By Nick Triggle
Health reporter, BBC News
NHS trusts now need licences to keep working in the health service
A dozen NHS trusts in England - meant to be among the elite - have been told to improve or face tough sanctions.
All 378 trusts need a licence from the Care Quality Commission to work in the NHS under a new regime from 1 April.
The regulator attached conditions to 22 - 12 of which were foundation trusts - meaning they could face fines or suspension if they do not act.
Patients' groups said the number of foundation trusts in the group raised questions about the elite status.
Foundation trusts are supposed to be the top-performing organisations in the health service.
This is the first time trusts have had to gain a licence
It was piloted last year for infection control, but 1 April marks the start of the process in full
Trusts have been assessed against 16 standards
Having conditions attached means they will face regular assessments
If they do not meet the improvement deadlines the CQC has tough sanctions available
These include fines, prosecution or suspending certain services. Previous regulators have only been able to urge ministers to take action
They have to show they are financially viable and provide good services and in return they are given more freedom to innovate and run their own affairs.
Nearly 130 trusts have been given foundation trust status since the scheme was launched in 2004.
But confidence in the process has already been dented by scandals at the Mid Staffordshire and Basildon and Thurrock trusts, both of which have foundation status.
These two organisations have faced heavy criticism in the past year with Mid Staffordshire even undergoing an independent inquiry.
Both are among the trusts told to improve under the new registration system.
Katherine Murphy, director of the Patients Association, said: "Foundation trusts are meant to be the premier league of the NHS. But these results call into question the assessment process and actual status.
"We believe there is too much emphasis placed on financial performance rather than quality of care. The foundation trust regime needs looking into."
The CQC also said it had concerns about performance at 40% of trusts - although they were not a serious enough risk to patient care to warrant conditions being attached to their licences.
The regulator made the announcement after assessing trusts responsible for running hospitals, ambulances and mental health units against 16 core standards.
It relied on inspections, performance data and staff and patient surveys.
Some of those with conditions have to act immediately, while others have several months to address the issues.
Care and welfare of patients and staffing levels and knowledge were the most common reasons for an organisation having conditions attached.
CQC chief executive Cynthia Bower said: "This makes clear that some trusts must do more to make sure people experience effective, safe and appropriate care."
A spokesman for Monitor, which is in charge of the foundation trust process, said the results were "disappointing".
He added: "We'll be working with the CQC to see if there are any patterns or lessons to learn from the conditions they have applied."
- The foundation trusts with conditions imposed are Basildon and Thurrock University Hospitals NHS Foundation Trust, Heart of England NHS Foundation Trust, Heatherwood and Wexham Park Hospitals NHS Foundation Trust, Medway NHS Foundation Trust, Peterborough and Stamford Hospitals NHS Foundation Trust, Sherwood Forest Hospitals NHS Foundation Trust, Tameside Hospital NHS Foundation Trust, Luton and Dunstable Hospital NHS Foundation Trust, Northern Lincolnshire and Goole Hospitals NHS Foundation Trust, Surrey and Borders Partnership NHS Foundation Trust, Mid Staffordshire NHS Foundation Trust and Milton Keynes Hospital NHS Foundation Trust.
- The other trusts with conditions are Barking, Havering and Redbridge University Hospitals NHS Trust, East and North Hertfordshire Primary Care Trust, East Riding of Yorkshire Primary Care Trust, Devon Partnership NHS Trust, Kent and Medway NHS and Social Care Partnership Trust, Mid Essex Hospital Services NHS Trust, Scarborough and North East Yorkshire Healthcare NHS Trust, Surrey and Sussex Healthcare NHS Trust, West London Mental Health NHS Trust, and Yorkshire Ambulance Service NHS Trust.