Emerging Issues in Infection Control in Clinical Office Settings...Emerging Issues in Infection...

Emerging Issues in Infection Control in Clinical Office Settings Dr. Maureen Cividino IPAC Physician Public Health Ontario Donna Moore Team Lead IPAC Regional Support PHO

Public Health Ontario, 2013

No conflict of interest to declare

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Objectives: by the end of the session participant will be able to identify

• Top 5 high risk Infection Prevention and Control (IPAC) practices linked to patient infections

• common and serious IPAC lapses or breaches that can occur in an office setting

• risk strategies to prevent and control transmission of infection to patients and staff

• key contacts and resources to support effective IPAC practices in the clinical office setting

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IPAC: Changing Landscape in Ontario

Patient morbidity

and mortality

Media interest

Public Trust

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Toronto Star September 2014

Brantford, November 2014

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• https://www.thestar.com/life/health_wellness/2014/09/20/public_not_told_of_infection_outbreak_at_private_toronto_pain_clinic.html

CDC: Healthcare-Associated Hepatitis B and C Outbreaks reported 2008 -2012

• 35 outbreaks of viral hepatitis, 33 (94%) occurred in non-hospital 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

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US Outbreaks Associated with Drug Diversion by HCWs (1983-2013)

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http://www.cdc.gov/injectionsafety/drugdiversion/drug-diversion-2013.html

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)

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Modes of Transmission

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Image Source: https://www.publichealthontario.ca/en/eRepository/IPAC_Clinical_Office_Practice_2013.pdf

Image Source: http://publications.gc.ca/collections/collection_2013/aspc-phac/HP40-83-2013-eng.pdf

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Used with permission from the Southern Nevada Health District

What drugs have been implicated in outbreaks?

• Insulin

• Heparin

• Propofol

• Midazolam

• Fentanyl

• Bupivicaine

• Lidocaine (xylocaine®)

• Dexamethasone

• Methylprednisolone

• Triamcinolone acetate

• Contrast injection

• Succinylcholine

• Atropine

• Palivizumab

• Epoetin alpha

• Vitamins

• Ranitidine

IV Solutions

• Normal Saline

• Lactated Ringer’s

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What organisms have been implicated?

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

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Who has been implicated?

• Physicians: anesthetists; endoscopists, hematologist/oncologists; GPs

• Nurses: nurse anesthetists; general duty nurses

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Where?

• Endoscopy Clinics

• Pain Clinics

• Family practice offices (more in US)

• Hospitals

• Dental clinics

• Haematology/Oncology Clinics

• Central pharmacy compounding

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GUIDELINES REGARDING REUSE OF SYRINGES ARE NOT NEW

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History: 1997

• Of over 5,400 HCWs surveyed, nearly 1% 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

• 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 20

Main reasons given

• Lack of awareness of harm to patients

• Denial that there is a true risk of harm for patients

• They were educated to reuse syringes

• Cost-saving

• Time efficiencies

• Environmental waste concerns

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22 http://www.cpso.on.ca/cpso/media/documents/cpso%20members/resources/practice-points_2015iss3.pdf

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So what are doing about it and what does it mean to me?

CPSO Partnership

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Image Source: http://www.cpso.on.ca/CPSO-Members/Out-of-Hospital-Premises-Inspection-Program

PublicHealthOntario.ca

April 2016

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http://www.health.gov.on.ca/en/news/bulletin/2016/docs/hb_20160504.pdf

http://www.publichealthontario.ca/


Recommendations in Report

• Develop a single system of oversight for all clinics, including OHPs (273); pain, colonoscopy and plastic surgery clinics and IHFs (935) such as diagnostic testing facilities

• Introduce quality oversight legislation and establish role of independent executive officer to helm the sector

• Require clinics to pass inspections, with plain-language summaries of inspection reports to be posted

• Create a transparent complaints process for patients and care providers

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March 2016

• http://www.health.gov.on.ca/en/pro/programs/publichealth/oph_standards/docs/guidance/ipac_lapse_disclosure_gd.pdf

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http://www.health.gov.on.ca/en/pro/programs/publichealth/oph_standards/docs/guidance/ipac_lapse_disclosure_gd.pdf



https://www.peelregion.ca/health/infectioncontrol/

Example of Public Health Unit report on website

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PIDAC Best Practice Documents

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PIDAC: Top 5 high risk IPAC Practices

1. Reuse of needles and/or syringes

2. Reuse of vacutainer holder and/or of blood collection devices for glucose monitoring (lancets, lancet hubs) without disinfection

3. Use of glucometers not designed for multiple patient use; Not cleaning glucometers between multi-patient use

4. Use of tonometers without proper disinfection between uses

5. Incomplete or inadequate sterilization logs

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PIDAC Checklist for Safe Injection Practices

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CDC One and Only Campaign: recognizing difference between SDV and MDV

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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

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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

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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.

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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

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1. Riess ML, Strong T. Near-embolization of a rubber core from a propofol vial. Anesth Analg 2008;106:1020-1.



Lancets, hubs, glucometers, 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 multi-patient 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

• Note that isopropyl alcohol >20% and

hydrogen peroxide adversely affected

the exterior surface

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Audit example

• https://www.peelregion.ca/health/infectioncontrol/prevention-investigation.htm

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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

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Source: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2771515/



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.

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Image Source: http://www.cdc.gov/injectionsafety/blood-glucose-monitoring.html



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

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Image source: BD.com



CDC One and Only Campaign

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Routine Practices are the cornerstone of IPAC

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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

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Hand hygiene sink; Liquid soap (never use bar soap and don’t top up)

• Always clean hands before patient contact and before aseptic procedure (injections, biopsies, venipuncture)

• Hand washing sinks should be dedicated to that purpose and not used for any other purpose, such as equipment cleaning or disposal of waste fluids

49 Public Health Ontario, 2013

Image Source: Microsoft Clip Art

• Sterile irrigation solutions • Ophthalmology ointments and

drops

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Environmental Cleaning

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1. Public component: public areas of the clinical office that are not involved in patient care, e.g., waiting rooms, offices, corridors. Public areas are cleaned with a detergent.

2. Clinical component: area involved in patient care, including examination rooms, procedure rooms, bathrooms and diagnostic and treatment areas. Clinical areas are cleaned with a detergent and disinfected with a hospital-grade disinfectant.

3. Surgical component: area involved in surgery and invasive procedures. Surgical areas are cleaned and disinfected according to Operating Room Nurses Association of Canada (ORNAC) standards.

Environmental cleaning of these 3 areas must be categorized and resourced differently in terms of cleaning priority, intensity, frequency and manpower.

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Clinical office settings have 3 components for cleaning purposes:

Disinfectants – PIDAC

• Cleaning and disinfecting products must: • Have a DIN#

• Disinfectants in health care should: • Be active against the usual microorganisms encountered in

the setting

• Effective use of a hospital-grade disinfectant includes: • Application of disinfectant after removal of visible soil • Following manufacturer’s instruction for dilution and

contact time • Appropriate use of Personal Protective Equipment (PPE)

http://www.publichealthontario.ca/en/eRepository/Best_Practices_Environmental_Cleaning_2012.pdf

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Reprocessing:

Cleaning, Disinfection and Sterilization of equipment

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Environment Controls: Physical Space Considerations

Facilities:

• Hand hygiene sinks

• Decontamination sinks

• Easily cleaned surfaces

• Slip-proof flooring

• Eye wash station

• Air changes/temperature/ humidity

• Airflow

• Quality of water supply

• Written contingency plans

Space and Design:

• Adequate space

• Away from client and clean areas

• Distinctly separate from areas where clean/disinfected/sterile devices or equipment are handled or stored

• Restricted access and one-way movement by staff

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Control of the Environment: Suggested Reprocessing Area Design

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Spaulding classification

PIDAC: Infection Prevention and Control for Clinical Office Practice, page 51

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Process for Cleaning

• Disassembly

• Sort and soak

• Removal of organic material

• Rinse

• Dry

• Inspect

Cleaning

• Manually clean instrument

• Clean lumens with brush/cloth

• Flush

• Rinse

• Inspect instrument

• Follow with mechanical cleaning if available (e.g., ultrasonic cleaner or

washer disinfector)

60 Image source: Just In Time Productions

High Level Disinfection or Chemical Sterilization

High Level Disinfection:

• Complex

• For semi critical medical devices

• Heat sensitive items

• Must follow manufacturer’s instructions for use

• Glutaraldehyde most commonly used HLD

• Soak in approved and properly mixed HLD fully immersed for the appropriate time

• Monitoring, auditing and documentation required

• Rinse with sterile water x 3 and dry

• Safety for use and OHS considerations such as ventilation and PPE (may have occupational exposure limits under the Occupational Health and Safety Act (O reg. 833/90)


Packaging

Important Basic Steps

1. Following cleaning

2. Open, unlock and / or disassemble

3. Place in plastic or paper sterilization pouch

• Only 1-2 lightweight items per pouch

• Leave 1 ½ “ between instrument & edges of pouch

• Insert internal chemical indicator*

• Seal envelope with heat sealer or self sealing package

• Date and initial

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Note: these scissors should have been “opened” prior to packaging and tip protected

Steam Sterilization Overview

• Methods of sterilization

• Biological and chemical sterilization monitors

• Monitoring, auditing and documentation


Factors Affecting Sterilization

Factors affecting the sterilization process:

• Level and Type of Contamination • Organic material such as mucous, blood, pus and tissue

• If left on instruments - will not sterilize properly

• Equipment to be Sterilized • Check manufacturer instructions to ensure the equipment you are using is

suited to method of sterilization

• Knowledge and Skill of Operator • Competency training, understanding of infectious agents and their

transmission, autoclave maintenance and documentation in logs to confirm proper processes

(CSAO, 2009)

Other Considerations: Sterilizer Requirements

Must:

• Meet PHAC standards as a sterilizer (www.mdall.ca)

• Have print out for time, temperature and pressure

• Have time, temperature and pressure indicators

• Sterilize instruments that are able to be wrapped/packaged

• Have sterilizer operating, maintenance and inspection instructions available

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Image source: Just In Time Productions

http://www.mdall.ca/

Sterilization Process Monitors

Sterility Assurance

Physical

Chemical Biological

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Physical monitors

• Digital readings

• Print-outs

• Alarms

• Indicate what is happening in the sterilizer and whether conditions are being met like: cycle, time, temperature, and pressure

• Do not verify items are sterile

67 Image Credit: Norfolk General Hospital. Used with permission.

Chemical Indicators

• Respond with a chemical or physical change to one or more parameters within the sterilization chamber

External Indicators

• Placed on outside of package

• Tape only gives visual proof that correct temperature achieved sometime during cycle

• Used for every load


Internal Chemical Indicator

• Placed inside each package with every load

• Colour change indicates that the steam reached the inside of the package

• Does not indicate that the package is sterile

Use of Biological Indicators

Biological Indicators (B.I.)

• Contain live bacterial spores of Geobacillus stearothermophilus

• Measures the sterilization cycle’s ability to actually kill spores

• 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.

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Recommendations from Canadian Standards Association: Each day sterilizer is used.

Biological indicators

• Routine use • Biological monitoring shall be conducted every day a sterilizer is used

and for each type of cycle used

• Items should be quarantined until the results of the BI are available

• Following maintenance • In the event major sterilizer repairs are required (replacing sterilizer

controls, replacing plumbing, major rebuilding, installation of new components, electrical failure), biological testing must be done on 3 consecutive empty loads

• Implant devices • All implant devices need a BI with every load

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Biological indicator and control testing

Image Credit: Hamilton Health Sciences. Used with permission 72

Record keeping Document:

• All materials that have been processed

• Results of all quality controls and monitors

• All sterilizer maintenance and calibration

Label:

• Each item to be sterilized with: • Lot number • Sterilizer number • Cycle number • Date and time • Initials of person completing reprocessing • Expiration statement (time-related or event-related)

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Storage and Transportation

Image Source: Microsoft Clip Art

Storage

The shelf life of a sterile

package is event-related

rather than time-related

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Safe Storage of Sterile Items

Physical Considerations:

• Clear separation between storage of sterile items and the reprocessing area

• Temperature between 15-30°C

• Relative humidity between 30-60%

• Restricting access to necessary personnel only

• Not on floor or near water source

• Open shelving units should have closed top and bottom shelves

• Medical devices should not be crowded or compressed when stored

Summary

• IPAC in clinical office settings is important for patient safety and increasingly on the radar of media, public health organizations and regulatory bodies

• Breaches and lapses in IPAC practice result in significant patient morbidity and mortality despite longstanding guidelines

• Accessible resources exist to review and improve your practice

• Improved patient outcomes are within our reach

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Tools and Resources

• Standards (e.g., CSA)

• Guidelines (e.g., PIDAC documents, appendices with sample checklists and Audits)

• IPAC-Canada Audit Tool Kit

• Partnerships, Networking and Communication with IPAC professionals and organizations

• PHO Online Reprocessing in the Community Course, 2015. Available at: http://www.publichealthontario.ca/en/LearningAndDevelopment/OnlineLearning/InfectiousDiseases/Reprocessing/Pages/Course.aspx

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http://www.publichealthontario.ca/en/LearningAndDevelopment/OnlineLearning/InfectiousDiseases/Reprocessing/Pages/Course.aspx



References

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• Best Practices for Cleaning, Disinfection and Sterilization in All Health Care Settings, 2013. Available from the PHO website at: http://www.publichealthontario.ca/en/eRepository/PIDAC_Cleaning_Disinfection_and_Sterilization_2013.pdf

• Central Services Association of Ontario. The Manual for Reprocessing Medical Devices- First Edition. CSAO. 2009

http://www.publichealthontario.ca/en/eRepository/PIDAC_Cleaning_Disinfection_and_Sterilization_2013.pdf



Reprocessing in the Community Self-directed Online Course

Modules

• Introduction to Reprocessing

• PPE for Reprocessing

• Pre-cleaning, Cleaning and Post-cleaning

• Disinfection

• Packaging for Reprocessing

• Loading a sterilizer

• Sterilization

• Unloading a Sterilizer

• Transportation and Storage

Features

• Self-paced learning

• Step-by-step demonstration

• Engaging activities

• Work related scenarios

• Interactive content

• Intuitive user interface

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http://www.publichealthontario.ca/en/LearningAndDevelopment/OnlineLearning/InfectiousDiseases/Reprocessing/Pages/default.aspx





More resources from PHO

PIDAC documents http://www.publichealthontario.ca/en/BrowseByTopic/InfectiousDiseases/PIDAC/Pages/PIDAC_Documents.aspx

Programs

• Just Clean Your Hands http://www.publichealthontario.ca/en/BrowseByTopic/InfectiousDiseases/PIDAC/Pages/Best_Practices_Hand_Hygiene.aspx

• Antimicrobial Stewardship Program http://www.publichealthontario.ca/en/BrowseByTopic/InfectiousDiseases/AntimicrobialStewardshipProgram/Pages/Antimicrobial-Stewardship-Program.aspx

• IPAC Core Competencies http://www.publichealthontario.ca/en/LearningAndDevelopment/OnlineLearning/InfectiousDiseases/IPACCore/Pages/default.aspx

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http://www.publichealthontario.ca/en/BrowseByTopic/InfectiousDiseases/PIDAC/Pages/PIDAC_Documents.aspx

http://www.publichealthontario.ca/en/BrowseByTopic/InfectiousDiseases/PIDAC/Pages/PIDAC_Documents.aspx

http://www.publichealthontario.ca/en/BrowseByTopic/InfectiousDiseases/PIDAC/Pages/Best_Practices_Hand_Hygiene.aspx

http://www.publichealthontario.ca/en/BrowseByTopic/InfectiousDiseases/PIDAC/Pages/Best_Practices_Hand_Hygiene.aspx

http://www.publichealthontario.ca/en/BrowseByTopic/InfectiousDiseases/AntimicrobialStewardshipProgram/Pages/Antimicrobial-Stewardship-Program.aspx






http://www.publichealthontario.ca/en/LearningAndDevelopment/OnlineLearning/InfectiousDiseases/IPACCore/Pages/default.aspx

http://www.publichealthontario.ca/en/LearningAndDevelopment/OnlineLearning/InfectiousDiseases/IPACCore/Pages/default.aspx

References

PIDAC: Infection Prevention and Control for Clinical Office Practice, 2013 http://www.publichealthontario.ca/en/eRepository/IPAC_Clinical_Office_Practice_2013.pdf

PIDAC: Updated guidance on the use of multidose vials, 2015 http://www.publichealthontario.ca/en/BrowseByTopic/InfectiousDiseases/PIDAC/Pages/Infection-Prevention-and-Control-for-Clinical-Office-Practice-Multidose-Vials.aspx

PIDAC: Cleaning, disinfection and sterilization in all healthcare settings, 2013 https://www.publichealthontario.ca/en/eRepository/PIDAC_Cleaning_Disinfection_and_Sterilization_2013.pdf

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http://www.publichealthontario.ca/en/eRepository/IPAC_Clinical_Office_Practice_2013.pdf




http://www.publichealthontario.ca/en/BrowseByTopic/InfectiousDiseases/PIDAC/Pages/Infection-Prevention-and-Control-for-Clinical-Office-Practice-Multidose-Vials.aspx























https://www.publichealthontario.ca/en/eRepository/PIDAC_Cleaning_Disinfection_and_Sterilization_2013.pdf




Emerging Issues in Infection Control in Clinical Office Settings...Emerging Issues in Infection...

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