The company at the centre of vaccination failures in Otago did not have cold chain accreditation at the time almost 1600 people received incorrectly stored vaccines.
Engage Safety was contracted by the Southern DHB to deliver the vaccines in Queenstown Lakes and Central Otago last year.
But failure to store the vaccines correctly meant 1576 people received a dose with questionable effectiveness.
An independent review into the fiasco was released today and uncovered a "chaotic" work environment, vaccines stored in a fridge at the directors' home and missing temperature data logs.
Southern DHB still has not been able to reach 112 people affected by the cold chain failure.
The public were first informed of the issue in March when, in a statement, Southern DHB said the vaccines were administered at various locations in Queenstown Lakes and Central Otago between 1 December 2021 and 28 January 2022.
The issue mainly affected booster shots but some were first and second doses of the vaccine.
There were no safety concerns surrounding doses, but due to the storage failure the vaccines' effectiveness was in question.
Engage Safety Limited's cold chain accreditation expired in November last year.
"At that time, the COVID-19 pandemic was dominating the health system and there was a government directive to vaccinate all eligible people over the age of 18 in Aotearoa New Zealand," the report said.
Several attempts were made to renew the accreditation, but no date was agreed and in early February it was decided to delay the accreditation until a new vaccine fridge was installed at the business' premises later that month.
When the immunisation co-ordinator visited on 2 March the cold chain failure was discovered.
"The visit to renew the CCA [cold chain accreditation] occurred on 2 March 2022. There was an expectation that the renewal of accreditation visit would be routine, having successfully achieved CCA status in the past. Had the CCA renewal been completed in November 2021, the potential cold chain failure in December 2021 and January 2022 may not have been discovered at this time or at all.
"Equally, if all cold chain management processes were in place as required, downloading of data and appropriate action in early December would have prevented the resultant breaches," the report said.
"[The] immunisation co-ordinator downloaded the data from the fridge data loggers. It was then discovered that there were discrepancies with the fridge temperature monitoring over the previous two months."
Engage Safety's director appeared unaware the breaches had occurred.
The director and the immunisation co-ordinator tried to find documentation to confirm the vaccine fridge's temperatures, but "the complete manual record of vaccine fridge temperature monitoring prior to 4 January 2022 was missing".
"At the time, very long hours of work were being recorded to keep all aspects of the business afloat; this was at times from 0600 hours to 2400 hours," the report said.
"This may have been a contributing factor to the situation described as 'chaotic' during the time of the drive through Covid-19 vaccination clinic. Essentially, a valid explanation for discrepancies on data loggers has not been found.
"Additionally, paper temperature monitoring [sighted by at least six staff including the ESL [lead] director], was unable to be located or provided to support the maintenance of vaccine fridge temperatures. Information was paper only and not kept in an electronic format.
"The director [lead] at ESL had the tikanga of mana whakahaere or full authority, and overall management of the cold chain process for the organisation. I tona ngakau pono, and in her utmost sincerity, she said that during the entire breach period that she does not believe that the vaccines were compromised.
"The director [lead] accepts that the data loggers show a breach. The data from the data loggers show intermittent download of the data, however on 3 March, the ESL director [lead] was not aware of the previous data discrepancies. However, kua huna, that truth is hidden and cannot be confirmed."
The report said there were several possible explanations for the data discrepancies including the possibility the freezer at the directors' home containing ice packs - and possibly the data loggers - was frequently accessed for other reasons such as to get out food out which might have varied the temperature or the data loggers might have been left turned off.
"Until the downloading of the data loggers on 2 March 2022, ESL was unaware that there had been a cold chain failure. This was based on the vaccine fridge located in the ESL directors' home having a loud alarm to alert the household if the fridge temperature was below +2 degrees Celsius or above +8 degrees Celsius. ESL directors reported that the fridge(s) in the ESL directors' home did occasionally alarm and this was quickly dealt with, the alarm was described as very loud and impossible to ignore."
'Isolated incident' - DHB
The Southern DHB said it welcomed the report and was committed to implementing the recommendations of the reviewers.
Southern DHB chief executive Chris Fleming said the DHB wanted to recognise the years of dedicated vaccination and health care service the provider has carried out within the Queenstown Lakes district.
"We would like to reassure our communities that this was an isolated incident. Vaccination providers across Southern have done a fantastic job and continue to do a fantastic job, vaccinating and protecting our whānau and loved ones.
"Southern would not have been able to get to a double vaccination rate of 97.5 percent and a booster rate of 74.7 percent if it were not for their dedication and hard work."
Anyone who has not yet received a replacement dose should call 0800 28 29 26 to check the status of their vaccination. People who received their vaccination at a pharmacy or GP were not affected.
RNZ
