The Health Service Executive and the State Claims Agency launched a policy on open disclosure in 2013, having piloted it at two hospitals – the Mater in Dublin and Cork University Hospital – from October 2010 until October 2012.
However, despite the policy and encouragement of open disclosure, many doctors practice defensive medicine.
This can partly be explained by the legal position and the lack of safeguards in place, which leaves the medical profession vulnerable to claims of medical negligence.
The long anticipated Civil Liability (Amendment) Act 2017 sought to address this by, among other things, creating legislative safeguards for the medical profession by promoting a culture of open disclosure.
The act provides that any open disclosure and/or apology within the provisions of the act shall not invalidate insurance, constitute admission of liability or fault, or not be admissible in proceedings.
Importantly, section 12 of the act states that a health-service provider ‘may’ make an open disclosure – however, there is no requirement to do so.
The act defines a ‘patient-safety incident’ as “an incident which has caused an unintended or unanticipated injury or harm to the patient and which occurred in the course of the provision of a health service to that patient”.
By contrast, the new Patient Safety Bill 2018 – which more closely resembles British law – requires open disclosure of any serious patient-safety incident.
According to the bill, ‘mandatory open disclosure’ requires the disclosure, by a health-service provider, of a “serious patient safety incident [that] is any unintended or unanticipated injury or harm to a service user that occurred during the provision of a health service.”
Such incidents include:
a) The death of the person,
b) A permanent lessening of bodily, sensory, motor, physical or intellectual functions (including removal of the wrong limb or organ or brain damage) (“severe harm”),
c) Harm that is not severe harm but results in:
i) An increase in the person’s treatment,
ii) Changes to the structure of the person’s body,
iii) The shortening of the life expectancy of the person,
iv) An impairment of the sensory, motor or intellectual functions of the person that has lasted, or is likely to last, for a continuous period of at least 28 days,
v) The person experiencing pain or psychological harm that has been, or is likely to be, experienced by the person for a continuous period of at least 28 days,
d) The person requiring treatment by a health practitioner in order to prevent:
i) The death of the person, or
ii) Any injury to the person that, if left untreated, would lead to one or more of the outcomes mentioned in paragraph (b) or (c).
The bill also provides that “serious patient safety incidents shall include, but not be limited to, such serious patient safety incidents as may be prescribed by the minister”.
Like the act, the bill retains safeguards to prohibit any adverse effect on civil liability or insurance cover arising from an apology or disclosure.
Curiously, however, the bill’s explanatory note, while referring to such protections, states that notifications of reportable incidents or other patient safety incidents would be admissible in evidence for other civil proceedings and in criminal proceedings.
The bill does not, however, provide examples of ‘other’ civil proceedings, but one might question whether professional inquiries – including those by the Medical Council or Bord Altranais – would fall within the definition of such other civil proceedings.
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Finally, the bill defines a ‘health-service provider’ as a person other than a health practitioner who provides one or more health services and, for that purpose, employs a health practitioner for the provision of health services.
In that regard, the ‘registered health-service provider’ – and not a registered ‘health practitioner’ – shall be guilty of an offence if the health-service provider fails to make a mandatory open disclosure or fails to notify a reportable incident in accordance with the apology and information provision.
A registered health-service provider faces, on summary conviction, a fine not exceeding €5,000 or imprisonment not exceeding three months or both, or, on indictment, a fine not exceeding €7,000 or imprisonment for a term not exceeding six months or both.
It is noteworthy that In Re Employment Equality Bill (1997), the Supreme Court held that it was unconstitutional to impose criminal liability on employers of offences committed by employees.
Furthermore, there is very little difference between a summary conviction fine of €5,000 versus a conviction on indictment of €7,000.
It will be very interesting to see whether the bill will be retained in its current form and enacted.
What is also not clear in the bill as it stands is who is required to make the mandatory open disclosure – the doctor, nurse, or service provider?
The bill defines a ‘registered health-services provider’ as intended to cover public and private health services and those who operate in both private and public, whether providing health services through a company, partnership, or their own – for example, the HSE, section 38 service providers, private hospitals, general practitioners – with an exclusive practice mix of private and public patients.
Therefore, who within this definition is actually required to make the mandatory open disclosure – the doctor or the service provider?
Whether the current act has (or the promised bill will) have an effect on improving medical care and reducing medical negligence is far from clear.
The first-ever empirical study evaluating similar laws in the United States found that laws that protect doctors who apologise for errors may actually impel more patients to sue. Benjamin J McMichael found that the effect of the apology laws was mixed.
There was evidence to suggest that malpractice claims against surgeons could be reduced by such law, but they also had a perverse effect on patients’ propensity to litigate, in particular against non-surgeons.
The study found that, while apology laws do encourage physicians to apologise, the laws actually appeared to increase the number of lawsuits against non-surgeons and had little effect on the number of lawsuits against surgeons: “Assuming it is easier to detect the malpractice of a surgeon than a non-surgeon (which is likely, given that surgical errors are more obvious to patients than nonsurgical errors, like misdiagnosis or failure to refer), the increase in the probability of a lawsuit for non-surgeons and the absence of an increase for surgeons is consistent with apology laws encouraging apologies that contain a signal of malpractice.”
The study found that “apologies may alert patients to errors they would not have discovered otherwise, encouraging them to file suit instead of settling or dropping their claims before filing in court”.
The empirical analysis examined over 1.6 million hospital stays of heart-attack patients and found no evidence that apology laws reduced defensive medicine.
Further, apology laws do not decrease the intensity of treatment received by patients but, rather, they actually increase the medical resources used to treat heart-attack patients, consistent with an increase in defensive medicine.
If apology laws decreased malpractice pressure, physicians should be more comfortable sending patients home a little earlier. However, the reverse is true – physicians kept patients in longer in the presence of such laws.
Moreover, the lack of guidance about apologies could lead to confusion, with poorly executed apologies and ‘botched’ apologies blamed for an increase in the risk of patients suing.
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In conclusion, while it is ethically the right thing for a medical practitioner to acknowledge and/or apologise where a mistake, error, or patient-safety incident has occurred, mandatory open disclosure within the Irish healthcare system – akin to the duty of candour in Britain – may be welcomed.
One could argue that it would be unwise to advise any medical professional to acknowledge and/or apologise where a patient-safety incident occurred without having safeguards in place, otherwise one would be effectively fuelling medical negligence claims.
Apology laws that protect disclosure are more common internationally, and international experience indicates that open disclosure will happen when fostering the development of an open and honest culture, in line with the Medical Council’s Guide to Professional Conduct and Ethics for medical practitioners, which refers to patients being entitled to honest, open, and prompt communication about adverse events that may have caused them harm, such as the cervical cancer scandal.