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Hospital Adverse Events Planning
Hospital Medical Negligence

Adverse Events, Near Misses and Serious Incidents In Hospitals

Every hospital should make every reasonable effort to eliminate accidents, incidents or near misses. There are legal requirements in relation to reporting certain accidents or incidents, where to report them and individual responsibilities. The importance of reporting adverse events and near misses is important to enable hospitals to investigate the causes for them so that remedial action can be taken. In time this can lead to improved systems and reduced medical negligence claims.

This article explores what actually amounts to adverse events, near misses and serious incidents in hospitals.

Adverse Events

Adverse events and near misses must be reported as quickly as possible. Adverse events or near misses that are assessed as Grade 4 or 5 must be reported immediately they are identified.

In turn, the Trust has a contractual obligation to report to the PCT within 24 hours of establishing a serious untoward incident has occurred.

It is recognised that some staff are reluctant to report incidents because of the fear of disciplinary action, particularly where the member of staff may themselves be involved. Indeed, certain studies have shown that consultants are the worst offenders here and that more junior members of staff are more prepared to report adverse incidents.

The hospital must support and encourage the reporting of mistakes and disciplinary action should not form part of an immediate response to the reporting of an adverse event or near miss except where one or more of the following applies:-

  • Where there is repeated professional misconduct involving the same individual following education and/or training; or
  • Where the incident has resulted in a police investigation; or
  • Where, in the view of the Trust and/or any professional registration body, the action constitutes gross professional misconduct; or
  • Where there is a failure to report an adverse event in which a member of staff was involved or about which they were aware.

Major incidents that fall within health and safety legislation must also be reported to the Health and Safety Executive.

Through various organisations, adverse events and other data should be analysed, staff informed and staff given feedback about patterns and trends.

Hospital Trusts Definitions

The following are examples of definitions which might be used within a Trust's policy for the management of adverse events and near misses:-

Adverse Event
An adverse event incorporates the terms “accident, incident, clinical incident and untoward incident”; an event or circumstances that could have resulted, or did result, in unnecessary damage, loss or harm such as physical or mental injury to a patient, staff, visitor or members of the public. It also includes losses of personal identifiable data.

Near Miss
A near miss is where an adverse event could have occurred but did not.

Serious Incident
An adverse event that occurred in relation to NHS funded services and care (regardless of the location) resulting in one of the following:-

  • Unexpected or avoidable death of patients, visitors or staff; serious harm to one or more patients, visitors or staff or where the outcome requires life-saving intervention, major surgical/medical intervention, permanent harm or will shorten life expectancy or result in prolonged pain or psychological harm;
  • Allegations of abuse; a “never event”;
  • Adverse media coverage or public concern about the Trust or the wider NHS;
  • A scenario that prevents or threatens to prevent the Trust's ability to deliver healthcare services, eg actual or potential loss of personal/organisational information, damage to property, reputation or the environment, or IT failure;
  • Healthcare associated infections; losses of personal identifiable data;
  • Significant loss of personal identifiable information.

Unexpected Death
Where natural causes are not suspected.

Permanent Harm
Directly related to the incident and not to the natural course of the patient's illness or underlying conditions, defined as permanent lessening of bodily functions, including sensory, motor, physiological or intellectual.

Prolonged Pain and/or Prolonged Psychological Harm
Pain or harm that a service user has experienced, or is likely to experience, for a continuous period of 28 days.

Severe Harm
A patient safety incident that appears to have resulted in permanent harm to one or more personals received NHS-funded care.

Major Surgery
A surgical operation within or upon the contents of the abdominal or pelvic, cranial or thoracic cavities or a procedure which, given the locality, condition of the patient, level of difficulty or length of time to perform, constitutes a hazard to life or function of an organ, or tissue (if an extensive orthopaedic procedure is involved, the surgery is considered “major”).

Abuse
A violation of an individual's human and civil rights by any other person or persons. Abuse may consist of single or repeated acts. It may be physical, verbal or psychological, it may be an act of neglect or an omission to act, or it may occur when a vulnerable person is persuaded to enter into financial or sexual transaction to which he or she has not consented or cannot consent. Abuse can occur in any relationship and may result in significant harm or exploitation of the person subjected to it.

Severity Grading

All adverse events and near misses that are recorded within the Trust or as part of the Trust service delivery are graded according to the severity of the outcome. Near misses are eventually graded as 0 after investigation as there was no actual harm, loss or damage.

All adverse event are graded between 1 and 5 depending on the significance of the outcome.

Never Event
A never event is an adverse event that should not occur under any circumstances, eg wrong site surgery.

Investigation
Investigations are required for all adverse events and near misses. It is important that where possible the underlying cause(s) are identified and that the focus of the investigation is on why something happened and not on whose fault the incident was. Capability, competency or disciplinary actions are out with the remit of adverse event reporting.

Causal Factors
The causal factors (commonly known as root causes) are the underlying reason why something occurred. It is important to establish the facts in relation to system or procedural weaknesses or failings – if these are not identified and remedial action taken the event is likely to recur.

Risk Reduction
One of the primary principles of investigating adverse events and near misses is to reduce the risk of future occurrences or reduce the likelihood of the hazard causing loss, harm or damage if the hazard cannot be eliminated.

Serious Clinical Incident Group

This is a group of senior employees and specialists that investigate and manage any serious clinical incident. The group is led by the Medical Director, or the Director of Nursing.

Duties

Duties within the Organisation

The Chief Executive is ultimately responsible for ensuring compliance with the Health and Safety at Work Act 1974 and associated legislation and that this policy is effective. The Chief Executive will ensure that the Trust has robust systems in place to manage serious untoward incidents and that staff are fully informed and skilled to carry out their responsibilities.

The Director of Human Resources has executive responsibility for health and safety.

The Medical Director has executive responsibility for clinical risk management and for informing the Chief Executive and Board of Directors about any significant patterns and trends or individual serious incidents.

The Medical Director and Director of Nursing are equally responsible to the Board of Directors for all clinical governance and patient safety matters.

The Director of Nursing is the Director for Infection Prevention and Control.

The Treating Consultant (or his/her senior medical colleagues) will ensure that the patient, or the parent/guardian in the case of a child, or the patient's next of kin where the patient is incapacitated or deceased, receives clear and concise information of any significant incident that affects the continued health or well being of the patient. The Treating Consultant is responsible for informing the patient's general practitioner of medical concerns and any future medical support. In the case of an unexpected death the Treating Consultant is responsible for ensuring that the Coroner's Office, Legal Services Department and Risk Management Department are informed without delay.

General Managers, Clinical Leads and Executive Directors are responsible, through local induction, for ensuring all employees (including temporary staff) understand the need to report all adverse events and near misses. Each must ensure that there are robust systems in place for investigating adverse events and near misses appropriate to the level of severity of the adverse event or near miss.

The On-Call Senior Manager will inform specialist managers/advisors (ie Facilities, Risk Management, Communications, etc) of any significant adverse event that needs to be investigated, or where support for services or staff is required, particularly out of hours.

On-Call Senior Manager/Duty Managers are also responsible for ensuring the appropriate application and operation of this policy at the time of any incident.

Duty Managers are required to communicate in and out of normal hours to the appropriate senior and/or specialist managers, where the adverse event has created significant impact on delivery of services, significantly affects patient care, creates significant damage to Trust buildings or involves external agencies.

All managers are responsible for ensuring that employees understand the requirements on them of this policy and the accompanying code of practice. This should take place through their local workplaces induction and other management arrangements. They must be made aware of the necessity to report adverse events and near misses. Managers must also ensure that on receipt of an adverse event form (paper or electronic) that they understand what is being reported, that the report is accurate, correctly coded, graded and immediate action taken where necessary. In addition, they must ensure that they have sufficient trained people to undertake local investigations.

The Caldicott Guardian is responsible for overseeing any investigation and reporting of breaches of Caldicott principles, including the loss of personal identifiable data under the Data Protection Act 1998.

The Company Secretary is the responsible person for Information Governance and is responsible for informing the Information Commissioner and Monitor of any reportable serious incidents.

The Local Security Management Specialist will report all incidents involving physical and non-physical assaults against staff and security related incidents resulting in loss or damage to the property of health bodies, staff or patients to the NHS Security Management Service via the Security Incident Reporting Services.

All Employees (including locum staff) are responsible for ensuring they understand their responsibilities on how and when to report all adverse events and other dangerous occurrences to their line manager or other suitable senior person, as soon as possible after the incident. All employees are required to be familiar with the Being Open policy on how information is to be shared with patients and/or relatives.

Volunteers, students, work experience placements are to report any incident to a member of staff who will then take on the responsibility for reporting.

All employees have a duty to report serious incidents or unexpected deaths as soon as is practicably possible and follow the serious untoward policy.

Trust Board of Directors – the Board of Directors has a role in challenging the systems and processes for managing patient safety and therefore adverse event and near miss management.

Clinical Governance Committee – The Corporate Clinical Governance Committee and relevant CBU committees have a responsibility to review the patterns and trend information and individual investigation reports to identify lessons that can inform clinical or managerial practice and propose and implement appropriate changes. In addition, the Corporate Clinical Governance Committee is to hold the lead CBU to account for ensuring that any action plans arising from investigations are completed satisfactorily and within agreed time frames.

CLAEP Group – The CLAEP group will meet on a quarterly basis and review the data arising from complaints, litigation, adverse events and PALs contacts along with information from Safeguarding and Dr Foster patient safety indicators. The CLAEP group will agree a quarterly report which is then widely circulated around the organisation for both action (action points included in the report) and for information about the lessons learned.

Reporting Transfusion related adverse events

A full description of the requirements to report transfusion related adverse events or near misses will be available to all employees.

Information Governance Losses

The definition of an information governance serious incident is any incident involving the actual or potential loss of personal information that could lead to identity fraud or have other significant impact on individuals should be considered as serious. Information governance losses will be reported internally to the Caldicott Guardian and to the Company Secretary (Board Lead for Information Governance). The Company Secretary will decide if the loss fits with the requirement to report externally as a serious untoward incident and inform Monitor, the SHA, NHS Peterborough and any other external agencies, as well as informing the Chief Executive.

Communication and Notification

Under the Data Protection Act 1998 and any associated legislation, all employees have a duty to safeguard personal (and sensitive) information concerning patients, staff and any other third parties.

Patient/Relative/Visitor/Contractor Communication Support

Where an adverse event has involved patients, visitors or members of staff there is to be no communication to the media or any other party externally until the patient, visitor or staff member, their relatives or next of kin are fully informed. It is the responsibility of the consultant to whom the patient is assigned to ensure the most appropriate person informs the patient (do not delegate to junior members of staff). Any information given to patients or relatives is to be recorded within the patient's notes.

Process by Which to Raise Concerns

There are established methods for raising concerns in existence in the Trust. The first is through the normal line management channels, if this is not possible then through the adverse event and near miss reporting process or direct to the respective Human Resources Manager.

External Communication

Where the serious incident involves patients, they (or their parent/legal guardian) must be informed before any other external person/agency.

Where the incident has led to a death or serious injury, the patient's next of kin must be informed before any media or other external contact is made. Those Trust employees responsible for reporting to external authorities shall simultaneously report to the Risk Management Department.

Commissioning PCT

An initial assessment of the incident will be undertaken with one working day of notification of the incident to risk management; a discussion with the Medical Director or Director of Nursing will ascertain if it is to be investigated as a serious incident.

Once it has been established that this is a serious incident, the Commissioning PCT will be informed as soon as possible via secure e-mail. A follow-up summary report should be sent within the following seven working days.

A full (anonymous) report is to be submitted within 45 working days from the date of the incident being identified. Extensions may be appropriate where a criminal case is being pursued or a Coroners Inquest is required.

Monitor and the Information Commissioner

Adverse events that are classified as serious incidents will be reported to Monitor by the Company Secretary as part of the quarterly quality exception report. The Company Secretary will report any data losses to the Information Commissioner as well as to Monitor.

General Practitioner

The patient's General Practitioner will be informed by the patient's consultant or by someone else nominated by the Medical Director. Where the patient needs ongoing support, further medical intervention or continuing care this will be discussed with the GP. The Bereavement Office will send a confidential fax message to the appropriate general practice to notify of a patient's death.

Maternal Deaths

A maternal death is defined as a the death of a woman while pregnant or within 32 days of delivery, miscarriage or termination of pregnancy, from any cause related to or aggravated by the pregnancy or its management, but not from accidental or incidental causes.

Healthcare Associated Infection

The following group of incidents relating to Healthcare Associated Infections will be reported to the main Commissioning PCT:

  • Outbreaks of healthcare associated infection (this includes the presumed transmission within a hospital and causes significant morbidity/mortality and/or impacts significantly on hospital activity);
  • Infected healthcare workers (incidents which necessitate consideration of a look back exercise);
  • Breakdown of infection control procedures/serious decontamination failures with actual or potential cross infection;
  • Other high profile infection incidents that meet the general SHA SI reporting criteria.

Definition of an outbreak can be gained from the Infection Control Team.

The Director of Infection Prevention and Control or the Matron for Infection Control is responsible for external reporting to the Commissioning PCT. Any serious incidents (infection related) will still be reported through the same process as all other serious incidents.

Safeguarding Children

In addition to informing the main Commissioning PCT, significant child protection concerns are to be reported to the appropriate Local Safeguarding Children's Board (LSCB) by the Trust representative.

Safeguarding Adults

The protection of vulnerable people is one of the most important tasks facing social and health care services. Awareness of adult abuse has received more growing attention from the public, the media and voluntary and statutory agencies over recent years. However, there is still much for agencies commissioning and providing services to vulnerable adults to do, in order to raise the profile of adult protection.

Ministry of Defence Hospital Unit (MDHU)

The Risk Management Department will inform the Commanding Officer or Officer Commanding Nursing where any military personnel are involved in a clinical adverse event that causes, or near miss that could have caused, significant harm to a patient.

National Patient Safety Agency (NPSA)

The Risk Management Department will transmit an electronic report of all patient safety adverse events and near misses to the NPSA on a daily basis (normal office days only).

Health & Safety Executive (HSE)

Reporting of Injuries, Diseases and Dangerous Occurrence Regulations 1995 (RIDDOR). RIDDOR is explained in full detail in the adverse event and near miss reporting code of practice. RIDDORS will be reported by the Health and Safety Team.

Fatalities – work place fatalities (staff and contractors, or exceptionally visitors or patients where the death was caused by Trust or contractors working systems) must be reported immediately via the Risk Management Department or the Health and Safety Department to the HSE.

Unexpected Patient Deaths

The treating consultant (or his/her medical team) is responsible for ensuring the Police or the Coroner's Office is immediately informed of any unexpected deaths. Legal Services and Risk Management Departments should be informed as soon as is reasonably practicable.

NHS Litigation Authority (NHSLA)

All communications to and from the NHSLA in relation to claims or other potential or proposed legal action will be via the Legal Services Department.

Centre for Communicable Diseases Control (CCDC)

Reports to the CDCC will be via the Infection Control Team.

Criminal Activity

Non-clinical crimes (theft, assault, etc) will normally be reported to the Police through the Duty Manager's office or through the Trust Local Security Management Specialist. In exception, any member of staff may report direct to the Police.

Medicines and Healthcare products Regulatory Agency (MHRA)

Full instructions for reporting of adverse reactions to drugs and defective medicines will be available to staff. The Medical Equipment Manager is the central alerting system (CAS) liaison officer for the Trust. All safety alerts and associated reports are managed through the CAS Officer.

Serious Hazards of Transfusion (SHOT)

The Haematology Manager provides all SHOT returns via Serious Adverse Blood Reactions and Events (SABRE).

NHS Estates (Fires)

The Fire Safety Officer will notify fires to the Department of Health Estates.

Environment Agency

Environment incidents and the subsequent reports will be made by a Facilities Manager or the Risk Management Department to the appropriate Environment Agency office.

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