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
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 firstname.lastname@example.org or write to:
National Congenital Anomaly and Rare Disease Registration Service
Public Health England
80 London Road
London SE1 6LH