Trust Policy and Procedure Document Ref. No: PP (17) 283 Central Alerting System (CAS) Policy and Procedure For use in: For use by: For use for: Document owner: Status: All areas of the Trust including Community Services All Trust members of staff To ensure all Central Alerting System (CAS) alerts are acknowledged and actioned appropriately Health, Safety and Risk Manager Approved Purpose of this Document: The purpose of this document is to give all West Suffolk NHS Foundation Trust (WSFT) employees comprehensive and clear guidance in the effective, systematic and auditable approach to the distribution and action requirements of safety alerts, notices and other communications concerning safety that have been issued via the Central Alerting System (CAS). Contents Page Introduction 1 to 2 Scope of the Policy 2 Definitions 2 to 3 Roles and responsibilities 3 to 5 CAS Process 6 to 7 Review and Monitoring 7 Distribution and Implementation 7 Appendix A (E&F local procedure for CAS 8 1. Introduction Safety alerts, emergency alerts, drug alerts, dear doctor letters and medical device alerts and any other relevant notices are issued by the Medicines and Healthcare Products Regulatory Agency (MHRA), NHS Improvement- National Patient Safety Alerting System (NPSAS), Department of Health Estates and Facilities (EFA), DH Estates and Facilities Notifications (EFN) and the Department of Health (DoH). The aim of the Central Alerting System (CAS) is to bring all alerts together into one electronic system to provide an effective method in which they are issued to the WSFT. CAS is a key means to communicate important safety information to the NHS, requiring action to address risks to staff and others (persons not in the WSFT employment e.g. patients, visitors and contractors) safety. There is a distinction between the two types of alerts sent via CAS: Non-emergency alerts issued on behalf of MHRA Medical Devices, NHS Improvement and DH Estates and Facilities, they have set deadlines for acknowledgement and completion of actions. NHS Trusts are required to submit responses on the action they have taken on alerts and are monitored on their compliance with completing such alerts within agreed deadlines. Source: Health, Safety and Risk Manager Status: Approved Page 1 of 8
Emergency alerts are currently sent by the following originators MHRA (Drug Alerts), MHRA (Dear Doctor Letters) and CMO Messaging. Although some of these alerts do have deadlines, these relate to how quickly the information contained should be cascaded onwards and do not require a response. As a matter of course they are sent to all Medical Directors and Chief Executives of NHS Trusts. The Trust s nominated CAS Liaison Officer is responsible for cascading these alerts to the relevant groups of staff, individual staff and entering responses into the CAS online database by the allocated deadline. The Central Alerting System has an associated website, which holds copies of all alerts, together with statistics on responses from the WSFT. The CAS website is situated within the public domain; therefore members of the public are able to access the system and look at any relevant alert information, including the date the alert was issued the deadline for compliance to the alert and whether the WSFT has responded to the alert. It is therefore essential that all alerts are disseminated promptly throughout the WSFT and the necessary actions are undertaken by the relevant staff within the allocated deadline. Patient Safety Alerts issued via NHS Improvement are monitored through their website. The data available to the public shows any patient safety alerts which have not been actioned by the allocated deadline. 2. Scope of policy This policy applies to all employees of the WSFT and incorporates the processes required for the management of any alerts issued via CAS. This policy does not replace the duty on employees to report any adverse incidents involving medical devices, hazardous products or unsafe procedures. 3. DEFINITIONS CAS Central Alerting System, web-based system for issuing patient safety alerts and other safety critical guidance to the NHS and other health and social care providers. CAS Liaison Officer The CAS Liaison Officer performs an important risk management role by acknowledging, disseminating and closing off safety alerts and completing where relevant an electronic feedback form to indicate what action has been taken. The Department of Health (DoH) The Department of Health is accountable to the public and the Government for the overall performance of the NHS, adult personal social services and the work of the Department itself. The Department works, at both a national and a regional level, with many different external partners, other government departments, the NHS, local authorities, arm s length bodies and other public and private sector organisations. Datix Safety Alert module the Trust uses the Datix safety alert module to disseminate alerts throughout the organisation and maintain records. DoH Estates and Facilities Alerts (EFA) A prime means of communicating safety information relating to non-medical equipment, engineering plant, installed services and the building fabric. DoH Estates and Facilities Notifications (EFN) - Alerts relating to notices for high and low voltage equipment received from the Energy Networks Association (ENA) by the Department of Health Estates & Facilities Team will be issued in the format of Estates and Facilities Notifications (EFNs). The Authorising Electrical Engineer for the WSFT is the Works Superintendent and is a registered professional with a duty to analyse the content of the notification and then determine the appropriate course of action. Source: Health, Safety and Risk Manager Status: Approved Page 2 of 8
Medical Devices Medical devices and equipment are items used for the diagnosis and/or treatment of disease, for monitoring patients, and as assistive technology. This does not include general workshop equipment such as power / machine tools, or general purpose laboratory equipment. Further information regarding medical devices can be found in the Trust s Management of Medical Equipment Policy PP024. Medical Device Alerts (MDAs) MDAs are the Medicines Healthcare products Regulatory Agency (MHRA) prime means of communicating safety information to medical device users in health and social care. Medical Device Safety Officer (MDSO) NHS trusts and primary care trusts in England have all designated a Medical Device Safety Officer (MDSO). The designated MDSO for the WSFT is the EBME Manager who will support local medical device incident reporting and learning, act as the main contact for NHS England, the MHRA, Medical Device Manufacturers and be a member of the new National Medical Devices Safety Network. This role is supported by a clinician. The Medicines and Healthcare products Regulatory Agency (MHRA) The Medicines and Healthcare products Regulatory Agency (MHRA) is the executive agency of the Department of Health charged with protecting and promoting public health and patient safety by ensuring that medicines, healthcare products and medical equipment meet appropriate standards of safety, quality, performance and effectiveness, and that they are used safely. Medication Safety Officer (MSO) - NHS trusts and primary care trusts in England have all designated a Medication Safety Officer (MSO). The designated MSO for the WSFT is the Deputy Chief Pharmacist who will be a member of a new National Medication Safety Network, support local medication error reporting and learning and act as the main contact for NHS England and MHRA. National Patient Safety Alerting System (NPSAS) provides urgent information to healthcare providers via the CAS. This three-stage alerting system also encourages information sharing between organisations so that examples of best practice can be widely adopted. It is used to provide useful educational and implementation resources to help healthcare providers improve patient safety around specific incident types: Stage One Alert: Warning (W) this stage warns organisations of emerging risks. It can be issued very quickly once a new risk has been identified to allow rapid dissemination of information. Stage Two Alert: Resource (R) may be issued some weeks or months after stage one and could consist of: sharing of relevant local information identified by providers following a stage one alert sharing of examples of local good practice that mitigates the risks identified in the stage one alert access to tools and resources that help providers implement solutions to the stage one alert access to learning resources that are relevant to all healthcare workers and can be used as evidence of continued professional development. Stage Three Alert: Directive (D) When this stage of alert is issued, organisations will be required to confirm they have implemented specific solutions or actions to mitigate the risk. A checklist will be issued of required actions to be signed off in a set time frame. These actions will be tailored to the patient safety issue. 3. Roles and responsibilities a) The Chief Executive Has overall responsibility for ensuring that the Trust has in place appropriate arrangements for the management and response to safety alerts. The Chief Executive delegate s responsibility for the management of safety alerts to the Executive Chief Nurse. Source: Health, Safety and Risk Manager Status: Approved Page 3 of 8
b) The Executive Chief Nurse Has delegated responsibility to ensure that: the WSFT has the necessary systems in place to enable the effective management of CAS alerts the WSFT has in place a nominated CAS Liaison Officer to support the Trust in complying with the required standards. c) Trust Directors Are to ensure that all General Managers and Clinical Directors are made aware of the policy and procedure and they will provide support in implementing its contents. d) Corporate Risk Committee (CRC) The CRC has responsibility for ensuring that the WSFT risk management procedures are effective in protecting staff and others, by ensuring that they comply with national requirements, and promote a positive learning culture amongst staff. The CRC s key responsibilities in relation to CAS alerts are: Approving the WSFT s policy and procedure for the CAS. Monitoring of any alerts beyond the allocated deadline and actions to ensure compliance Monitoring CAS compliance via a quarterly report provided by the CAS Liaison Officer. e) General Managers, Clinical Directors Are responsible within their Divisions for ensuring all of the actions detailed in any relevant CAS alerts are implemented, managed and monitored within the required timeframes. f) Deputy General Managers, Lead Clinicians, Service Managers, Matrons, Ward Managers and Heads of Department Are to ensure: Any relevant alert whether for information or action is distributed to the required staff and completed by the given deadline. Any evidence to prove compliance to the alert is sent electronically or as hard copy through completion of the action plan to the CAS Liaison Officer located in the Risk Office. That all staff including Community Services both current and new are made aware of their responsibilities in relation to CAS and that staff are confident and competent in the management and implementation of alerts That any bank, agency or other contractors working for the WSFT within their department are aware of their requirements in relation to the CAS alert process. g) CAS Liaison Officer The Health, Safety and Risk Manager is the nominated CAS Liaison Officer for the WSFT. The CAS Liaison Officer will ensure that: All alerts are received on email via the CAS system Notifies the identified Trust lead or Community Services lead through Datix or by direct email to assess the relevance of the alert, and then the identified lead (if alert relevant to the Trust) actions the alert or disseminates the alert for implementation. The CAS website is updated to acknowledge receipt of the alert and updated as and when further information is made available, and eventually closing the alert off as compliant within the required time scale. Any alert not likely to be completed by the allocated deadline, cost more than 50k to implement or cannot be implemented is risk assessed with the relevant lead and included onto the Trusts Risk Register (Datix). Keep an electronic record on Datix of all alerts received, sent out and responses received Make any arrangements for managing CAS when on annual leave or off site Source: Health, Safety and Risk Manager Status: Approved Page 4 of 8
Produces a quarterly report on alert status to the Corporate Risk Committee Produces a monthly report on alert status to the Estates and Facilities Governance steering group Produces monthly report on alert status to the Community Quality and Patient Safety Assurance Group and Provider Management Group To carry out a quarterly audit on a random selection of not relevant, relevant and actioned alerts and report the findings to the Corporate Risk Committee. i) Estates and Facilities Nominated Lead The Estates and Facilities nominated lead will receive CAS Alerts relevant for the Estates and Facilities Division via Datix or direct email (facilities.safetyalerts@wsh.nhs.uk). They are to ensure: Assess whether the alert is relevant to the WSFT and where necessary disseminate further and action appropriately through their areas of responsibility. Respond to the email received from the CAS Liaison Officer indicating if the alert is or isn t applicable to the WSFT and actions to be taken, within the timescale stated on the email. Ensure that CAS alerts are actioned promptly and make any arrangements for completing alerts for when they are on annual leave or off site. Where the original lead delegates the action of providing the return information to the CAS Liaison Officer, then that lead must ensure the CAS Liaison Officer is aware of the name of the nominated person. Ensure that all emails relating to the alert are copied into the Estates and Facilities email address (facilities.safetyalerts@wsh.nhs.uk) j) Estates and Facilities Compliance Officer The Estates and Facilities Compliance Officer will receive CAS Alerts relevant for the Estates and Facilities Division via Datix or direct email (facilities.safetyalerts@wsh.nhs.uk). They will: Open emails in the Estates and Facilities inbox Monitor the progress on each alert Ensure each alert is responded to in the required timetable Escalate any alert actions outstanding k) The Employee All employees where appropriate will ensure they are aware of their responsibilities in relation to the management of CAS alerts and act accordingly. On receipt of an alert they will take the necessary actions within the required deadline and submit responses to the CAS Liaison Officer and or the originator of the alert. 4. CAS Process The Central Alerting System is managed by the CAS Liaison Officer located within the Risk Office. A quick reference guide is included as appendix A. Upon receiving an alert the CAS Liaison Officer will: Acknowledge the alert within two working days on the CAS website Identify the type of alert received and disseminate via Datix or direct email to the identified lead below: Type of Alert Medical Device Alert (MDA) Identified Lead EBME Manager (electrical equipment) Purchasing Manager (consumables) Source: Health, Safety and Risk Manager Status: Approved Page 5 of 8
National Patient Safety Alerting System (NPSAS) The Medicines and Healthcare Products Regulatory Agency (MHRA) The Department of Health (DoH) including: Dear Doctor Letters Department of Health- Estates and Facilities Alerts (EFA) Department of Health-Estates and Facilities Notifications (EFN) All above alerts Relevant lead most appropriate to contents of alert e.g. General Managers Medical Directors Clinical Directors Service Managers Heads of Department Chief Pharmacist Clinical Trials Technician EBME Manager (electrical equipment) Occupational Health Manager Chief Pharmacist Clinical Trials Technician Medical Directors Clinical Directors Estates and Facilities Compliance Officer Nominated Lead Estates and Facilities Works Superintendent Nominated lead Any other relevant person appropriate to the contents of the alert Monitor any responses received within the required deadline. Chase up any recipients of a CAS alert if they have failed to respond to the notification email within 7 days. Ensure that the CAS website is updated within the specified deadline. Keep the Trusts Datix Safety Alert database up to date with information received. Ensure that any alert not completed within the allocated deadline, cost more than 50k to implement or cannot be implemented is risk assessed with the allocated lead as per Risk Assessment Policy and Procedure PP132 and included onto the Trusts Datix risk register. On receiving an alert from the CAS Liaison Officer the nominated lead will: Assess whether the alert is relevant to the WSFT and where necessary disseminate further and action appropriately through their areas of responsibility. Respond to the email received from the CAS Liaison Officer indicating if the alert is or isn t applicable to the Trust and actions to be taken, within the timescale stated on the email. Ensure that CAS alerts are actioned promptly and make any arrangements for completing alerts for when they are on annual leave or off site. Where the original lead delegates the action of providing the return information to the CAS Liaison Officer, then that lead must ensure the CAS Liaison Officer is aware of the name of the nominated person. On receiving an NPSAS alert from the CAS Liaison Officer the nominated lead will: Assess whether the alert is relevant to the WSFT and where necessary disseminate further and action appropriately through their areas of responsibility Respond to the email received from the CAS Liaison Officer indicating if the alert is or isn t applicable to the Trust and actions to be taken, within the timescale stated on the email. Complete the action plan with evidence of compliance and return to the CAS Liaison Officer before the allocated deadline. Confirm to the CAS Liaison Officer that the alert can be closed off as fully actioned. Complete a risk assessment on Datix risk register if the deadline for the alert cannot be achieved. Source: Health, Safety and Risk Manager Status: Approved Page 6 of 8
5. Review and Monitoring This policy will be reviewed two yearly or in the event of any changes being made to the CAS management system. The CAS Liaison Officer will ensure that any alerts relevant to the Trust are monitored to ensure they are completed within the allocated deadline. When an alert is not going to be completed in time, cost more than 50k to implement or cannot be implemented then the CAS Liaison Officer will discuss the issue with the identified lead and complete a risk assessment to be added to the Trusts Datix risk register. The CAS Liaison Officer will provide a: Quarterly report to the Corporate Risk Committee to demonstrate the management of alerts within the Trust. Monthly report on alert status to the Estates and Facilities Governance steering group Monthly report on alert status to the Community Quality and Patient Safety Assurance Group and Provider Management Group 6. Distribution and Implementation This document will be widely circulated within the Trust, including all Heads of Department and Ward Managers and will be made available on the Trust s Intranet. Author(s): Other contributors: Approvals and endorsements: Consultation: M Dixon, Health, Safety and Risk Manager None Corporate Risk Committee Issue no: 2 File name: CAS PP (17) 283 Supercedes: PP(14)283 Equality Assessed Yes Implementation See section 6 Monitoring: (give brief See section 5 details how this will be done) Other relevant policies/documents & references: http://www.mhra.gov.uk/ http://www.npsa.nhs.uk/ http://www.dh.gov.uk/cmo https://www.cas.dh.gov.uk/home.aspx Additional Information: None Source: Health, Safety and Risk Manager Status: Approved Page 7 of 8
Appendix A Quick reference guide ALERT RECEIVED MDA and EFN Alerts: Alert captured on datix CAS Liaison Officer sends alert detail to relevant leads to confirm relevant. Confirmation of relevance received from lead NPSAS Alerts CAS Liaison Officer / Head of Patient Safety: to nominate Lead to capture alert on Datix YES NO Relevant lead: Ensures all actions contained within the alert are completed within the required deadline. Feedback to CAS Liaison Officer provided via Datix or direct email. Confirms alert can be closed as completed CAS Liaison Officer: Receives notification the alert has been actioned via Datix or direct email Receives confirmation the alert can be closed Alert is closed on CAS system and on Datix CAS Liaison Officer: closes alert on CAS website as not applicable and on Datix Areas of noncompliance to be subject to a risk assessment Nominated Lead: Identifies required actions Ensures identified actions are completed within required timescales. Actions completed: Nominated Lead complete and returns to the CAS Liaison Officer the completed action plan with evidence of compliance Confirms alert can be closed CAS Liaison Officer: Closes off CAS alert on CAS system and Datix Status of alerts monitored via: Quarterly reports from the CAS Liaison Officer to the Corporate Risk Committee Monthly reports from the CAS Liaison Officer to the Estates and Facilities Governance Steering Group Monthly reports to the Community Quality and Patient Safety Assurance Group Source: Health, Safety and Risk Manager Status: Approved Page 8 of 8