Shot in the dark

Childhood vaccination errors are a national problem in general practice, Julie Wilson, MPS’s clinical risk programme manager and Dr Tom Lloyd, medicolegal adviser, get to the point of safe immunisations

Rachel, a 32-year-old practice nurse, sat with her head in her hands shaking, as tears rolled down her hot cheeks. Her stomach was churning as she listened to her phone ring and ring: how could she bring herself to answer it? Looking longingly at her coat and bag, she wanted to run from the practice and give up being a nurse forever. Eventually she stood up; her only recourse was to tell the senior partner, Dr Morgan, what she had done.

"Harry was due the second pneumococcal vaccine at his four-month-old appointment. In her haste, Rachel had got them confused"

Rachel slowly walked down the corridor and tapped lightly on Dr Morgan’s door. “Come in”, he boomed. She walked in and sat heavily on a chair. Dr Morgan stared intently at Rachel, and asked: “What on earth’s the matter?” She began to recite her tale.

Rachel had been extremely busy that Wednesday morning and the baby immunisation clinic was due to start at 11am, but it did not start until 11:20. Mrs Kent and Harry, her three-month-old baby, were the first to arrive. Mrs Kent was very angry that Harry’s immunisation was taking place 30 minutes late. Rachel apologised for the delay and hastily retrieved the vaccinations from the fridge, while Harry wailed. She had then immunised Harry.

Only when Mrs Kent had left the practice, did Rachel realise that she had given Harry the wrong injection; she had administered the pneumococcal vaccine instead of the meningitis C vaccination. Harry was due the second pneumococcal vaccine at his four-month-old appointment. In her haste, Rachel had got them confused.

Rachel is not alone in making a mistake of this kind; in fact, they are alarmingly common. Could this happen in your practice? Do you know a healthcare professional who has made an immunisation error? Should Rachel be disciplined for her mistake?

Learning from mistakes

It is vital that Rachel deals with the situation promptly. Harry’s mother should be alerted to the error at the earliest reasonable opportunity. However, before doing so it would be reasonable to seek clinical advice in relation to any likely adverse effects related to the early administration of the pneumococcal vaccination, when the next pneumococcal vaccination should be administered, and when it would be appropriate to administer the meningitis C vaccination. Such information could be sought from the local consultant in public health or paediatrics.

"Rachel is a good nurse, who simply made a mistake, so she will need reassurance and support from her team"

The best way to contact the mother would be by telephone, but it would be helpful to follow up the telephone conversation with a letter to include an apology, an explanation as to what happened, details as to what steps need to be taken in relation to Harry’s ongoing immunisations and what steps the practice have taken as a result of the incident.

Rachel is a good nurse, who simply made a mistake, so she will need reassurance and support from her team. This incident should be promptly but thoroughly considered via the practice Significant Event Audit (SEA) procedures in order to identify why the error occurred, and so that all reasonable steps can be taken to prevent a similar occurrence in the future. The senior partner and/or Rachel may wish to contact his/her medical protection organisation for advice.

Ten top tips to safer prescribing

1. Be aware of human factors

To err is human: we are all prone to make mistakes. As James Reason, Professor of Psychology, said: “We can’t change the human condition but we can change the conditions humans work under”. The following are human factors that can cause error:

• Fatigue
• Hunger
• Lack of concentration
• Stress
• Distraction
• Lack of training
• Lack of access to information
• Other factors, eg, alcohol, drugs, illness.

2. Delegation of tasks

GPs are responsible for vaccination and immunisation procedures, so if this is delegated to a practice nurse/ nurse practitioner, they must be competent and trained to undertake the role, as they will be held accountable for the tasks they undertake.

GMC advice: “When you delegate care or treatment you must be satisfied that the person to whom you delegate has the qualifications, experience, knowledge and skills to provide the care or treatment involved.”³

Nursing and Midwifery Council advice: “You must deliver care based on the best available evidence or best practice” and “You must recognise and work within the limits of your competence.”⁴

Nurses should also have signed and agreed up-to-date Patient Group Directions (PGDs) for the vaccines to be administered.⁵

3. Training

"Consider the organisation of your clinic; healthcare professionals should have sufficient time between appointments, for administration"

The new immunisation schedule for children is now extremely complicated, so it is essential that all healthcare professionals involved in it are fully familiar with the schedule and attend regular training. Annual training should be organised in the management of anaphylaxis and paediatric cardiopulmonary resuscitation (CPR).

4. Storage of vaccines

Vaccines in the refrigerator should be stored in an organised way and be well labelled; this can prevent errors caused by staff grabbing the wrong vaccine in a hurry.

• Different childhood vaccines should be stored on separate shelves and adult vaccines should be kept in a separate refrigerator.
• Vaccines in similar packaging should not be stored next to each other.
• The minimum and maximum refrigerator temperatures should be recorded daily. The Green Book states that: “temperatures in the refrigerator must be monitored and recorded at least once each working day and documented on a chart for recording temperatures”.⁶
• Ensure that stock is rotated regularly and have a system for checking vaccines’ expiry dates.
• Keep a record of destroyed vaccines.

5. Busy clinics

Mistakes happen when tasks are rushed, as in Rachel’s case. Consider the organisation of your clinic; healthcare professionals should have sufficient time between appointments, for administration. Consider having two people, eg, a nurse and a healthcare assistant (HCA), running the clinic. The HCA could then complete paperwork and check the vaccines, while the nurse administers them.

6. Consent

The first step is to confirm with the parent/guardian, which immunisation is due, and this can be done by checking practice records for immunisation status and the date of previous injections.

Childhood immunisations represent a significant risk with:

• children who have recently moved to the area, and whose old GP records have not yet arrived
• children without a child health book (eg, red book)
• children who have come from abroad where there is a different immunisation schedule
• children who are involved in catch-up programmes.

Use the necessary sources of information to check that the child is going to receive the appropriate vaccines.

If any uncertainty remains around a child’s health record, the immunisation must be postponed until the immunisation status can be confirmed.

"Always ensure that consent is obtained, for each vaccine being given, from the parents and guardians"

Always ensure that consent is obtained, for each vaccine being given, from the parents and guardians. This cannot be underestimated. In the case above, if Rachel had gone through the vaccination schedule with Mrs Kent, explained what Harry was going to have that day and obtained Mrs Kent’s consent, the error would not have occurred.

Parents should feel involved in the procedure, have their concerns addressed and fully understand what their child is being given. If you cannot allay the fears of the parent, contact a senior healthcare professional in the practice, or seek advice from the community paediatrician or a consultant in communicable diseases.

Be aware that the person giving the consent must have parental responsibility.

• The mother – would be assumed to have parental responsibility (save for exceptional circumstances when parental responsibility is removed by the court).
• The father – in accordance with the Children’s Act (1989), as amended, would have parental responsibility if:
  • he was married to the mother when the child was born
  • the child’s birth was registered after 15 April 2002 in Northern Ireland, 1 December 2003 in England and Wales, or 4 May 2006 in Scotland, and the father’s name is on the birth certificate then he would hold parental responsibility (unless it has been removed by the courts)
  • he holds a custody or residence order for the child
  • he holds a Parental Responsibility Order
  • a Parental Responsibility Agreement exists with the mother.
• Other individuals or organisations (such as social services) – may be given parental responsibility by court order, or by being appointed as a guardian on the death of a parent.
• Grandparents – do not have parental responsibility unless they have been given it by a court order. If the parent wants a grandparent (or another third party) to bring their baby to be immunised, they should provide a signed consent letter instructing the practice what vaccinations are being given consent for.

7. Checking procedures

Before immunising a patient, health professionals should double check:

• any previous reactions to the vaccine
• that the child is fit to receive an immunisation
• agreed injection site for specific vaccines
• immunisation schedule
• the expiry dates for each vaccine.

8. Record keeping 

Record the names of the following in the child’s computerised records:

• vaccines
• batch numbers
• sites used
• expiry dates.

Also, document consent obtained (READ code). Record whether information leaflets are given to the parents/guardian and record the information in the red book.

9. Sharps and waste

Ensure that needles and sharps are disposed of correctly. Practices should have an up-to-date needlestick injury policy.

10. Conduct SEAs

When errors occur, apportioning blame is not the answer; practices should use them as a learning tool. SEA meetings should be held to investigate the reasons why the mistake occurred. The National Patient Safety Agency (NPSA) has published guidance for general practice teams on how to conduct SEAs in seven simple stages so that general practice teams can learn from them.²

Ensure that the patient is safe and any clinical needs are met.

• Investigate the incident thoroughly and inform the family of what is being done.
• Adopt a policy of openness to encourage full and frank discussions with staff involved in significant events.
• Carefully examine the steps that led to the incident.
• Identify areas to improve spatient safety.
• Feedback the findings to the family.
• Support the staff involved in the error and consider their learning and training needs.²

References

1. National Patient Safety Agency, Vaccination incidents involving children in Reporting and Learning System Data Summary, Issue 10, England, (2008)
2. National Patient Safety Agency, SEA guidance for Primary Care Teams, (2008)
3. General Medical Council, Good Medical Practice, London (2006)
4. Nursing and Midwifery Council, The Code: Standards of conduct, performance and ethics for nurses and midwives. London, (2008) 5. Department of Health. Patient Group Directions (England only), HSC, 026 (2000)
5. DH, Immunisations against infectious disease, Green Book, updated February 2009, (2006)

Last updated: May 2009

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Please note: Medical Protection does not maintain this article and therefore the advice given may be incorrect or out of date, and may not constitute a definitive or complete statement of the legal, regulatory and/or clinical environment. MPS accepts no responsibility for the accuracy or completeness of the advice given, in particular where the legal, regulatory and/or clinical environment has changed. Articles are not intended to constitute advice in any specific situation, and if you are a member you should contact Medical Protection for tailored advice. All implied warranties and conditions are excluded, to the maximum extent permitted by law.