Ricliardson

alarms is necessary. All nurses, physi- cians, and ancillary staff members must respond to clinical alarms either passively or actively, and they must know that they have a duty to respond. Educating personnel about clinical alarms will ensure a timely and appropriate response.

When JCAHO surveys a health care organization, the surveyors usually will request information on institu- tion-wide policies and procedures for the setup of a1arms.j High and low limits on alarm settings should be set in accordance with that policy because surveyors will check these settings. In addition, JCAHO surveyors may talk to staff members to investigate whether alarms can be heard and whether staff members can differenti- ate between various alarms. Surveyors also may investigate staff members’ abilities to respond quickly to a triggered alarm and whether there are any nuisance alarms in the surgical environment. The elimination of turn-off capabilities must be verified, and all staff members who are involved must be knowledgeable about clinical alarms in their areas.

Training should be a part of annual competency evaluations. In addition, selected individuals should arbitrarily observe alarm response when any cli i- cal alarm is triggered. Clinical alarms tend to trigger often in perioperative areas, so usually there is no need to stage a test-just wait and observe.

The Joint Commission developed national patient safety goals based on data resulting from sentinel events. It is taking a proactive preventive approach by disseminating this information to health care organizations, along with recommendations that help protect patients. Perioperative nurses usually are knowledgeable about routine alarms; however, clinical alarm systems are designed to protect patients by alerting staff members that a patient needs help or immediate attention. Creating

an effective, on-going clinical alarm systems testing program and elevated awareness among the entire surgical department will produce a safer environment for patients. 9

Wesley Richardson, RN, MSN, is a staff nurse at Methodist Healthcare System, San Antonio.

Editor’s note: The author would like to thank Cindy Strzelecki, RN, MBA, vice president of nursing, Methodist Specialty and Transplant Hospital, Methodist Healthcare System, San Antonio; Patrick Burell, director of biomedical seruices, Methodist Healthcare System, San Anto- nio; Mickey Parsons, RN, MHA, PhD, of the University of Texas Health Science Center at Sun Antonio; Carole Reineck, RN, PhD, CNAA-BC, CCRN, University of Texas Health Science Center at Snrz Antonio; and Nancy Girard, RN, PhD, FAAN, at the University of Texas Hcalth Science Center at Sun Antonio, for their ivlspiration and assistance zuith this project.

NOTES 1. ”Facts about the 2004 national patient safety goals,” Joint Commission on Accreditation of Healthcare Organizations, k t tp://www. jcnko.org/accredited+orgnll izn tio1is/patient+snfety/04+npsglfncts+abo~it+tlze+ 04+npsg.ktm (accessed 17 June 2004). 2. ECRI, ”Critical alarms and atient safety: ECRI’s guide to developing effective alarm strategies and respondin to JCAHO’s alarm-safety goal,” H e i d Devices 31 (November 2002) 397-417. 3. “2004 national patient safety goals: FAQs,” Joint Commission on Accreditation of Healthcare Organizations, http://zu~zu .jcnho.org/accredited+organiza tioiis/pntii,i~t+snfe ty/04+npsg/04fnqs.~Itm (accessed 17 June 2004). 4. “2003 JCAHO national patient safety goals: Practical strategies and helpful solu- tions for meeting these goals,” Joint Commission Resources, kttp://iuzuiu.jrrinc .conz/subscribers/patien tsafetymp!durki=3746 &site=22Gretur11=3988 (accessed 17 June 2004) 5. M C Mooney, ”Embracing national patient safety goals,“ Nursing Mniingement 34 (August 2003) 20-21.

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clinical alarm systems testing—a program assessment model

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