Healthcare Commission NHS investigations criteria

The Healthcare Commission works to improve both the NHS and private or voluntary sector healthcare. One of its functions is to investigate serious failures in NHS services.

Background

The Healthcare Commission's functions include conducting investigations into the provision of healthcare by and for English NHS bodies and cross border special health authorities. The Healthcare Commission is required to make a report (to the Secretary of State, National Assembly of Wales or the Independent Regulator of foundation trusts as appropriate) where it identifies 'significant failings' in the provision of healthcare.

An investigation is conducted in response to specific concerns of which the Healthcare Commission becomes aware. An investigation involves obtaining evidence on, and developing an understanding of, the reasons for a serious failing in the provision of healthcare and making recommendations to prevent repetition. The Healthcare Commission will, when it conducts an investigation, take account of standards published by the Secretary of State for Health and criteria published by the Healthcare Commission or, in their absence, other articulations of good practice (for example from professional bodies).

Where the Healthcare Commission has serious concerns about the provision of healthcare it will consider whether it needs to conduct an investigation. Triggers that might alert the Healthcare Commission to the potential need for an investigation include:

direct contact from patients, the public, NHS staff or the media
issues brought to light during Healthcare Commission's screening processes, reviews or visits
trends or issues highlighted in the monitoring of complaints which reach the independent stage
requests from the Secretary of State, Welsh Assembly Government in respect of cross border special health authorities, or from other inspectorates

Criteria for investigation

The Healthcare Commission has a wide discretion as to the circumstances in which it will investigate the provision of healthcare by and for an English NHS body or a cross border special health authority.

Generally, the Healthcare Commission will only commence an investigation where it possesses credible information that suggests that there may have been, or there may be, a serious failing in the provision of healthcare by or for an NHS body that has resulted, or is resulting, in an adverse impact on the safety of patients, clinical effectiveness, or responsiveness to patients.

If a case does not feature such a serious failing, the Healthcare Commission will nevertheless consider whether an investigation should be commenced, having regard to the particular facts of the case.

Factors which might trigger the Commission to commence an investigation, include:

a higher number than anticipated of unexplained death(s)
serious injury or permanent harm, whether physical, psychological or emotional
events which put at risk public confidence in the healthcare provided, or in the NHS more generally
a pattern of adverse effects or other evidence of high-risk activity
a pattern of failures in service(s), or team(s), or concerns about these
allegations of abuse, neglect or discrimination against patients (particularly those less able to speak for themselves or assert their rights)

In determining whether to investigate, the Healthcare Commission will consider the extent to which local resolution, referral to an alternative body, or other action might offer a more effective solution.

Generally, the Healthcare Commission will not investigate:

individual complaints that have not been pursued through the NHS complaints procedure or the Healthcare Commission's second stage, except if it raises an immediate concern
individual complaints about professional misconduct
changes to service configurations
matters being considered by legal process
specific matters already determined by legal process

This does not preclude Healthcare Commission from investigating circumstances surrounding such matters. A matter that has been determined under one of the processes outlined above may raise general concerns about patient safety or suggest that organisational systems are flawed.

Investigation staff will ensure that they have sufficient information to enable them to make a recommendation on the action to be taken and if appropriate will carry out initial enquiries of the NHS body in question in order to obtain further information and in particular to elicit the initial response of that body to an allegation that has been made. The information required to assess the need for an investigation will include:

a summary and analysis of the concerns
any initial response received from the NHS body in question
a brief chronology of events
an account of the experience of the patient(s)
any evidence of a breach of accepted standards
report of any local investigation if there has been one
other investigations underway, for example a coroner's inquest

Staff in the investigations unit will consider all allegations of serious failings. Staff will identify whether rapid action is required (for example to suspend service for the protection of patients) and will liase with the Department of Health, the strategic health authority, the trust and other relevant bodies. Staff will determine whether the matter falls within the Healthcare Commission's jurisdiction and refer it elsewhere if more appropriate (for example to the General Medical Council). If a matter is referred elsewhere staff will tell the informant and will ask the body to which it is referred to report back to the Healthcare Commission on action taken.

Why the Healthcare Commission investigates - easy read (PDF, 162K) (opens new window)

Organisation and staffing

Staff of the Healthcare Commission helpline will sift initial enquiries and refer allegations of serious failings (or other matter that may warrant investigation) to the Investigations unit. As described above, staff in the Investigations unit will undertake initial consideration of referrals for investigation and make recommendations for action. Staff will have rapid access to clinical expertise from advisers of the Healthcare Commission and through the clinical advisory team; access to legal advice; and access to a database of experts and lay members to form an investigation team. The Healthcare Commission will adopt a flexible and responsive approach to meet the unpredictable demands of calls for investigation.

The Healthcare Commission?s approach

The purpose of an investigation will be to identify the underlying (or root) causes of the failings in the provision of healthcare. It will identify both failings in systems and individual behaviours, which may have contributed. It will provide an explanation of what has happened and why and will make recommendations to prevent repetition, both in the NHS organisation being investigated and more widely. Investigations will set in motion arrangements for monitoring future performance and for any specific follow up action.

Range of responses

Following initial consideration, the range of responses that the Investigations unit staff might recommend include:

no further action: log concerns in case further data subsequently come to light; explain to informant why no further action is planned
monitor performance and follow up where necessary (e.g. outliers)
detailed statistical analysis (for example of trends in mortality) possibly commissioned from an independent expert
visit by a member of the investigations team or Healthcare Commission's local staff to obtain additional evidence, to question staff or patients about the events, to discuss findings with senior management of the NHS organisation and to produce recommendations (where appropriate) for further action by the NHS body and/or the Healthcare Commission
undertake an investigation by establishing an investigation team to obtain more detailed information, analyse the evidence and report, with recommendations. An investigation team may consist of staff from the Healthcare Commission, external experts, or a combination depending on circumstances
engaging an external agency to undertake the investigation and provide a report
refer the matter for investigation by another body where appropriate

Arrangements for governance

An investigation committee comprising five commissioners and four senior operational staff from the Healthcare commission will decide on the need for an investigation, agree its terms of reference, monitor progress and review final drafts of reports [see terms of reference 3.3]. [The Head of Investigations and/or Head of Operational Development will decide the need to instigate initial fact finding enquiries, including exploratory visits by staff of the Healthcare Commission and will report the results to the investigation committee for information. The chief executive (or nominated representative) will consult with the chair of the investigations committee (or nominated representative) where an urgent decision is needed to recommend suspension of an NHS healthcare service.

Summary

The Healthcare Commission will respond to concerns raised with it and will liaise with the Department of Health, the relevant strategic health authority and other agencies in deciding how to pursue allegations that warrant investigation by the Commission or other agencies. The Healthcare Commission will investigate allegations of serious failings with implications for the safety of patients, clinical effectiveness, or responsiveness to patients. It will produce reports that identify the causes of failings and make recommendations to address them. The Healthcare Commission will disseminate the learning from investigations and monitor the action taken. It will ensure that its other procedures, such as those for screening, reviews and handling complaints are used appropriately, to identify matters, which may need to be referred for investigation.

Asking the Healthcare Commission to investigate?

by telephone: 0845 601 3012
by fax: 020 7448 9391
by letter: Lea Pickerill
Helpline Manager
Healthcare Commission
Finsbury Tower
103-105 Bunhill Row
London EC1Y 8TG
by e-mail:

feedback@healthcarecommission.org.uk

Healthcare providers