The Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023 (the "Act") was signed into law on 2 May 2023, but has not yet been formally commenced. The HSE has advised that there are number of preparatory steps required before the Act can be formally commenced. The intention is to commence it as soon as possible. The HSE are currently working on an implementation project and aim to provide more practical guidance as to how the Act will be implemented before it is commenced.
The Act provides for a procedure whereby certain "Notifiable Incidents" are subject to mandatory open disclosure and must be communicated to patients and / or their families by healthcare professionals. The core purpose of the Act is to facilitate open and honest disclosure amongst patients and Health Services Providers and Practitioners. The Act seeks to facilitate a culture of open disclosure and honesty across all health services. The intention is to make open disclosure the norm as opposed to merely the focus of mandatory disclosures.
This Act builds upon the framework put in place by the HSE's Open Disclosure Policy (2013) and Part 4 of the Civil Liability (Amendment) Act 2017 which provided for voluntary open disclosure only. As it stands, practitioners and health providers may make an open disclosure of any patient safety incident, including those which did not result in harm. The key difference the new Act will introduce once commenced is that there will now be certain types of notifiable incidents which will require a mandatory open disclosure by the Health Services Providers and Practitioners as opposed to simply allowing them the option to make an open disclosure. The existing framework will however, also remain in place.
Who Does the Act Apply to?
The Act applies to doctors, dentists, pharmacists, nurses and midwives amongst others, who are defined in the Act as Health Services Practitioners.
The Act is also applicable to Health Services Providers being a person or a company that employs a Health Services Practitioner, enters into a contract for services with a Health Services Practitioner or enters into an arrangement with the Health Services Practitioner for the provision of a health service. This includes partnerships of two or more Health Services Practitioners. It is therefore extremely important for any medical practice, hospital and private consultants to be on notice of the provisions of the act in terms of its applicability to staff members and the sanctions for non-compliance which are set out below.
An open disclosure of a Notifiable Incident can be made to the patient concerned or a so-called "relevant person" where the patient has died, is lacking in capacity or the patient has requested the disclosure be made to the relevant person. The patient can also elect to nominate a relevant person to be present with them at the open disclosure meeting.
Relevant persons include those appointed under the Assisted Decision Making (Capacity) Act 2015, those with enduring power of attorney in respect of the patient, someone nominated in writing by the patient, a parent or guardian among others.
What is a Notifiable Incident?
The Notifiable Incidents currently stipulated by the Act are set out below. They currently all relate to the death of an individual (meaning, as things stand, open disclosures will only be made to relevant persons rather than the patient themselves, save for still born deaths or perinatal deaths):
- A death arising from surgery performed on the wrong patient;
- A death following surgery performed on the wrong site;
- A death following the wrong procedure being performed on a patient;
- A death following the unintended retention of a foreign object in a patient;
- The death of an otherwise healthy patient undergoing an elective procedure, where this death directly relates to the procedure or anaesthesia, and not related to any underlying illness or condition of the patient;
- Any unanticipated or unintended death occurring at any premises or place where a health services provider provides a health service that is directly related to any medical treatment, where the death is not related to any underlying condition or illness;
- A death subsequent to the transfusion of incompatible blood;
- A patient death arising from medication error, where the death was not related to any underlying illness or disease;
- An unanticipated death of a woman while pregnant or within 42 days of the end of the pregnancy related to the management of the pregnancy as opposed to as a consequence of an illness of the patient or an underlying condition of the patient;
- Still born deaths where the child did not have any fatal foetal abnormality and was at full gestational age, not related to the management of the pregnancy and the death is not related to illness of the child or an underlying condition of the child;
- Perinatal deaths where the infant was alive at the onset of care in labour and was at full gestational age, not related to the management of the pregnancy and the death is not related to illness of the child or an underlying condition of the child;
- Death by suicide where the patient was being cared for in or at a place or premises in which a health services provider provides a health service whether or not the death was anticipated or related to illness or an underlying condition of the patient.
There is also provision in part 2 of the Act for disclosure of incidents involving infants being referred for therapeutic hypothermia, or were considered for, but did not undergo therapeutic hypothermia as, in the clinical judgment of the health practitioner, such therapy was contraindicated due to the severity of the presenting condition. Therapeutic hypothermia is a treatment that lowers a newborn infant's body temperature in order to prevent or minimize brain damage caused by lack of oxygen or another injury before or during birth.
There is provision under section 8 of the Act for the Minister for Health to add additional Notifiable Incidents provided they meet a certain criteria. There is the possibility that incidents of harm rather than solely death related incidents will fall under this category. However, the harm must have continued for more than 28 days or result in a shortened life expectancy as per section 8(2)(b)(iii) of the Act . As above, while all Notifiable Incidents currently involve the death of a patient, future Notifiable Incidents may not. As such, the below steps include references to involvement of patient themselves in the process.
What to do if a "Notifiable Incident" Occurs?
The below is a summary of the steps required as per Parts 2 and 3 of the Act.
- Where a Notifiable Incident as set out above occurs, a Health Services Practitioner must notify the Health Services Provider as soon as practicable. The Health Services Provider is obliged to notify HIQA or the relevant regulatory authority of the incident, depending on the type of service being provided.
- Where a Health Services Provider or Practitioner is satisfied a Notifiable Incident has occurred, whether they were the providing the service or not, a Notifiable Incident disclosure meeting must be held.
- The Health Services Provider must consider what the appropriate timing for this meeting shall be having regard to what information is currently available and the circumstances of the patient.
- This meeting should be held in person unless the patient or relevant person requests otherwise.
- The open disclosure should be made by the principal Health Services Practitioner in relation to the patient or a designated party as per section 16 of the Act which includes employees of the health provider and health practitioners who also provide services to the health provider.
- The following should be outlined in the Notifiable Incident
meeting:
- A description of the incident;
- The date the incident occurred;
- The date the incident came to the attention of the Health Services Provider;
- The manner in which it came to the attention of the Health Services Provider;
- Where the Health Services Provider believes physical or psychological consequences of the Notifiable Incident have occurred or are likely to develop for the patient or relevant person, then they should be informed of these consequences. Where these consequences have already developed, the Health Services Provider should provide the patient or relevant person with information in respect of treatment and the relevant clinical care;
- Where the Health Services Provider has reasonable grounds to believe there is or will not be physical or psychological consequences for the patient or relevant person, they must provide a statement to this effect;
- If the Health Services Provider has determined that an apology is to be provided this can be provided at the meeting; and
- The Health Services Provider can also outline any actions or proposed next steps they are taking as a result of the Notifiable Incident.
- A statement must also be provided to the patient or relevant
person. It must:
- Be in writing;
- Set out the information outlined above;
- Contain an apology if one was given;
- State that the open disclosure of the Notifiable Incident was made pursuant to their obligation to so, outlined in section 5 of the Act;
- Specify the date on which the open disclosure was made;
- State that the meeting was held in accordance with their obligation to so, outlined in section 5 of the Act; and
- Be signed by the principal Health Practitioner or the Health Practitioner referred to in section 13 who made the open disclosure on behalf of the provider.
What are the Consequences of an Open Disclosure?
- The information disclosed and apology (if provided) is not an express or implied admission of fault or liability nor can it be used as evidence of fault or liability in clinical negligence proceedings or in any professional misconduct, unfitness to practise or similar proceedings;
- The information disclosed and any apology provided, does not invalidate any insurance or indemnity held by the Health Services Provider or Health Service Practitioner;
- Records must be maintained and not destroyed; and
- The Health Service Provider or Practitioner must notify the relevant authority within 7 days of the incident. This may include HIQA, the Mental Health Commission or another regulatory body depending on the nature of the incident.
What Happens if an Open Disclosure is Not Made?
Section 77 of the Act provides that where someone fails to disclose a Notifiable Incident, they will be guilty of an offence and liable on summary conviction to a Class A fine (up to €5,000). It must be proven that there is no reasonable explanation for the failure to disclose a Notifiable Incident.
Where a company fails to disclose a Notifiable Incident, and it can be proven that the offence was committed with the consent or assistance of a person who was a director, manager, secretary or other officer of the company, both will be guilty of an offence and liable as per the above. The same applies where the affairs of a company are managed by its members.
Conclusion
It is important for all Health Services Providers and Health Services Practitioners to familiarise themselves with this legislation before it is enacted. All Health Services Practitioners have a duty arising from the Act to inform the relevant Health Services Provider if any Notifiable incident occurs. Healthcare Practitioners should also rest assured that the disclosure of any Notifiable Incident cannot be used against them or taken as any admission of liability in potential future clinical negligence claims or any other regulatory complaint. Health Services Practitioners should contact their indemnity bodies for support and advice in advance of making an open disclosure. As outlined above, the core and overarching purpose of the Act is to facilitate open and honest disclosure between patients, relevant persons and Health Services Providers.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
