Guidance for NCARDRS notifiers

Congenital differences and rare disease we collect information on include:

• congenital differences, (suspected or confirmed) – structural (excluding normal variants), genetic and chromosomal conditions and metabolic/biochemical disorders
• enhanced data collection on NHS FASP physical conditions and trisomy 21

We collect information for cases booked in England for all pregnancy outcomes, for example pregnancy losses (all gestations), terminations of pregnancy (TOPS), stillbirths and live births. There is no limit on gestation or age. It is important to notify all other suspected/confirmed congenital conditions.

When a physical condition is suspected, all scan reports must be sent to NCARDRS. This includes the initial scan report and any follow up fetal medicine scan reports with the outcome. This will include scan reports where the suspected condition is confirmed, changed or not present. If in doubt, please contact NCARDRS for advice or notify us. If a notification should be excluded, or is a duplicate, it will be deleted. The common antenatal and postnatal exclusions are listed below.

These are NCARDRS exclusions which may still need to be referred as per local guidelines. Please refer to the Fetal Anomaly Screening Programme Handbook for more information.

Common antenatal exclusions (when isolated)

• enlarged nuchals (NTs or nuchal folds) of any size without suspicion of further registerable condition

Normal variants seen on ultrasound:

• choroid plexus cysts
• dilated cisterna magna
• echogenic foci in the heart
• two vessel cord
• echogenic bowel
• short femurs
• renal pelvic dilatation (RPD) if less than 10mm (please only notify us if RPD is equal or greater than 10 mm)
• ventriculomegaly if less than 10mm (please only notify us if ventriculomegaly is equal or greater than10 mm)

Common postnatal exclusions (when isolated)

• patent ductus arteriosus (PDA) or persistent foramen ovale (PFO) in preterm infants
• right sided aortic arch
• positional talipes
• heart murmurs
• clicky hips - unless USS at 6 weeks confirms congenital hip dysplasia
• undescended testes
• birth marks
• accessory nipple
• tongue tie
• pyloric stenosis
• sacral dimples – spina bifida occulta

Below are guidelines to support those completing NCARDRS notifications:

1. All notifications must be electronic and secure.
2. Send notifications before final confirmation or outcome.
3. Send all 20-week screening scan reports with a suspected or unconfirmed finding and do not rely other colleagues or departments to notify.
4. Send as much information as you have available. It is not a problem if the data is incomplete.
5. For twins/triplets, make sure it's clear which fetus has the condition.
6. If you have a clinical report, such as an ultrasound scan report, post-mortem or discharge summary that contains most of the information you have you can send us a copy to avoid transcribing data.
7. The appropriate electronic notification should be completed when the anomaly is first suspected.

Antenatal suspicion

Complete the antenatal notification and note in the ‘additional details’ box if the pregnancy is continuing or if it has been terminated (date, location and TOP type if available). For continuing pregnancies, we will request outcome information after the estimated delivery date.

Delivery/postnatal suspicion

Complete a delivery notification or complete a postnatal notification as appropriate, and we will then contact you for the relevant antenatal information.

NCARDRS is aiming to move to a more electronic format so bulk downloads are preferred.
The secure NCARDRS data collection portal can be used - this contains a copy of each notification type and allows you to add six attachments per submission. Please note this link opens in a new window. 

If you are currently sending in pdfs/excel files and would like to switch to bulk downloads or using the portal, please contact your regional NCARDRS office via email.

The regular Ultrasound Scan feed (USS), exported from Viewpoint or Astraia, can be submitted via the National Data Registration Service Data Submission Portal. Please note this link opens in a new window. 

You can upload data for specific data feeds once your Trust has an account. If you need further information, please contact the Data Liaison Manager via email.

PDF notifications, reports and excel files can be emailed to our regional office via nhs.net email. Please ensure PDF notifications are in a format where text can be copied- ideally as electronic PDFs, not image files. We recommend that you request delivery and read receipts. We will confirm receipt within three working days, via email.

National Data Opt-Outs

National data opt-outs will not apply to the collection of the data for the NCARDRS because to fulfil the National Disease Registries Directions 2021, NHS England will issue a Data Provision Notice (DPN) to the holders of the data, in accordance with section 259 of the 2012 Act. A DPN imposes a legal obligation on the provider to supply the data to NHS England and the national data opt-out policy does not apply where there is a legal obligation to share data.

National data opt-outs will be applied in accordance with the national data opt-out policy to the dissemination of data from the NCARDRS via UKHSA’s ODR function or via DARS to restrict the dissemination of an individual’s confidential patient information by NHS England where the national data opt-out applies.

More information about the national data opt-out is available on the NHS Digital website.

NCARDRS opt-out

Patients are able to opt-out of their personal data being collected into the NCARDRS as a matter of Department of Health and Social Care Policy. NCARDRS has a Standard Operating Procedure that describes the process that must be followed, including how a request to opt-out should be handled, the records that are kept regarding the request, and the technical measures in place to ensure subject data is removed. Individuals are offered a call with a clinician to discuss the opt-out process and any concerns or questions they may have.

Where an individual has opted out from NCARDRS, information provided by the holder of the data will not be processed and will be deleted. In accordance with this opt-out, a request by a patient for their details to be removed from the registry will also be upheld. A secure opt-out list is maintained to ensure that those who have opted out are not inadvertently registered or re-registered.

More information is available on the NDRS opt out pages of this website. 

NHS England is directed to put measures in place as part of the establishment and operation of the Information System to ensure that where an individual opts out of their personal data being held or a person with parental responsibility for a child opts out of that child’s personal data being held no new data about them is collected.