1. June 28, 2004 Mark Duffett Leslie Gauthier The Medley ® Pathway to Patient Safety

2. “If you find a path with no obstacles, it probably doesn’t lead anywhere”

3. July 2001: Investment in the Medley ® Infusion System Hamilton first to implement hospital-wide Implemented a “pump for a pump” Guardrails were only a promise Safety features: –drug calculator –free flow protection –tamper protection –ergonomic design Software log—new way of investigating incidents Beginning of a partnership with Alaris Medical

4. Initial Issues Identified “Air-in-line” alarms Secondary infusions: –Different, louder alarm when infusion complete –Alarm if secondary med not “unclamped” –Infusion issues related to high rates (>200mL/hr) Keypad noises –awaking patients or a safety feature? No graphic display of site pressure Door Failure VTBI rate set too low

5. Canada Day Weekend 2001: Problems “System/Communication Errors” appeared on units in the PICU There was the perception that the devices powered down and stopped infusing Investigation: –Software log confirmed the devices continued to infuse –Caused by a capacitor problem First upgrade!

6. February 2002: Guardrails Significant milestone for Hamilton Consensus building for the dataset Practice standardization But… No bolus feature available Limited number of drugs supported Added complexity

8. July 2002: Disaster Mode Multiple incidents the week of July 16 th “Runaway infusions”, incorrect rates and programming Response: –Communication and education for all staff –Mandated use of solusets –Reiterate mandatory use of guardrails –Eliminate bolusing from continuous infusions

9. July 2002: Investigation Joint investigation with HHS, St. Joseph’s and Alaris Findings: –“Fluid Ingression” problems –4 malfunctioning keypads identified –Log analysis showed that after each keypad malfunction ”START” was selected Twofold problem: –Technical malfunction –User/technology interface

10. June 2002: Results Improved processes for incident investigation, including: –Biomedical Support 24 hrs/ 7 days/week –Medley incident form –Segregation of the Medley devices and tubings –Completion of incident reports Feedback to Alaris: –Customer Call Centre and the turnaround time for analyzing the software logs –Why are Guardrails under the “OPTIONS” key?

11. June 2002: Results Provided staff an opportunity to verbalize their concerns regarding their perceptions of the safety of the Medley ® system Upgrade in August 2002 to replace keypads Practice issues –Guardrails underused –Bolusing from continuous infusions Competency checklists

12. October 2002: Upgrade Hardware: APM seals Software: Guardrails for bolus doses of infusions Increased capacity of Guardrails system CQI software installed

13. May 2003: Upgrade Hardware: Correct “System/Communication Errors” Software: revisions to the Guardrails 1 st download of CQI data: –10% of all devices in the city over 6 months

14. Dobutamine Incident RN description of event: The pump “all of a sudden” increased the rate to 905 mL/h following the hanging of a new 250 mL bag of dobutamine Software log showed: The pump alarmed for the VTBI absorbed Door opened 75 seconds later new VTBI selected 245 entered in the dose field instead of the VTBI field “START” selected Guardrails were not being used

16. Overinfusions A number of incidents where the RN identified that the pump “ran away” Software log showed no problems Most likely caused by improper set loading resulting in free flow Solution to be implemented soon!

17. December 2004: Upgrade Hardware: Capacity for syringe platform (NICU, PICU, OR) Corrective actions for fluid ingression Software: Guardrails are not under “OPTIONS” Updates to the Guardrails –to deal with issues identified in the CQI download in May 2003 Direct access to the Guardrail Software Easier access to the CQI data 2 nd CQI download

19. June 2004: Audit Software: Download of CQI data Are channel labels used appropriately? Guardrails audit –Use of guardrails –Overrides of alerts –Appropriate patient profile used Can we gain insight into the overrides? Hardware: Are we using this expensive technology appropriately?

20. June 2004: Device Use Audit HendGeneralMUMCNICU # pumps14923521155 # pumps with a pt901189535 # LVP not used with a pt30563238 No clear indication (%)20% 14%0% Not plugged in (%)27% 22%2%

21. June 2004: Guardrails Audit HendGeneralMUMCNICU Guardrails not used27% (3) 15% (9) 20% (2) 30% (3) Channel labeled (%)43%56%54 %97% Wrong patient profile81870 Current guardrail alert0121

22. System Improvement Using CQI Data Does the system prevent errors? Can we increase Guardrail use? Can we reduce nuisance alerts? Can we improve the response to alerts?

23. What Do With CQI Data? CQI Data Adverse Events Prevented Guardrail Changes Opportunities to improve practice!

24. Improving Guardrails: Then Guardrails Changes Practice Changes Clinical Practice Staff Feedback

25. Improving Guardrails: Now Guardrails Changes CQI Data Practice Changes Clinical Practice Staff Feedback

28. Summary of Downloaded Data (analyzed by event) TotalChanges Alerts26752509.3 % Events83719623 % 69 potentially clinically significant events = 576 events/year prevented at Hamilton Health Sciences

29. Can We Reduce Nuisance Alerts?

30. Can We Increase Guardrail Use?

32. Can We Improve the Response to Alerts?

33. Work in Progress: Hardware Issues with secondary medication infusions: –Alarms, clamps etc. Correction for the free flow problem Fluid Ingression Batteries Keypad Failure related to an electronic circuit Disposables, e.g. blood filters for NICU Allocation of this expensive resource

34. Work in Progress: Software Improve Guardrails dataset Guardrails for secondary infusions Improvements to Guardrails software Improvement in CQI data downloading and analysis.

35. Work in Progress: Practice Better incident reporting Improve front line staff’s knowledge, skill and understanding of the safety platform Standardization of practice Improve decision making skills related to alerts and overrides Improve understanding of over-rides Disseminate audit/download results.

36. What Have We Learned? This is a process, not a project. This is a complex process. Buying technology to improve patient safety isn’t an easy fix. It requires continuous investment in staff and infrastructure to support it at make it successful.

37. It took Thomas Edison 2000 experiments to invent the light bulb. He said, “I never failed once. It just happened to be a 2000 step process”