3.2 BASE TEORICA
3.2.2 Teorías y Programas sobre Arquitectura y Discapacidad Intelectual
• Staff should aim to raise any genuine concern [they] may have about a risk, malpractice or wrongdoing at work (such as a risk to patient safety, fraud or breaches of patient confidentiality), which may affect patients, the public, other staff or the organisation itself, at the earliest reasonable opportunity.45
Incident reporting and investigation obligations
2.3.7 NHS England has a statutory function to ‘give advice and guidance, to such persons as it considers appropriate, for the purpose of maintaining and improving the safety of the services provided by the health service’46.
2.3.8 It fulfils that function through the National Reporting and Learning System (NRLS), a service
that collates health service incident data. All incidents classified as having caused severe harm or death are individually analysed. There are around 250-400 reports per week. Similarly, aggregate data from all reports received by NRLS (circa 1.4 million per year) are assessed and, where learning from an incident could be beneficial, recommendations for preventing such incidents occurring in the future are shared nationally.
2.3.9 Local Risk Management Systems (LRMS) feed information into the NRLS. All trusts have systems, such as Datix, Sentinel and Ulysses, in place for the recording of incidents and will have local policies relating to when and by whom reports can be made. The Care Quality Commission (CQC) treats failure to upload concerns from LRMS at least monthly, or implausibly low rates of reported concerns, as a ‘risk’ or ‘elevated risk’ in its Intelligent Monitoring System.
Statutory duty of candour
2.3.10 Regulations implementing the statutory duty of candour came into effect for NHS
healthcare bodies on 27 November 201447. Subject to further legislation, which the Government expects to lay in early 2015, the duty will be extended to all providers registered with the CQC from April 2015.
2.3.11 The duty of candour requires NHS bodies to be open and honest with people. Where, in the view of a healthcare professional, an unintended or unexpected incident has resulted in, or could still result in, death, severe or moderate harm, or prolonged psychological harm to a patient, the regulations prescribe a formal set of notification procedures that the provider must follow when informing the patient, or their representative, of that harm.
2.3.12 Providers must notify the patient, give an apology and follow up the incident in writing. The 42 NHS Terms and Conditions of Service Handbook, section 21.1 Pay Circular (A for C) 4/2014
43 NHS Terms and Conditions of Service Handbook, section 21.2 Pay Circular (A for C) 4/2014
44 NHS Terms and Conditions of Service Handbook, section 21.3 Pay Circular (A for C) 4/2014
45 NHS Constitution for England, p15
46 National Health Service Act 2006 section 13R(4) as amended by Health and Social Care Act 2012 47 The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (S.I. No. 2936)
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duty does not apply to individuals, but to provider organisations. However, in practice the task of being open with patients will be carried out by individual staff, and organisations are expected to consider what additional support and training they need to provide to staff to comply with the requirements of the duty.
2.3.13 Compliance with the duty will be part of a provider’s CQC registration requirement, and CQC will be able to use its enforcement powers if necessary. This could include bringing a prosecution against a non-compliant NHS provider, or, in the worst cases, cancelling registration.
Fit and Proper Persons Test
2.3.14 It is already the case that NHS bodies must take steps to ensure that staff are fit and proper persons for the role they are being employed to undertake. The same regulations that impose the statutory duty of candour also introduce a new requirement on NHS bodies to ensure that their board-level directors (or equivalents) are fit and proper persons for their role. The timescales for implementation are the same as for the duty of candour.
2.3.15 The criteria for eligibility as a director includes a requirement that they must not have been responsible for, or have permitted or colluded in, any serious misconduct or mismanagement, in the course of carrying out an activity regulated by CQC. This could be particularly significant in the context of whistleblowing, where directors are sometimes alleged to have been responsible for victimisation of the whistleblower or failing to act appropriately when such victimisation occurs.
2.3.16 The regulations require providers to give CQC evidence to assess whether the Fit and Proper Person Test (FPPT) has been properly applied. However, they also allow CQC to take action in respect of an individual they deem to be an unfit director, including requiring the provider to remove the individual from the post if considered appropriate.
2.4 Roles and responsibilities of
regulators and others
2.4.1. This section covers:
• system regulators
• professional regulators
• other bodies.
It does not cover all organisations with a role in raising concerns but highlights some of the key players.
System Regulators
Care Quality Commission (CQC)
2.4.2 CQC is the independent regulator of health and social care in England. Its role is to make sure that hospitals, care homes, dental and general practices and other care services in England provide people with safe, effective and high-quality care, and to encourage them to make improvements.
2.4.3 All organisations that carry out ‘regulated activities’ as prescribed by the Health and Social Care Act 2008 are required to be registered with the CQC. Regulated activities include most healthcare and adult social care services. Registration is dependent on meeting a range of registration requirements, and the CQC regularly inspects registrants to satisfy itself that they continue to meet those requirements.
2.4.4 A number of changes have been made to the way CQC operates in the wake of the public inquiry into the failings in Mid Staffordshire. Three new roles, Chief Inspector of Hospitals, Chief Inspector of Primary Care and Chief Inspector of Adult Social Care have been tasked to ensure that inspections will no longer be seen as just a ‘tick box’ exercise.
2.4.5 In addition, CQC has developed a new inspection framework which sets out five ‘domains’ against which to assess providers. These are
whether they are: safe; effective; caring; responsive to people’s needs; and well-led48. Significantly, the well-led domain covers the leadership and culture of a provider, not just its governance arrangements. 48 Raising standards, putting people first: Our strategy for 2013 to 2016, Care Quality Commission
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In hospital inspections in particular, the inspection process includes discussions about how the organisation deals with concerns and handles whistleblowers. Following inspections, providers are given a rating: outstanding; good; requires improvement; or inadequate. The inspection report also identifies any non-compliance with regulatory requirements and what action has been taken or is required as a result.
2.4.6 From April 2015, twelve ‘Fundamental Standards’ of care will come into effect for all CQC registered providers of healthcare services. Inspections will look to assess whether these standards are being met. Of particular relevance to this Review are the requirements that:
• care and treatment must be provided in a safe way for service users. In order to comply, among other things, providers must do all that is reasonably practicable to mitigate risks to health and safety, and ensure that staff have the necessary competence, skills and experience to provide the service safely49
• service users must be protected from abuse and improper treatment by the establishment and effective operation of systems and processes to investigate, immediately upon becoming aware of any allegation or evidence of such abuse50
• systems or processes must be established and operated effectively which, among other things, assess, monitor, and improve the service’s quality and safety, and seek and act on feedback on the service for the purpose of continually evaluating and improving it51
• sufficient numbers of suitably qualified, skilled and experienced staff must be deployed to meet the requirement of the Fundamental Standards, and such persons must receive appropriate support, training, professional development, supervision and appraisal as necessary to enable them to perform their duties52
• staff employed by the service must have the necessary skills and competence, and where a person employed no longer meets that requirement the provider must take such action as is necessary and proportionate to ensure that the requirement is met.53
2.4.7 Every registered healthcare provider of NHS services will have to comply with these requirements, and the CQC will be monitoring and, where appropriate, enforcing compliance. CQC will have a range of enforcement options available to it in the event of non-compliance, including, in extreme cases, prosecution or withdrawal of registration. NHS staff will have a major role to play in ensuring that providers meet these obligations, as well as the duty of candour referred to in 2.3.54
2.4.8 CQC is also a prescribed person for the purposes of the 1996 Act (see 2.2). It therefore receives and has mechanisms in place to respond to concerns raised with it. In 2012 following a review of its National Customer Service Centre processes, CQC set up a dedicated Safety Escalation Team to receive concerns from NHS and social care workers as well as members of the public. This Safety Escalation Team (SET) ensures all high risk information is processed and forwards whistleblowing concerns to the local inspectors. The SET monitors the progress of the concern until there is a final outcome.
Monitor
2.4.9 Monitor is the sector regulator for health services in England. Its responsibilities include ensuring that: independent NHS foundation trusts are well-led so that they can provide quality care on a sustainable basis; essential services are maintained if a provider gets into serious difficulties; the NHS payment system promotes quality and efficiency; and procurement, choice and competition operate in the best interests of patients.
49 Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (S.I. 2014/2936), reg 12 50 Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (S.I. 2014/2936), reg 13 51 Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (S.I. 2014/2936), reg 17 52 Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (S.I. 2014/2936), reg 18 53 Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (S.I. 2014/2936), reg 19 54 The duty of candour appears in regulation 20 of the 2014 regulations
Chapter 2 – Overview of the legal aid policy context 45
2.4.10 Monitor is a prescribed person for the purposes of the 1996 Act. Its website contains information and guidance55 for NHS workers who wish to raise concerns with it. The guidance requires that concerns about an organisation are set out fully and as clearly as possible, stating:
• the issue(s) that have arisen, with a view on which of its activities the concerns relate to
• to which part or parts of the whistleblowing legislation the concerns relate
• where concerns have already been raised with an employer, what happened as a result.
2.4.11 Monitor’s guidance states that any action taken on information disclosed to it will depend on whether it falls within its scope to act on, and if so, Monitor’s assessment of the seriousness of the concern raised. If satisfied that it is within their remit to act, Monitor will generally do one or more of the following:
• make a record of the concerns to add to its database of information about organisations covered by its regulatory duties
• raise the issue directly with the organisation if this is considered appropriate
• notify another regulator or official body if it is appropriate for it to look into the concern instead of, or as well as, Monitor.
NHS Trust Development Authority
2.4.12 The NHS Trust Development Authority (NHS TDA) is a Special Health Authority responsible for providing leadership and support to those NHS trusts that are still working towards foundation trust status. Its key functions include:
• monitoring the performance of NHS trusts, and providing support to help them improve the quality and sustainability of their services assurance of clinical quality, governance and risk in NHS trusts
• supporting the transition of NHS trusts to foundation trust status
• appointments to NHS trusts of chairs and non-executive members and trustees for NHS Charities where the Secretary of State has a power to appoint.
2.4.13 The NHS TDA was added to the list of prescribed persons for the purposes of the 1996 Act in October 2014. It is currently developing its procedures and policies for dealing with protected disclosures made to it. Its website confirms its commitment in general terms to treating all concerns raised with it with fairness and transparency and in line with legislation. To do this, the NHS TDA states that it will work closely with the CQC and NHS trusts as necessary. If the NHS TDA decides that the concern would be better addressed by another body, it may pass the information on to them – if it does, it commits to letting the person who raised the concern know.
Professional regulators
2.4.14 Most healthcare professionals are required to be registered with the relevant professional regulator in order to practise in the UK. The regulators require compliance with codes of
conduct, and have powers to investigate allegations of misconduct or malpractice that call into question the fitness to practise of an individual. Reports of alleged misconduct or malpractice may be made by employers, other healthcare professionals, patients or members of the public.
2.4.15 As indicated in 2.3, the professional codes place obligations on registrants to report untoward incidents to their employers, and failure to do so may itself amount to professional misconduct.
2.4.16 All the professional regulators are prescribed persons for the purposes of the 1996 Act, and must therefore have arrangements in place to deal with protected disclosures made to them. There is some evidence from the contributions received by the Review that the professional regulators tend to respond to such disclosures by instigating formal fitness to practise proceedings, which do not necessarily prioritise ensuring that the initial concern about patient safety risks are quickly and effectively dealt with.
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Other bodies
Health Education England
2.4.17 Health Education England (HEE) was established as a Special Health Authority in June 2012. It provides leadership for the new education and training system by ensuring that the shape and skills of the future health and public health workforce evolve to sustain high quality outcomes for patients in the face of demographic and technological change.
2.4.18 HEE is not a prescribed person for the purposes of the 1996 Act. However, its 2014/15 Mandate requires development of minimum mandatory training requirements with specific reference to training staff on how to raise concerns about patient care or safety.
NHS Protect
2.4.19 NHS Protect, a subdivision of the NHS Business Services Authority, is the lead organisation for receiving and investigating allegations of fraud, bribery, corruption and other unlawful activity (such as market fixing) in the health service. Each organisation has responsibility to carry out these functions locally, whilst NHS Protect aims to:
• educate and inform those who work for or use the NHS about crime in the health service and how to tackle it
• prevent and deter crime in the NHS by removing opportunities for it to occur or to re-occur
• hold to account those who have committed crime against the NHS by detecting and
prosecuting offenders and seeking redress where viable.
2.4.20 NHS Protect is not a prescribed person for the purposes of the 1996 Act.
Royal Colleges
2.4.21 There are a number of medical Royal Colleges across the UK which offer an Invited Review Mechanism. These reviews are requested by organisations rather than individuals and generally
relate to the performance of a particular unit or department. The resulting recommendations go to the trust management although issues of serious concern can be referred to a professional or system regulator. NHS England and Clinical Commissioning Groups
2.4.22 NHS England funds clinical commissioning groups (CCGs) who commission services for their local communities. NHS England also directly commissions some specialist services on a national basis.
2.4.23 Both NHS England and CCGs are
responsible for promoting the NHS Constitution and play a vital role in setting the values and organisational norms across the NHS as a whole. As commissioner and ‘payer’, NHS England and CCGs are responsible for defining the relationships between providers and other organisations in the health service and the way these relationships work. Their role in terms of staff concerns is still emerging following the recent health service restructure. Neither is a prescribed person for the purposes of the 1996 Act.
2.4.24 There is a mandate from the Government to NHS England which sets out the strategic direction for NHS England and ensures it is democratically accountable. It is the main basis of Ministerial instruction to the NHS. Point 5 of the mandate is about treating and caring for people in a safe environment protected from avoidable harm.