1. Evaluate the impact of human factors engineering on patient-controlled analgesia (PCA) administration setup Sue M. Bosley, PharmD System, Patient Clinical Safety Specialist Alegent Health - Quality Improvement Omaha, Nebraska May 23, 2003

2. Quality Improvement Division Page 2 Alegent 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.

3. Quality Improvement Division Page 3 Acknowledgements Faculty Advisor: Ben-Tzion Karsh, PhD Assistant Professor of Industrial Engineering University of Wisconsin-Madison

4. Quality Improvement Division Page 4 Project Timeline January 6 - 14 IRB review and approval Questionnaire Project Presentation to Management and Staff 8 - 22 FebruaryMarch Observation Analysis 24 - 14 AprilMay 6 - 30 June Redesign, Test, and Analyze 2 - 20

5. Quality Improvement Division Page 5 IHI PDSA Methodology – Small Tests of Change for Improvement Hunches Theories Ideas Changes That Result in Improvement AP SD A P S D D S P 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. AP SD

6. Quality Improvement Division Page 6 Literature and Clinical Experience http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM

7. Quality Improvement Division Page 7 Human 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

8. Quality Improvement Division Page 8 Objectives for Research Project 1. 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.

9. Quality Improvement Division Page 9 Methods: 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.

10. Quality Improvement Division Page 10 Recruitment Letter for Survey Participation

11. Quality Improvement Division Page 11 Methods: Survey Tool

12. Quality Improvement Division Page 12 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 Section

13. Quality Improvement Division Page 13 Survey Ranking Results: Contributing Factors Leading to Errors

14. Quality Improvement Division Page 14 Methods: Observation Task Analysis Tool

15. Quality Improvement Division Page 15 Process 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.

16. Quality Improvement Division Page 16 Next 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

17. Quality Improvement Division Page 17 References Lin 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

18. Quality Improvement Division Page 18 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. References