The new Fundamental standards have come about as a result of the failings in both the health and social care. The health social care act 2008 had for the first time combined the function of the regulator for health care and social care into one. This was presumably for economic reasons. The regulator Care quality commission set about re registering all services and at the same time it let go of a number of experienced inspectors and replaced them with generalist. Following the abuse of winterbourne view care home and The Mid Staffordshire NHS Foundation Trust abuse. The government set up any enquiry led by Robert Francis.
Francis in his summary wrote:
The system of regulation which the Health care commission (HCC ) was given to run failed to prevent or detect over three-quarters of its lifetime what has been described as the biggest scandal in NHS history.
He went on to highlight the CQC internal environment as part of the causes of its failure:
While it is clear that the CQC aspires to be an organisation which welcomes constructive comment, the Inquiry has seen evidence of a defensive institutional instinct to attack those who criticise it, however honestly and reasonably those criticisms are made. A healthcare regulator needs to be a model of openness and therefore welcome constructive criticism.
He stated that the regulator should not be responsible for ensuring improvement but rather to ensure compliance with fundamental standards. He stated that the role of the regulator CQC should be to ensure compliance in regards to governance and financial sustainability.
Fundamental standards according to Robert Francis should be clear and be able to be understood and accepted by providers, patients and the public. While he understood that they required government approval in the form of regulations. He states that they should not be imposed as top down standards but through consultations to ensure that staff that work with residents have full confidence in them such as nurses and doctors. Previously guidance and regulations were not always well synchronized and it was not clear from the guidance if breaches of the regulations had occurred. The new guidance will seek to improve this by focusing the regulations more closely on outcomes, rather than on the steps that must be taken to achieve that outcome, and by clearly specifying the offences.[i]
Robert Francis stipulated that as the fundamental standards and their associated regulations will be simple and easily understood and without ambiguity, failure to comply would lead to harsher penalties for the provider.
Francis proposed that CQC as a regulator will be given powers to act immediately without notification if it is in the patient interest even while investigating. Noncompliance with the fundamental standards that potentially seriously endangers patient’s health CQC will be given powers to prosecute as criminal offence.
New inspection methodology
From this has emerges a new methodology for inspection. Inspection are to concentrate not as much on breach of regulation but rather on these specific questions.
• Is it safe?
• Is it effective?
• Is it responsive?
• Is it caring?
• Is it well-led?
The approach that CQC took to establish areas that required examination of a service when using the five questions were from an earlier consultation. A number of questions were put forward and consulted upon. From the question asked a number of areas were seen as relevant and fit to be included in the fundamental standards and these included the following.
• I will be cared for in a clean environment.
• I will be protected from abuse and discrimination.
• I will be protected from harm during my care and treatment.
• I will be given pain relief or other prescribed medication when I need it.
• When I am discharged, my on-going care will have been organised properly first.
• I will be helped to use the toilet and to wash when I need it.
• I will be given enough food and drink and helped to eat and drink if I need it.
• If I complain about my care, I will be listened to and not victimised as a result.
• I will not be held against my will, coerced or denied care and treatment without my consent or the proper legal authority.
CQC have legal obligation to publish and disseminate information about the regulations Health social care Act 2008 under section 23. However, from examination of the current guidance there appears to be little change in the style and description of the way CQC provide guidance. There remains a great deal of ambiguity and subjectivity in regards to the interpretation of the regulations. There still time for improvement as the regulations are unlikely to come in to force until the April 2015
Duty of Candour regulation 20
It has been felt that poor care has been known in a number of services and there has been a failure to report this to the authorities. Parliamentary select committee -After Francis: making a difference – Health Committee stated[ii]:
The Committee believes that Trusts and other care providers have a fundamental duty to establish an environment where concerns about patient safety and care quality raised by clinicians or managers are addressed openly and directly.
The regulation impose a duty on the provider to be honest and open and to notify the relevant body of any incident with all the facts. CQC state this includes providing a truthful account of the incident, providing an explanation in writing about the enquiries and investigations that will be undertaken and offering an apology in writing. If CQC believe that the provider has not been fully truthful and transparent in regards to an incident or has not made and appropriate apology, then CQC can prosecute, without issuing a warning notice
Enforcement Powers of CQC
The first major change is that CQC will be given powers to prosecute without first issuing a warning notice. Secondly and perhaps more ominous CQC can use its enforcement powers to hold certain individuals within providers to account. Those individuals are any director, manager or secretary of a body corporate (or a person purporting to act in that capacity), or an officer of an unincorporated association or member of its governing body. Under section 5 of the new regulations it makes it clear that individuals who have authority in organisations that deliver care are responsible for the overall quality and safety of that care can be held accountable. The regulation and guidance from CQC states that the provider must ensure that its directors have the necessary authority and are fit for the role (See regulation 19 Fit and proper workers employed). While currently CQC cannot directly prosecute under this regulation they can related breaches in other areas and related to regulation 5.
The regulation that CQC can prosecute without first serving a warning notice are as those in italics:
Dignity and respect
Need for consent*
Safe care and treatment*
Safeguarding service users from abuse*
Meeting nutritional needs*
Cleanliness, safety and suitability of premises and equipment*
Receiving and acting on complaints
Fit and proper persons employed
Duty of candour*
CQC have the powers to impose through civil action in noncompliance of regulations that cannot be prosecuted by imposing conditions such suspending or cancelling registration
CQC have cautioned providers in their guidance [iii] that serious failure to meet some of those requirements which are not offences, such as person-centred care and dignity and respect, would be likely to result in a breach of other requirements which are offences, such as abuse or safe care and treatment, and could therefore result in a prosecution via that route.
[i] Introducing Fundamental Standards Consultation on proposals to change CQC registration regulations. DEPT of Health. January 2014
[ii] After FrancisHealth comitteehttp://www.publications.parliament.uk/pa/cm201314/cmselect/cmhealth/657/65705.htm
[iii]http://www.cqc.org.uk/sites/default/files/20140725_fundamental_standards_and_enforcement_consultation_final.pdf – p20