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Patient Safety: A New Dawn Delayed?

‘Those who do not remember the past are condemned to repeat it.’ George Santayana, Spanish philosopher.

In 2016, I published an article in The Verdict entitled ‘Patient Safety: A New Dawn? My paper examined the Health Information & Patient Safety Bill which at the time I hoped would introduce a major package of patient safety reforms that represented ‘major changes for patient rights, safety and welfare in Ireland.’ Five years on, the key proposals are now subsumed into The Patient Safety (Notifiable Patient Safety Incidents) Bill 2019 which is currently before the third Dail Committee stage.

It would be unfair to suggest however that no progress has been made in the patient safety arena. The original proposals contained in the Bill for periodical payment orders have been introduced by way of the Civil Liability (Amendment) Act 2017 and important ancillary measures such as the establishment of the new National Patients Safety Office and Patient Safety Council have now been established and are operational.

So what happened in those intervening 5 years? In short, CervicalCheck and the power of the patient. The CervicalCheck controversy first emerged in 2018 with several brave women such as Vicki Phelan suing the HSE and certain laboratories after incorrect smear test results for cervical cancer. Increased scrutiny for other patient services such as BreastCheck and Bowel Check quickly followed. The Government scoping inquiry into the controversy led by Dr Gabriel Scally was scathing in its assessment and found that the principle of open disclosure, which requires a hospital or healthcare provide to provide an open, consistent approach to communicating with patients and their families when things go wrong, to be ‘deeply contradictory and unsatisfactory’. Since then, the Government has produced an implementation plan with 126 actions following on from Scally’s recommendations. The Government set up a statutory Tribunal of redress for CervicalCheck victims which unfortunately has been delayed by the current Covid-19 pandemic. Legal redress in the High Court has also been curtailed for all except terminally ill victims.

Open Disclosure & Mandatory Reporting

The Bill provides for mandatory open disclosure of serious patient safety incidents, and notification of reportable incidents. The legislation facilitates a consistent approach to communicating with patients and their families when things go wrong in healthcare and it restates the legal protections for healthcare professionals who engage in open disclosure. The emphasis in the Bill is commendable, to remove the blame culture and ensure when mistakes are made, they are openly communicated and addressed.

Importantly, the Bill closes the current loophole which did not include private hospitals under the regulatory remit of the Health Information and Quality Authority (HIQA). This means patients in both the public and private sectors will benefit equally in terms of ongoing monitoring and standard setting. If passed, the type of incidents covered by the new legislation will include wrong site surgery, patient deaths, a serious disability resulting from a medication or diagnostic error and errors with screening and maternal deaths.

It is proposed that health service providers will have to notify the State Claims Agency and either HIQA or the Mental Health Commission of any serious patient safety incidents. Any such incidents shall be reported as soon as the body becomes aware of the incident and, in any event, not later than 7 days after becoming so aware.

Other Jurisdictions

The policy of mandatory open disclosure set out in the Bill arguably goes further that the statutory duty of candour system introduced in the UK since 2014 following the public enquiry into Mid-Staffordshire NHS Foundation Trust. A lack of training for medical practitioners and staff in the UK prior to introduction of the legislation was thought to be one of the early learning lessons for Ireland.

In the US., research from Illinois and Michigan where a duty of candour system was introduced revealed that malpractice expenses and claims fell substantially. The pre-eminent US. expert on Patient Safety, Dr Timothy Montgomery, sums it up best when he states: “words and actions matter most.”

Black Box Thinking

So what is a black box and what is black box thinking? Matthew Syed argues that to learn from failures we need the right systems and mindset, exemplified by the aviation industry with its progressive approach to failures. The aviation sector has shifted from once been a safety laggard to now the safest form of travel through learning and an extreme focus on safety. An aircraft has two black boxes: one that records mechanical information and the other records cockpit pilot communications. In accident or emergency situations, these black boxes provide unbiased, holistic information to uncover truly what happened, to ensure that corrective measures can be taken to prevent future accidents. Pilots are encouraged and indeed rewarded for reporting mistakes. Accident insights are shared and forensically disseminated to facilitate a learning and continuous improvement culture. Syed argues with much credibility that such an approach can be applied in other industries or sectors including healthcare.

Impact of Covid-19

The current pandemic places our healthcare system under enormous strain for both healthcare professionals and patients alike. Unquestionably, our healthcare workers have been herculean in their efforts so far. However, when the pandemic subsides and stretched and fatigued resources, longer waiting lists and overcrowding returns, the potential for a patient safety time-bomb is real. In short, the enactment of the Patient Safety Bill 2019 must now be a priority against the ominous backdrop of Covid-19.


We must no longer seek to blame but to learn. The Patient Safety Bill, when finally enacted, will improve our healthcare system for patients and healthcare professionals. Open disclosure and mandatory reporting will bring Ireland into line with international best practice but also promote accountability, learning and confidence. Under the Bill, patients will become front and center in the Irish health system whilst also supporting our health professionals. Comprehensive training for medical professionals and staff together with robust enforcement regulation will be key elements to the Bill’s success. Covid-19 means that time is now very much of the essence. By adopting a Black Box Thinking approach, the Bill can mark a new era and major positive step forward to build a patient centered healthcare system. So yes a new dawn delayed but perhaps it just might be worthwhile after all.

If you need more information, please see www.sellors.ie or contact me by email at [email protected]


Published On: February 1, 2021

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