Central Alert System (CAS) Policy and Procedure Document Summary

Transcription

1 Central Alert System (CAS) Policy and Procedure Document Summary To manage the distribution and response to internal and externally generated Safety Alerts, DOCUMENT NUMBER POL/002/053 DATE RATIFIED November 2014 DATE IMPLEMENTED March 2015 NEXT REVIEW DATE March 2017 ACCOUNTABLE DIRECTOR Director of Quality and Nursing POLICY AUTHOR Patient Safety Lead Important Note: The Intranet version of this document is the only version that is maintained. Any printed copies should therefore be viewed as uncontrolled and, as such, may not necessarily contain the latest updates and amendments.

2 TABLE OF CONTENTS Contents 1 Scope Introduction Statement of Intent Definitions Duties Arrangements for the Management of Safety Alerts Health RECEIPT & DISSEMINATION OF ALERTS FOLLOW UP TO OVERDUE RESPONSES / ACTIONS RECORDS OF ALERTS Training Monitoring Compliance with this Policy References/ Bibliography Related Trust Policy/Procedures... 9 Appendix 1 - Process Flowchart for Receipt, Dissemination and Response to Safety Alerts... Page 2 of 10

3 1 SCOPE This policy applies to all members of staff employed within the Trust who are involved in any aspect of alert dissemination, action, and/or review. The purpose of this document is to define the systems to be used for the dissemination of safety alerts, emergency alerts, drug alerts and medical device alerts. 2 INTRODUCTION The Central Alert System (CAS) is an electronic cascade system developed by the Department of Health and is the key route to communicate and disseminate important patient safety and device alerts information within the NHS. The CAS facilitates distribution of safety, emergency, medical device, drug and estates alerts, field safety notices, Chief Medical Officer messages and Dear doctor letters issued by; the Medicines and Healthcare products Regulatory Authority (MHRA) NHS England Department of Health (DH) NHS Department of Estates and Facilities Internal alerts by the Trust may also be issued. These alerts will be used to provide rapid dissemination of information. CAS also provides an electronic feedback form that has to be completed to confirm that where Trusts have received a safety alert notice their response and compliance to it are actioned. 3 STATEMENT OF INTENT It is the aim of CPFT to ensure that all alerts are communicated promptly to all relevant members of staff employed within the Trust and that action to comply with alerts is taken within DH timescales in order to safeguard patients, visitors, and staff from harm. Cumbria Partnership NHS Foundation Trust recognises and accepts its duty to distribute and action safety alert notices received via the Central Alerting System (CAS). The Trust will apply the procedures outlined in this document to distribute and action alerts received from external agencies via the Central Alerting System (CAS) as well as any internally generated alerts. 4 DEFINITIONS 4.1 Central alerts system (CAS)-This is the electronic system developed by the DH for sending important safety and device alerts to NHS organisations 4.2 Safety alert bulletins-a generic term for Alerts issued relating to medical devices, NHS Estates and NHS England alerts 4.3 MHRA - Medicines and Health Regulatory Authority. They are a DH body who Page 3 of 10

4 4.4 DH Estates and Facilities alerts (EFA) issued by NHS Estates. A means of communicating safety information relating to engineering, installed services and building fabric. 4.5 NPSAS alerts-alerts issued by NHS England on various patient safety and governance issues. There are three levels of alerts; Stage One - warning alert is issued to ensure healthcare staff are made aware of the potential issue at the earliest opportunity. Stage Two - if the Stage One alert requires further action, a Stage Two resource alert will follow, with more in-depth information and advice. Schedules and evidence of action taken to mitigate risks locally. Stage Three - necessary, a Stage Three directive alert will be issued, requiring organisations to confirm that they have undertaken specific actions and introduced specific processes to mitigate the risk. 4.6 Internal Alert Notices (IANs) An internally generated alert notice which is issued at the request of a Trust specialist adviser or senior manager in order to share learning or raise awareness. Depending on the nature of the IAN, actions may or may not be required from recipients. IANs will be issued and monitored in the same manner as Alerts received via the CAS system. 4.7 Drug alerts- Drug alerts are managed by the pharmacy team but will occasionally involve asking each ward/team to check their stock. The monitoring of these alerts will be undertaken by the Lead Pharmacist and reported to the Medicines Management Committee, which is a sub group of the Trust Wide Clinical Governance Meeting. 4.8 Field safety notices-are issued by the MHRA, published on the MHRA website and arise from Manufacturer s. They involve recalls or warnings regarding medical devices. 4.9 Dear doctor letters-are issued by the Chief Medical Officer and usually concern emergency or international/national key messages 5 DUTIES 5.1 Chief Executive The Chief Executive will assume overall responsibility for ensuring the Trust has appropriate arrangements in place for the management and response to safety alerts. The Chief Executive delegates responsibility for the management of safety alerts to the Director of Quality and Nursing Page 4 of 10

5 5.2 Director of Quality and Nursing The Director of Quality and Nursing has delegated responsibility for ensuring the Trust has in place appropriate policies and procedures for the management and response to all safety alerts. 5.3 Patient Safety Lead The Patient Safety Lead is the designated interim Accountable Officer for CAS in CPFT and is responsible for the management of safety alerts. This role has responsibilities including; Receiving alerts via CAS on behalf of CPFT Updating CAS on progress with alerts and closing the alerts when actions are completed Co-ordination and leading the Trust action plan on specific alerts Evaluating the evidence to determine if appropriate actions have been taken Formulating and reviewing policy guidance for alerts In association with each Care Group s Quality and Safety Manager (Or equivalent), undertake an annual review of performance with the policy standards (including audits re alert compliance) Providing support and guidance to Care groups regarding alerts Providing training regarding alert processes for relevant members of staff With the Director of Nursing and Quality identify appropriate staff to lead on specific alerts Providing a bi-monthly highlight report of the status of all alerts received to the Clinical Governance group Providing a quarterly report to the medical devices group on medical device alerts 5.4 CAS Support Officer role is to Deputise for the Accountable Officer to receive alerts Maintain a central record of alerts received, disseminated and actions taken Distributing alerts to Care groups as instructed by the Accountable Officer Maintaining an up to date list of nominated liaison officers in each Care group Participating in audits in Care group settings 5.5 Head of Pharmacy has responsibility to Review alerts relevant to medicines and where necessary co-ordinating actions to ensure compliance Provide reports to the Medicines Management Committee on alerts received and action taken 5.6 Associate Director of Nursing Has responsibility to ensure arrangements are in place for effective dissemination, action and providing evidence of compliance with the alert. This will include the nomination of Care Group Liaison Officer(s) for the alerts process and that arrangements are in place to provide cover when the liaison officer is on annual leave or sickness.. Page 5 of 10

6 5.7 Care Group Liaison Officers The Care Group Liaison officer responsibility is to manage the alerts process within their Care group. They will be an individual with the necessary experience and authority to implement the actions identified within each alert. It is expected that this role will be the Quality and Safety Managers or a senior staff member with Specialist knowledge in the Care group or relevant Corporate team Responsibilities will include; Maintaining a system for distribution of alerts to relevant departments within the care stream Maintaining records confirming distribution and actions taken with related departments Maintain a Care group reference file for alerts To provide the Accountable Officer with confirmation of actions by the timely completion of alert response forms (see appendix 1) Notify the Accountable Officer of changes to individuals performing the Care Group Liaison role Ensure a named deputy is available to manage alerts in the absence of the Care Group Liaison Officer Provide guidance to departments within own Care group with regard to alerts Provide the Care Group governance meeting with regular reports on progress and risks Log any risks identified on the Care Group Risk Register 5.8 Purchasing/Supplies/Estates department will, upon the request of the Accountable Officer provide information to confirm whether or not CPFT has any products and/or devices affected by MDA alerts. The same process will also apply to field safety notices. The Accountable Officer will forward field safety notices to the relevant teams care groups. 5.9 The Clinical Governance Committee has overall responsibility for the performance management of the alerts process and is the Committee responsible for receiving evidence in ensuring compliance 6. MANAGEMENT OF ALERTS All alerts are received via the CAS, and the CAS Accountable Officer (or deputy) should access the CAS and provide acknowledgement no later than 48 hours since the release of the alert. (No acknowledgement is required for drug alerts and CMO messaging). 6.1 MEDICAL DEVICE ALERTS All alerts are received via the CAS relating to medical devices and equipment will be assessed, and advice sought from the Purchasing Manager and/or Medical Engineering Manager in relation to usage, stock levels and location of devices and equipment in order to assess the relevance of the alert for CPFT. When confirmation is not possible, the Accountable Officer will make a judgement regarding the relevancy in relation to the type of procedure the equipment is used in, in addition to taking advice from those with specialist knowledge. Page 6 of 10

7 The alert is then disseminated via to the appropriate Care Group Liaison Officer who must cascade the alert to all relevant wards/departments within the Care group, to ensure that all areas in the Care group are reviewed in accordance with the alert. An action response form (see appendix 1) is sent with the alert for completion indicating relevance of the alert and appropriate actions. The Care Group Liaison Officer will coordinate the Care group response for action within the specified timescales 6.2 FIELD SAFETY NOTICES A Field Safety Notice (FSN) is a communication sent by medical device manufacturers, or their representatives, in connection with a Field Safety Corrective Action (FSCA). 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 tell their customers about a FSCA that they are undertaking and provide instructions or advice on what action is needed and by whom. The MHRA assesses each FSCA received and decides whether to issue further advice, this is usually via a Medical Device Alert. The MHRA places manufacturers' FSNs on their website for information and these will not normally require further action by users unless contacted directly by the manufacturer or if supplementary advice has been issued. Field Safety Notices may be issued but not all FSNs result in a Medical Device Alert. 6.3 NHS ENGLAND ALERTS When a new alert is received, the Accountable Officer will assess the alert, and escalate to the Associate Director of Clinical Governance, where necessary, to identify a Trust Lead(s) for the alert. The Accountable Officer will make contact with the identified lead and discuss the relevance of the alert, and required actions. The Accountable Officer will continue to monitor progress of the alert and provide regular progress reports. 6.4 ESTATES AND FACILITIES ALERTS All alerts received via the CAS relating to estates and Facilities will be forwarded to the Head of Estates who will assess the relevance of the alert and any implications for CPFT. The Head of estates will coordinate the response for action within specified timescales. 6.5 DRUG ALERTS Drug alerts are published by the MHRA. The pharmacy department will action all drug alerts as received, and in accordance with, the national cascade system. This will often be undertaken by the pharmacy department supplying the medicines. A report including all the drug alerts goes to the Medicines Management Committee which includes alert information. 6.6 INTERNAL ALERTS On occasions, internal alerts may need to be issued within CPFT to provide rapid and effective distribution of information, e.g. following failure of a procedure, piece of Page 7 of 10

8 equipment or other serious patient safety incident. The distribution will follow that of the alerts procedure. 6.7 EMERGENCY ALERTS Emergency alerts are currently sent by the following originators MHRA Drug Alerts, MHRA Dear Doctor Letter and CMO Messaging. Although 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 such alerts to the relevant groups and individuals and entering responses into CAS. 6.8 Compliance with alerts All recipients of a safety alert have the duty to respond with details of how they have, or will, implement the requirements of the safety alert. They must also respond to indicate if they consider no action is necessary. The safety alert system (through Outlook) will generate reminders to alert recipients to remind of deadlines. Responses will also be monitored and acted upon by the Safety Lead to ensure responses are appropriate and provide sufficient details and evidence that actions have been taken. The central safety alert system maintained by the Clinical Governance team will be used to collate information regarding actions taken, and to monitor whether recipients have responded. Where there is non-compliance with the alert(s), the Accountable officer will enter this on the Trust risk register detailing the area and specific concerns regarding noncompliance. 7. Training Attendance at training is managed in accordance with the Learning and Development Policy. 8. MONITORING COMPLIANCE WITH THIS POLICY The table below outlines the Trusts monitoring arrangements for this policy/document. The Trust reserves the right to commission additional work or change the monitoring arrangements to meet organisational needs. The Accountable Office will provide regular reports regarding the timescales and also arrange random audits of the whole process by testing a sample of alerts in some services. Aspect of compliance or effectiveness being monitored Alerts are responded to on CAS are within Monitoring method Audit of responses from CAS Individual responsible for the monitoring Lead for Patient Safety Frequency of the monitoring activity Group / committee which will receive the findings / monitoring report Annual Assurance - Quality and Safety Committee Group / committee / individual responsible for ensuring that the actions are completed Lead for Patient Safety Page 8 of 10

9 required timescales Compliance with a sample of alerts is tested across all care delivery streams Managers respond to alert distributions within required timescales system Monitoring Trust Wide Clinical Governance Group Dependent on the alert being tested Audit of responses from Ulysses system Patient safety Lead Lead for Patient Safety Annual Assurance - Quality and Safety Committee Monitoring Trust Wide Clinical Governance Group Annual Assurance - Quality and Safety Committee Monitoring Trust Wide Clinical Governance Group Patient safety lead Lead for Patient Safety 9. REFERENCES/ BIBLIOGRAPHY An introduction to the NHS England National Patient Safety Alerting System 10. RELATED TRUST POLICY/PROCEDURES Medical Devices Policy Page 9 of 10

10 APPENDIX 2 CAS (SABS) RESPONSE/ACTION FORM MDA EFA NHS England Field Safety Notices Alerts Internal Alert CMO Message/Dear Doctor Title of Alert: Please return to the CAS Accountable Officer jackie.rigby@cumbria.nhs.uk no later than I acknowledge that I have received and read the attached Safety Alert Is any action required YES/NO YES/NO If no action is required, please state a reason(s): If action is required, please state what action is necessary: (Please enter lot numbers/batch numbers and quantity to be returned when identified, do not contact manufacturer/company direct) Do you need to follow up any actions for this alert to be completed? YES/NO If Yes please state date you will be following up to confirm action required has been completed (please ensure this meets the DH timescales for completion) Care Group: Named Lead: Job Title: Date: Page 10 of 10