Guidance

Fetal anomaly screening programme checks and audits

Published 4 July 2018

1. NHS Fetal Anomaly Screening Programme

The NHS Fetal Anomaly Screening Programme (FASP) aims to:

• ensure there is equal access to uniform and quality-assured screening across England
• provide women with high quality information so they can make an informed choice about their screening and pregnancy options
• provide education and training resources for staff covering all stages of the process, from informing women of test availability, through to understanding and supporting their decisions

2. Screening pathways

Each NHS screening programme has a defined care pathway. The pathways show how the individual undergoing screening moves from one stage of the pathway to the next. Checks are needed at each stage to ensure the individual moves seamlessly and safely through the pathway unless they choose not to.

If these checks are not in place there is a risk that an individual does not complete the pathway or the pathway is delayed unnecessarily. Quality assurance of screening programmes includes checking these failsafe procedures are in place and operating effectively.

3. Failsafe in screening programmes

In screening programmes when we refer to the need to have failsafe processes in place we want to ensure if something goes wrong that it can be easily identified at the time that it is going wrong and action can be taken to correct it before any harm occurs. The concept of failsafe is not widely understood so we provide an example here.

3.1 Example of a screening failsafe process

Mrs Russell books and accepts HIV screening at 8 weeks of pregnancy. Her blood sample is taken and dispatched to the screening laboratory. Do you:

1. Check that you have her results within 8 working days as per national standards?

2. Follow up with the screening laboratory if you do not have a result within 8 working days?

3. Wait until her next appointment which might be around 16 weeks?

Her blood sample taken at 8 weeks was lost and never arrived in the laboratory. If you only checked her results before her appointment at 16 weeks you would have lost 8 weeks and delayed any potential intervention she may need. Consider what would happen if she was found to be HIV positive on subsequent screening.

We have evidence from screening safety incidents reported that some providers are not checking screening results in line with the above standards. They therefore do not discover a screening sample was inadequate or needs repeating or the sample never arrived in the screening laboratory until reporting on key performance indicators 3 months later.

Failsafe processes must be timely. They help you to identify when and what is going wrong in real time, as it is happening.

4. Methodology

For each pathway we:

• mapped all the screening safety incidents including serious incidents reported
• applied findings from peer review quality assurance visits
• used information from queries received by the PHE screening helpdesk
• listened to a range of stakeholders about risks

This process enabled us to focus on where there are known weaknesses in the pathway.

5. Using the template

The template outlines:

• what: this is what we recommend you do
• why: these are the reasons we are recommending this
• how: this is how you might do this
• when: this is how often we recommend you undertake the action or perform the check

As you work through the template you may wish to check if:

• you already have local processes in place to do these checks
• there are any gaps
• you are doing these checks often enough

If the answer is no to any of questions above you can use the last column (provider response) to develop an action plan.

The completed failsafe document, any action plan developed and the results of any audits can be used as evidence for quality assurance activities, including peer review visits.

6. Annual audits

We have also included additional annual audits that providers should undertake. These audits will help determine if the whole system is working effectively.

7. Other important resources

The template should be used in conjunction with:

• service specifications
• standards
• screening pathway
• handbooks for screening and laboratories

8. Vignettes

We provide the following vignettes to demonstrate what can go wrong when there are no checks in place or when checks are not robust or timely.

8.1 All parts of the screening test not completed

Woman had booking appointment at 11 weeks gestation and chose to have combined screening. Nuchal translucency was measured but blood sample was not taken. This was not detected until the woman was 28 weeks pregnant and too late to offer any screening.

A woman had booking appointment at 12 weeks gestation and chose to have combined screening. The nuchal translucency could not be measured despite 2 attempts and the woman was offered the quadruple test which she accepted. The woman was informed that an appointment for the quadruple test would be sent to her by post but this did not happen. This was not detected until the maternity service was submitting key performance coverage data 3 months later.

A woman chose to have combined screening and booked early. At the dating scan she was only 9 weeks gestational age, which is too early to measure the nuchal translucency. A request was made to rescan in 3 weeks but her appointment was sent for 5 weeks later and when scanned was too late to have combined screening. She was offered the quadruple test instead.

8.2 Samples not arriving in the screening laboratory

Fifteen Down’s syndrome, Edwards’ syndrome and Patau’s syndrome screening samples taken on a Friday were not dispatched to the screening laboratory. The samples were discovered in a tray in the antenatal clinic the following Monday.

8.3 Fetal anomaly ultrasound scan not completed within recommended timescales

A maternity service submitting key performance data found that scans were not always completed at the right time. They were not aware that this was happening until they started collecting data for the KPI. When they looked at their data they found:

• 4 women did not have a completed fetal anomaly scan recorded
• 2 women had anomaly ultrasound appointments incorrectly cancelled or rescheduled and were completed outside of required timescales
• 2 women were not given a fetal anomaly ultrasound appointments following their dating scan
• 61 women received initial anomaly ultrasound appointment after 20+6 weeks without a documented reason for this
• 15 women required a repeat USS appointment to complete the anomaly scan and this was scheduled for after 23+0 weeks without a documented reason for this