Rebecca Ryan, partner at Matheson's Healthcare Law Group, looks at the instances in which open disclosure will become mandatory and provides some practical advice for clinicians
Open disclosure is an open and consistent approach to communicating with patients and their families when things go wrong in healthcare. This includes expressing regret for what has happened, keeping the patient informed, providing feedback on investigations and taking steps to prevent a recurrence of the adverse event. Open disclosure is important for building patient and public trust in the health system.[1]
As you may have read in the previous issue of Practice Matters earlier this year, there is currently legal protection in place for apologies to patients issued through the open disclosure procedure.[2] Until September 2018, an apology given to a patient could potentially be used as evidence in legal proceedings or referred to in a complaint to the Medical Council.
While this procedure is currently voluntary, the Patient Safety Bill 2018 proposes to make open disclosure mandatory in certain ‘serious patient safety incidents’. As the previous article sought to make readers aware of the relatively new legal protection for apologies, this article aims to serve as a follow up, detailing the instances in which open disclosure will be mandatory and providing practical advice for clinicians.
While there is currently no certain timeline for the implementation of the Patient Safety Bill, clinicians need to prepare appropriately well in advance of the passage of the Bill into law.
Timeline and updates on legislation
The status quo will remain for the foreseeable future despite criticism following the Scally Report.[3] The legislation, intended to implement recommended changes, still only exists in the form of a general scheme published in July 2018 by the Department of Health and Social Care.
Earlier this year, the Minister for Health, Simon Harris, indicated an intention to commence the passing of mandatory open disclosure into law by the end of 2019. While it remains to be seen whether the legislation to effect this change to the open disclosure procedure will be implemented this year, clinicians can be expected to abide by existing guidelines in the short term. While it is anticipated to provide clarity on the provision of apologies and on open disclosure this year, the 9th edition of the Medical Council’s Ethical Guide and Code of Conduct remains unpublished as yet.
The law as it stands
The law surrounding open disclosure is currently governed by the Civil Liability (Amendment) Act 2017. The Act provides the legal framework to support voluntary open disclosure; it applies to all patient safety incidents including near misses and no-harm events. It provides for an open and consistent approach to communicating with patients and their families, allowing an apology, as appropriate, when things go wrong in healthcare. The approach is intended to create a positive voluntary climate for open disclosure.
The Act defines a patient safety incident as one of the following:
• an incident that resulted in an unintended or unanticipated injury, or harm, to a patient during the course of provision of a health service
• an incident that has not resulted in actual injury or harm but where a clinician has reasonable grounds to believe a patient was placed at risk of unintended injury or harm
• the prevention by timely intervention or chance of an unanticipated injury or harm which the clinician has reasonable grounds to believe that, in the absence of the prevention, could have resulted in injury or harm to a patient.
[4]
The Patient Safety Bill and mandatory open disclosures
The government approved the general scheme of the Patient Safety Bill on 5 July 2018. This Bill provides for mandatory open disclosure, mandatory external notification of patient safety incidents, clinical audit guidance and the extension of the remit of HIQA to private hospitals.
While the current form of the Bill may only be in a general scheme, we can discern critical definitions and procedures from Head 5 of the scheme (mandatory open disclosure) as it is proposed by the Department of Health and Social Care.
Mandatory open disclosures are intended to be required when a serious patient safety incident arises. These are defined as:
• the death of a patient
• the permanent lessening of functions, eg organ/brain damage or the removal of the wrong limb (referred to as ‘severe harm’)
• non-severe harm that results in the increase in a patient’s treatment
• change in the structure of the body
• shortened life expectancy
• impairment of sensory, motor or intellectual functions for a period of at least 28 continuous days
• the experience of physical or psychological pain for a period of at least 28 continuous days
• that a person requires treatment to prevent death or injury that if left untreated, would lead to severe harm or non-severe harm.
[5]
It is important to note that this list may not be exhaustive in future and the Bill, as proposed, gives the Minister for Health the discretion to prescribe more definitions in the future.
In terms of the new proposed reporting framework, Head 9 of the scheme (Notification of reportable incidents) establishes a timeline for the reporting of serious incidents. A person will be required to report the incident to the HSE as soon as possible, and within no more than seven days of the incident occurring. The HSE must then contact the State Claims Agency and the relevant regulators (Medical Council or Dental Council) within the same timeframe, commencing when the relevant health service provider received notification. The regulators are intended to be HIQA, the Chief Inspector of Social Services in the case of residential services, and the Mental Health Commission in the case of mental health services. Where a notification is received under this Head, the regulator will be in a position to take action as it considers appropriate under its own legislation.[6]
Practical implications for clinicians
As the Patient Safety Bill proposes to keep the current framework surrounding the open disclosure procedure, clinicians do not need to worry about an increased workload on this front. However, it will be important to note the definitions of serious incidents within the new regulations as it will be these, and only these, that are considered mandatory to report and disclose. When the changes are implemented, it will be important for all relevant health service providers to have systems in place to process the reporting of serious patient safety incidents within the required timeframe. This is absolutely vital, as failure to comply with the legislation will carry severe penalties. A less serious violation of the new regulation could result in a fine of up to €5,000, a prison sentence not exceeding three months, or both. A more serious violation could result in the health service provider being fined up to €7,000, a prison sentence not exceeding six months, or both.
For these reasons it is essential for clinicians to put the appropriate systems, policies and checklists in place in preparation for the mandatory open disclosure procedure. The 9th Edition of the Medical Council’s Ethical Guide and Code of Conduct is being published this year and should provide greater clarity on the mandatory open disclosure procedure.
References
[1] Health.gov.ie. (2019). Department of Health. [online] Available at: https://health.gov.ie/
2 S.I. 10 No. 237/2018 – Civil Liability (Open Disclosure) (Prescribed Statements) Regulations 2018
3 Scally, G. (2018) Scoping Inquiry into the CervicalCheck Screening Programme. Final report. Dublin, September 2018.
4 Section 8, Civil Liability (Amendment) Act 2018.
5 Head 5, Patient Safety Bill 2018
6 Head 9, Patient Safety Bill 2018