Brucella canis laboratory errors

Ms Buckley made this Freedom of Information request to Animal and Plant Health Agency Automatic anti-spam measures are in place for this older request. Please let us know if a further response is expected or if you are having trouble responding.

The request was successful.

Dear Animal and Plant Health Agency,

In the last two months I am aware of THREE dogs that have been falsely identified as sero-positive for Brucella canis due to laboratory errors within your laboratory, and I am aware that you are currently contacting veterinary practices due to a wider error due to faulty reagent I think. This is somewhat concerning when the Chief Veterinary Office keeps reiterating that the only way to eliminate risk is to euthanase positive dogs and so some veterinary practices are only offering euthanasia. Therefore, it is essential that both owners and the veterinary profession understand how commonly errors occur within your laboratory (and are identified).

Please can you tell me:

Breaking down each of the points below by year (i.e. 2020, 2021, 2022, 01.01.2023 up until 14.07.2023)
1. How many incidents of laboratory error (e.g. faulty reagent, manual data error, etc) have been identified by the APHA laboratories since 2020?
2. What was the cause of each of the incidents (e.g. manual data entry error, faulty reagent, etc).
3. Of these, how many (case + sum of individual dog(s)) involved the:
a. Elisa
b. SAT
c. RSA
4. For each incident, how many individual dogs were affected? And what is your known error rate (known individual dog errors divided by total number of tests undertaken)?
5. In each case, how many of the dogs were falsely identified as positive on a test when they were actually negative?
6. In each case, how many of the dogs were falsely identified as negative on a test when they were actually positive?
7. In the most recent reagent error that affected multiple dogs (June 2023), what quality assurance process was not undertaken to allow this to happen? And what measures have been put in place to prevent this happening again?
8. How many dogs are you aware of that have died as a consequence of these errors?

Yours faithfully,

Ms Buckley

APHA Access to Information Team (ATI),

Our ref: FOI2023/13408

Dear Ms Buckley

Thank you for your email which we received on the 8th July requesting
information. Your request is being considered in respect to the access to
information legislation.

We aim to answer your request no later than 8th August, which is 20
working days from the date we received it. If we are unable to meet this
deadline we will contact you to explain the reason.

If you have any queries about this email, please contact us at the email
address below.

Yours sincerely

Access to Information Team

[1][Animal and Plant Health Agency request email]

References

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Dear Animal and Plant Health Agency,

By law, I am aware that you should normally have responded promptly and by 7 August 2023. This is critical information that is important to both owners and the veterinary profession to have access to in order to but understand the reliability and accuracy of the tests that you are currently offering.

I am acutely aware that in June 2023 that was a reagent error that resulted in multiple dogs erroneously testing positive, but also a manual reporting error in May 2023 that resulted in a dog with a negative ELISA quantitative result being qualitatively reported as positive.

All of the dogs that I am aware of were, as a consequence, erroneously recommended for euthanasia and all veterinary care was withdrawn from these dogs by the veterinary practices involved. Therefore, as you can appreciate, the stakes are high for owners of dogs being tested for Brucella canis by the APHA testing laboratories, and knowledge of reporting errors and other factors that may affect reliability and accuracy of your testing protocols and reporting procedures is essential.

Yours faithfully,

Ms Buckley

APHA Access to Information Team (ATI),

1 Attachment

Dear Ms Buckley,

Please find attached the response to your request of 8th July for
information on Brucella Canis Testing.

Yours sincerely

Access to Information Team

[1][Animal and Plant Health Agency request email]

References

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Dear Animal and Plant Health Agency,

Please pass this on to the person who conducts Freedom of Information reviews.

I am writing to request an internal review of Animal and Plant Health Agency's handling of my FOI request 'Brucella canis laboratory errors'.
1. The figure of 2023 with respect to the number of dogs that were erroneously reported positive is incorrect. I believe it affects incident number two which was an ELISA test. In this case, they reported the quantitative result as below the threshold (it was a negative number) but the qualitative result was reported as a positive. This has been confirmed by the APHA to be a manual error entry issue (which the above also supports) but it is not reported as a dog that was falsely identified as a positive in question 6. This brings into question the validity of the reporting of this data.
2. In question 4, I requested the number of individual dogs per incident to allow me to work out how many dogs were affected by these errors. While I appreciate this data was not available, by reporting only the total number of test results reported (i.e. not by year), I am unable to establish how many test results were affected by errors in each of the years. I would like to request reporting this at the level of the year to allow me to calculate something that more closely approximates my original request.

Many thanks for your time.

A full history of my FOI request and all correspondence is available on the Internet at this address: https://www.whatdotheyknow.com/request/b...

Yours faithfully,

Ms Buckley

APHA Access to Information Team (ATI),

Dear Ms Buckley,

Thank you for your email which we received on 8th August, challenging our
response to your request for information. We are handling this as a
request for an internal review.

If your request was handled under the Freedom of Information Act 2000
(FOIA), section 45 Code of Practice states that an internal review should
take no longer than 20 working days, or 40 in exceptional circumstances.

If your request was handled under the Environmental Information
Regulations 2004 (EIRs), regulation 11(4) requires a public authority to
consider the complaint and respond to the complainant as soon as possible
and no later than 40 working days from the time when the complaint was
received.

We can inform you that the 4th October is the 40 ^th working day from the
date we received your complaint.

If you have any queries about this email, please contact us at the email
address below.

Yours sincerely

Access to Information Team

[1][Animal and Plant Health Agency request email]

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SM-APHA-Enquiries APHA, Animal and Plant Health Agency

 

Dear Ms Buckley

 

Thank you for your email of 8 August 2023, our reference FOI2023/13408.

 

APHA acknowledged your request (see below) in which you were advised our
response was due by the 8 August 2023.

 

Your request was received on 8 July 2023 and the Freedom of Information
Act (FOIA) legislative 20 working days following that date, was 8 August
2023, which is the date APHA’s response was sent to you.

 

The figure of 20 working days, under the FOIA, excludes Bank Holidays of
which there were two, (Northern Ireland) July 12th and (Scotland) 7th 
August.

 

You have already submitted a request for an Internal Review on this case
which APHA acknowledged on 9 August reference IR2023/15653.  Whilst the
Internal Review is in progress, no further correspondence on this case
will be accepted.  This does not prevent your right to submit a complaint
regarding this request to the Information Commissioner’s Office.

 

 

Regards

 

Access to Information team

APHA

[1][Animal and Plant Health Agency request email]

 

 

 

 

show quoted sections

Dear SM-APHA-Enquiries APHA,

The request for an internal review was sent BEFORE you replied. You were late (by a day) replying, and the What Do They Know website sent an automatic reply to let me know this. So I triggered the internal review process as advised on the page. You replied about 1 - 2 hrs after I triggered this process. I think your email below suggests that you may not be aware of this which may mean that there is a time delay releasing these requests by the page or with you reaching this request. My apologises for any confusion there.
However, my subsequent query in relation to whether the data reported is accurate remains. I am aware of an additional case that is not accounted for by the reporting below and suggests therefore that there is a reporting error in your original reply to me. I am not reporting the lab test reference for this in this request (to protect client anonymity) but can do so privately if requested as this may better help you to understand where and why any reporting error has occurred.

Yours sincerely,

Ms Buckley

APHA Access to Information Team (ATI),

1 Attachment

Dear Ms Buckley,

Please find attached the response to your request for an internal review
of 8th August for information on Brucella Canis Testing.

Yours sincerely

Access to Information Team

[1][Animal and Plant Health Agency request email]

References

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Dear Animal and Plant Health Agency,
Many thanks for your helpful response.
I understand that you also undertook Brucella canis testing of human samples during part of this period. Can you confirm please whether any of the sample sizes reported for the individual tests included human samples? If so, which tests? and what is the corrected figure once human samples are removed? As I was asking for dog data it is pertinent to request this clarification as it is not clear from the reporting.
Many thanks.

Yours faithfully,

Ms Buckley

APHA Access to Information Team (ATI),

Our ref: FOI2023/17671

Dear Ms Buckley

Thank you for your email which we received on the 7th September requesting
information. Your request is being considered in respect to the access to
information legislation.

We aim to answer your request no later than 5th October, which is 20
working days from the date we received it. If we are unable to meet this
deadline we will contact you to explain the reason.

If you have any queries about this email, please contact us at the email
address below.

Yours sincerely

Access to Information Team

[1][Animal and Plant Health Agency request email]

References

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APHA Access to Information Team (ATI),

2 Attachments

Dear Ms Buckley,

Please find attached the response to your request of 7th September for
information on Brucella Canis - Human Sample Testing.

Yours sincerely

Access to Information Team

[1][Animal and Plant Health Agency request email]

References

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