1. 1 Evelyn McKnight, AuD www.HONOReform.org www.OneandOnlyCampaign.org www.ANeverEvent.com A Look at a “Never Event” and how it is Fostering a National Passion for Patient Safety

2. Learners will be able to describe… 2 how reuse of syringes and multi-dose vials can lead to patient to patient transmission of bloodborne pathogens how a large scale healthcare associated hepatitis outbreak affects how the public accesses healthcare two patient outcomes of the Nebraska Hepatitis C outbreak

3. 3 Our Story 3

4. www.ANeverEvent.com 4

5. 5 What went wrong?

6. A Never Event. Arbor Books, 2008. 6 What Went Wrong? Improper port flush procedure

7. 7

8. A Never Event. Arbor Books, 2008. 8 What Went Wrong? Improper port flush procedure Index case came to clinic in 2000 Complaints from housekeeping, pharmacy, lab, nursing and patients “No jurisdiction” Unsafe practices for at least 16 months

9. 9 What Happened to the Victims? 6 deaths from HCV not cancer 33 antiviral therapy, 28 achieved SVR 1 sexually acquired HCV 11 died of cancer, including 2 SVR’s 89 lawsuits, $16M paid from NELF Hepatology 2009; 50: 361-368

10. 10 Not just once, long ago 10

11. Not just once, long ago 11 In past 11 years, 620 patients were infected in 52 outbreaks Majority of outbreaks (42 out of 51) occurred in non-hospital settings Thompson NT et al. Abstract #396. A review of hepatitis B and C virus infection outbreaks in healthcare settings, 1998-2008. Fifth Decennial Conference on Healthcare-Associated Infections 2010.

12. 12 Outbreaks of bacterial infections associated with unsafe injections, United States, 2001-2011 At least 25 outbreaks identified/reported Majori ty in outpatient settings Common breaches: Repetitive use of single-dose vials/saline bags, multi- dose vials entered multiple times with non-sterile syringes/needles, pooling leftover contents of vials. Poor hand hygiene, aseptic technique, and improper storage and labeling of medications. htttp://shea.confex.com/shea/2010/webprogram/Paper2113.html;

13. 13 What happens in Vegas …

14. Outbreak of Hepatitis C at Outpatient Surgical Centers, Southern Nevada Health District,12/09 14 2/2008 - 63,000 patients exposed through syringe reuse at endoscopy center 9 definite cases, 106 possible Estimated cost of outbreak investigation, response and testing is $16-$21M

15. …happens elsewhere! 15 Nebraska 2002 New York 2007, 2011 Nevada 2008, 2011 N Carolina 2008, 2010 Texas 2009 South Dakota 2009 New Jersey 2009 Colorado 2009 Pennsylvania 2010 West Virginia 2010 New Mexico 2010 Wisconsin 2010, 2011 Florida 2010 California 2011 Minnesota 2011 Mississippi 2011

16. Basic lack of infection control 16 Same syringe to administer medication to more than 1 patient, even if the needle was changed. Same vial for more than 1 patient and accessing the vial with a syringe that has already been used to administer medication to a patient Common bag of IV fluid for more than 1 patient, and accessing the bag with a syringe that has already been used to flush a patient’s catheter

17. This will NOT prevent infections! 17 Changing the needle, but reusing the syringe Injecting through intervening lengths of intravenous tubing Always maintaining pressure on the plunger to prevent backflow of body fluids Noting lack of visible contamination or blood

18. Unsafe injection practices result in: 18 Untold human suffering Distrust in healthcare system Bloodborne viruses and other infections Disciplinary actions against providers Malpractice suits and other legal actions A medical, financial, emotional and social disaster

19. 19 Medical disaster Glenn from NE Byron&Amber from SD Michael from OK

20. 20 Financial disaster Melisa from FL Johnny from NC Jill from NE

21. 21 Emotional disaster Karen from NV Emil from NE Nurse from OK

22. 22 Social Disaster The history of health care in Las Vegas can be divided into two eras: the one before last year’s hepatitis C outbreak and the one after it. -Las Vegas Sun, 3/1/2009 UNLV School of Public Health survey after outbreak showed 57% of respondents were less likely to get a colonoscopy in Las Vegas.

23. 23 It’s hard to believe this happens in the US

24. Anesthesiology News, Jan 2012 24 50 NY anesthesiology residents surveyed 49% sometimes used same vial for more than one patient 25% did not always use a new syringe or needle when drawing from a vial 8% had reused syringes on different patients Anesthesiology News Survey,1/2012

25. Premier Healthcare Alliance Survey 25 5446 respondents (89% RN or MD) 0.9% “sometimes or always” reuse a syringe but change the needle for reuse of a second patient 15.1% reuse a syringe to re-enter a multidose vial and then 6.5% reuse that vial for use on another patient (1.1% overall) Am J Infect Control 2010;38:789-98

26. Infection Control Assessment of ASCs pilot study in MD, NC & OK 26 6% reused single use device 28% reused single dose vials for multiple patients 21% reused fingerstick lancing device 32% failed to disinfect glucose meter after each use JAMA 2010;303(22):2273-2279

27. Drug Shortages complicate the issue 27 Combining single dose vials for reuse MDV’s accessed with reused syringes or needles

28. Request change of CMS rules re: SDVs 28 16 signatories, including 6 MD’s Led by Rep Whitfield (KY-R) Backed by ASIPP

29. Letter to CMS states… * BUT what about when they are NOT used? 29 “There is no evidence that transmission of blood borne pathogens during health care procedures continue to occur because of the use of single dose vials in multiple patients when* appropriate sterile procedures are used.”

30. AND… 30 Am J Infect Control 2010;38:167-72. Single dose vials lack preservatives to prevent microbial growth Re-entry into vial introduces microbes Microbial growth begins within 1-4 hours, exponential growth thereafter

31. But we can do something about it 31

32. Striving to prevent healthcare transmission of disease due to unsafe injections H epatitis O utbreaks N ational O rganization for Reform

33. In 2011 15 presentations to 5000 people BUT 9 outbreak notifications to 6000 people!

34. 34 Alliance for Injection Safety Congressional Briefing GAO report Programmatic funding FDA, CMS, HHS & CDC collaboration Response to SDV controversy

35. 35 Safe Injection Practices Coalition Raises awareness about safe injection practices Aims to eradicate outbreaks resulting from unsafe injection practices AAAHC, AANA, APIC, BD, CDC, CDCF, Covidien, Hospira, HONOReform, NACCHO, NE Med Soc, NV Med Assn, Premier, MEDRAD, FDA; State Partners: NV, NJ,NY, NC

36. 36 http://www.cdc.gov/hicpac/pdf/isolation/Isolation2007.pdf www.ONEandONLYcampaign.org Based on Standard Precautions for Safe Injection Practices http://www.cdc.gov/ncidod/dhqp/pdf//Isolation2007.pdf

37. 37 Use aseptic technique Never administer meds from same syringe to multiple patients Do not reuse a syringe to enter a vial Do not administer meds from single-dose vials to multiple patients Limit the use of multi-dose vials and dedicate them to a single patient Standard Precautions Highlights

38. 38 Provider education Medscape and Epocrates CME CDC guidelines for injections and outpatient infection control Injection safety resource center Safe injection practices training video Provider toolkit for training www.ONEandONLYcampaign.org

39. 39 JAMA. 2010; 303:2273-79 http://www.cms.hhs.gov/SurveyCertificationGenInfo/downloads/SCLetter09_37.pdf Infection control survey tool for certified/licensed facilities

40. 40 http://www.cdc.gov/HAI/settings/outpatient/outpatient-care-guidelines.html Guide to Infection Prevention for Outpatient Settings: Minimum Expectations for Safe Care Infection prevention checklist for outpatient settings: Minimum expectations for safe care

41. 41 Needed: A culture of safety Empowerment to stop colleagues from unsafe practices

42. 42 Thank you! 42 Outbreaks continue to affect many people

43. And you can help prevent them!

44. 44 Speak up when you see unsafe practices! Visit OneandOnlyCampaign.org Sign up for e-newsletter at www.HONOReform.org Recommend us for a presentation Recommend A Never Event to others Write a review of A Never Event on Amazon Here’s how you can help

45. 45 Thank you! Any questions? Evelyn McKnight, AuD www.HONOReform.org www.OneandOnlyCampaign.org www.ANeverEvent.com