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The Health Service Executive (HSE)’s proposed definition of a ‘patient safety incident’ and ‘harm’ are too broad and could risk undermining the concept of open disclosure, according to the Medical Protection Society (MPS). In its response to the consultation on HSE’s Open Disclosure Policy Revision, MPS said the broad definitions as outlined in the HSE’s draft policy would lead to any side-effect of investigation or treatment, or any unfavourable outcome of an illness, to be categorised as a harm or a patient safety incident, and would therefore be subject to the HSE Open Disclosure Policy.

MPS, which supports 16,000 healthcare professionals in Ireland, said this would lead to a significant and unnecessary increase in the amount of work for healthcare professionals and providers, and called on HSE to ensure the premise of a patient safety incident or harm for open disclosure purposes is instead based on error and ‘near misses’.

Dr Rob Hendry, Medical Director at MPS, said: “A mandatory open disclosure process which relies upon broad definitions of a patient safety incident or harm would be another bureaucratic endeavour adding to the everincreasing workload and pressure for doctors. If a patient’s condition fails to improve or continues to deteriorate despite the best care and treatment, then this should not be categorised as a ‘patient safety incident’ or ‘harm’.

“Similarly, many patients will experience some degree of discomfort as a side-effect of surgery, and some patients who are prescribed medicines may experience unpleasant side-effects. By the proposed definitions in the HSE’s draft policy, this could be categorised as harm or a patient safety incident, and could therefore be subject to the HSE Open Disclosure Policy.

“Applying the open disclosure policy to clinical outcomes such as these is illogical and undermines the concept of open disclosure. It could also cause confusion for patients who have accepted the risks of treatment in return for its potential benefits, following discussion with the clinician prior to a treatment or procedure. Patients understand that there are rarely any guarantees when it comes to medical care and treatment, and illnesses can take unpredictable turns.

“We believe there is a strong argument for the definitions to be based on errors and ‘near misses’, so these incidents can be openly discussed and learnt from, with patients receiving an appropriate explanation and apology. “When an adverse outcome, such as a sideeffect of treatment or the natural progression of an illness, occurs, clinicians should of course engage in a dialogue with the patient. This is an established component of good medical practice and does not require categorisation as a patient safety incident under the HSE Open Disclosure Policy.”

The HSE also suggested that when a patient declines the process of open disclosure, the patient can re-open the process within five years of refusal. MPS said it considers that the five-year period for re-opening of the process of open disclosure to be too long, given the possibility that the senior clinician may have retired or changed employment. MPS said it believes that the duration of re-opening the process of open disclosure should be reduced to 12 months.