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3 Time to Come Clean Preventing IPAC Lapses Through Appropriate Medical Device Reprocessing and Injection Practices Dr. Maureen Cividino, IPAC Physician Ms. Anne Augustin, Program IPAC Specialist October 17, 2017 PHO Grand Rounds

4 Authors Dr. Maureen Cividino, IPAC Physician Ms. Anne Augustin, Program IPAC Specialist 2

5 Disclosures No conflicts to disclose Views and opinions are those of the presenters and not necessarily those of Public Health Ontario 3

6 By the End of the Session, Participants Will be Able to: Identify key high risk infection prevention and control (IPAC) practices in office settings that result in infection transmission Describe the extent of infection transmission and infectious disease outbreaks and their impact on patient morbidity and mortality and community follow-up Outline roles and responsibilities of PHO and partners in an IPAC Lapse investigation, based on a risk assessment algorithm Describe key principles in medical device reprocessing including steps in cleaning, transport, disinfection, sterilization and recording Access useful IPAC resources and educational modules on the PHO website 4

7 IPAC Lapses: Changing Landscape Hot Topics In the News 5

8 Ottawa Endoscopy IPAC Lapse http:// 6

9 Toronto Star September y_clinics_kept_secret.html 7

10 Toronto Star September _at_private_toronto_pain_clinic.html 8

11 CPSO Dialogue: Patient Infections, License Suspension Multiple Hospitalized Cases: bacterial meningitis, sepsis, epidural abscesses, emergency laminectomy, spinal decompression Issue-1,

12 Brantford Expositor November

13 CBC News Kitchener Waterloo March patients sent letters for testing Of Hepatitis B, C, and HIV 11

14 CTV News June 2017 Dental Clinic Temporarily Closed Until Issues Resolved 9,000 patients recommended to go for testing 12

15 IPAC Practices Resulting in Infectious Disease Outbreaks Modes of Transmission IPAC Errors in Practice 13

16 Activities Implicated in Outbreaks UNSAFE INJECTION PRACTICES Reuse of needles Reuse of syringes Reuse of single dose vials Misuse of multi-dose vials (MDVs) Reuse of syringes for flushing from IV saline bag Poor hand hygiene Inadequate disinfection of vial diaphragm (stopper) 14

17 Reuse of Syringes 15

18 Guidelines Regarding Use of Syringes Are Not New History:

19 US Outbreaks Associated with Drug Diversion by HCWs ( ) 17

20 Drugs Implicated in Outbreaks Insulin Heparin Propofol Midazolam Fentanyl Bupivicaine Lidocaine (xylocaine ) Dexamethasone Methylprednisolone Triamcinolone acetate Contrast injection Succinylcholine Atropine Palivizumab Epoetin alpha Vitamins * Ranitidine Normal Saline Lactated Ringer s 18

21 Organisms Implicated in Outbreaks Viral Hepatitis B virus Hepatitis C virus Parasitic Plasmodium falciparum Fungal Exserohilum rostratum Bacterial Serratia marcescens Burkholderia cepacia (formerly known as Pseudomonas cepacia) Mycobacterium abscessus Enterobacter cloacae Klebsiella pneumoniae Staphylococcus aureus Serratia liquefaciens 19

22 HBV/HCV Outbreaks (CDC) 59 HBV and HBC outbreaks (2 or more cases) 56 of 59 (95%) occurring in non-hospital settings HBV: 24 total outbreaks (one HBV/ HCV) resulting in 179 cases, >10,935 persons notified for screening 18 outbreaks in long-term care: 133 cases 1,680 at risk persons notified for screening 83% related to assisted blood glucose monitoring (ABGM) 20

23 HBV and HBC Outbreaks Cont d 5 HBV outbreaks occurred in other settings, one each at: a free dental clinic in school gymnasium, an outpatient oncology clinic, a hospital surgery service, and two at pain remediation clinics (one outbreak of HBV and one with both HBV and HCV), with 46 outbreak-associated cases of HBV and > 8,500 persons at-risk persons notified for screening HCV: 36 total outbreaks including one of both HBV and HCV, >288 outbreak-associated cases, >105,048 at-risk persons notified for screening 21

24 Outbreaks Specific to Dental Settings Dave Buchwald - Own work Hepatitis B and hepatitis C transmission Mycobacterium abscessus infections due to waterline contamination 22

25 First Case of HCV Transmission in a Dental Setting (CDC) 2013: an HCV case in a dental clinic Oklahoma State Department of Public Health Dental Healthcare-Associated Transmission of Hepatitis C, Final Report of Public Health Investigation and Response, 2013 Contaminated medication vials used on more than one patient, possibly involving propofol suspension Important to recognize dental encounters as a risk for HCV transmission 23

26 Transmission of Blood-borne Pathogens in US Dental Health Care Settings: 2016 Update. Cleveland JL, Gray SK, Harte JA, Robison VA, Moorman AC, Gooch BF. BACKGROUND: reported transmissions of blood-borne pathogens (BBPs) in dental settings over the past decade METHODS: Authors reviewed literature from 2003 through 2015 for reports of transmission of BBPs in dental or related settings and relevant reports submitted by state health departments to the Centers for Disease Control and Prevention RESULTS: 3 published reports described transmission of hepatitis B virus and hepatitis C virus J Am Dent Assoc Sep;147(9): doi: /j.adaj Epub 2016 May 24 24

27 Two reports described single-transmission events (from one patient to another) in outpatient oral surgery practices Third report described possible transmission of hepatitis B virus to 3 patients and 2 dental health care personnel in a large temporary dental clinic Lapses included failure to heat-sterilize handpieces between patients, lack of training for volunteers on BBPs, and the use of a combination of unsafe injection practices Transmission of blood-borne pathogens in US dental health care settings: 2016 update. Cleveland JL, Gray SK, Harte JA, Robison VA, Moorman AC, Gooch BF. 25

28 Mycobacterium abscessus Infections 26

29 2016: M. abscessus Outbreak in Pediatric Clinic Georgia Between Jan 2014-Jan ,386 pulpotomies performed in a dental practice 20 cases M. abscessus: 11 confirmed and 9 probable Age range 3 to 11; median age 7 Median incubation period 65 days (range days) All severely ill requiring hospitalization, with 17 requiring surgical excision and 10 receiving outpatient IV antibiotics by PICC line Peralta G, Tobin-D Angelo M, Parham A, et al. Notes from the Field. Mycobacterium abscessus Infections Among Patients of a Pediatric Dentistry Practice Georgia, MMWR Morb Mortal Wkly Rep 2016;65: DOI: 27

30 Waterline Contamination Determined as Cause Water samples from all seven dental stations had bacterial counts above CDC recommendation of 500 colony forming units/ml; average counts 91,333 CFU/mL M. abscessus isolated from all water samples All water and patient isolates indistinguishable by PFGE indicating common source Outbreak caused by contaminated water used during pulpotomies, introducing M. abcessus into the chamber of the tooth during irrigation and drilling M. abscessus can cause severe infection in immunocompetent children, is ubiquitous in the environment thus posing a contamination risk Peralta G, Tobin-D Angelo M, Parham A, et al. Notes from the Field. Mycobacterium abscessus Infections Among Patients of a Pediatric Dentistry Practice Georgia, MMWR Morb Mortal Wkly Rep 2016;65: DOI: 28

31 So What Does This Mean For Me? CPSO and PIDAC develop IPAC Best Practices Document for Clinical Office Practice 2013 MOHLTC IPAC Complaint Protocol 2015 MOHLTC OPHS and Infectious Diseases Protocol 2016 IPAC Lapse Disclosure Guidance Document

32 MOHLTC Documents 30

33 March March

34 ORGANIZA TION Roles and Responsibilities for Clinical Office Practice IPAC Lapse MOHLTC ROLES AND RESPONSIBILITIES No direct role; would not inspect offices on a routine basis INSPECTION/INVESTIGATION Investigation, including inspections implemented by the Boards of Health through the 36 public health units; can be involved to co-ordinate when more than one PHU involved PHO Provision of scientific and technical advice to support PHU lapse investigations Laboratory coordination of samples and further testing (genetic sequencing) No routine role in clinic inspections but may provide field support to PHUs to inform risk assessment process CPSO Responsibility for oversight and licensing of physicians; investigate as part of QA and complaints process Can assess member s practice as necessary. To notify facility or member-specific complaint asap; may conduct joint investigation inspection with PHU 32

35 Infection Prevention and Control Lapse Disclosure Guidance Document e_gd.pdf 33

36 PHU Investigation Triggered by Complaint or Laboratory Notification of Case(s) Routine case investigation/inspection/practice review Local iphis data review of BBIs looking for links to: facility/procedure or list of clinic clients with known BBI or link with BBI reported cases Lit search/resource review for similar situations/clusters Contact regulatory College if relevant Contact MOHLTC if involves more than one PHU Control orders to address identified issues during inspection, voluntary or via HPA Initial conclusions 34

37 Community IPAC Lapse Algorithm Assessment of Risk of transmission Prevalence of each BBI in the community Frequency of exposure to the breach Reduction of burden by cleaning/disinfection/ster ilization Range of transmission estimates Evidence in support of transmission Temporal linkage Spatial linkage Linkage to specific HCW practice Prevalence exceeds expected background Molecular /genetic match sequencing results 35

38 36

39 PHU Actions/Recommendations PHU requests additional support as needed Discussion with regulatory college(s) Control orders to address identified issues Identification of population at risk Notification of at-risk individuals Counselling/testing program Communications Board of health; community; media; post publicly as per transparency requirements 37

40 Page 41 38

41 IPAC Lapses in Ontario Where Complaints Come From Categories of Complaints 39

42 Where Have Inspections Taken Place? Family doctor offices Midwifery and birthing centres Pharmacy Acupuncture clinic Dental Clinics Community laboratory clinics Fertility Clinic Personal service settings 40

43 What Are the Complaints? (Dental complaints highlighted in colour by Section) Reportable disease Unsafe injection practices Improper sterilization or recording 41

44 Office Cleaning: General complaints Cleaning agent does not have a DIN No regular cleaning schedule Equipment Cleaning/Disinfection Equipment not cleaned or disinfected between patient use Blood collection devices not cleaned between patient use Visible blood on blood collection devices Medical equipment cleaned in public washroom or hand hygiene sink Improper storage of clean equipment No separation of clean and contaminated areas 42

45 Poor pre-cleaning and cleaning practices of equipment/instruments rinsed rather than cleaned not disassembled prior to cleaning Reuse of single use devices 43

46 High Level Disinfectant Inadequate percentage of disinfectant No testing to verify strength Inadequate ventilation No proper rinsing post-use 44

47 Medication preparation and storage not in clean separate area Preloading syringes (sometimes days ahead) Expired medications; expired local anesthetics No dating MDV when opened; no labeling for specific patient Expired alcohol/insufficient percentage of alcohol Reuse of syringes; reuse of lancet hubs Use of MDV beyond acceptable date Needle left in MDV for quick access 45

48 Improper Sterilization or Recording Equipment to be sterilized is not properly cleaned Equipment that should be sterilized uses high level disinfectant Sterilizers do not demonstrate parameters of sterilization; no printouts; spore testing not done; improper use of chemical integrator Sterilizers do not either have manufacturer s instructions or follow them; no maintenance schedule or documentation Sterilizers are not Health Canada approved There is no training or certification of those performing sterilization Improper sterilizati on or recording 46

49 Improper packaging too many per pack locked position no disassembly where MIFU indicates it is needed Improper sterilizati on or recording 47

50 Does not meet minimal standards of % alcohol minimal 62% ideally 70% Hand Hygiene not performed before patient care or in between patients Hand Hygiene not performed before aseptic procedure Bar soap used No dedicated hand hygiene sinks No dedicated hand hygiene sink in reprocessing area 48

51 Gloves not available Gloves not in right sizes Gloves not used appropriately Gloves used as multi-layered and cleaned with ABHR Gowns not available Masks not available No recommendations for proper usage or disposal of PPE 49

52 Reportable Disease (Invasive Group A Strep) Reportable disease 5 post-partum women with same rare strain of GAS and indistinguishable PGFE pattern All clients of same midwifery practice, or hospital where midwives held privileges or birthing centre 3 midwives/1 admin staff GAS+ (3 identical type) ; 2 symptomatic and 2 asymptomatic carriers 1 hospital staff GAS+ but not typed All 9 epi-linked with strong laboratory evidence of transmission 50

53 GAS Outbreak HCWs worked while symptomatic Inadequate or improper use of PPE Inadequate hand hygiene Incorrect or inadequate reprocessing Lack of IPAC knowledge or training Improper cleaning and disinfection in clinic practice Lack of IPAC policies/procedures Reportable disease 51

54 Key IPAC Practices That Make a Difference Safe Medication Practices Office Policies and Procedures Immunization Routine Practices 52

55 Priority IPAC Practices: Reprocessing and Med Admin 53

56 Safe Injection Practices Single dose vials are preferred All needles are SINGLE PATIENT USE ONLY All syringes are SINGLE PATIENT USE ONLY Do not reuse single dose vials They should be entered once and then immediately discarded Cleanse the access diaphragm of vials using friction and 70% alcohol. Allow to dry before inserting a needle into the vial The leftover contents of single dose vials should never be combined or pooled 54

57 Multi-dose Vials (MDVs) All needles are SINGLE PATIENT USE ONLY All syringes are SINGLE PATIENT USE ONLY NEVER re-enter a vial with a used needle OR used syringe Once medication is drawn up, the needle should be IMMEDIATELY withdrawn from the vial. A needle should NEVER be left in a vial to be attached to a new syringe Use multi-dose vial for a single patient whenever possible and mark the vial with the patient s name Mark the multi-dose vial with the date it was first used, to facilitate discarding at the appropriate time 55

58 Product Monograph Xylocaine Use single dose vials whenever possible due to increased risk of microbial contamination Discard MDV once open more than 3 days Keywordsuggest.org 56

59 Coring and Fragmentation With Rubber Cap and Blunt Needle Coring or shearing off of a portion of the rubber stopper from a medication vial can occur Cored fragments are difficult to visualize due to small size, the masking effect of the vial labels, or the medication opacity Riess ML, Strong T. Near-embolization of a rubber core from a propofol vial. Anesth Analg 2008;106:

60 Blood Collection Devices SINGLE USE Blood collection tube holders (vacutainer holders) are PREFERRED If blood tube holder must be reused, it MUST be designed for reuse and must be cleaned and disinfected after each use as per manufacturer s instructions Now also mentioned in CSA 2013 Phlebotomy Standard Prevention-and-Control-for-Clinical-Office-Practice-Top-5-Risks.aspx 58

61 Assisted Glucose Monitoring Lancets must be SINGLE USE ONLY Lancet hubs (holds the lancet) must be SINGLE USE ONLY Insulin pens must be SINGLE PATIENT USE ONLY Blood glucose monitoring devices (Glucometers) and other blood testing devices, should not be shared between patients If they must be shared, the device must be approved for multi-patient use Cleaned and disinfected after each use, as per manufacturer s recommendation Prevention-and-Control-for-Clinical-Office-Practice-Top-5-Risks.aspx 59

62 Tonometers Tonometers and other ophthalmologic equipment that touch the eye must undergo high-level disinfection (e.g. glutaraldehyde) between patient use. Cleaning with alcohol is not sufficient. 60

63 Separate Clean Areas from Contaminated Areas Clean areas should be used for the preparation, handling and storage of medications and unused (clean) supplies and equipment Contaminated areas are where used supplies and equipment are handled Do not handle or store medications or clean supplies in the same area as where used equipment or blood or body fluid samples are handled 61

64 PIDAC Checklist for Safe Injection Practices 62

65 Sharps Regulation and Containers Standard All sharps shall be Safety Engineered (needle safety regulation) Containers should be at point of use (i.e., every exam room) and out of reach of children Tamper proof Puncture proof Must have proper lid Should be filled to ¾ fill line only Prompt safe disposal arrangements when full

66 Immunization Measles Mumps Rubella Varicella Influenza Hepatitis B Tetanus, diphtheria Pertussis Immunization + TST at beginning of employment

67 Routine Practices All health care providers should follow Routine Practices for all patients during all care in all clinical office settings Elements include: Risk Assessment and Screening Hand Hygiene Control of the Environment Administrative Controls Personal Protective Equipment 65

68 66

69 Risk Categories in Checklist 67

70 Remember Your Top 5 High Risk IPAC Activities Reuse of syringes Reuse of single dose vials Misuse of MDVs Misuse of glucometers, insulin pens, lancets, hubs Errors in medical device reprocessing cleaning, disinfection, and sterilization of equipment and necessary recording 68

71 Medical Device Reprocessing (Cleaning, Disinfection and Sterilization) Reprocessing Cycle Spaulding Classification Chemical and Biological Indicators Checklists 69

72 Education and Training Staff assigned to reprocessing tasks Complete formal education and training in reprocessing; theoretical and practical components Trained to a level required for the volume and complexity of the equipment being reprocessed Receive device-specific reprocessing instructions from the device manufacturer s representative Trained upon hire and regular re-education process Documentation of training 70

73 Reprocessing Cycle Complex Process Preclean Clean Inspect Package Sterilize Storage Patient use Quality Assurance 71

74 Spaulding s Classification for Dental Settings RCDSO. Guidelines Infection Prevention and Control in the Dental Office. February

75 Section 4: Physical Space CPSA. Reprocessing Critical & Semi-Critical Equipment - A Physician Tool Kit, Revised August

76 Chemical Indicators Respond with a chemical or physical change to one or more parameters within the sterilization chamber External Indicators Class 1 Used for every package Placed on outside of package Tape only gives visual proof that correct temperature achieved sometime during cycle

77 Class 2 Indicator Class 2 indicator (Bowie-Dick) Measures a specific attribute such as air removal or steam Used on pre-vacuum autoclaves 75

78 Internal Chemical Indicator Class 4, Class 5 or Class 6 Placed inside each package (if not integrated into the package) Class 4 Colour change indicates that the steam reached the inside of package Does not indicate that the package is sterile

79 Class 5 Indicators Integrating indicators are designed to react to all critical process variables. Time Temperature Pressure The stated values are generated to be equivalent to, or exceed the performance requirements for biological indicators 77

80 Class 6 Indicators Emulating indicators are designed to react to all critical process variables for specified sterilization cycles. The stated values are generated from the critical process variables of the specified sterilization process and are related to the minimum values required to achieve sterilization. 78

81 Biological Indicators Items in the processed load should not be released until the results of the BI test are available There are contingency plans (i.e., recall policy and procedure) in the event of reprocessing failures. Sterilizer is tested with a biological indicator (BI) each day the sterilizer is used. A colour change of the indicator indicates the spores are growing i.e., the sterilization process failed. No colour change indicates the spores have been destroyed 79

82 Checklist Reprocessing in the Dental Practice Setting Reprocessing Dental specific examples Clarification regarding: Packaging Eyewash stations Removal of all references to high level disinfection 80

83 Checklist IPAC Core Elements Additions! Dental Unit Waterlines and Water Quality Handpieces Suction Addresses the use of barriers Barriers are used on difficult to clean equipment Dental Radiography Dental Laboratory Medication Room/Area and Injectable Medication Vials or Solutions 81

84 FAQ s A dental office s practice is to load sterilization pouches with all the instruments needed for one procedure, often exceeding 5 instruments per pouch. Is there a limit to the number of instruments per pouch? 82

85 FAQ s It is not practical for offices to hold routine equipment until the Biological Indicator (BI) has passed as this usually takes hours. What do we have to do to use equipment if we don t hold it until the BI is read? 83

86 FAQ s A setting is currently cleaning and reprocessing instruments at the end of the day only. What is recommended regarding the delay in cleaning devices and instruments? 84

87 Summary Complex process Policies and Procedures Staff education and training Dedicated space Quality Assurance program - all chemical indicators, biological indicators and physical parameters are reviewed, verified and documented to under pin it all!! Watch for the new PHO checklists for reprocessing and IPAC CORE! 85

88 86

89 References 1. PIDAC: Infection Prevention and Control for Clinical Office Practice, ractice_2013.pdf 2. PIDAC: Updated guidance on the use of multidose vials, PIDAC/Pages/Infection-Prevention-and-Control-for-Clinical-Office-Practice- Multidose-Vials.aspx 3. PIDAC: Cleaning, disinfection and sterilization in all healthcare settings, nfection_and_sterilization_2013.pdf 87

90 References 4. Checklist for IPAC CORE Elements in Clinical Office Practice E_Elements.pdf 5. Checklist for Reprocessing of Medical Equipment/Devices in Clinical Office Practice ocessing.pdf 6. PHO Online Reprocessing in the Community Course, Available at: earning/infectiousdiseases/reprocessing/pages/course.aspx 88

91 References 7. College of Physicians and Surgeons of Alberta (CPSA). Reprocessing Critical & Semi-Critical Equipment - A Physician Tool Kit. Revised August Available at: cpsa.ca/wpcontent/uploads/2015/04/ipac_reprocessing A_Physician_Toolkit.pdf?p df=reprocessing-toolkit Accessed: October 9, Canadian Standards Association (CSA). Z , Effective sterilization in health care settings by the steam process Royal College of Dental Surgeons of Ontario (RCDSO). Guidelines Infection Control in the Dental Office

92 Acknowledgements Cassandra Taylor Virginia Tirilis Dr. Sonica Singhal Sandra Callery Laurie Rodnick Dr. Gary Garber Donna Moore 90

93 For More Information About This Presentation, Contact: Public Health Ontario keeps Ontarians safe and healthy. Find out more at 91