CONCERNS AND COMPLAINTS POLICY GENERAL POLICY NO 1

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1 CONCERNS AND COMPLAINTS POLICY GENERAL POLICY NO 1 Applies to: All staff employed by Wirral Community Trust Committee for Approval Quality and Governance Committee Date of Approval December 2011 Review Date December 2016 (or sooner if legislation changes) Name of Lead Manager Complaints Manager Version 1 UNLESS THIS VERSION HAS BEEN TAKEN DIRECTLY FROM TRUST WEB SITE THERE IS NO ASSURANCE THIS IS THE CORRECT VERSION

2 CONTENTS Concerns and Complaints Policy Paragraph Page 1 Introduction 4 2 Aim of the Policy 4 3 Principles Ensuring Fairness and Equality in Complaints and Concerns Handling 6 4 Objectives 6 5 Definitions Duties/Responsibilities Chief Executive Director of Quality and Nursing Head of Quality and Nursing Governance Manager Complaints Manager Senior Complaints Officer Divisional Managers Quality and Governance Advanced Practitioners/RCA/SBAR Leads All Staff 10 7 Quality, Patient Experience and Risk Group Quality and Governance Committee 11 8 Key Issues Why is Investigation Necessary? Learning from Experience Organisation Improvements Communications 12 Being Open with Patients and Relatives 12 Supporting Staff 12 9 Staff Training How are Complaints Investigated? Complaints Relating to Local Authority (Part/While) or other Organisation How are Concerns Investigated? Concerns Process Following Risk Assessment Situation, Background, Assessment and Recommendation (SBAR) 17 Investigation 11.3 Root Cause Analysis Who May Complain or Raise a Concern? Patient Confidentiality 18 2/41

3 14 Access to Health Records Merseyside and Cheshire Healthwatch Advocacy Vulnerable Adults/Child Fairness and Equality Dissemination of the Complaints Procedure Monitoring and Reporting Compliance Disciplinary Issues Legal Matters/Issues Other Procedures 22 Appendices Appendix 1 Process Chart for Handling Complaints 23 Appendix 2 Patient Concerns Pathway 24 Appendix 3 Organisation Risk Matrix Appendix 4 Root Cause Analysis Lead Pathway 28 Appendix 5 Complaints That Cross Organisational Boundaries Appendix 6 Habitual/or Vexatious Protocol Appendix 7 Monitoring Compliance with the Policy Appendix 8 Organisational Chart 41 Version No Type of Change 1.1 Minor Editing Date Description of change September 2013 Minor changes made to meet Francis Report (2013) recommendations 3/41

4 Review and Amendment Log 1. Introduction Wirral Community NHS Trust recognises the importance of listening to the views of patients, relatives and carers in helping to improve the quality of services provided. This policy is to be applied when patients, relatives and carers make complaints or raise concerns. It should also be acknowledged that complaints and concerns are also part of the Patient Centred Patient Experience Model. It is the responsibility of all Trust staff to be receptive to all forms of patient feedback, including complaints and concerns. The Trust appreciates that such information is an essential element of clinical governance. The way our patients, relatives and carers perceive the services the Trust provides is critical to the success of service delivery. The Trust is committed to equality of opportunity and no complainant or informant will be treated differently to any other individual on the grounds of race, disability, age, religion or belief, gender or sexual orientation. The Trust has a statutory obligation to investigate all complaints under the NHS (Complaints) Regulations 2004, 2006 Amendment Regulations, SI 2006 No 2084 and Local Authority Social Services and National Health Service Complaints (England) Regulations 2009; and is committed to meeting the standards laid down in these regulations. The Trust will provide accessible and impartial complaints service and will respond actively and positively in a timely and effective manner, learn from complaints and implement changes to prevent the re-occurrence of problems which have arisen. A number of clinical or non-clinical complaints/concerns may be the subject of a Root Cause Analysis (RCA). RCA is defined as the process by which the underlying cause(s) of patient safety and clinical incidents are established. By doing this the appropriate actions can be planned and implemented to prevent the incident from occurring again in the future. The handling of and response to complaints may involve the Trust offering the complainant an apology. An apology is not an admission of liability. 2. Aim of the Policy The aim of this policy is to have an easily identifiable and recognisable process for dealing with complaints and concerns. The aims reflect the key expectations of the Department of Health s: Listening, Improving, and Responding: The complaints process should: Be easily accessible and open 4/41

5 Resolve complaints and concerns quickly and effectively Be fair to staff and complainants alike. Information gained from handling complaints and concerns should be used to: Contribute to clinical governance processes Feed into claims, incidents and risk mechanisms Promote learning in the organisation and where things have gone wrong avoid similar situations arising again Monitor complaints/concerns that come into the Trust to identify trends that might cause concern Identify training needs Maintain good practice and quality standards Effective complaints and concerns handling can enhance the reputation of the Trust. All key staff should be made aware of the Concerns and Complaints Policy. This will be via designated leads, i.e. Divisional Managers. 3. Principles The NHS Complaints Regulations state that arrangements for dealing with complaints must 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 complaints procedure, Advice on where they may obtain such assistance Complainants receive a timely and appropriate response Complainants are told the outcome of the investigation and actions taken, if appropriate Complaints should also be handled in the spirit of the Parliamentary and Health Service Ombudsman s (PHSO) principles Principles of Good Administration, Principles of Good Complaints Handling and Principles for Remedy. The PHSO recommends NHS organisations follow these principles to ensure effective complaints handling, which the Trust also applies to concerns: Getting it Right Being Customer Focused Being Open and Accountable Acting Fairly and Proportionately Putting things Right Seeking continuous improvement These principles should not be applied as a checklist & staff should use their judgment in applying them to produce reasonable, fair and proportionate remedies. Full details of the PHSO principles can be found at: 5/41

6 3.1 Ensuring fairness and equality in complaints and concerns handling Under the complaint regulations complainants must not be discriminated against because they have made a complaint about any Trust service, this equally applies to concerns that are raised by patients, family, friends or carers. The Trust is committed to dealing with complaints and concerns in a non-discriminatory manner. Complainants can seek advice on how to make their complaint from the complaints team. The Trust supports the use of independent advocacy within the complaints procedure, any complainant wishing to access independent advocacy will be provided with information on Manchester, Merseyside and Cheshire Healthwatch Advocacy. If a complainant or informant does feel that they have been discriminated against in any way as a result of making a complaint or raising a concern, they can contact the Complaints Manager to discuss how these issues will be addressed. The Trust is committed to operating a learning, fair blame culture when dealing with complaints and concerns providing staff have not: Intended to cause harm Acted recklessly and taken an unjustifiable risk Negligently brought about a consequence which a reasonable competent person with his/her skills should have foreseen and avoided Acted illegally by committing a criminal act including circumstances resulting in a Police investigation or prosecution Inappropriately or deliberately failed to comply with protocols or policies applicable to Wirral Community NHS Trust Repeated poor performance that has not improved with training Breached legal requirements, contractual obligations or Professional Codes of Conduct. 4. Objectives The Concerns and Complaint Policy is designed to: Enable complaints and concerns to be dealt with as swiftly as possible, in a conciliatory and courteous manner Not distinguish between verbal and written complaints and concerns, and to grant them a full and fair investigation, other than those minor complaints and concerns which can be dealt with immediately Empower staff to deal with complainants and informants wherever possible Entitle complainants and informants to a full and fair investigation of their complaint or concern without fear of retribution 6/41

7 Ensure the complaints and concerns procedure is fair to staff, complainants, and informants Ensure that the system for complaints and concerns is simple and accessible Improve the quality of services provided Ensure lessons are learned from complaints and concerns 5. Definitions Complaint A complaint is defined as an expression of dissatisfaction, (written or verbal), about a service provided or which is not provided, which requires a response. Examples of complaints include: issues about the quality of service provided; the following of standard procedures and good practice; poor communication; and the attitude or behaviour of a member of staff. If Trust employees have complaints that relate to other employees these should be raised through existing HR policies. Concern A concern is an informal complaint which can usually be resolved immediately by the service involved. Concerns are received in the first instance by the Patient Experience Service (PES). Independent Provider A person or body who provides health care in England under arrangements made with an NHS body; and is not an NHS body or primary care provider. Root Cause Analysis A way of conducting an investigation into an identified problem that allows the investigator(s), and other involved parties, to understand better the root, or fundamental, cause of the problem so that it can be put right. Responsible body A Local Authority, NHS body, primary care provider or independent provider. Responsible person A person designated in accordance with the Local Authority and Social Services and National Health Service Complaints (England) Regulations 2009 to be responsible for ensuring compliance with the arrangements. Investigation To examine, study, or inquire into systematically; search or examine into the particulars of; examine in detail. 7/41

8 6. Duties/Responsibilities 6.1 Chief Executive The Chief Executive is: The designated officer accountable for ensuring compliance with the arrangements made under the NHS Complaint Regulations, and in particular ensuring that action is taken if necessary in the light of the outcome of a complaint and personally signs all complaint response letters. Responsible for the statutory duty of quality and clinical governance and takes overall responsibility for this policy. Responsible for delegating a nominated Executive Director, in their absence, for ensuring compliance with the arrangements. Responsible for deciding if a complainant is to be treated as vexatious. 6.2 Director of Quality and Nursing The Director of Quality and Nursing is: The responsible Executive for clinical governance including patient safety. Reports to the Chief Executive and is responsible for the strategic development of systems and processes which are established, maintained and continue to be developed in relation to the receipt, response to, communication and escalation of complaints and concerns in the Community Trust. 6.3 Head of Quality and Nursing The Head of Quality and Nursing is: Responsible for the performance management of this policy. Responsible for escalating concerns to the Director of Quality and Nursing. 6.4 Governance Manager The Governance Manager is: Responsible for the management of the Complaints Team Responsible for ensuring all complaints and concerns risk rated as amber or red are dealt with under the Being Open Policy in accordance with the principles of openness, transparency and candour. Responsible for ensuring that patient feedback regarding clinical concerns risk rated as amber or red, are subject to investigation and response, of the same quality as a formal complaints, whether or not the informant has indicated a desire to have the matter dealt with as such. 8/41

9 6.5 Complaints Manager The Complaints Manager is: Responsible for ensuring effective implementation of the complaints procedures Responsible for the satisfactory management of complaints/concerns handling and considering complaints in accordance with the arrangements made under the Complaint Regulations and Trust standards. Responsible for preparing reports for the Quality, Patient Experience and Risk Group Assess the severity of the complaint, whether escalation is required and the need to contact other agencies Responsible for managing the procedures for handling concerns risk rated as amber or red. Responsible for the monitoring of key performance indicators for dealing with concerns and complaints. Responsible for providing/ensuring appropriate training for all Trust staff handling complaints 6.6 Senior Complaints Officer The Senior Complaints Officer is: Responsible for supporting the implementation of the Concerns and Complaints Policy. Responsible for providing advice to complainants who require assistance in making a formal complaint and will ensure that all formal complaints are forwarded to the relevant Divisional Manager in a timely manner in accordance with the NHS Complaints Regulations Responsible for providing guidance, help and support to staff that are responding to formal complaint and concerns risk rated as amber or red. Responsible for maintaining the complaints module on the Datix system. Responsible for assisting the Complaints Manager ensuring all relevant action plans are followed up, and reported to the relevant Group or Committee. 6.7 Divisional Managers Divisional Managers are responsible for: Setting the standards of care that Wirral Community NHS Trust expects to be delivered by the individual professions. Ensuring complaints relating to their service are investigated appropriately and promptly and keep an open mind. The investigation of a complaint may be performed by any person authorized by the Divisional Manager to act on their behalf. However, accountability cannot be delegated. 9/41

10 Ensuring staff within the Division actively participate and engage in the process for the investigation of concerns rated as amber or red, as directed by the Governance Manager. Establishing systems to ensure that feedback is provided to all members of staff involved in complaints. Ensuring that key learning points are disseminated and actions are taken or plans produced and managed to completion to reduce the likelihood of re-occurrence. Ensuring systems are in place to make certain that changes in practice are implemented as a result of lesson learned through individual and overall trends in formal complaints, collating evidence as required and meeting follow up deadlines. Ensuring that the Director of Quality & Nursing is aware of all red clinical risks. 6.8 Quality and Governance Service Advanced Practitioners/Root Cause Analysis/Situation, Background, Assessment and Recommendation Leads Quality and Governance Service Advanced Practitioners / Root Cause Analysis / Situation, Background, Assessment and Recommendation Leads, are responsible for: The investigation of complaints/concerns risk rated as amber or red in accordance with the Trust s Incident Reporting Policy, under the guidance of the Governance Manager. 6.9 All Staff All members of staff employed by the Trust are expected to be aware and adhere to the complaint and concern handling process described within this document. Staff should receive feedback, openly and honestly. All staff, including contracted staff are responsible for treating patients, relatives, carers, visitors and colleagues with empathy, dignity and respect. They should also recognise that the way the service is perceived by service users is critical in measuring the quality of service delivery. 7. Quality, Patient Experience and Risk Group In particular, the Quality, Patient Experience and Risk Group will: Review any service level risks identified as a result of complaints or concerns risk rated as amber or red, and escalate them, when appropriate, to the Quality and Governance Committee. Ensure an effective interface between claims handling, complaints management and incident reporting is taking place to ensure robust communication. 10/41

11 7.1 Quality and Governance Committee The Quality and Governance Committee will: Review the findings and ensure implementation of recommendations arising from internal audits of the Trust s concerns and complaints process. Receive assurance that the Trust meets all relevant statutory and regulatory obligations in relation to the concerns and complaints process through its reporting and monitoring structures. Receive assurance that concerns risk rated as amber or red are appropriately investigated, with action plans being monitored and reviewed by the relevant Group. Advise the Trust Board of all significant risks, areas for development and exceptional good practice, ensuring lessons are learned and shared as a result of formal complaints and concerns risk rated as amber or red. 8. Key Issues 8.1 Why is Investigation Necessary? Investigations are necessary to provide a retrospective review of an event in order to identify what, how, and why an incident occurred. The findings from the investigation should then be used to identify areas for change, recommendations and sustainable solutions, to help minimise re-occurrence. 8.2 Learning from Experience Organisation Improvements Lessons learnt from complaints and concerns are an important tool to assist in the quality of services provided and improve the patient s overall experience. The Complaints Manager will report the lessons learned were appropriate at the Quality, Patient Experience and Risk Group and to appropriate managers within the Trust to ensure that any identified risk management lessons are shared. Where it is found that action is required following a formal complaint an action plan must be completed and sent to the complaints team without delay. All actions proposed/taken will be reported to the Quality, Patient Experience and Risk Group. The actions will be monitored via the Quality, Patient Experience and Risk Group until it has been closed. Any actions which are not completed will be escalated to the Quality and Governance Committee. Complaints data is presented annually to the Department of Health. The Governance Manager will ensure that clinical concerns risk rated as amber or red are subject to an appropriate level of investigation, as required to maximise learning from experience. Investigations will be conducted in accordance with the Trust s Incident Reporting Policy. Any investigations conducted will result in the development of an action plan to address any identified service improvements. 11/41

12 Action plans resulting from Situation, Background, Assessment and Recommendation (SBAR) investigations will be monitored by the Quality, Patient Experience and Risk Group. Action plans resulting from Root Cause Analysis (RCA) investigations will be monitored by the Quality and Governance Committee as detailed in Appendix 2: Patient Concerns Pathway. The Trust s Medical Director, Director of Quality and Nursing and Director of Operations will also be notified where appropriate so that organisational and clinical risks may be added to the Trust s Risk Register as required. 8.3 Communications Being Open with Patients and Relatives Related Trust Policy: Being Open Policy GP43 In accordance with the recommendations of the Francis report (February, 2013), the Trust is committed to improving communication with patients and/or carers. When things go wrong it is essential that relevant parties are kept fully informed and feel supported. The Being Open process underpins both the local resolution stage of the complaints process and the handling of clinical concerns risk rated as amber or red. Supporting staff Related Trust Policy: Stress Management Policy HRP 29 The Trust acknowledges that staff whose actions may have led to another person raising a complaint or a concern are often upset and distressed and may need support whilst any investigation is on-going. It is important to consider not only how the complainant feels in such situations, but also those in the organisation being complained against as this can be an extremely stressful experience. Staff will be supported by their Line Manager, in the first instance, and if required, the Trust will provide confidential counselling for staff involved in complaints and concerns via the Occupational Health Provider, PAM Assist. It is also necessary to examine the details of a formal complaint as quickly as possible to assess if any immediate action needs to be taken to protect patients, staff or Trust property or to secure information that might be subsequently lost. Staff should be assured that it is not the intention of the concerns and complaints handling process to apportion blame. They should be assured that the intention is to resolve the issue and to take steps to learn from the event and prevent reoccurrence. 9. Staff Training An annual training needs analysis is overseen and co-ordinated by the Learning and Development Group (L&D) which produces a: 12/41

13 Trust Wide Mandatory Training Matrix Divisions oversee staff annual appraisals and if needed update their: Service Specific Mandatory Training Matrix The Trust s Learning and Development Policy outlines how the organisation monitors attendance at training and follows up persistent non-attendance. Specific support will be provided to those who require it on a case by case basis from the patient experience and complaints leads. 10. How are complaints investigated? The complaints procedure has two stages: a). Local Resolution b). Review by the Health Service Ombudsman A complaint must be made no later than 12 months after the date on which the matter which is the subject of the complaint occurred; or if later, the date on which the matter which is the subject of the complaint came to the notice of the complainant. The time frame shall not apply if the Trust is satisfied that the complainant had good reason(s) for not making the complaint within the time limit, and not withstanding the delay, it is still possible to investigate the complaint effectively and fairly. a) Local Resolution Receive, acknowledge, investigate, respond and listen Ideally complaints will be and are, where appropriate, resolved on the spot by frontline staff effectively and efficiently. Staff are encouraged to make a record of locally resolved complaints including the name, what the complaint was about, what steps were taken to respond to the complaint and whether the complainant was happy that the complaint was resolved. Receive A complaint may be made orally, in writing or electronically. If a complaint is received initially by a service, it should be forwarded immediately to the complaints team. All complaints, including those resolved informally on the spot, must be recorded for monitoring purposes. This will demonstrate that the Trust is responsive to comments, complaints, concerns and compliments and will provide management information for monitoring the current quality of service provision and to inform future service changes and developments. A register of all complaints received will be maintained by the complaints team. 13/41

14 Service users verbal complaints, comments, concerns, and compliments are to be recorded by staff on the Patient Experience Service leaflet. This leaflet will be made available in all services and can be accessed at Acknowledge All complaints must be acknowledged by the complaints team no later than 3 working days after the date the complaint is received. The acknowledgment may be made orally, or in writing. When a complaint is acknowledged, the Complaints Manager or Senior Officer will discuss with the complainant:- The manner in which the complaint is to be handled; The timescale within which the investigation of the complaint is likely to be completed and, the response is likely to be sent to the complainant. If the complainant does not accept the offer of a discussion, the Complaints Manager will determine the response period and notify the complainant in writing of that period. Investigate When a complaint is received it will be forwarded to the Divisional Manager who will: Investigate the complaint in a manner appropriate to resolve it speedily and efficiently, and; Throughout the investigation keep the complaints team informed as far as reasonably practicable of the progress of the investigation. Respond Once the investigation is completed, details of the complaint investigation must be recorded on the Datix file and a draft response must be forwarded to the complaints team who will forward it to the Governance Manager for ratification. A response will be compiled by the complaints team for signature by the responsible person (Chief Executive), or any person delegated with responsibility on their behalf. The response will include: An account of how the complaint was investigated, the conclusions reached and any actions taken. The complainant s right to take their complaint to the Health Service Ombudsman where the complaint relates wholly to health or if the complaint relates in part to Local Authority the Local Government Ombudsman. Complainants have the right to a complete reply to their complaint as quickly as possible. In exceptional circumstances this may not be possible. If the Trust does 14/41

15 not send a response within 6 months of receiving the complaint the complainant will be notified in writing that the complaint is still under investigation and explain the reasons why they have not received a response and send the complainant a full response in writing as soon as reasonably. If a complainant contacts the Trust after receiving their response requesting further information or explanation, every effort will be made to answer the enquiries at Local Resolution. It may be that a meeting to discuss the issues could be offered. If the complainant remains unhappy following further efforts to provide a further response they will be advised to contact the Health /Government Service Ombudsman. Should a complainant raise new issues at this stage that were not included in the original complaint, these must be investigated as a separate new complaint. Listen Wirral Community NHS Trust s vision is to be the outstanding provider of high quality integrated community services to Wirral and beyond. Our values show what we stand for, believe in and are passionate about: Providing excellent care and service Listening and responding Being supportive and empowering Demonstrating knowledge and professionalism Promoting the value of services in the community Positive partnerships and team working Embracing change. Wirral Community NHS Trust believes it is important that the Trust listens and learns from patient experiences of our services. The Trust supports the presentation of these experiences to the Trust Board on a monthly basis. Service Users should be encouraged to complete our online feedback form, b) Review by the Health Service Ombudsman (Commonly known as Parliamentary and Health Service Ombudsman (PHSO). Every effort should be made to resolve a complaint at the local resolution stage but if a complainant is unhappy with the response they have the right to contact the Health Service Ombudsman and request a review of their complaint. Further information on the role of the PHSO can be found at:- 15/41

16 10.1 Complaints relating to Local Authority (Part/Whole) or other organisation Where a complaint is received that contains material which relates wholly or in part to a Local Authority or other organisation, the Trust will ask the complainant whether s/he consents to details of the complaint being sent to that organisation. If the complainant consents, details of the complaint will be sent as soon as reasonably practicable. Where the responsible body receives a complaint via the Trust in the circumstances referred to above, they must co-operate. In some cases the Trust will take the lead in co-ordinating the handling of the complaint thus ensuring that the complainant receives a co-ordinated response to the complaint. Further guidance on the handling of complaints that cross organisational boundaries attached in (Appendix 6). 11. How are concerns investigated? Patient concerns are received by the Trust through a variety of routes e.g. , feedback cards, telephone and via the Trust website. All concerns must be recorded onto Datix within one working day of receipt into the Quality and Governance Service; an automatic will be generated by the system, and sent to the Service Lead and other appropriate managers. Non-clinical concerns will be managed by the relevant Service Lead. Clinical and non-clinical concerns will be allocated for triage by the dedicated Patient Experience Administrative Support Office, once inputted onto the Datix system. All clinical and non-clinical concerns are triaged by a clinician working within the Quality and Governance Service using the Trust s Risk Assessment process. Triage only occurs on working days: Monday Friday, this does not include Bank Holidays. Clinical and non-clinical concerns inputted on a working day between the hours of 08:30hrs midday, will be triaged and risk assessed on the same working day. Clinical and non-clinical concerns inputted onto Datix on a working day between the hours of midday 17:00hrs will be triage and risk assessed on the following working day. Case note reviews may at times be requested by the Quality and Governance Service to inform a comprehensive risk assessment process. All Divisions within Wirral Community NHS Trust must provide the requested health care records within the timescales agreed with the Quality and Governance Service, to support the concerns risk assessment process Concerns process following risk assessment Following the risk assessment of clinical and non-clinical concerns, the Clinical and non-clinical Concerns Management Pathway will be followed, as per Appendix 3. 16/41

17 11.2 Situation, Background, Assessment and Recommendation (SBAR) Investigation SBAR investigations may be allocated by the Governance Manager for clinical concerns with an amber risk rating of 12 following a comprehensive risk assessment, which may require a clinical case note review. Following allocation, SBAR investigations should be completed within ten working days by a member of the Quality and Governance Service. SBAR investigations provide a robust framework to investigate amber risk rated concerns in a timely manner, ensuring lessons learned can be identified, with resulting actions being initiated promptly to maximise patient safety, reducing the likelihood of reoccurrence. SBAR documentation will be used in accordance with the Trust s Incident Reporting Policy Root Cause Analysis All complaints/ concerns are initially graded using the Trust s Risk Matrix (Appendix 3) to ascertain the severity of the issues raised in order to ensure they are appropriately managed. If a complaint is graded amber consideration to enter the complaint on the Risk Register will be made on an individual basis. If a complaint is graded red an entry should be made on the Risk Register. The investigation method for complaints graded amber or red is Root Cause Analysis/SBAR. Complaints which are graded amber or red will only be closed when all actions are completed. On occasion, situations result in which a formal complaint or concern may need to be reported to external agencies. This should be done as a result of the incident itself and not because a complaint/concern has been made. It is important to ensure that the following have occurred, as appropriate, when a complaint is upheld: Where there is suspicion of gross professional misconduct then the General Medical Council or Nursing & Midwifery Council or other professional body may need to be informed, staff must liaise with the Director of Quality and Governance. Complaints involving a request for compensation as a result of allegedly negligent treatment must be referred to the Trust s Claims Manager who will liaise with the NHS Litigation Authority. Concerns and Complaints involving medical devices or consumable products should be notified to the Medicines and Healthcare Products Regulatory Agency (MHRA). Staff must report incident to MHRA on line and attach documentation to a competed Trust Datix Incident Form as evidence of reporting the incident. 17/41

18 Complainants and informants may refer their complaint about the Trust to the commissioning body who may investigate the matter themselves or with the consent of the patient refer the matter to the provider 12. Who may complain or raise a concern? Existing or former patients who receives or has received services from the Trust; a person who is affected or likely to be affected by the action, omission or decision of the Trust; Complaints may be made on behalf of patients by anyone who has the patients consent. Where a patient is unable to act, his or her consent shall not be required; A person who is acting on behalf of a patient who has died, is a child, or unable to make the complaint themselves because of physical incapacity; or lack of capacity within the meaning of the Mental Capacity Act 2005 (18). Patients, relatives and carers must be assured that if they have to raise any concerns/complaints regarding treatment and care that these issues will be dealt with in a professional and caring manner; and that by raising such concerns, their future treatment and care will not be compromised. Staff must also be aware that to discriminate against a patient who has raised a complaint/concern could result in disciplinary action being taken against them. 13. Patient confidentiality The use of the patient s personal information to investigate a concern or complaint is a purpose for which it is not always necessary to obtain the patient s consent. However, care must be taken at all times throughout the concerns and complaints procedure to ensure that any information disclosed about the patient is confined to that which is relevant to the investigation of the concern or complaint and only disclosed to those people who have a demonstrable need to know it for the purpose of investigating the concern or complaint. Further information on sharing information can be sought from the Trust s Caldicott Guardian and/or Information Governance lead. Where a complaint is made on behalf of a patient who has not authorised someone to act for him/her, care must be taken not to disclose personal health information to the complainant or informant, unless the patient has expressly consented to its disclosure. Concerns and complaints records will be held by the Complaints Department. Concerns and complaints records must be kept separate from health records, subject to the need to record any information which is strictly relevant to his or her health in the patient s health records. 14. Access to Health Records Related Trust Policies: Managing the Quality of Health Records Policy GP6, Freedom of Information Policy GP34 18/41

19 Access to relevant records is important in the context of concerns and complaints and a potential source of difficulty in some cases. The Trust operates in accordance with the provisions of the Access to Health Records Act 1990 (for deceased patients); Data Protection Act 1998; and the Freedom of Information Act Policy. 15. Healthwatch Independent Advocacy Merseyside and Cheshire Healthwatch Independent Advocacy Merseyside and Cheshire currently provides external independent advocacy to people wishing to complain about the treatment or care they received under the NHS in Merseyside and Cheshire. There is a statutory requirement to provide advice on where complainants may obtain assistance. Therefore, this service must be signposted to the complainant no matter what level their complaint is being dealt with. Trained advocates with knowledge of the NHS Complaint Procedures help clients to understand whether they wish to pursue a complaint and where needed advocates provide support to clients in doing so. The support offered ranges from helping the client with initial preparation in ordering their thoughts and thinking about what a good resolution would look like to them, through to attendance at resolution meetings and helping people with correspondence. 16. Vulnerable Adults/Child Related Trust Policy: Safeguarding Adults Policy GP12 and Local Safeguarding Children Board, Any concerns raised regarding vulnerable people in relation to safeguarding; access to patient (including that afforded to volunteers or celebrities) in the first instance to be raised with the Director of Quality and Nursing. 17. Fairness and Equality Related Trust Policy: Equality and Diversity Policy HRP36 Making a complaint or raising a concern does not mean that a patient/complainant or informant will receive less help or that things will be made difficult for them. Everyone can expect to be treated fairly and equally regardless of age, disability, race, culture, nationality and sexual orientation. The Trust will aim to collect equality and diversity data across all 9 characteristics to monitor trends and avoid discrimination taking place. Trust staff needs to reassure patients and their carers that they are not discriminated against when a concern is raised or a complaint is made and that their on-going treatment will be unaffected. Complaint records must be kept separate from clinical records. 19/41

20 18. Dissemination of the Complaints Procedure This procedure will be available to staff on the Staff Zone of the Intranet under General Policies (GP1). 19. Monitoring and Reporting The complaints team will maintain a record of each complaint received, the subject matter and outcome of each complaint, the agreed response period including any amendments to that period, and whether a response was sent out within the response period. The complaints team will review complaint files on a monthly basis to ensure evidence has been provided confirming actions from a complaint have been completed. If no evidence has been received the complaints team will contact the relevant Divisional Manager. Divisional Managers are responsible for monitoring and ensuring all actions as a result of a complaint are completed by due dates after the investigation has been completed. A report outlining number of written complaints received and actions taken will be reported in the Quality and Governance Report and submitted to the Quality and Governance Committee on a monthly basis. An Annual Report will be produced on complaints for the Trust Board. The report will: Specify the number of complaints received Specify the number of complaints the Trust were founded Specify the number of complaints referred to the Health Service Ombudsman Summarise the subject matter of complaints received, any matters of importance, and any matters where action has been taken to improve services as a consequence of complaints. 20. Compliance The compliance of this policy will be monitored by the following auditable Key Performance Indicators prior to review in a year or earlier in response to changes in legislation. 1) The Concerns and Complaints Policy meets NHSLA minimum requirements B8A0 B45F95F56F84/0/Documentfortheinvestigationofincidentscomplaintsan dclaims.doc 2) Key individuals have received training with regards to this policy 3) Actions are taken in response to concerns and complaints and outstanding issues are followed up by Divisional Managers. 20/41

21 4) Trends identified will be documented in Quality & Governance Committee Report. 5) Complaints raised will have a complaint file will all information pertaining to the complaint. 6) Concerns and complaints will be acknowledged within 3 working days. 7) Complaints will be responded to within the time frame agreed with complainant. 8) Complaints graded amber - 12 or red will be for inclusion on the Trust s Risk Register. 21. Disciplinary Issues It is not appropriate to address disciplinary matters through the Concerns and Complaints Policy, however, evidence from concerns and complaints may be used as part of a disciplinary process. 22. Legal Matters/Issues If formal legal action has been initiated by the complainant, there is no requirement for the NHS complaints procedure to cease. However, if advised by an appropriate body, i.e. NHS Litigation Authority, the Police, that to continue with a complaint investigation may jeopardise a legal matter, then the complaint investigation will cease and the necessary parties informed. The NHS complaints procedure would not be able to assist complainants with claims for compensation. 23. Other Procedures Related Trust policies: Incident Reporting Policy-GP8 and Risk Management Strategy-GP5. Should a clinical concern or complaint lead to the identification of a serious untoward incident, the Trust s policy for Incident Reporting and Risk Management Strategy must be followed. 21/41

22 Appendix 1: PROCESS CHART FOR HANDLING COMPLAINTS. Complaints team receive complaint. If received by the service fax immediately to complaints team on safehaven fax Complaint recorded on Datix and risk assessed using organisations risk matrix. Complaints team discuss handling of complaint with complainant and agree time frame etc. Complaint team discuss issue/time frame required to address complaint with Divisional Manager. Complaints team to acknowledge complaint within 3 working days of receipt. Forward complaint details, via Datix, to Divisional Manager requesting investigation into matter. Complaints team receives complaint investigation findings and draft response in time frame agreed. Draft response quality assured by Quality and Governance Team before forwarding to Chief Executive for approval and signing off. If, there is no further contact from complainant, close complaint & update Datix. If complainant has further questions, they can approach complaints team. Response to be forward to complainant identifying organisational learning and advising of action plan. Also advise of recourse to the PHSO. One month from file being closed check actions have been completed. Complaint information to be collated and reported monthly to Quality & Governance Committee 22/41

23 Appendix 2: Patient Concerns Pathway PES receives concern - Acknowledges concern within 3 working days PES forwards concern to Service Manager via Datix for Service Manager to address Service Manager investigates concern and feeds back to caller (if requested) within specified time frame as advised by PES Service Manager to feedback to PES by completing relevant Datix sections as advised by PES PES to liaise with Advanced Practitioner to triage concern using risk matrix (Quality & Governance concerns triage process to be followed) GREEN AMBER RED No SBAR/RCA required Follow Green pathway but if caller requests feedback Service Manager to compile draft response (using template letter provided) and also feedback to PES by completing relevant Datix sections as advised by PES PES to liaise with Governance Manager to triage to establish if SBAR/RCA required No feedback required Yes SBAR/RCA required PES to inform Service Manager concern requires SBAR/RCA Service Manager MUST contact caller within time frame specified by PES, to advise concern being investigated and establish if caller requires feedback Yes feedback required AMBER / RED May require SBAR/RCA Advanced Practitioner to inform PES SBAR/RCA undertaken by Q&G Team with Service Manager aim to complete RCA in 25 working days and SBAR in 10 working days, and disseminate to Service Manager Q&G Team and Service Manager to review report and Service Manager advised outcome can be shared with caller Service Manager to inform caller of the outcome of the investigation within time frame as specified. Following feedback to caller Service Manager to compile draft response (using template letter provided) if written feedback is requested by caller or concern raised has been risk rated as red. The Service Manager must also feedback to PES by completing relevant Datix sections. 23/41

24 Appendix 3: Risk Matrix Descriptor Staff/Patient/Visit or Injury (Physical/ Psychological) Patient Experience Environmental Impact Staffing & Competence Complaints/ Claims Financial Negligible 1 >Adverse event requiring no/minimal intervention or treatment Impact prevented any patient safety incident that had the potential to cause harm but was prevented, resulting in no harm Impact not prevented any patient safety incident that ran to completion but no harm occurred >Reduced level of patient experience which is not due to delivery of clinical care >Minor onsite release of substance >Not directly coming into contact with patients, staff or members of the public >Short term low staffing level (<1 day) temporary disruption to patient care >Minor competency related failure reduces service quality,1 day >Low staff morale affecting one person >Informal/locally resolved complaint >Potential for settlement/litigation < 5K >Small loss >Theft or damage of personal property < 50 Minor 2 >Minor injury or illness first aid treatment needed Health associated infection which may/did result in semi permanent harm >Affects 1-2 people >Any patient safety incident that required extra observation or minor treatment w and caused minimal harm to one or more persons >Unsatisfactory patient experience directly due to clinical care readily resolvable >Onsite release of substance contained >Minor damage to Trust Property easily remedied < 10K >On-going low staffing level minor reduction in quality of patient care >Unresolved trend relating to competency reducing service quality >75% - 95% staff attendance at mandatory/key training >low staff morale (1% - 25% of staff) >Overall treatment/service substandard >Formal justified complaint >Minor implication for patient safety if unresolved >Claim < 10K >Loss < 50K >Loss of % of budget >Theft or loss of personal property < 750 Moderate 3 >Moderate injury or illness requiring professional intervention >No staff attending mandatory/key training >RIDDOR/Agency reportable incident (4-14 days lost) Adverse event which impacts on a small number of patients >Affects 3-15 people >Any patient safety incident that resulted in a moderate increase in treatment x and which caused significant but not permanent harm to one or more persons >Unsatisfactory management of patient care local resolution (with potential to go to independent review) >On site release no detrimental effect >Moderate damage to Trust property remedied by Trust staff/replacement of items required 10k - 50k >Late delivery of key objectives/service due to lack of staff >50% - 75% staff attendance at mandatory/key training >Unsafe staffing level >Error due to ineffective training/competency >Low staff morale (25% - 50% of staff) >Justified complaint involving lack of appropriate care >Claim(s) between 10K- 100K >Major implications for patient safety if unresolved >Loss of 50K- 500K >Loss of % of budget >Theft or loss or personal property > 750 Major 4 >Major injury/long term incapacity/disability (e.g. loss of limb) >14 days off work Affects people >Any patient safety incident that appears to have resulted in permanent harm y to one or more persons >Unsatisfactory management of patient care with long term effects > Significant result of misdiagnosis >Offsite release with no detrimental effect/ on-site release with potential for detrimental effect >Major damage to Trust property external organisations required to remedy associated costs > 50K >Uncertain delivery of key objective/service due to lack of staff >25% - 50% staff attendance at mandatory/key training >Unsafe staffing level >5 days >Serious error due to ineffective training and / or competency >Very low staff morale (50% - 75% of staff) >Multiple justified complaints >Independent review >Claim(s) between 100K- 1M >Non-compliance with national standards with significant risk to patients if unresolved >Loss of 500K- 1M or loss of 0.5-1% of budget >Purchasers failing to pay on time Catastrophic 5 >Fatalities >Multiple permanent injuries or irreversible health effects >An event affecting >50 people >Any patient safety incident that directly resulted in the death z of one or more persons >Incident leading to death >Onsite/Offsite release with realised detrimental/ catastrophic effects >Loss of building/major piece of equipment vital to the Trusts business continuity >Non-delivery of key objective / service due to lack of staff >On going unsafe staffing levels >Loss of several key staff >Clinical error due to lack of staff or insufficient training and / or competency >Less than 25% attendance at mandatory / key training on an on-going basis >Very low staff moral (>75% of staff) >Multiple justified complaints >Single major claim >Inquest/ombudsman inquiry >Claim > 1M >Loss > 1M or loss > 1% of budget >Loss of contract/payment by results 24/41

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