Guidelines for the Storage, Transportation and Handling of ...

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Guideline for the Storage, Transportation and Handling of
Refrigerated Medicines, Vaccines, and Blood in Queensland Health
Facilities
1. Purpose
This guideline has been developed to assist Queensland Health facilities in
managing appropriate storage, transport and handling of refrigerated medicines and
temperature sensitive clinical trial medicines, vaccines, and blood products (in sites
without separate storage).
2. Scope
2.1 Includes all Queensland Health staff (permanent, temporary and casual)
involved in the storage, handling or dispensing of refrigerated medicines, and
those responsible for refrigerator maintenance.
2.2 The guidelines apply throughout to medicines. Where vaccines and/or blood
products are stored in the same refrigerator, additional requirements detailed
either in the text, or in Appendix 6 and/or Appendix 7 must be observed.
2.3 The guideline excludes Central Pharmacy, which has its own procedures for the
management and handling of refrigerated medicines.
3. Definitions
Refrigerated medicines are pharmaceutical products, including vaccines and
temperature sensitive clinical trial medicines, that require storage between +2 ° C and
+8 ° C to maintain a quality product.
Refrigerated blood products are red cell components separated from whole blood
for transfusion, and products manufactured from human plasma , that require storage
between 2 o C and 6 o C to maintain a quality product.
BTS refers to Biomedical Technology Services
BEMS refers to Building Engineering Maintenance Services
Cold chain: refers to the processes in place to ensure refrigerated medicines and
vaccines are stored, handled and transported at the recommended temperature
range of +2 ° C to +8 ° C for medicines, and +2 ° C to +6 ° C for blood and blood
products 1,2,5,6 .
Cold chain breach (or adverse storage event) is a situation when storage
temperatures have gone outside the recommended range of +2 ° C to +8 ° C for
medicines, and +2 ° C to +6 ° C for blood and blood products. This excludes excursions
A Guideline for the storage and handling of refrigerated medicines in Queensland Health facilities.
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up to +12 ° C, lasting no longer than 15 minutes, when stock taking or restocking)
GMP refers to Good Manufacturing Practice
GDP refers to Good Distribution Practice
NVSG: National Vaccine Storage Guidelines
QH: Queensland Health
QHIP: Queensland Health Immunisation Program
The Standard: Medical refrigeration equipment- for the storage of blood and blood
products Australian Standard AS 3864-1997
4. Background
All medicines must be stored and handled in accordance with the manufacturer’s
guidelines in order to maintain the quality of the product. The World Health
Organization (WHO) recommends special storage conditions, such as the need for
refrigeration, are checked and monitored to ensure appropriate data is recorded
(correct storage) for refrigerated medicines 7 . Manufacturers must follow good
manufacturing practice (GMP) during production, storage and transportation 1,2,3,4,11,13
and it is essential that Queensland Health (QH) facilities store and handle
refrigerated medicines in optimal conditions to provide a quality product for the
patient 15,16 . Storage outside the recommended temperature range can result in
chemical and/ or physical changes to the product which may lead to a loss of efficacy
and/or altered patient response with potential to cause harm to patients.
Inappropriate storage and handling practices of refrigerated medicines may result in
potential spoilage of the medicines and consequent financial impact for the facility eg
insulin and products of biotechnology require refrigeration and are generally high cost
medicines. Incorrect storage and consequent disposal of these medicines may have
a significant impact on the budget of the facility, their ability to opportunistically
vaccinate or treat patients.
This document supercedes the previous Queensland Health Policy Statement titled
Maintenance of the Vaccine Cold Chain modified on the 17 May 2005.
5. Principles
There is currently no Australian Standard for refrigeration equipment for the storage
of refrigerated medicines or vaccines. Australian Standard AS3864-1997 applies to
storage of blood and blood products. 1°
The NVSG must be complied with for vaccines. However, AS3864 contains a number
of relevant points that will guide the storage of all three categories or product, such
as:
• A temperature recording system is in place in the refrigeration equipment and
that this is checked at least daily (but preferably twice daily) using chart and/or
digital recording methods or a manual record of temperature.
• For refrigerators without inbuilt probes, the temperature probe must be located
in the warmest part of the refrigerator; this is generally the front top portion,
unless advised otherwise in the manufacturer’s documentation.
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• The target temperature of the refrigerator equipment is set as close as
possible to +4 ° C for blood products and +5 ° C for medicines and vaccines.
• Alarm points are set at +2.5 ° C and +7.5 ° C (+5.5 ° C for blood products), to alert
to instances of temperature breaches outside this range.
• The refrigerator alarm function is checked weekly via a process developed in
conjunction with hospital maintenance services, or with the supplier, and detail
of the check is recorded in an appropriate manner as per Appendix 2.
• The refrigeration system device that controls the refrigerator cooling is
separate from any temperature alarm/ temperature recording equipment 1°
such that the failure of one shall have no effect on the continued performance
of the other.
• A check of the calibration of the refrigeration equipment must be conducted no
less than annually by an approved QH service provider e.g. Biomedical
Technology Services (BTS) or Building Engineering Maintenance Services
(BEMS).or by the Supplier
• A process is in place to ensure refrigerated medicines are kept not less than
4cm from the back-plate and for confirming with the manufacturer whether
refrigerated medicine(s) can be stored in the bottom of the refrigerator 5,7 .
• If refrigerated medicines occupy only a small proportion of the refrigerator
space it is necessary to add sufficient thermal mass. Use as many bottles of
water or 0.9% sodium chloride in the vacant space to ensure even
temperature is maintained throughout the refrigerator.
6. Process
6.1 Transportation of Refrigerated medicines to outreach clinics and/or smaller
regional QH Facilities
All QH staff and contractors need to ensure the following:
• Refrigerated medicine for transportation outside the building from where
they are supplied must be monitored with appropriate devices that will
indicate exposure to 0 ° C and temperatures >+8 ° C when packed and in
transit to ensure that the temperature range is maintained between +2 ° C
and +8 ° C 11, 12 .
• Handling and transportation time to the destination should be kept to a
minimum to ensure that the refrigerated medicine maintains optimal
efficacy. Appendix 1 provides information on suitable packaging processes
for the transportation of refrigerated medicines.
• Domestic style coolers, eg. Esky or Willow, are not adequate for
transporting and handling of refrigerated medicines for longer than 3 to 4
hours.
• If portable fridges are used for transportation of refrigerated medicines it is
essential that temperature range is maintained between +2 ° C and +8 ° C
and a power supply is available to access in an emergency.
• A temperature monitoring device (eg data logger, minimum/maximum
thermometer or temperature strip) should be used to record the minimum
and maximum temperature range of the refrigerated medicine during the
transportation process. The temperature monitoring device should be
placed in the middle of the package of refrigerated medicine. See appendix
1
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• If using a miminum/maximum thermometer to monitor temperatures during
transport temperatures should be recorded in an outreach Temperature
Log Book available from QHIP
• The temperature monitoring device must be checked on arrival at the
destination. If a temperature breach has occurred during the transportation
process then refer to the table below 5, 6 .
• If transport is within a single building, and transit time is less than 15
minutes, then the products should be transported in an insulated container
(e.g. polystyrene esky or coolbag). No additional cooling or monitoring is
required
Origin of product
Reporting a cold chain breach
Responsible organisation Contact
Vaccines supplied by QH
QHIP (Monday to Friday – 3328 9888
Immunisation Program
8am to 4.30pm)
Medications and other vaccines Central Pharmacy (Monday
to Friday 8am to 5pm)
3120 8500
Clinical Trial medicines and vaccines Clinical Trial Principal Dependent on
Investigator
investigator
Blood and blood products Blood Bank supervisor Supplying
Laboratory
Privately purchased medicines and
vaccines
Manufacturer Manufacturer
6.2 Breach of Temperature Range in Transportation to or at a QH Facility
• When a temperature breach is noted the affected refrigerated medicines
must be labelled as ‘Not to be used’ and isolated in a separate section
of the refrigerator. The minimum and maximum temperature variations
must be documented by the observer. Contact the relevant body listed
above to report the breach and for further advice on how to manage the
exposed products 5,6,15 . or contact Pharmacist/Director of Pharmacy
for assistance in obtaining relevant manufacture’s information on
drug stability.
• If there is a mechanical issue with the refrigeration equipment the
mechanic must be contacted to undertake necessary and appropriate
maintenance work.
• Exceptions:
� If blood and blood products are involved in temperature
breaches outside +2°C to +6°C, contact the Blood Bank
Supervisor (from laboratory who supplies blood) immediately and
quarantine the blood. This product cannot be used for transfusion 16 .
� If Clinical Trial refrigerated medicines are involved in
temperature breaches outside +2°C to +8°C, contact the Clinical
Trial Principal Investigator to inform of the breach and to seek
advice.
• All temperature breaches need to be documented in either the QHIP
Temperature Log Book or the Minimum/maximum temperature chart, or as
per Appendix 3 or as per Appendix 4 if blood products are present. Actions
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taken (e.g. the Director of Pharmacy or Nurse Unit Manager contacted and
refrigerated medicines quarantined) must be documented.
• All temperature recording documentation must be retained for 10 years in
accordance with QH (clinical records) retention and disposal
schedule 16 .The legal requirements for refrigerated blood storage differs
from those relating to clinical records with records to be retained for 20
years 17 .
In the event of a power failure the refrigeration equipment door should be kept closed
and urgent action should be taken to prepare for removal of medicines to alternative
monitored storage particularly where purpose built refrigerators with glass doors are
in use. These refrigerators may not hold their temperature so it will be important to
vigilantly monitor for temperatures approaching the designated maximum of +8°C,
then products will need to be moved to appropriate, monitored storage facilities that
are identified in the unit emergency plan 5,6 . If a temperature breach occurs then refer
to relevant appropriate area eg QHIP, Manufacturer, Central Pharmacy etc for advice
as soon as possible (in business hours).
7. Storage of Refrigerated Medicines in QH facilities
This section provides guidance on the responsibilities of QH staff for storage,,
handling and dealing with temperature breaches of refrigerated medicines.
Districts will be responsible for the safe management, scheduled maintenance
and yearly auditing of their refrigerated medicines, vaccines and blood storage
and ensure maintenance of the cold chain is included in the district Risk Register.
7.1 Queensland Health Pharmacy Departments
• All departments must have a designated staff member (and back up staff)
to ensure appropriate storage of refrigerated medicines. All staff must be
trained and supported in their roles and responsibilities for temperature
monitoring and recording in real time. The designated staff member/s must
provide education and training to all staff regarding the guideline and
procedures for storage and handling of refrigerated medicines 3,5,6 .
• Refrigerated medicines must be stored in refrigeration equipment meeting
the criteria in Section 5, the minimum and maximum temperature of which
must be monitored and checked at least daily (ideally twice daily) as
outlined in section 8.2. The refrigeration equipment must be equipped with
temperature recorders or devices that provide continuous recording of
temperature and will indicate when and for how long the specific
temperature range has been breached. The documented temperature data
must be reviewed regularly 5,6,7,9 .
• Document, the minimum and maximum in the approved QHIP Temperature
Log book or Minimum/maximum temperature chart available from QHIP or
as per Appendix 3 5,6,19 This documentation must be retained for 10 years
in accordance with QH (clinical records) retention and disposal schedule 17 .
7.2 Queensland Health Ward/Unit/Clinic Areas and Community Health Clinics
• The Nurse Unit Manager (NUM) will allocate a staff member to be
responsible for ensuring appropriate storage and handling of refrigerated
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medicines. This will involve responsibility for twice daily monitoring of the
minimum and maximum temperatures, reporting any cold chain breaches
to QHIP for vaccines, the Blood Bank Supervisor for blood products and
the hospital pharmacy for refrigerated medicines.
• Refrigerated medicines must be stored in refrigeration equipment meeting
the criteria in Section 5, the minimum and maximum temperature of which
must be monitored and checked at least daily (ideally twice daily) (as
outlined previously) 19 . The refrigeration equipment must be equipped with
temperature recorders or devices that will indicate the minimum and
maximum temperature, when and for how long the specific temperature
range has been breached. The documented temperature data must be
reviewed regularly 5, 6, 7, 9 .
• The allocated staff member needs to be educated and trained on the
procedures for storage and handling of refrigerated medicines, and
assessed for competency 3,5,6 . A second nominated “back up” staff
member should also be educated and trained in case of leave/absence of
the allocated staff member.
• Document, no less than twice daily, the minimum and maximum
temperatures in the approved QHIP Temperature Log Book or
Minimum/maximum temperature chart or as per Appendix 3 5,6 The
temperature documentation must be retained for 10 years in accordance
with QH (clinical records) retention and disposal schedule 17 .
• The allocated staff member must provide education and training in
temperature monitoring and recording of the refrigerators to all staff
members involved in the storage and handling of refrigerated medicines.
• If refrigerated medicines are stored in the same refrigerator as blood
products, the appropriate temperature range of +2 ° C to +6 ° C is required for
the refrigerator as per The Standard 10,16 .
• As a clinical standard the staff involved in temperature monitoring and
recording need to be assessed for competency. It is important that this is
maintained at the local level.
8. Equipment
8.1 Refrigeration
• Refrigeration equipment must be purchased in accordance with the current
Standing Offer Arranagement for Vaccine/Pharmacy Refrigerators
• Adequate clearance from the floor is needed to allow cleaning of floor
beneath the refrigerator or wheels to allow easy movement for cleaning.
• The contents of the storage compartment is to be seen without reliance on
external lighting. Where not possible, internal lighting shall be fitted.
• The refrigeration system should not produce any undue noise or vibration.
• The refrigerator should not progressively accumulate frost or ice over
successive defrost cycles.
• All QH facilities should only be using a purpose built refrigerator for storage
of vaccines, medicines and blood. Domestic refrigerators are not
recommended for the storage of medicines and vaccines and must not be
used for blood products 5 .
• Refrigerators required for Cytotoxic products must not be used to store
other pharmaceuticals and vaccines.
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• The refrigerator must only be used for the specified purpose, and MUST
NOT be used for storage of any other items, such as food or pathology
samples. Separate arrangements must be made for these.
8.2 Temperature Recording Devices
• Any temperature recording device in use in refrigeration equipment in QH
facilities needs to record to an accuracy of ±0.5 ° C in the range +0 ° C to
+20 ° C in the refrigeration cabinet. Temperature recording devices requiring
electrical mains power for their operation must be connected to a secure
power supply that is different to the power supply for the refrigerator itself
and be able to operate for 24 hours in the event of the loss of mains
power 10 .
• The temperature recording device needs to display the minimum and
maximum temperatures recorded over time not just the current
temperature.
• The temperature recording device needs to be checked visually at least
once (but preferably twice) each working day, and results recorded in the
QHIP temperature log book or the Minimum/maximum temperature chart
available from QHIP
• Manual and electronic temperature measuring and recording devices
should be calibrated annually by QH service provider eg BTS ,using a
traceable reference device 10 .
• The alarm functions for high/low temperature need to be checked weekly
at the designated set points and documented as per Appendix 2 3,9,10 .
• Charts will be changed weekly, or as recommended by the manufacturer.
Data loggers (Digital Temperature Recorders) will be downloaded at least
weekly. If blood is stored, then a copy of the chart must be forwarded to
the blood supplying laboratory.
8.2.1 Chart Recorders
• Chart recorders must be capable of recording a temperature range of -5 ° C
to +20 ° C and provide capacity for at least 7 days recording and needs to
be visible on the exterior of the refrigerator. The chart shall be scaled at not
less than 1mm/ ° C, and have increments not exceeding
+2 ° C. The chart should have an identifying band or strip for the
temperature range +2 ° C to +8 ° C 10 .
• A process must be established to monitor the chart record, record results,
ensure charts are changed regularly (weekly), pens are working and
alarms are active and working effectively 5, 7 .
• The minimum and maximum temperatures must be recorded at least once
(and preferably twice) daily in the QHIP temperature log book or the
Minimum/maximum temperature chart available from QHIP or as per
Appendix 3 5 .
8.2.2 Digital Temperature Recorders
• A digital temperature recorder (where used) must be able to print a
permanent record of the refrigerator cabinet temperature at a rate of no
less than one reading per 15 minutes within the temperature range. The
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ecord shall include the time and date of readings, as well as the time at
which an alarm state occurs, and the time at which this is rectified 1° .
• Temperatures must be recorded at least once (and preferably twice) daily
in the QHIP temperature log book or Minimum/maximum temperature chart
available from QHIP or as per Appendix 3 .
8.2.3 Temperature Probes
• All purpose built vaccine/blood refrigerators in use in QH facilities should
have lagged temperature probes ie the refrigerator should already be set
up with a temperature probe in specific material (e.g. fluid or metal) so
reduce the short term fluctuations in temperature of the purpose built
refrigerator. Lagging gives a better indication of the actual temperature of
the products and prevents the alarm going off unnecessarily 5 .
• Temperatures must be recorded at least once (and preferably twice) daily
in the QHIP temperature log book or the Minimum/maximum temperature
chart available from QHIP or as per Appendix 3 .
8.3 Alarm Systems
• Alarms must be located in a 24 hour staffed area, connected to a
pager/mobile phone of an on-call staff member, or connected to a 24-hr
facility service area (eg: Switchboard) that can arrange necessary action.
• Battery-operated alarm systems must incorporate audible and flashing
visual alarms 1° .
� The audible and visual alarms shall activate:
� If the temperature of the lagged probe falls to +2.5 ° C or reaches
+7.5 ° C (+5.5 ° C if blood is stored)
� If there is an interruption of the electrical supply to the
refrigerator
� Where the audible alarm can be muted, a process for its automatic
reactivation after a 15-30 minutes time interval must exist, if the alarm
condition still exists.
• Centrally monitored alarm systems must have a separate terminal outlet for
the alarm system to connect to a remote site. Any circuit failure shall not
affect the correct functioning of the basic alarm system 10 .
9. Other Considerations
An audit checklist is provided at Appendix 5. Annual audit or an audit at the time a
cold chain breach occurs will assist sites in assessing their compliance with these
guidelines. Completion of this will generally will fall within the responsibilities of
the Director of Pharmacy, District vaccine management coordinators and/or
Director of Nursing, but may be delegated to the staff member(s) as designated in
Section 7
10. Implementation Date
Effective from July 2011
Where local district guidelines for management of vaccine, refrigerated
medicines and blood are developed, these should be based on the information
contained in this document.
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11. Legislative or other Related Documents
• QIS document 21684 Regarding storage of blood and blood products
• Appendix 1: Refrigerated medicine package process
• Appendix 2: Weekly Alarm Tests Form
• Appendix 3: Daily Temperature Records for Refrigerated Medicines
• Appendix 4: Daily Temperature Records for Refrigerated Medicines and
Blood Products
• Appendix 5: Audit Checklist for Fridges
• Appendix 6: Additional requirements for Vaccines
• Appendix 7: Additional requirements for blood
• Appendix 8: QHIP Outreach Temperature Log Book
12. References
1. Good Distribution practices (GDP) for pharmaceutical products WHO2004
QAS/04 068.
2. Guidelines for temperature control of drug products during storage and
transportation. Website http://www.hc-sc.gc.ca/dhp-mps/compliconform/gmp-bpf/docs/index_e.html
3. Taylor J. Recommendations of the control and monitoring of storage and
transportation temperatures of medicinal products. Pharm. J 2001; 267: 128-
131.
4. Australian code of good manufacturing practice for medicinal products. TGA
16 th Aug 2002
5. National vaccine storage guidelines Strive for 5. Australian Government
publication 2005.
6. Langley A, Grant S. Proceedings of the National Vaccine Storage Workshop
Brisbane June 2004.
7. The Australian Immunisation Handbook 9 th edition 2008
8. http://www.clinetserv.com/index.php
9. Medical refrigeration equipment- for the storage of blood and blood products
Australian Standard AS 3864-1997
10. Guidance for shippers, transport service providers and sub-contractors
involved in the distribution of pharmaceutical products registered for storage
between 2 ° C and 8 ° C
11. Australian code of good manufacturing practice for medicinal products. TGA
16 th Aug 2002
12. Guidelines for good Clinical Practice E6 (R1). International Conference of
harmonisation of technical requirements for registration of pharmaceuticals
for human use. 10 June 1996
13. 3M Monitor Mark Arrow Scientific Pty Ltd. www.arrowscientific.com.au
14. Irish medicines Board. Guide to control and monitoring of storage and
transportation temperature conditions for medicinal products and active
substances Ed.003Version01 March 2006
15. Guidelines for pre-transfusion laboratory practice. Australian & New Zealand
Society of Blood Transfusion Ltd. 5 th Edition March 2°°7.
16. Queensland State Archives. Qld Health (Clinical Records) Retention and
Disposal Schedule: QDAN546 v.3 Aug2008
17. Queensland State Archives. Qld Health (Pathology Laboratory Records)
Retention and Disposal Schedule: QDAN614 v.1 June 2006.
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18. Communications with the Cold Chain Testing Centre, a division of the
Pharmacy Guild of Australia NSW Branch, August 2008.
13. Further Information
For further general information please contact Medication Services Queensland
-Telephone (07) 3131 6521 or Fax (07) 3131 6568
Approved by: Ruth Hay
Position: Director, Medicines Infrastructure and Support,
Medication Services Queensland
Date:
Signature
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APPENDIX 1: Refrigerated Medicine Package Process
Example of refrigerated medicine/vaccine package process if transporting to clinic,
unit or ward is shown in the diagram below: 5
General principles for transport of refrigerated medicines:
A Guideline for the storage and handling of refrigerated medicines in Queensland Health facilities.
Figure 1:
Example of portable fridge
Note: Ice packs or gel packs are not required with portable fridges. Refrigerated medicines
transported in portable fridges need to be stored in the baskets provided, and avoid contact
with the inner wall.
• Manufacturer’s storage conditions need to be adhered to in order to maintain an
efficacious product.
• The cooler or portable fridge should be kept out of the sun and in the coolest part of the
vehicle during transportation.
• Remove medicines/vaccines from the cooler/portable fridge only as required
• Temperature monitor needs to be able to measure if the temperature range has been
exceeded and the time duration outside the temperature range. Real time temperature
monitoring is preferred.
• When the refrigerated medicine arrives at the destination ensure that temperature range
is checked. If the temperature range has been maintained then remove from
cooler/portable fridge and store in a refrigerator that complies with The Standard for
refrigerators.
• If the temperature range has not been maintained, contact either the manufacturer,
Central Pharmacy, Queensland Health Immunisation Program or Blood Bank Supervisor
for action required for the refrigerated product.
Instructions for conditioning ice packs/gel packs:
NB: Incorrectly conditioned or unconditioned ice packs/gel packs are too cold for safe
storage of medicines/vaccines and may easily cause these items to freeze.
• Remove the ice packs/gel packs from the freezer
• Lay out ice packs/gel packs in a single row on their sides (where possible) leaving
a 5cm space around each ice pack to allow maximum air exposure to reduce the
“conditioning” time
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• Wait until the ice packs/gel packs begin to sweat. This will take up to one hour at
+20 ° C and much less at higher temperatures.
• The ice packs/gel packs are conditioned as soon as water begins to “slosh” about
slightly inside the ice pack.
Instructions for packing a cooler:
• Chill the inside of the cooler prior to use by placing ice packs/gel packs in it for a
few hours
• Place suitable insulating material (eg bubble wrap, polystyrene chips, shredded
paper) at the bottom of the container to eliminate hot and cold spots. Packaging
such as polystyrene chips is preferable to bubble wrap which stops air from
circulating. However if using bubble wrap avoid wrapping tightly.
• Place freeze sensitive medicines in the centre of the container, and freeze
tolerant medicines closest to the ice packs/gel packs.
• Place the minimum/maximum temperature monitoring device in the centre of the
medicines
• Surround the medicines with packing material which allows cold air to circulate
• Place the conditioned ice packs/gel packs on top, close and seal the lid of the
cooler; if using a larger cooler, place conditioned ice packs/gel packs around the
sides of the cooler as well as on top. The optimal combination of ice packs/gel
packs and packaging will vary depending on factors such as the ambient
temperature, amount of medicines, size of cooler etc.
• Ensure medicines are not in direct contact with the ice packs/gel packs to
minimise the risk of freezing
• Monitor the temperature of the cooler before you leave, when you arrive, prior to
administering medicines and regularly whilst medicines are in the cooler (at least
hourly)
A Guideline for the storage and handling of refrigerated medicines in Queensland Health facilities.
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APPENDIX 2: Weekly Alarm Tests Form
WEEKLY ALARM TESTS
Fridge Name/Identifier: _________________________________________________________________________________________________
DATE LOW
ALARM
TEMP °C
HIGH
ALARM
TEMP °C
POWER
LOSS
ALARM
LOW
BATTERY
ALARM
REMOTE
ALARM
TESTED
A Guideline for the storage and handling of refrigerated medicines in Queensland Health facilities.
Chart
Changed &
checked
Problems/
Comments
Performed
by
Checked
by
13

APPENDIX 3: Daily Temperature Records for Refrigerated Medicines
Year
Month:
Performed
by
Problems/
Actions
DAILY TEMPERATURE RECORD o C
(Expected Temperature Range 2 o C-8 o C, however if blood products are stored in the fridge then use Appendix 4 )
Contact QH service provider eg BTS, BEMS if the fridge is not within limits.
Fridge Check by:
Date 1 2 3 4 5 6 7 8 9 1° 11 12 13 14 15 16 17 18 19 2° 21 22 23 24 25 26 27 28 29 3° 31
+2° or
above
+18
+16
+14
+12
+1°
+8
+6
+4
+2
°
-2
or
below
Immediate action required is temperature in shaded area
Immediate action is required if temperature in shaded area
Date: Date: Date: Date:
Maintaining and Monitoring of Refrigerator Temperature
1. If the temperature recorded is in the orange zone then refer to the Guideline for Storage and Handling of Refrigerated Medicines in Queensland
Health Facilities section 7: Breach of temperature range within or during transportation to the QH facility
2. Document action taken e.g. Contacted Central Pharmacy, change in expiry of refrigerated medicine.
A Guideline for the storage and handling of refrigerated medicines in Queensland Health facilities.
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APPENDIX 4: Daily Temperature Records for Refrigerated Medicines and Blood Products
Year
DAILY TEMPERATURE RECORD o C
(Expected Temperature Range 2 o C-6 o C, if blood products are stored in the fridge with refrigerated medicines
Contact QH service provider eg BTS, BEMS if the fridge is not within limits.
Fridge Check by:
Date 1 2 3 4 5 6 7 8 9 1° 11 12 13 14 15 16 17 18 19 2° 21 22 23 24 25 26 27 28 29 3° 31
+2° or
above
+18
+16
+14
+12
+1°
+8
+6
Month +4
Performed by
Problems/
Actions
+2
°
-2
or
below
Immediate action required is temperature in shaded area
Immediate action is required if temperature in shaded area
Date: Date: Date: Date:
Maintaining and Monitoring of Refrigerator Temperature
1. If the temperature recorded is in the orange zone then refer to the Guideline for Storage and Handling of Refrigerated Medicines in Queensland
Health Facilities section 7: Breach of temperature range within or during transportation to the QH facility
2. If blood products involved contact Blood Bank supervisor immediately and quarantine the blood
3. Document action taken e.g. Contacted Central Pharmacy, change in expiry of refrigerated medicine
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APPENDIX 5: Audit Checklist for Fridges
Facility:
Location of Refrigerator:
Asset Number of the Refrigerator:
Date Audit Undertaken:
Contact person and Phone no.:
REQUIREMENT
Are vaccines stored in the refrigerators?
Contact person and Back up contact
Are the refrigerated medicines ever removed from
the fridge for more than 4 hours and then returned
to the fridge?
Are temperature checks (chart and digital)
recorded daily?
Are alarm points set for 2.5 ° and 7.5 ° C?
Are blood products stored with refrigerated
medicines?
Are the alarm points set for 2.5 ° and 5.5 ° C?
Compliance
YES
NO
A Guideline for the storage and handling of refrigerated medicines in Queensland Health facilities.
Comments
If YES refer to Queensland Health Facility Vaccine Management Audit
tool below. If NO , continue with this checklist
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Is the high and low alarm checked and recorded
weekly?
Is the temperature chart changed weekly?
Is the alarm system monitored 24 hours a day,
(either in or away from the fridge area)?
Has the yearly calibration of the refrigerator, alarm
and temperature monitoring devices been
performed?
Queensland Health Facility – Vaccine Management Audit Tool
Facility:
Location of Vaccine
Refrigerator:
Asset Number of Refrigerator:
Date Audit Undertaken:
Contact Person and Phone
no.:
Section 1 – Protocols/Training
1.1 Who is the designated person/position and a
back up person, assigned to oversee vaccine
management in your facility/unit?
A Guideline for the storage and handling of refrigerated medicines in Queensland Health facilities.
DATE: ___/___/_______
Designated
person:__________________
Back up person:_____________________
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1.2 Does your facility have a Vaccine Management
Protocol which covers the following:
� Receiving Vaccine
� Managing cold chain breaches & reporting to
QHIP
� Power failures
� Transporting vaccines
� Storage of vaccines
Date protocols were last reviewed
If you answered No to any of the above please
provide further details …
1.3 Do all staff who handle vaccines receive
training at orientation and an annual update to
enable them to manage the refrigerator and
vaccines according to the current National
Vaccine Storage Guidelines?
If so, WHEN was the annual update
presented?
Who provided the training?
A Guideline for the storage and handling of refrigerated medicines in Queensland Health facilities.
Yes � No �
Yes � No �
Yes � No �
Yes � No �
Yes � No �
____/____/_____
Yes � No �
____/____/_____
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1.4 What reference material are you currently using
for Vaccine Management and Maintenance of
the Cold Chain?
Where is the reference material located?
Section 2 – Vaccine purpose-built refrigerator
2.1 Have you sighted the previous min/max
temperature records since the last audit?
(Vaccine refrigerator temperature records
are to be retained for 10 years.)
If No to the above question, why?
2.2 Has the vaccine refrigerator temperature been
maintained between +2°C to +8°C since the
last audit?
If No were there any contributing factors such
as power failure, plug removed from socket,
etc?
Was it reported to QHIP?
Date Reported:
Was the Vaccine Management Coordinator
notified?
A Guideline for the storage and handling of refrigerated medicines in Queensland Health facilities.
Yes � No �
Yes � No �
Yes � No �
����____/____/_____
����____/____/_____
Yes � No �
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2.3 Is there anything else other than
pharmaceuticals stored in the refrigerator – if
Yes what else is stored?
2.4 When was your vaccine refrigerator last
checked either for routine maintenance or a
mechanical issue?
2.5 What is the age of the vaccine refrigerator in
years?
2.6 Is your vaccine refrigerator connected to the
auxiliary power outlet or do you have an
emergency generator/power supply for the
vaccine refrigerator?
2.7 Is the refrigerator large enough to store the
quantity of vaccines used by your facility?
2.8 Are the appropriate stickers placed on the
refrigerator and power source?
2.8 Are vaccines stored in their original
packaging?
2.9 Is the refrigerator alarmed?
Is the alarm turned on?
Is the alarm checked weekly?
A Guideline for the storage and handling of refrigerated medicines in Queensland Health facilities.
Yes � No �
Date: ____/____/_____
Yes � No �
Yes � No �
DO NOT Turn off or disconnect this
refrigerator Yes �
No �
STOP Do you need to open it?Yes � No
�
Yes � No �
Yes � No �
Yes � No �
Yes � No �
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2.10 Can it be heard and responded to 24 hours a
day?
2.11 Is there a protocol in place regarding the
response to the alarm?
2.12 Who is trained and responsible to respond to
the alarm?
2.13 Who is responsible for changing the chart
recorder paper and pencil – if applicable?
Is the chart recorder paper changed weekly?
2.14 What temperatures are the alarm parameters
set at?
2.15 Is the vaccine refrigerator lockable (this is NOT
mandatory)?
If so is it locked at all times?
2.16 During a power outage do you have equipment
ie “coolers”, thermometer, etc (please refer to
page 26 to 35 of the current guidelines) ready
to use if required?
Issues following this audit:
A Guideline for the storage and handling of refrigerated medicines in Queensland Health facilities.
Yes � No �
Yes � No �
Name: _________________________
Name: _________________________
Yes � No �
Minimum temperature _____°C
Maximum temperature _____°C
Yes � No �
Yes � No �
Yes � No �
Last checked:
Date: ____/____/______
Signature:______________________
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Recommendation following this audit:
Auditor: Date: ____/____/____
A Guideline for the storage and handling of refrigerated medicines in Queensland Health facilities.
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APPENDIX 6: Additional requirements for handling of vaccines
Background
Vaccines are delicate biological substances that can become less effective or destroyed if they are exposed to temperatures outside the safe range of
+2°C to +8°C. The ‘cold chain’ is the system of transporting and storing vaccines within the temperature of +2°C to +8°C from the time the vaccine is
manufactured to the point of administration.
The National Vaccine Storage Guidelines: Strive for Five (Department of Health and Ageing 2005) is a concise, practical and user friendly guide to
vaccine storage. This publication can be accessed from the Queensland Health website at:
www.immunise.health.gov.au/internet/immunise/publishing.nsf/Content/provider-store
The National Vaccine Storage Guidelines contains specific details on setting up the infrastructure for a vaccination service and immunisation service
providers should refer to this to ensure that satisfactory equipment and procedures are in place before commencing vaccination services. The National
Vaccine Storage Guidelines also provides instructions on how to best transport vaccines from the main storage facility to outreach or external clinics
using a cooler.
With correct temperature monitoring and adherence to the National Vaccine Storage Guidelines any problems in vaccine storage should be detected
early and handled appropriately before compromised vaccine is administered.
The storage of vaccines in Queensland Health facilities
All Queensland Health staff who handle vaccines in any way must be familiar with, and adhere to, the National Vaccine Storage Guidelines.
The Queensland Health Immunisation Program (QHIP), based within the Communicable Diseases Branch of Queensland Health, is charged with
coordinating the ordering, distribution and delivery of government-funded vaccine to service providers throughout Queensland. QHIP also provides
information and resources to vaccine service providers, and manages vaccine cold chain breaches.
Issues for Queensland Health staff to note
The minimum and maximum temperatures of the vaccine refrigerators need to be recorded at least daily but it is highly desirable to check refrigerator
temperatures twice daily. Queensland Health staff should use either the Queensland Health Minimum Maximum Temperature Chart or the Queensland
Health Daily Temperature Log Book (available on request from QHIP).
A ‘cold chain breach’ is when vaccine storage temperatures have gone outside the recommended range of +2°C to +8°C*. When a cold chain breach has
been identified staff in Queensland Health must take the following steps:
1. Isolate the vaccines to ensure that they are not used pending advice from QHIP
2. Advise immediate colleagues not to use the vaccines until further notice
3. Notify the District Cold Chain Coordinator (if applicable)
4. Phone QHIP on 3328 9888 to report the breach (office hours are from 8am to 4.30pm). If after hours, keep the vaccines isolated and phone on
the next business day.
A Guideline for the storage and handling of refrigerated medicines in Queensland Health facilities.
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* This excludes minor excursions of vaccine refrigerators temperatures up to +12°C, lasting no longer than 15 minutes when stock taking or restocking. In
this situation this does not constitute a cold chain breach. The reason for the minor breach should be documented but it does not need to be reported to
QHIP. The storage, transportation and handling of vaccines by Queensland Health staff must always be consistent with the National Vaccine Storage
Guidelines.
A Guideline for the storage and handling of refrigerated medicines in Queensland Health facilities.
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APPENDIX 7: Additional requirements for handling of blood
Storage of Blood Products
• Blood must only be stored in refrigerators which are fan-forced, rather than using cooling plates, and the same standard is
recommended for vaccines and medicines.
• Blood will be stored on a separate or partitioned shelf/drawer from refrigerated medicines.
• Where it is necessary to store medicines in the same refrigeration equipment as blood products, the temperature range of +2 ° C to
+6 ° C (appropriate for blood products) is required as per The Standard 10 .
• The target temperature should be set as close as possible to +4 ° C.
• Alarm points must be set at +2.5 ° C and +5.5 ° C 10,16 .
• A temperature recording device must be checked twice daily and results recorded for both refrigerated medicines and blood
products as per Appendix 4.
• Document, no less than twice daily, temperatures as per Appendix 4. The temperature documentation should be retained for 20
years in accordance with QH (pathology laboratory records) retention and disposal schedule 18 .
• Temperature recording devices alarm function must be checked weekly and recorded appropriately as per Appendix 2.
• A check of the calibration of refrigeration equipment is conducted no less than annually by an approved QH service provider e.g.
Biomedical Technology Services (BTS) or Building Engineering Maintenance Services (BEMS).
• Copy of the chart(s) must be forwarded to the blood supplying laboratory
• All charts and testing documentation must be kept on site for review by accrediting bodies
Transport of blood products
• Transport of blood must be in a validated container, packed by a validated method.
A Guideline for the storage and handling of refrigerated medicines in Queensland Health facilities.
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8. Amendment History
Revision Date Author/s Amendments
V0 01 Oct 2008 Michele Cree First issue
V0.1 30 October Michele Cree/ Minor changes
2008 Andrew Jagels
V0.2 4 December Michele Cree Minor changes
2008 Andrew Jagels
V0.3 17 April 2009 Michele Cree Minor changes in format.
V0.4 4 September
2009
Michele Cree Changed to guideline.
V0.5 October 2009 Muriel
Woodhouse
Minor changes
V0.6 18 November Ruth Hay Minor format changes
2009 Michele Cree
V07 5 January
2010
Nick Sherlock Minor changes
V0.8 6 January Andrew Jagels, Minor changes
2010 Ruth Hay
VO.9 8 January Alisha
McDermott
Minor Changes in Format.
V0.10 11 March Andrew Jagels Incorporation of comments after circulation
2010
of V0.9
V0.11 7 June 2010 Vicki Bryant Included comments from PHN –
Immunisation and CDB
V0.12 20 October
2010
Andrew Jagels Reorganisation of content
V0.13 17 November Andrew Jagels Trackchanges by Madeline Hall accepted.
2010
Additional comment from Ruth Hay
V0.14 13 April 2011 Andrew Jagels Amendments following further meeting
between R.Hay, A.Jagels, V.Bryant, M.Hall
V1.0 19 April 2011 Andrew Jagels Signature table added. Final version for
circulation
A Guideline for the storage and handling of refrigerated medicines in Queensland Health facilities.
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