15 - RISK MANAGEMENT POLICY /PROCEDURE: CENTRAL ALERT SYSTEM (CAS)

Transcription

1 Central Alert System (CAS) SECTION: 15 - RISK MANAGEMENT POLICY /PROCEDURE: NATURE AND SCOPE: SUBJECT: POLICY- TRUST WIDE CENTRAL ALERT SYSTEM (CAS) The Central Alert System (CAS) (formally the Safety Alert Broadcast System known as SABS) is a central electronic distribution system for safety alerts issued by the Department of Health and other Agencies The aim of CAS is to improve the way safety alerts and notices are disseminated and dealt with throughout the NHS by bringing them together on one electronic system and providing evidence of actions taken. DATE OF LATEST RATIFICATION: DECEMBER 2015 RATIFIED BY: HEALTH AND SAFETY COMMITTEE REVIEW DATE: JANUARY 2019 IMPLEMENTATION DATE: FEBRUARY 2016 ASSOCIATED TRUST POLICIES AND PROCEDURES: Medical Devices Equipment Decontamination Reporting of Accidents, Untoward Incidents and Near Miss Situations including Serious Incidents ISSUE 5 FEBRUARY 2016

2 1.0 Introduction 2.0 Policy Statement 3.0 Scope of Policy 4.0 Definitions 5.0 Responsibilities Central Alert System (CAS) UNOTTINGHAMSHIRE HEALTHCARE NHS FOUNDATION TRUST UCENTRAL ALERT SYSTEM POLICY UCONTENTS 5.1 Executive Director - Forensic Services 5.2 CAS Liaison Officer (CLO) & Deputy CAS Liaison Officer (DCLO) 5.3 Medicines Safety Officer 5.4 CAS Lead Persons Division or Service Areas 5.5 General Managers (GMs), Heads of Service (HoS) and Heads of Departments (HoD) 5.6 Department Managers 6.0 Actions by the Trust Risk Systems Team (TRST), CLO and the DCLO 6.1 Actions on Receipt of Alert 6.2 Safety Alerts that are not Relevant to the Organisation 7.0 CAS Alert Types 8.0 Action Deadlines 9.0 Medical Device Safety Officer (MDSO) 10.0 Other Communications issued via the CAS Process 11.0 Monitoring Compliance and Effectiveness 11.1 Medical Devices Alerts 11.2 Estates Alerts 11.3 Medicines Alerts 11.4 Patient Safety Alerts 11.5 Trust Escalation 12.0 Safety Alert Procedure 12.1 Medical Device Alerts/Estates Alerts 12.2 Patient Safety Alerts 12.3 Chief Medical Officer (CMO) Messaging 12.4 Drug Alerts Issued Via CAS on the Trust Risk Management System 13.0 Training 14.0 Target Audience 15.0 Champion and Expert Writer 16.0 Review Date 17.0 References Appendix 1 - Appendix 2 - CAS Alert Receipt Flow Chart Examples of Responses to CAS Alerts ISSUE 5 FEBRUARY

3 Appendix 3 - Appendix 4 - Record of Changes Employee Record of Having Read the Procedure ISSUE 5 FEBRUARY

4 1.0 UINTRODUCTION Central Alert System (CAS) UNOTTINGHAMSHIRE HEALTHCARE NHS FOUNDATION TRUST UCENTRAL ALERT SYSTEM POLICY 1.1 Nottinghamshire Healthcare NHS Foundation Trust is committed to ensuring that there is continual improvement to the safety of patients and staff. 1.2 The following is from the Care Quality Commission (CQC) Essential Standards of Quality and Safety: Outcome 4: Care and welfare of people who use services: 4M. People who use services benefit from a service that: Ensures that patient safety alerts, rapid response reports and patient safety recommendations issued by the National Patient Safety Agency (NPSA) (now the National Commissioning Board) and which require action are acted upon within required timescales. 1.3 The Central Alert System (CAS) is an electronic distribution system for safety alerts developed and managed by the Department of Health (DOH) in conjunction with the Medicines and Healthcare Products Regulatory Agency (MHRA), DH Estates and Facilities and the NHS Commissioning Board National Reporting and Learning System (NRLS). 1.4 Safety Alerts and other notices are issued to NHS organisations by these agencies either for action or information. 1.5 The aim of CAS is to improve the way safety alerts and notices are disseminated and dealt with throughout the NHS by bringing them together on one electronic system. 1.6 All new safety alerts are ed to The Trust Risk Systems Team (TRST) and the nominated lead - CAS Liaison Officer (CLO [see 5.0 responsibilities] and nominated Deputy) in the Trust. The TRST then disseminates the alert (on behalf of the CLO) to those who need to take action or note for information. The role of the TRST/CLO also carries the responsibility for completing an electronic feedback form to confirm that action has been taken in response to the alert. Copies of all alerts and also news updates can be found on the following website: 30TUhttps:// 1.7 The CAS Alerts will take the form of a three level system for highlighting patient safety risks in NHS organisations, and implementing action to reduce risk. (Please see paragraph 12 below). 2.0 UPOLICY STATEMENT 2.1 Nottinghamshire Healthcare NHS Foundation Trust is committed to the continuous improvement of patient, staff and visitor safety through the reduction of risk and thus acknowledges the importance of the CAS system in the clinical governance and risk management programme. 3.0 USCOPE OF POLICY 3.1 This policy applies to all staff working in the Nottinghamshire Healthcare NHS Foundation Trust. 3.2 Each Directorate will ensure the flowchart (appendix 1) is implemented and reviewed in order to ensure the efficient operation of CAS within their Directorates ISSUE 5 FEBRUARY

5 4.0 UDEFINITIONS 4.1 Central Alerting System: A web based cascade system for issuing patient safety alerts, important public health messages and other safety critical information and guidance to the NHS and others, including independent providers of health and social care. 4.2 Alerts: An alert results from the analysis of reports of patient incidents and safety information from other sources. They cover a wide range of topics relating to patient care. 5.0 URESPONSIBILITIES 5.1 UExecutive Director: Forensic Services Division The Executive Director-Forensic Services has overall responsibility for overseeing the implementation of this policy and ensuring compliance by all staff. The Executive Director is also responsible for the nomination of the Trust CLO and Deputy (DCLO) in accordance with the directions of the Department of Health. 5.2 UCAS Liaison Officer (CLO) & Deputy CAS Liaison Officer (DCLO) The Executive Director, Forensic Services has nominated the Trust Health & Safety Manager to act as the CLO who in turn will ensure appropriate deputisation 5.3 UMedicines Safety Officer This role will be undertaken by the Trust Lead Pharmacist Medicines Safety who will ensure compliance with drug/medicine alerts and ensure appropriate deputisation where necessary 5.4 UCAS Lead Persons Division or Service Area CAS Lead Persons will be identified in each Division/Service Area by the Head of Governance/Head of Quality, Risk and Patient Safety. These persons will be responsible for receiving the alerts and distributing them accordingly throughout their Division or Service Area. The CAS Lead will also monitor the actions taken within their Division/Service Area and ensure that relevant feedback and appropriate assurance about the actions taken is recorded on the Trust Risk Management System. (The deadlines and feedback required will be identified on each alert and will be indicated on each alert by TRST) CAS Leads will ensure appropriate qualitative feedback is given to the TRST and indicated divisional meetings (see flowchart Appendix 1), in order to evidence assurance requirements of the CQC. Examples of appropriate and inadequate responses can be found in Appendix UGeneral Managers (GMs), Heads of Service (HoS) and Heads of Departments (HoD) It is the responsibility of GMs, HoS and HoD to ensure that there are sufficient CAS Leads (see section 5.4) within their Division/Service Area to ensure the efficient flow of information GMs, HoS and HoD will ensure that CAS Leads are afforded sufficient time to carry out their required actions. Any action plans resulting from CAS alerts will be monitored for progress and tracked within the Divisions GMs, HoS and HoD will ensure that timely reports are made to the TRST/CLO (and/or Deputy CLO) regarding the actions taken by the CAS Leads. Any delays ISSUE 5 FEBRUARY

6 the CAS Leads experience in meeting the given deadlines will be escalated to the HoS/HoD and GMs. 5.6 UDepartment Managers Department Managers are required to ensure that processes are in place within their department to implement the actions required by each alert and to ensure that staff are made aware of the alerts that are circulated for information Department Managers will also ensure that actions taken are fed back to the CAS Leads in respect of each alert received. CAS Leads will determine if the response contains sufficient qualitative information that will provide the necessary assurance. 6.0 UACTIONS BY THE TRUST RISK SYSTEMS TEAM (TRST), CLO AND THE DCLO 6.1 UActions on Receipt of Alert The Trust Risk Systems Team (TRST) are responsible for receiving and cascading alerts within the organisation and providing timely feedback to CAS via the dedicated CAS website on actions taken to deal with each alert. On receipt of a safety alert the TRST will: acknowledge receipt of the safety alert within agreed timescales on the CAS website determine (working with the CLO/Deputy CLO) whether the safety alert is relevant to the Trust using resources available; distribute relevant alerts to the designated CAS Lead Persons using the electronic distribution facility in the Trust Risk Management System, and within the agreed timescales; ensure that each safety alert is distributed individually and that these are not accumulated and distributed in a batch; not edit text from any safety alert, as this could change the context of the message; provide feedback in the CAS website when action is underway to implement recommendations contained in the alert; provide feedback in the CAS website if the Trust is going to delay implementation of the recommendations contained in the alert and give the reasons; provide feedback in the CAS website when the actions required by the alert have been completed as advised by the CAS Leads; maintain records to show: date circulated to CAS Leads; assurance from CAS Leads that required actions have been taken including details of the actions taken (for example, how staff have been made aware of the alert, withdrawal of equipment, etc.) ensure that the relevant reports are provided to the Patient Safety & Effectiveness Committee highlighting exceptions; Medical Devices & Assurance Committees; and the Health and Safety Committees, for information and sanction where required. ISSUE 5 FEBRUARY

7 6.2 USafety Alerts that are not Relevant to the Organisation As the Department of Health s priority is to alert all Trusts of issues potentially relevant to them, it targets the whole of the NHS so there will be occasions when safety alerts are not relevant to this Trust In the interests of patient safety it is important that each safety alert received is checked and acted upon as necessary. This action may be merely to document within the CAS website the reasons why the safety alert is not relevant to the Trust. This will be done by the TRST on behalf of the CLO after seeking suitable advice If a MDA is deemed not relevant it will be sent to the Medical and Nursing recipients for information only, stating that the alert has not been distributed to the CAS Leads. 7.0 UCAS ALERT TYPES 7.1 A number of different types of Alert can be distributed via the CAS System. The Trust is required to respond to Medical Device Alerts (MDA), Estates Alerts, Patient Safety Alerts (PSA) and Organisational Alerts (OA) Medical Device Alerts (MDA) and Estates Alerts (EFN) are received by TRST for Action or Immediate action and usually relate to identified issues with Medical Equipment/Devices. Medical Device Alerts (MDA) are distributed to identified CAS Leads as relevant via Ulysses. (Section 12.1) Patient Safety Alerts (PSA) are distributed by NHS England and will often define the required person to respond. This will depend on the type of alert. (Section 12.2) The MHRA Drug Alerts are also issued via CAS and are distributed via Ulysses. Drug alerts are received via the Pharmacies and also through notifications to staff in the TRST. (Section 12.3) Organisational Alerts are distributed through the Ulysses System. This type of alert is 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 alert, actions may or may not be required from recipients. They will be issued and monitored in the same manner as Alerts received via the CAS system. 8.0 UACTION DEADLINES 8.1 Deadlines for action taken are detailed on each alert. These deadlines reflect the urgency of the alert and must be adhered to. 8.2 In general each alert has 3 deadlines and these are as follows:- 1st Acknowledging Receipt of Alert - Done by the TRST on behalf of the CLO/DCLO 2nd Confirm Actions Underway - Done by the TRST on behalf of the CLO/DCLO on CAS website after feedback from UEACHU CAS Lead 3rd Confirm Actions Complete - Done by the TRST on behalf of the CLO/DCLO on CAS website after satisfactory feedback from UEACHU CAS Lead confirming all actions have been completed or an action plan is in place to complete the required actions by a specified time. 9.0 UMEDICAL DEVICES SAFETY OFFICER (MDSO) ISSUE 5 FEBRUARY

8 9.1 The Trust has a nominated MDSO: the Trust Health and Safety Manager. The MDSO duties are outlined within the Medical Devices Equipment Policy (Policy Ref: 15.14) 9.2 There is a requirement that all incidents involving medical devices are reported via the electronic Incident Reporting system used by the Trust and that the MDSO and nominated deputy are informed. (Reporting of Accidents, Untoward Incidents and Near Miss Situations including Serious Incidents Policy Ref: 15.01). 9.3 NOTE: In the event of the failure of a device it must not be disposed of unless this is for safety or infection control reasons. Any details (for example packaging, batch no, etc) should be retained for the MDSO (Decontamination Policy - Policy Ref: 18.01) UOTHER COMMUNICATIONS ISSUED VIA THE CAS PROCESS From time to time there will be a requirement to disseminate information in the interests of safety other than the official safety alerts issued by the Department of Health. Where these require actions to be taken by various parts of the Trust the CAS process will be used. Staff will place the same importance on these communications as on the CAS alerts and use the same procedures UMONITORING COMPLIANCE AND EFFECTIVENESS 11.1 UMedical Devices Alerts All medical devices alerts will be managed and monitored through the governance procedures within the Divisions. As required, reports on new alerts and completed alerts will be provided to the relevant Divisional groups overseeing medical devices by the TRST Alert responses made to the CAS Leads will be audited by them and also on a quarterly basis by the CLO/DCLO, to ensure there is evidence of an appropriate/qualitative and timely response An assurance report will be provided by the chair of each of the Divisional groups to the Trust Medical Devices Assurance Group on a quarterly basis. This report will highlight any exceptions, issues or difficulties experienced in dealing with the safety alerts. It will also highlight any alerts where the completion of the actions has not, or may not be completed within the given timeframes Any alerts where the completion of the action has not or may not be completed within the given timelines will be noted by the TRST and an official reminder from CLO sent. The alerts falling into this category will be monitored and audited by TRST and CLO/DCLO and quarterly reports sent to MDAG Where issues have been reported to the Trust Medical Devices Assurance Group and these remain unresolved they will be escalated to the Trust Patient Safety and Effectiveness Group UEstates Alerts All Estates alerts (sent to the identified heads of facilities to action as appropriate) and others not relevant to medical devices will be monitored through the Trust Health & Safety Committee. A regular report on new and completed alerts will be provided to the Trust Health & Safety Committee by the TRST UMedicine Alerts Medicine alerts will be received and responses/action monitored by the Lead Pharmacist Medicines Safety and the Medication Safety Committee. ISSUE 5 FEBRUARY

9 11.4 UPatient Safety Alerts Patient Safety Alerts will be received by the Patient Safety & Effectiveness Committee who will monitor the quality and effectiveness of the responses/actions made Data will be published monthly on the NHS England website about any Trusts that have failed to declare compliance with stage one, two or three alerts by their due date. This information is also likely to be used by the CQC in their monitoring of overall quality improvement UTrust Escalation Where issues have been reported to the Patient Safety & Effectiveness Committee and Medication Safety Committee and these remain unresolved they will be escalated to the Quality and Risk Committee USAFETY ALERT PROCEDURES 12.1 UMedical Device Alerts/Estates Alerts MDA/EFN Alerts are distributed to the CAS Leads for action or immediate action. This is dependant on the nature of the alert and is set by the MHRA when the alert is distributed. MDA/EFN Alerts may also be sent to the CAS Leads for information only if it is determined that no action is required UPatient Safety Alerts Patient Safety Alerts are distributed as directed by each individual alert issued. Following publication of updated NHS England and MHRA documentation all safety alerts are categorised as below: (NHS England: An Introduction to the NHS England National Patient Safety Alerting System (January 2014) and MHRA Managing Medical Devices (April 2014) UStage One Alert: Warning This stage will warn organisations of an emerging risk. It will encourage the Trust to: Consider if the risk issue could happen/has happened locally Consider if action can be taken locally to reduce risk Disseminate the warning to relevant staff, departments and organisations as directed by individual alert. It will also give the Trust the opportunity to help inform the development of stage two and three alerts by the: Sharing of learning Sharing of local good practice UStage Two Alert: Resource This may be issued some weeks or months after a Stage One alert and may include: Sharing of relevant information provided by organisations in Stage One Sharing examples of good practice ISSUE 5 FEBRUARY

10 Access to tools/resources that will help organisations implement solutions to the stage one alert Access to learning resources The alert will contain guidance as to what actions should be completed before sign-off. A timeframe will be set to complete this process UStage Three Alert : Directive At this stage the Trust will be required to confirm that it has implemented specific solutions or actions within the given timeframes UChief Medical Officer (CMO) Messaging Most of these notices are for information and will not require wider circulation. The Medical Director and Associate Medical Directors are the CAS Leads for the purpose of this type of alert/message UDrug Alerts Issued Via CAS on the Trust Risk Management System The MHRA Drug Alerts will also be distributed via CAS on the Trust Risk Management System. Drug alerts are received via the Pharmacies and also through notifications to staff in the TRST Where Pharmacy services are bought in it is expected that the supplying Pharmacies will action the Drug Alerts using their own systems and processes. However, Pharmacy Heads/nominated Medicine Management Advisors will implement internal governance and assurance arrangements to ensure that all drug alerts have been dealt with appropriately Drug alerts are graded for severity and speed of action as follows: Class 1 Class 2 Class 3 Class 4 Immediate action including out of hours Action within 48 hours Action within 5 days Caution in use 13.0 UTRAINING The Trust Pharmacy Services will inform the TRST of the need for onward circulation, if any. The TRST has developed a Drug Alert type on the Trust Risk Management System and this will contain the distribution lists as supplied above. The TRST will provide appropriate training for the identified staff on how to use the system to record their responses to Drug Alerts Training is available to all nominated CAS Leads in the use of the Trust Risk Management System through which safety alerts are managed. Training will be carried out by the TRST There will be general awareness discussions with all new starters in the Trust Risk Induction sessions UTARGET AUDIENCE 14.1 All Trust staff ISSUE 5 FEBRUARY

11 15.0 UCHAMPION AND EXPERT WRITER 15.1 The Champion of this policy is the Executive Director, Forensic Services. The Expert Writers are Ian Freegard, Trust Health and Safety Manager/CLO, & Tina Asquith, Deputy CLO, May 2014 to reflect changes in legislation UREVIEW DATE 16.1 This policy will be reviewed in 3 years or earlier in the light of any changes in requirements or guidance UREFERENCES Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (Part 3) Care Quality Commission (Registration) Regulations 2009 (Part 4) Trust Risk Management Strategy (Trust Intranet) Medical Devices Equipment Policy Decontamination Policy Reporting of Accidents, Untoward Incidents and Near Miss Situations including Serious Incidents NHS England: An Introduction to the NHS England National Patient Safety Alerting System (January 2014) MHRA: Managing Medical Devices (April 2014) MHRA Stage Three Directive: Improving medication error incident reporting and learning (March 2014) ISSUE 5 FEBRUARY

12 UCENTRAL ALERT SYSTEM UALERT RECEIPT FLOW CHART APPENDIX 1 Alert received by Trust CAS LIAISON OFFICER (CLO) (acknowledged on CAS website by TRST) CAS website updated Initial Check for relevance by CLO/Dep CLO/TRST Not applicable to Trust Drug Alerts NHS ESTATES ALERTS (only applicable to Estates) MHRA, DOH & NPSA Alerts Organisational Available on Ulysses website for information Pharmacy Leads To Estates Leads for action To CAS Leads for action Safety Alert closed On CAS Website CAS website updated Alert Leads Acknowledge/Action Underway CAS website updated Feedback Completion of Action Response/Action audited by CAS Leads/CLO/MDSO CAS website updated Report on Actions sent to relevant divisional assurance monitoring groups ISSUE 5 FEBRUARY

13 UExamples of Responses to CAS Alerts APPENDIX 2 You may receive alerts that require you to acknowledge them only. You need to follow the instructions given for how to do this and do so as promptly as possible. If you know you are going to be absent then let the TRST know and provide the name of a deputy who can undertake your role whilst away. It is important to provide evidence that CAS alerts have been responded to in a manner that provides qualitative assurance that all necessary steps/actions have been completed fully and as necessitated by each individual alert, in addition it is good practice to make sure that any future auditor is able to identify which team/division/directorate/organisation is making the response. If action is undertaken provide evidence in your comments to substantiate this. (See table below) Alert (Example Only) Appropriate Response Inappropriate Response MDA/2015/027: Steel cannula infusion sets manufactured by Unomedical Alert not relevant to (team name) but shared with the team for information NHS/PSA/W/2014/017: Risk of death and serious harm from delays in recognising and treating ingestion of button batteries EFN/2015/09: High voltage Hazard Alert National Equipment Defect Report (NEDER) Update FKI Eclipse Equipment not used by (team name) (Team name) teams are not involved in the provision prescription use or maintenance of this equipment alert not relevant no action required. This alert was discussed in detail at the Sept FQGG and TPSG. It was agreed that (initials) would be the divisional contact and would feed into the trust wide response Alert displayed in clinic rooms and on notice boards in (team name) units. Alert to be discussed at all staff team meetings This alert is considered very low risk for the type of patients on (team name). However there is a potential for accidental ingestion so alert forwarded to clinical team to highlight urgency needed if ingestion is suspected. Alert to be shared with teams via staff meetings. This alert is only relevant to 2 staff members within (team name). Both staff are aware of the protocol outlined in the alert and have a management plan in place to raise awareness with patients and carers. Noted (where noted, who knows about it what actions if any have been carried out) Not used by this team (need to specify team/directorate) Acknowledged (who has acknowledged what have they done and where, have any management plans for future occurrence and safety been made) Guidance noted within the service (what service how evidenced) Information received (who by and what has been done with it. Has any action been carried out as a result of greater awareness) Information from a previous sent to staff (what evidence is there that the was relevant, what action has been carried out if any following this , any responses from those receiving the ) Action complete (what action, where, who by, any outcome) ISSUE 5 FEBRUARY

14 APPENDIX 3 Title of Procedure: CENTRAL ALERT SYSTEM Issue: 05 Status: Author Name and Title: APPROVED Ian Freegard, Trust Health and Safety Manager, Tina Asquith Deputy CLO. Issue Date: FEBRUARY 2016 Review Date: JANUARY 2019 Approved by: Distribution/Access: TRUST HEALTH AND SAFETY COMMITTEE NORMAL RECORD OF CHANGES DATE AUTHOR POLICY DETAILS OF CHANGE 01/08 G Clements GG/CM/15 Changes throughout policy 01/12/2010 G Clements Changes throughout. Various changes throughout policy following April 2013 G Clements process changes I Freegard/ Various changes throughout following Safety Alert May 2014 T Asquith (Issue 4) process changes Various changes throughout policy following I Freegard/ process changes: Sections 5.3, 5.4.2, , 7.1.4, Aug T Asquith , 11.3, , 12.3, 17 and App 1. Appendix 2 added ISSUE 5 FEBRUARY

15 EMPLOYEE RECORD OF HAVING READ THE POLICY APPENDIX 4 Title of Policy: CENTRAL ALERT SYSTEM I have read and understand the principles contained in the named policy. 0BPRINT FULL NAME SIGNATURE DATE ISSUE 5 FEBRUARY