1. Implementation of Non Invasive Prenatal Test (NIPT) as a contingency test in Wales
Presented by: Sharon Hillier/ Director of Screening Division, Public Health Wales
November 2018

2. Implementation of Non Invasive Prenatal Test (NIPT) as a contingency test in Wales
June UK National Screening Committee (NSC) recommended screening for Edwards’ syndrome and Patau’s syndrome in the first trimester
UK NSC also recommended screening in twin pregnancies
January 2016 UK NSC recommended evaluative roll out of NIPT as a contingency test for Down’s Syndrome, Edwards’ syndrome and Patau’s syndrome

3. Combined Screening in Wales
In Wales offer of combined screening for Down’s syndrome was fully implemented from September 2015
Offer of screening in twin pregnancies and screening for Edward’s and Patau’s syndromes was not possible to implement until combined screening was implemented for all eligible women in the first trimester
The decision taken in Wales was to include these changes to the pathway at the same time as NIPT so that managing one change process

4. Implementation Plan Project initiation Project initiation document
Project Board
Scope Issues and finances
Obtain recommendation of how to implement from Welsh Government
Devise education and information strategy to promote women making personalised informed decisions

5. Stakeholder engagement
Colleagues from Wales (screening, Welsh Government and services) are represented in the UK level groups for NIPT implementation. Groups have wide representation
Project board in Wales had wide representation including charities representing parents with children with the syndromes.
Information produced underwent focus group discussions for feedback and review.
Effective working with the genetic laboratory in Cardiff UHW who procured and validated test (a lot of work).

6. Implementation Decisions (Welsh Government)
Initial Screening Test
Combined screening:
Offered for Down’s syndrome, Edwards’ syndrome and Patau’s syndrome
To women at weeks with a singleton or twin pregnancy.
Quadruple screening:
Offered for Down’s syndrome where NT measurements not obtained and when too late for the combined test in singleton pregnancies.

7. Implementation Decisions (Welsh Government ) NIPT
Following a higher chance screening result from the combined or quad test:
Non-invasive prenatal testing (NIPT) or an invasive test offered to women with a singleton pregnancy
An invasive test offered to women with a twin pregnancy

8. Important points
Personal informed choice: Women to be offered choice at each stage of the pathway and their choice supported. Women can opt out of the pathway at any point.
The NIPT test result is not a diagnostic test for the condition. An invasive test is a diagnostic test
If the NIPT test is low chance then the woman is not offered an invasive test.
The cut off of higher chance remains 1 in 150
It is expected that the number of unnecessary invasive tests is reduced in Wales due to the offer of NIPT as a contingency test

9. Health Board Implementation
All Health Boards agreed to education and implementation date (it was ambitious!)
Health Boards had regular implementation meetings with relevant stakeholders
Project team supplied action list to be used if required
Project team member attended health board implementation meetings

10. Project resources Project supplied:
Cascade training session and resources for roll out to promote choices (FASP and voluntary organisations supplied resources and undertook the face to face training)
Mandatory E-Learning package for professional information and education
Information resources for women:
pretest written information and film clip
post test information written information and scan pads
Information for professionals on screening in twin pregnancies
Mandatory E-Learning package for professional information and education
Information resources for women, including pretest written information and a flim clip, and post test information

11. Implementation Date
The date of 30th April 2018 was set for implementation - any woman having her scan on or after this date was on the new pathway for screening
No major issues with implementation across Wales
Health Boards reported being prepared for the implementation

12. Evaluation Supply data to UK NSC evaluation
Pre implementation agreement to evaluate in Wales using data and questionnaires
Evaluation board to be developed from members of project board
Six monthly reporting to the board
Delay in England

13. Data to be evaluated UK NSC evaluation to look at:
how many women choose NIPT when it’s offered
how well NIPT detects Edwards’ and Patau’s syndromes
how often NIPT fails to produce a result and why this is

14. Data collection in Wales Questions to be answered
What decisions do women make?
What is the laboratory turnaround time for NIPT tests in Wales?
How does the NIPT test perform for Down’s syndrome, Edwards’ syndrome and Patau’s syndrome?
How often is the laboratory unable to give a result and the reason?
What are the sample collection to laboratory turn around times?
How often are there sampling or request card errors?

15. Evaluation of Information for Women
Pre test written information:
Reviewed as part of the implementation process – subject to routine annual review by Antenatal Screening Wales.
Pre test film clip:
New resource for implementation, reviewed by focus groups and project board prior to implementation.
Post implementation evaluation with women completed
Post test written information:
Three former booklets were reviewed and amalgamated into new, more comprehensive book and reviewed by project board prior to implementation
Post test evaluation with midwives and women just completed

16. Ongoing Evaluation of Information
Focus groups planned
Input from Nuffield Council on Bioethics and other voluntary organisations

17. Data Publication
Data will be published to stakeholders when the pathway is completed for the first cohort of women.