While the year has been dominated by the Covid 19 pandemic it should not be forgotten that two major reports into medical governance were published this year. To quote the authors of those reports:
‘This report is not simply a story about a rogue surgeon…it is far worse. It is the story of a healthcare system which proved itself dysfunctional at almost every level when it came to keeping patients safe…’ The Rt Revd Graham James, Chair of the Paterson Inquiry.
‘Systemic failures, spanning the breadth of the healthcare system and ‘institutional resistance to patient safety.’ Baroness Julia Cumberledge, Chair of the Independent Medicines and Medical Devices Safety Review (‘IMMDSR’).
While there were two reports, one about a rogue surgeon, the other about safety issues arising from Primodos, Sodium Valproate and vaginal mesh, there was one common theme: more work needs to be done to learn from harm to prevent recurrence and improve patient safety.
The reports identify similar issues as requiring action for improvement.
To facilitate clearer understanding of treatment options risks and benefits, the Paterson Inquiry Report recommended that consultation letters are sent to patients, copied to the referring GP, rather than the other way round as at present. It also recommended a mandatory period of reflection for surgical procedures, a recommendation echoed in the wider context in the IMMDSR report First Do No Harm (‘FDNH’).
Although consent should be dealt with in a face-to-face discussion, the consultation letter is important as it provides the patient (and GP) with an information source about the discussion and an opportunity to reflect and ask questions. It is integral to the medical notes and a crucial record of the consent process for patient and doctor. Following the Supreme Court decision in Montgomery (2015) it is essential that patients are provided with all treatment options (including conservative treatment or doing nothing) and details of the risks material to the patient.
Both Reports recommend clearer signposting of how to complain. The Paterson report considered that the means to escalate a complaint to an independent body should be communicated more effectively and that all private patients should have the right to ‘mandatory independent resolution’ of their complaint. FDNH recommends that patterns and trends should be identified and shared.
Complaints are one of the earliest warning signs that care is unsafe and they should be analysed regularly to spot trends to prevent future harm. It is essential that complaints are triangulated against claims as well as incident reporting to extract the maximum learning.
Duty of candour
FDNH noted that a culture of denial, fear of blame and absence of accountability still exists. The Paterson Inquiry found that apologising was conflated with admitting legal liability despite the duty of candour and guidance on saying sorry.
An apology is not an admission of liability and should be given at an early stage if things go wrong. You should also discuss this with your insurer ideally before any formal written apology is given so as not to prejudice your position in any way.
Performance and regulation
A common theme can be identified around sharing concerns. Specifics include a recommendation that suspension should follow a hospital investigation into a healthcare professional’s behaviour, if there is a perceived risk to patient safety. Concerns should be communicated to any other provider where he / she works. Failure to follow guidance which adversely impacts on patient safety should be reported by colleagues and the GMC alerted.
In the post – Paterson era it is likely that there will be a greater level of communication and inquiry between health providers as well as between providers and the surgeons they have operating at their hospital to ensure all relevant information regarding patient safety is known and shared.
Quality and assurance
FDNH considered that systems for clinical audit and quality assurance should be strengthened. Better governance arrangements around conflicts of interest (individuals and organisations) were needed as well.
The Paterson Inquiry Report recommended a central register of the location of consultant practising privileges and other data such as how frequently and recently a procedure has been carried out. Its use by NHS and independent sector managers and healthcare professionals should be mandatory.
All healthcare organisations should ensure that their systems for clinical audit, quality assurance and managing conflicts of interest are robust. Work on bringing consultants’ performance data across the two sectors into line has started with a consultation on the Acute Data Alignment Programme.
Culture in the health sector has changed in recent years, but it appears that there is still some way to go. Healthcare practitioners and their organisations need to ensure that they comply with the duty of candour, obtain fully informed consent and have robust governance processes in place. Instilling a learning culture in all healthcare organisations is key to preventing future harm. The government’s response to both reports is awaited but it is likely that in 2021 they will address this further.