Healthcare organisations often need to set up investigations, both internal and external. Whether these take the form of a statutory or non-statutory public inquiry, an investigation or a review, and whether the organisation is conducting its own process or participating in someone else’s, governance issues arise.
Such issues include everything from protecting data privacy to applying the right terms and conditions to the appointment of investigators and ensuring they discharge their reporting obligations in full.
At every stage, good governance is critically important, says Catherine Allen, partner and head of public, regulatory and investigations at Mason Hayes & Curran. This is a message she will deliver as part of her keynote speech at Future Health Summit, a major international event for the healthcare industry, which takes place on Wednesday, May 29th and Thursday, May 30th at the Royal Dublin Convention Centre, Dublin 8.
Mason Hayes & Curran, an award-winning business law firm employing more than 600 people that has the largest healthcare legal team in Ireland, is a key sponsor of the event.
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Allen has spent more than two decades providing multifaceted advice to public bodies and regulators on various aspects of public and information law. She also advises on the conduct of investigations for professional regulators. She will be passing on the benefit of that expertise to the more than 600 C-suite delegates set to attend.
The kind of investigations Allen helps healthcare clients with can be external, dealing with organisations such as the Health Information and Quality Authority (Hiqa), and the Mental Health Commission, or internal, where a mistake has been made in the provision of healthcare and a need exists to identify the cause to ensure it doesn’t happen again. In such cases the healthcare organisation, which could be a public, voluntary or private hospital, or a nursing home, can set up an investigation either completely internally, or through bringing in external investigators.
Allen’s work covers everything from adverse events and compliance issues to quality-of-care failings, abuse and fraud.
Right now, many healthcare organisations are preparing for the forthcoming Covid-19 inquiry, the date for which has yet to be set.
Motivations good, methods bad
When things go wrong healthcare organisations, by their nature, are keen to investigate – but haste is not their friend, Allen says.
“Sometimes, because there is a desire on the part of the organisation to be proactive about having an investigation when an adverse event has occurred, they want to just jump straight in and find out what happened, to make sure it doesn’t happen again,” she explains. “But the problem is that jumping into an investigation without having a plan can create more difficulties.”
When setting up an investigation, it is important to be clear about what you are trying to achieve, she advises. It is essential your investigators know too.
“Do they know what you expect from them in terms of delivering a report back to you, for example?” she asks. “We have seen in the past people putting a lot of work into an investigation only for it to fall foul of issues such as failure by the investigators to follow due procedures, or because of a lack of awareness around things like data privacy issues. And because those issues contaminate the investigation, you’re left at the end with a report you can do very little with.”
For investigating organisations, that’s the worst possible outcome, Allen notes.
“What I’ll tell healthcare organisations at the Future Health Summit is, yes, of course – do these investigations. But do your planning in advance so that you set them up right, do them properly and get what you want at the end of them. That is, identify the learnings and provide confidence and reassurance to your patients, their families and other stakeholders.”
It’s not about criticism, she points out. “In all cases the intention is really good. People want to find out what went wrong and make sure it doesn’t happen again. But in their eagerness to jump in they might, for example, ask an external investigator to look at their records, or review a file. But have they put a confidentiality agreement in place? Have they a data-sharing agreement in place?
“Have they told the other stakeholders, the patients, the family members, that they are doing this investigation? Are the family members going to be involved or are they going to be surprised at the end of the day by a report from an investigation they didn’t even know was going on?”
Such simple, open communication “can sometimes be forgotten about in the rush to get somebody in and the issue looked at”, Allen says.
Fair and due process
In many cases an organisation will be investigating its own staff, who may have a right to know what is going on and perhaps even to comment on what is being said about them.
“It’s why it is so important for investigators to follow fair procedures,” says Allen. “Again, this can nearly be viewed as getting in the way of getting answers quickly – but if you haven’t followed fair procedures you might end up with something you can’t use, so it’s about putting the right steps in place first.”
Because this is healthcare, which involves people’s wellbeing and people’s lives, the sensitivity stakes could not be higher.
“Sometimes people don’t think about where a report is going to end up afterwards,” says Allen. “They think they are just writing to their line manager a comment that they will understand. They forget that organisations are subject to GDPR and that people can make data subject access requests. Very many of our hospitals are freedom of information bodies too, so are subject to FOI requests,” she explains.
Also, many hospitals are funded by the HSE, or other organisations which have the right to receive copies of any documentation.
“You might have thought you were writing just for one pair of eyes and therefore were less concerned about defamation issues arising,” Allen says.
The best way to proceed with any investigation is to have a culture of awareness from the top down and good policies in place to support it, she advises.
“Healthcare organisations are always going to have to do investigations,” she adds. “Things are always going to happen – that’s natural, unfortunately – and people will want to do the right thing. But the way to do that is to be ready to set up your investigation and have all your policies and procedures in place beforehand, so as not to get caught by surprise.”
For any investigation to be truly successful, the lessons it holds for future governance must be actioned, Allen points out, not left to gather dust on a shelf.
“That’s a big part of getting this right,” she adds.
To read more about Future Health Summit visit futurehealthsummit.com. To contact Catherine Allen and her team visit MHC.ie/Health24