June 2018

Immunization Toolkit

Thank you

To our partners thank you for your ongoing commitment of promoting immunization in Nova Scotia.

Immunization programs have saved more lives in the last century than any other health intervention.

Ongoing immunization programs with high vaccine coverage are needed to maintain low levels of vaccine-preventable diseases.

We have created this provincial resource to help guide your safe and effective participation in our provincial immunization programs. We hope that you find this tool kit helpful in your day to day

practice.

Stacey Dunphy RN BScN MHSc Immunization Coordinator, Science and System Performance

Public Health 902-481-5865

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Table of Contents

Contacts...................................................................................................................................................... 4

Storage and Handling of Vaccine ............................................................................................................ 5

General Information ................................................................................................................................ 5

Cold Chain Flow Chart ........................................................................................................................... 6

Vaccine Fridges....................................................................................................................................... 7

Thermometers and Temperature Monitoring .......................................................................................... 8

Appendix A – Keep Vaccine Safe ........................................................................................................ 10

Appendix B - Vaccine Temperature Log Day 1-15 .............................................................................. 11

Appendix C - Vaccine Temperature Log Day 16-31 ............................................................................ 12

Anticipating a Power Outage - Urgent Vaccine Storage & Handling................................................ 13

Appendix D - Vaccine Management Emergency Event Recovery Plan............................................... 14

Appendix E - Inventory of Vaccine – Alternate Storage in Event of Power Outage ........................... 17

Management of Cold Chain Failure ...................................................................................................... 18

Appendix F - Vaccine Cold Chain Failure Incident Report ................................................................. 19

Ordering Vaccine and Inventory Procedures ...................................................................................... 21

Appendix G – Requisition for Publicly Funded Vaccine ..................................................................... 22

Appendix H – Vaccine Request for High Risk Patients ....................................................................... 23

Appendix K – Vaccine Returns from Service Providers ...................................................................... 26

Reporting Requirements ........................................................................................................................ 27

Reciprocal Notification ......................................................................................................................... 28

Appendix L - Reciprocal Notification Form......................................................................................... 29

Adverse Events Following Immunization (AEFI)................................................................................ 30

Appendix M - It's the Law: Reporting Adverse events Following Immunization Poster ..................... 31

Appendix N - AEFI User Guide ........................................................................................................... 32

Appendix O - AEFI Form ..................................................................................................................... 33

Urgent Issues in Immunization .............................................................................................................. 37

Appendix P - Tetanus Prophylaxis in Wound Management................................................................. 37

Appendix Q - Public Health Tetanus Immune Globulin Reporting Form ............................................ 38

Appendix R - Rabies ............................................................................................................................. 39

Appendix T - Rabies Immune Globulin Dosage................................................................................... 44

Resources for Health Care Professionals.............................................................................................. 45

Resources for Parents ............................................................................................................................. 46

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Please contact

Public Health

before giving

school based

vaccines.

Contacts

Central Zone Public Health Switchboard ...........................................................(902) 481-5800

Communicable Disease Prevention and Control Intake Line .......(902) 481-5824 Immunization Records .................................................................(902) 481-5890

Vaccine Orders and Immunization Resources..............................(902) 481-5813 Family Practice Support for Vaccine Management ......................(902) 481-4956 Questions related to Immunizations for the following groups

Children .................................................................(902) 481-4956 Adults and High Risk Clients ................................(902) 481-5824

Report of an Adverse Event Following Immunization (AEFI)

CDC Intake Line (902) 481-5824

Fax (902) 481-5889

For Central Zone Vaccine Orders

Tel: (902) 481-5813 Fax: (902) 481-5923

Email:PublicHealthVaccineOrders@nshealth.ca

For Reporting Immunizations Given

Send all Reciprocal Notification Forms or Immunization Records to the following address:

Attention: Immunization Records Public Health, Central Zone

7 Mellor Avenue, Unit 5 Dartmouth, NS B3B 0E8

Stacey Dunphy, RN, BScN, MHSc Immunization Coordinator

Science and System Performance, NSHA Public Health Tel: 902-481-5865

Email: Stacey.dunphy@nshealth.ca

Please contact your local Public Health Office for:

Immunization Records

Vaccine Orders

Questions related to Immunizations

Report of an Adverse Event following Immunization

Amherst Public Health…………………………902-667-3310

Antigonish Public Health………………………902-867-4500 ex 4800 Bridgewater Public Health……………………..902-543-0850 Central Zone Public Health…………………….902-481-5800

New Glasgow Public Health…………………...902-752-5151 Sydney Public Health…………………………..902-563-2400

Truro Public Health…………………………….902-893-5820 Wolfville Public Health………………………...902-542-6310 Yarmouth Public Health………………………..902-742-7141

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Storage and Handling of Vaccine

General Information

Successful immunization programs are dependent upon proper handling, storage and rigorous cold chain

management of vaccines. Cold chain is the process to maintain optimal conditions during the transport, storage, and handling of vaccines. This process begins at the vaccine manufacturer and ends with vaccine administration

to the client. The optimum temperature for refrigerated vaccines is between +2°C and +8°C.

Vaccines are subject to gradual loss of potency over time. Potency loss may happen more quickly if vaccines are transported or stored under sub optimal conditions. Biological products when maintained at the correct temperature are subject to gradual loss of potency. Vaccines may not be effective if exposed to excess light,

heat or freezing. Products exposed to temperature or conditions outside of cold chain require further investigation before being used or disposed of. If your practice has a cold chain failure, complete a Cold Chain

Failure Incident Report and send to Public Health. Public Health must be consulted to determine if

exposed products are safe for use.

Vaccines must be:

Stored under refrigerated conditions between +2°C and +8°C.

Used before the expiration date. Expiry is the last day of the month indicated on the product

packaging.

Transported between Public Health and other sites in a vaccine cooler with appropriate amount

of packing equipment to maintain cold chain temperatures between +2°C and +8°C.

Reconstituted with the diluent provided for the product. Reconstitution of vaccines should be

done immediately prior to vaccine administration. Discard unused reconstituted vaccines.

Quarantined if cold chain has been compromised. Vaccines must be stored in a fridge until

consultation is made with Public Health. DO NOT dispose of products unless advised by

Public Health.

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Cold Chain Flow Chart

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Office Procedures for Storage and Temperature Monitoring

All staff should be aware of office procedures for proper storage and handling of vaccine products. Offices should designate one staff and a back-up person to be responsible for vaccine ordering, storage and handling.

Vaccine Fridges

Offices must store biologicals in a dedicated vaccine refrigerator. Refrigerators should be selected carefully and used properly.

Any refrigerator used for vaccine storage must be:

Able to maintain vaccine storage temperatures (between +2ºC to +8ºC).

Large enough to hold a month of inventory.

Equipped with a thermometer or data logger.

Dedicated to the storage of vaccines only.

Fridge preventative maintenance on a regular basis.

Bar fridges are unpredictable for maintaining proper vaccines temperatures. They are not approved for vaccine storage because of the high risk of products freezing.

The fridge temperature becomes room temperature when the door is opened. When the door closes the fridge compressor is activated and often overcools the fridge

causing freezing.

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Organizing the Vaccine Fridge

Here are some key tips for organizing the vaccine fridge to Keep Vaccine Safe.

Stock vaccine on a “first-in, first used” basis to make sure products that expire first are used first.

Store full bottles of water on shelves and the door to prevent temperature fluctuations.

Do not store vaccines on door shelves as the temperature on the door fluctuates greatly.

Thermometers and Temperature Monitoring

Use thermometers and temperature recording devices that provide continuous recording or maximum-minimum

thermometers. Place the thermometer probe in the center of the refrigerator.

The Vaccine Temperature Day 1-15 and Day 16-31 log is a tool to record the current temperature and the minimum and maximum fridge temperatures.

Record the temperature at beginning and end of each work day.

Place an “X” in the box that corresponds to the current temperature, record min/max readings.

Record the time the reading was taken, the dial setting on the fridge, the ambient room temperature .

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If the temperature recorded is outside the recommended +2.0°C to +8.0°C range immediate action is necessary:

Immediately report the incident to your designated staff person. Label vaccine “exposed”.

Keep all exposed vaccines separate from non-exposed vaccines, in a functioning refrigerator.

Complete a Cold Chain Failure Incident Report and send to Public Health. DO NOT USE the exposed vaccine until the vaccines have been assessed by Public

Health and deemed fit for use

Public Health will request your temperature log with a cold chain

How to Read a Min/Max Thermometer

The Min/Max thermometer has a digital readout and a wire probe that is long enough to remain permanently inserted in the fridge. The probe

should be attached to a water bottle or Glycol solution or inside an empty vaccine box. The digital readout should be in an easy to read

location (not in the fridge). Temperatures are checked twice a day.

1. Ensure that the In/Out switch is set to “Out”. This will give you

the reading of the air from inside the fridge. 2. Record the current temperature. 3. Press the Min/Max button once to record the Min temperature.

Once the temperature is read press clear. 4. Press the Min/Max button again and record the Max

temperature. Once the temperature is read press clear.

Recommended type

Public Health recommends Canadian Scientific or another Min-Max thermometer that is calibrated to +/- 1° accuracy:

We check

our fridge

temp twice

a day.

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Appendix A – Keep Vaccine Safe

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Appendix B - Vaccine Temperature Log Day 1-15

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Appendix C - Vaccine Temperature Log Day 16-31

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Anticipating a Power Outage - Urgent Vaccine

Storage & Handling

When providers have cause to believe weather conditions or

emergencies might affect vaccine storage, urgent procedures should be implemented in advance of the event to minimize

vaccine wastage. Providers should have a Vaccine Management

Emergency Recovery Plan. Agencies/practices are encouraged to arrange a back-up plan with local pharmacies or other providers

with a back-up generator.

In the absence of a back-up plan Public Health Biologicals Depot could be designated as the alternate vaccine storage facility for

your agency/practice. Contact us Monday – Friday 8:30am to 4:30pm.

Make advance arrangements with the Public Health Biologicals Depot to

have the Depot designated as the back-up or alternate storage facility for your agency/practice. Contact us Monday – Friday 8:30am to 4:30pm.

Provide the following:

Name of practice/agency, and hours of operation.

Address and contact information, including name of primary vaccine contact person and back-up person for

your practice.

Name and contact info for courier that will be used.

What you need to do:

Develop a protocol for vaccine transport to and from the Public Health Biological Depot.

Designate staff to pack vaccine to maintain cold chain temperatures (+2.0°C to +8.0°C).

Have packing materials on hand (e.g. vaccine cooler, refrigerated and frozen gel packs).

Record the inventory by lot number, amount of doses, and pack in a clear plastic bag with the inventory list visible as the packing list. Use the form: Inventory of Vaccine – Alternate Storage in Event of Power

Outage.

Make advance arrangements with a courier service or staff to transport vaccine.

Contact your Public Health office if you have any questions regarding the safe packing and transport of vaccines

Do I have a back-up

plan?

Local pharmacy

Uninterrupted

power supply

(UPS)

PH Bio Depot

Develop protocol

Packing requirements

are met

Arrangements with

courier

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Appendix D - Vaccine Management Emergency Event Recovery Plan

Vaccine Management Emergency Event Recovery Plan

PHS office: Date

Person completing form:

This plan offers guidance for developing a vaccine emergency event recovery plan. Included are steps to follow when your refrigerator fails. Fill in the contact information for the

emergency service providers identified on this form. In advance of an event, all providers should

• identify an alternative storage facility with backup power where the vaccine can be

properly stored and monitored for the interim

• ensure the availability of staff to pack and move the vaccine

• maintain the appropriate packing/insulating materials

• ensure a means of transportation for the vaccine to the alternative storage facility

• train staff and post information about these emergency procedures

Note: Whenever possible, suspend immunization activities BEFORE the onset of the

emergency event to allow sufficient time for packing and transporting of vaccines.

Written instructions for entering your facility and vaccine storage spaces in an

emergency if the building is closed or it is after hours.

These instructions should include the building security and after-hours access procedure and location of the following:

• doors

• flashlights

• spare batteries

• light switches

• keys

• locks

• alarms

• packing materials

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Emergency Procedures

A. Emergency phone numbers, companies, and points of contact

• List the designated person(s) responsible for • monitoring the operation of the vaccine storage equipment and systems daily

• tracking inclement weather conditions • assuring the appropriate handling of the vaccine during the emergency event

Name of employee Title of employee Work phone Home phone

• Determine if your refrigerator is having a mechanical failure or if the building has

lost electrical power. Check with the building maintenance to ensure that the generator is operational and has been activated.

Building maintenance Point of contact Work phone Emergency phone

• Contact the designated company responsible for restoring power to the location in

the event of a power failure.

Power company Point of contact Work phone Emergency phone

• Contact the designated company responsible for repair where the compressor or the refrigeration equipment has been destroyed or you need emergency maintenance.

Repair company Point of contact Telephone number

• If a time frame for the restoration cannot be determined, implement the following

procedures for transferring the vaccines to an alternative storage facility with backup power.

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B. List emergency phone numbers and points of contact for location with a backup generator

• This may be the local hospital, LTCF, etc. Make arrangements with the site to store

your vaccine there when weather predictions call for inclement weather or when your vaccine storage equipment cannot be fixed or the power cannot be restored

within 6 hours. Before moving your vaccine, call the location to ensure that their backup generator is working.

Alternative facility Point of contact Work phone Emergency phone

C. Describe how to enter the building and vaccine storage spaces in an emergency if

closed or after hours. Include a floor diagram and the locations of the following

Item Location(s)

Doors

Flashlights

Spare batteries

Light switches

Keys

Locks

Alarms

Packing/insulating materials

D. Conduct an inventory before you move the vaccine.

E. Package the vaccine as per packing instructions.

F. Move vaccine to backup storage according to prearranged plans.

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Appendix E - Inventory of Vaccine – Alternate Storage in Event of Power Outage

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Management of Cold Chain Failure

A temperature reading outside +2.0°C to +8.0°C range means the vaccine products have been exposed to wrong temperatures and could be compromised. Follow this procedure:

Check if the thermometer is working correctly; the battery may need to be changed.

Record the date, time, and refrigerator temperatures as per log sheet.

Reset the thermometer.

Adjust the refrigerator setting to +2.0°C to +8.0°C.

Clearly label exposed vaccine “Do Not Use – Cold Chain Failure” and mark the date and time. Place exposed

products in a working refrigerator.

Keep exposed vaccines separated from non-exposed vaccines.

Complete the Vaccine Cold Chain Failure Incident Report and consult with Public Health to determine whether vaccines can still be used.

Monitor the temperature of the affected fridge twice daily for 3 days prior to returning product to the fridge,

ensuring all readings have been between +2.0°C to +8.0°C. Record readings on the Vaccine Temperature Log and submit to Public Health.

After Consulting with Public Health

Clearly label biological products that have had an initial cold chain breach, but were deemed safe for use. This

is important information for Public Health to have if the practice has a second cold chain break.

Consult with Public Health regarding the temperature readings of the fridge prior to returning any vaccine to

the affected fridge.

Dispose of any products only upon direction of Public Health. Return vaccine product to the Public Health Office with the Vaccine Return Form

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Appendix F - Vaccine Cold Chain Failure Incident Report

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Ordering Vaccine and Inventory Procedures

A MONTH’S WORTH

Order enough vaccine for a month supply for your practice.

MONTHLY AUDIT

Audit biological products inventory once a month. Check for expired products.

Return expired products to Public Health Biologicals Depot. Please complete the Vaccine Returns from

Service Providers, (Appendix K) form.

FOR ROUTINE VACCINE REQUESTS

Complete a Requisition for Publicly Funded Vaccine, (Appendix G) and submit to the Public Health

Biological Depot at the Public Health Services Main Office by fax to (902) 481-5923, or by contacting your local Public Health office in Western, Eastern and Northern zones.

FOR NON-ROUTINE VACCINE REQUESTS (HIGH RISK)

Complete a Vaccine Request for High Risk Patients (Appendix H) and fax to your Public Health Office.

Publicly funded vaccines are provided for individuals at high-risk of vaccine-preventable disease as outlined by The Department of Health and Wellness. Consult the NS Immunization Manual high risk policy for eligibility requirements.

After hours/weekend requests should be directed to the Medical Officer of Health through Capital Health

locating (902) 473-2222.

All ordering forms for Public Health are available at the NSHA website: http://www.cdha.nshealth.ca/immunization-forms

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Appendix G – Requisition for Publicly Funded Vaccine

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Appendix H – Vaccine Request for High Risk Patients

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Appendix I - Requisition for Hospital /Community Agencies

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Appendix J – Requisition for Long Term Care Facilities

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Appendix K – Vaccine Returns from Service Providers

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Reporting Requirements

Records

Each person receiving an immunization should receive an individual record. A personal immunization

card is provided to all newborn infants in the information package at the IWK Health Centre. Additional copies may be requested from Public Health.

Each practice or agency should develop protocols for documentation of immunization in accordance to

professional documentation standards. The following information is required for documentation:

Name

DOB

Health Card Number

Vaccine Given

Lot Number

Date Given (Day, Month, Year)

Site

Route

Dose

Professional signature and designation

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Reciprocal Notification

Public Health enters all immunization records of vaccines administered within the district into a provincial database called Application for Notifiable Disease Surveillance (ANDS).

Providers MUST supply immunization records to Public Health for each vaccine administered. Providers can either mail/fax the record using the Reciprocal Notification (Appendix L) form or send

a copy of the electronic records (PHIM, Nightingale, or other). Submit immunization records monthly to Public Health.

The following data elements are required to be entered into ANDS:

Name

DOB

Health Card Number

Vaccine Given

Lot Number

Date Given (Day, Month, Year)

Site

Route

Dose

This will ensure up to date records can be provided on request of the client or health care provider, and can be used in calculating immunization coverage rates.

All vaccine

providers must

provide a record of

immunizations

given to be entered

into the provincial

immunization

registry.

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Appendix L - Reciprocal Notification Form

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Adverse Events Following Immunization

(AEFI)

Under the Nova Scotia Health Protection Act, Adverse Events Following Immunization (AEFI) must be reported to public health.

If a patient experiences an adverse event following immunization, please complete the AEFI FORM and contact your local public health office. These AEFI instructions can assist you to

complete this form. Visit chapter 8 of the NS Immunization Manual for further information on AEFI reporting

Public Health Agency of Canada collects case reports on adverse events following immunization from provincial and territorial health departments, health care professionals and the

pharmaceutical industry.

The data is stored in the Canadian Adverse Events Following Immunization (CAEFI) database and is used to signal adverse events that may require more in-depth investigation. Canadian Adverse Events Following Immunization Surveillance System (CAEFISS) monitors AEFIs to

ensure the safety of vaccines on the Canadian market.

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Appendix M - It's the Law: Reporting Adverse events Following Immunization Poster

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Appendix N - AEFI User Guide

To download the AEFI User Guide please visit http://www.phac-aspc.gc.ca/im/pdf/AEFI-ug-gu-eng.pdf

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Appendix O - AEFI Form

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Urgent Issues in Immunization

Appendix P - Tetanus Prophylaxis in Wound Management: Tetanus Poster

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Appendix Q - Public Health Tetanus Immune Globulin Reporting Form

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Appendix R - Rabies: Fact sheet

Detailed information about rabies in the province can be found in NS Rabies Response Plan. This Rabies Poster can help health care providers assess concerns about animal bites and rabies

exposure. Further information about rabies can be found in chapter 9 of the NS Communicable Disease Prevention and Control Manual

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Appendix S - Rabies letter to Physicians post exposure prophylaxis

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Appendix T - Rabies Immune Globulin Dosage

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Resources for Health Care Professionals

Canadian Immunization Guide Evergreen Version

http://www.phac-aspc.gc.ca/publicat/cig-gci/index-eng.php

Department of Health and Wellness Information for Professionals site http://novascotia.ca/hpp/cdpc/info-for-professionals.asp

Immunize Canada http://www.immunize.cpha.ca/en/default.aspx

Immunization Competencies for Health Professionals Public Health Agency of Canada

http://www.phac-aspc.gc.ca/im/pdf/ichp-cips-eng.pdf Keeping Vaccine Safe

http://novascotia.ca/hpp/publications/13114_Keep-Vaccine-safe.pdf

National Advisory Committee on Immunization http://www.phac-aspc.gc.ca/naci-ccni/#rec

Nova Scotia Communicable Disease Prevention and Control Manual http://novascotia.ca/hpp/cdpc/cdcmanual/

Nova Scotia Immunization Manual http://www.gov.ns.ca/hpp/cdpc/docs/Immunization-Manual.pdf

Nova Scotia Rabies Response Plan http://www.gov.ns.ca/hpp/publications/100999_CDPC_Rabies-Response-Plan.pdf

Nova Scotia Routine Childhood Immunization Schedule

http://www.gov.ns.ca/hpp/cdpc/docs/Immunization-Manual.pdf Nova Scotia Immunization Schedule for Adults

http://www.gov.ns.ca/hpp/publications/13155_AdultImmunizationSchedule_En.pdf

Nova Scotia School Immunization Schedule http://www.gov.ns.ca/hpp/publications/13153_SchoolImmunizationSchedule_En.pdf

Pain Management http://www.immunize.ca/en/health-care-providers/painmgt.aspx

Public Health Agency of Canada http://www.phac-aspc.gc.ca/index-eng.php

Vaccine Preventable Diseases and Immunization http://www.gov.ns.ca/hpp/resources/vaccine.asp

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Vaccine Shoppe

https://www.vaccineshoppecanada.com/index.cfm

Vaccine Storage and Handling Guidelines for Physicians, Pharmacists and Other Immunization Providers www.gov.ns.ca/hpp/cdpc/docs/Vaccine_Storage_and_Management_Guidelines_for_PhysiciansV1.pdf

Vaccine Tear Sheets for Childhood Immunizations

http://novascotia.ca/hpp/cdpc/vaccine-publications.asp

Resources for Parents

Canadian Pediatric Society

http://www.caringforkids.cps.ca/handouts/immunization- index Immunization Action Coalition

http://www.immunize.org/

It’s Time to Immunize http://www.phac-aspc.gc.ca/im/iyc-vve/index-eng.php

Vaccinate Your Baby http://www.vaccinateyourbaby.org/

Your Childs Best Shot https://bookstore.cps.ca/stock/details/your-childs-best-shot-a-parents-guide-to-vaccination-3rd-edition