With the launch of the Care Quality Commission, GPs will be directly regulated for the first time. The government concedes that the number of reported patient safety incidents is too low, so how closely should the new inspector look, asks Charlotte Santry

Despite 90 per cent of patient contact with the NHS being with primary care, regulators have traditionally focused on the more overtly high risk services in hospitals. This is soon to change.

Under proposals set out in a Department of Health consultation published last week, primary care services, including those provided by GP and dental practices, would be included in the mainstream regulation regime for the first time.

This means that by 2011, practices would have to register with the new health and social care watchdog, the Care Quality Commission, active from next April, and be subject to spot checks. To register, they will need to demonstrate compliance with a new set of standards, also being consulted on.

As the new commission will have much greater powers than the organisations it replaces - the Healthcare Commission, Commission for Social Care Inspection and Mental Health Act Commission - substandard GP practices could be fined or shut down.

Doctors have cautiously welcomed the plans. NHS Alliance chair Michael Dixon says it is “rather extraordinary” that GPs have not been directly regulated to date. But he warns: “The weight of regulation needs to be in proportion to the size of the organisation being regulated. If we make it an enormous imposition for small practices, we’re actually driving them out at a time when we know patients, public and staff say they prefer smaller practices to larger ones.” He also argues for a gradual introduction, “not 1,000 forms on day one”.

Royal College of GPs chair Steve Field agrees that general practice should register with the commission. However, he is keen for the profession to retain an element of self-regulation.

Do the minimum

The college is piloting an accreditation scheme in 46 practices across four primary care trusts in England. Due to end in December, it assesses areas such as health and safety, the practice environment and access to care.

“We believe a system of professional accreditation is better than the micromanagement that the regulator might impose,” Professor Field says. He argues that if the pilot scheme is a success and can be applied universally, practices should be exempt from regulators’ inspections. “If we have professionally led accountability, the doctors and nurses will want to perform better, but when you have a regulation system, people just do the minimum,” he says.

However, PCT Network director David Stout sees the college’s scheme as “more about recognising progress beyond the registration standards” than an alternative to mainstream regulation which would provide a baseline.

The DH paper A Consultation on the Framework for the Registration of Health and Adult Social Care Providerscertainly seems to be pushing for a more standardised system. It says: “It is important that patients have the same degree of regulatory protection - regardless of the care setting - whenever these services pose a potentially significant risk.

“Although GPs and other healthcare professionals are individually registered by their professional governing bodies, this may not be enough to protect people in the future, as services in primary care become ever more complex.”

It is difficult to assess how much of a safety risk primary medical care poses, as GP practices are not contractually required to report patient safety incidents to the National Patient Safety Agency.

A public accounts committee report published last September noted serious shortcomings in the ability of practices and PCTs to identify doctors whose poor performance was putting patients at risk.

In 2006-07, 2,410 general practice incidents were reported to the NPSA, the most common being medication (25 per cent), followed by consent/confidentiality/communication (13 per cent) and access/transfer/discharge (12 per cent). The DH consultation acknowledges it “strongly suspected” these figures are “artificially low”. It is hoped a registration system will provide more realistic safety indicators, while improving clinical governance so that the frequency of incidents will fall.

An impact assessment accompanying the consultation predicts that improved standards resulting from registration would result in 30,000 fewer emergency admissions each year, saving£78m. But will regulation really drive up standards of safety and care among providers or simply guarantee that they manage the basics?

“I don’t think it will improve the standards of practice but it will guarantee a minimum standard,” says Dr Dixon. “The important thing is it will get those practices that are underperforming. Most PCTs would say they have one or two in their patch, especially in inner city areas.”

The ability and willingness of PCTs to closely monitor GP practices appears, anecdotally, to vary significantly. “Some have been reported to have been rather heavy handed and others are completely indifferent to the affairs of individual doctors,” Professor Field says. “Inspections aren’t being carried out in some areas. We don’t want standards that vary, or a punitive system.”

Light touch

One problem is that the powers granted to PCTs under the general medical services contract to deal with problems are weak. PCTs are required to make an annual visit to practices as part of the quality and outcomes framework but often find it difficult to respond robustly when problems are identified. “Using the contract as a device [to deal with problem GP practices] is limited,” Mr Stout says.

The contract was always meant to be “light touch”, says Peter Reader, chair of the NHS Alliance professional executive committee network and medical director at Islington PCT. This has led to practices in some areas getting away with creating a “smokescreen” by having relevant paperwork in place.

Inspections carried out in Islington have revealed major variations, “from practices that have everything in place to practices really struggling with new management structures and moving from the old world of medicine to evidence-based and proactive care”, he says.

“One of the frustrations that many PCTs have found is that a lot of Healthcare Commission work is hugely secondary care focused and there did seem to be a blind spot as to how these things related to primary care. That’s improved but there’s still a long way to go,” Dr Reader adds.

He calls for quality standards to be much more clearly set out and monitored in primary care on a national level.

However, the hands-off approach is unlikely to change drastically. “We’re not saying the new regulator should replace the visiting role of the PCT,” says Amanda Hutchinson, head of the long-term conditions and older people strategy team at the Healthcare Commission.

“If the systems are in there, we won’t be looking to do a rolling programme of inspections of GP practices.”

The Healthcare Commission has designed a methodology for analysing performance that clusters practices according to the number of full-time equivalent partners, local demographic structure and index of multiple deprivation. It hopes this will enable its successor to target inspections by focusing on the most risky practices.

The Care Quality Commission should take a “reactive approach” to primary care based on surveillance data, says Alex Baylis, independent healthcare strategy lead at the Healthcare Commission. “It needs to be about the idea of a safety net for assuring the public and providing PCTs with a back-up if required.”

Overly bureaucratic

The safety net’s robustness will depend on the registration requirements. The DH has come up with a set of 18 broad standards that will apply to health and social care services. These will replace the current core standards for better health, which apply to NHS trusts, and the national minimum standards and regulations, which apply to social care and independent sector health providers. They include areas such as infection control and having sufficient numbers of competent staff.

It is felt the current standards focus on processes rather than outcomes and can be overly bureaucratic.

Few people were willing to comment on the specific wording of the proposed standards while consultation is continuing, although the fact that there is a single set of standards may alarm CSCI, which has previously issued warnings about the difficulties of applying the same tests to large acute trusts and small care homes.

A universal set of standards is aimed at ironing out inconsistencies such as the requirement for independent providers to register with the Healthcare Commission while NHS services are performance managed by PCTs, a disparity that some feared could lead to problems under competition law. It has also given independent sector providers an incentive to obtain NHS contracts that take up only a small proportion of their time in order to avoid regulatory scrutiny, according to a discussion paper published a fortnight ago by the Healthcare Commission.

The registration requirements will be supplemented by “compliance criteria” to be developed by the new commission, tailored to particular types of activities.

Dr Rory McCrea, chair of alternative primary care providers ChilversMcCrea, says some areas, such as medicines management, will need to be worded “entirely differently” for primary and secondary care.

Finding a balance between rolling out the standards to services with little history of regulation, while ensuring they are malleable enough to work in different settings, could well be key to the success of the entire scheme.

Services to require registration: the proposals

  • Personal care

  • Accommodation, together with personal or nursing care

  • Accommodation, together with intensive treatments

  • Palliative care

  • Surgical services

  • Dental services

  • Diagnostic services

  • Specialist medical services

  • Maternity services - obstetrics and gynaecology

  • Emergency and urgent care

  • Termination of pregnancy

  • Specialist mental health services

  • Detention or deprivation of liberty for care or treatment

  • Nursing care

  • Prescribing, administration, sale and supply of medicines

  • Therapies

  • Telemedicine and telecare (not NHS Direct)

  • Primary medical services

Proposed topics for registration requirements

  • Making sure people get the care and treatment that meet their needs safely and effectively

  • Safeguarding people when they are vulnerable

  • Managing cleanliness, hygiene and infection control

  • Managing medicines safely

  • Making sure people get the nourishment they need

  • Making sure people get care and treatment in safe, suitable places which support their independence, privacy and personal dignity

  • Using equipment that is safe and suitable for people’s care and treatment and supports their independence, privacy and personal dignity

  • Involving people in making informed decisions about their care and treatment

  • Getting people’s ongoing agreement to care and treatment

  • Responding to people’s comments and complaints

  • Supporting people to be independent

  • Respecting people and their families and carers

  • Having arrangements for risk management, quality assurance and clinical governance

  • Keeping records of the provision of care and treatment

  • Checking that workers are safe and competent to give people the care and treatment they need

  • Having enough competent staff to give people the care and treatment they need

  • Supporting workers to give people the care and treatment they need

  • Working effectively with other services

For more analysis, see GPs in the dock: case for the defence