Background
From time to time, vaccine administration errors can and do occur. Effective and prompt management of these clinical scenarios is vital for the prevention of any future administration errors. The way that errors are communicated to those impacted is also important for maintaining confidence in the vaccination process and to encourage uptake of future vaccines.
What is open disclosure?
Open disclosure describes having an open and honest conversation with a person (and their parent/guardian/support person) about an immunisation incident/error that has affected them.
These conversations are not designed in any way to point blame. Instead, they provide the affected person with an understanding of how the incident occurred, what happens next, and an opportunity to receive an apology with a respectful acknowledgement that something has gone wrong. The conversation is a time to allow the affected person to share their experience and understand the measures that will be implemented by the clinic/provider to ensure these types of incidents do not occur again.
The open disclosure framework
To support these conversations, the Australian Commission on Safety and Quality in Health Care (ACSQHC) have developed a framework for clinicians to follow.
Table: Using the open disclosure framework for communicating vaccine administration errors
| Open disclosure step | Explanation | Hypothetical example |
| Incident detection and reporting | The open disclosure process commences with the recognition that the patient has suffered unintended harm during their treatment; once recognised the priority is appropriate clinical care and prevention of further harm (vaccination errors). Initial assessment should determine the level of response | Administration staff member at a busy Community Health centre notices that a junior nurse has inadvertently given a 1-year-old child Infanrix-hexa instead of Hiberix; the admin staff immediately notifies the junior nurse; junior nurse stops work and seeks advice from a senior immunisation nurse |
| Disclosure of the facts | A discussion of what should have happened and what did happen in an open and honest manner; disclosure of the facts known should occur as soon as possible after recognition of the adverse event. Where possible, the person making the disclosure should be the most senior healthcare professional who is responsible for the care of the patient | “There has been an immunisation error. Your baby was supposed to receive the Hib vaccine on its own; however, he/she received the combination Hib vaccine (called Infanrix-hexa) that is normally used at 2, 4 and 6 months of age. It seems the incorrect vaccine was taken from the fridge and administered” |
| Expression of regret | Expression of empathy and regret for harm that resulted from the adverse event | “We sincerely regret for this error has occurred and any worry that it has caused you” |
| Listen to the patient/family’s concerns and answer their questions | Ensure that the patient/ family has a clear understanding of what occurred; address any questions and concerns that they may have; indicate to them that their concerns are being addressed | “Do you have a clear understanding of what has happened? Do you have any questions? We will do everything we can to ensure...” |
| Explain short- and long-term consequences | Explain any side effects/ risk associated with revaccination/ ongoing care | “Fortunately, there is very little risk of harm resulting from this error. The Infanrix-hexa has the Hib component included so repeat vaccination is not needed. Your baby has received an unnecessary dose of other vaccine components [provide details] but this should not cause any harm. There is a small risk of increased local reaction to the vaccine he/she has received [provide details]” |
| Follow up with patient/ carer/ support person | Offer ongoing support to the patient/ family; may include information on how to take the matter further including any complaint processes available to them | Phone review the next day and 1 week later; offer that the family may speak with the senior immunisation staff member about the error and offer an outpatient appointment |
| Strategies to reduce repeat errors | Assurance to the patient/ family that the error will be investigated in order to learn from the mistake and prevent further such errors; they will be informed of the findings of any further investigation that will take place to determine why the adverse event occurred; provide information on how this feedback will be provided and the timeframe. (Note: often the investigation into the event will have occurred already and can be discussed at initial interview) | Explain to the family that we will learn from this error and look at ways to reduce the chance of this error occurring with other infants |
| Documentation | Disclosure of an adverse event and the facts relevant to it must be properly recorded; documentation includes medical records, incident reports and records of the investigation process | Nurse involved documents events in the patient medical record and completes incident report form |
| Notification | Consider notification to: - person responsible for clinical risk management within provider's organisation - insurers, organisational management - general practitioner or other community care provider (to assist with follow-up care) - relevant statutory authorities in cases of serious adverse events | Senior immunisation nurse notifies the health service’s Clinical Risk Manager; also informs the child’s GP so that GP is aware of incident in case child requires further assessment |
| Follow up with staff | Staff involved should be offered support and advice | Senior immunisation nurse conducts a debriefing session with junior nurse and administration staff involved in the event |
| Confidentiality and privacy | Consideration given to patient’s, carer’s and staff’s privacy and confidentiality at all times, ensuring compliance with relevant legislation; permission sought to share information with third parties in line with relevant legislation | Staff member discuss with the family/ carer any notification that needs to occur (e.g. to child’s GP) as a result of this incident |
Source: Compromised Vaccine Guidelines for Jurisdictional Immunisation Coordinators pp34-37
The below role play provides an example of an open disclosure conversation using the framework following a vaccine administration error:
For more information on vaccine error management and prevention refer to the Victorian Department of Health: Vaccine error management.
Open disclosure is an accreditation requirement of all health services under the National Safety and Quality Health Service (NSQHS) standards. The primary aims of the NSQHS Standards are to protect the public from harm and to improve the quality of health service provision.
Open disclosure can be challenging and complex for clinicians and families alike. However, it can produce benefits, such as improved transparency and communication between clinicians and patients; and opportunities for health services to improve care delivery systems and processes.
Resources
- MVEC education portal: Vaccine errors: Prevention, management and open disclosure (eLearning)
- Australian Commission on Safety and Quality in Health Care: Open disclosure – Information for clinicians and health service organisations
- Australian Commission on Safety and Quality in Health Care: Open disclosure resources for consumers
- Victorian Department of Health: Vaccine error management
- Victorian Department of Health: Open disclosure framework
- MVEC education portal: Vaccination procedures (eLearning)
Authors: Katie Butler (MVEC Education Nurse Coordinator) and Georgina Lewis (Clinical Manager, SAEFVIC, Murdoch Children’s Research Institute)
Date: February 2024
Materials in this section are updated as new information and vaccines become available. The Melbourne Vaccine Education Centre (MVEC) staff regularly reviews materials for accuracy.
You should not consider the information on this site to be specific, professional medical advice for your personal health or for your family’s personal health. For medical concerns, including decisions about vaccinations, medications and other treatments, you should always consult a healthcare professional.