In healthcare law open disclosure is currently voluntary. However, in the future it will be mandatory in certain serious patient safety incidents. Dr Rachel Birch, Editor-in-Chief and medicolegal consultant, provides practical advice on steps that practices can take now in preparation

The current law surrounding open disclosure is governed by the Civil Liability (Amendment) Act 2017.¹ At present, under this law, open disclosure of patient safety incidents is a voluntary process. This is regardless of whether there has been actual harm or a ‘near miss’, or ‘no-harm’, situation.

In December 2019 the Minister for Health published the Patient Safety (Notifiable Patient Safety Incidents) Bill 2019.² Although this Bill has now lapsed with the dissolution of the Dáil and Seanad, which have since reconvened, it is likely to signal the potential shape of things to come. The Bill introduced a new requirement for mandatory open disclosure of specific serious “notifiable” patient safety incidents. It also outlined steps to ensure that the framework was future-proof, by allowing the Minister for Health, through regulations, to update and add to the list of notifiable patient safety incidents, in line with clinical advancement

What were the implications of the Bill for general practice?

Health service providers, including GP practices, would be required to be open and transparent with patients and their families when a notifiable patient safety incident has occurred during their care. The Bill clearly sets out how the process should work and how it applies to both public and private healthcare.

Alongside this legal obligation to be open with patients and their families, there would also a mandatory obligation to notify the appropriate regulator within seven days; this would usually be the Health Information and Quality Authority (HIQA), but could also be the Chief Inspector of Social Services (CISS) or the Mental Health Commission (MHC), depending on the nature of the concerns.

There was also provision to support clinical audit in the health service. It is clear that one of the main purposes of the legislation was to ensure there is learning from events, at both a local and national level, with the aim of supporting health service-wide improvements to minimise potential patient harm.³  

There would be serious consequences for GPs if they do not comply with this legislation and they could be liable on summary conviction to a Class A fine, as well as the likelihood of Medical Council investigation with potential risk to their registration.

What is a notifiable incident?

The Bill outlined the current list of notifiable incidents as:

• Unanticipated and unintended death due to
  
  
  • Surgery performed on the wrong patient
  • Surgery performed on the wrong site
  • The wrong surgical procedure being undertaken
  • Retention of a foreign object in a patient after surgery
  • A surgical operation, anaesthesia or medical treatment
  • A medication error or the transfusion of incompatible blood or blood components
• Maternal death (while pregnant or within 42 days of delivery)

   

• Perinatal death (either stillbirth or the death of a baby shortly after birth)
  
  
• Death believed to be caused by suicide
  
  
• A baby requiring therapeutic hypothermia, or who was considered for this, but it was contraindicated due to the severity of their condition

Many of these notifiable incidents are more likely to have occurred in secondary care rather than primary care. However, under the new legislation all health service providers (including GPs) will be responsible for ensuring that open disclosure occurs, even if that notifiable incident occurred during treatment provided by another health service provider. This is to ensure that patients receive information as quickly as possible and that there are no delays from deciding on responsibilities.

The process of open disclosure

The Bill would have placed an obligation on GPs and practices to ensure that all relevant information is provided at an open disclosure meeting. The legislation stated that the information can be provided to the patient or their family (in circumstances where the patient has provided consent, has died or lacks capacity but it is in their best interests). Since the majority of the current notifiable incidents relate to the death of a patient, the obligation would be to provide information to the patient’s family.

Practices would have needed to appoint a “designated person” to liaise with the patient or family and arrange an open disclosure meeting. Open disclosure should occur as soon as it is practical to arrange it, although individual circumstances would need to be considered. Patients and families may decline the offer of an open disclosure meeting, although they would have up to five years to change their mind.

The open disclosure meeting should take place in person, unless the practice is requested to conduct it over the telephone or by video, such as Skype. Wherever possible the open disclosure should be made by the main health practitioner providing care to the patient. The meeting should be an opportunity to provide information on what happened, detail any action or treatment necessary, offer an apology where appropriate and outline the steps that the practice will take to investigate and learn from the incident.

The patient or family must also be given information in writing about the open disclosure, either at the meeting or up to five days after the meeting. There would be legal protection for any apology, given at the meeting or in writing afterwards; it cannot be used as evidence in a clinical negligence claim or in Medical Council proceedings.

What does the Medical Council say?

GPs have an existing professional duty of candour and should ensure that they promote a culture of patient safety within the practice, ensuring that patient safety incidents are investigated promptly. The Medical Council already advises doctors that, when discussing adverse events with patients and their families, they should acknowledge that the event happened, explain how it happened, apologise if appropriate and provide assurance that the cause of the event will be investigated and steps taken to reduce the chance of it happening again.⁴

This is the case for any adverse event that occurs and this will continue to apply after the introduction of the Patient Safety (Notifiable Patient Safety Incidents) Bill 2019. However, the legislation will now make mandatory the open disclosure of the specific list of notifiable incidents.

The Medical Council is likely to publish new guidance once the legislation changes.

What practical steps can you, as a practice, take now?

Although the Patient Safety (Notifiable Patient Safety Incidents) Bill 2019 has now lapsed, it is probable that, in the future, similar legislation will be proposed and ultimately introduced, requiring mandatory open disclosure in certain serious patient safety incidents. As such, it is important for practices to be aware of what was proposed in the Bill and it might be helpful for them to consider how they could prepare for mandatory open disclosure.

As there is already a professional duty of candour, most practices will have an existing process for conducting open disclosure meetings with patients and their families. However, it might be prudent to spend time now, ensuring that your practice’s process is in line with that outlined in the Bill. For example, is there a “designated person” who would liaise with patients and their families? If not, consider who the best person would be to undertake this role. In many practices the practice manager would be most suitable, but a GP partner could also fulfil this role. Are patients and families
provided with written advice following an open disclosure meeting currently? If not, you might wish to introduce this now. You should also ensure that all written open disclosure correspondence is stored securely, while remaining accessible, if required.

As a practice, you may wish to take steps now to emphasise your culture of patient safety with all staff members, so that there are no obstacles to raising concerns or reporting adverse incidents. There is no place in today’s healthcare for blame or finger pointing; everyone should be confident to report adverse events, review them and learn from them. You should make sure that the practice has an adverse incident reporting policy and that all staff members are familiar with this. It would be helpful to develop an adverse incident log, if you do not already have one.

Are you already reviewing and discussing adverse events? If not, you should consider introducing regular or ad-hoc opportunities to meet as a team to do so, with the aim of putting in place measures to prevent future similar incidents.

You may consider discussing, as a practice, how notifiable patient safety incidents can be identified. Many will become apparent during the course of a patient’s clinical care or referred to in clinical correspondence from secondary care. However, is there a chance that a patient safety incident could slip through the net and be missed? Perhaps a regular search for certain clinical codes could be a useful back-up system. Administrative staff members, on dealing with correspondence, may be invaluable as a further safety net.    

In advance of mandatory open disclosure becoming law, you will wish to arrange training for all your practice staff, so that they are aware of what the practice’s obligations will be and know what action they should take within the practice. You should develop a practice open disclosure policy, outlining each staff member’s responsibility and what to do when staff members are on leave. This could also include details of how to report incidents to HIQA and provide their contact details. All staff members should be given access to this policy, including any locum GPs that come to the practice.

Finally, while the enactment of further legislation may be some way off, it is likely that further guidance will emerge in due course. Keep a lookout for further updates from the HSE and ICGP, which Medical Protection will also communicate via our website.

References

1. Civil Liability (Amendment) Act 2017
2. Patient Safety (Notifiable Patient Safety Incidents) Bill 2019
3. Department of Health, Summary Guide to the Patient Safety (Notifiable Patient Safety Incidents) Bill 2019
4. Medical Council, Guide to Professional Conduct and Ethics for Registered Medical Practitioners 8^th edition (2016)