Guidance

Abdominal aortic aneurysm screening: failsafe processes

Updated 18 December 2019

1. Failsafe processes

A failsafe is a mechanism in addition to usual care. It explains what action is necessary to ensure a safe outcome for the screening programme and the individual.

There are detailed failsafe processes for each NHS population screening programme.

This guidance sets out the failsafe processes that abdominal aortic aneurysm (AAA) screening providers should have in place to:

• identify anything that is going wrong
• determine what action to take to correct errors before any harm occurs

Failsafe should be a ‘closed loop’ process. The points at which a required activity is started and finished must be noted for failsafe to be effective. This is usually through a systematic process and an IT system.

A system also needs to be in place to make sure all opened loops are closed within an appropriate timescale.

1.1 Opening the loop

A loop is opened by a trigger that indicates a process requiring a failsafe control for an individual has started. For example, a pregnancy reported either by self-referral or through primary care triggers the offer of an antenatal screening test.

1.2 Closing the loop

A loop is closed by an event or a stage of the screening pathway that denotes the conclusion of a process requiring failsafe control for an individual. For example, the dispatch of a letter to inform parents that the results of newborn blood spot screening are normal would close a loop.

A number of events can result in a particular loop being closed. For example, a loop which is opened by a ‘condition suspected’ antenatal screening result might be closed by:

• diagnostic testing confirming the pregnancy is not affected
• parental choice to continue an affected pregnancy
• termination of an affected pregnancy

1.3 Ensuring the loop has been closed

This is an additional check, usually on a group of individuals, to identify any individual for whom a failsafe loop has been opened but not closed within a defined timescale. For example, for blood spot screening this could be a systematic check that blood spot sample cards have been received at the screening laboratory for all babies born 17 or more days previously.

Most screening pathways involve multiple failsafe loops at different levels of detail. Loops can exist within other loops. For example, a failsafe loop to make sure every screen-positive woman is offered diagnostic testing can exist within a broader loop, ensuring every woman who is screened is notified of their screening result.

2. Failsafe strategy

Failsafe strategy requires action at national, regional and local level. The main roles and responsibilities are outlined below.

2.1 PHE Screening

PHE Screening assesses the screening pathway and identifies areas of high risk that require failsafe measures. It considers the probability of an error occurring and the severity of the consequence, drawing on learning from incidents.

2.2 Quality assurance

Regional screening quality assurance service (SQAS) teams provide expert advice to screening providers and commissioners on reducing risks in local services. They assess local arrangements through audit, as part of peer review and in the investigation of incidents.

2.3 Commissioners

NHS England regional teams, via their screening leads, are responsible for making sure the whole pathway is commissioned and that everyone communicates properly to make all failsafe processes work. Working with providers, they should make sure safeguards are in place throughout the screening pathway and for high risk groups. This requires clarity about roles and responsibilities.

2.4 Providers

All providers should review and risk-assess local screening pathways in the light of national guidance and work with commissioners to develop, implement and maintain appropriate risk reduction measures. This should involve mechanisms to audit implementation and report incidents.

Effective implementation requires routine staff training and development and may need changes to local roles and responsibilities. Providers should also make sure there are appropriate links with internal governance arrangements, such as risk registers.

See separate AAA screening pathway: failsafe overview attachment for screening pathway and associated failsafe points.

3. Failsafe AAA2

3.1 Process

Identification of eligible population and offer of screening.

3.2 Opening the loop

Population identified, eligibility established. Men aged over 65 informed of self-referral process through local awareness-raising.

3.3 Closing the loop

All eligible men in cohort are offered screening. All eligible men who self-refer are offered screening. PHE Screening provides guidance on offering screening to men identified through other sources such as prisons.

3.4 Ensuring the loop has closed

Data is downloaded daily from GP systems by Health and Social Care Information Centre (HSCIC). This is integrated with the national AAA screening Screening Management and Referral Tracking (SMaRT) IT call-and-recall system. Screeners check subjects’ details to confirm eligibility before carrying out the screening test. PHE Screening monitors the use of inappropriate screening outcomes via SMaRT. Local providers adhere to national guidelines for screening men identified through other sources.

3.5 Local provider tasks

Check data included in monthly activity reports and quarterly key performance indicator (KPI) reports.

4. Failsafe AAA3

4.1 Process

Follow-up of those who move out of or do not complete the pathway.

4.2 Opening the loop

GP notified if screening not completed. Where non-completion is due to physical move out of the area, the record is transferred to new local screening provider in SMaRT.

4.3 Closing the loop

Local screening provider makes sure all subjects who are pending a final ‘did not attend’ (DNA) decision are offered a further appointment. Further scan declined by subject. Reasons noted on SMaRT and GP informed.

4.4 Ensuring the loop has closed

Following a DNA, SMaRT produces letters to be sent to the subject and his GP. After first DNA, subject is offered a new appointment. After second DNA, subject is informed they will not be offered an appointment unless they contact the programme. Regular demographic updates are obtained from HSCIC to minimise postal returns. Telephone numbers are collected from men who are placed on surveillance so the local provider can contact them if they DNA. SMaRT has a system search for subjects requiring appointments following a DNA. Records are made on SMaRT of attempts to contact individuals for further investigation.

4.5 Local screening provider task

DNA patients’ addresses are checked against Personal Demographics Service (PDS) to make sure there have been no changes since the initial invitation was generated. If a change of address is found, then this is amended and a new appointment issued.

5. Failsafe AAA4

Screen those who accept the offer.

5.1 Opening the loop

Screeners obtain verbal consent or decline and record in SMaRT. Screener carries out screening test.

5.2 Closing the loop

Attendance recorded on SMaRT or paper pro formas as soon as subject arrives at clinic.

5.3 Ensuring the loop has closed

Screener checks SMaRT or pro formas at end of clinic to make sure outcome is recorded (DNA or screening test).

5.4 Local screening provider task

Check data included in monthly activity reports for programmes. Review alerts daily and clear incomplete records.

6. Failsafes AAA5a, 11, 12 and 13

All screening results received and recorded.

6.1 Opening the loop

Screener enters individual screening test results into SmaRT. Local coordinator or administrator enters any paper-based test results into SMaRT.

6.2 Closing the loop

Screener sets screening outcomes in SMaRT and checks measurement against image. Screener must record 2 measurements per man – in the longitudinal and transverse planes. Note: SMaRT suggests correct screening outcome based on test results profile.

6.3 Ensuring the loop has closed

All images and results are archived and stored as per national guidance. SMaRT system alert for appointments in the past with no outcomes recorded is checked daily.

6.4 Local screening provider task

Check data recorded in monthly activity reports and programme’s annual report. Check alerts.

7. Failsafe AAA5b

Follow-up of men whose aorta is non-visualised at screening appointment.

7.1 Opening the loop

Screeners record non-visualised screening outcome on SMaRT system. Letters sent to GP advising of non-visualisation.

7.2 Closing the loop

Local screening service arranges further scan appointment and sends further invitation. Further non-visualisation: refer to vascular lab or medical imaging. If further scan declined, note reasons on SMaRT and inform GP.

7.3 Ensuring the loop has closed

SMaRT allows a decision to recall for screening non-visualised subjects or to refer them to medical imaging. SMaRT has alerts for:

• subjects awaiting a non-visualised decision
• subjects referred to vascular lab/medical imaging with no outcome recorded

Search available on SMaRT for subjects in state of ‘Requires Appointment – Re-screened’.

7.4 Local screening provider task

Either re-book non-visualised men into a screening clinic or arrange an appointment with the local medical imaging department or vascular laboratory.

8. Failsafe AAA15

All men with screen-detected AAA measuring 3.0 to 5.4cm enter next stage of pathway

8.1 Opening the loop

Screeners record AAA measurement in SMaRT. Outcomes are also sent to men and their GP within one week. Subjects are offered an appointment with the local screening service’s nurse practitioner on or before their first scan in surveillance

8.2 Closing the loop

Follow-up appointments offered at regular intervals – annually for 3.0 to 4.4cm aneurysms and 3-monthly for 4.5 to 5.4cm aneurysms. If further scan is declined, then reasons should be noted on SMaRT and the GP/vascular nurse informed. Written instruction should be signed by the subject or his representative to confirm his informed dissent from surveillance recall.

8.3 Ensuring the loop has closed

Surveillance scans completed at appropriate time and results entered on to SMaRT. Coordinator acts upon SMaRT alert if surveillance due dates are breached. Note: SMaRT suggests correct screening outcome based on test results profile unless the screener overrides the automatically generated outcome. Co-ordinator acts upon SMaRT alert for outstanding nurse appointments.

8.4 Local screening provider task

Data in monthly activity reports for local screening services. Monitor alerts for surveillance appointments due within 6 weeks and surveillance due date has passed with no recall appointment booked.

9. Failsafe AAA18

All men with screen-detected AAA>=5.5cm referred to vascular services.

9.1 Opening the loop

Screening outcomes are given to subjects verbally by the screener at the time of test. Outcomes are also sent in writing to the subjects and to their GP. GPs should be informed within one working day. Local screening service makes referral to vascular services.

9.2 Closing the loop

Assessment appointment date recorded in SMaRT. If further investigations are declined, then reasons should be noted on SMaRT and GP/nurse informed.

9.3 Ensuring the loop has closed

Screening coordinator checks screen positives appointed in vascular services as per national guidance. National AAA screening standard AAA-S11 states that all referrals should be seen in a vascular outpatients department within 2 weeks of the referral being made by the co-ordinator. SMaRT has a system alert for ‘subjects with vascular service referral sent but no receipt or action taken’.

9.4 Local screening provider task

Referrals included in monthly activity reports. Monitor alerts for referrals required and alerts in referral tracking to ensure timeliness of appointments and surgery.

10. Failsafe AAA21

All who accept referral get it.

10.1 Opening the loop

Appointment for vascular assessment received by patients.

10.2 Closing the loop

Vascular assessment completed and results entered into SMaRT.

10.3 Ensuring the loop has closed

Screening coordinator:

• checks that referrals have attended vascular assessment as per national guidance
• audits that the time from screen detection to first attended vascular assessment is within 2 weeks as per pathway standards
• audits time from screen detection is within 8 weeks as per pathway standards

The progress of each referral made to a provider of vascular services should be tracked and action taken to detect and rectify any delays in the man being seen for assessment or subsequent treatment. The provider should be aware of all final outcomes for each man referred.

10.4 Local screening provider task

Referrals included in monthly activity reports and in annual report. Timeliness of assessments and surgery is managed in referrals tracking module within SMaRT with alerts for those who have breached the waiting times.