Introduction

1. In accordance with the National Immunisation Schedule, children aged from 11 years are offered free immunisation with the booster dose of the tetanus, diphtheria, and whooping cough vaccine (Boostrix).[1]
   
   
2. It is important to outline at the outset that whilst the free immunisation is carried out at schools across the country, it is Health New Zealand|Te Whatu Ora (Health NZ) who is the provider of this service and has been subject to this investigation.

Complaint

3. On 8 July 2024 this office received a complaint from Miss A, the mother of Miss B (aged 11 years). Miss A complained that despite her having signed a consent form stating that she did not give consent, Miss B was given a Boostrix vaccination at her school, and the error was disclosed to the wrong family member, and Health NZ did not respond to her complaint appropriately.
   
   

Scope of investigation

4. The following issue was investigated:

• • Whether Health New Zealand|Te Whatu Ora provided [Miss B] with an appropriate standard of care on 17 June 2024 and whether the subsequent communication and complaint process was appropriate.
    
    

Background

5. Miss A advised that in the lead-up to immunisation taking place at the school, she received the Boostrix Immunisation consent form (the consent form), which she completed. She ticked the box showing that she did not give consent to Miss B receiving the Boostrix immunisation at the school, preferring her to have it administered by her general practitioner in case of a reaction. The consent form was sent with Miss B to the school on 17 June 2024.
   
   
6. On Monday 17 June 2024 the students in Miss B’s class at the school were called for the Boostrix immunisation. Miss B advised HDC that she stayed in the classroom, as she was aware that her mother had stated on the consent form that she did not give consent. However, Miss B said that her teacher told her to go with her classmates to be immunised.
   
   
7. Miss B told HDC that on arrival at the school hall, she provided the first nurse she saw (a public health nurse, RN C) with the signed consent form withdrawing consent by Miss A. Miss B said that RN C acknowledged that she should not be getting the Boostrix immunisation and asked a second nurse to ring Miss A to check, and for Miss B to wait whilst this happened. Miss A advised HDC that this call was not made, and there is no evidence from Health NZ or its staff to support this call having been made.
   
   
8. Miss B stated that she was confused and stressed by a lot of questions by the second nurse, which she did not understand or know the answers to, including whether she had had ‘concussion or stuff’. The second nurse was stated to have said to Miss B, ‘You look old enough to have this,’ and sent her to a third nurse, RN D, who proceeded to vaccinate Miss B at around 11am.
   
   
9. Miss A told HDC that around 2.50pm that same day, she received a phone call from RN D to advise of the error that Miss B had been immunised without consent. At this stage, Miss A advised RN D that she wished to make a complaint and was told that someone would contact her the next day. Miss A is concerned that it took Health NZ until that time to let her know of the error.
   
   
10. Miss A said that once aware of the error, she went to pick up Miss B from the school and met with the principal, and again made a complaint about the incident and stated that it was unacceptable. The principal has confirmed to HDC that he assured Miss A that he would ‘look into the matter immediately’. Miss A was provided with a telephone number for the Health NZ Public Health Nursing Service to make a complaint, which she did. A text message was received from RN D confirming that the service manager was aware of the incident and stating that someone would ‘definitely be in touch tomorrow’.
    
    
11. The principal of the school confirmed to HDC that following his discussion with Miss A, he contacted RN C to clarify the situation. The principal confirmed that he was told by RN C that Miss B had in fact received the immunisation in error and consent had not been provided by Miss A. The principal said that he was also told that Miss A had contacted them and that a representative from Health NZ would be contacting Miss A ‘within the next 24 hours to address the incident directly’.
    
    
12. Miss A later found out that RN D had called Miss A’s mother first in error to report the incident, despite Miss A’s phone number being provided on the consent form. When RN D called Miss A’s mother, RN D is reported to have failed to ask who she was speaking to before proceeding to advise Miss A’s mother about what had happened. Miss A’s mother said that when she advised that she was not Miss B’s mother, and that RN D should be calling Miss A, RN D was reported to have said that she did not have Miss A’s telephone number. However, this was on the consent form and on Miss B’s medical records.
    
    
13. On 18 June 2024 Miss A received a call from the principal of the school to advise that Health NZ would be calling her at 3pm that day regarding the complaint. Miss A received a text message that day from RN D to advise that her complaint had been referred to the clinical manager and was being reviewed.
    
    
14. On 17 September 2024 Miss A confirmed to HDC that she had received no contact from Health NZ. Miss A also stated that the principal had told her that he would take the matter to the Ministry of Education to make a complaint himself, and she had not heard further from him despite being told that she would receive a confirmation email. Miss A also said that no apologies had been provided.

Information gathered

Response to complaint

15. In response to HDC, Health NZ advised that as the consent form was received on the day of vaccination, the process was that RN C checked the medical questions on the form and initialled that they were correct. RN C confirmed that she would have asked Miss B to take a seat and wait whilst her form was checked further on the Aotearoa Immunisation Register (AIR). RN D’s statement about the incident is that whilst these checks took place, Miss B was sent to wait by herself away from the other students waiting to be vaccinated. However, ‘[s]omehow’ Miss B joined these students. 
    
    
16. RN D confirmed that she was the second nurse who asked Miss B the questions[2] on the day of immunisation (17 June 2024), after having introduced herself. Referring to the consent form, RN D said that she saw the ‘tick’ and read it as consent.[3] She stated that the medical history section (Section A) of the consent form was completed, which is headed ‘complete if your child is receiving the Boostrix immunisation’ and no concerns were identified. RN D said that a further section (Section B) underneath this entitled ‘Complete if you do not want your child to receive the Boostrix immunisation at school’ was not completed.
    
    
17. RN D said that she checked the back of the consent form, and no notes were written on the back page, and she was happy with all the checks carried out, and so she administered Miss B with the Boostrix immunisation at 11.41am, as noted on the ‘Vaccinator use only’ section of the consent form. RN D said that she does not recall Miss B saying ‘no’ or being upset, and Miss B remained in the hall for 20 minutes and was sent to the recovery area.
    
    
18. Health NZ advised that it was only when the error had been identified later that a call was made to the Public Health Nursing Service office at around 2.30pm to inform staff of this. The staff at the office asked RN D to call Miss A. RN D said that as the daytime emergency contact name on the consent form was stated as Miss B’s grandmother, she called her instead of Miss A. The call was made at around 2.45pm. RN D said that she explained who she was and her role and stated that an error had occurred, and Miss A’s mother told her that she needed to speak with Miss A, not her, which subsequently she did.
    
    
19. Health NZ’s Planning and Delivery of School Based Immunisation Programmes policy (the Immunisation Policy) states that the administrator on the day, after asking the child’s name, ‘finds their consent form and ensures it is [for] consent prior to giving the form to the child and sends [the child] to the waiting area’. The Immunisation Policy also states that immunisation should be deferred if ‘unsure or queries are unable to be followed up’ and to ‘Inform parent’.
    
    
20. In its response to HDC, Health NZ provided an apology for Miss A and Miss B dated 2 October 2024, which acknowledged that ‘several significant oversights occurred’, namely:

‘1.   It was explicitly stated on the form that consent for the vaccination was not given.

2.    It was clearly indicated that [Miss A] wished for Miss B to receive her vaccination at [her] GP.

3.    [Miss A’s] contact number was correctly listed on the form, yet the emergency contact was called instead.

4.    When [Health NZ] contacted the emergency number, [the nurse] failed to verify who [she was] speaking with, and personal information was unfortunately disclosed to Miss B’s grandmother rather than [Miss A].’

Responses to provisional decision

21. Miss A and Miss B were given an opportunity to respond to the provisional decision and did not make any comments.
    
    
22. Health NZ was given an opportunity to respond to the provisional decision. Health NZ accepted the findings and agreed that aspects of the care provided did not meet the expected standard in this case. Health NZ stated that it is ‘committed to addressing any deficiencies in care or process to ensure the safety and wellbeing of our communities, patients and clients’.
    
    
23. Health NZ also said that it is ‘committed to fostering a culture of continuous improvement and learning’. As part of its quality assurance processes, this incident ‘has been reviewed at both clinical and governance levels to prevent reoccurrence and enhance overall standards of care’.
    
    
24. Health NZ said that in response to the incident, and in recognition of the provisional findings, it also took the following actions:

     •  Improved consent form documentation.

• • Revision of clinical policies and procedures on the SBIP [School Based Immunisation Programme].
    
    
  • The Public Health Nursing Service team completed additional training.
    
    
  • Debriefing and support to the staff involved and any new staff.’

25. In response to a recommendation made in the provisional decision that Health NZ consider any further amendments to the consent form necessary to avoid any confusion in the future, Health NZ confirmed that it had made several changes to the earlier version of the SBIP Boostrix Consent Form. Health NZ said that the updated version, which included shifting the consent/non-consent sections to separate pages and colour coding these to better differentiate the two, was published on 5 September 2024.[4]
    
    
26. Health NZ also stated that since the events it had ‘sought health legal advice about the need for tick boxes in the SBIP consent forms and ha[d] received guidance that these can be removed with a minor amendment to the sentence structure’. Health NZ said that ‘[t]his change will be made to the next version in time for SBIP implementation in 2026’.
    
    
27. The school was given an opportunity to respond to the provisional decision and made no submissions or comments.
    
    

Decision: Health NZ — breach

28. First, I acknowledge Miss B’s efforts to notify her teacher and the nurses that she should not be receiving the Boostrix immunisation.
    
    
29. Having reviewed all the available information in this case, I consider that Health NZ breached Right 4(1) of the Code of Health and Disability Services Consumers’ Rights (the Code), which states that every consumer has the right to have services provided with reasonable care and skill. In breach of Right 4(1), Miss B was administered the Boostrix immunisation vaccine, despite the box on the consent form having been ticked clearly to state that Miss A did not consent for Miss B to have this, and at least one of the nurses having been aware of the non-consent. Health NZ has acknowledged this significant oversight.

Adverse comment

Personal information sharing

30. I acknowledge that Miss A’s mother was listed as a daytime emergency contact number on the consent form. However, directly above this, Miss A’s number was clearly visible. I am critical that Miss A’s mother was contacted in error and that personal information about Miss B was disclosed to her before the nurse had verified the person to whom she was speaking.

Complaint response

31. I am also critical that after the complaint made by Miss A to Health NZ on 17 June 2024, Health NZ failed to contact and update Miss A, despite having informed her that this would happen. Given that Health NZ had recognised the error, I consider this to have been a poor response. However, I acknowledge the transparency of the apology that has since been provided to Miss A and Miss B.
    
    
32. Miss A was unhappy that Health NZ delayed notifying her of the error until the afternoon of 17 June 2024. However, given that Health NZ contacted Miss A once aware of the error in the afternoon on 17 June 2024, I am not critical of the time taken to contact her that day.

Decision: RN D — educational comment

33. RN D failed to recognise that Miss A had clearly ticked the non-consent box on the consent form, and subsequently RN D decided to administer the Boostrix immunisation vaccine to Miss B. I acknowledge that there was some confusion on the day, which resulted in Miss B waiting with the students to be vaccinated, and that Section A of the consent form was completed by Miss A instead of Section B. However, RN D said that she saw the tick and read it as consent, although it is clear that Miss A ticked that she did not consent to Miss B receiving the vaccination.
    
    
34. Although I consider that the tick was clear, in my view if RN D was unsure about it, she should have followed Health NZ’s Immunisation Policy and deferred administration of the vaccine or ensured that Miss A was contacted. I recommend that RN D take sufficient time to review consent forms and either seek clarification on the day or defer vaccination, to avoid such an incident in the future.
    
    

The school

35. I acknowledge the school’s role as the host of Health NZ staff whilst the immunisation programme takes place. I note that the principal did what he could by following up with Health NZ for Miss A once the error was identified. I consider that this action was reasonable and make no findings in relation to the school. In reference to the comments from the school regarding what actions it could consider in the future to prevent a similar situation from occurring, I trust that the recommendations for Health NZ as part of this decision will avoid this, recognising the importance of the immunisation programme for the health of children at the school.

Changes made since events

36. Health NZ has confirmed that it has taken these errors very seriously and is fully committed to learning from the incident. It has implemented the following changes to reinforce its processes and prevent such an incident in the future:

1. 1. The Public Health Nursing Service team was provided with additional training in a meeting on 24 June 2024. This included a discussion of the consent error and the importance of double-checking consent forms with children as they arrive for immunisations, and for students who arrive late after class immunisation has been completed to be left for the follow-up catch-up programme, so that all checks can be completed accurately and in a timely manner, as outlined in its Immunisation Policy. Staff were also instructed to document any contacts or events.
      
      
   2. Health NZ sent an email to the Public Health Nursing Service team on 11 September 2024 asking staff to complete learning modules[5] and to put in place triple checking of consent forms.[6]
      
      
   3. Health NZ is enhancing how it handles communication to ensure that consent forms are followed accurately, and that privacy is strictly maintained.

37. In response to the complaint, the principal of the school stated that whilst ‘the school cannot be held responsible for the actions’ of Health NZ, to prevent a similar situation from occurring in the future, he believes ‘the most appropriate course of action may be to discontinue the use of [the] school as a venue for [Boostrix immunisations]’.
    
    

Recommendations

38. Noting that Health NZ has already provided a written apology to Miss A and Miss B and has taken what I consider to be substantive steps to prevent a reoccurrence of this incident around learning for the Public Health Nursing Service team staff, I recommend that Health NZ:

1. 1. Provide clarification that all Public Health Nursing Service team staff emailed on 11 September 2024 have carried out the recommended training by Health NZ referred to above (paragraph 36b), within three months of the date of this report.
      
      
   2. Use this case as a basis for its ongoing education and induction training for Public Health Nursing Service staff. Evidence confirming the content of the education/training as part of the induction process is to be provided to HDC within three months of the date of this report.

39. I recommend that RN D:

1. 1. Provide a written apology for Miss A and Miss B. The apology should be provided to HDC, for sending to Miss A and Miss B, within three weeks of the date of this report.
      
      
   2. Complete the HDC online learning module ‘What you need to know about informed consent’.[7] Evidence of completion of this module is to be provided to HDC within one month of the date of this report.
      
      

Follow-up actions

40. A copy of this report will be provided to Miss A and Health NZ, and a redacted copy will be provided to the school.
    
    
41. A copy of this report with details identifying the parties removed, except Health NZ, will be placed on the Health and Disability Commissioner website, www.hdc.org.nz, for educational purposes.

 

 

Dr Vanessa Caldwell

Deputy Health and Disability Commissioner

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