Newborn outcomes project: definition and implementation
- Public Health England
- Part of:
- Sickle cell and thalassaemia screening: commission and provide and NHS sickle cell and thalassaemia (SCT) screening programme
- First published:
- 4 June 2015
This document explains the outcomes evaluation project for the linked antenatal and newborn sickle cell and thalassaemia (SCT) screening programme.
The newborn outcomes project uses named data for babies and children under 5 with sickle cell disorders or thalassaemia to assess:
- the health of babies or children affected with sickle cell disorders or thalassaemia
- timeliness of entry in to care and start of treatment for affected babies or children
- antenatal screening history
Professionals need to collect named patient data on babies and children under age 5.
To ensure the project monitors all babies, it collects their data without parental consent.
This guidance explains:
- how to inform parents about their right to opt out
- actions for health professionals at each stage of the project
Newborn outcomes project process pathway
Use the process flowchart to see the whole pathway and actions for professionals at each stage.
The following professionals need to provide data:
- newborn screening laboratories
- health 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:
- screen positive (have sickle cell or beta thalassaemia major)
- under the age of 5 years and attend for clinical care
- from the above groups who die
- not in groups 1 or 2 who die with codes linked to sickle cell and thalassaemia
Do not collect data on babies who are carriers. The programme will review the data to see whether:
- 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 if a baby dies
Inform 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 about using data and how to opt out. Ensure parents understand the process:
- parents and their health professional will receive the baby’s newborn blood spot result
- the screening programme will store data that could identify their baby
- the information is used to monitor and improve screening and care
- the screening programme has ethical permission from the HRA to collect this data
If parents wish to opt out they can phone 020 7848 6627 where they can speak to someone in a language of their choice.
The screening programme undertook a formal consultation about the ethics of using patient data without consent.
The Confidentiality Advisory Group (CAG) of the Health Research Agency (HRA) reviewed the project and gave the project formal permission.
The CAG review this permission every year.
The screening programme works closely with the Sickle Cell Society and UK Thalassaemia Society.
The Newborn Outcomes Information Governance and Clinical Board Group brings together:
- professionals in screening and care
- voluntary sector representatives
It monitors the project to ensure it uses data in an appropriate way and addresses relevant clinical issues.
Other organisations that advise the project include:
- The Caldicott Guardian of King’s College Health Schools
- Head of Division of Health and Social Care Research of King’s College London
- UK National Screening Committee Director of Programmes
NHS population screening helpdesk
NHS population screening helpdesk
Public Health England Zone B
Floor 2 Skipton House
80 London Road
Contact form http://legacy.screenin...
Helpdesk phone number 020 3682 0890
Please note the helpdesk is not for media enquiries.
The helpdesk and national programmes do not have access to screening results.
Parents: contact your midwife or health visitor for information on screening results.
Health professionals: contact the local screening team, screening laboratory or local child health records department.
Published: 4 June 2015