While there is still no clear timeframe for the new Patient Safety Authority, James Fogarty looks at similar organisations overseas to garner a sense of how the new Authority might operate
HIQA’s damning report into the failures at Tallaght Hospital identified numerous flaws. Chief among them were concerns regarding patient safety. According to the report, many staff at the hospital raised concerns, but these concerns were not acted upon. However, HIQA pulled no punches when it criticised some staff members’ attitude to patient safety.
“The cultural belief by individuals in any hospital that the routine practice of accommodating patients on trolleys in corridors is acceptable should not be tolerated. This is not acceptable for patients and the public and should cease,” it said.
The planned Patient Safety Authority (PSA) will be of major importance to the Government’s plans of reform, not just in hospitals but all over the service. Initially it was reported that the Authority would be launched sometime this summer, but it is now unclear when the PSA will be established and, crucially, what shape it will take. However, given that so much is dependent on the Authority’s success, it is perhaps understandable that the Department is keeping tight-lipped about the project.
The PSA was first mooted in last year’s Programme for Government. According to this document, the PSA will not only incorporate HIQA and its current functions, it will also act as the mechanism for the introduction of hospital trusts.
Earlier this year, Chief Medical Officer Dr Tony Holihan said the Authority would be the “patient’s friend”. Furthermore, it was reported in The Irish Times that the PSA would be able to impose financial penalties on hospitals which fail to “adequately” inform patients or their families about safety incidents. According to the article, the Authority could also introduce immunity against prosecution for doctors and hospitals which admit safety incidents.
However, the Department of Health says “it is not possible, at this stage, to indicate when a PSA would be established”.
“The Department is continuing to consider the options and possible organisational structures of the PSA, taking account of the international experience and the existing structures and organisations in the Irish system,” a spokesperson said.
HIQA, too, was unable to say what form the PSA would take. However, the Department did hint as to what we might expect from the PSA. As well as discussing the project with the HSE, HIQA, and the National Patient Safety Group, the Department has met with “experts from a number of countries including Canada, Denmark and Scotland”.
Denmark
The last 11 years has seen major changes in patient safety in Denmark, where patient power and patient safety have moved to the heart of the health system. Dr Beth Lilja, an obstetrician and Director of the Danish Society for Patient Safety, told the Medical In-de-pendent (MI) that a shocking statistic provided the catalyst for these changes.
“Eleven years ago a study was published that showed that almost one out of 10 patients was harmed due to care at the hospitals. That was the starting point for the Danish health system to start discussing patient safety. There was the recognition that we had safety problems and we needed to do something,” she explained.
However, according to the Danish Society for Patient Safety, these changes have not been met with resistance by healthcare professionals, as doctors, nurses and patients have benefited from them.
“What the stakeholders did was they got together and launched the Danish Society for Patient Safety. Instead of saying that the hospitals always blame the doctors, they didn’t do their jobs well etc, or the doctors and nurses blaming the hospital for not providing the right circumstances and so forth, all stakeholders said we all have to change, to do things differently from now on,” she explained.
In 2001 it was decided to integrate and systematise existing quality initiatives, creating the Danish Quality Model. As part of this, all hospitals were to be accredited according to general standards for “optimal patient treatment and flow”. Initially rolled-out at secondary level, the model was applied to primary care, municipal health service, and pharmacies. The organisation charged with creating and monitoring these standards is the Danish Institute for Quality and Accreditation in Healthcare.
According to the Danish Society of Patient Safety, the Institute judges health provider performance in three ways – a general category covering medication and information of patients, an organisational category covering hygiene and quality management, and a category on the treatment of specified diseases, for example, lung cancer and schizophrenia.
In the hope of creating more transparency, the data collated by the Danish model is made available to healthcare staff and the general public. The results are available on an integrated website for health matters in Denmark, www.sundhed.dk. Interestingly lay people can, by using a digital signature, view their own medical records and the prescription medication they have purchased.
In 2006, the country la-unched a website comparing the country’s hospitals. According to the Society, the site’s information must be easy to absorb and help the patient make a decision on which hospital to attend. As well as providing information on a hospital’s clinical quality – the number of complications, patient satisfaction rates etc – it also rates the hospital’s hygiene and organisational efficiency.
“On the website, patients can compare information on different hospitals. For a number of treatments it is possible to see how the different hospitals perform in relation to each other and compared to the national average, by choosing information on length of stay in hospitals, number of re-hospitalisations, waiting time for treatments, hygiene, etc,” the Society said.
The information on this website is supplemented by data gleaned from a nationwide patient survey, conducted every second year by the Danish municipalities and the Ministry of Health and Prevention. The survey not only compares hospitals but also their performance at medical specialities.
The information collected is also being used by patients to choose which hospitals they will attend, a factor which may prove crucial if and when Money Follows the Patient is in-troduced in Ireland.
ADR reporting
One of the biggest achievements of the Society was lobbying the Government to enshrine adverse reactions reporting in law.
In January 2004, the Danish parliament unanimously passed the Danish Act on Patient Safety, establishing a national reporting system for adverse events. The hope behind the system was that by collecting, analysing and communicating knowledge of adverse events, the number of adverse events in the healthcare system would be reduced.
“The message the law sent to the healthcare system was that you really, really need to know what goes on, and if you tell the truth, we promise that we’ll do something about it. We will tackle the circumstances which create these incidents,” said Dr Lilja.
In order to achieve this, a chain of reporting was introduced. However, reporting only goes halfway. Hospitals and the Department of Health must also act on adverse reporting. Once hospital owners receive reports they must act on them, analysing adverse events and reporting them to the National Board of Health. On the basis of this information, the National Board of Health is required to advise the healthcare system on the findings of these reports. Furthermore, all types of adverse events, including potential adverse events, occurring in hospitals, must be reported.
According to the Danish Society for Patient Safety, reporting is divided into the following categories:
Adverse drug events
Adverse events in connection with surgical or invasive procedures
Falls
Suicide and suicide attempts
Adverse events in connection with procedures of anaesthesia
Mistakes and confusion or miscommunication
Break of continuity
Heart failure or unexpected death
Other adverse events, which are at risk of reoccurring.
From a doctor’s point of view, one of the most interesting consequences of the law is that it requires healthcare professionals to report any adverse events they become aware of in connection with a patient’s treatment or stay in hospitals. According to the Act, the purpose of the reporting system is to learn, not punish. However, healthcare workers who do not report incidents are liable to disciplinary action and litigation.
“A front-line person who reports an adverse event cannot as a result of that report be subjected to investigation or disciplinary action from the employer, the Board of Health or the Court of Justice.”
Under the terms of the Act, individual healthcare workers do not have to give their names or any other identifiable information when reporting. However, it has been acknowledged that this anonymity makes the collection of additional information difficult for the investigating team. Furthermore, as the reporting system is strictly confidential, Denmark’s municipalities are forbidden from disclosing information about a reporting healthcare professional’s identity. This, however, has not led to an informant culture.
“I know in the UK they had a similar system and they had a problem getting the doctors involved. We haven’t had that problem. The number of reports that come from doctors equal the number that work in the system. Very often what people do is that they report about themselves, they don’t report about what someone else did,” said Dr Lilja.
According to the Society, the Act is working. A 2006 study into the reporting system revealed that the number of reports has almost tripled, going from 5,740 in 2004 to 15,556 in 2006.
As a consequence of the initiative’s success, it was expanded to the primary healthcare sector and the public during 2009. As a result of this expansion, the reporting system of adverse events now covers all sectors of the healthcare system.
However, an analysis of the system showed that not all adverse events are reported, with some healthcare workers unsure of the definition of an adverse event, while others cited lack of time and resources. Last year, around 90,000 incidents were reported, split relatively evenly between hospital and primary care sectors.
“In the early years, it (a patient safety incident) could be wrong side surgery and after a few of these incidents, it was decided that you had to put a cross on the side you intended to operate on, that the surgeon had to sign the side he/she was going to operate on,” explained Dr Lilja, adding that this has subsequently evolved into the WHO Safe Surgery Concept.
While the Society describes itself as a lobby group, its influence is considerable. A few years ago it forced the pharmaceutical industry to change the wording on 40 of its products. Furthermore, it can be engaged to help Denmark’s municipalities train staff.
“It’s a lobby group, but it’s a lobby group that is given tasks by different stakeholders for instance after the law was ex-tended to the municipalities. The municipalities have asked the Society to train the staff to understand and analyse these reports. So we put a training process in place and now train people from all over the country to take care of these issues,” said Dr Lilja.
One issue which Dr Lilja identified is a “real problem” is the reluctance to apologise for mistakes. This reluctance has led to the development of the ‘Say Sorry’ programme. The programme tries to break down the various reasons why staff sometimes feel unable to apologise, including pride and fear of legal action.
“One of the reasons for making an apology is for the patient to feel that providers acknowledge responsibility for the situation and for the patient. The patient needs to feel that in order to restore his or her trust in the providers, the organisation and the healthcare environment in which treatment of the patient has to continue,” a spokesperson for the programme said.
“Are patient’s really safer now? That’s really difficult to say because the problems in the healthcare system are changing all the time. Do we have a culture right now where if we implement something we know that it won’t harm patient safety? I’m not really sure that we can say that we’re there,” Dr Lilja said.
However, the Society has managed to put patient safety and reporting on the agenda and keep it there.
“Ten years ago nobody was talking about patient safety, now they’re talking about it. It’s on the agenda and it’s staying on the agenda,” said Dr Lilja.