The government is considering changing the duty of candour law just three months after it came into effect, following a threat of judicial review by a patient charity.
The Department of Health is planning a public consultation on the duty of candour regulations this summer, including a proposal to bring the threshold for care provided by independent organisations into line with NHS trusts.
“We were forced into a situation where we had to threaten legal action to protect patients’ interests”
The decision follows a legal threat by charity Action Against Medical Accidents (AvMA), which has warned existing regulations mean some incidents in non-NHS trust settings, including general practice, would not be covered.
It claimed the introduction of different wording in the regulations was unlawful and had not been subject to proper public consultation.
AvMA chief executive Peter Walsh said the charity had been forced to take legal action after ministers refused to acknowledge the problem.
The candour law requires NHS organisations to identify when an incident that “could have resulted” in death, or severe or moderate harm has occurred, and to inform the patient, investigate and apologise. Guidance was issued to nurses and doctors about the new legal duty on Monday.
However, the regulations, which came into force on 1 April, only require non-NHS organisations to act when an incident “appears to have resulted in” harm.
The AvMA believes this narrower definition will lead to significant errors or mistakes with the potential to cause harm being treated differently depending on provider.
Failure to comply with the statutory duty of candour, a key recommendation of the Francis public inquiry, is a criminal offence and can carry a fine of up to £2,500. It is enforced by the Care Quality Commission.
A letter sent last week from the government’s legal department to lawyers working on behalf of AvMA states: “The secretary of state will use the consultation proposed for this summer to seek evidence and views in relation to the thresholds for the duty of candour requirement…
“The secretary of state proposes to seek views specifically on extending the threshold that applies to ‘health service bodies’ to all other providers registered with the [CQC],” said the letter seen by Nursing Times’ sister title Health Service Journal.
“We have always intended to keep the new duty under review”
Department of Health
The DH said the difference in the regulations was due to separate, pre-existing reporting requirements on non-NHS providers for care failures.
It said the current regulations were not unlawful and did not create a two-tier system.
But Mr Walsh said: “We were disappointed that the DH decided to create what is clearly an unsatisfactory two-tier duty of candour in spite of our advice to the contrary. We were forced into a situation where we had to threaten legal action to protect patients’ interests.”
He added: “We are grateful to Jeremy Hunt for eventually agreeing to do what we asked. It is vital that this potentially huge advance for patients’ rights and patient safety is got right.”
A DH spokeswoman, asked about the consultation plan, said: “We have always intended to keep the new duty under review, and will seek further views on how it is working.”