The dawn of a new regulatory era: The guidance arrives

Providers have been gearing up to a new regulatory regime for almost a year now and have been eased gently into the new era through an adapted system of rating and new style inspections which were implemented in October 2014. Providers will already be aware that their services will now be examined by CQC using five key questions: Is the service safe? Is the service effective? Is the service caring? Is the service responsive? and Is the service well-led? On 11 February 2015 the final piece of the puzzle fell into place when the Care Quality Commission published its new guidance for providers, plainly entitled: “Guidance for providers on meeting the regulations”. This new guidance will act as a guide to help providers ensure compliance with the two sets of regulations that underpin the regulatory regime:

  • Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (the new set of regulations containing the Fundamental Standards that will be in force from 1 April 2015, replacing the previous regulations, “the 2014 Regulations”)); and
  • Care Quality Commission (Registration) Regulations 2009 (Part 4) (these regulations have not changed)

Whilst the guidance itself isn’t legally binding, Regulation 21 of the 2014 Regulations states that registered persons “must have regard” to the new guidance. In addition, the Health and Social Care Act 2008 makes clear that CQC will take the guidance into account when deciding whether a provider is meeting the requirements of the regulations.  The importance of this new document can therefore not be overstated.

Providers will immediately notice a distinct difference between the Fundamental Standards and their predecessor the “Essential Standards”. In the Fundamental Standards each regulation is set out one by one. The new guidance then provides a summary of the regulation which is intended to make the legislation easier for the Provider to digest. The regulation is then broken down into components and for each the Provider is given guidance that CQC states it “must have regard to”. This is a much more formulaic and “checklist” way of ensuring that Providers achieve compliance. On the face of it the new guidance is easier to follow and reads like a rule book. The language differs from that in the Essential Standards. In light of the recommendations of the Francis Inquiry, gentle prompts have been replaced by a litany of “Musts” and “Shoulds” – it is clear that CQC intend to take a much harder line with Providers and is determined to show the public and the press that it has teeth and it isn’t afraid to use them!

In holding Providers to account, CQC have developed a new Enforcement Policy that will operate alongside the Fundamental Standards. CQC’s new powers are significant. In line with the new legislation the regulator will be able to directly prosecute Providers for breaching some regulations without first issuing a Warning Notice (see Regulations 11, 16 (3), 17 (3), 20 (2) (a), 20 (3), 20A). Providers will be able to defend themselves against these offences where they are able to show that they took all reasonable steps and acted with all due diligence. In addition to these offences, a provider could also be prosecuted under Regulations 12, 13 and 14 if the breach results in service users being exposed to harm or significant risk of such harm.

In addition to the new Fundamental Standards and a beefed up Enforcement Policy, a new Memorandum of Understanding (“MOU”) has been created between CQC, the Health and Safety Executive and Local Authorities in England. The MOU will take effect from 1 April 2015, the same date as the new regulations, and states that the CQC will assume responsibility for all safety and quality of treatment and care matters involving patients and service users in receipt of a health or adult social care service from a provider registered with CQC, including health and safety issues. The enforcement of health and safety in relation to staff and members of the public will remain the responsibility of councils (in regard to residential homes) and the HSE (in regard to nursing homes and hospitals). This adds a new layer of responsibility to CQC’s existing duties and means that CQC will be responsible for deciding whether regulatory action is needed for health and safety incidents that involve people who are cared for by registered providers. This could result in them prosecuting a Provider and imposing a significant fine.

CQC has developed a new “structured decision process” that it believes will help it to decide where enforcement action should be taken, which enforcement powers should be used and how it will approach this action. The new Enforcement Policy states as one of its main purposes “Being on the side of the people who use services”. Whilst it is obvious that vulnerable people require protection from the regulator, it is again the Provider that is set as the default “bad guy”. There are poor Providers out there, however, the regulator has made it clear that it is its function to weed out the bad rather than celebrate the good.

One element of the Enforcement Policy will offer a glimmer of hope to Providers and that is CQC’s aim to only take action that they deem to be “proportionate”. Granted, we have heard this before and Providers on the receiving end of such action are unlikely to agree that CQC is a proportionate regulator, however, this assurance should be relied upon in any representations. CQC also reassures Providers that “if the provider is able to improve the service on their own and the risks to people who use services are not immediate, we will generally work with them to improve standards rather than taking enforcement action”.  This sounds positive, but will it work in practice, especially when CQC’s main purpose now appears to be to punish and expose? Providers will remain sceptical.

The Francis Inquiry left CQC battered, bruised and with a point to prove. The public perception of the regulator was at an all-time low and confidence had to be restored. The consequence is a new set of hard-hitting regulations, tougher enforcement powers and the risk that a potentially trigger happy CQC will take no prisoners in a bid to prove a point.

Providers should ensure that they are familiar with the 2014 Regulations, the new guidance and the new Enforcement Policy. If CQC takes action that is unnecessarily heavy handed then Providers should consider taking legal advice on their position and how they can make sure they’re not a statistic designed to help CQC win back the public’s trust.

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