Central Alert System (CAS) Policy and Procedure

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1 Central Alert System (CAS) Policy and Procedure POLICY NUMBER Risk, Health & Safety.068 POLICY VERSION RATIFYING COMMITTEE Professional Practice Forum Most Recent DATE RATIFIED 26 April 2015 DATE OF EQUALITY & HUMAN RIGHTS January 2015 IMPACT ASSESSMENT (EHRIA) NEXT REVIEW DATE April 2018 POLICY SPONSOR Helen Greatorex, Executive Director of Nursing and Quality POLICY AUTHOR Glen Woolgar Health and Safety Manager KEY POLICY ISSUES: Central Alert System Definition Responsibility of the Trust When a Central Alert is received How the Central Alert System works If you require this document in another format such as large print, audio or other community language please contact the Governance Support Team on or Did you print this document yourself? Please be advised that the Trust discourages the printing and retention of hard copies of policies and can guarantee that the policy on the Trust website is the most up-to-date version. As a contingency a full set of up-to-date Trust policies are held by the Governance Support Team based at Trust HQ, Swandean

2 1.0 Introduction CONTENTS 1.1 Purpose of policy 1.2 Definitions 1.3 Scope of policy 1.4 Principles Policy Statement Duties Procedure Development, consultation and ratification Equality and Human Rights Impact Assessment (EHRIA) Monitoring Compliance Dissemination and Implementation of policy Document Control including Archive Arrangements Reference documents Appendices Appendix 1. Central Alerting System Receipt Flowchart Appendix 2. Internal Timeline for Alerts Received Through the Central Alerting System (CAS) 13.0 Glossary of 15

3 1.0 INTRODUCTION The Central Alert System (CAS) is a national, web-based network used for issuing patient safety alerts and other safety critical guidance to NHS trusts, CCG (Clinical Commissioning Groups) ambulance service trusts, health authorities and social services for information and/or action. The system was introduced in September 2008 and brings together the Public Health Link (PHL) and Safety Alert Broadcast System (SABs). The Chief Medical Officer led the merging of the existing systems to provide a robust and streamlined means of distributing safety alerts to the NHS and other health and social care providers, with the potential to expand as needs arise. Safety alerts, emergency alerts, drug alerts, Dear Doctor letters and medical device alerts will be sent through the CAS system on behalf of the following originators:- National Reporting and Learning System MHRA Drug Alerts CMO Messaging NHS Blood and Transplant DH Estates and Facilities Department of Health MHRA Medical Device Alerts National Institute for Health and Clinical Excellence NHS Estates MHRA Dear Doctor Letter Others All alerts issued by the originators are transmitted nationally and are received electronically. It enables alerts and urgent patient safety specific guidance to be accessed at any time. 1.1 PURPOSE OF POLICY The purpose of this policy is to establish and promote an effective auditable approach to the management of all CAS notifications in order to: ensure Trust staff receive relevant safety alerts and notifications in a timely manner for them to action as necessary minimise risks to service users and staff through the above actions ensure the right people, receive the right alerts at the right time provide evidence to the Board of Directors that any necessary action has been taken This policy applies to all Trust staff. The Central Alert System has two basic elements:- Firstly, it is simply a means to new alerts to a nominated member of the Trust (CAS Liaison Officer), who disseminates the message to those who need to take 3 of 15

4 action. The system replaces distribution of alerts by fax, post or other means, which has often been relied upon. Secondly, is a feedback function with the nominated member of the Trust (CAS Liaison Officer) having the additional responsibility of completing a short feedback form to confirm that action has been taken in the Trust in response to an alert. Completed feedback forms are available on the dedicated Central Alerting System website, along with copies of all new alerts. 1.2 DEFINITIONS Central Alert System (CAS) A system for issuing patient safety alerts and other safety critical guidance to NHS organisations. 1.3 SCOPE OF POLICY This policy applies to all employees of the Trust and those seconded to work in the Trust. There will be an active lead from managers to ensure the risk management of CAS alerts and notifications is a fundamental part of the total approach to service delivery, risk management and health and social care governance. The Board recognises that the risk management of CAS alerts and notifications is an integral part of good management practice. The Board is therefore committed to ensuring that response and action to CAS alerts and notifications forms an integral part of its risk management process and that responsibility for implementation is accepted at all levels within the organisation. 1.4 PRINCIPLES This policy is to ensure that all alerts received through the Central Alert System (CAS) are acknowledged, determined, disseminated, actioned and responded to in accordance with legislative, regulatory and best practice requirements. 2.0 POLICY STATEMENT The Trust places great importance on the distribution and administration of alerts received through the Central Alert System (CAS) and is committed to putting in place all reasonable measures to ensure the health and safety of Trust staff and service users and anyone else who may be affected by the activities of the Trust. 3.0 DUTIES Responsibility of the Trust 1. The Trust s nominated CAS Liaison Officer must have the necessary authority, facilities, training, ability and contact network to administer the system to help manage safety risk within the Trust. The Department of Health Central Alert System (CAS) Administration Team is informed of changes to CAS Liaison Officer contact details as soon as they occur. 2. DH approved timescales for distribution of the various alerts in the Trust are set, used and monitored. 4 of 15

5 3. Necessary local action is taken on alerts issued via CAS to ensure the safety of patients, users and others. 4. Arrangements exist to cover the CAS Liaison Officer function when the usual Liaison Officer is unavailable. 5. Relevant clinical commissioning croups, local area teams and other interested parties are kept informed of changes to improve the use of CAS in the Trust. 6. Monitoring is undertaken to ensure that local procedures are effective and are being followed. CAS Liaison Officer There is one designated CAS Liaison Officer in every trust. The Liaison Officer must: 1. Ensure that the Department of Health has accurate and up to date contact details for the Liaison Officer role and that any changes are notified promptly to the CAS Helpdesk. 2. Ensure adequate cover is in place if the CAS Liaison Officer is away. 3. Ensure CAS administrators acknowledge receipt of the alert within one working day. 4. Ensure CAS administrators cascade alerts to relevant staff as applicable within their Trust. 5. Ensure CAS administrators collate the responses from those who are responsible for taking action in response to an alert. 6. Ensure that any non-responders to CAS alerts are contacted and actions completed. 7. Ensure any necessary reports are produced on CAS performance for the Medical Devices and Infection Control Committee. CAS Administrator When a CAS alert is received, the CAS Administrator is expected to: 1. Send the alert to the CAS Liaison Officer in the organisation in order for them to determine whether the alert is relevant to the organisation. (This must be in accordance with the alert cascade timeline). 2. Acknowledge receipt of the alert, in accordance the category of the alert or within one working day at the latest (see Appendix 2). 3. Upon advice from the CAS Liaison Officer, distribute the alert to the appropriate staff within the organisation (including the appropriate recipients identified on each alert). Clearly detail on the distribution for each alert the expected response deadline this is to be appropriate to the alert and within suitable locally agreed timescales. (See Appendix 2). 5 of 15

6 4. Ensure that each alert is distributed individually and not accumulated and distributed together. 5. Not cut and paste text from any alert (this could change the context of the message). 6. Provide feedback via CAS when action is in hand to implement the recommendations contained in the alert. 7. Inform the CAS Liaison Officer where there is delay to implement or action the alert and provide feedback via CAS if the Trust is going to delay implementation of the recommendations contained in the alert (in such cases they should ensure that the Trust s Risk Register is updated appropriately). 8. Continually monitor progress of distributed alerts against expected response deadlines. 9. Ensure that CAS is regularly reviewed and updated in accordance with procedures. Professional Leads: Trust wide Medical Devices Liaison Officer (MHRA Medical Devices Alerts) Deputy Director of Nursing Standards and Safety (Patient Safety Alerts, Infection control) Head of Risk and Safety (NPSA, DOH, NICE alerts) Chief Pharmacist Governance & Professional Practice (MHRA Drug Alerts) Director of Estates and Facilities (DH Estates and Facilities or NHS Estates the Directors of Estates and Facilities alerts) Executive Medical Director (CMO Messaging, NHS Blood and Transplant or MHRA Dear Doctor) When an alert is received via CAS from the originators identified in brackets above the professional lead is expected to: 1. Determine whether the alert is relevant to the organisation. 2. Advise the CAS Liaison Officer/CAS Administrator on the action to be taken with the alert i.e. it is relevant or not relevant. 3. Provide clear instructions as to the actions and level of urgency required by staff on the alert. 4. Following dissemination across the organisation, and notification that all relevant recipients (Medical Device Co-ordinators/Managers) have responded back on the alert - advise the CAS Liaison Officer/CAS Administrator that they are satisfied that the appropriate action has been taken within the organisation in relation to medical devices and that the alert can be closed (action completed). Matrons /Team Managers / Service Managers (Medical Device Managers) 6 of 15

7 CAS alerts will automatically be sent to the medical device manager. Medical device managers are responsible for ensuring medical device alerts, patient safety notices and other safety alerts are acknowledged by the managers and to act on their managers behalf when they are unavailable. The Medical Device Manager is expected to: 1. Acknowledge receipt of the alert. 2. Provide feedback to the CAS Administrator if their team is going to delay implementation of the recommendations contained in the alert (in such cases they should ensure that the Care Group Risk Register is updated appropriately). 3. Ensure their managers provide feedback via the CAS Administrator, in accordance with the expected response deadline, when action has been completed to implement the recommendations contained in the alert. 4. Ensure that the Medical Device Co-ordinators regularly maintain their local Medical Device Register. 5. Ensure that the Medical Device Co-ordinators conduct a risk assessment and record any action plan development which takes place following receipt of an alert. Medical Device Co-ordinators (Ward / Home / Team Managers) When an alert is received via CAS, the Medical Devices Co-ordinator is expected to: 1. Acknowledge receipt of the alert within agreed timescales as described within this procedure. (Section 4) 2. Determine whether the safety warning is relevant to their area of responsibility. 3. Carry out the actions described within the CAS alert. 4. Distribute the alert and any other relevant information to staff / end users in a manner appropriate to the warning and within suitable locally agreed timescales. 5. Ensure that each alert is distributed individually and not accumulated and distributed together. 6. Not cut and paste text from any alert (this could change the context of the message). 7. Provide feedback, in accordance with the expected response deadline, when action has been completed to implement the recommendations contained in the alert. 8. Maintain records to show (for example): date issued; signed assurance from recipient that required actions have been taken (for example, appropriate staff have been made aware of the alert). 9. Conducts a risk assessment and record any action plan development which takes place following receipt of an alert. For further information on the safe management of medical devices, roles and responsibilities, refer to the Trust s Medical Devices Policy. 7 of 15

8 The Trust will implement the Central Alerting System using the existing network of Service Managers / Matrons and Ward / Home / Team Managers (who will act as the designated Medical Devices Managers and Medical Devices Co-ordinators), Estates and Facilities Management and other key personnel as deemed necessary by the CAS Liaison Officer. Matrons and Residential Home Managers have a vital role to play in this process in ensuring that their managers are maintaining the highest possible standards in the handling and use of medical devices and the processing and implementation of alerts. The Trust CAS Liaison Team are as follows:- Trust CAS Liaison Officer Health and Safety Manager Trust CAS Administrator - Risk and Safety Administrators 4.0 PROCEDURE Receiving Alerts Notification of Alerts The CAS Liaison Officer / CAS Administrator will be notified of alerts by . The header always includes the words "Central Alerting System" in the subject line and the alert title. The will contain a description of the problem the alert is highlighting and links to PDF attachments and other websites containing further information. Within the Trust alert s are currently sent to:- CAS Administrator (for acknowledgement) CAS Liaison Officer (for information/action) Head of Risk & Safety (for information/action) There are a number of categories that an alert might fall into, depending on its nature and urgency. The following outlines the categories found in alerts, which require a response: 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 on the advice. Action: Used where the recipient is expected to take action on the advice, where it is necessary to repeat warnings on long-standing problems, or to support or follow-up manufacturers' field modifications. Update: Used to update the recipient about previously reported incidents or series of incidents, possibly on a topical or device group basis, and where further follow-up safety information is judged beneficial. 8 of 15

9 Information Request: Used to alert users about a specific issue that may become a problem and where we are requesting feedback. These alerts may be sent out with additional questions to be completed. Other alerts will have these categories: Immediate: Cascade within 6 hours. To be used infrequently in exceptional cases where potentially serious health risks are implicated. Urgent: Cascade within 24 hours. The most common category. Non-urgent: Cascade within 48 hours. For information: This is used in circumstances where there is no need to cascade the information and only those who receive the message directly need to be aware of its content. Acknowledging and Responding to Alerts The CAS Liaison Officer /CAS Administrator are required to acknowledge and respond to alerts; all other recipients are currently not required to do so. In their absence the Incident and Alert Clerk will deputise. The CAS Liaison Officer / CAS Administrator must first acknowledge alerts before submitting any other responses. Within the Trust the following acknowledgement and cascade timelines will apply to all alerts received:- Category of Alert Immediate Action or Immediate Urgent or Action Non-urgent or Update or Information Request For information Acknowledgement Timeline Immediately Within 1 working day Within 2 working days Within 2 working days Cascade Timeline Within 6 hours (of acknowledgement) Within 24 hours (of acknowledgement) Within 24 hours (of acknowledgement) No need to cascade the information. Only those who receive the message directly need to be aware of its content. 9 of 15

10 Responding to Alerts Alerts sent to the CAS Liaison Officer/CAS Administrator will have a range of possible responses to the alert. A response must be selected to indicate the status of an alert. These are listed below:- Acknowledged This option should be chosen to acknowledge receipt of the alert. Action Not Required - This option should be chosen if, having considered the alert carefully and consulted with the CAS Liaison Officer as necessary that the action required in the alert is not relevant to the organisation. Assessing Relevance This option indicates that inquiries are being made within the organisation to determine whether action is required, what this action might be, and who is responsible for taking any action. Action Not Started This option indicates that there is agreement within the organisation that action is required to address the issues raised in the alert. Planning of action is taking place and timescales and responsibilities are clearly identified. The people responsible for action in the organisation know who they are, what they need to do and by when. However, the work required has not yet started. Action Required: Ongoing - This option indicates that the people within the organisation, who need to take action in response to the alert, have started to implement the agreed action. All ongoing risks should normally be identified in the organisation's risk register. Some alerts will clearly state a deadline by which the organisation would normally be expected to have agreement in place about what action to take and to have begun the work required. If the organisation is not able to select this option and confirm work has started, by the stated deadline, the organisation s response form will be highlighted with the Trust statistical reports. The organisation may wish to give any reasons for missing the deadline in the text box provided. Action Completed This option indicates that the organisation considers that it has dealt with all the issues in the alert which are applicable, to the final deadline shown in the alert. The organisation considers it is fully compliant with the requirements set out in the alert and agreed processes are in place to address ongoing requirements, such as training or other needs. Processing Alerts 1. Alert receipt to be acknowledged, in accordance the category of the alert, or within 2 working days at the latest (See Appendix 2). CAS website is to be updated Acknowledged ; 2. Alert to be sent to the CAS Liaison Officer within the organisation in order for them to determine whether the alert is relevant to the organisation. (This must be in accordance with the alert cascade timeline See Appendix 2). CAS website is to be updated Assessing Relevance ; 10 of 15

11 3. Upon advice from the Professional Lead that the alert is applicable or not to the organisation, the alert is to be distributed electronically to the appropriate staff within the organisation (including the appropriate recipients identified on each alert). CAS website to be updated Action Required: Ongoing 4. Any alerts that are not applicable to the organisation are to be closed on the CAS website entering details as to why it is not relevant in the text box. CAS website to be updated Action Not Required. 5. If the organisation is going to delay implementation of the recommendations contained in the alert, the trust s risk register must be updated appropriately. CAS website to be updated Action Not Started 6. On the distribution for each alert the expected response deadline is to be clearly detailed. The expected response deadline is to be appropriate to the alert and is to be at least 5 working days before the alert deadline. (See Appendix 2) 7. Each alert is to be distributed individually to relevant staff where the alert applies and not accumulated and distributed together. 8. Text within an alert should not be cut and paste (this could change the context of the message). 9. Progress of the distributed alert(s) is be continually monitored against the expected response deadline(s). The CAS website is regularly reviewed and updated in accordance with procedures. 10. Where appropriate, 10 working days before the expected response deadline the relevant distribution list is to be ed and responses chased up for the distributed alert. (See Appendix 2). 11. Continue to monitor progress of distributed alerts against expected response deadlines. 12. A three day reminder is sent out to alert staff the deadline is approaching. 13. Where appropriate, 7 working days before the expected response deadline, if no response has been received, an escalation is to be sent to the appropriate manager/line manager and the Director of Nursing Standards and Safety advising them of the expected response deadline. (See Appendix 2). 14. When all responses are received for the distributed alert, inform the CAS Liaison Officer and they will determine if the appropriate action has been taken within the Trust and advise that the alert can now be closed. 15. Upon advice from the CAS Liaison Officer, provide feedback via CAS when action has been completed to implement the recommendations contained in the alert; (See Appendix 2) 11 of 15

12 CAS website to be updated Action Completed 16. CAS Administrator to maintain records and archives to show (for example): date issued; signed assurance from recipient that required actions have been taken (for example, appropriate staff have been made aware of the alert). 5.0 DEVELOPMENT, CONSULTATION AND RATIFICATION This policy and protocol were developed by the Risk and Safety Team in conjunction with matrons and members of the Medical Devices and Infection Control Committee. The policy and protocol were delegated to the Professional Practice Forum for final ratification. 6.0 EQUALITY AND HUMAN RIGHTS IMPACT ASSESSMENTS (EHRIA) This policy and procedure has been subject to an EHRIA in accordance with the Organisation wide policy for the development and management of procedural documents (076/2010/Corporate). 7.0 MONITORING COMPLIANCE The CAS Liaison Officer will ensure that all identified areas are monitored for their responses to CAS alerts within the required time frames. Where there are late / delayed responses the CAS Liaison Officer will discuss these issues with the appropriate manager. The CAS Liaison Officer will provide reports to the Medical Devices and Infection Control Committee to demonstrate the management of alerts within the Trust. This will be provided quarterly showing the alerts due for closure during the period and our performance on acknowledgement. An agreed number of random internal audits will take place of the complete process in relation to specific alerts to ensure compliance with identified standards. Auditable processes will include: Identification of required actions Distribution of notices Formal documented feedback procedures 8.0 DISSEMINATION AND IMPLEMENTATION Following ratification of this policy the Sponsor will ensure the document is forwarded to the Governance Support Team who will allocate an official policy number and upload the policy to the website. 8.1 Dissemination Publication will be announced via the Communications e-bulletin to all staff. 8.2 Training Medical device managers should undertake medical devices training as per the Essential Training policy. 9.0 DOCUMENT CONTROL (INCLUDING ARCHIVING ARRANGMENTS) 12 of 15

13 This policy and protocol will be stored and archived in accordance with the organization wide policy for the development and management of procedural documents (076/2010/Corporate) REFERENCES Central Alerting System Website (Department of Health) Central Alerting System Recipients Manual, Department of Health Information Services, Version 02, September CROSS REFERENCE Sussex Partnership NHS Trust Medical Devices Policy Risk Management Strategy and Policy 12.0 APPENDICES Appendix 1. Central Alerting System Receipt Flowchart Appendix 2. Internal Timeline for Alerts Received Through the Central Alerting System (CAS) 13.0 Glossary CAS - Central Alerting System CGMDC - Care Group Medical Devices Co-ordinator CMO - Chief Medical Officer DOH - Department of Health MDA - Medical Devices Agency (ceased to exist in April Now known as MHRA) MDC - Medical Devices Co-ordinator MDM - Medical Devices Management MHRA - Medicines and Healthcare Products Regulatory Agency (a new agency formed by combining the Medical Devices Agency and the Medicines Control Agency in April 2003) NAO - National Audit Office NICE - National Institute of Clinical Excellence NRLS - National Reporting and Learning System PHL - Public Health Link 13 of 15

14 Assess if Alert is relevant to Trust Central Alert System (CAS) policy & procedure CENTRAL ALERTING SYSTEM ALERT RECEIPT FLOWCHART Appendix 1 ALERT ISSUED BY ORIGINATOR AGENCY (VIA CENTRAL ALERTING SYSTEM) ( address checked daily) CAS Liaison Officer / CAS Administrator Update CAS system Up-date Trust Alert Database Log on to CAS website and acknowledge receipt of Alert on-line and send to the Professional Lead within the Trust as identified in section 3 of this policy Trust Medical Devices Liaison Officer Head of Risk & Safety Chief Pharmacist Gov & P.P. Director of Estates Executive Medical Director CAS Liaison Officer / CAS Administrator (Collates returns from MDM s) Alert not applicable to Trust Relevant Specialist to approve closure of Alert Alert is applicable to Trust Alert disseminated to Medical Device Managers (MDMs) Alert - action complete for Department MEDICAL DEVICE MANAGER (MDM) (Considers and distributes as appropriate and collates responses) Alert is not applicable to Department Alert is applicable to Department Conduct Risk Assessment. Record any action taken or action plan development which takes place following receipt of an Alert. 14 of 15

15 INTERNAL TIMELINE FOR ALERTS RECEIVED THROUGH THE CENTRAL ALERTING SYSTEM (CAS) Appendix 2 Within 2 working days Acknowledge Alert on CAS Within 1 working day Send to Professional Lead Within 1 working day Professional Lead to determine if applicable Within 1 working day If applicable, distribute within Trust 10 working days before ERD 10 working days before expected response deadline (ERD) - chaser to be sent 7 working days before ERD 7 working days before expected response deadline (ERD) escalation to be sent to manager / line manager / Director of Nursing Standards and Safety 5 working days before Alert deadline Expected Response Deadline (to be at least 5 working days before Alert deadline) 2-3 working days before Alert deadline Professional Lead to determine alert can be closed 1 working day before Alert deadline Update CAS and close Alert Alert deadline 15 of 15

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