Guidance

Sickle cell and thalassaemia screening: outcome data

This guidance explains the collection and use of outcome data to evaluate the sickle cell and thalassaemia (SCT) screening programme

The National Congenital Anomaly and Rare Disease Registration Service (NCARDRS) collects patient-identifiable data without the need for individual informed consent with permission from the National Information Governance Board under section 251 the NHS Health ACT 2006 and the authority of the Health Service (Control of Patient Information) Regulations 2002 (CAG ref: CAG 10-02(d)/2015).

Sickle cell disease and thalassaemia are both rare disorders.

NCARDRS collects named data for babies and children with sickle cell disorders or thalassaemia to assess:

  • the health of affected babies or children

  • timeliness of entry into care and start of their treatment

  • their antenatal screening history

This guidance explains:

  • the newborn outcomes data collection process

  • actions for healthcare professionals at each stage of the project

  • how healthcare professionals should inform parents about their right to opt out

Newborn outcomes data collection process

Use the process flowchart to see the whole pathway and actions for healthcare professionals.

The flowchart includes actions for:

  • babies with a newborn blood spot screen positive result

  • clinical presentation of an affected child or infant

  • the death of an unflagged baby

Collecting data

The following professionals need to provide data:

  • newborn screening laboratories

  • healthcare professionals caring for affected babies and children

  • specialists working in sickle cell and thalassaemia centres

  • staff in the Office of National Statistics and Medical Research Information Services

Use the data collection templates to record and submit data on babies and children who are:

  • SCT screen positive

  • attending for clinical care

  • from one of the above groups and who die

  • not from one of the above groups and who die with codes linked to SCT

Do not collect data on babies who are carriers. The SCT programme and NCARDRS will review the data to enable national monitoring of detection rates and outcomes to find out if:

  • all babies are entering care in a timely way

  • clinical services are providing immunisations and regular check-ups to the correct standard

  • there are any learning points for services when a baby dies

Informing parents of the opt out mechanism

Check that parents have received the Screening tests for you and your baby booklet explaining all antenatal and newborn screening tests.

The section on newborn blood spot screening explains the use of data and how to opt out.

NCARDRS hopes to register every baby and child who has SCT. However, parents can opt out at any time.

More information to inform an opt-out decision can be found on the NCARDRS website.

To opt out, please email optout.ncardrs@phe.gov.uk or write to:

National Congenital Anomaly and Rare Disease Registration Service
Public Health England
Skipton House
Second Floor
80 London Road
London SE1 6LH

Published 31 March 2017