Evaluate the impact of human factors engineering on patient-

controlled analgesia (PCA) administration setup

Sue M. Bosley, PharmDSystem, Patient Clinical Safety Specialist

Alegent Health - Quality Improvement

Omaha, Nebraska

May 23, 2003

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Alegent Health SystemAlegent Health System

                                                

                                                 

Seven acute care hospitals (licensed for 1,400+ beds) with plans to expand Lakeside Park into a hospital by 2005.

One long-term care facility, home health care and a primary care physician network of more than 35 clinic sites supporting over 100 employed physician associates and an 800-physician member serving Eastern Nebraska.

284-bed acute care hospital and 40-bed mental health facility.

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AcknowledgementsAcknowledgements

Faculty Advisor:

Ben-Tzion Karsh, PhD

Assistant Professor of Industrial Engineering

University of Wisconsin-Madison

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Project Timeline Project Timeline

January

6 - 14

IRB reviewand approval

QuestionnaireProject Presentation to Management and Staff

8 - 22

February March

Observation

Analysis

24 - 14

April May

6 - 30

June

Redesign, Test, and Analyze

2 - 20

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IHI PDSA Methodology – IHI PDSA Methodology – Small Tests of Change for ImprovementSmall Tests of Change for Improvement

HunchesTheories

Ideas

Changes That Result in

Improvement

A P

S D

APS

D

D SP A

DATA

Cycle 1b: Pilot on one nursing unit.

Cycle 1c: Implement on second nursing unit.

Cycle 1a: Simulation Lab (Med Surgery unit with 6 nurses). Monitor performance measures and error rate with usability testing. - Fellowship Research Project

Cycle 1d: Make new process standard practice for PCA pump training and practice for hospital and monitor.

A P

S D

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Literature and Clinical ExperienceLiterature and Clinical Experience

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM

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Human Factors Engineering ApplicationsHuman Factors Engineering Applications

“Human factors,” = “human engineering,” = “usability engineering,” = “user-centered designed = “ergonomics”.

Definition: “Human factors (HF) is designing systems for the psychological, physical and behavioral capabilities, and limitations of humans in their work environment.” Opposite is a design that forces the user to rely on work around or

shortcuts, forces the user to make extra effort to complete tasks.

Use HF to help us see why their decisions and actions make sense.

When can it be applied:

Designing or evaluating work-station layout

Developing or evaluating patient safety training activities

Procurement of medical equipment and throughout the product life

Developing or evaluating user instructions or protocols

Improving speech communication

Root cause analysis

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Objectives for Research ProjectObjectives for Research Project1. Identify use-related hazards during the

administration setup of patient controlled analgesia (PCA) on already purchased equipment.

2. Based on the limitations and capabilities identified, redesign the process using human factors principles to reduce set up errors in the simulation lab, and ultimately reducing errors in practice.

3. To improve reporting of equipment errors associated with PCA pumps.

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Methods: Study DesignMethods: Study Design Equipment

Abbott Lifecare PCA Plus II 4100 model Usage - 25 pumps / month for the hospital

Phase 1: Survey Tool Deployed to 100% of the nurses (25) on Medical Surgical

floor. Received 32% (8) completed surveys during the first week.

Phase 2: Simulation Lab

Hazard Analysis and Usability testing Observation: PCA administration set up of current process

based on written scenarios. Redesign: Based on analyses from the survey and

observation.

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Recruitment Letter for Survey Recruitment Letter for Survey ParticipationParticipation

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Methods: Survey Tool Methods: Survey Tool

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Most Difficult to Remember

“Checking if I correctly set rate for basal and dose are difficult to distinguish….”

“Remembering to choose the right drug and concentration”.

“Clearing the pumps previous history”.

“Trying to figure concentrations whether in mg or ml”.

“Buttons are very sensitive” “Flat buttons are difficult to

press”.

Memory Aids

“None available”.

“I triple check”.

“Have another person check”.

Survey Results: Narrative SectionSurvey Results: Narrative Section

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Survey Ranking Results: Survey Ranking Results: Contributing Factors Leading to ErrorsContributing Factors Leading to Errors

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Methods: Observation Task Analysis ToolMethods: Observation Task Analysis Tool

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Process MeasurementsProcess Measurements

Measure changes in behavior which will affect

frequency of errors and potentially improve

patient safety.

1) Reduce the average completion time set up.

2) Reduce the number of errors by 25% during PCA Pump administration step up in the simulation lab.

3) Increase the number of reported errors with PCA pumps by 50% in 6 months from implementation in the hospital.

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Next StepsNext Steps Corrective Actions

Target the identified capabilities and limitations of humans from the analyses and retest in the simulation lab.

From the literature, possible environmental and user-interface design problems and that tend to invite errors include:

• Interruptions

• Rushed

• Specific keys do not operate in a consistent manner across modes

• Ambiguous or difficult-to-read displays

• Unconventional arrangement of controls, displays, and tubing

• Hard-to-remember, and/or confusing device operating procedures

• Inadequate device feedback

• Poorly designed labeling

• Poor information display

• Volume entry mechanism not convenient for user

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ReferencesReferencesLin L. Isla R, Doniz , Harkness, Vicente K, Doyle DJ. Applying human factors

engineering to the design of medical equipment: Patient-controlled analgesia. J Clin Monit 1998;14:253-263.

Lin L, Vicente K, Doyle DJ. Patient safety, potential adverse drug events, and medical device design: A human factors engineering approach. J Biomed Informatics. Spring 2002.

Gosbee JW, Lin L. The role of human factors engineering in medical device and medical system errors. In C. Vincent (ed.) Clinical Risk Management: Enhancing Patient Safety. London: BMJ Press, 2001.

Reason, J. (1990). Human error. Cambridge, England: Cambridge University Press.

http://www.fda.gov/cdrh/humfac/doitpdf.pdf

http://www.fda.gov/cdrh/humfac/1497.html

ECRI. 5200 Butler Pike, Plymouth Meeting, PA 19462. Web site: http://www.ecri.org

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Reason (1990). The nature of error. Human Error. New York: Cambridge University

Press. (pp. 1-19).Moray, N. (1994). Error reduction as a systems problem. In

Human Error in Medicine, edited by M.S. Bogner, Lawrence Erlbaum Associates,

Hillsdale, NJ.

Croteau and Schyve (2000). Proactively error-proofing health care processes. In P. L. Spath (Ed). Error Reduction in Health Care: a Systems Approach to Improving Patient Safety. (pp. 179-198). San Francisco: Jossey-Bass.

Spath (2000). Reducing errors through work system improvements. In P. L. Spath (Ed). Error Reduction in Health Care: a Systems Approach to Improving Patient Safety. (pp. 199-234). San Francisco: Jossey-Bass.

ECRI. Medication Safety: PCA Pump Programming Errors Continue to Cause Fatal Overinfusions. Health Devices 31 (9), September 2002; pp. 342-346.

ReferencesReferences