Central alerting system (CAS) policy

1. Introduction
2. Purpose
3. Scope
4. Responsibilities, accountabilities and duties
5. Procedure or implementation
6. Training implications
7. Equality impact assessment screening
8. Links to any other associated documents
9. References
10. Appendices

The national reporting and learning system (NRLS) is a central database of patient safety incident reports. Since the NRLS was set up in 2003, over four million incident reports have been submitted. All information submitted is analysed to identify hazards, risks and opportunities to continuously improve the safety of patient care.

1.1.3 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 or machine tools, or general-purpose laboratory equipment. Examples of medical devices can be found in the trust’s medical devices management policy.

1.1.4 Medical device alerts (MDA)

Medical device alerts (MDAs) are the medicines healthcare products regulatory agency (MHRA) prime means of communicating safety information to medical device users in health and social care.

2 Purpose

The purpose of this policy is to set out the trusts arrangements for managing the risks associated with safety alerts issued by the CAS. As such, it supports the implementation of the trust’s risk management framework.

The trust is proactive by acting on national safety alerts, information and guidance, being aware of the safety issues that might emerge and making the safety of patients an integral part of everything they do.

The policy sets out procedures for responding appropriately to, and monitoring action on alerts issued through the CAS within the defined timescales.

3 Scope

The policy applies to alerts issued through the CAS. It applies to all staff and departments throughout the trust and identifies key staff with specific duties and responsibilities.

4 Responsibilities, accountabilities and duties

4.1 Chief executive

The chief executive is accountable for the trust having the necessary management systems in place for CAS alerts, including the nomination of a responsible director.

4.2 Director of nursing and allied health professionals

The director of nursing and allied health professionals is the nominated director responsible for the implementation and monitoring of the CAS policy including the nomination of a CAS liaison officer to support the trust to comply with the required standards.

4.3 Deputy director of nursing and deputy director of safety and quality

Support the director of nursing and allied health professionals in implementation of this policy and ensuring alerts identify a relevant lead person to develop an action plan to implement for any patient safety alerts received within the organisation where applicable actions are required.

4.4 Care group directors

Care group directors are responsible for:

• the implementation of CAS alerts within their service
• following up and managing the occasions when the nominated manager fails to respond to an alert notification within the given time frame

4.5 Central alerting system (CAS) liaison officer (head of patient safety)

The head of patient safety or patient safety specialist is the nominated CAS liaison officer (CLO) and is responsible for:

• assessing relevance of alerts
• ensuring appropriate steps are taken and actions created and completed to comply with the alert requirement
• share any learning from alerts
• reporting any incident associated with noncompliance with alerts

4.5.1 Safety alerts administrator

• Receiving the CAS alerts and acknowledging them on the CAS website.
• Logging all alerts on the Ulysses alerts module.
• Confirming relevance of alerts, seeking guidance where required from CLO and distributing them via email to the relevant managers with a request for a response within the identified timeframe.
• Maintaining accurate and timely records of dissemination and response.
• Monitoring the responses to CAS alerts within the required time frame.
• Sending a reminder for a response where a response has not been received within the identified timeframe.
• Escalating when following a reminder, there remains an incomplete response.
• Updating the CAS website within the action complete required deadline.
• Producing a monthly monitoring report for the health, safety and security forum.
• Producing a monthly monitoring report for commissioners.
• Arranging training programs on the use of the safeguard alerts module web interface as required.

Some of this function may be delegated to a member of the Patient Safety team.

4.6 Nominated managers

Managers nominated to receive the CAS alert notifications are responsible for:

• implementing and monitoring the CAS policy within their services
• receiving alerts and deciding as appropriate whether any further dissemination is necessary
• making all staff both current and new aware of their responsibilities in relation to CAS policy

4.7 Chief pharmacist

The chief pharmacist is responsible for:

• receiving alerts relating to medicines and drugs and decide as appropriate whether any further dissemination is necessary
• taking any further action to ensure the effective dissemination of information to medical, prescribing, and pharmaceutical staff
• providing a single completed response on behalf of their service to the safety alerts administrator within the required timeframes
• making all staff both current and new aware of their responsibilities in relation to CAS policy

4.8 All staff

All staff where appropriate will be aware of their responsibilities in relation to the CAS policy and act accordingly

5 Procedure or implementation

When a new alert is added to the (CAS) web page, an e-mail notification is also sent to central alerts system email address for the safety alerts administrator to process.

Following the e-mail notification of a new alert, the safety alerts administrator accesses the CAS web page, using a dedicated username and password where the full alert can be viewed and downloaded.

Upon receiving the alert, the safety alerts administrator sends an electronic acknowledgement of receipt back through the CAS web page.

The trust has a specified time frame in which to assess the relevance of the alert and decide on the appropriate course of action identified on the alert.

When receiving a field safety notice recording on the Ulysses alerts module

5.1 Categories of alerts

• 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.
• Action, used where the recipient is expected to take action on the advice where necessary, to repeat warning on long standing problems, or support or follow-up manufacturer’s modifications.
• Update, used to update the recipient about previously reported incidents or series of incidents and where further follow-up safety information is judged to be beneficial.
• Information request, used to alert users to specific issues that may become a problem and where the NHSE or NHSI requests feedback information.

5.2 Action deadlines

Some alerts are issued with action deadline requirements which relate to the seriousness of the identified safety issue. The trust is responsible for updating the CAS website in relation to all action deadlines.

• Action underway, at the time of acknowledgment of the alert the trust registers that it is assessing relevance, after it has been established the trust is responsible for the issues raised. Deadlines are set by the NHSE or NHSI for this part of the process.
• Action completed, the date the NHSE or NHSI requires the trust to have had completed any necessary action.

5.3 Ulysses alerts module

All the alerts are entered onto the alerts module by the safety alerts administrator, with a short summary of the issue and action required, as well as web links to the relevant CAS online pages.

5.4 Dissemination

The CLO and safety alerts administrator assesses the relevance of the alert to the trust. The safety alerts administrator sends a notification to the nominated managers in the areas that the alert is relevant to. This enables the managers to investigate and assess the implications within their services.

If the CLO and safety alerts administrator are unable to identify whether an alert is relevant or not, the alert is sent to all nominated managers to ensure any areas of concern are identified.

5.5 Action required by manager

Nominated managers receive the alert via email and are to:

• examine the information provided on the alert and decide if the alert is relevant to their area, obtain further information to ascertain if the alert is relevant, or begin to implement the action required to comply with the alert if it is relevant. This is to be completed within the specified timeframe (see appendix A flow chart as a guide)
• the manager should oversee the action being taken, and report to the safety alerts administrator that the alert is not applicable, the action is underway and or the action is complete

5.6 Reminders of the deadline

Two weeks before the deadline, or less for shorter action periods, the Safety team will issue a reminder to all managers who have not responded via the alerts module.

Non-responses following the deadline will be escalated to the CLO.

5.7 Action upon completion

The safety alerts administrator, through the CAS web page, of actions completed or non-applicability of the alert to the trust. The response from the trust is recorded against the particular alert on a trust specific page on the CAS website.

6 Training implications

There are no specific training needs in relation to this policy, but the following staff will need to be familiar with its contents:

As a trust policy, all staff need to be aware of the key points that the policy covers. Staff can be made aware through a number of means such as newsletters, team briefings and associated training programs such as health and safety and security.

7 Equality impact assessment screening

To access the equality impact assessment for this policy, please email rdash.equalityanddiversity@nhs.net to request the document.

7.1 Privacy, dignity and respect

The NHS Constitution states that all patients should feel that their privacy and dignity are respected while they are in hospital. High Quality Care for All (2008), Lord Darzi’s review of the NHS, identifies the need to organise care around the individual, ‘not just clinically but in terms of dignity and respect’.

As a consequence the trust is required to articulate its intent to deliver care with privacy and dignity that treats all service users with respect. Therefore, all procedural documents will be considered, if relevant, to reflect the requirement to treat everyone with privacy, dignity and respect, (when appropriate this should also include how same sex accommodation is provided).

7.2 Mental Capacity Act (2005)

Central to any aspect of care delivered to adults and young people aged 16 years or over will be the consideration of the individual’s capacity to participate in the decision-making process. Consequently, no intervention should be carried out without either the individuals informed consent, or the powers included in a legal framework, or by order of the court.

Therefore, the trust is required to make sure that all staff working with individuals who use our service are familiar with the provisions within the Mental Capacity Act (2005). For this reason all procedural documents will be considered, if relevant to reflect the provisions of the Mental Capacity Act (2005) to ensure that the interests of an individual whose capacity is in question can continue to make as many decisions for themselves as possible.

8 Links to any other associated documents

• Health and safety policy
• Medical devices management policy

9 References

• Medicines healthcare products regulatory agency (opens in new window)

10 Appendices

10.1 Appendix A Central alerting system process flow chart

1. Alert received from CAS system or other means by safety alerts administrator.
2. Decision to disseminate, the head of patient safety or patient safety specialist and the safety alerts administrator decides if and who, to disseminate the alert to.
3. Alert disseminated as required, the module entry is created and activated and disseminated. Reminder to complete is sent to managers by CAS liaison officer, at least two weeks (shorter if required) before competition due date, safety alerts administrator will send a reminder to those managers who have not completed the required action.
4. Received by manager, the manager nominated to receive alerts decides what action is required in their service, it will on of the three:
   • no action required, after examining the alert, it is assessed that the alert is not applicable to this service. Either the service is not provided, the item is not used, does not fit the specific criteria or is not under the control of the service
   • need to check, the receiving manager is not sure if the alert applies and so is going to investigate within the service
   • action is required, after examining the alert it is assessed that the alert does apply to items held or services provided within the service. Manager arranges for required action to be carried out within the time scale specified. The alert is examined, and the required action identified, implemented, and completed as described in the alert. It is the responsibility of the manager to ensure the action is satisfactorily completed and the issues is closed
5. CAS alert closed on the CAS website, on or just before completion due date, safety alerts administrator accesses CAS alert website and closes the alert.

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Document control

• Version: 11.1.
• Unique reference number: 625.
• Approved by: Corporate policy approval group.
• Date approved: 11 January 2024.
• Name of originator or author: Head of patient safety.
• Name of responsible individual: Quality committee.
• Date issued: 12 January 2024.
• Review date: June 2025.
• Target audience: Directors, Care group nurse directors, chief pharmacist and medical director, and other staff with responsibility for identifying the relevance of alerts to their services, taking action and providing assurance for monitoring purposes.