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New report: Vaccine Wastage in Australia due to temperature monitoring failures.

Posted: Wed, 17.05.2017

Better Management for Vaccine Refrigerators under Strive for 5 Guidelines
Written by John Cupit HLP Controls May 2017

Immunisation788055870.jpg

Over the last ten years significant effort has been made by Australian Federal Government, advisory bodies NIC, NCIRS, ATAGI, TGA, and state based peak bodies, nursing and general practitioners to support improved health outcomes for Australians by creating and supporting the Essential Immunisation Program, and marketing the benefits of immunisation.

The National Immunisation Program Schedule includes vaccines against a total of 16 diseases. http://www.immunise.health.gov.au/internet/immunise/publishing.nsf/Content/nips

These include routine childhood vaccinations against diseases that were once widely fatal, such as measles, diphtheria and whooping cough (pertussis), as well as more recently developed vaccines, such as Human Papillomavirus (HPV) and the meningococcal C vaccine. These vaccines are free for all Australians under the Pharmaceutical benefits scheme.

These benefits are passed from the Federal Government to the States in a package called the National Partnership Agreement on Essential Vaccines, through the Essential Vaccines Procurement Strategy. This comprises free vaccines, and policies relating to administration.

Cost associated with Immunisation
There is real cost and risk associated with managing the immunization process, and this leads to the opportunity to improve process, and use technology to automate process, remove human error and drive cost improvements.

Department of Health Annual Report 2015-2016 http://webarchive.nla.gov.au/gov/20170421051751/http://www.health.gov.au/internet/main/publishing.nsf/Content/annual-report2015-16

From the Federal Government Annual Performance statements for Outcome 1.
Population health
Program 1.3: Immunisation

Total spend for Immunisation Program  $AUD 290,246,000  ( under budget $AUD 307,768,000 )

Under the National Partnership Agreement on Essential Vaccines payments are made to each state if they meet predetermined benchmarks.

The Annual Report affirms that all states met the Immunisation benchmarks namely...

Benchmark 1 – maintain or increase coverage rates for Indigenous Australian children
Benchmark 2 – maintain or increase coverage in areas of low immunisation.
Benchmark 3 – maintain or decrease vaccine wastage and leakage to 10% or below.
Benchmark 4 – maintain or increase coverage rates for four year olds.

From the Federal Government Productivity Commission performance report 2015-16
National Partnership Agreement on Essential Vaccines

Data on the leakage or wasted vaccines is listed by state in this report as follows:

N.S.W 6.9% wastage
VIC 7.1% wastage
QLD 5.2% wastage
WA 6.7% wastage
SA 6.3% wastage
NT 8.2% wastage
ACT 5.2% wastage
TAS 6.8% wastage

To quantify this, if for example an arbitrary figure of 7% wastage of vaccines is used, this equates to $AUD 20.3M on the total spend for the 2015-16 year.

This does beg one very obvious question, why is $AUD 20.3M wastage acceptable ?
Eliminating this waste aligns specifically to The Strategic Priorities 3, 4 and 5 in the Department of Health National Immunisation Strategy for Australia 2013-2018.
http://www.immunise.health.gov.au/internet/immunise/publishing.nsf/Content/immunisation-strategy-2013-18-cnt

Understanding operational aspects of managing Delivery of Vaccines
The Australian Government has several standards in place for the management of quality and competence in medical laboratories, namely AS 15189, and AS 3864.1 for the manufacture of .. and AS 3864.2 for the management of refrigerators used for blood products. These standards are used by the National Association of Testing Authorities, “ NATA” for accreditation and assessment and training.
There is currently no specific standard relating to vaccine refrigerators.

The Federal Government Department for Health and Ageing has also issued a set of Guidelines known as National Vaccine Storage Guidelines – Strive for 5, 2nd Edition
ISBN: 978-1-74241-989-3, Online ISBN: 978-1-74241-990-9, which provide a guide on daily management of vaccine refrigerators, and an audit compliance guide.
Despite these measures we continue to have many Cold Chain Breeches
WHY ?
What can we do differently?
Can we use new technology to minimise risk and cut cost ?

Vaccine Storage
Different vaccines can be unstable in extreme cold, or room temperature or direct sunlight, so the Strive for 5 Guideline outlines policy for storing and keeping vaccines, in line with WHO guidelines, between 2 degrees and 8 degrees, until ready for use.

Medical refrigerators by definition are used to hold vaccines, blood products or samples,  which are required to be stored and maintained at specific temperatures.

If vaccines are allowed to fall below the minimum temperature, or above the recommended maximum temperature they can become less effective, ineffective or even toxic and people may need to be recalled to be re vaccinated.  

In the worst case a person who is vaccinated with an ineffective vaccine might acquire a serious illness.

How do we manage medical fridges today using the Strive for 5 Guidelines ?
How do we respond today , and when do we know there is a breach ?
How can we neutralize the effects of Cold Chain episodes completely ?
What new Technology is available ?

Case studies
In 2015,  2016 and 2017 we have seen significant Cold Chain Breaches in NSW in RPAH, Shoalhaven District Hospital Lidcombe and in Bankstown.
http://www.smh.com.au/nsw/royal-prince-alfred-hospital-contacts-hundreds-of-women-after-vaccine-fault-20150127-12ywio.html

At RPAH, almost 600 women and nine babies may have received ineffective vaccines between Aug 2013 and Jan 2015 after a faulty refrigerator thermostat at Royal Prince Alfred Hospital went undetected for more than a year!

The hospital's general manager Deborah Willcox said there was no risk associated with receiving the potentially less effective vaccines, but did not mention that, during that period the people involved were at risk of infection as they were effectively “unvaccinated”.
Health Minister Jillian Skinner said the failures at the hospital were "disappointing" and she had asked the department to ensure the error was not occurring elsewhere. Ms Skinner went on to say "A full investigation is underway to guarantee all public hospitals are compliant with medication storage protocols".

Yet Cold Chain incidents in vaccine refrigerators keep happening, and it seems no one is questioning the Medication Storage Protocols, or updating the Strive for 5 Guidelines.

In 2016 and 2017 we have seen significant Cold Chain Breaches in NSW in Shoalhaven District Hospital, Lidcombe and in Bankstown.
http://www.sbs.com.au/news/article/2017/02/13/more-mums-and-babies-might-need-be-revaccinated-after-fridge-error

At Bankstown-Lidcombe Hospital, 256 babies were involved in a faulty vaccine storage problem, which manifested with multiple Cold Chain Breach Events.

South Western Sydney Local Health District spokesman Dr Stephen Conaty said in a statement "We want to reassure all involved that potentially less effective vaccine is not harmful”, but neglected to mention that those people affected were at risk, and effectively not vaccinated .

A SWSLHD investigation into the mishap said overcrowding in the hospital's fridges was behind three separate Cold Chain Breaches.

After reading the following report...


Fault was laid at the feet of process failure and the way the refrigerators were packed. *

The more likely fault was likely to be and continues to be, systemic failure of manual processes, human error, the position of the fridge manufacturer’s temperature sensor  “which did not respond”, and that we have not adopted world best in class practice to automate temperature monitoring.

With technology available today, Cold Chain Breaches can be eliminated, or the negative impacts removed, using Automation, Real Time Logging, and Alerts to Voice, plus SMS and Email to key people. The technology is robust and inexpensive, and represents best practice.

In spite of several excellent working committees, and straightforward guidelines we continue to have many Cold Chain Breaches, the cost to Australia in the last Budget papers was around $AUD 20.3M in wastage, and the human inconvenience, health risk and damage to the reputation of the program is so high, what can we do differently?

* The SWSLHD Cold Chain Breech report suggested that airflow in the refrigerator was restricted, and the sensor in the refrigerator thought temps were high, subsequently forcing the refrigerator to lower the temperature, and not alerting on the actual temperature, meaning staff were unaware that the temps were running below 2 Degrees.

How do we manage Medical fridges today using the Strive for 5 Guidelines ?

http://www.health.gov.au/internet/immunise/publishing.nsf/content/D7EDA378F0B97134CA257D4D0081E4BB/$File/strive-for-5-guidelines.pdf
 
  • Practitioners are required to have thermometers in refrigerators, measure min and max temperatures twice daily, and manually update a monitoring chart.
  • They are required to keep temp logging devices in refrigerators and manually audit weekly
  • They are required to produce records on request
  • They are required to self Audit on an annual basis

How do we respond to a Cold Chain Breach today, and when do we know there is a problem ?
  • When temperatures are checked twice daily, it should be obvious at that moment in time if there is a problem. It does not capture any event which happened when no-one was looking at the thermometer. If no problem is evident the vaccines are assumed to be good.
  • Data loggers are to be downloaded weekly and the data manually checked to look for any excursions outside the acceptable temp range, for example a during defrost cycle.
  • If an “event” is noted in the logs, or at the time a thermometer is checked, the COLD CHAIN BREACH Protocol is enacted, the reporting process laid out in the Strive for 5 Guideline followed, and the affected vaccines are isolated.
  • Human safety, Product security and Audit integrity relies wholly on manual processes.


How can we neutralize the effects of Cold Chain episodes completely ?

The problem with the current set of manual processes is that, for a number of reasons, the processes may not be followed, and secondly the processes are retrospective.
For example minimum temps might be recorded, but not maximum temps.
Human error is the most significant contributing factor.
The most effective way to eliminate Cold Chain Breaches is to remove the human interface, and automate the measurement and alerting process, so that key people are alerted at the exact time a breach occurs.

There are other considerations, for example applying backup power to a site where a power outage is at fault, and contingency plans in place for when a fridge comprehensively fails.
In terms of being able to guarantee the integrity of the vaccines it is necessary to know as close to the event as possible when an event happens.

The current processes are retrospective, and in many cases daily temperatures are missed from day to day, and even if weekly logs are audited, people may have been given faulty vaccines for one week!


What is the new technology ?3243-2.jpg

Simplify
Automate
Drive down cost




Closed loop  (3).jpg

Real Time Temperature logging and alerts to key personnel
Automated fridge temperature real time logging with Alerts to SMS and email to key people.



With new technology, managing Cold Chain Breaches is easy, Audit and reporting is automated.
Cold Chain breaches can be controlled at the exact time of the fault, eliminating the cost and inconvenience of lost vaccines, not to mention the human cost.

The department of Industry, Innovation and Science, have sponsored solutions to eliminate Cold Chain Breaches and this technology is available now!

Automation is driving cost reduction and better health outcomes in the health industry

There is a very simple way the issues at Lidcombe, Bankstown and others could have been avoided, in fact ALL Cold Chain breaches can be minimised or controlled, and that is to automate the processes and remove human error completely.

It is inexpensive, and will potentially save millions of dollars in lost product, human resources, public inconvenience, health industry management, and the flagging reputation of those promoting Immunisation.

What does a Real Time Data logger do ?
Wireless medical refrigerator temperature monitoring, alerts and maintaining accurate Audit data.
  • logs to the cloud service at preset intervals, Eg 5 minute
  • Provides real time alerts to phone, voice and email of fridge outages
  • Removes the need for manual processes
  • Removes human error from reading temperatures and filling in charts.
  • Provides absolute accuracy of records.
  • Gives the ability to place the temperature probe anywhere in the fridge, this is important.
  • Central visibility of all fridges on all sites
  • Easy reporting graphs and audit
  • Provides unlimited storage of audit data
  • Minimise or eliminate the effects of Cold Chain Breaches

To Summarize:
Great progress has been made by the governing bodies and practitioners who fight to protect Australia from communicable diseases, something for which all Australians should be grateful.
There is a very large cost to Australia, in financial terms and human terms associated with Cold Chain management, specifically in vaccine refrigerators.
It is time to use real time technology in the distribution and management of vaccines
Process and human error are contributing to and will continue affect Cold Chain Breaches, until changed.
Too often the hospitals and delivery points are held accountable for systemic process failures
We can enable providers by adopting technology to notify key Staff to act at the exact time of a Cold Chain Breach, allowing them the opportunity to correct the problem  or put contingencies in place, limiting or eliminated faulty vaccines.

Caveats:
  • Data in this report was taken from Department of Health Websites.
  • The assumption was made that the wastage baseline referred to in the Productivity Commission report on Essential Vaccines 2015-16, is a percentage of net spend.
  • The data relating to the number of Cold Chain Breaches was not available at the time of this report.
  • The data around numbers of people affected by using ineffective vaccines due to Cold Chain Breaches was not available at the time of this report.
  • Any implications of people contracting disease whilst not immunised as a result of ineffective vaccines was not available at the time of this report.


Questions raised by this report:
  • How many Cold Chain Breeches were investigated in 2015-16 by NATA ?
  • How many people were treated with ineffective vaccines ?
  • Did any people acquire a disease whilst they were not fully vaccinated ?
  • Is Government Policy going to change to include automation of vaccine fridge monitoring ?
  • How many hospitals in the Public Health system are currently using manual monitoring ?
  • What steps are being taken to guarantee people will not be given ineffective vaccines ?
  • Does the government wish to drive down cost, and why is 10% wastage acceptable ?
  • So much effort is made to gain public acceptance of immunisation, this visibility Cold Chain Breaches must be damaging the public perception, let’s automate and remove the cause.


Thanks to the following agencies for help in compiling this report
NIC, NPAAC, NATA, ACI and CEC, The Department of Industry, Innovation and Science.


HLP Controls is an Australian Company, with a grant from the Department of Industry, Innovation and Science, to create solutions including those to provide better health outcomes for all Australians. http://www.hlpcontrols.com.au/

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