Policy for the Management of Safety Alerts issued via the Central Alerting System (CAS)

Policy for the Management of Safety Alerts issued via the Central Alerting System (CAS)

Policy Title: Executive Summary: Policy for the Management of Safety Alerts issued via the Central Alerting System (CAS) A number of agencies including the Patient Safety Agency (PSA), Department of Health (DH), NHS Estates and the Medicines and Healthcare Products Regulatory Agency (MHRA), as well as others issue safety Alerts and other notices. Supersedes: V4.0 Description of Amendment(s): The Department of Health introduced the Central Alerts System (CAS) as a means of sending, electronically, these notices to nominated leads usually CAS Liaison Officers in Trusts in a more streamlined way, to improve the method in which they are issued, delivered and implemented. This policy describes the framework for the distribution of safety alerts within the organisation and the mechanisms for communication of action needed or completed back to the various agencies which use this system. Minor text amendments Job title changes and directorate changes Changes to performance and monitoring This policy will impact on: This policy will be applicable to all Service Lines Financial Implications: None identified with the implementation of the policy Policy Area Corporate Document ECT002902 Reference: Version Number: 5.0 Effective Date: January 2018 Issued By: Director of Corporate Review Date: January 2021 Affairs and Governance Author: Andy Chambers Head of Safety, Risk and Resilience APPROVAL RECORD Committees / Group Date Consultation: Risk Management Sub Committee December 2017 Approved by: Approved by Director Lorraine Jackman Deputy Director of Corporate Affairs and Governance Julie Green Director of Corporate Affairs and Governance December 2017 December 2017 Received for Information: Medical Devices Group December 2017

Contents 1.0 Policy Statement 2.0 Scope 3.0 Organisational Responsibilities 4.0 Planning and implementation 5.0 Definitions 6.0 Measuring performance & audit 7.0 Review Appendix 1 Process map PSA Alerts Appendix 2 Process map DH/EFA Alerts (General) Appendix 3 Process Map EFA Alerts (Electrical Only) Appendix 4 Process map MDA Alerts Appendix 5 Process map Dear Dr Letters/CMO Alerts Appendix 6 Escalation of actions not taken Appendix 7 Datix Safety Alerts Guide for Recipients of Alerts Appendix 8 Equality impact assessment

1.0 Policy Statement A number of agencies including the Patient Safety Agency (PSA), Department of Health (DH), NHS Estates and the Medicines and Healthcare Products Regulatory Agency (MRHA), as well as others issue safety Alerts and other notices. The Department of Health introduced the Central Alerts System (CAS) as a means of sending, electronically, these notices to nominated leads in Trusts in a more streamlined way, to improve the method in which they are issued, delivered and implemented. This policy describes the framework for the distribution of safety alerts within the Trust and the mechanisms for communication of action needed or completed back to the various agencies which use this system 2.0 Scope This policy covers the following types of alerts that are issued to the Trust via the Central Alerting System (CAS): Patient Safety Agency (PSA) alerts Medical Device Alerts (MDA) Department of Health Alerts (DH) Estates and Facilities Alerts (EFA) Chief Medical Officer Alerts (CMO) Dear Doctor Letters (DDL) The Pharmacy Department has a separate procedure in place for the management of drug alerts received. These alerts are both entered onto Safety Alert section of Datix and managed by the Pharmacy Department. 3.0 Organisational Responsibilities 3.1 Chief Executive Has ultimate responsibility for the implementation and monitoring of the policies in use in the Trust. This responsibility may be delegated to an appropriate colleague. 3.2 Director of Corporate Affairs and Governance Is the Executive Lead for risk management and works closely with the Chair, Chief Executive, Executive Directors and Risk Managers to implement and maintain appropriate risk management strategies and processes, ensuring that effective governance systems clinical and non-clinical risk processes are in place to assure the delivery of Trust objectives and preservation of public sector values. 3.3 Deputy Director of Corporate Affairs and Governance Is responsible for ensuring appropriate Central Alerting System processes and systems that are in place are adequate to ensure that the Trust meets its duties in relation to the acknowledgement and implementation of alerts issued. Is responsible for the identification of appropriate leads for safety alerts. 3.4 Patient Safety Officer Receives all CAS alerts and distribute alerts to relevant staff. Will manage the CAS system, to receive all replies, communicate with staff in the Trust and ensure full documentation and audit trail is maintained. 3.5 Executive/ Deputy Director Lead Where an Executive/ Deputy Director Lead is allocated to an alert they are responsible for liaising with the nominated lead to ensure that the alert is complied with within the

timescales set and, where required, for providing assurance regarding evidence of implementation. 3.6 Clinical Director / Associate Director A Clinical Director and Associate Director is allocated to all alerts and they are responsible for liaising with the nominated lead (who will be a member of their Service Line staff) to ensure that the alert is complied with within the timescales set and that issues are escalated to the Executive Lead that cannot be managed. They are responsible for responding to any escalations of concerns raised by the Patient Safety Officer or Nominated Lead. 3.7 Nominated Lead Where an alert has a nominated lead they are responsible for the implementation of the alert across all appropriate areas of the Trust. They are responsible for escalating issues that may impact on implementation to the Associate Director, Clinical Director and/or Executive/ Deputy Director Lead and for reporting progress through to the Patient Safety Officer. 3.8 Supplies Team Are responsible for checking if particular piece of equipment or device is used within the Trust and reporting these findings through to the Patient Safety Officer. 3.9 Other identified staff Within the process of implementing CAS alerts individual staff will be identified as having specific roles. Where staff are identified they must respond to the requests for action in a timely fashion (as per the guidance on the request) and ensure that any issues with the actions required are escalated to the Associate Director, Clinical Director and/or Executive Lead. 4.0 Planning & Implementing Appendices 1, 2, 3 and 4 provide flow charts of the processes described below. Acknowledgement & Logging 4.1 When a new alert is added to the CAS website, an e-mail notification is sent to the CAS email address. The Trust has 48 working hours in which to acknowledge receipt of the alerts. 4.2 Following the e-mail notification of a new alert, the Patient Safety Officer accesses the CAS website, using a dedicated user name and password where the full alert can be viewed and downloaded. 4.3 Upon logging into the CAS website the Patient Safety Officer acknowledges receipt via the website and saves a copy of the alert into the appropriate area within the CAS alert folder on the shared drive. 4.4 All alerts carry deadlines for completion that depend on the subject of the alert as follows: Categories of Alerts Immediate action: used in cases where there is a risk of death or serious injury and where the recipient is expected to take immediate action Action: used where the recipient is expected to take action on the advice where necessary, to repeat warning on long standing problems, or support or follow-up manufacturer s modifications.

Action Deadlines All CAS alerts are issued with action deadline requirements which relate to the seriousness of the identified safety issue. The Trust is responsible for updating the CAS website in relation to all action deadlines. Deadline: Action underway: at the time of acknowledgment of the alert the Trust registers that it is assessing relevance, after it has been established the Trust is responsible for the issues raised. Deadlines are set by the Department of Health for this part of the process. Deadline: Action completed: the date the Department of Health requires the Trust to have had completed any necessary action. 4.5 All the alerts are centrally logged and managed via the Datix Integrated Risk Management system. Appendix 7 provides a guide for staff to use to respond to alerts sent to them. The Patient Safety Officer has a local procedure in use for the management and cascading of alerts. 4.6 The Patient Safety Officer will assess the relevance of the alert to the Trust and circulates them as below 4.7 Circulation of Alerts Once an alert has been acknowledged and it has been assessed as potentially relevant to the Trust it will be circulated. 4.8 Circulation will follow the following process: DH/Estates and Facilities Alerts: will be circulated to the Estates Compliance Officer or Electrical Engineer (Electrical Alerts only) and where relevant to the Estates Lead and Health and Safety Manager. PSA Alerts: on receipt they will be sent to the Deputy Director of Corporate Affairs and Governance who will identify an appropriate lead Deputy Director Lead. Once the individuals have been identified they will be emailed via Datix with the alert and any other associated documents. The email will inform them that they have been identified as the lead for the alert. The alert should also be copied to the Chief Pharmacist for information. MDA Alerts: on receipt if it is identified that they are potentially relevant in the Trust they will be sent to the Supplies Team to see if the devices are purchased or used in the Trust. The Supplies Team will respond to inform the Patient Safety Officer if the devices are purchased or used in the Trust and if they are which areas are affected. CMO / DDL Alerts: will be circulated to the Medial Director and Deputy Medical Director for sharing with relevant Clinical Directors. 4.9 Implementation of/compliance with alerts Alerts will be implemented as follows: 4.10 DH/Estates and Facilities Alerts: upon receipt it is the responsibility of the Estates Compliance Officer or Electrical Engineer (Electrical Alerts only) to review the alert and decide if it is relevant or applicable in the Trust. If it is relevant or applicable then the relevant Officer must implement the actions required within the required timescales as identified by the alert. Depending upon the implementation time period for the alert monthly updates may be requested.

PSA Alerts: upon receipt it is the responsibility of the Nominated Lead to review the alert and decide if it is relevant or applicable in the Trust. If it is relevant or applicable then the Nominated Lead must implement the actions required within the required timescales as identified by the alert. The nominated lead must ensure that the alert is implemented in all appropriate areas across the Trust. Monthly updates will be required. MDA Alerts: if the Supplies Team identifies that the Trust is affected by a particular MDA alert the alert will be sent to the appropriate manager of a particular area for implementation of actions required. CMO / DDL Alerts: upon receipt it is the responsibility of all recipients to cascade as necessary to all relevant staff and to confirm the cascade has taken place as soon as possible. 4.11 Timescales All emails sent in relation to all alerts will clearly specify the timescales sent for the implementation of alerts. 4.12 Alerts for information only On occasion there are alerts that are not applicable for implementation within the Trust but they may be useful to raise the awareness of staff who may see patients affected by the issue or risks identified. The Patient Safety Officer will identify alerts of this nature and will send the alert to the most appropriate staff for cascading to their wider team. 4.13 Closure of alerts It is the responsibility of the Nominated Lead to ensure that the alert is implemented fully within the timescales set. 4.14 The alerts will be closed as follows: DH/Estates and Facilities Alerts: Once confirmation of the implementation of actions has been received via Datix from the nominated Officer the alert will be sent to the Deputy Director of Finance for sign off before being closed on the Datix and CAS systems. If no action is required, the alert will be closed without going through the sign off process. PSA Alerts: Once confirmation of the implementation of actions has been received via Datix from the Nominated Lead the alert will be sent to the relevant Deputy Director for sign off before being closed on the Datix and CAS systems. If no action is required, the alert will be closed without going through the sign off process. MDA Alerts: If the Supplies Team identify that the device affected by the alert is not used in the Trust it will be signed off the CAS system as action not required. If it is applicable, once confirmation of the implementation of actions has been received via Datix from all appropriate areas the alert will be sent to the relevant Deputy Director for sign off before being closed on the Datix and CAS systems. CMO / DDL Alerts: As these are for cascade only and often sent out of hours, the CAS system does not request the status of these alerts to be changed, therefore closure is not required. However, the alert will not be closed on the Datix System until confirmation of cascade has been received along with a copy of the relevant minutes from the Clinical Directors Meeting. 4.15 Advice and guidance on the implementation of alerts can be obtained from the Patient Safety Officer.

4.16 Reports on PSA, DH, EFA, MDA, Drug, CMO and DDL alerts are produced weekly to the risk management team meeting and an assurance report submitted on a bi-monthly basis to the Risk Management Sub-committee. 4.17 Escalation of issues or action not taken Appendix 6 provides details of the escalation process in place for the Patient Safety Officer to follow when there is no response from identified staff in the Trust. 4.18 Field Safety Notices (FSN) Under European legislation, manufacturers are obliged to inform all relevant Authorities (the MHRA in the UK), of any Field Safety Corrective Action (FSCA) that they are undertaking. A manufacturer undertakes a FSCA for technical or medical reasons connected with the characteristics or performance of a device, where death or serious injury might result. Manufacturers use a Field Safety Notice (FSN) to inform their customers about any FSCA that they are undertaking. Field Safety Notices are entered onto the Safety Alert section of Datix by the Medical Devices Safety Officer (Clinical and Professional Development Training Manager) and cascaded to all relevant staff. 5.0 Definitions 5.1 Central Alerts System (CAS) - This is the electronic system developed by the Department of Health for sending important safety and device alerts to Trusts via the Patient Safety Officer in East Cheshire Trust for local assessment and implementation. 5.2 Medical Device - Medical devices consist of a whole range of equipment used for the diagnosis and treatment of disease or for monitoring of patients. Devices do not include general workshop equipment such as power tools or machine tools, or general-purpose laboratory equipment. 5.3 CAS Alert- a generic term for Alerts issued relating to medical devices, NHS Estates and PSA patient safety notices. 5.4 Medical Device Alerts (MDA) - Alerts concerning faulty medical devices, issued by the MHRA. 5.5 DH Estates & and Facilities Alerts (DH/EFA) - issued by NHS Estates. A prime means of communicating safety information relating to non-medical equipment, engineering plant, installed services and building fabric. Alerts concerning faulty estates systems or equipment, 5.6 PSA Alerts (PSA) - Alerts concerning patient safety, issued by PSA 5.7 Drug Alerts (EL) - Alerts concerning defective medicines issued by the MHRA 5.8 Chief Medical Officer Alerts (CMO) Alerts concerning Medical Emergencies issued by the CMO. 5.9 Dear Doctor Letters (DDL) Public Health Alerts issued by the CMO 6.0 Measuring performance & Audit 6.1 Number of overdue CAS alerts reported to trust board monthly 6.2 Review of all new and outstanding CAS alerts at weekly risk management team meeting 6.3 Informing Directorates of ongoing CAS alerts through monthly data packs

6.0 Review This policy will be reviewed on a three yearly basis by the Head of Safety, Risk and Resilience. Appendix 1 Process Map PSA alerts Email sent to the Trust from CAS CAS Liaison logs into CAS Within 48 working hours Alert acknowledged on CAS Alert saved onto shared drive CAS Liaison Officer follows internal SOP on the management & logging of alerts on Datix Email sent via Datix to the Deputy Director of Corporate Affairs and Governance to identify leads Deputy Director of Corporate Affairs and Governance responds via Datix with names of leads Email sent via Datix to leads to identify alert and timescales and copied to Chief Pharmacist for information Nominated lead sends monthly update via Datix Bi monthly report sent to RMSC Response via Datix to confirm actions taken E-mail to relevant Associate Director to request closure Response to confirm closure Alert closed on CAS Alert closed on Datix

Appendix 2 Process Map DH/EFA alerts (General) Email sent to the Trust from CAS CAS Liaison logs into CAS Within 48 working hours Alert acknowledged on CAS Alert saved onto shared drive CAS Liaison Officer follows internal SOP on the management & logging of alerts on Datix Email sent to the Compliance Officer via Datix Compliance Officer identifies if alert is applicable to the Trust Applicable Not Applicable Compliance Officer implements alert Compliance Officer sends monthly update Bi monthly report sent to RMSC Response via Datix to confirm actions taken Response from Compliance Officer on Datix to confirm Alert closed on CAS Alert closed on Datix E-mail to Deputy Director of Finance to request closure Response to confirm closure Alert closed on CAS Alert closed on Datix

Appendix 3 Process Map EFA alerts (Electrical Only) Email sent to the Trust from CAS CAS Liaison logs into CAS Within 48 working hours Alert acknowledged on CAS Alert saved onto shared drive CAS Liaison Officer follows internal SOP on the management & logging of alerts on Datix Email sent to the Electrical Engineer via Datix Electrical Engineer identifies if alert is applicable to the Trust Applicable Not Applicable Electrical Engineer confirms receipt of alert and informs what action is to be taken Electrical Engineer confirms receipt of alert and informs no action required E-mail to Deputy Director of Finance to request closure Response to confirm closure Alert closed on CAS Alert closed on Datix Alert closed on CAS Alert closed on Datix N.B Electrical Alerts are considered completed by CAS once Electrical Engineer confirms receipt of the alert.

Appendix 4 Process Map MDA alerts Email sent to the Trust from CAS Within 48 working hours CAS Liaison logs into CAS Alert acknowledged on CAS Alert saved onto shared drive Email sent to appropriate person in the Trust via Datix CAS Liaison Officer follows internal SOP on the management & logging of alerts on Datix To identify if device used in Trust Used Alert sent to appropriate manager(s) to action Response to confirm action taken via Datix Not used Response to confirm via Datix Alert closed on CAS Sent to appropriate manager for action (known to be applicable to Trust) Response via Datix to confirm actions taken E-mail to relevant Associate Director to request closure Alert for cascade only Alert sent to appropriate manager(s) to action Response to confirm cascade via Datix E-mail to relevant Associate Director to request closure Alert closed on CAS Alert closed on Datix Alert closed on CAS Alert closed on Datix Alert closed on CAS Alert closed on Datix Alert closed on Datix

Appendix 5 Process Map Dear Doctor Letters/CMO Alerts Email sent to the Trust from CAS CAS Liaison logs into CAS Alert saved on shared drive Alert sent to Clinical Director of each Service Line, Medical and Deputy Medical Director via Datix Response to confirm cascade via Datix and copy of minutes from Clinical Director Meeting Alert closed on Datix N.B These alerts do not require closure on CAS as they are for cascade only

Appendix 6 Escalation of actions not taken Alert acknowledged as per process described in appendix 1, 2, 3 and 4 Emails sent to appropriate staff as per appendix 1, 2, 3 and 4 Email copied into Head of Service and Clinical Director No response? Follow up reminder email and telephone call to appropriate staff and nominated Head of Service / Clinical Director alerted. No response or progress? CAS Officer to escalate in person to Deputy Director of Corporate Affairs and Governance to discuss with appropriate Deputy Director If required, Deputy Director of Corporate Affairs and Governance escalates as appropriate to Executive Team Response and management of alert continues as per appendix 1, 2, 3 and 4

Appendix 7 - Datix Safety Alerts Guide for Recipients of Alerts The Datix system is used for the logging of safety alerts received by the Trust. When staff are in receipt of a Datix notification in relation to an alert request they are expected to respond in a timely fashion to requests for information or action. The following guide shows how alerts should be responded to on Datix.

When an alert is received in the Trust the CAS liaison Officer logs the record on Datix and decides who needs to respond to the alerts this will depend upon the nature of the alert and actions required. If you are a recipient you will receive an email like this one with a web link on it. You should click on the web link to view the alert and respond to the CAS Liaison Officer

Once you have clicked on the link you will be taken to the login page and then the alert Enter your Datix username and password in the boxes and click login

You should read the alert request front page and the alert that is attached in the documents section. The email you were sent will also identify anything specific that you need to address in your response. You need to decide what actions are required from the alert on your part this will/may be assisted by the contents of the email that you received initially which may ask you for specific answers/actions.

To read the alert itself you will need to click into the documents section The alert will have been attached as a PDF hover over it and click to open it

When you are responding to a safety alert you should do the following: You should select a response type from the drop down list. The choice is: action underway action complete no action required not applicable cascaded More detail on these response types are detailed below You should put in the date you are responding (this may be the same as the read on date). You should also put in some comments as to why you have responded as you have i.e. The device is not used in the Trust. Once you have done this click save. The CAS Liaison Officer will pick up your response and act accordingly.

When considering response types the following may be useful: Response type Comment PSA alerts Comment EFA/DH alerts Comment MDA alerts Action underway This response should be selected when an alert is applicable in the Trust and the lead has commenced implementation Action complete This response should be selected when all actions relating to the alert have been implemented by the particular recipient for either their particular area or for the Trust This response should be selected when an alert either is applicable in the Trust and action is underway or when investigations are underway to identify if the alert is applicable This response should be selected when all actions relating to the alert have been implemented by the particular recipient for either their particular area or for the Trust No action required N/A this will have been identified on receipt This response should be selected if we are affected by the alert in the Trust but no action is required i.e. if there is a piece of equipment in use but we are not affected by that particular batch number Not applicable N/A this will have been identified on receipt This response should be selected if we are not affected by the alert in the Trust DDL Alerts / CMO Alerts: This response should be selected when an alert either is applicable in the Trust and action is underway or when investigations are underway to identify if the alert is applicable i.e. if supplies are investigating if we purchase/use a particular device in the Trust This response should be selected when all actions relating to the alert have been implemented by the particular recipient for either their particular area or for the Trust This response should be selected if we are affected by the alert in the Trust but no action is required i.e. if there is a device in use but we are not affected by that particular batch number on the alert This response should be selected if we are not affected by the alert in the Trust ie. we do not purchase/use the device in the Trust Response type Cascaded and Discussed No action required Comment Documents for Cascading This response should be selected when an alert has been cascaded to and discussed with all appropriate members of your team This response should be selected when the alert that has been sent to you for cascading is not applicable to your area of work

Appendix 8 - Equality Analysis (Impact assessment) 1. What is being assessed? Policy for the Management of Safety Alerts issued via the Central Alerting System Details of person responsible for completing the assessment: Name: Andy Chambers Position: Head of Safety, Risk and Resilience Team/service: Corporate Affairs and Governance State main purpose or aim of the policy, procedure, proposal, strategy or service: (usually the first paragraph of what you are writing. Also include details of legislation, guidance, regulations etc which have shaped or informed the document) This policy describes the framework for the distribution of safety alerts within the organisation and the mechanisms for communication of action needed or completed back to the various agencies which use this system. 2. Consideration of Data and Research To carry out the equality analysis you will need to consider information about the people who use the service and the staff that provide it. 2.1 Give details of RELEVANT information available that gives you an understanding of who will be affected by this document Cheshire East (CE) covers East Cheshire CCG. Cheshire West & Chester (CWAC) covers Vale Royal. In 2011, 370,100 people resided in CE and 329,608 people resided in CWAC. Age: East Cheshire and South Cheshire CCG s serve a predominantly older population than the national average, with 19.3% aged over 65 (71,400 people) and 2.6% aged over 85 (9,700 people). Vale Royal CCGs registered population in general has a younger age profile compared to the CWAC average, with 14% aged over 65 (14,561 people) and 2% aged over 85 (2,111 people). Since the 2001 census the number of over 65s has increased by 26% compared with 20% nationally. The number of over 85s has increased by 35% compared with 24% nationally.

Race: In 2011, 93.6% of CE residents, and 94.7% of CWAC residents were White British 5.1% of CE residents, and 4.9% of CWAC residents were born outside the UK Poland and India being the most common 3% of CE households have members for whom English is not the main language (11,103 people) and 1.2% of CWAC households have no people for whom English is their main language. Gypsies & travellers estimated 18,600 in England in 2011. Gender: In 2011, c. 49% of the population in both CE and CWAC were male and 51% female. For CE, the assumption from national figures is that 20 per 100,000 are likely to be transgender and for CWAC 1,500 transgender people will be living in the CWAC area. Disability: In 2011, 7.9% of the population in CE and 8.7% in CWAC had a long term health problem or disability In CE, there are c.4500 people aged 65+ with dementia, and c.1430 aged 65+ with dementia in CWAC. 1 in 20 people over 65 has a form of dementia Over 10 million (c. 1 in 6) people in the UK have a degree of hearing impairment or deafness. C. 2 million people in the UK have visual impairment, of these around 365,000 are registered as blind or partially sighted. In CE, it is estimated that around 7000 people have learning disabilities and 6500 people in CWAC. Mental health 1 in 4 will have mental health problems at some time in their lives. Sexual Orientation: CE - In 2011, the lesbian, gay, bisexual and transgender (LGBT) population in CE was estimated at18,700, based on assumptions that 5-7% of the population are likely to be lesbian, gay or bisexual and 20 per 100,000 are likely to be transgender (The Lesbian & Gay Foundation). CWAC - In 2011, the LGBT population in CWAC is unknown, but in 2010 there were c. 20,000 LGB people in the area and as many as 1,500 transgender people residing in CWAC. Religion/Belief: The proportion of CE people classing themselves as Christian has fallen from 80.3% in 2001 to 68.9% In 2011 and in CWAC a similar picture from 80.7% to 70.1%, the proportion saying they had no religion doubled in both areas from around 11%-22%. Christian: 68.9% of Cheshire East and 70.1% of Cheshire West & Chester Sikh: 0.07% of Cheshire East and 0.1% of Cheshire West & Chester Buddhist: 0.24% of Cheshire East and 0.2% of Cheshire West & Chester Hindu: 0.36% of Cheshire East and 0.2% of Cheshire West & Chester Jewish: 0.16% of Cheshire East and 0.1% of Cheshire West & Chester

Muslim: 0.66% of Cheshire East and 0.5% of Cheshire West & Chester Other: 0.29% of Cheshire East and 0.3% of Cheshire West & Chester None: 22.69%of Cheshire East and 22.0% of Cheshire West & Chester Not stated: 6.66% of Cheshire East and 6.5% of Cheshire West & Chester Carers: In 2011, nearly 11% (40,000) of the population in CE are unpaid carers and just over 11% (37,000) of the population in CWAC. 2.2 Evidence of complaints on grounds of discrimination: (Are there any complaints or concerns raised either from patients or staff (grievance) relating to the policy, procedure, proposal, strategy or service or its effects on different groups?) No complaints received to date 2.3 Does the information gathered from 2.1 2.3 indicate any negative impact as a result of this document? No 3. Assessment of Impact Now that you have looked at the purpose, etc. of the policy, procedure, proposal, strategy or service (part 1) and looked at the data and research you have (part 2), this section asks you to assess the impact of the policy, procedure, proposal, strategy or service on each of the strands listed below. RACE: From the evidence available does the policy, procedure, proposal, strategy or service affect, or have the potential to affect, racial groups differently? Yes No X Explain your response: This policy will be used for the cascade of safety alerts in the trust. Alerts are sent to the responsible manager who will follow the trust interpretation policy if required to support explanation of associated procedures. GENDER (INCLUDING TRANSGENDER): From the evidence available does the policy, procedure, proposal, strategy or service affect, or have the potential to affect, different gender groups differently? Yes No X Explain your response: This policy will be used for the cascade of safety alerts in the trust. No anticipated impact regarding gender or trans status.

DISABILITY From the evidence available does the policy, procedure, proposal, strategy or service affect, or have the potential to affect, disabled people differently? Yes No x Explain your response: This policy will be used for the cascade of safety alerts in the trust. The responsible manager receiving the alert will follow the trust interpretation policy if information is required to be provided in another format, ie British Sign Language, easy read. AGE: From the evidence available does the policy, procedure, proposal, strategy or service, affect, or have the potential to affect, age groups differently? Yes No x Explain your response: This policy will be used for the cascade of safety alerts in the trust. Any alerts involving safety affecting children under our care will aim to improve safeguards and protect them from harm. LESBIAN, GAY, BISEXUAL: From the evidence available does the policy, procedure, proposal, strategy or service affect, or have the potential to affect, lesbian, gay or bisexual groups differently? Yes No x Explain your response: This policy will be used for the cascade of safety alerts in the trust. No anticipated impact regarding sexual orientation. RELIGION/BELIEF: From the evidence available does the policy, procedure, proposal, strategy or service affect, or have the potential to affect, religious belief groups differently? Yes No x Explain your response: This policy will be used for the cascade of safety alerts in the trust. No anticipated impact regarding religion/belief. CARERS: From the evidence available does the policy, procedure, proposal, strategy or service affect, or have the potential to affect, carers differently? Yes No x Explain your response: This policy will be used for the cascade of safety alerts in the trust. Where carers are involved in delivering care of a relative while they are in hospital or at home, appropriate information regarding any alerts will be given to the carer.

OTHER: EG Pregnant women, people in civil partnerships, human rights issues. From the evidence available does the policy, procedure, proposal, strategy or service affect, or have the potential to affect any other groups differently? Yes No x Explain your response: This policy will be used for the cascade of safety alerts in the trust. No other impacts identified. 4. Safeguarding Assessment - CHILDREN a. Is there a direct or indirect impact upon children? Yes No x b. If yes please describe the nature and level of the impact (consideration to be given to all children; children in a specific group or area, or individual children. As well as consideration of impact now or in the future; competing / conflicting impact between different groups of children and young people: c. If no please describe why there is considered to be no impact / significant impact on children This policy will be used for the cascade of safety alerts in the trust. Any alerts involving safety affecting children under our care will aim to improve safeguards and protect them from harm 5. Relevant consultation Having identified key groups, how have you consulted with them to find out their views and that the made sure that the policy, procedure, proposal, strategy or service will affect them in the way that you intend? Have you spoken to staff groups, charities, national organisations etc? Risk management sub-committee 6. Date completed: January 9 th 2017 Review Date: January 9 th 2020 7. Any actions identified: Have you identified any work which you will need to do in the future to ensure that the document has no adverse impact? Action Lead Date to be Achieved

8. Approval At this point, you should forward the template to the Trust Equality and Diversity Lead lynbailey@nhs.net Approved by Trust Equality and Diversity Lead: Date: 9.1.18