1. Invasive Methicillin-Susceptible Staphylococcus aureus Infections Associated with Epidural Injections Janet Briscoe Kanawha-Charleston Health Department Rachel Radcliffe Division of Infectious Disease Epidemiology CDC Assignee 1

2. Objectives Describe outbreak of healthcare-associated infections Discuss public health implications associated with outbreak 2

3. Methicillin-Susceptible Staphylococcus aureus (MSSA) Gram positive bacteria Colonizes skin and mucous membranes of people Primary reservoir for infection Common cause of healthcare associated infections Sensitive to methicillin and oxacillin antibiotics 3

4. Epidural Injections Epidural Space Between vertebrae and dura Fill space with anesthetic or steroid Alleviate pain Control inflammation Complications Allergic reaction Headache Abscess 4

5. 5

6. Outbreak Notification Kanawha-Charleston Health Department Division of Infectious Disease Epidemiology May 29, 2009 3 in-patients at same hospital Invasive MSSA infections Epidural abscess, meningitis Recent injections from same pain clinic Consulted Centers for Disease Control and Prevention (CDC) 6

7. Clinic Site Visit June 1, 2009 Physician interview 9 hospitalized patients Cultures positive for MSSA Injection procedures May 4–6, 2009 Collected opened medicine vials for testing Requested clinic stop injection procedures 7

8. Initial Actions Specimens from hospitalized patients sent to CDC Organism identification Relatedness testing Epi-Aid Division of Healthcare Quality Promotion Healthcare associated infections 8

9. Study Objectives Assess injection procedures and other practices for infection control breaches Determine the extent of the outbreak Implement control measures 9

10. Study Methods Clinic Investigation Patient Investigation Laboratory Investigation 10

11. Clinic Investigation Staff interviews Nasal swabs Observed mock procedures Assess infection control practices Identify breaches 11

12. Patient Investigation Cohort study Study population Patients receiving injection procedures Study period Injection procedures April 27–May 13 12

13. Time Period of Cohort Study Case Injection Procedures 13

14. Cohort Study Chart review Collected data on procedures Reviewed information from follow-up visit Conducted telephone interviews with patients lacking follow-up visit Patients reporting complications Collected symptom and treatment information Reviewed medical charts when available 14

15. Case Definition Confirmed Clinic patient Symptoms of acute infection within 14 days of injection AND MSSA positive culture within 14 days of injection from one of the following: Sterile site Epidural abscess 15

16. Case Definition Probable Clinic patient Symptoms of acute infection within 14 days of injection AND At least two of the following: Increased heart rate: > 90 beats per min Fever: >38°C (100°F) Leukocytosis: >12,000/uL Increased respiratory rate: >20 breaths per min 16

17. Laboratory Investigation Nasal swabs Culture Pulsed-field gel electrophoresis (PFGE) Case isolates PFGE Medicine vials Culture for bacterial pathogens 17

18. Results Clinic Description and Staff Interviews 18

19. Clinic Description Single-physician practice Serves approximately 3200 patients annually 40-60 patients per day Clinic layout Three exam rooms One triage room One procedure room Fluoroscopy equipment 19

20. Clinic Procedures Epidural injections Lumbar, cervical Trigger point injections Nerve blocks Joint injections Radiofrequency ablation 20

21. Staff Interviews 9 of 12 (75%) staff interviewed Staff involved in direct patient care Office staff Formal infection control training not required Hand hygiene reportedly good No recent major illnesses New medical assistant Trained during time of infections 21

22. Nasal Swabs Seven nasal swabs 6 employees that perform direct patient care 1 wound swab from employee working in office 22

23. Results Observations from Mock Procedures 23

24. Patient Preparation Two methods observed Alcohol only Povidone-iodine and alcohol Performed by medical assistant Patient could wait up to 30 minutes after skin prep before procedure began

25. Epidural Injections Physician did not wear mask Sterile field not maintained Injection safety Syringe used to access patients epidural needle was reused to access multi-dose medication vials 25

26. Medication Storage and Handling Contrast agent Labeled as single-dose Used for multiple patients One vial served 12–25 patients Steroid agent Labeled and used as multi-dose One vial served 8–10 patients Labeled for room temperature storage Stored in refrigerator 26

27. Medication Storage and Handling Each exam room had labeled tray for medication storage in refrigerator Multiple vials of same medication open at same time Vials dated when opened 27

28. Results Cohort Study 28

29. Cohort Study April 27–May 13, 2009 111 procedures 110 patients 6 confirmed cases 2 probable cases 7% attack rate 29

30. Description of Cases Diagnoses of cases 4 septicemia 3 epidural/presacral abscess 1 meningitis 7 (88%) hospitalized 2 admitted to ICU Median length of stay 11 days 30

31. Patient Characteristics, N=110 Patient Characteristic Ill, n=8 Not Ill, n=102 Median age (years)6557 Female (%)6354 Median body mass index (BMI) 2829 31

32. Procedure Characteristics, N=111 Procedure Characteristic No. ExposedAR No. Unexposed AR Epidural injection6912%*420% May 4–May 75019%*610% Contrast injected6313%480% Steroid agent X injected959%160% *p-value<0.05 32

33. Results Laboratory Analysis

34. Laboratory Results Medicine vials No bacterial pathogens Case isolates (2) MSSA USA600 strain Indistinguishable by PFGE Nasal swabs 1 positive for USA600 strain Indistinguishable from cases 34

35. Limitations Delayed outbreak notification Medicine vials not available Only 2 case isolates available Cases had similar procedures Limited data analysis 35

36. Conclusions Outbreak of invasive MSSA infections occurred among patients receiving epidural injections May 4–6, 2009 Laboratory analysis Matching S. aureus strains in 2 cases Matched strain colonizing staff directly involved with procedures 36

37. Infection Control Breaches Inadequate injection safety Syringe re-used between patient and multi- use vials Contaminated vial Single-dose vials used for multiple patients Inadequate patient preparation, barrier precautions, sterile technique 37

38. 38 Nasal colonization of employee MSSA

39. 39 Nasal colonization of employee Employee involved in procedures MSSA

40. 40 Nasal colonization of employee Employee involved in procedures Employee did not wear mask MSSA

41. 41 Nasal colonization of employee Employee involved in procedures Employee did not wear mask Poor skin preparation MSSA

42. 42 Nasal colonization of employee Employee involved in procedures Employee did not wear mask Poor skin preparation MSSA Poor sterile technique

43. 43 Nasal colonization of employee Employee involved in procedures Employee did not wear mask Poor skin preparation MSSA Syringe reused between epidural needle and multi-dose vial Poor sterile technique

44. 44

45. Recommendations Certified infection preventionist (IP) On-site infection control training Assess infection control practices Provide health department with recommendation regarding safety of resuming injections Mandatory OSHA training in bloodborne- pathogens Document annual training for clinic staff 45

46. One Needle, One Syringe, One Time Injection safety New needle, new syringe for each injection Supplement kit with extra syringes Medication handling Single-dose vials preferred Store in accordance with manufacturers instructions Store away from potentially contaminated equipment 46

47. Recommendations Standard precautions and maintenance of sterility Hand hygiene Patient skin preparation Barrier precautions Mask Documentation Staff training Procedures in medical chart 47

48. Additional Recommendations Infection control policies Written policy tailored to clinic Surveillance Report infections immediately to health department Post-procedure discharge instructions Environmental cleaning and disinfecting Assess by IP Follow CDC/HICPAC guidelines 48

49. Update on Clinic Status July 2009 On site training with IP Revised policy and procedure manual Reviewed by state and county health departments 49

50. Update on Clinic Status August 2009 IP assessed cleaning and disinfecting September 2009 State and local health department observed mock procedures with revised practices Local health department approved re-initiation of injection procedures 50

51. Public Health Implications 1998-2008 33 outbreaks of HBV and HCV in nonhospital healthcare settings identified nationally Numerous outbreaks due to bacterial pathogens Difficult to ensure adherence to proper infection control policies in these settings West Virginia No licensing agency for outpatient clinics 51

52. Public Health Implications Injection safety is major concern Public health partnerships Infection control and provider organizations Licensing bodies Outreach to healthcare providers Stay informed with continuing education Mandated in some states Assess infection control practices Adopt updated procedures 52

53. Acknowledgments WVDHHR Dee Bixler Maria del Rosario Loretta Haddy Cathy Slemp Allie Clay Suzanne Wilson Thein Shwe Sandi Comstock Vicki Hogan Sherif Ibrahim Kay Shamblin Judy McGill Amy Atkins Alana Hudson Jonah Long Sandy Graham Dondeena McGraw WVDHHR (contd) Christi Clark KCHD Janet Briscoe Rahul Gupta Tonya Yablonsky CDC Elissa Meites Priti Patel Jeff Hagemann Joe Perz Judith Noble-Wang Gregory Fosheim Sigrid McAllister Bette Jensen Brandi Limbago 53

55. Attack Rates All procedures April 27–May 13, 2009 7% attack rate All procedures May 4–6, 2009 22% attack rate All lumbar epidural procedures May 4–6, 2009 35% attack rate

56. Procedure Characteristics, N=111 ExposedUnexposed Procedure Characteristic IllNot Ill ARIllNot Ill AR Epidural injection86112%*0420% May 4–May 784219%*0610% Contrast injected85515%0480% Steroid agent X injected8879%0160% *p-value<0.05

57. Study Methods Staff interviews Nasal swabs Observed mock procedures Laboratory analysis Nasal swabs Case isolates Medicine vials Cohort study Injection procedures April 27–May 13 Prioritized patients receiving procedures May4–6, 2009

58. Epidural Injections Physician did not wear mask Sterile field not maintained Epidural tray kit Provided 2 syringes and 2 needles 3 rounds of injections performed 1 needle used to draw up all medications 1 syringe used in 2 rounds of injections Accessed multi-use vials after contact with patient

59. Procedure Characteristics, N=111 Procedure Characteristic Ill (%) n=8 Not Ill (%) n=102 Epidural injection10059 May 4–May 710041 Contrast injected10053 Steroid agent X injected 10085

60. Patient Notifications Theoretical risk of bloodborne-pathogen transmission Consulted CDC and other states Sent 110 letters to cohort in July Recommended testing for Hepatitis B Hepatitis C, and HIV Test immediately Follow-up test 6 months from last injection Partnered with Office of Laboratory Services Assessment of notification ongoing 60

61. Time Period of Cohort Study Case Injection Procedures 61