FOI release

Freedom of Information request on a member of the public's late father's treatment and Homerton Hospital’s letter of response (FOI 21/507)

Published 28 June 2021

28th May 2021 FOI 21/507

Dear

Thank you for your email dated 13 May 2021 regarding your late father’s treatment and Homerton Hospital’s letter of response where you’ve asked:

“6. I understand that reporting of blood transfusion of adverse events is recorded on the MHRA’s SABRE database. Please confirm if and when: (i) Homerton Hospital reported any blood transfusion/product adverse reactions to the MHRA or a national blood service at all (for any cases and or my late father’s case) in 2007, in 2021 or in any of the intervening years. (ii) Homerton Hospital asked the MHRA or a national blood service for any blood transfusion products to be checked for the presence of Hepatitis B (iii) If requested, were any Homerton Hospital blood transfusion products that were checked found to be infected with Hepatitis B or other infection such as Hepatitis C or HIV?

Homerton Hospital’s letter dated 16.04.2021 (attached) cites in paragraph 7 the serial numbers and dates of transfusion.

1. Please note that the very last paragraph of the 16.04.2021 letter from Homerton Hospital signed by the Chief Executive (Tracey Fletcher) refers to the Parliamentary Health Service Ombudsman (PHSO) and confirms that Homerton Hospital is refusing to provide me with any information that it will receive from the MHRA in response to the queries which it has claims to have raised with the MHRA because of my email (dated 16.03.2021) to it. This is despite the fact that the questions are those I have raised in relation to my late father. This is draconian, unfair, and contradicts the Cumberlege Report (2020) – “First Do No Harm”. This has forced me to write to directly the MHRA directly. Please do help me.

2. I am asking for the MHRA experts on blood transfusion reactions, including for infectious diseases, if a blood sample is taken from a patient to test for a hepatitis viruses and HIV screen after a blood transfusion, is it acceptable for that blood sample NOT to be reported on until 12 days after the sample was taken for pathology tests?

3. I am asking for the MHRA experts on blood transfusion reactions, including for infectious diseases, for the timescales over which IgM antibodies against Hepatitis B virus would be expected to be detectable and then undetectable.”

Regarding the question and response to paragraph 6 and the relevant sub-sections, the MHRA does not hold the viral screening records for blood components supplied to the UK market. The NHS Blood and Transplant (NHSBT) holds this information so I would suggest that you send the letter with your request to the NHSBT through their Freedom of Information process through this link: https://www.nhsbt.nhs.uk/who-we-are/transparency/freedom-of-information-and-privacy/

For your request in paragraph 6 of your email, I can confirm that the MHRA does not hold any information regarding Serious Adverse Reactions pertaining to your father’s case in our SABRE database. The Blood Safety and Quality Regulations (BSQR) state that this should have been reported to us via the Serious Adverse Blood Reactions and Events system as soon as known. MHRA will raise this with Homerton Hospital for further information and to investigate further to assess if any breach of the BSQR has occurred. Please be aware that any outcome from our investigation into this will be a matter for the MHRA and therefore the disclosure would be prohibited under Section 44 of Freedom of Information Act.

With regards to your request at paragraph 7 of your email, I can only advise that you take this issue up with the Parliamentary Health Service Ombudsman (PHSO), as advised by Homerton Hospital.

For expert opinion on your questions about antibody detection and viral testing, please contact JPAC via their website: https://www.transfusionguidelines.org/contact

To address your question raised in paragraph 8. I understand the question to be: is it acceptable to take a blood test for blood-borne virus serology and wait 12 days for a result? On this assumption, this is not a question for the MHRA as the regulator of these tests (IVDs), but rather for the internal governance of the laboratory in question, which should be able to report turn-around times, in line with national standards. At present most laboratories refer to turn-around standards (key performance indicators) from the Royal College of Pathologists. I suggest that you ask the local laboratory to provide you with the intended and actual turn-around times for the tests in question. There are always nuances, however. For example, a sero-positive test result that leads to a new diagnosis of blood-borne virus, will often be sent for external testing at a reference laboratory, which will inevitably delay the final result.

To address your question raised in paragraph 9. There are several markers for hepatitis B (HBV) infection, including HBsAg, HBcAb (total), HBcAb IgM, HBeAg, HBeAb, HBV DNA-PCR; their natural course over time depends on whether infection is acute, chronic, or previously resolved. In acute infection, HBsAg will increase rapidly in line with viral replication and is a marker of acuity – this will be detectable before symptoms. HBcAb IgM will appear alongside symptoms (e.g. biochemical transaminitis), i.e. its detection will be delayed compared to that of HBsAg. HBcAb IgM typically disappears after 3 to 6 months and is replaced by HBcAb (total) which will remain positive for life.

If you have any additional queries, please reply to this email.

If you are unhappy with our decision, you may ask for it to be reviewed. That review will be undertaken by a senior member of the Agency who has not previously been involved in your request. If you wish to pursue that option please email: info@mhra.gov.uk
After that, if you remain dissatisfied, you may write to the Information Commissioner. They will make a decision on whether or not we have interpreted the FOIA correctly in handling your request.

Due to the ongoing Covid-19 situation, we are not able to accept delivery of any documents or correspondence by post or courier to any of our offices.

Yours sincerely

MHRA Customer Service Centre Medicines and Healthcare products Regulatory Agency 10 South Colonnade, Canary Wharf, London E14 4PU Telephone 0203 080 6000