The Department of Health has confirmed that it will end the voluntary system for reporting patient safety incidents to the National Patient Safety Agency.
Instead, it will make it mandatory for all NHS trusts in England, including hospitals, primary care trusts, mental health services and ambulance services to report instances of harm or death to the NPSA.
Trusts must begin reporting incidents such as patients falling or being given the wrong medication to the NPSA from April 2010; the date from which they will have to register with the Care Quality Commission.
A DH spokesperson told E-health Insider: “We want to encourage trusts to start to apply for registration as early as possible in January and to work together with the CQC so that if any potential problems are identified, these can be addressed in time for registration on 1 April.”
The duty will also extend to doctors’ surgeries, dental practices, private healthcare providers and providers of adult social care by 2012.
The DH spokesperson added: “We want to ensure that the NHS is fully focused on meeting these essential safety and quality requirements. We will expect every trust in England to investigate all serious incidents and unexpected deaths and report them to the NPSA."
The House of Commons Health Committee heard calls for incident reporting to be made mandatory earlier this year, during its inquiry into patient safety.
The CQC’s predecessor, the Healthcare Commission, expressed concerns that incident reporting in many trusts is inadequate. It also noted that it was difficult to provide comparative information on trust performance because of under-reporting by some organisations.
The DH spokesperson said mandatory reporting would bring "consistency" to organisations that provide NHS care.
“Ninety per cent of NHS organisations already report patient safety incidents directly to NPSA, who are establishing an information-sharing protocol with the CQC to ensure that they receive the information required.”
Trusts that fail to comply with the new regulation could face warning notices, fines of £4,000 and the risk of prosecution.