Primary medical services – the CQC registration journey
The journey for CQC registration of NHS primary medical services (1) providers is well under way. Over the summer, CQC wrote to GP practices inviting them to set up their online accounts and start completing their application forms, and to book an application window in which to submit their completed forms.
Out of around 8,500 anticipated applicants, approximately 7,600 had set up their online accounts by the first week in September. There are four application windows running until the end of December 2012. Applicants in the first window will already have submitted their applications but any providers who have not yet set up their online account, and booked a window to submit their application, should now do so urgently. Failure to submit applications in time may result in providers not being registered by 1 April 2013; this would make their continued provision of services after that date a criminal offence which could be the subject of enforcement action by CQC.
The ease of the process?
Much work has been undertaken by CQC, in conjunction with GPs across the country, to simplify and test the application process. The application forms are submitted online and CQC anticipates that they should take providers less than 2 hours to complete. However, although completion of the form itself may be straight forward, the whole process of ensuring providers are properly prepared to make the application, and geared to deal with ongoing monitoring of compliance following the grant of registration, raises important questions for GPs to consider:
The identity of the applicant?
Firstly, providers need to identify the entity which carries on the primary medical services and, therefore, which needs to apply for registration. Although it may seem obvious, it is essential that it is the legal entity (whether an individual, partnership or organisation) that actually delivers the primary medical services which applies for registration; it is an offence if the entity providing the services is not registered even though a related entity (e.g. a sister company in a corporate group) is registered.
In most cases, it will be obvious which entity is carrying on the primary medical services and needs to apply for registration. However, there may be some practices where different services are delivered by different entities. For example:
There may be situations where NHS Primary Medical Services are delivered by a partnership, but where some of the partners have set up a separate entity (e.g. an LLP) to provide certain private services.
The CQC guidance also makes the point that, in the case of “federated practices”, it will be necessary to understand whether the federated practice constitutes a separate legal entity delivering all the services in its own right, or whether each of the individual practices retains responsibility and, therefore, need to submit their own applications for registration as separate providers.
‘Joint venture’ type situations require very careful consideration as although CQC’s guidance states that complex partnerships (e.g. comprising two companies which have formed a partnership) should register as “organisations”, it goes on to state that, in the case of joint ventures which are reflected in contracts or agreements – rather than in organisational form – each party may need to register separately.
Providers should, therefore, give very careful consideration to identifying the entity which should apply for registration and, if uncertainties remain in an individual case, they should discuss this with CQC or seek separate advice.
As part of the application for registration, applicants need to identify the location(s) at which they need to be registered. Again, it is important to identify locations correctly. Even if a provider is registered with CQC at certain locations, operation from a location which is not correctly identified is a breach of condition which, itself, is an offence and could result in enforcement action being taken.
Not all venues where GPs see patients (e.g. patients’ own homes or care homes) need to be treated as “locations” for the purposes of CQC registration. CQC only counts a place where people may be treated as a location “if the regulated activities provided [there] are managed independently”. Some complications may arise in relation to branch surgeries, but CQC’s guidance confirms that branch surgeries will only be treated as locations in their own right if they treat patients from a different registered patient list to that of the main surgery.
Even if particular premises operated by a provider do not require identification as a “location” in their own right, however, providers still need to ensure compliance with CQC’s standards at those premises and non-compliance could result in enforcement action being taken.
Which regulated activities to apply for?
Providers also need to give careful consideration to the regulated activities for which they wish to be registered. There are 15 different regulated activities. CQC’s guidance states that it is expected that all GPs will need to register for the activity of Treatment of disease, disorder and injury and that most GPs would also register for the activities of:
- Diagnostic and screening procedures
- Surgical procedures – but this is not required if practices only perform curettage, cautery or cryocautery of warts, verrucae or other skin lesions; and
- maternity and midwifery services.
In addition, many GPs are expected to register for the activity of Family planning services (but note this is only required if practices fit or remove IUCDs).
Although these are CQC’s expectations, the actual regulated activities any practice should apply for will depend upon the precise nature of services the practice provides. For instance, some practices may require registration for Transport services, triage and medical advice provided remotely.
Practices are therefore urged to give very careful consideration
to the regulated activities which apply to their services.
The definitions of some of the regulated activities are
complex. It is essential that practices apply for
registration for all regulated activities they carry on as it is an
offence to carry on any regulated activity without being registered
for that activity, even if the provider holds registrations for
other regulated activities.
The regulatory scheme requires there to be an individual in day to day charge of the regulated activities that can influence how those activities are delivered. This means that, whenever the provider is a partnership or an organisation, they need to identify someone to apply for registration as the registered manager. Individual providers also need to identify a separate person to apply for registration as registered manager if they, themselves, are not going to be in day to day charge of the regulated activities they deliver.
These individuals need to apply for registration in their own right, and once registered, they are jointly responsible, with the provider, for ensuring ongoing compliance with the requisite standards. In view of this responsibility, CQC’s guidance is that the person applying for registration as registered manager should hold a role that enables them to ensure that the standards are being met. In some cases the practice manager may have a sufficient position in the practice to be able to influence and ensure compliance with the standards. However, CQC state that, in most cases, they anticipate that a partner is the most appropriate person to apply for the role of registered manager.
There is no restriction on the number of regulated activities that an individual can be registered to manage. Equally, providers can appoint more than one registered manager where appropriate (e.g. in job share arrangements).
In those cases when the applicant is an organisation, the provider also needs to nominate an individual (“the nominated individual”) responsible for supervising the management of the regulated activities. If they wish, organisations can nominate different individuals for different regulated activities and CQC’s guidance confirms that the same person can take on the roles of both nominated individual and registered manager.
As part of making applications for registration, providers will need to declare whether or not they comply with each of the 16 key standards (ie those that relate most directly to quality and safety of care) within CQC’s Essential standards. Providers should also ensure they are putting systems in place to comply with the other standards which relate to more administrative aspects such as notifying events (including unexpected deaths) and absences to CQC and ensuring the nominated individual and registered manager have the appropriate skills, qualifications, and experience. Providers should also ensure that they have appropriate policies and procedures in place as well as an appropriate Statement of Purpose - a CQC required prospectus setting out prescribed details of the providers’ services.
In terms of the key standards, providers should have been gathering information to inform their declarations of compliance. As CQC’s guidance points out, providers may wish to use information they have already gathered, for instance for the Quality and Outcomes Framework, PCT contract monitoring, or as part of an RCGP practice accreditation scheme. In addition, providers’ declarations should be informed by feedback from patients about their experiences of care, for example via patient participation groups.
Capturing evidence of the ‘patient voice’ in this way is incredibly important for providers. The need for all providers (in all parts of the health economy) to be able to capture, and learn from, the ‘patient voice’ is likely to be one of the underlying themes of the Mid Staffordshire Inquiry when it reports early next year. Specifically in the context of CQC registration, taking appropriate steps to involve service users in decisions regarding the way in which services are run is, itself, one of the key standards (Outcome 1). More widely, however, the patient voice is one of the main sources of evidence which CQC itself will use in determining compliance with all the essential standards and it is imperative, therefore, that providers should be aware of, and respond to, those views.
Whilst there is no ‘ranking’ amongst the 16 key standards, we believe, particularly in the light of the Winterbourne View case, GPs should give particular prominence to ensuring compliance with Outcome 7 “Safeguarding people who use services from abuse”.
It is essential that, when making their declarations, providers are honest about any areas of non-compliance: making a false statement in an application is, itself, an offence.
In cases where providers identify non-compliance with a particular standard, they will need to submit an action plan along with their application for registration, setting out the steps they will take to ensure compliance and proposed timescales. CQC will consider the applications for registration alongside any other information it holds regarding the practices. Even where there is non-compliance with one or more standards, CQC will, in most cases, grant registration although it may impose compliance conditions requiring corrective action to be taken within certain timescales. Adopting the approach CQC took in the monitoring of other sectors brought in to registration, we presume that assessing compliance with such conditions imposed will be one of the first steps CQC takes as part of its ongoing monitoring of compliance post-registration.
Post-registration monitoring of compliance
Having been granted registration, providers will need to continue to comply with the essential standards. Providers, themselves, are required to put in place, and implement, appropriate systems to assess and monitor the quality of their services on an ongoing basis, as one of the key standards (Outcome 16). Although not obligatory, providers can use CQC’s Provider Compliance Assessment tool to assist them with this.
As with any services carrying on regulated activities, providers of Primary Medical Services will be subject to ongoing inspection by CQC after the grant of registration.
CQC have indicated that GP services will be inspected at least once every 2 years, although inspections may be carried out at any time if CQC becomes aware of concerns (e.g. as a result of a particular incident or information received from members of the public or staff whistle blowers). CQC has indicated that its inspections are likely to be announced, unless it is responding to concerns. Providers should be aware, however, that CQC has the power to carry out inspections on an unannounced basis, and is likely to do so when responding to concerns. Providers should also be aware that, at the time of inspection, inspectors have extremely wide ranging powers including the power to copy and seize relevant documents (including medical records), to inspect premises, and to interview patients (if they consent) and members of staff, in private.
Re-organisation of services
Matters of registration do not end with the initial grant of registration. Providers also need to consider the potential impacts of the registration system upon any subsequent restructuring of services. Depending upon the nature of the restructuring, applications for registration may be required by new entities, or, alternatively, existing registered providers may need to add new regulated activities and/or locations to their registrations prior to the restructuring of services taking effect. Providers will, therefore, need to keep these matters under close review whenever considering any subsequent service changes.
How can Bevan Brittan help?
Bevan Brittan has extensive experience of advising clients in connection with the implications of registration upon restructuring, the making of applications for registration, and compliance and enforcement issues.
If you require any advice in connection with any of these matters, please do not hesitate to contact a member of our team.
(1) For the purpose of this article we are referring to all NHS Primary Medical Services requiring registration with CQC as “Primary Medical Services”, regardless of whether they are delivered under GMS, PMS, APMS, or other contracts.