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A 12-year-old girl attended the medical centre for her first dose of the Gardasil vaccine, but was given the Boostrix vaccine in error, found a Health & Disability Commissioner report.

Deputy Health and Disability Commissioner Meenal Duggal this week released a report finding a practice nurse and medical centre in breach of the Code of Health and Disability Services Consumers’ Rights (the Code) following the vaccination incident in 2017.

The practice nurse, a registered nurse, assumed the girl had come for the Boostrix vaccine commonly given around age 11 and asked “Have you had this vaccine before?” but did not state the name of the vaccine, and the girl responded that she had not.

Although the girl’s immunisation history showed that she had received the Boostrix vaccine already, the nurse did not scroll down far enough on the practice management system to see the entry. When she got an authorised nurse to check the vaccine it was in another room and she asked the other nurse to check the “11-year-vaccine” which the nurse confirmed.

The practice nurse became aware of the administration error when she updated the girl’s immunisation history. She and a senior nurse apologized and then discussed the issue with the girl and the girl’s mother and it was agreed to have Gardasil administered in her other arm.

Neither of the vaccines were administered under a standing order or prescription, and at the time the nurse was not an authorised vaccinator in accordance with the Medicines Act 1981. She had completed the  two day vaccinator theory training course six months previously but was still gaining vaccination experience before becoming an authorised vaccinator and had told the girl and her mother she was under indirect supervision of another registered nurse.

Duggal said that the registered nurse, by failing to identify and administer the correct vaccine, did not provide services with reasonable care and skill. Duggal also found that the registered nurse, and medical centre, in not providing the vaccines in accordance with the Medicines Act, had not provided services that complied with legal requirements.

The nurse had submitted an incident report to her lead nurse, on the day of the incident but the lead nurse did not complete her section of the report until over a month later leading to her receiving an adverse comment from the HDC deputy commissioner.

Advice from expert nurse

A primary health expert nurse advisor to the HDC, Wendy Findlay, recommended that an improvement to ensure this error didn’t occur in the future, would be for the practice to create a team approach to vaccination.

“From the documentation supplied by the girl’s mother the reception staff were advised that the girl was attending the practice for an HPV vaccination, this information could have been communicated to the nursing staff, the supervising and checking nurse could have verified the vaccination event with the patient. A robust policy and a systematic approach to clinical practice when vaccinating would assist to ensure this event doesn’t occur again.”

Findlay also suggested to prevent a similar instance of this occurring the checking of the vaccine could occur in the same room as the patient and utilise the patient (or caregiver) to confirm the vaccine by name, batch number and expiry date. This provides an opportunity for the patient to be involved in their care and also provides a double check that the correct vaccine is to be administered

She added that the nurse appeared to have followed the policy document for administering vaccines to patients. “In my view the policy document could be further enhanced to guide the nurse (particularly nurses new to vaccinating) through the process.”

As a result of the incident, the medical centre told HDC that it had made the following amendments to its vaccination policy:

  • There is now a clause stating that nurses are to check for outstanding vaccines appropriate for age and gender.
  • There is now a clause stating that nurses are to refer to the vaccine to be administered by name.
  • The steps have been reorganised to better reflect the order in which each action should take place.
  • There is now a specific section on what action to take in the event of a vaccination error or incident. This includes the requirement to notify the patient’s preferred provider as soon as practicable.

The medical centre told HDC that the nurses involved with vaccination have been informed of the changes made.

Medicines Act requirements for vaccinators

Duggal acknowledged that RN C had completed a vaccinator training course and “felt competent” administering vaccines but she did not administer the Boostrix and Gardasil vaccines under a standing order or prescription, and was not an authorised vaccinator at the time. By failing to comply with the Medicines Act 1981, the practice nurse also breached Right 4(2) of the Code.[7]

Under section 19 of the Medicines Act 1981 and regulation 44A of the Medicines Regulations 1984 a vaccine may be administered only under a standing order or prescription unless it is undertaken by an authorised vaccinator for the purposes of an approved immunisation programme.

The Medical Centre was found to be in breach of the Medicines Act for permitting the nurse to administer the vaccine without a standing order or prescription.

The medical centre told HDC that the nurse, at the time of the administration error, “was not working under any standing orders for childhood vaccinations as she is an authorised vaccinator” which was incorrect.

“The medical centre’s vaccination policy did not provide any information on the legal restrictions around who could administer vaccines. In addition, the medical centre appeared unaware that the completion of a vaccination training course was not sufficient to authorise RN C to vaccinate as required by the Medicines Regulations,” said the HDC report.

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