Version: V1
Ratified by: Quality Reference Group
Date ratified: 03/06/2024
Job Title of author: Specialist Quality & Safety Team Leader
Reviewed by Committee or Expert Group Quality Reference Group
Related procedural documents n/a
Review date: 03/06/2027
It is the responsibility of users to ensure that you are using the most up to date document template – i.e. obtained via the intranet.
In developing/reviewing this procedure Provide Community has had regard to the principles of the NHS Constitution.
Version Control Sheet
Version Date Author Status Comment
Version 1 April 2024 Specialist Quality & Safety Team Leader Ratified Replaces QSPOL05 and QSPOL11
1. Introduction
Provide is committed to the efficient and effective dissemination of Safety Alerts and National Institute for Health & Excellence (NICE) Guidelines to ensure information is appropriately shared with General Managers/Heads of Service/Service Leads and necessary actions implemented as required.
The Quality & Safety Team assess all incoming safety alerts and NICE Guidelines for relevance and identify which services throughout Provide Group the alerts are relevant to.
Provide uses Datix Cloud (DCIQ) as a cascading system for issuing service user safety alerts, NICE Guidelines, important public health messages and other safety critical information to General Managers/Heads of Service/Service Leads. The alerts distributed include NHS Improvement Patient Safety Alerts, NICE Guidelines, Estates and Facilities Alerts, Medicines and Healthcare Products Regulatory Agency (MHRA), Dear Doctor Letters, Medical Device Alerts, Drug Alerts, Chief Medical Officer Alerts and Department of Health & Social Care Supply Disruption Alerts, CQC Notifications and Field Safety Alerts.
General Managers/Heads of Service/Service Leads receive an email notification to advise that there is an alert in the Datix system for them to action. Upon opening the alert in the Datix system the General Manager/Head of Service/Service Lead is required to read the attached alert document and complete the ‘Safety Alert Responder’s Form’ to acknowledge the alert and evidence what action they have taken. The deadline for response is detailed within the alert record and any breaches are reported to the Quality Reference Group.
2. Purpose
The purpose of this procedure is to outline the process for distributing and responding to safety alerts relevant to Provide services.
The procedure aims to: -
• Give clear definitions of responsibilities in relation to distributing and responding to alerts.
• Set out a process for timely distribution.
• Ensure alerts are acknowledged and actioned consistently and promptly.
3. Scope
This procedure must be followed by all staff responsible for the distribution of safety alerts and NICE guidance, and staff who are required to acknowledge and respond to the alerts.
4. Definitions
Central Alerting System (CAS)
The Central Alerting System (CAS) is a web-based cascading 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.
Drug Alerts
Alerts and recall notices that include instructions on what to do to ensure that a defective batch of product is removed from supply chain and how to return it to the recalling organisation.
Estates and Facilities Alerts
Alerts concerning faulty estates systems or equipment, issued by NHS Improvement Estates and Facilities.
Field Safety Notices
An important communication about the safety of a medical device that is sent to customers by a device manufacturer, or their representative. Field Safety Notices tell you what you need to do to reduce the specified risks of using the medical device.
Interventional Procedures Guidelines
Guidance used for diagnosis or treatment including: -
• making a cut or a hole to gain access to the inside of a patient's body, for example an operation or inserting a tube into a blood vessel.
• gaining access to a body cavity without cutting, for example carrying out treatment inside the stomach using an instrument inserted via the mouth
• using electromagnetic radiation, for example using a laser to treat eye problems.
Medical Device Alerts
Alerts, recalls and safety information issued by the Medicines and Healthcare products Regulatory Agency (MHRA) relating to drugs and medical devices.
Medical Technologies and Diagnostics Guidance
This guidance evaluates new, innovative medical devices and diagnostics. It looks at medical technologies that: -
• deliver treatment - like those implanted during surgical procedures.
• give greater independence to patients.
• detect or monitor medical conditions.
National Patient Safety Alerts
Official notices issued by NHS England which give advice or instructions to NHS bodies on how to prevent incidents which may cause serious harm or death.
NICE Guidance & Quality Standards
Evidenced based standards and recommendations for health and care in England. They set out the care and services suitable for most people with a specific condition or need, and people in particular circumstances or settings. They support health and social care professionals to prevent ill health, promote and protect good health, improve the quality of care and services, adapt and provide evidence-based high-quality health and social care services.
NICE Quality Standards set out priority areas for quality improvement in health, public health and social care. They highlight areas with identified variations in current practice. Each standard includes: -
• a set of statements to help improve quality.
• information on how to measure progress.
Technology Appraisals
Recommendations on the use of new and existing medicines and treatments within the NHS. These can be medicines, medical devices and diagnostic techniques.
5. Responsibilities
Chief Executive Officer & Director of Nursing and Allied Health Processionals
Has overall accountability for ensuring that the Provide Group has the necessary management systems in place to enable the effective implementation of all Health & Safety, Risk Management and Quality Standards
Deputy Director of Nursing and Quality/Development and Compliance Lead
• Review all alerts received via the safety alert email or Central Alerting System (CAS) to assess relevance to Provide services.
• Access the NICE Website on a monthly basis to identify and download new guidance relevant to Provide services.
• Identify which Provide services (if any) alerts should be distributed to and share this information with the Quality & Safety Administration Team.
Head of Health, Safety and Compliance
Review Estates & Facilities Alerts and Field Safety Notices to identify which Provide services (if any) the alerts should be distributed to and share this information with the Quality & Safety Administration Team.
Medicines & Management Team
Review Drug Alerts to identify which Provide services (if any) the alerts should be distributed to and share this information with the Quality & Safety Administration Team.
Medical Device Safety Officer
Review Medical Device Alerts to identify which Provide services (if any) the alerts should be distributed to and share this information with the Quality & safety Administration Team.
Procurement Team
Review National Patient Safety Alerts relating to equipment/supplies to identify which Provide Services (if any) the alerts should be distributed to and share this information with the Quality & Safety Administration Team.
Quality & Safety Administration Team
• Securely save a copy of each alert relevant to Provide services.
• Distribute all alerts via the DCIQ Safety Alerts Module (see Appendix 1) to the services identified by the Clinical Quality Team, Head of Health, Safety & Compliance, Medicines Management Team, Procurement Team.
• Email the General Managers/Heads of Service/Service Leads within the services identified to inform that there is an alert in DCIQ awaiting their acknowledgment and response.
• Monitor the open alerts within DCIQ and send email chasers to General Managers/Heads of Service/Service Leads that have not acknowledged and responded to alerts.
• Escalate non-responders to appropriate Director/Managing & Operations Director and obtain breach reports for alerts responded to after deadlines or still outstanding a response.
• Close alerts within DCIQ once all responders have acknowledged and documented their actions taken following receipt of the alert.
• Update and maintain alert distribution lists in DCIQ.
Directors/Managing & Operations Directors
• Receive a copy of all distributed alerts for information purposes and oversight
• Inform the Quality & Safety Administration Team by email of any gaps in staffing e.g. sick leave, which could impact the distribution and sharing of an alert.
General Managers/Head of Service/Service Leads
• Acknowledge receipt of alerts via DCIQ (see Appendix 2) within timeframes identified and outline actions taken as a result of receiving the alert.
• Upon receipt of a request from the Q&S Administration Team complete breach reports for any alerts not acknowledged and responded to within identified timeframes.
• Inform the Quality & Safety Administration Team by email of any staff changes to ensure alert distribution lists are updated. Failure to notify the Quality & Safety Team may result in alerts not being received and/or actioned.
6. Monitoring
The Quality & Safety Team collate monthly assurance reports that are submitted to Provide’s Quality Reference Group to monitor the organisation’s compliance status with acknowledging and responding to alerts within identified timeframes. Breach Reports for non-compliance are presented alongside the assurance report.
A safety alert audit report forms part of Provide’sClinicalAuditProgramme which assesses the organisation’s overall compliance with responding to alerts and identifies themes from actions taken.
An audit to monitor current practice against issued NICE Guidance forms part of Provide’s Clinical Audit Programme.
The Quality & Safety Committee have oversight of the compliance assurance reports and clinical audit programme.
7. References
Central Alerting System https://www.cas.mhra.gov.uk/Home.aspx
DCIQ (Datix Cloud) https://providecic.gateway.prod-uk.datixcloudiq.co.uk/auth/login
National Institute for Health and Clinical Excellence www.nice.org.uk
Appendix 2: DCIQ Safety Alert Responder Form
