Openness and transparency in the NHS : the new duty of candour and fit and proper person test explained
The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (Regulations), Regulation 5 and 20 , which impose a fit and proper person’s test and duty of candour on health service bodies (i.e. NHS trusts, NHS foundation trusts and any special health authorities carrying on a regulated activity) came into force last week (27 November 2014). Regulated activities are defined in Schedule 1 to the Regulations.
The Regulations are regarded as an important step in developing a more honest and open culture in the NHS. Regulations 5 and 20 were introduced in direct response to the failings at Winterbourne View Hospital and the Francis Inquiry report into Mid Staffordshire NHS Foundation Trust, both of which recommended the imposition of such new duties and requirements on the health service bodies.
Who does this affect?
NHS bodies in England.
For now, Regulation 5 and 20 apply only to health service bodies but the duties and requirements contained within them will be of interest to other providers, as the Government intends to extend the Regulations to all providers in England from 1 April 2015.
Regulation 5 – Fit and proper person’s test
Regulation 5 intends to ensure that all board members are fit and proper to be responsible for the overall quality and safety of care and for making sure that the requirements of the Regulations are met. It seeks to ensure that individuals in a position of control within health service bodies are physically and mentally fit in order to sustain the management function. They must also be of a good character and have the necessary qualifications, skills, competence and experience for the position for which they are employed.
Further, Regulation 5 also bars individuals from board-level appointments who:
- are prevented from holding office (such as those under a director’s disqualification order);
- have been responsible for, been privy to, contributed to or facilitated any serious misconduct (e.g. assault, fraud and theft) or mismanagement (e.g. mismanaging funds or not following recognised care quality practice and processes) in the course of carrying on a regulated activity, or providing a service elsewhere which, if provided in England, would be a regulated activity; or
- meet any of the “unfit” criteria (see Part 1 of Schedule 4 to the Regulations).
The health service body must also consider the matter listed in Part 2 of Schedule 4 to the Regulations in assessing a director’s character.
Ultimate responsibility lies with the chair of the relevant health service body to discharge the requirement placed on the health service body that all board members meet the fitness test and do not meet any of the "unfit" criteria. Executive and non-executive, permanent, interim, and associate members of the board (collectively, "directors"), irrespective of their voting rights, must be fit and proper persons. It is a breach of the Regulations to have in place someone who does not satisfy the fit and proper person test.
In order to comply with Regulation 5, the health service body must also have processes in place of assure itself that the fitness criteria are met and that none of the unfitness criteria apply, which could include investigating allegations and carrying out independent enquiries. The health service body must regularly review directors’ fitness to ensure that they remain fit for their roles and must investigate any concerns about directors’ fitness.
The chair of the health service body will be required by the Care Quality Commission (CQC) to self-declare that appropriate checks have been undertaken in reaching a judgment that all directors are deemed to be fit and none meet any of the unfit criteria. The CQC will only follow this up where it has concerns about the recruitment process. Alternatively, if the health service body is unable to demonstrate that it has undertaken the appropriate checks in the appointment of its board in accordance with Regulation 5(5), the CQC will consider whether to take regulatory action alongside the NHS Trust Development Authority and Monitor.
If concerns are raised – for example, by a member of the public or staff member – about directors, CQC will deal with the matter in line with its safeguarding and whistleblowing protocols. If necessary, it will convene a panel to determine whether the information is significant and should be considered by the health service body. If so, consent will be requested from the relevant director to pass the information to the provider and, if this is not obtained, the CQC will consider whether the information can be shared under the Data Protection Act 1998.
Regulation 20 – The duty of candour
The duty of candour places a legal duty on health service bodies to act in an "open and transparent way in relation to care and treatment provided to service users in carrying out a regulated activity".
If, for example, the patient dies; is a person who is under 16 and not competent to make decisions about his or her care and treatment; or a person aged 16 or over who lacks capacity to make decisions about his or her care and treatment, this duty of openness and transparency extends to people acting lawfully on that patient’s behalf ("other relevant person") such as their families and carers.
Regulation 20 also imposes a duty to inform, provide support, and apologise to a patient (or, where appropriate, a person acting lawfully on his or her behalf) following a notifiable safety incident. A notifiable safety incident is an unintended or unexpected incident that could result in, or appears to have resulted in, death, severe harm, moderate harm or prolonged psychological harm to the patient. Regulation 20 contains definitions of the terms severe, moderate and prolonged psychological harm. If there has been a ‘near miss’ and no harm has been caused to the patient, it is not necessary to inform and apologise to the patient.
The CQC, in newly-published guidance, interprets the duty of candour by reference to Robert Francis QC’s definitions of openness, transparency and candour (the "Francis characteristics") used in his report (see paragraph 1.176 of the report):
- Openness: enabling concerns to be raised and disclosed freely without fear, and for questions to be answered;
- Transparency: allowing true information about performance and outcomes to be shared with staff, patients and the public;
- Candour: ensuring that patients harmed by a healthcare service are informed of the fact and that an appropriate remedy is offered, whether or not a complaint has been made or a question asked about it.
To demonstrate that these characteristics are being attained, it requires "all organisations and those working in them to be honest, open and truthful in all their dealings with patients and the public" (see paragraph 1.177).
In order to achieve compliance with Regulation 20, a health service body, therefore, has to make sure it:
- acts in an open and transparent way in relation to caring and treating patients in carrying on a regulated activity;
- informs the patient (or other relevant person) as soon as reasonably practicable after becoming aware that a notifiable safety incident has occurred and provides them with support (such as treating the patient with respect, consideration and empathy; offering the option of a family member or friend attending during notifications; and providing details of independent sources of advice and counselling);
- provides an account of the incident including all of the facts of which the health service body is aware as at the date of the notification – this should be in a manner which the patient will understand and given even if the enquiries are not yet complete;
- advises the patient (or other relevant person) what further enquiries it believes are appropriate;
- offers an apology (see the NHS Litigation Authority’s guidance in relation to making an apology); and
- keeps a written record of all communication.
Best practice guidance suggests that the notification to the patient (or other relevant person) should be no later than ten working days after the incident being reported.
If it is not possible to contact the patient (either because he or she cannot be found or declines to speak to the representative of the health service body), a written record of the attempts made to speak to him or her must be kept.
Practical steps to achieve openness, transparency and candour
- Ensure that the Board is commitment to being open and transparent in relation to the care and treatment of patients.
- Develop a safety culture which encourages the Francis characteristics at all levels.
- Have policies and procedures in place to foster the development of the Francis characteristics and take steps to ensure that these are followed.
- Institute a system which identifies possible breaches of the duty of candour by staff; investigate and escalate, as necessary.
- Provide training to staff to help them to understand their professional duty and individual responsibilities in relation to the duty of candour.
- Provide appropriate support to staff involved in notifiable incidents.