Appendix 19: further guidance on managing complaints and incidents within homecare services

Sections on this page

  1. Introduction
  2. Scope and purpose
  3. Regulation of complaint and incident reporting in homecare services
  4. Overarching process for reporting and managing complaints and incidents
  5. Primary and secondary investigator(s)
  6. Serious incidents
  7. Information for patients
  8. The complaints and incidents process: Step by step
  9. Management of specific complaint and incident types
  10. Process-based analysis, root cause analysis and risk assessment
  11. Complaint and incident management training
  12. Key Performance Indicators (KPIs)
  13. Complaint and incident coding

introduction

In 2014, the National Homecare Medicines Committee (NHMC) subgroup working on the national standard for Key Performance Indicators (KPIs) (see Appendix 10a) resolved that the complexity and diversity of complaint, incident and non-conformance processes between organisations meant that it was not possible at that time to agree national standard governance KPIs. Furthermore, differences in terminology between clinical referring centres and homecare providers was causing confusion and undermining trust in the medicines and clinical homecare sector. The revised operational KPIs were published in March 2015 with a recommendation for further work to develop governance KPIs.
 
The NHMC initiated a further multi-stakeholder workgroup with the following aims:
  1. to document integrated and streamlined processes for the management and reporting of all types of complaints, incidents and non-conformances in homecare; and
  2. to define national standard governance KPIs
The workgroup have produced this detailed guidance on how reporting and learning systems should operate in homecare services in order to meet the requirements of patients, carers, regulators, NHS customers, independent healthcare customers, manufacturers (Medicine Authorisation Holder and Device Manufacturer) and other stakeholders. The draft document was published for consultation in November 2015 and all those who responded are thanked for their input.
 
The RPS Handbook for Homecare Services in England1 includes some information on managing complaints and incidents (page 33):
 
“As homecare is often a shared care arrangement involving multiple organisations, complaints processes which allow the sharing of complaints and co-operation in the investigation of root causes and implementation of preventative actions should be in place and integrated between the parties involved in providing the homecare services as far as possible. Complaints processes should ensure complaints are received, recorded, investigated, acted upon and reviewed, and these processes documented in the Technical Agreement between the parties.”
 
The RPS Handbook (Domain 3 Governance of Homecare Services) includes guidance on:
  • Managing complaints (page 32)
  • Patient safety incidents and adverse drug reactions (ADR) reporting and learning (page 33)

Whilst these sections provide general guidance, with the aim of reducing duplication of reporting, the differences in the process of handling complaints, incidents and non-conformances within different organisations was recognised as continuing to result in gaps and duplication.

2. Scope and purpose 2. Scope and purpose

The purpose of this guidance is to provide:

  1. A standardised and integrated complaints and incidents process which, if implemented by all organisations involved in the homecare service, will:
    • Improve patient safety (freedom from accidental harm in healthcare) by defining clear responsibilities and information sharing between the parties,
    • Minimise the risk of mishandling complaints, incidents and non-conformances,
    • Minimise duplication of effort and ineffective use of scarce resources,
    • Ensure incidents are identified, investigated, reported and root causes monitored at local and national level so that learnings can be shared to improve patient safety, clinical outcomes and patient satisfaction.
  2. A guide to the national reporting requirements for complaints and incidents of the following types:
    • Patient Safety including Duty of Candour,
    • Pharmacovigilance (Adverse Drug Reactions and Adverse Drug Events),
    • Faulty Medicines and Devices,
    • Safeguarding,
    • Information Governance,
    • Formal and Informal Complaints,
    • Non-conformances (e.g. incidents not involving patients in Good Distribution and Good Manufacturing Practice)
  3. A standard high level reporting data set, which should be used by all organisations delivering medicines and clinical homecare services.
  4. Coding and sub-coding within the high level reporting data set, which should be used where appropriate to drill down into areas of concern.
  5. Templates for reporting and data collection.
  6. Example reports and templates for complaint acknowledgements and responses.
  7. Outline of training framework for complaints and incidents.
  8. Templates for patient information on raising complaints and reporting incidents.
  9. A summary of Key Performance Indicators for complaint and incident reporting in homecare services.

Health and safety incident reporting is out of the scope of this document.

3. Regulation of complaint and incident reporting in homecare services 3. Regulation of complaint and incident reporting in homecare services

Box 1 (below) lists the regulations, legislation, standards and guidance that might apply to a given circumstance, please note this list is not exhaustive. Further information can be found within each section of this guidance and in Annex 1. Managing complaint and incident reporting in homecare services is complex, regulations overlap and incidents may need to be reported to several national bodies. Whilst this guidance does not remove the need for specialists to develop competencies in each area, following this guidance should help avoid common reporting issues; minimise duplication of effort and reporting; and foster a common language for understanding and learning from mistakes, issues and trends irrespective of the organisation providing the homecare service.

Due to the complexity of the regulatory background, this guidance is necessarily quite technical and detailed. It should always be remembered that the overall aim of complaint and incident management is to improve patient safety, patient experience and clinical outcomes. The complaint and incident reporting described here should be considered as the start of a continuous improvement process - a means to an end rather than an end in its own right.

Box 1 Regulations, legislation and standards governing homecare services complaints and incidents processes.

Regulatory framework

  • Good Manufacturing Practice for Medicinal Products for Human use (2003/94/EC), and updating
  • EU Directive 2001/83/EC relating to medicinal products for human use as amended by 2004/27/EC, and updating
  • EU Directive 93/42/EEC relating to medical devices, and updating
  • EU Directive 2001/20/EC relating to clinical trials, and updating
  • Guidelines on Good Distribution Practice of Medicinal Products for Human Use (2013/C 343/01), and updating
  • Falsified Medicines Directive 2011/62/EU and delegated regulation EU 2016/161
  • Home Office Misuse of Drugs Act 1971 and amendments
  • The Human Medicines Regulations 2012
  • The Medicines Act 1968 and Regulations made under the Act
  • Health and Social Care Act 2008 (Regulated Activities) Regulations 2014
  • Care Quality Commission (Registration) Regulations 2009
  • Safeguarding Vulnerable Adults Act 2006
  • Children Act 1989 updated 2004
  • The Children (Northern Ireland) Order 1995
  • The Children (Scotland) Act 1995
  • Mental Capacity Act 2005
  • The Human Rights Act (1998)
  • UN Convention on the Rights of the Child
  • Data Protection Act 1998
  • Freedom of Information Act 2000
  • Bribery Act 2010
  • Competition Act 1998
  • Access to Medical Reports Act 1988
  • Access to Health Records Act 1990
  • Health and Safety (Sharp Instruments in Healthcare) Regulations 2013.

Standards and codes of practice

  • Royal Pharmaceutical Society Professional Standards for Homecare
  • National Clinical Homecare Association Code of Practice for Homecare Providers
  • Nursing and Midwifery Council Code of Conduct
  • General Medical Council Code of Conduct
  • Medicines, Ethics and Practice
  • General Pharmaceutical Council Standards

 

Registration, audit and monitoring

  • General Pharmaceutical Council registration of pharmacy premises and pharmacists and pharmacy technicians
  • Medicines and Healthcare products Regulatory Agency registration of manufacturers, wholesalers and distributors of medicinal products and medical devices
  • Care Quality Commission registration of NHS Trusts and nursing agencies
  • The Department of Health/NHS Connecting for Health Information Governance Toolkit registration of organisations managing NHS patient data
  • Information Commissioner’s Office registration under the Data Protection Act
  • UKAS accredited bodies for certifying compliance with ISO 9001:2008, ISO 14000

4. Overarching process for reporting and managing complaints and incidents 4. Overarching process for reporting and managing complaints and incidents

4.1 Rationale 4.1 Rationale

fig.1---4.1-

There is significant overlap between complaint and incident type definitions and the information that homecare providers are obliged to report to regulators, NHS, manufacturers, patients and other stakeholders. Research has demonstrated a multiplicity of terms, definitions and, most importantly, functional meanings of medication safety terminology2. A single homecare service complaint or incident may need to be managed as one or more types (See Figure 1 and Practice Example 1).


PRACTICE EXAMPLE 1

Example of a single homecare incident that meets multiple type definition

A vulnerable adult, who has difficulty self-administering their injectable medicine and has very limited support from a carer, is sent their own medicines and medicines intended for another patient. The patient does not detect that the additional medicines are labelled with another patient’s name and self-administers this medicine. As a direct result of the additional medicines the patient experiences symptoms and has to be admitted to hospital and makes a formal complaint.

Incident and complaint types:

  • Adverse drug reaction
  • Patient safety incident
  • Safeguarding incident
  • Information governance incident
  • Formal complaint

Historically, there have been separate reporting methods and records for different types of complaints and incidents within homecare services. There is a significant risk of gaps, duplication and of different organisations believing that another is following up. This may result in incidents not being fully recorded, coded, investigated and preventative actions not being implemented. Responses and external reports may not be complete which means that lessons cannot be learned and shared. Multiple reporting methods require multiple data entry and introduce risks of incomplete and different versions of the same complaint or incident on different reporting systems.
Training homecare staff on how to use multiple reporting systems and processes (usually in different training sessions) is also difficult and the overlap in complaint and incident type definitions, information required and methods of reporting frequently cause confusion and incorrect use.

It is therefore recommended that homecare services operate an overarching process for reporting and managing complaints and incidents in order to reduce the risks of both gaps and duplication. This overarching process for reporting all types of complaints and incidents will include:

  • All clinically significant complaints and incidents being reported to the relevant clinical referring centre
  • One method of reporting all types of complaints and incidents within a single homecare organisation
  • Triage of all complaints and incidents, and the application of one or more complaint and incident codes
  • The complaint or incident is documented in individual patient records (where a patient has been involved) as well as in the local quality management system
  • Regular reviews of serious complaints and incidents reports and trends by the relevant Clinical Governance Group(s) related to the specific homecare services, as well as by the homecare organisation’s Pharmacy Clinical Governance Group(s) or equivalent
  • A national standard set of data fields describing the complaint or incident to be recorded
  • A data field structure and data entry policy which enables data from non-personal identifiable fields to be shared as part of the quality audit processes with external auditors
  • A training programme for homecare staff on how to correctly follow the complaints and incidents reporting and learning procedures

It is recommended that the incident reporting processes are able to distinguish between reports relating to events occurring as part of the homecare service and those relating to complaints and incidents that have occurred elsewhere within the clinical referring centre.

4.2 Complaints and incident types 4.2 Complaints and incident types

The overarching process ensures consistency of approach between organisations, which enables co-ordination of actions, shared learning and removal of duplication. The main types of complaints and incidents which require specific escalation, investigation and reporting processes, in addition to the standard elements applied to all complaints and incidents, are shown in Box 2. All applicable types should be applied to an individual complaint or incident. Depending on the complaint and incident types applied to any individual complaint or incident, different staff and workflows will be used to investigate, categorise and prepare a response. A section of this guidance is dedicated to each of these types and guidance on the allocation to each type of complaint or incident is further detailed in section 8.4.

Box 2 – Complaint and incident types

2.2.1 - Patient safety incident including Duty of Candour
2.2.2 - Adverse Drug Reactions and Adverse Drug Events
2.2.3 - Faulty medicinal product or device
2.2.4 - Safeguarding incident
2.2.5 - Information governance incident
2.2.6 - Non-conformance
2.2.7 - Complaint – formal – written response requested
2.2.8 - Complaint – informal – no written response requested
2.2.9 – Not reportable – downgraded following triage/investigation

4.3 Overarching process for complaints and incidents (irrespective of organisations involved) 4.3 Overarching process for complaints and incidents (irrespective of organisations involved)

The process flow is shown in Figure 2 below. Immediate corrective and preventative actions must be taken to ensure patient safety on receipt of any incident report or complaint and, where appropriate, resolve the incident or complaint without the formality of a written response. Where the incident report meets the criteria described in this guideline, or a complaint is not easily resolved, or the reporter requires a written response, the overarching complaint and incident process should be followed.

Report details are recorded and then quality checked and triaged, to ensure that the known details are recorded and initial demographic and event coding applied is correct. Where appropriate, the report is also coded to one or more of the main complaint and incident types and escalated for further investigation and reporting by the appropriately trained specialist investigator. The primary investigator organisation is assigned, if multiple organisations are involved in the investigation, and the named lead investigator is assigned (see section 5).

When the complaint or incident process is initiated, an acknowledgement is sent to the patient and/or reporter.

The overarching complaints and incidents process, and the additional processes for each type, are described in this guidance.

When the specialist investigators and/or secondary investigator organisation(s) have completed their analysis and reported back, the lead investigator will prepare the final complaint and incident report. At this point, any interim reports to regulators and stakeholders are reviewed in the context of the full investigation, and any corrections and/or updates submitted. The lead investigator also prepares a closing written response for the patient and/or complainant that describes any actions identified to improve processes and services and how they will be implemented.

The lead investigator is responsible for retaining and archiving the documentation relating to the complaint or incident.

Once contributory factors and root causes have been identified, the organisation risk registers should be reviewed to check if the factors and root causes are recorded as a known risk, with associated corrective/preventative/mitigating actions. Further decisions are required on whether any existing mitigating actions have been effective or whether additional investigation and actions are required, including additional entries in the organisations’ risk registers. Each organisation should have processes in place to assess the effectiveness of corrective and preventative actions (CAPAs) that have been implemented arising from complaints and incidents.

Figure 2 Over-arching process for complaints and incidents irrespective of organisations involved

fig_2---4_3-


 

4.4 Timelines for investigation and reporting 4.4 Timelines for investigation and reporting

The timelines to be applied to general complaints and incidents reporting, and the reporting requirements for frequently encountered types of complaints and incidents, are outlined below. The timelines for other specific reports are included within the relevant section of this guideline.

On receipt of a complaint or incident report any immediate corrective or preventative actions necessary to make the patient safe should be undertaken including engagement with the clinical referring centre as appropriate.

Box 3 – Summary of complaint and incident timelines

Type of incident or complaint

Action Required

Responder

Recipient

Timescale

Complaint Timelines

Complaints and incidents (no written response requested)

Simple investigation and corrective/preventative actions.

Receipting organisation

Complainant and/or reporter

Usually by next business day

Simple coding for KPI/trend analysis

Receipting organisation

Clinical referring centre

Periodically

Complaints and incidents
(written response requested)

Written acknowledgement

Primary investigator

Complainant (copy to clinical referring centre)

Within 3 business days of the complaint raised

Final written response to the complainant (copy to clinical referring centre)

Primary investigator (supported by secondary investigator(s) as appropriate)

Complainant (copy to clinical referring centre)

Within 30 business days (unless agreed otherwise by the complainant and the primary investigator)

Complaints and incidents involving multiple organisations
(written response requested)

Share draft of the proposed written response

Primary investigator

Secondary investigator(s)

Minimum of 5 business days before issuing to the complainant

Appeals against a written response

Written acknowledgement

Primary investigator

Complainant (copy to clinical referring centre)

Within 3 business days of the complaint raised

Final written response to the complainant (copy to clinical referring centre)

Primary investigator (supported by secondary investigator(s) as appropriate)

Complainant (copy to clinical referring centre)

Within 30 business days (unless agreed otherwise by the complainant and the primary investigator)

Serious Incident Reporting Timelines

Patient Safety Incident Duty of Candour

Inform the patient and/or carer

Primary investigator or clinical referring centre as appropriate

Patient and/or carer

As soon as reasonably practicable

Major or hazardous Manufacturing Fault with the potential to cause patient harm

Confirm incident type criteria met and report

Primary investigator

Manufacturer and/or MHRA via the yellow card system

At the earliest opportunity

Safeguarding referrals

Followed up by the provider safeguarding lead

The organisation discovering the safeguarding issue

Relevant safeguarding organisation(s)

Within 24 hours or the next business day

Safeguarding referrals

Follow up meeting

The organisation discovering the safeguarding issue

Relevant safeguarding organisation(s)

Within 3 days after the initial referral

Information Governance Serious Incidents Requiring Investigation (IG SIRI)

Initial report, updates and closure

The organisation discovering the IG SIRI

Health and Social Care Information Centre (HSCIC) recently renamed NHS Digital

Initial report within 24 hours and updated with full details within 5 days of an incident becoming known. Closure expected within 90 days.

Health and Social Care Act (HSCA) notifiable incident (see Annex 1)

Initial report and updates

The organisation performing the regulated activity that gave rise to the incident

Care Quality Commission (CQC)

without delay

NHS England serious incidents (See Annex 2)

Notification or Acknowledgement

Primary investigator

Clinical referring centre and Patient and/or carer

2 business days

Complete initial review and confirm level of investigation required

Primary investigator

Clinical referring centre

3 business days (normally combined with above)

Final response/report following investigations

Primary investigator

Clinical referring centre and patient and/or carer

Normally 20 business days however, NHS England framework allows for 60 business days or 6 months for independent investigations

5. Primary and secondary investigator(s) 5. Primary and secondary investigator(s)

Each complaint and incident must have an organisation assigned as the primary investigator. This organisation holds responsibility for ensuring the complaint and incident is investigated appropriately and, where required to do so, providing a written response to the complainant and/or reporter. By default, the receipting organisation should be considered the primary investigator, unless it is more appropriate for one of the other parties involved to be the primary investigator and responsibility is formally passed to the other party. Where a written response is requested by the complainant and/or reporter they must be informed when the primary investigator status is transferred.

The primary investigator must identify other organisations that have, or may have, regulatory or reporting responsibilities relating to the incident. The Medicines and Healthcare products Regulatory Agency (MHRA)3 and the European Medicines Agency (EMA)4 provide detailed guidance on complaint handling. One or more secondary investigators may be required to work collaboratively with the primary investigator to appropriately investigate the complaint and incident. For complaints and incidents requiring a written response there is a duty for parties to co-operate toward provision of a co-ordinated response to the complainant. A complaint response that explains errors or failings made by any organisation other than the reporting organisation, or by multiple organisations, should be reviewed by all the organisations involved prior to being sent to the complainant.

The secondary investigators may have their own regulatory responsibilities with respect to an incident investigation and should manage their investigations in line with these guidelines and their own internal procedures. Care should be taken to avoid unnecessary duplication of external and regulatory reports. Where duplication is necessary, the other parties references should be included in the regulatory report to allow the duplicate reports to be easily identified.

6. Serious incidents 6. Serious incidents

The term ‘serious’ incident means different things to different people in different organisations and in different contexts. In this guidance, we have avoided using the term ‘serious’ unless it is in relation to a particular type of incident when it is used solely in that context and as defined by the relevant regulations.

What is clear from a review of the use of the term ‘serious incident’ in relation to specific complaint and incident types is that the term ‘serious incident’ should be used sparingly. Generally, the term should be applied only to incidents that are ‘serious’ enough to require the deployment of additional resources, and/or to be reported, in some form, to the relevant organisations Board of Directors. It is likely that serious incidents are controlled and managed through the organisation’s risk management and reporting processes.

Healthcare organisations which are registered with CQC are required to report ‘notifiable incidents’ (see Annex 1). These ‘notifiable incidents’ are defined in the regulation with the definitions being different for NHS bodies and independent healthcare providers (‘other registered persons’). Where duplication of notifiable incident reports to CQC is required because the incident is related to a regulated activity performed by more than one registered organisation, care should be taken to ensure duplicate reports can be cross-referenced.

In NHS organisations only, there is currently a requirement to report ‘serious incidents’ via the Strategic Executive Information System (STEIS) reporting system (see Annex 2). In other organisations significant incidents should be reported to the Board of Directors 

7. Information for patients 7. Information for patients

The patient is at the heart of the complaints and incidents process. Each element of the process is focused toward ensuring patients, and/or their carers, are informed, empowered and encouraged to report any issues. The process also promotes and supports continual collaborative learning, and improvement of the service for the benefit of future patients.

Patients should be provided with information describing the complaints and incidents procedure upon registration or with the first homecare delivery. The clinical referring centre is responsible for ensuring information is provided although depending on local arrangements, this may be provided by the referring centre, the homecare provider or a combination thereof. The clinical referring centre is considered the primary provider of information to patients with the homecare provider giving additional company specific detail or re-enforcing the referring centre’s information as appropriate.

Information provided should include:

  • How to make a complaint and/or report an incident; including
    • Which organisation to contact (and alternative)
    • Contact details (referring centre)
    • Contact details (homecare provider)
    • Examples of incidents that should be reported
  • How a complaint or incident will be handled; including
    • How confidentiality will be maintained
    • Reassurance that their treatment will not be detrimentally affected by making a complaint or reporting an incident
    • When a response should be expected
    • Information on next steps if they are unsatisfied with the formal response provided
  • Details of what constitutes a Duty of Candour patient safety incident
  • Patient support services available

Useful example


To reflect the nature of most complaints and incidents, as well as the relative resources available, patients are directed to contact their homecare provider’s customer patient services teams with any concerns in the first instance. However, some patients may prefer to speak to a healthcare professional at their clinical referring centre and provision should be made to allow this.

Formal communication with the patient following complaints or Duty of Candour incidents should use patient centred terminology wherever possible, remembering that patients may be unfamiliar with the terminology and associated definitions used within the complaints and incidents process. Templates are provided for the initial acknowledgement of a complaint or incident (section 8.3) and the closing complaint response (section 8.6).

A patient may raise a ‘complaint’ which meets the definitions of one or more incidents types (as defined in section 4.2 of this document); any communication with the patient should be in reference to their original ‘complaint’ rather than individual incidents which have been identified within it.

8. The complaints and incidents process: Step by step 8. The complaints and incidents process: Step by step

Section 8 describes the steps of the complaints and incidents process which are applicable to all types of complaint and/or incident as described in Section 4.The information which is common to many types of complaint and/or incident is highlighted so it can be collected once in the early stages of the process to ensure the necessary information is available to the investigating teams without duplication of effort and avoiding the need for repeated contact with the patient. The additional elements of the complaints and incidents process relating to complaints and to specific types of incident are described in Section 9.

8.1 Receipt of complaint and incident reports 8.1 Receipt of complaint and incident reports

The recipient of a complaint and/or incident report should first ensure that appropriate immediate action is taken to make the patient safe, including gaining support from other organisations as necessary. Immediate corrective and preventative actions must be taken with the aim of resolving issues without the need for escalation as a formal complaint requiring a written response.

8.2 Recording of complaint and incident details 8.2 Recording of complaint and incident details

A standard data set for recording all types of complaints and incidents received has been developed for use by any organisation receiving a complaint or incident to ensure consistency, aid cross-organisational working and allow efficient investigation at an appropriate level. Essential data fields are flagged as mandatory ensuring that all data required is captured during the first contact wherever possible. These data fields are shown in Tables 1 - 3.

Table 1 – Demographic codes for homecare complaints and incidents

1.1 - Patient Details*
1.1.1 - Homecare provider patient number
1.1.2 - NHS number
1.1.3 - Hospital number
1.1.4 - Surname
1.1.5 - Forename
1.1.6 - Carer or guardian name
1.1.7 - Date of birth
1.1.8 - Gender
1.1.9 - Ethnicity
1.1.10 - Address
1.1.11 - Country
1.1.12 – Diagnosis
1.3 - Reporter Details

 

1.3.1 - Reporting organisation
1.3.2 - Reporter type
1.3.3 - Reporter name
1.3.4 - Reporter telephone
1.3.5 - Reporter email
1.3.6 - Reporter address
1.3.7 - Reporter organisation

1.4 - Recipient Details
1.4.1 - Recipient name
1.4.2 - Recipient position/job title
1.4.3 - Recipient organisation name
1.4.4 - Recipient contact telephone

 

*Patient details are not required for complaints and incidents which do not involve patients. e.g. faulty medicine incident discovered prior to delivery to the patient.

Table 2 – Complaint and incident detail codes

2.1 - Incident/complaint details
2.1.1 - Description of incident/complaint (anonymised)
2.1.2 - Personal identifiable data relating to description of incident/complaint
2.1.3 - Supporting files/documents/information for incident/complaint description
2.1.4 - Immediate corrective actions taken
2.1.5 - Impact of immediate corrective actions
2.1.6 - Relevant medical history
2.1.7 - Date incident/complaint first reported
2.1.8 - Time incident/complaint first reported
2.1.9 - Date incident/complaint occurred
2.1.10 - Time incident/complaint occurred
2.1.11 - Location event occurred
2.1.12 - Number of patients affected
2.1.13 - Number of staff members affected
2.1.14 - Response to reporter requirement
2.1.15 - Consent for manufacturer to contact reporter
2.1.16 - Was the patient actually harmed?
2.1.18 - Description of harm
2.1.19 - Prevention of incident/complaint

 

2.3 - Medicine Details
2.3.1 - Description of medicine
2.3.2 - Approved name
2.3.3 - Proprietary name
2.3.4 - Non-proprietary name
2.3.5 - Dose form
2.3.6 - Strength
2.3.7 - Container type
2.3.8 - Container size

2.3.9 - Route/administration method
2.3.10 - Manufacturer (medicine)
2.3.11 - Supplier/wholesaler/importer (medicine)
2.3.12 - Parallel Importer
2.3.13 - Batch number (medicine)
2.3.14 - Expiry date (medicine)
2.3.15 - DM&D code
2.3.16 - Manufactured special
2.3.17 - Clinical trial supply
2.3.18 - Medicine for inspection
2.3.19 - Medicine administered/taken by patient?
2.3.20 - Reporter's opinion of medicine causality to the reported incident/complaint
2.3.21 - Description of other medicines taken
2.3.22 - Patient access scheme (PAS)

 

2.4 - Device Details
2.4.1 - Device name
2.4.2 - Model
2.4.3 - Catalogue number
2.4.4 - Serial number
2.4.5 - Manufacturer (device)
2.4.6 - Supplier/wholesaler/importer (device)
2.4.7 - Batch number (device)
2.4.8 - Expiry date (device)
2.4.9 - Date of manufacture
2.4.10 - Quantity defective
2.4.11 - Device for inspection
2.4.12 - Device type

Full medicine and device data (Table 2) is not required for complaints and incidents that do not involve medicines or devices, but the manufacturer should still be recorded to enable KPI reporting by manufacturer. Where more than one medicine or medical device is involved in the incident, data should be collected for each medicine and/or device.


Useful examples

  • A template complaint and incident report form (Appendix 20a) has been developed for use by homecare organisations (e.g. clinical referring centre) where data is not entered directly and immediately into an appropriate complaint and incidents management system.
  • A template patient self-reporting form for homecare complaints and incidents is also available for the patient or complainant to complete themselves (Appendix 20b). Follow-up communication may be required with the complainant to ensure all required data is available for investigation.

8.3 Acknowledgements of complaints and incidents requirings a written response 8.3 Acknowledgements of complaints and incidents requirings a written response

Where the complainant indicates that a written response to a complaint or incident is required, a written acknowledgement should be sent by the organisation receiving the initial complaint or incident report to the complainant and/or reporter within three business days of notification of the complaint or incident requiring a written response. When a complaint or incident can be investigated and resolved within three business days of the notification then a separate acknowledgment communication is not required.

Any acknowledgement should include the following (where applicable/available):

  • Complaint or incident reference number
  • Homecare provider patient number
  • NHS number or clinical referring centre number
  • Patient and/or carer’s name
  • Address
  • Clinical referring centre
  • Homecare service or therapy
  • Date of acknowledgement
  • Date of incident
  • Date incident was reported
  • Summary of the original complaint or incident
  • Duty of Candour declaration
  • Apology statement
  • Confirmation that an investigation into the incident will take place and the expected timescales for response. If more than one organisation is involved in the incident, this will include details of which organisations are involved as primary and secondary investigators.
  • Signature
  • Job title
  • Contact details if complainant would like to clarify or discuss any information in this investigation
  • Notification that a copy of this response will be sent to the clinical referring centre

Useful example

 

8.4 Complaint and incident triage 8.4 Complaint and incident triage

The introduction of a common process for all types of complaints and incidents requires that these incidents are allocated to the appropriate complaint incident type for appropriate follow up. It is recommended that homecare organisations introduce a triage process so that all complaints and incidents are reviewed centrally soon after they are first reported. The triage team should first ensure that any urgent actions are taken to address immediate patient safety concerns.

The initial report should receive a quality check, to ensure that the details are sufficient for reporting and learning. The central triage team can ensure that data quality requirements for reported incidents are met and request additional information from reporters if essential data fields are not completed, or contain insufficient information for learning and assign one or more complaint or incident types as appropriate.

The report details are coded to one or more complaint and incident types and the investigators assigned. This triage step is important as depending on the complaint and incident types selected, different staff and workflows will be used to further investigate, code, analyse, risk assess and report the incident. Complaints and incident reports must be allocated to all of the appropriate complaint and incident types (see Box 2 in section 4.2) to ensure that all complaints and incidents are recorded in full and are handled appropriately.

The lead investigator for the primary investigator organisation, see section 5, is assigned along with any secondary investigator organisation(s) as needed. The complaint and/or incident details should be forwarded to the appropriate specialist team(s) and secondary investigators.

8.5 Investigation, reporting and root cause analysis 8.5 Investigation, reporting and root cause analysis

The primary investigator’s lead investigator is responsible for checking the incident types assigned by the triage team and overseeing the activities of the specialist investigators for each type and any secondary investigator organisations. The specialist and secondary investigators must report regularly to the lead investigator on the progress of their investigation and provide to the lead investigator their findings and copies of any external reports and relevant correspondence.

Further guidance on investigation, reporting and coding of each type of incident are in section 9 and the overall coding framework is described in section 13.

Further guidance on root cause analysis, process based analysis and risk assessment is included in section 10.

8.6 Written responses 8.6 Written responses

Where the complainant and/or reporter requests a written response to their complaint or incident the primary investigator should provide a full response within 30 business days of the initial complaint or report being made; unless a longer period is considered necessary to appropriately investigate and that this period is agreed by the complainant and primary investigator prior to the expiry of the initial period.

Whilst the Local Authority Social Services and National Health Service Complaints (England) Regulations 20095 define a relevant period as six months, 30 business days is considered appropriate for most complaints and incidents relating to a homecare service and allow sufficient time for organisations to work collaboratively toward a single cohesive response to the complainant as required.

Any written response should include (where applicable or available):

  • Homecare service patient number
  • Homecare incident number
  • NHS number or clinical referring centre number
  • Patient and/or carer’s name
  • Address
  • Clinical referring centre
  • Homecare service or therapy
  • Date of written response
  • Details of the investigation and response concerning a reported patient safety incident
  • Date of incident
  • Date incident was reported
  • Summary of the original complaint or incident
  • Apology
  • Summary details of the investigation/chronology of the reported patient safety incident
  • Contributing factors and root causes of the incident
  • Actions that have been taken to minimise this re-occurring in the future
  • Final apology
  • Signature
  • Job title
  • Contact details If complainant would like to clarify or discuss any information in this investigation
  • Confirmation that a copy of the response will be sent to the clinical referring centre for information

Useful example

Collaborative approach to complaint and incident responses

Where a multi-organisational investigation has been undertaken (see section 5) for a complaint or incident requiring a written response the primary investigator should provide the draft response to the secondary investigator(s) a minimum of five business days prior to issuing to the complainant.
It is the responsibility of the secondary investigator(s) to respond with approval or any concerns within the time period. The primary investigator should not delay response to the complainant beyond the agreed period due to absence of timely approval from the secondary investigator(s).

8.7 Appeals against a written response 8.7 Appeals against a written response

Complainants should have the opportunity to appeal against a response provided to a formal complaint where there is reason to believe:

  • Facts provided are incorrect or misrepresented,
  • The investigation was not thorough enough to identify the cause of error,
  • Any element of the complaint was not addressed,
  • Any corrective or preventative actions identified are not appropriate or suitable.

Appeals should be handled in the same way as any new complaint or incident requiring a written response. The same requirements, and associated timelines, for written acknowledgement and response should be followed. Any continued dispute should be referred to the Parliamentary and Health Service Ombudsman.

9. Management of specific complaint and incident types 9. Management of specific complaint and incident types

Depending on the complaint and incident types applied to any individual complaint or incident, different staff and workflows will be used to investigate, code and prepare a response. The main types of complaint and incident which require specific escalation, investigation and reporting processes, in addition to the standard elements applied to all complaints and incidents, are detailed in this section.

9.1 Patient safety incidents 9.1 Patient safety incidents

Definition

The National Reporting and Learning Service defines a patient safety incident (PSI) as: "any event that led to actual harm to a patient or had the potential to harm a patient"

Patient safety incidents (PSIs) are preventable, and include errors of commission (e.g. wrong medicine prescribed/dispensed/administered), and omission (e.g. where medicine doses, pathology tests and clinical examinations have been omitted).

Reports that are identified as patient safety incidents require investigation and documentation of a chronology of events and the identification of the organisations, service departments and personnel involved. NHS National Reporting and Learning System (NRLS) Codes, homecare process codes and root cause codes should be applied.

A process flow for patient safety incidents is described in Figure 3, below.

A chronology of events should be compiled to describe the details of the patient safety incident. From this descriptive information, the investigatory team(s) should be able to apply NRLS codes to the incident. It should also be possible to identify the process steps involved and to compare risks identified in the incident with risks recorded in the organisation’s risk registers. Where the risks identified in the incident are not already included in risk registers (with corrective and mitigation actions) and there is a requirement for additional investigation, these should be allocated appropriately in accordance with the organisation’s local procedures.

From information recorded already in risk registers or from information received during the investigation process, final investigation reports should be prepared to describe root causes, and recommended actions to minimise similar incidents occurring in the future.

Figure 3 Process flow for coding and managing patient safety incidents

 Patient safety incident codes

Table 3 – Degree of patient harm

3.1.1.1 - None
3.1.1.2 - Low
3.1.1.3 - Moderate

3.1.1.4 - Severe
3.1.1.5 - Death
3.1.1.6 - Unknown harm

Table 4 – Patient safety incident type

3.1.4 - Patient Safety Incident Type
3.1.4.1 - Medication error (medication administered)
3.1.4.2 - Medication error (medication not administered)
3.1.4.3 - Medical device error
3.1.4.4 - Treatment/procedure error not medication or medical device related
3.1.4.5 - Clinical assessment error
3.1.4.6 - Consent/confidentiality
3.1.4.7 - Safeguarding

3.1.4.8 - Disruptive, aggressive behaviour towards staff
3.1.4.9 - Patient accident
3.1.4.10 - Infection control
3.1.4.11 - Communication related error
3.1.4.12 - Administration/documentation related error
3.1.4.13 - Time related implementation of care error
3.1.4.14 - Infrastructure
3.1.4.15 - Unclassified patient safety incident

Table 5 – Stage of medication process

3.1.6 - Medication stage
3.1.6.1 - Prescribing
3.1.6.2 - Dispensing/preparation
3.1.6.3 - Administration

3.1.6.4 - Monitoring
3.1.6.5 - Advice
3.1.6.6 - Unclassified

Table 6 – Medication error description

3.1.7 - Medication error description
3.1.7.1 - Wrong patient
3.1.7.2 - Adverse drug reaction
3.1.7.3 - Contraindication
3.1.7.4 - Dose(s) omitted or delayed - medication not available to patient
3.1.7.5 - Dose(s) omitted or delayed – adherence or compliance issue
3.1.7.6 - Dose(s) omitted or delayed - medication available to patient (excluding adherence or compliance issues)
3.1.7.7 - Extravasation
3.1.7.8 - Wrong expiry date
3.1.7.9 - Wrong information leaflet
3.1.7.10 - Wrong patient direction/instruction/misunderstanding

3.1.7.11 - Wrong label
3.1.7.12 - Wrong product dose/strength
3.1.7.13 - Wrong drug
3.1.7.14 - Wrong formulation
3.1.7.15 - Wrong frequency
3.1.7.16 - Wrong method of preparation/supply
3.1.7.17 - Wrong quantity supplied or administered
3.1.7.18 - Overdose (intentional wrong quantity administered/taken)
3.1.7.19 - Wrong route
3.1.7.20 - Wrong storage
3.1.7.21 - Drug taken beyond expiry date
3.1.7.22 - Unclassified medication error

Table 7 – Medical device error description

3.1.8 - Medical device error description
3.1.8.1 - Failure of device
3.1.8.2 - Lack of availability of device 
3.1.8.3 - User error

3.1.8.4 - Wrong device
3.1.8.5 - Other
3.1.8.6 - Unclassified

National Reporting and Learning System (NRLS) reporting of patient safety incidents

Patient safety incidents should be coded using the NHS National Reporting and Learning System (NRLS) Codes.

It is important that all NRLS reports relating to homecare are identifiable. Until there is a specific NRLS location code for homecare, all NRLS reports of homecare incidents must contain the keyword homecare in their description.

Homecare providers should share patient safety incidents arising from homecare services to patients in England and Wales with the NRLS.
There are two ways to report incidents to the NRLS:

  • Individual reports via the NRLS website. Each report has to be keyed in separately.
  • Batch reporting via the NRLS data portal

The NRLS can set up individual homecare providers with direct access to the NRLS data portal. Batches of patient safety incident reports in a specified xml data file format can be uploaded to the NRLS database. Batch reporting of patient safety incident data generated from homecare quality system databases is the only option for reporting large numbers of incident reports, to ensure data quality and the timeliness of reporting. Homecare providers are currently waiting for the NRLS to provide access to the NRLS data portal (correct at time of writing August 2016).

NRLS provides benchmark reports for organisations to assess their reporting performance against other similar organisations7.

NRLS provides further guidance which contains an overview of the National Reporting and Learning Service (NRLS)’s detailed guide to good practice, which covers building a safer culture and managing, reporting and learning frompatient safety incidents. It sets out the seven steps that NHS organisations should take to improve patient safety8.

9.2 Duty of Candour incidents 9.2 Duty of Candour incidents

Duty of Candour requirements apply to all regulated activities and are set out in Regulation 20 of The Health and Social Care Act 2008 (Regulated Activities) 20149.

The regulations place a formal requirement on all independent healthcare providers to be open and support patients when they suffer harm related to care or treatment. The Care Quality Commission provides an easy access point for the relevant regulations and guidance on the implementation in their Regulation 20: Duty of Candour Information for all providers: NHS bodies adult social care, primary medical and dental care, and independent healthcare guidance10.

Duty of Candour reporting applies to the sub-set of patient safety incidents which cause significant harm to patients.

In practice, patient safety incidents coded with the NRLS outcome codes as moderate or severe or death will usually meet the notifiable safety incidents criteria under Duty of Candour regulations. With the addition of the patient communication steps as described below, following the patient safety incident process in Figure 3 (above, section 9.1), the process for patient safety incidents will meet Duty of Candour requirements.

  • Tell the relevant person, in person, as soon as reasonably practicable after becoming aware that a notifiable safety incident has occurred, and provide support to them in relation to the incident, including when giving the notification;
  • Provide an account of the incident which, to the best of the provider’s knowledge, is true of all the facts the body knows about the incident as at the date of the notification
  • Advise the relevant person what further enquiries the provider believes are appropriate
  • Offer an apology
  • Follow up the apology by giving the same information in writing, and providing an update on the enquiries
  • Keep a written record of all communication with the relevant person

CQC registered healthcare organisations are required to report certain notifiable incidents to CQC. For further information see Annex 1.

NHS Bodies are required to report certain serious incidents via STEIS. For further information, see Annex 2.


Coding of Duty of Candour incidents

The majority of coding has already been described as Duty of Candour incidents are all by definition patient safety incidents. Additional coding relates to the timing of the specific Duty of Candour reports to the patient.

Table 8 – Duty of Candour incident

3.2 - Duty of Candour incident
3.2.1 - Is this a Duty of Candour (DoC) incident?
3.2.2 - Date of initial DoC report to patient

3.2.3 - Time of initial DoC report to patient
3.2.4 - Date of closing DoC report to patient

9.3 Adverse drug reaction incidents and adverse drug event reporting 9.3 Adverse drug reaction incidents and adverse drug event reporting

This section deals only with investigation and reporting of adverse drug reactions and adverse drug events. Furthermore, this section seeks to clarify the pharmacovigilance reporting responsibilities of each party involved in delivering the homecare service, with the overall aim of ensuring compliance with good pharmacovigilance practice, whilst avoiding duplication of reports11.

Note: Throughout this section 9.3 the term manufacturer should be read as the manufacturer or marketing authorisation holder (MAH) if different.

Definiton: Adverse drug reaction (ADR)

Adverse Drug Reaction is defined in DIR 2010/84/EU as a response to a medicinal product that is noxious and unintended (side effect)” which results not only from the authorised use of a medicinal product at normal doses, but also from medication errors and uses outside the terms of the marketing authorisation, including the misuse and abuse of the medicinal product and occupational exposure.

Definition: Serious adverse drug reaction

The serious adverse drug reaction is defined in DIR 2001/83/EC Art 1(12) as an adverse reaction which results in death, is life-threatening, requires in-patient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a congenital anomaly/birth defect or any suspected transmission via a medicinal product of an infectious agent is also considered a serious adverse reaction.

Definition: Spontaneous adverse drug reaction report

A spontaneous adverse drug reaction report is defined in GVP VI as an unsolicited communication by a healthcare professional, or consumer to a competent authority, marketing authorisation holder or other organisation (e.g. Regional Pharmacovigilance Centre , Poison Control Centre) that describes one or more suspected adverse reactions in a patient who was given one or more medicinal products and that does not derive from a study or any organised data collection systems where adverse events reporting is actively sought, as defined in VI.B.1.2.

Stimulated reporting that occurs consequent to a “Direct Healthcare Professional Communication”, publication in the press, questioning of healthcare professionals by company representatives, communication from patients’ organisations to their members, or class action lawsuits should be considered spontaneous reports.

Definition: Solicited adverse drug reaction report

GVP VI VI.B.1.2 refers to solicited ADR reports as defined in ICH-E2D. Solicited reports of suspected adverse reactions are those derived from manufacturer’s organised data collection systems, which include clinical trials, non-interventional studies, registries, post-approval named patient use programmes, other patient support and disease management programmes, surveys of patients or healthcare providers, compassionate use or name patient use, or information gathering on efficacy or patient compliance.

Solicited ADR reports to the regulator are made by the manufacturer (or marketing authorisation holder if different) and are classified as study reports.

Reports of suspected adverse reactions obtained from any of the data collection systems listed above report should not be considered spontaneous. This is with the exception of:

  • suspected adverse drug reactions in relation to those adverse drug events for which the protocol of non-interventional post-authorisation studies provides differently and does not require their systematic collection (see VI.C.1.2.1.),
  • suspected adverse drug reactions originating from compassionate use or named patient use conducted in European Member States where the active collection of adverse events occurring in these programmes is not required (see VI.C.1.2.2.).

Definition: Validated adverse drug reaction report

To be valid for submission to the MHRA, an adverse drug reaction report (also known as Individual Case Safety Report or Yellow Card Report) requires the following elements:

  • Anonymised Patient reference e.g. initials and gender
  • Reporter identifier e.g. name/staff type/homecare provider name
  • Name and details of the medicine
  • Details of the adverse drug reaction

The report should also confirm:

  • that the medicine was taken
  • that the patient was harmed

There is reasonable suspicion or knowledge that the harm was caused by the medicine taken, usually conformed by the person first identifying or reporting the adverse drug reaction. GVP VI refers to WHO guidance on assessment of causality. It is important to note that the fact that a spontaneous ADR report is submitted to the regulator is taken to imply that the reporter has reasonable suspicion or knowledge of causality. 12

Definition: Adverse drug event (ADE)

For the purposes of this guideline, the definition of an adverse drug event is

  • any untoward medical occurrence in a homecare patient administered a medicinal product and which does not necessarily have a causal relationship with the medicinal product or is related to one or more omitted doses or otherwise does not meeting the definition of a validated adverse drug reaction
  • overdose, abuse, off-label use, misuse, medication error or occupational exposure with no associated adverse reaction
  • pregnancy related exposure where the embryo or foetus may have been exposed to medicinal products (either through maternal exposure or transmission of a medicinal product via semen following paternal exposure) or infant exposure during breastfeeding with no associated adverse reaction.

An adverse drug reaction, by definition, results in actual patient harm so must always also be treated as a patient safety incident as described in section 9.1. Adverse drug events of clinical significance should also be reported immediately to the clinical team and treated as patient safety incidents e.g. patient harm or other clinical concerns which are not caused by the medicine; patient harm arising from omitted doses due to failed medicine delivery or medicine shortage.

The reporting of adverse drug events, which do not meet the criteria of a patient safety incident, is not so clear-cut (see section 9.3.6). Where it is suspected that an adverse drug event may meet the requirements of a valid ADR it should be reported as a possible ADR that is then subject to further validation by the manufacturer.

Whilst this section is specific to medicine and drug related incidents, it is good practice to have a similar reporting process for medical devices to capture device related events which do not fulfil the criteria for Faulty Medical Device reporting (see section 9.4), especially where the medical device manufacturer funds the homecare service.

9.3.1 MHRA Yellow Card Scheme 9.3.1 MHRA Yellow Card Scheme

The MHRA operates the "Yellow Card Scheme"13 The Yellow Card Scheme is the ‘catch-all’ reporting scheme which anyone (including patients, carers, NHS clinicians, community pharmacists, GPs, other healthcare professionals and homecare providers) can use to report a suspected adverse drug reaction directly to the MHRA. Circumstances where homecare organisations should use the Yellow Card Scheme are outlined below. It is also possible to report suspected adverse drug reactions to the MHRA via the NRLS (National Reporting and Learning System) or via the manufacturer. There is no need to duplicate reports made to the manufacturer or NRLS reports in the Yellow Card Scheme, although it is preferable to use the online Yellow Card reporting form as this is the most efficient and ensures the highest quality of reporting.

For established medicines the MHRA are interested in reports of serious adverse drug events. There are additional monitoring requirements for new medicines and some specified existing medicines (section 9.3.2, below).

9.3.2 Additional monitoring 9.3.2 Additional monitoring

New medicines are subject to additional monitoring as described in Guideline on Good Pharmacovigilance Practices (GVP Module X)14to ensure that any safety hazards not apparent from pre-marketing clinical studies are identified promptly. Some well-established products may also be subject to additional monitoring for instance if the product has been approved for use in a significantly new indication or in a new population. Medicines subject to additional monitoring are denoted by an inverted Black Triangle symbol (▼). This symbol appears next to the name of a relevant product in the patient information leaflet and many reference sources including the British National Formulary (BNF)15.

The MHRA publishes a full list of medicines subject to additional monitoring and further guidance on the Yellow Card Scheme16. It should be noted that many homecare medicines are subject to additional monitoring.

9.3.3 NHS clinical referring centre reporting of adverse drug reaction incidents 9.3.3 NHS clinical referring centre reporting of adverse drug reaction incidents

The responsibility to report adverse drug reactions identified within the NHS clinical referring centre remains with that centre as the primary investigator. NHS clinical referring centres are required to report patient safety incidents via NRLS (see section 9.1). If an adverse drug reaction has been reported via NRLS as part of a patient safety incident, there is no need to make a duplicate report in the Yellow Card Scheme (see section 9.3.1) as NRLS data is routinely shared with the MHRA.

It is homecare industry standard practice for the homecare providers to routinely report adverse drug reactions to the manufacturer in addition to the patient safety and clinical reporting to the prescriber and/or NHS clinical referring centre (see Figure 4 and sections 9.3.5 and 9.3.6). Where an adverse drug reaction is identified by a homecare provider and referred to the NHS clinical referring centre for further investigation the clinical referring centre is the primary investigator. There is no need for NHS clinical referring centres to duplicate via Yellow Card Report any adverse drug reaction already reported to the manufacturer as the manufacturer must further report to the MHRA (see section 9.3.4). Where regulatory reporting is via the manufacturer, the NHS primary investigator should lead the clinical investigation and assist the manufacturer with the information necessary to fulfil their obligation to report the adverse drug reaction to the MHRA.

It is recommended that the contract or agreement between the NHS clinical referring centre and the homecare provider includes consent to share NHS clinical referring centre contact details with manufacturers for the purposes of adverse drug reaction and faulty product reporting.

Figure 4 Flow chart for NHS reporting of an Adverse Drug Reaction in homecare

fig.4---9.3.3


9.3.4 Manufacturers' pharmacovigilance obligations 9.3.4 Manufacturers' pharmacovigilance obligations

Medicine manufacturers, or the Marketing Authorisation Holder if different, supplying medicines to the UK are required to operate a process to receive, collate and submit serious adverse drug reactions as Individual Case Safety Reports (ICSRs) to the Medicines and Healthcare products Regulatory Agency (MHRA). Manufacturers must report serious adverse drug reaction reports to the European regulators within 15 days as required by the European guideline on Good Pharmacovigilance Practices11 (GVP Module VI)17. There is a further requirement to submit other adverse drug reaction reports to the regulators within 90 days of initial report to the manufacturer of the suspected adverse drug reaction although this does not come into force in the UK until November 2017.

An adverse drug reaction reported by a patient or NHS clinical team, but which was not actively sought, is, for regulatory purposes, treated as a spontaneous report from the marketplace and managed as individual case safety reports (ICSRs) unless they meet the definition of a solicited ADR report.

In addition to spontaneous adverse drug reaction reports, manufacturers are also required to report validated solicited adverse drug reactions as study reports.

It is very important for ADR incident investigators and staff engaged in pharmacovigilance reporting within homecare providers, and within manufacturers, to understand the differences between spontaneous adverse drug reaction reports and solicited adverse drug reaction reports so that ADR reports contain information to allow them to be correctly reported to the regulator.

Solicited adverse drug reaction reports to regulators are always from the manufacturer, and are related to manufacturer commissioned patient support programmes (see section 9.3.7), or via the manufacturer searching of any database the manufacturer holds or can reasonably be expected to have access to.
For the purpose of safety reporting, solicited reports from homecare patient support programmes should be classified as study reports from individual patient use. The reports should have an appropriate causality assessment, to consider whether they refer to suspected adverse reactions and therefore meet the criteria for reporting. The reporting rules of solicited reports of suspected adverse reactions to the EudraVigilance database modules are dependent on the types of organised collection systems where they occurred, the recommendations provided in VI.C.6.2.1 should be followed.

If an adverse drug event does not result in harm and/or cannot reasonably be assessed to have been caused by the medicine, reporting to MHRA as an adverse drug reaction related individual case safety report is not required. GVP VI17and GVP VII18, however, may require reporting of these events amongst others within the periodic benefit-risk evaluation report (PBRER)19 which used to be known as the periodic safety update reports (PSUR).

Manufacturers must submit periodic benefit-risk evaluation reports (PBRER)19 using information the MAH may reasonably be expected to have access to and that are relevant to the evaluation of the safety or benefit risk profile. PBRERs are expected to contain information from manufacturer run patient support programmes (see section 9.3.7). In cases of drug exposure during pregnancy or breastfeeding, the manufacturer should, where possible, follow-up in order to collect information on the outcome of the pregnancy and development of the child after birth.

The manufacturer is ultimately responsible for the assessment of validity of the ADR report they make to the regulator taking into account the level of harm and assignment of causality using the data within the ADR/ADE report from the homecare organisation.

9.3.5 Homecare providers reporting of adverse drug reactions 9.3.5 Homecare providers reporting of adverse drug reactions

An adverse drug reaction by definition results in actual patient harm so must always be reported to the clinical referring centre as a patient safety incident as described in section 9.1. This will normally result in the clinical referring centre taking the role of primary investigator and therefore taking on responsibility for reporting the ADR via NRLS as described in section 9.3.3.

When the NHS is the primary investigator and/or reporter and reporting to a manufacturer is required, the suspected adverse drug reaction report from the homecare provider to the manufacturer should clearly state

  • that the homecare provider is the secondary investigator and/or reporter,
  • give the contact details of the primary investigator and/or reporter, provided consent is not withheld,
  • the primary investigator’s incident report reference where available.

Where a homecare provider becomes aware of a valid or suspected adverse drug reaction related to a homecare service funded by a manufacturer, the homecare provider is also under contract to report the incident to the manufacturer. Manufacturers are only required to report valid adverse drug reactions to the MHRA and other regulators as individual case safety reports (ICSRs). Invalid ADRs are defined as ADEs (see section 9.3.6).
Homecare providers and manufacturers who fund homecare services must be assured that their internal governance processes allow all valid serious adverse drug reactions to be submitted to the relevant regulator(s) via the relevant manufacturer within 15 days. Regulatory reporting of valid ADRs causing low harm have longer timescales (see section 9.3.4).

Any drug related patient safety incident associated with severe or moderate harm should, in practice, be classified as suspected adverse drug reactions within the homecare organisation’s complaints and incidents system and reported, as a suspected ADR, to the relevant manufacturer in real time or within 24 working hours. This will ensure further investigation to confirm their status and ensure the manufacturer is able to meet European regulatory reporting timescales for ADR reporting. Causality may not be immediately obvious and may only be assigned on investigation.

Where homecare organisations can reasonably obtain information to validate an adverse drug reaction report they should do so, however, there is no regulatory requirement to seek further information from the initial reporter. It would be reasonable for the homecare organisation to seek further information to validate an otherwise invalid ADR report if the report is of severe or moderate harm which the reporter believes to be caused by the medicine or in cases of exposure during pregnancy or breastfeeding.

Robust management and validation of causality and severity of ADRs by manufacturers is important to prevent over-reporting of ADRs. Adverse drug event reports from the homecare providers, where causality cannot reasonably be assumed, should not be translated into ADR individual case safety reports to the regulator (see section 9.3.7). The MHRA is required to assume causality within a spontaneous adverse drug reaction reports - even if the report states the adverse reaction was not related to the drug. The level of harm caused by the adverse drug reaction may be less than the patient safety incident harm outcome, but not vice versa (see RPS Homecare Service Handbook - Patient Safety Incidents and Adverse Drug Reactions (ADR) – reporting and learning p33 and Useful Definitions and Guidance on Classifying Events p34).

Section 9.3.6 describes the reporting necessary where further investigation or review by a healthcare professional results in the incident being downgraded to an adverse drug event.

Adverse drug events associated with low harm which are upgraded to non-serious ADRs after investigation should be reported to the manufacturer within 24 hours of confirmation of the re-classification as an ADR. This is to ensure the manufacturer is able to comply with the regulatory reporting timeline for submission of the ICSR which starts at the initial incident report to the homecare organisation (see section 9.3.4).

9.3.6 Homecare providers reporting adverse drug events 9.3.6 Homecare providers reporting adverse drug events

Homecare providers should report adverse drug events which are also classified as patient safety incidents to the clinical team and further reporting via NRLS (see section 9.1). There is no specific requirement for further adverse drug event reporting in NHS-led homecare services.

Further adverse drug event reporting is only applicable to a manufacture’s patient support programmes or where required within the technical agreement between the homecare organisation and the manufacturer. It is common practice for manufacturers using third parties to provide supply chain services, including homecare delivery services, to contractually require their sub-contractors to report adverse drug events. However, the regulatory basis for this is unclear where the service does not meet the regulatory requirements of a patient support programme (see section 9.3.7).

The definition of an adverse drug event is wide and the term somewhat misleading as some reportable adverse drug events are not associated with harm and there is no requirement for the event to be directly caused by the drug. GVP VI.B.6.3 specifically states that reports of overdose, abuse, off-label use, misuse, medication error or occupational exposure with no associated adverse reaction should be considered in periodic benefit-risk evaluation reports as applicable.

The definitions and requirements for reporting of adverse drug events to manufactures from homecare organisations should be carefully considered. The number of stimulated or solicited adverse drug event reports generated from routine communication with homecare patients may be high but not result in valid ADR reports. PBERs are derived from information the manufacturer can reasonably be expected to have access to and that are relevant to the evaluation of the safety or benefit risk profile. Whilst manufacturer’s fund homecare services, they often do not have access to patient level data held by the homecare organisation. If the definition of an adverse drug event is wide, every nurse visit, or telephone call with a nurse or pharmacist within a patient support programme, has the potential to result in an adverse drug event report. The information collected in adverse drug event reports should be for regulatory compliance, be of scientific interest or enhance patient safety.

Adverse drug events associated with severe or moderate harm should be initially classified as suspected adverse drug reactions within the homecare organisation’s complaints and incidents system to ensure any potential serious ADRs are captured in a timely manner (see section 9.3.5).

Adverse drug events associated with low harm that are re-classified as non-serious ADRs after further investigation should, where required, be reported promptly to the manufacturer because the regulatory reporting timelines for ADR individual case safety reports start at the time of the first report to the homecare provider. (see section 9.3.4).

9.3.7 Adverse drug reaction and adverse drug event reporting in patient support programmes 9.3.7 Adverse drug reaction and adverse drug event reporting in patient support programmes

Adverse drug reaction reports arising from patient support programmes are solicited adverse drug reaction ICSRs (see definition of solicited adverse drug reaction) and classified as a study report17.

Adverse drug event report collection is a mandatory requirement of the European wide legislation governing pharmacovigilance when manufacturers provide patient support programmes. Where the manufacturer funds homecare services and/or patient support programmes due consideration must be given within contracts and technical agreements with providers to ensure regulatory reporting requirements are met (see section 9.3.4).

Patient support programmes (PSP’s) are set up by companies to help patients and/or healthcare professionals better manage disease and optimise treatment. There is currently no regulatory definition of what constitutes a patient support programme. ABPI defines a patient support programme (PSP)20 as a service for direct patient or patient carer interaction/engagement designed to help management of medication and/or disease outcomes (e.g. adherence, awareness and education), or to provide healthcare professionals (HCPs) with support for their patients.

A PSP definition will only apply if the programme includes direct contact with patients or patient carers. The intention is to support patient care provided by the manufacturer or by a third party on the manufacturer’s behalf. Patients need to provide informed consent prior to enrolling on PSPs where they will be directly contacted. The Association of the British Pharmaceutical Industry (ABPI) guidance document providing information on pharmacovigilance requirements of PSPs20 recommends that careful consideration should be given to the design and collation of data to ensure compliance with relevant pharmacovigilance legislation and reporting requirements.

Manufacturer contracts for provision of a patient support programme related to a homecare service usually require that all known adverse drug events are captured and reported to the manufacturer. The reporting clock is started when any member of staff (nurse, pharmacist, customer services or driver) who is involved in delivering the service on behalf of the manufacturer is first made aware of the potential adverse drug event irrespective of whether they are employed by the manufacturer or the homecare provider.

Where there is direct interaction with patients within a patient support programme, there is always the possibility that adverse drug events or product complaints relating to any of the manufacturer’s products may be mentioned in passing. In these instances information may need to be recorded and reported as an adverse drug event.

In relation to manufacturer led patient support programmes, regular reconciliations are required to match adverse drug events reported by the sub-contracted homecare provider with those received by the manufacturer. In recent years, there have been increasingly onerous manufacturer audits of pharmacovigilance reporting processes within homecare providers to verify that PV reports have been complete and accurately reflect the information in the original record. In particular, manufacturers increasingly request access to source data (i.e. original clinical and patient service records). However, this is resource intensive as homecare organisations can only share non-personal identifiable data with manufacturers for audit purposes due to patient confidentiality.

When designing systems for adverse drug event reporting within patient support programmes the following should be carefully considered:

  • How the essential data elements required for a valid adverse drug event report will be documented in the patient’s clinical record and how that will be captured in a suitable format for reporting
  • How versions will be reconciled if there is more than one version of the adverse drug event record in various manufacture, NHS and homecare systems
  • How the process for asking and documenting patient consent for the medicine homecare provider to release their contact details to the manufacturer will facilitate follow-up where needed
  • How information governance regulations will be applied when sharing adverse drug event data with the manufacturer. Personal identifiable data of patients, carers, healthcare practitioners and others will need to be removed unless informed consent to share this information has been obtained
  • How the adverse drug event report will be processed and sent to the manufacturer within the contracted reporting time, including consideration of weekends and public holidays.
  • The capacity planning processes that are required to ensure sufficient resources are available to maintain robust adverse drug event reporting systems
  • The systems that are in place to document investigations and corrective and preventative actions and reporting performance
  • How adverse drug event reports will be validated and routinely and regularly reconciled with the manufacturer
  • How samples of source data/patient records within the PSP database (where an adverse drug event has been reported and also when no event has been reported) will be identified, validated and if required reviewed by the manufacturer
  • How adverse drug events that are also patient safety incidents (and vice versa) will be identified and handled

There is currently no clear definition within the European regulations of what constitutes a patient support programme, so it is currently the responsibility of the manufacturer to justify whether a homecare service, or part of a service, which they fund is to be treated as a patient support programme for regulatory purposes or not. In any case, the decision to designate or not designate a scheme as a patient support programme should be documented and detailed in the technical agreement between the manufacturer, and any third parties involved in delivery of the homecare service. Therefore, it is strongly recommended that homecare services defined as PSPs, or PSPs provided as optional additions to an existing homecare service, are designed in collaboration with pharmacovigilance, clinical and legal colleagues.

9.3.8 Adverse drug reaction and adverse drug event coding 9.3.8 Adverse drug reaction and adverse drug event coding

The coding of adverse drug reactions and adverse drug events is broadly similar, the differences generally being the level of patient harm and causal link to the medicine. From 2017 manufacturers will be required to submit individual case safety reports (ICSRs) for the UK via the European pharmacovigilance database using the ICH E2B (R3) coding)21. The homecare complaints and incident codes are aligned with these standards to ensure they are compatible with E2B (R3).

Table 9 – High level adverse drug reaction and adverse drug event codes

3.3 - Adverse Drug Reaction/Adverse Drug Event Incident
3.3.1 - Medication error
3.3.2 - Off label/unlicensed use
3.3.3 - Pregnancy related ADR/ADE
3.3.4 - Unexpected beneficial therapeutic effects
3.3.5 - Lack of drug efficacy
3.3.6 – Side effect

 
3.3.7 - Drug interaction
3.3.8 - Drug misuse
3.3.9 - Suspected transmission of an infectious agent via a product
3.3.10 - Occupational exposure
3.3.11 – ADR/ADE validated by a healthcare professional

9.3.9 Adverse drug reaction and adverse drug event training 9.3.9 Adverse drug reaction and adverse drug event training

It is important that training on these topics is provided in the wider context of the reporting culture and overarching process for reporting all types of complaints and incidents in a medicines homecare provider.

Homecare staff should undertake a generic training programme on the general principles of adverse drug reaction and adverse drug event reporting. Duplication of this general training with individual manufacturer branded training programmes is not recommended, and may introduce new risks where staff are not dedicated to delivering specific manufacturer’s service(s). Manufacturer training for clinical and pharmacy staff on the safe use and risk management of specific medicinal products is supported by adverse drug reaction and adverse drug event training, but this training should not duplicate information in other generic training modules.

See section 11 for more information.

9.4 Faulty medicine and faulty medical device incidents 9.4 Faulty medicine and faulty medical device incidents

Definition: Faulty medicine incident

Any incident arising from faulty manufacture, product deterioration, , non-compliance with the marketing authorisation or product specification file, or any other serious quality problems including detection of falsification or counterfeit22.

Definition: Faulty medical device incident

Any medical device incident relative to the appearance, identity, quality, durability, reliability, safety, effectiveness or performance of a medical device or a product with a medical device component including detection of falsification or counterfeit22.

Definition: Counterfeit and/or falsified products

Any products deliberately and fraudulently mislabelled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products. Counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients, or with fake packaging22.

Medicines and devices are an integral part of most homecare services. There is a comprehensive process of reporting and monitoring manufacturing faults in licenced medicines and devices (including counterfeit or falsified medicines and devices) which is equally applicable in the homecare setting. This guidance aims to standardise terminology used in the homecare setting, however, it is important to note that these types of incident may also be referred to as product complaints, product technical complaints or product quality defects, particularly in communications with manufacturers. The terms ‘faulty’ and ‘defective’ have the same meaning in this context and may be used interchangeably, however, the NHMC recommends that the term ‘faulty’ is used in homecare. The NHMC recommends reviewing and revising the reporting lines to make the reporting more robust, and to use resources more effectively, whilst minimising duplication. The NHMC recommends that these reporting guidelines will be implemented at the earliest opportunity by all homecare organisations.

All NHS organisations and larger homecare providers are required to appoint a named person as Medicines Safety Officer and a Medical Device Safety Officer. Safety Officers are responsible for local investigation and reporting of faulty medicines and medical devices. They are named individuals and form part of the national network of Medicines Safety Officers and Medical Device Safety Officers that seeks to learn from trends and improve patient safety.

This section deals only with investigation and reporting of manufacturing faults in regulated medicines and medical devices. Medication errors not associated either with a manufacturing fault, nor with inappropriate use of devices and equipment, but which lead to actual or potential patient harm, are reported as patient safety incidents. It is good practice to report equivalent faults in non-regulated equipment which impacts the delivery or quality of the homecare service e.g. patient’s own fridge, therefore a type code for equipment is included in the coding list (Appendix 22). However, it must be remembered that the presence of a faulty medicine or device incident may not be immediately apparent, and may only be uncovered as a cause during the root cause investigation of a patient safety incident.

Incidents might arise that are specific to homecare, particularly where medicines and devices that are normally used in a hospital setting are used in the home by patients to self-administer medicines. There is an opportunity for homecare providers to improve the monitoring of trends in faulty products in homecare services by detecting potential patient safety issues earlier and avoiding duplication of effort.

9.4.1 Reporting of faulty medicines and medical devices 9.4.1 Reporting of faulty medicines and medical devices

The routes of reporting faulty medicines and devices are via

Any clinically significant faults must also be classified as patient safety incidents and therefore reported to the clinical team at the clinical referring centre.

Figure 5 Faulty medicine and faulty medical device incident process

 

fig.5---9.4.1

 

NHS England and the Medicines and Healthcare products Regulatory Agency (MHRA) issued two patient safety alerts on 20 March 201423 to help healthcare providers increase incident reporting for medication errors and medical devices.

The alerts instruct providers to take specific steps that will improve data report quality; and established national networks to maximise learning and provide guidance on minimising harm relating to these two incident types.

The patient safety alerts call on large healthcare provider organisations across a range of healthcare sectors, along with healthcare commissioners, to identify named leaders in both medication and medical device safety roles. These leaders will be supported by two new national networks for medication and medical device safety. The networks will improve communication and feedback on reported safety issues, and enable safer practice to be discussed and shared through webinars, online forums, conferences and workshops.

Smaller healthcare provider organisations should continue to report medication and device incidents, take action to improve medication and device safety locally and work with local safety champions.

9.4.2 Manufacturing faults 9.4.2 Manufacturing faults

The MHRA is responsible for monitoring faulty medicines and faulty medical devices in the UK. Manufacturers have responsibility to record, investigate, perform trend analysis and onward report to the MHRA, therefore, where a manufacturer funds a homecare service, the homecare provider may be required to report manufacturing faults direct to the manufacturer in addition to the routine reporting of minor faults to the NHS AIC database as described in this section.

When a major or hazardous fault is systematic (affecting multiple packs/devices), and has potential for serious harm to other patients, and/or might reasonably be considered to result in a product or batch recall, this should be escalated at the earliest opportunity by reporting directly to the MHRA via the Yellow Card Scheme, as well as reporting directly to the manufacturer of the medicine or medical device.

Where there is a risk of harm to patients, the MHRA may then issue a Drug Alert or Medical Device Alert. In some circumstances, the MHRA permits manufacturers to issue a Company-led recall (for medicines) or a Field Safety Notice (for medical devices) directly to customers.

The MHRA has published guidance on defective medicines and drug alerts24.

The NHS systematically collates reports of faulty medicine within the NHS AIC Database, managed by the NHS Regional QA team based in the South West. All data collected by the NHS AIC team may be shared with the MHRA in order to meet the regulatory requirements for reporting manufacturing faults and trends.

9.4.3 Responsibility for reporting faulty medicines and devices 9.4.3 Responsibility for reporting faulty medicines and devices

Any faulty medicine and device incident should be reported by the organisation discovering the fault, unless agreed otherwise by the lead investigator within a multi-organisation investigation. Clinically important faults or faults where additional costs are incurred should also be reported to the relevant clinical team and/or commissioner as appropriate. If there is actual or potential patient harm, the incident must also be classified and reported as a patient safety incident.

Homecare organisations should ensure that ‘minor’ faults in medicines e.g. difficult to read batch number on an individual pack, one tablet squashed in a blister or those issues which could be classified as user error (e.g. premature activation of needle guard mechanisms) are captured for trend analysis.

NHS clinical referring centres generally report all faulty medicines to the Regional Pharmaceutical QA Service. The Regional Pharmaceutical QA Service reports major or hazardous faults to the relevant manufacturer and the MHRA. Each Regional Pharmaceutical QA Service collates reports from their individual hospitals and submits a summary report on a monthly basis to the NHS AIC Database

NHS bodies routinely report relevant incidents to the NHS AIC database on a monthly basis, including those received from homecare providers, with the escalation of individual serious faults direct to the MHRA via the Yellow Card Scheme.

Homecare providers routinely report to the manufacturer with escalation of individual serious faults direct to the MHRA via the Yellow Card Scheme. It is recommended that the contract or agreement between the NHS clinical referring centres and the homecare provider includes consent to share NHS clinical referring centres contact details with manufacturers for the purposes of adverse drug reaction and faulty product reporting.

Currently, homecare providers report faulty medicines and devices, relating to NHS commissioned services, to the relevant clinical team and/or commissioner. Homecare providers should prepare a monthly summary of all reported defects (minor, major or hazardous) related to NHS services and send to the NHS AIC database in the prescribed format.

Useful example

9.4.4 Counterfeit and falsified medicines and devices 9.4.4 Counterfeit and falsified medicines and devices

Medicines or medical devices suspected as being counterfeit or falsified should be investigated and reported in the same way as other faulty medicines and devices. All proven cases of counterfeit medicines or medical devices entering the homecare supply chain must be reported directly to MHRA by the company identifying the counterfeit. The MHRA produced useful information for pharmacists in June 200925.

The Falsified Medicines Directive has been supplemented by further regulation to be implemented in UK by 2019 which will require a unique identifier (a 2D data matrix code and human readable information) to be placed on medical products that can be scanned at fixed points along the supply chain and tamper evident features on each pack.

The European Commission has produced further information regarding falsified medicines and links to the regulations26.

9.4.5 Near miss reporting and supporting continuous improvement in design 9.4.5 Near miss reporting and supporting continuous improvement in design

The reporting processes for faulty medicine and devices should include reporting of medicine and device related patient safety incidents where the investigation finds that design elements related to the medicine, or medical device, directly contributed to the incident. An example might be poor spacing, location or labelling of device buttons where it is easy to press them incorrectly.

Where there is an initial report of a faulty medicine or medical device, but on investigation it is not the product or device that is faulty, it may still be appropriate to report the incident. Where there is evidence of inappropriate use (e.g. inappropriate choice of device), or user error (e.g. user did not follow instructions given), these incidents should still be captured and reported via the faulty product and device incident reporting mechanisms as they will contribute to trend analysis. For example, this may result in evidence that one type of needle guard system may be more prone to pre-activation than other similar devices.

9.4.6 Faulty product and device trend reviews in homecare 9.4.6 Faulty product and device trend reviews in homecare

It is important that the NHS AIC database contains the full set of faulty product reports so that it maintains a complete picture of faulty medicines and devices, and their inappropriate use in the homecare setting, so that emerging trends can be monitored. NHS bodies should ensure their Medication and Device Safety Officers understand the importance of reporting all homecare related incidents using the processes described in this guidance.

The NHS AIC team provide consolidated monthly trend analysis reports showing the data source only as NHS Region or anonymised as ’Homecare’ where submitted by a homecare provider. Reports are provided to the MHRA, and to each of the NHS Regional QA Services and homecare providers who submit data. NHS AIC team specifically notifies the Chair of the National Homecare Medicines Committee (NHMC) when significant trends relevant to homecare are identified.

Table 10 – Faulty medicinal product or medical device

3.4 - Faulty medicinal product or medical device
3.4.1 - Fault Category
3.4.1.1 - Faulty/defective medicine
3.4.1.2 - Faulty/defective medical device
3.4.1.3 - Faulty/defective equipment
3.4.2 - Fault type
3.4.2.1 - Labelling or leaflets
3.4.2.2 - Container or packaging
3.4.2.3 - Not compliant with product specification

3.4.2.4 - Foreign body or contamination
3.4.2.5 - Failed to operate correctly
3.4.2.6 - Counterfeit
3.4.2.7 - User error
3.4.2.8 - Inappropriate use
3.4.2.9 – Unclassified
3.4.3 - Fault severity
3.4.4 - Legal status of medicine

9.5 Safeguarding incidents 9.5 Safeguarding incidents

Definition
Any incident involving “children under 18 years of age and vulnerable adults associated with abuse, harm or neglect”27

Safeguarding principles for homecare organisations

  • All clinical homecare providers will have robust safeguarding policies in place for both children and vulnerable adults
  • All patient facing staff providing direct clinical care to patients will have level 2 safeguarding training
  • All organisations will have a designated safeguarding lead for both adults and children who will ensure policies, procedures and training are up to date
  • Each individual contract will include the commissioning organisation’s safeguarding processes and assurance that these are followed at all times and in all cases
  • Any safeguarding concerns will be communicated to providers by commissioning organisations as part of the patient referral process in order to ensure that appropriate risk assessments can take place
  • All safeguarding referrals will be followed up by the referring homecare organisation’s safeguarding lead within 24 hours of referral or the next business day to ensure appropriate handovers have been made to relevant agencies
  • The primary investigator will notify the CQC of all safeguarding alerts involving abuse or allegations of abuse. Any incident reported to police is notifiable. Where a secondary investigator is required to independently report the same incident to the CQC, the report should be cross-referenced to identify duplicate reports
  • A further follow up meeting of the safeguarding representatives of primary and secondary investigators and other organisation involved in the referral will take place three days after the initial safeguarding referral
  • All homecare providers will work closely with clinical referring centres and commissioners to ensure action and investigation is completed in a timely and safe manner
  • A debrief meeting will be held between of the safeguarding representatives of primary and secondary investigators and other organisation involved in the referral to ensure lessons learned are captured and translated into training where required

Figure 6 Safeguarding incident management process

 

Table 11 – Safeguarding incident types and categories

3.5.1 - Safeguarding incident type
3.5.1.1 - Sexual abuse
3.5.1.2 - Physical abuse
3.5.1.3 - Psychological abuse
3.5.1.4 - Domestic abuse
3.5.1.5 - Discriminatory abuse
3.5.1.6 - Financial abuse
3.5.1.7 - Neglect
3.5.1.8 - Unclassified

3.5.2 - Safeguarding category
3.5.2.1 - Patient abuse by a staff member
3.5.2.2 - Patient abuse by other professional
3.5.2.3 - Patient abuse by family/neighbour/carer
3.5.2.4 - Staff abuse by patient
3.5.2.5 - Staff abuse by other professional
3.5.2.6 - Staff abuse by member of the public
3.5.2.7 - Self-harming behaviour
3.5.2.8 - Unclassified

NHS Bodies are required to report certain serious incidents via STEIS for further information for further information see Annex 2.

9.6 Information governance (IG) incidents 9.6 Information governance (IG) incidents

Definition
Any instance “where patient or personal information has been shared to an unauthorised individual” 28

It is essential that all Information Governance Serious Incidents Requiring Investigation (IG SIRIs) which occur in Health, Public Health and Adult Social Care services are reported appropriately and handled effectively; homecare is no exception.

All reporting of serious incidents must follow Health & Social Care Information Centre (HSCIC) Guidelines currently v5.1 May 201529. Initial reports, however incomplete, must be completed and submitted within 24 hours of an incident becoming known with full incident details updated within 5 days. It is expected that incidents will be closed within 90 days. This section highlights the key elements of the HSCIC guidance that all homecare staff involved in the management of complaints and incidents need to know. Homecare staff involved in the triage or management and reporting of serious information governance incidents must refer directly to the HSCIC guidelines29 for detailed guidance.

From June 2013, all organisations processing health and adult social care personal data have been required to use the IG Toolkit Incident Reporting Tool to report level 2 IG SIRIs to the Department of Health (DH), Information Commissioner’s Office (ICO) and other regulators. In 2015, the guidance was updated to include more detailed provisions for reporting of cyber SIRIs where an information asset has been compromised within cyberspace.

The HSCIC guidance document29 and supporting online IG Incident Reporting Tool applies to all organisations providing or supporting Health and Adult Social Care services in England. Commissioned services should be subject to the same requirements to report data breaches to the commissioner of the service directly through the arrangements described in this document. Local systems may be used for local purposes, but cannot replace the need for reporting in line with the HSCIC guidance29.

9.6.1 Serious Incident Requiring Investigation (IG SIRI) 9.6.1 Serious Incident Requiring Investigation (IG SIRI)

There is no simple definition of a serious information governance incident. On further investigation, what may at first appear to be of minor importance may be found to be serious and vice versa.

As a guide, any incident which involves actual or potential failure to meet the requirements of the Data Protection Act 1998 may constitute an IG SIRI. This includes unlawful disclosure or misuse of confidential data, recording or sharing of inaccurate data, information security breaches and inappropriate invasion of people’s privacy and/or the common law of confidentiality. Such personal data breaches could lead to identity fraud or have other significant impact on individuals. This applies irrespective of the media involved and includes both electronic media and paper records. If patient information is sent to the wrong place, but is received in another organisation’s safe haven, this is likely to be classified as Level 0 or ‘near miss’, however, it is recommended that cases where patient information crossed organisational boundaries are all escalated to the organisation’s IG specialist for assessment.

The HSCIC guidance checklist should be used by all staff involved in investigating and reporting IG breaches29. It is important to note that much of this checklist will be applicable to ‘near misses’. All homecare staff should know to whom they should report and escalate for further investigation any suspected, or actual, information governance incidents, and should also understand the importance of early notification. As the parameters for determining the level of the incident are complex, it is recommended that all actual and ‘near miss’ information governance breaches are escalated to the organisation’s IG specialist for assessment. Staff should be encouraged to report IG ‘near misses’ and the opportunity taken to identify and disseminate the ‘lessons learnt’.

NHS Bodies are required to report certain serious incidents via STEIS for further information for further information see Annex 2.

9.6.2 Information governance incident process 9.6.2 Information governance incident process

Information governance incidents must be escalated to the organisation’s information governance specialist at the earliest opportunity in accordance with the organisation’s internal procedures. The investigation and reporting of serious information governance incidents (IG SIRIs) should follow HSCIC guidance. The process flow in figure 7 gives guidance on how to manage serious IG incidents that involve more than one homecare organisation and where local reports should be shared in addition to the national reporting via the IG Toolkit website.

Figure 7 Information governance high level process flow

fig.7---9.6.2


 

It is important to note that all information recorded under a ‘closed’ IG SIRI on the IG Toolkit Incident Reporting Tool will be published on a quarterly basis by the HSCIC. IG SIRI report on the IG Toolkit will be automatically closed where no updates to an ‘open’ record have been undertaken within the last 90 days. Organisations must therefore check the content recorded to ensure that no information has been included that would not normally be provided, or published, if requested under the Freedom of Information Act 2000 prior to the record being closed. See the Publication Statement on the IG Incident Reporting Tool landing page or accessible via the IG Toolkit Knowledgebase30 for further details.

The organisation’s annual report must include a summary of IG incidents in the format shown in the HSCIC Guidance. This includes individual reports of each level 2 incident and the total number of level 1 IG incidents under certain breach types. At the time of publication the breach types were as below (see Table 12, 3.6.3):-

A Corruption or inability to recover electronic data
B Disclosed in error
C Lost in transit
D Lost or stolen hardware
E Lost or stolen paperwork
F Non-secure disposal –hardware
G Non-secure disposal –paperwork
H Uploaded to website in error
I Technical security failing (including hacking)
J Unauthorised access/disclosure
K Other

Table 12 – Information governance incident

3.6 - Information Governance Incident
3.6.1 - IG Toolkit severity level (HICSC)
3.6.2 - Number of records involved (HICSC)
3.6.3 - Breach type (HICSC)
3.6.4 - Breach caused by (HICSC)
3.6.5 - Data format (HICSC)
3.6.6 - Personal data type (HICSC)

3.6.7 - Sensitivity (HICSC)
3.6.8 - IG non-conformance reported to (HICSC)
3.6.9 - Summary of incident for IG Toolkit Report (HICSC)
3.6.10 - Details of incident for IG Toolkit Report (HICSC)

9.7 Complaints 9.7 Complaints

Definition – formal complaint
An expression of dissatisfaction about an act, omission or decision of any party in relation to the provision of a homecare service either verbal or written, and whether justified or not, where the complainant requests a written response. 4 26 31

Definition – Informal complaint
An expression of dissatisfaction about an act, omission or decision of any party in relation to the provision of a homecare service which is made verbally and is resolved to the complainant’s satisfaction no later than the next business day on which the complaint was made. An informal complaint may also be described as a “concern” within NHS organisation’s complaints systems and processes. 5 27 32

Each responsible NHS body must make arrangements in accordance with The Local Authority Social Services and National Health Service Complaints (England) Regulations 200923 for the handling and consideration of formal complaints states:-
The arrangements for dealing with complaints must be such as to ensure that:

  • Complaints are dealt with efficiently
  • Complaints are properly investigated
  • Complainants are treated with respect and courtesy
  • Complainants receive, so far as is reasonably practical -
    • Assistance to enable them to understand the procedure in relation to complaints or
    • Advice on where they may obtain such assistance
  • Complainants receive a timely and appropriate response
  • Complainants are told the outcome of the investigation of their complaint and
  • Action is taken if necessary in the light of the outcome of a complaint

Relationship between complaints and incidents

As identified in section 4 the definitions of complaints and incidents overlap. A patient may report the occurrence of an incident but express no dissatisfaction. Conversely, a patient may be dissatisfied with a service provided and seek a written response or other redress to a complaint in which no defined incident has occurred.


Useful example

Examples of complaints that do not meet any defined incident type include:

  • Delivery outside agreed time window on multiple occasions
  • Rude or inappropriate behaviour of a delivery driver (which is not a safeguarding incident)
  • Long wait time to speak to customer service team (which does not impact patient safety)


Incidents identified through informal complaint

Where an informal complaint is raised and resolved to the complainant’s satisfaction but highlights occurrence of a defined incident, appropriate investigation and external reporting should be undertaken for the relevant incident type. No further communication to the patient is necessary unless Duty of Candour is applicable.

Table 13 – Complaint

3.7 - Complaint
3.7.1 - Date acknowledgement issued to complainant
3.7.2 - Date proposed written response issued to secondary investigator(s)
3.7.3 - Date of written response issued to complainant

3.7.4 - Complaint not valid
3.7.5 - Date appeal against written response received
3.7.6 - Complainant's reason for appeal

9.8 Non-conformances (incidents not involving patients or faulty medicines/devices) 9.8 Non-conformances (incidents not involving patients or faulty medicines/devices)

Definition – Non-conformance with Good Manufacturing Practice (GMP)
Failure to act in accordance with formal requirements set out in the EU Guide to Good Manufacturing Practice3 6.

Definition – Non-conformance with Good Distribution Practice (GDP)
Failure to act in accordance with formal requirements set out in the EU Guide to Good Distribution Practice3.

Definition – Non-conformance within ISO 9001 Quality Systems
Non-conformance may occur in a service, product, process, or system. It occurs when something does not meet the specifications or requirements in some way. Those requirements might be defined by customers, regulatory bodies, or the internal procedure of the company34.

For the purposes of this guideline, the non-conformance type is intended to capture any complaints and incidents which an organisation is required to, or wishes to, record and manage, but are not specifically detailed elsewhere in this guidance. It is not necessary to categorise a complaint or incident as a non-conformance if it has been correctly dealt with under another type heading. For example, a medicine with a manufacturing fault results from a GMP non-conformance, but this is already covered under as a faulty medicines and device incident.

These non-conformance incidents are usually associated with Good Distribution or Good Manufacturing Practicesor ISO 9001 accreditation 34 35. They can involve other patient related incidents or complaints, but usually are non-patient related ‘internal’ organisational issues. There may be specific requirements for regulatory non-conformances to be reported to the regulator and other stakeholders, particularly those included in the definitions above.

Non-conformance means that something went wrong – a problem has occurred and needs to be addressed, or a process was not followed correctly. Non-conformance may occur in a service, a product, a system, or in the process itself. It occurs when something does not meet the specifications or requirements in some way. Those requirements might be defined by the customer, a regulatory body, or in the internal procedures of the company. A non-conformance could be identified through customer complaints, internal or external audits, through incoming material inspection or simply during normal testing and inspection activities. Non-conformances are addressed with corrective and preventive actions3.

ISO 9001 requires organisations to document non-conformance procedures and to keep records of non-conformance issues that have been identified and the actions taken.
Non-conformance procedures within organisations should take into account the following:

  • How to decide what immediate actions will be taken to correct the problem, and who is responsible for the decision. These immediate actions can be seen as ‘damage control’ and need to:
    • stop further non-conformance
    • assess the effects of the problem – how much, how bad (e.g. scrap/rework),
    • contain the effects – e.g. quarantine defective items
    • notify affected customers, if necessary
  • How reworked items should be checked (if different from normal inspection)
  • How and where a non-conformance should be recorded
  • What steps should be taken to identify any defective product released to a customer
  • What, if any, concessions or discounts will be given to the customer
  • How a decision will be made on whether further actions are necessary

Homecare provider organisations are not required to inform NHS organisations or regulators of all non-conformance incidents. If they involve patient care, they should also be coded as one or more of the patient related complaints and incidents types as previously described and communicated to the NHS via that process.

Records of relevant non-compliance reports and corrective and preventative actions must be available for inspection during audit by MHRA, NHS and manufacturer audits.

10. Process-based analysis, root cause analysis and risk assessment 10. Process-based analysis, root cause analysis and risk assessment

All complaints, incidents and non-conformances should be subject to some degree of root cause analysis (RCA). The minimum requirement for root cause analysis is to log the process step which caused the event, to enable trend analysis and facilitate process improvement. Any serious incident associated with the service should be subject to full investigation and detailed root cause analysis. The aim is to identify preventative actions and/or risk control measures which will be applied in future to minimise the likelihood and impact of recurrence of a similar event.

10.1 Process-based analysis 10.1 Process-based analysis

The aim of process based analysis and coding is to identify the earliest process stage which resulted in the complaint or non-conformance, irrespective of which organisation involved in the pathway was responsible for that process step.

Incidents are unlikely to have one single cause and there will certainly have been multiple process steps where the cascade of events could have been halted before serious impact occurred. Therefore, in addition to the identification of the earliest stage from which the events cascaded, it is recommended that organisations record process steps which were secondary and those which were contributory factors.

The process based coding would normally identify the stage where the error actually occurred, not the internal checking stage that failed to identify and correct the error - although it may be useful to record the failure of the corresponding checking step as a contributory factor and/or to inform future risk mitigation actions.

Table 14 – High level process based codes

4.1 - Service implementation/change control
4.2 - Patient registration and patient services
4.3 - Prescribing
4.4 - Prescription management
4.5 - Purchasing/warehouse/manufacturing

4.6 - Dispensing
4.7 - Despatch
4.8 - Delivery
4.9 - Clinical/nursing Service
4.10 - Invoicing/finance

Process base sub-coding is included in full coding list described in section 13.

10.2 Root cause analysis 10.2 Root cause analysis

Once the process step(s) are identified, the nature of the error or root cause can be analysed. This text does not seek to give full guidance on root cause analysis, further guidance is available from NRLS36.Specialist training is advisable for staff undertaking root cause analysis of incidents. The root cause coding below is based on the NRLS root cause coding. In the full code list, additional sub-codes are provided for trend analysis and to guide the implementation of preventative actions.

Table 15 – High level root cause analysis codes

5.1 - Work and environment factors
5.2 - Equipment and resource factors
5.3 - Medicine or medical device triggers
5.4 - Task factors
5.5 - Education & training factors

5.6 - Communication factors
5.7 - Organisation and strategic factors
5.8 - Team and social factors
5.9 - Patient factors

10.3 Risk assessment 10.3 Risk assessment

Further guidance on risk assessment in homecare services is being prepared by the NHMC in line with NHS standards. In the context of managing complaints and incidents, risk assessment codes have been provided. These should be used to assess the risk of an incident recurring before and after preventative actions have been implemented. If the residual risk is significant, the risk should be added to the organisation’s risk register in accordance with locally approved procedures.

Table 16 – Risk assessment codes

6 - Risk control measures
6.1 - Reoccurrence prevention
6.2 - Preventative action taken
6.3 - Risk Rating - before control measures
6.3.1 - Very low risk
6.3.2 - Low risk
6.3.3 - Moderate risk

6.3.4 - High risk
6.3 - Risk rating - after control measures
6.4.1 - Very low risk
6.4.2 - Low risk
6.4.3 - Moderate risk
6.4.4 - High risk

11. Complaint and incident management training 11. Complaint and incident management training

All healthcare organisations (NHS and independent) have regulatory responsibility to have effective processes in place to manage complaints and incidents. Training all staff on how to respond to a complaint or incident is integral to the effectiveness of these processes.

NHS staff have a duty to report all incidents on the clinical referring centre’s incident reporting systems; this includes homecare complaints and incidents. All clinical referring centres should have a complaints and incidents policy which includes clear instructions to ensure that all staff are trained to report complaints and incidents. The policy should give clear guidance on how to report a complaint or incident and the appropriate assignment, roles and responsibilities of the investigator and/or handler for each report.

11.1 Level 1: Training for all homecare staff 11.1 Level 1: Training for all homecare staff

Reporting and safety culture and local systems, processes and procedures for complaint and incident management and reporting for all staff as mandatory training on job induction and with an annual update should include the following:

  • Understanding the different types of complaints and incidents that may be encountered when delivering services to homecare patients
  • Being open, honest and friendly when someone wishes to report a complaint or incident and understanding the rationale of an effective reporting and safety culture
  • Offering an apology, recognising that an apology does not constitute acceptance of responsibility
  • Taking initial corrective and preventative actions including escalation to a more senior member of staff, this is particularly important to ensure patient safety
  • How to document and report complaints and incidents using local systems, processes and procedures
  • Understanding the timescales and processes once a complaint or incident report has been made
  • Obtaining feedback on risks and areas for improvement that have been identified by the reporting process, as well as how the healthcare provider organisation is addressing and improving services to further minimise these risks and improve the quality and safety of the healthcare services to patients. A review of KPI data on complaints and incidents should be included as feedback.

11.2 Level 2: Training for members of complaints and incidents team 11.2 Level 2: Training for members of complaints and incidents team

Following level 1 training, other topic specific training may also be required as part of mandatory training on induction and as an annual update for staff involved in managing and reporting complaints and incidents.

These topics may include:

  • Pharmacovigilance (ADE/ADR) training
  • Safeguarding
  • Information governance
  • Patient safety
  • Faulty medicines/medical devices
  • Formal and informal complaints
  • Non-conformances

11.3 Level 3: Training for lead and specialist investigators 11.3 Level 3: Training for lead and specialist investigators

Central specialist teams in healthcare provider organisations that process, investigate, prompt improvements, and prepare individual responses for patients, carers, clinical referring centres, manufacturers, regulators and other external stakeholders require additional training for their specialist roles. There should be mandatory training provided to staff on induction and as an annual update. The update should include feedback on risks, and areas for improvement, that have been identified by the reporting process in the specific specialist area, including what is being done to improve reporting and learning and the quality and safety of the healthcare services to patients. Review of KPI data on complaints and incidents should be included as feedback.

It is expected that continuing professional development (CPD) relevant to their role is in place for specialist investigators for particular types of incident e.g. Safeguarding Leads, CQC Responsible Manager, Caldicott Guardian, Senior Information Risk Officer, MHRA Responsible Person, MHRA Qualified Person, Superintendent or Chief Pharmacist.

12. Key Performance Indicators (KPIs) 12. Key Performance Indicators (KPIs)

The set of Key Performance Indicators (KPIs) for homecare medicines services were updated (November 2016) to include relevant KPIs for management of services in line with this guidance. Version 4 remains in force whilst implementation plans are put in place for the updated version 5.


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13. Complaint and incident coding 13. Complaint and incident coding

A standard list of complaint and incident codes has been compiled and developed for application within organisations’ own systems. A selection of these codes have been extracted and presented in Tables throughout this document to aid understanding of their use in the context of the relevant guidance for each step of the process or complaint and incident type.

Whilst not exhaustive, the homecare complaints and incidents coding list is a comprehensive coding system for homecare and includes the codes included in the Tables of this guidance. The master code list (Appendix 22) includes the majority of data fields required for reporting to regulators and other national bodies. The codes list is compatible with data capture for the national standard governance KPI reporting endorsed by the National Homecare Medicines Committee.

The process codes are mapped to the homecare medicines process map in the RPS Homecare Handbook page 19 Fig 1.

Other codes are optional and may be used internally within companies for their own internal process control and review. From time to time, it may be appropriate to report on additional codes or sub-codes to investigate trends or where KPI results indicate that performance is lower than expected.

Each main category list includes an ‘unclassified’ category which should be used by default and where classification is unclear or no suitable code exists. Provided that ‘unclassified’ data entries are not related to serious incidents and are few in number this is acceptable. Should additional codes be required from local experience, please inform the NHMC and/or the RPS, so they can be included in subsequent reviews of this standard coding and the RPS Homecare Services Handbook.


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