New legal protections for clinical audit will not facilitate an Irish audit of surgical mortality, the Medical Independent can report.
The aim of the proposed audit was to improve practice and reduce surgical mortality through systematic independent peer review. It was first planned by the National Office of Clinical Audit (NOCA) over 10 years ago. However, the provisions in the Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023 do not cover the peer review processes required.
“While NOCA welcomes the Act, concerns remain about it inhibiting learning and improvement-based practices involving peer review which falls outside the definition of clinical audit. Therefore, we are currently considering other national clinical audits in surgery,” said a NOCA spokesperson.
NOCA had requested that the definition of clinical audit should align with the broader description used in the HSE National Review of Clinical Audit (2019).
“We also requested that other recognised quality improvement activities should be given protection, not just clinical audit, eg, mortality and morbidity reviews, root cause analysis, peer review, confidential enquiries.”
In 2008, the Commission on Patient Safety and Quality Assurance recommended legislation to give exemption from Freedom of Information law and grant legal protection from disclosure to data related to patient safety and quality improvement, which was collected and analysed for internal use or shared with others solely to improve safety and quality.
In the new Act, clinical audit is described as a clinically led quality improvement process for the purpose of improving patient care and outcomes through the systematic review of care against explicit clinical standards or clinical guidelines. A number of legal protections apply to information or data submitted as part of clinical audit activities.
A Department of Health spokesperson said the provisions represent “significant legal protection to enable an environment which is supportive of a wide range of quality assurance activities”.
“It should be noted that clinicians are already required to participate in clinical audit processes. This provision provides a new level of protection to clinicians which was not previously available to them.”
The definition of clinical audit in the Act was developed “through extensive engagements with stakeholders and experts in clinical audit”.
An extension of legal protections beyond clinical audit to cover wider quality improvement activities raised policy and legal issues, according to the Department.
“From a policy perspective, without a clear and discrete definition of quality improvement activities, concerns could arise for the public about too wide an application of extensive legal protections and their alignment with the principle and spirit of open disclosure.”