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Objectives At the end of the presentation, participants will be able to: Identify the Top 5 highest risk activities likely to result in patient infection with bloodborne pathogens Recognize the importance of communication and partnerships when addressing IPAC lapses in community settings Describe the future directions of IPAC with respect to development of tools, educational resources and adoption of implementation science principles PublicHealthOntario.ca 4
No conflict of interest to declare PublicHealthOntario.ca 5
12:00 to 12:10 Context and Objectives W5-What Who Where When Why 12:10 to 12:20 IPAC Lapses Overview Agenda 12:20 to 12:30 Top 5 High Risk IPAC Activities 12:30 to 12:40 IPAC Lapses and discussion of Roles, Responsibilities, Partnerships 12:40 to 12:50 Current and Future Tools and Resources 12:50 to 1:00 Question and Answer Period PublicHealthOntario.ca 6
Image Source: http://www.cbc.ca/news/canada/kitchener-waterloo/endoscope-didn-t-cause-hepatitis-coutbreak-at-kitchener-clinic-1.2944380 PublicHealthOntario.ca 7
Brantford, 2014 PublicHealthOntario.ca 8
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Toronto Star PublicHealthOntario.ca 10
Toronto Star PublicHealthOntario.ca 11
75 cases of hepatitis B in GTA 2000 PublicHealthOntario.ca 12
2001 $$$$$$ PublicHealthOntario.ca 13
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Modes of Transmission Image Source: https://www.publichealthontario.ca/en/erepository/ipac_clinical_office_practice_2013.pdf 15
Image Source: http://publications.gc.ca/collections/collection_2013/aspcphac/hp40-83-2013-eng.pdf 16
Common Vehicle Transmission Defined Image Source: http://publications.gc.ca/collections/collection_2013/aspc-phac/hp40-83-2013-eng.pdf 17
What drugs have been implicated in outbreaks? Insulin Heparin Propofol Midazolam Bupivicaine Lidocaine Dexamethasone Methylprednisolone Triamcinolone acetate Contrast injection Succinylcholine Palivizumab Epoetin alpha Vitamins Ranitidine IV Solutions Normal Saline Lactated Ringer s 18
What organisms have been implicated? Viral Bacterial Hepatitis B virus Hepatitis C virus Parasitic Plasmodium falciparum Fungal Exserohilum rostratum Serratia marcescens Burkholderia cepacia (formerly known as Pseudomonas cepacia) Mycobacterium abscessus Enterobacter cloacae Klebsiella pneumoniae Staphylococcus aureus Serratia liquefaciens 19
What activities are implicated with outbreaks? UNSAFE INJECTION PRACTICES Reuse of needles Reuse of syringes Reuse of single dose vials Use of multi-dose vials (MDVs) Reuse of syringes for flushing from IV saline bag Poor hand hygiene Inadequate disinfection of vial diaphragm (stopper) 20
WHO is doing it? 21
Regulated Health Professionals Physicians: anesthetists; endoscopists, hematologist/oncologists; GPs; pain specialists Nurses: nurse anesthetists; general duty nurses Pharmacists: compounding PublicHealthOntario.ca 22
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JULY 17, 1996 Hemodialysis unit: multiple cases hep B after receiving heparin in MDV shared with pt with chronic infection: Partially used heparin vials returned to common area PublicHealthOntario.ca 24
December 10, 2010 PublicHealthOntario.ca 25
ISMP Acute Care Survey December 2010 A recent online survey of 5,446 healthcare practitioners reveals an alarming lapse in basic infection control practices associated with the use of syringes, needles, multiple-dose vials, single-use vials, and flush solutions Survey respondents registered nurses (89.5%) who worked in hospitals place patients at risk for transmission of blood-borne diseases PublicHealthOntario.ca 26
Disturbing Results Nearly 1% of respondents admitted to sometimes or always reusing a syringe for more than one patient after only changing the needle 6% of respondents admitted to sometimes or always using single-dose/single-use vials for multiple patients 15% of respondents reported using the same syringe to re-enter a multiple-dose vial numerous times; of this group, about 7% reported saving these multiple-dose vials for use with other patients 9% of respondents sometimes or always use a common bag or bottle of IV solution as a source of flushes and drug diluents for multiple patients. PublicHealthOntario.ca 27
Canadian Journal of Anaesthesia 1998 PublicHealthOntario.ca 28
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Locally, provincially, nationally and internationally Hemodialysis clinics Hematology/Oncology Clinics Endoscopy clinics Pain clinics Family Practices (more US) Hospitals Dental clinics Central Pharmacy Compounding Sites (US) 31
HBV Transmission Private Dr. Office NY City 2 acute cases noted in office; on further investigation 19 more 1042 patients tested; 38 positive (incl. the 19) from 2000-02 Majority HBV DNA sequencing identical Retrospective cohort study among 275 patients during 10 months preceding outbreak 18 had acute HBV infection 2002 Typically used doses of atropine, dexamethasone and vitamin B 12 drawn from multiple-dose vials into one syringe 32
HBV and HCV Transmission in a Pain Clinic 6 patients with suspected acute HCV infection Oklahoma 2002 Reuse of needles and syringes done routinely by certified registered nurse anaesthetist Single needle and syringe to administer each of midazolam, fentanyl and propofol to up to 24 sequentially treated patients administered through heparin locks connected to IV cannulas In follow-up of 793 of 908 patients tested; 69 HCV and 31 HBV infections 33
HCV Transmission Hematology/Oncology Clinic 4 patients with recent HCV infection reported All had received chemo at same hem/onc clinic Nebraska--2002 Follow-up identified 10 cases available genotyping in 6/10 was HCV 3a, rare in US Routine use of same syringe to draw blood from patients CV catheters and to draw catheter-flushing solutions from 500 cc saline bags used for multiple patients 486/613 tested for HCV 99 clinic-acquired identified all 3a genotype; higher evidence of transmission in those with implantable CV catheter 34
Reuse of syringes on individual patients and use of single-use medication vial on multiple patients; 40,000 notified; 6 confirmed cases 35
Alberta 2008 Endoscopy Clinic 2700 patients followed up 36
Healthcare-Associated Hepatitis B and C Outbreaks reported to CDC 2008 to 2012 35 outbreaks of viral hepatitis, 33 (94%) occurred in nonhospital settings Hepatitis B 19 outbreaks; 153 associated cases; >10,000 notified for screening Hepatitis C 16 outbreaks; 160 outbreak-associated cases; >90,000 at-risk persons notified for screening Two outbreaks due to drug diversion by HCV infected HCWs 37
Immunization Clinic UK 1964 38
4/10 developed streptococcal abscesses Results Streptococcus pyogenes of same serological type isolated from the children, nose of the doctor, throat of the nursing attendant and scissors used at the clinic Doses of vaccine drawn in sequence from MDV using same stock needle Experimental model showed once butt of stock needle contaminated, repeated insertion of clean needles could result in transference of infection into the contents of the vial References: Allison VD (1938) Lancet; Bigger, JW, et al (1940) BMJ; Medical Research Council (1962) The sterilization use and care of syringes (memo) 39
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Used with permission from the Southern Nevada Health District 41
GUIDELINES REGARDING REUSE OF SYRINGES ARE NOT NEW History: 1997 42
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Canadian Journal of Anaesthesia 1998 44
Health Quality Council Alberta Report 2009 Report and Recommendations Root cause analysis Autonomous atmosphere in OR setting Reuse of syringes accepted practice in the 1990s Anaesthesia 2007 guidelines ambiguous Swiss cheese model Multiple recommendations for orientation and training 45
Main reasons given in CDC survey Lack of awareness of harm to patients Denial that there is a true risk for patients Educated to reuse syringes Cost-saving Time efficiencies 46
Well What are we doing about it? Image Source: Micrsoft Clip Art PublicHealthOntario.ca 47
CMOH Report 2013 PublicHealthOntario.ca 48
Ministry Response: Implementation Plan Gaps have been reviewed and form the basis of the Community IPC Lapses Implementation Plan, which is being implemented in two phases, by the following governance structure: Steering committee Oversees implementation comprised of representation from the ministry and PHO Supported by: Risk Assessment Working Group Education Working Group and Legal Consultation CPSO Collaboration PHO - Development of Online Toolbox PublicHealthOntario.ca 49 49
MOHLTC Response Risk Assessment Working Group Development of process map and guidance materials for community IPC lapses Education Working Group Discussion of IPC education options (training and continuing education requirements) Clarity on Roles and Responsibilities -> Ministry-led process/document In collaboration with all stakeholders Development of Online Toolbox with PHO Checklists, risk assessment tools CPSO Collaboration Cost and Accountability PublicHealthOntario.ca 50
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Transparency: Initial /Final Report Initial Report must be completed and posted online by a board of health if a medical officer of health or designate becomes aware of and identifies an IPAC lapse The lapse could be identified as a result of a complaint, communicable disease surveillance, or referral from a regulatory college, other medical officer of health or the ministry Final Report to be completed and posted when identified issues resolved PublicHealthOntario.ca 52
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CPSO Proposes Single Regulatory Framework for out-of-hospital facilities the Future? CPSO Supports HQO with its review of facilities regulation COMPARABLE PROGRAMS, RISKS AND MITIGATION -> -> -> Singular Regulatory System with focus on the risk of services delivered PublicHealthOntario.ca 54
CPSO Partnership PublicHealthOntario.ca Image Source: http://www.cpso.on.ca/cpso-members/out-of-hospital-premises-inspection-program 55
PIDAC Best Practice Documents PublicHealthOntario.ca 56
Infection Prevention and Control for Clinical Office Practice PublicHealthOntario.ca 57
PublicHealthOntario.ca CPSO/PHO Collaboration Actively involved in development of PIDAC Best Practice document for Clinical Office Practice April 2014 presentations to CPSO Peer Assessors, Investigations and Resolutions and OHP/IHF group Assisted in development of Peer Assessor Tool Fluid Survey for assessment of IPAC in clinical offices in review Piloting Audit Tool for office practice; includes safe medication practices as well as general office practice audit (cleaning, hand hygiene, respiratory etiquette, etc.) Communication with members including publishing Top 5 High risk IPAC practices in Members Dialogue PHO developing education program for CPSO staff with auditing responsibilities 58
PIDAC: Top 5 high risk IPAC Practices Reuse of needles Reuse of syringes Reuse of blood collection holders without disinfection Reuse of blood collection devices for glucose monitoring (lancets, lancet hubs) Use of glucometers not designed for multiple patient use Not cleaning glucometers between patient use Use of tonometers without proper disinfection between uses Incomplete or inadequate sterilization logs PublicHealthOntario.ca 59
Single Dose Vials Single dose vials are preferred 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. Always use a new sterile syringe and needle when entering a vial The leftover contents of single dose vials should never be combined or pooled. PublicHealthOntario.ca 60
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 multidose vial for a single patient whenever possible and mark the vial with the patient s name Mark the multidose vial with the date it was first used, to facilitate discarding at the appropriate time PublicHealthOntario.ca 61
Multi-dose Vials continued Discard the multidose vial immediately if sterility is questionable or compromised or if the vial is not marked with the patient s name and original entry date Review the product leaflet for recommended duration of use after entry of the multidose vial. Discard opened multidose vials according to the manufacturer s instructions or within 28 days, whichever is shorter* *Exceptions can be considered for MDVs used for a single patient (e.g. allergy shots) if the manufacturer s instructions state that the vial can be used for longer than 28 days. All of the above steps must be followed and the vial must only be used for a single patient. PublicHealthOntario.ca 62
Coring and Fragmentation with rubber cap and blunt needle 1. Riess ML, Strong T. Near-embolization of a rubber core from a propofol vial. Anesth Analg 2008;106:1020-1. 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 PublicHealthOntario.ca 63
Lancets, hubs, glucometers and insulin pens Lancets must be SINGLE USE ONLY Lancet hubs (holds the lancet) 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 designed for multipatient use and cleaned and disinfected after each use, per manufacturer s recommendation. If the manufacturer does not specify how the device should be cleaned and disinfected then the device cannot be shared PublicHealthOntario.ca 64
Image Source: https://www.health.ny.gov/professionals/diseases/reporting/communicable/infection/2009-02- 17_health_advisory_preventing_exposure_to_bloodborne_pathogens_during_diabetes_care February 13, 2009 PublicHealthOntario.ca 65
Image Source: http://www.ncbi.nlm.nih.gov/pmc/articles/pmc2771515/ Thompson, Nicole and Pertz, Joseph: Eliminating the Blood: Ongoing Outbreaks of Hepatitis Virus Infection and the Need for Innovative Glucose Monitoring Technologies Since 1990 18 HBV infection outbreaks associated with improper use of blood glucose monitoring equipment. 147 cases acquired HBV during these outbreaks; 6 deaths Related to spring-loaded finger-stick-devices on multiple persons Sharing of glucometers without cleaning and disinfection between uses PublicHealthOntario.ca 66
Image Source: http://www.cdc.gov/injectionsafety/blood-glucose-monitoring.html Safer Option Single-use, auto-disabling fingerstick devices: These are devices that are disposable and prevent reuse through an auto-disabling feature. In settings where assisted monitoring of blood glucose is performed, single-use, auto-disabling fingerstick devices should be used. PublicHealthOntario.ca 67
Image Source: http://www.hc-sc.gc.ca/dhp-mps/md-im/activit/announceannonce/md_notice_gluco_im_avis_glyco-eng.php PublicHealthOntario.ca 68
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Blood Collection Devices SINGLE USE Blood collection tube 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 PublicHealthOntario.ca 70
Image Source: http://www.bd.com/vacutainer/labnotes/2004winterspring/best_practice.asp Reuse of Blood Collection Tube Holders PublicHealthOntario.ca 71
March 10, 2015 Safety and Health Information Bulletin: same message; still happening Image Source: https://www.osha.gov/dts/shib/shib101503.html PublicHealthOntario.ca 72
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 Thoroughly rinse with tap water and let air dry PublicHealthOntario.ca 73
Sterilization Logs Sterilization logs, including indicators documenting successful sterilization, are required for all office/desktop autoclaves Logs must document time, temperature and pressure (physical indicators) at completion of each load An external chemical indicator must be used with every packaged item to indicate the item has been sterilized An internal chemical indicator must be placed inside every packaged item to be sterilized Daily testing of biological indicator (BI) is required when a sterilizer is in use SCOPE disinfection and sterilization logs must be kept, including test strip monitoring, concentration and exposure time, and disinfectant temperature for automated endoscope reprocessors (AER). PublicHealthOntario.ca 74
Next Steps PublicHealthOntario.ca 75
Risk Assessment Working Group IPAC Lapse Algorithm PublicHealthOntario.ca 76
Risk Assessment Working Group- IPAC Checklist (PHO) PublicHealthOntario.ca 77
Reprocessing Online Learning Modules PublicHealthOntario.ca 78
Core Competency Modules PublicHealthOntario.ca 79
CDC One and Only Campaign PublicHealthOntario.ca 80
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Summary Infection Prevention and Control (IPAC) lapses related to unsafe injection practices and basic infection control breaches continue despite clear best practice guidelines Significant adverse outcomes for patients include acquisition of bloodborne viral infections, bacterial and fungal infections It is a challenge to the field to identify, manage and follow lapses due to unique characteristics of each situation and complexities of roles and responsibilities based on setting and jurisdiction Current and future strategies to mitigate negative outcomes and improve practice through partnerships, tools and resources are encouraging PublicHealthOntario.ca 82
Acknowledgements Dr. Gary Garber Dr. Kevin Katz Dr. Erika Bontovics Liz McCreight Cathy Egan Mandy Deeves Grace Volkening Claudine DeSouza Isabelle Langman Sam MacFarlane Tim Cronsberry PublicHealthOntario.ca 83
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