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Explainer: What is open disclosure, and where does it fit in the smear test scandal?

What are the obligations to tell a patient when a mistake has been made in their healthcare?

shutterstock_736552108 Shutterstock / S_L Shutterstock / S_L / S_L

THE CERVICALCHECK CONTROVERSY this week has led to discussions about who is responsible for telling patients when a mistake has been made in their medical treatment.

In the case of Vicky Phelan, a Limerick mother-of-two, she didn’t find out that there was a mistake made with the results of her 2011 smear until 2017. A review of her smear test was carried out in 2014, the year she was diagnosed with cervical cancer.

The delay in informing Phelan about the review of her case has caused uproar and concern, specifically about the obligations of medical practitioners to tell their patients when a mistake is made or when something is missed.

So what are healthcare professionals obliged to do in the event of a mistake, and what happens if they don’t follow those rules?

What is open disclosure?

The HSE defines open disclosure as “an open, consistent approach to communicating with service users when things go wrong in healthcare”.

“This includes expressing regret for what has happened, keeping the patient informed, providing feedback on investigations and the steps taken to prevent a recurrence of the adverse event.”

In the Medical Council’s guidelines, it states under the heading “Open disclosure and duty of candour”:

Open disclosure is supported within a culture of candour. You have a duty to promote and support this culture and to support colleagues whose actions are investigated following an adverse event.
If you are responsible for conducting such investigations, you should make sure they are carried out quickly, recognising that this is a stressful time for all concerned.
Patients and their families, where appropriate, are entitled to honest, open and prompt communication about adverse events that may have caused them harm.

“When discussing events with patients and their families, you should:

  • Acknowledge that the event happened
  • Explain how it happened
  • Apologise, if appropriate, and
  • Assure patients and their families that the cause of the event will be investigated and efforts made to reduce the chance of it happening again.”

Open disclosure Page 43 of the Medical Council's guidelines. Medical Council guidelines Medical Council guidelines

In cases where the patient has died, their information remains confidential, unless otherwise stated. If it’s unclear whether the patient agreed to their medical history being shared with loved ones, the guidelines state that “you should consider how the disclosure might benefit or cause distress to the deceased’s family or carers”.

It’s important to note that although this applies to registered doctors, this isn’t in itself a legal requirement – more on that further down in this piece.

How does it play into the Cervical Check controversy?

Vicky Phelan settled her High Court action against Clinical Pathology Laboratories Inc, Austin, Texas last Wednesday over her 2011 smear test which was later found to have shown abnormalities in a 2014 review. She was awarded €2.5 million.

In the aftermath of the case, the head of the National Cancer Control Programme Dr Jerome Coffey attracted criticism after saying that the decision on whether doctors should tell their patients the result of a review was “between the physician and the patient”.

The next day, the Clinical Director of CervicalCheck Dr Grainne Flannelly said that although clinicians were instructed by CervicalCheck to tell patients that their smear test results had been reviewed, it wasn’t certain whether the women were then told.

It was subsequently revealed by the HSE that of the 1,482 cases of cervical cancer that were brought to the attention of the CervicalCheck programme, a review was warranted in 442 cases.

In those 442 smear tests, 208 were found to have needed a different result or additional action (such as further tests). Of that total, only 46 women were told that their smear tests had been reviewed.

The remaining 162 of the women were not told that they may have had a delayed diagnosis and could have benefitted from earlier treatment.

17 women whose smear tests were reviewed have since died. It hasn’t been confirmed what caused their deaths.

The incident has raised questions about what responsibility doctors have to tell their patients about errors made in their medical treatment.

‘Mandatory’ open disclosure and political involvement

In November 2015, Leo Varadkar, who was Minister for Health at the time, published plans to make “open disclosure and duty of candour” – which is the Medical Council guideline for medical practitioners - a legal requirement.

Among the recommendations made in the patient safety package, was to make ‘serious reportable events’ a legal requirement, and this inclusion on open disclosure:

“Open disclosure, which has been policy since 2013, will be enshrined in legislation being drafted in cooperation with the Department of Justice.

Open disclosure extends beyond healthcare and includes errors that cause no harm at all, or even possible errors that turn out not to have happened.
The legislation will ensure that all open disclosures will be protected and that offering an apology or giving full information up front cannot be seen as an admission of liability.
This is designed to guarantee a culture of openness in healthcare and was recommended by the Commission on Patient Safety and Quality Assurance chaired by Dr Deirdre Madden of UCC.

But in January 2016, the Minister said that he would shelve those plans and had “adjusted” his view based on evidence from the chief medical officer at the time Dr Tony Holohan.

In a statement to The Irish Times, Holohan said that doctors and nurses would be more fearful if those policies were introduced:

An automatic duty of candour where patients are told about every error or near miss may lead to defensive documentation and a large bureaucratic overhead that distracts from patient care.

In March 2017 Health Minister Simon Harris received approval from Cabinet to bring in a voluntary form of open disclosure where medical professions would be proteced from legal action for any information given following a patient safety incident.

An amendment was made to the Civil Liability Act in 2017 as a result – which included the voluntary open disclosure (meaning there’s no legal obligation):

“Where a patient safety incident occurs in the course of the provision by a health services provider of a health service to a patient, the health services provider may make, in accordance with this Part, an open disclosure of the patient safety incident…”

Civil liberties act Civil Liability (Amendment) Bill 2017 Civil Liability (Amendment) Bill 2017

Making a complaint

If there’s a concern that other medical practitioners aren’t adhering to the Medical Council’s guidelines in a way that affects patient safety, the guidelines state that these instances can be reported.

When a complaint is made to the Medical Council, they’re initially handled by the Preliminary Proceedings Committee (PPC). In serious cases they can refer the complaint to the Fitness to Practice Committee.

Other outcomes to a PPC investigation are:

  • No further action is necessary
  • The complaint needs to be referred to another body or authority
  • The doctor should be referred to the performance assessment scheme
  • Mediation if deemed appropriate could resolve the complaint and restore the doctor/patient relationship.

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