Background

Over the last five years, the MDU has opened over 200 files on cases related to immunisation errors or concerns. This is a 20% increase in cases compared to an earlier review over the same length of time, which in part can be explained by dilemmas related to COVID vaccinations.

How to deal with immunisation errors

Let's consider the following fictional example: a GP calls the MDU advice line after the practice nurse tells them that a child had been immunised with a vaccine past its expiry date. They only realised this after the patient left the surgery.

The GP asks for advice on how to inform the patient's parents and what their next steps should be.

Establish the scope and extent of the problem

The first concern should always be the patient's safety when such incidents arise. However, it can be helpful to determine the risk and what the likely impact of a vaccination error is before you speak to the patient - unless of course there is an immediate need to check how they are.

Start by considering some key issues:

• How many patients have been affected?
• Is there an ongoing risk to other patients that needs immediate action? For example, if there has been a cold chain failure, the affected vaccines should be isolated, clearly marked and kept in the cold chain so they are not administered to other patients until the issue has been investigated.
• Can the affected patients be identified?

Get expert advice

When establishing the impact of immunisation errors, it's helpful to speak to the vaccine manufacturer and your Public Health agency or your local NHS Screening and Immunisation Team. Your ICB may also have a liaison pharmacist or prescribing adviser who might be able to help.

Not only will this demonstrate a robust investigation, but you will be able to explain to patients affected any repercussions for their health, based on the expert advice provided.

For example, a vaccine past its expiry date may not be as effective, and the patient may need to be offered the option of revaccination. However, if a patient has received an incorrect vaccine, there may be more serious repercussions.

Tell the patient

Once you have this information, contact the patient to alert them to the error, the likely repercussions and to offer a plan. Depending on the number of patients involved and the urgency, it might be wiser to call the patient directly, and follow up with a letter.

The GMC is clear in 'Good medical practice' (2024) that healthcare professionals must be open and honest with patients when something goes wrong that causes, or has the potential to cause, harm or distress. This means offering an apology, putting matters right if possible, and explaining fully and promptly what has happened and the likely effects.

Apologising meaningfully when things go wrong is vital for everyone involved in an incident. It is not an admission of legal liability for what has happened, but an acknowledgement that something could have gone better. It can also support learning and improve patient safety.

Put it right where possible

Discuss with the patient a plan for putting things right, if possible, within an appropriate time period. For example, if an ineffective travel vaccine has been given and the patient is travelling soon, this may be more pressing than re-vaccinating if they have already travelled.

In the latter situation, tell the patient they may not have been adequately protected while travelling and the consequences of this.

Reporting

If the patient has come to any harm because of the vaccination error, the practice should also consider if the threshold is met for it to be reported to the CQC or covered by the statutory duty of candour.

In addition, the Learn From Patient Safety Events (LFPSE) service encourages healthcare staff to report patient safety incidents, whether they result in harm or not.

LFPSE is a national NHS system for recording and analysing patient safety events that occur in healthcare, and replaces the NHS National Reporting and Learning System (NRLS).

Investigate further and review systems

In the longer term, practices would be advised to carry out a formal significant event audit or root cause analysis of the incident and tell the patient(s) involved that this is happening. The practice could also offer to feed back on the outcome of that review in due course, if the patient(s) would like this.

This step can often reassure patients that a practice is taking the matter seriously and is acting to reduce the chance of it happening again. It will also reflect well on the practice if the matter is escalated.

Depending on the error, the learning outcomes will vary, but might include:

• staff training
• alternative ways of storing vaccines
• separating vaccines in similar packaging to different areas
• organising immunisation clinics to minimise the risk of incorrect vaccine administration
• changes to the cold chain system.

Further reading

For more information, read our website's guide on performing a significant event analysis. And remember, our advisers are always on hand to advise MDU members and practices if a vaccine or immunisation error occurs.

This article first appeared in GP Online and has been edited for publication here.