Clinical Safety & Effectiveness

1. Clinical Safety & Effectiveness Improvement of Chemotherapy Order Preparation Process to Improve Patient Safety in the Gyn Onc Center DATE

2. The Team • Team Members • Judith Smith, Pharm.D., BCOP, FCCP, FISOPP Associate Professor, Department of Gynecologic Oncology and Reproductive Medicine, Division of Surgery • Tracy Spinks, B.B.A. Project Director, Institute for Cancer Care Excellence • Elizabeth Garcia, RN, MPA Clinical Administrative Director, Gynecologic Oncology Center • Facilitator • Russell Content, MBA Clinical Business Manager, Gynecologic Oncology Center • Sponsor • Charles Levenback, M.D. Professor & Deputy Chair, Department of Gynecologic Oncology and Reproductive Medicine, Division of Surgery Medical Director, Gynecologic Oncology Center

3. Our Why • 37 year old female • Mother of two girls • 2 weeks post partum • Curable cancer • Admitted for Bleomycin, Etoposide, Cisplatin (BEP)

4. Our Why • Orders prepared, reviewed & signed off • Advance Practice Nurse • Fellow • Attending • Orders dispensed • Two pharmacists checked • Orders Administered • Two Registered Nurses • Patient Rounded on daily • Advance Practice Nurse • Clinical Pharmacist • Fellow • Attending

5. Our Why • Orders prepared, reviewed & signed off • Advance Practice Nurse • Fellow • Attending • Orders dispensed • Two pharmacists checked • Orders administered • Two Registered Nurses • Patient rounded on daily • Advance Practice Nurse • Clinical Pharmacist • Fellow • Attending • Cisplatin dose was a 4x overdose • Suppose to be: 20 mg/m2 x 5 days • Written: 75 mg/m2 x 5 days • Error wasnot caught until Day 5 just prior to last scheduled dose

6. Our Why • Orders prepared, reviewed & signed off • Advance Practice Nurse • Fellow • Attending • Orders dispensed • Two pharmacists checked • Orders administered • Two Registered Nurses • Patient rounded on daily • Advance Practice Nurse • Clinical Pharmacist • Fellow • Attending • Cisplatin dose was a 4x overdose • Suppose to be: 20 mg/m2 x 5 days • Written: 75 mg/m2 x 5 days • Error wasnot caught until Day 5 just prior to last scheduled dose • Patient HARM: • Acute renal toxicity • Plasma pheresis & hospital admission x 10 days • Permanent hearing loss

7. We have a problem…. ….it is time for change.

8. Timeline Chemo Labs check box, ATC scheduling 3hr block Independent second check education; Chemotherapy Standard Doses & references database On Call Schedule Updated; Patient Safety Lectures; Chemotherapy Competency Launched Sentinel Event 1/16/2010

9. What are we trying to accomplish? Improve patient safety when receiving chemotherapy No chemotherapy errors reaching our patients

10. What are we trying to accomplish? Improve patient safety when receiving chemotherapy • Aim statement • To decrease the number of gynecologic oncology chemotherapy order set clarifications by 20% by July 2011. • Rationale • Decreasing chemotherapy order set clarifications will reduce the likelihood of a chemotherapy error reaching the patient Get it right the first time. • Business Case • To decrease associated financial and emotional costs with chemotherapy error reaching patient. 10

11. Process Analysis

12. Process Analysis CS&EFocus

13. Process Analysis

14. Process Analysis

15. Process Analysis

16. CS&E InterventionGoal: Labs results available for chemotherapy order process • Patient Education • Signage in Gyn Onc Center Lobby • “Got labs?” button • Updated "Tips for Convenience" • Provider Education & Resources • Education reminder to order labs • Prompt on order form to order labs with chemotherapy

17. CS&E InterventionsGoal: Increase consistency and reduce information overload • Chemotherapy Education • Chemotherapy Education Checklist • Documenting on 1st cycle “Chemotherapy teaching provided see IPOCTR” under “interventions” • Chemotherapy Preparation • Chemotherapy Order Checklist • Accountability reports

18. Order set clarificationsWhat we measured • Measures: • Process: Percentage of chemotherapy order sets with clarifications • Efficiency: Chemotherapy order processing time • Create to Accept • Create to verify • Verify to Attending sign • Time was based on 12-hour workday • Excluded any clarification beyond 20 days from time created

19. Order set clarificationsWhat we measured • Data source: • EMR reports • ONLY included chemotherapy order sets • Only clarifications that were drug-related • Four twelve-week periods • Baseline - 10/26/2009 - 01/15/2010 • First Interventions - 03/08/2010 - 05/28/2010 • Second Interventions - 10/18/2010 - 01/07/2011 • Third (CS&E) Interventions - 03/21/2011 - 06/10/2011

20. Chemotherapy Clarifications by PeriodP-Chart Sentinel Event 01/16/2010 CS&E Interventions 03/21/2011 UCL=.16 CL=.14 UCL=.12 LCL=.11 CL=.09 LCL=.06 Baseline10/26/2009 – 01/15/2010 First Interventions 03/08/2010 - 05/28/2010 Second Interventions 10/18/2010 - 01/07/2011 CS&E Interventions 03/21/2011 - 06/10/2011

21. Chemotherapy Clarifications in context of clinic volume

22. Chemotherapy Clarifications in context of clinic volume 49% decrease from the Baseline period to the CS&E intervention period.

23. Time Assessment “Create to Accept” (in Hours)Inside and Outside Clinic Hours 7.7% w/ Clarifications 25.0% w/ Clarifications 250.00 50.00 "Create to Accept" (in Hours) 25.00 0.00 Inside Clinic Hours Outside Clinic Hours Median Time – Orders w/ No Clarifications Average Time – All Orders Median Time – Orders w/ Clarifications Third (CS&E) Interventions - 03/21/2011 - 06/10/2011

24. Orders Without Clarifications Baseline: Create to Verify: 14 minutes Verify to Signed: 25 minutes TOTAL: 39 minutes Orders Without Clarifications CSE Interventions Create to Verify: 15 minutes Verify to Signed: 15 minutes TOTAL: 30 minutes Orders With Clarifications Baseline: Create to Verify: 16 minutes Verify to Signed: 22 minutes TOTAL: 38 minutes Orders With Clarifications CSE Interventions Create to Verify: 14 minutes Verify to Signed: 15 minutes TOTAL: 29 minutes It’s not a matter of rushing…..Time assessment PRIOR to order being sent to ATC Pharmacy p > 0.05, NS p > 0.05, NS

25. Annual Time Assessment for Chemotherapy Order Clarifications

26. Return on Investment

27. Return on Investment Equals $167 saved per chemotherapy order

28. Lessons Learned • Educational interventions reduced number of clarifications • It was not a matter of time spent on order preparation • Data does not support rationale that “rushing” contributing factor • Times of day with limited resources increases risk for clarifications/errors

29. Next steps

30. Next steps • In Department Gynecologic Oncology: • Faculty complete chemotherapy competency • Develop annual re-assessment tool • Develop specific assessment tool for level III • Define set hours for writing chemotherapy orders • Between 8 AM to 5 PM • Monday – Friday • At Institutional Level: • Proposal being considered for implementation • Chemotherapy competency • Restricting hours for writing elective/non-emergent chemotherapy orders

31. AcknowledgementsTeam of Stakeholders • Physicians • Shannon Westin, M.D., MPH • Larissa Meyer, M.D. , MPH • Judith Wolf, M.D. • Pharmacists • Benjamin Yee, RPh • Ginger Langley, Pharm.D., BCPS, CPHQ • Patient Advocate • Ashley Dubbelde, B.A.A.S. • Nursing: • Kimberly Burns, RN, WHNP • Sandy Knight, RN, CPON • Donna Branham, RN • EMR Development &Support • Karl Jonsson, B.S. • Business Center: • Linda Beardon, RN, CHAM • Administrative Support: • Marisa Ortega, CPS • Dana Hedge

32. Patient Safety …chemotherapy safety putting together the pieces of the puzzle…. Thank you! jasmith@mdanderson.org