nhs fetal anomaly screening programme annual report...

Screening Programmes

Fetal Anomaly

NHS Fetal Anomaly Screening Programme Annual report2011–2012November 2012

Version 1: November 2012

NHS Fetal Anomaly Screening Programme Annual Report 2011–20122

NHS FASP Annual Report 2010–2011 October 2012

www.fetalanomaly.screening.nhs.uk

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NHS Fetal Anomaly Screening Programme Annual Report 2011–2012 3

Annual ReportNHS Fetal Anomaly Screening Programme

2011–2012


Tables 5

Figures 5

Executive summary 6

Contributors 7

Introduction 7

Provenance of the programme 8

Governance of the programme 8

The structure of the core team and expert groups 8

NHS FASP receives accreditation 9

Overall programme aims and objectives 10

The ultrasound screening scan 10

The Down’s syndrome screening test 11

Remit 11

The roll out of first trimester combined screening 11

Meeting the “Model of Best Practice” 2007 – policy statement 12

National programme standards and this year’s performance against them 13

Down’s syndrome screening – results for cycle 10 13

Down’s syndrome screening – results for cycle 11 14

Diagnosis of Down’s syndrome pregnancies 15

Uptake of Down’s syndrome screening 15

Project development to support improvements 16

Failure Modes and Effects Analysis (FMEA) tool for the NHS FASP 16

Standards – T21 National Standards and Guidance for England 17

Fetal Anomaly ultrasound screening 18

Standards 18

18+0 to 20+6 weeks Fetal Anomaly scan: National standards and guidance for England 18

“Incidental markers” indicative of Patau’s syndrome (T13) and Edwards’ syndrome (T18)

in the first trimester of pregnancy 21

Education and training 22

Regional Obstetric ultrasound Screening Co-ordinator (ROSCO) Group 22

The development of care pathways for Fetal Anomalies 24

Congenital heart disease clinical care pathway project 25

Gastroschisis audit report 2011 26

Diagnostics 28

The impact of introducing a national policy for Down’s syndrome screening on

the diagnostic invasive procedure rate in England 28

Invasive testing and pregnancy outcome data collection system for England: amniocentesis

and chorionic villus sample national audit pilot project (Phase 2) 28

Literature searches 29

External research activities 29

NICE Guidance 29

National conferences and events 30

Programme information systems 30

Contents


Equity/Equality 31

Programme expenditure 32

Future work, aims and long-term objectives 32

Appendix – The NHS FASP Expert Group Membership 33

NHS FASP Steering Group (FASPSG) 33

Programme Executive Group (PEG) 34

Laboratory Quality Control Advisory Group (QC Group) 34

Public and Professional Information Group 35

Diagnostic Audit Group 36

NT Management Group 36

References 37

Useful Websites 38

Tables Table 1 - Number of screening tests included in submission, number screened positive and standardised SPRs for

this cycle. Laboratories provided data over varying lengths of time so annualised figures are given. Standardised

SPRs are estimated from the annualised figures 14

Table 2 - Number of screening tests included in submission, number screened positive and standardised SPRs for

this cycle. Laboratories provided data over varying lengths of time so annualised figures are given. Standardised

SPRs are estimated from the annualised figures. 15

Table 3 - Uptake rate of Down’s syndrome screening in England and Wales 15

Table 4 - The criteria and subsequent action following assignment of a flag 22

Table 5 - Outcome of gastroschisis diagnoses 27

Table 6 - Diagnosis at delivery 27

Table 7 - Programme expenditure for the period 1 April 2011 to 31 March 2012 32

Figures Figure 1 – The structure of the core team and expert groups 8

Figure 2 – Implementation of the combined screening test on 1 April 2012 11

Figure 3 – Implementation of the combined screening test on 31 March 2012 12

Figure 4 – Primary screening method offered by hospitals in England, April 2011 12

Figure 5 – Primary screening method offered by hospitals in England, March 2012 13

Figure 6 – Example of the new layout of the T21 National Standards and Guidance for England 17

Figure 7 – 18+0 to 20+6 weeks Fetal Anomaly scan: National standards and guidance for England 18

Figure 8 – NHS FASP care pathway for Fetal Anomaly scan 20

Figure 9 – The changes in the flag status assigned for cycle 8, 9 and 10 23

Figure 10 – Development cycle of NHS FASP care pathways 24

Figure 11 – Equality page on the NHS FASP website 31


The National Health Service Fetal Anomaly Screening Programme (NHS FASP) and its aims and objectives have now been firmly embedded into maternity services for women in England during the period we have been operating since 2001. Many changes have taken place during that time and we certainly have a better-managed service with set standards, supporting information and education and training resources. The commissioning framework to underpin this has been firmly established with available specifications for the service to work to. One of our core values will always be choice, and supporting that choice whatever it may be. Although we have looked at reducing the time window for screening, the evidence remains limited before 10 weeks of pregnancy so our screening window remains from 10 weeks up to 21 weeks, which includes the Fetal Anomaly ultrasound aspect. Undoubtedly with the advent of new non-invasive prenatal diagnostic tests this may change. We will keep this under constant review, working closely with the UK NSC policy-making arm.

Major changes to the service have taken place in previous years and we have endeavoured recently to try and provide time for the service to take on board these changes and embrace the standards. Our work during this report period has therefore concentrated on providing support to staff with education and training, through our Regional Obstetric ultrasound Screening Co-ordinators (ROSCOs) and guidance by developing clinical pathways for each condition. These work streams will be ongoing.

The period 2011–2012 saw the commencement of a review of the national antenatal and newborn screening programmes structure. Many of the programmes had been set up ten years ago with little change to their function, purpose and overall objectives. The review gave an opportunity to provide organisational changes particularly in tandem with the overall NHS changes taking place to public health. From 2013 NHS FASP, along with the UK National Screening Committee (UK NSC), will become part of the new Public Health England (PHE) with possible centralisation in London.

Overall as NHS FASP begins to change in response to the general NHS restructuring we look back to see how much has been accomplished in that time. Our overall aim has always been to help and support women, their partners and the staff who have and continue to work hard to deliver that service through some very difficult times.

Executive summary


We would like to thank the following people who have contributed to the 2011/12 NHS FASP Annual Report:

Mrs Pat Ward, National Programme Director – NHS FASP

Miss Alissa Delbarre, National Programme Associate – NHS FASP

Mrs Elaine Green, PA to the National Projects Officers – NHS FASP

Mrs Joanne Harcombe, National Education Lead – UK NSC

Mrs Donna Kirwan, National Projects Officer – NHS FASP

Mrs Fiona Maddocks, National Projects Officer – NHS FASP

Ms Louise Mitchell, PA to Pat Ward – NHS FASP

Miss Karen Toulalan, National Programme Associate – NHS FASP

Dr Amy Baker, Senior Research Fellow – Down’s Syndrome Screening Quality Assurance Support Service (DQASS)

Mr Paul Newell, Research Fellow – DQASS

There has always been a discussion around where the work and responsibility of the NHS FASP ends. Is it when the screening result has been returned to the pregnant woman, or is it our responsibility to follow it into the diagnostic arm? Usually we are fairly clear that from our position we have responsibility until the diagnostic result is returned to the pregnant woman, but not beyond that into treatment and clinical management care. However, as we manage a screening programme which screens for 12 conditions in total, some of them lethal either before or shortly after birth, we have been provided with a remit from the UK NSC to work in partnership with other relevant services to provide some guidance on clinical pathways.

A number of clinical pathways have been agreed with stakeholders and are now available for the service to use. There is still much work to do in these areas and this is the commencement of ensuring a complete care pathway for those who wish to be screened.

One of the key areas we have been concentrating on is the development of assessment of risk within the screening pathway. Previously we have developed an FMEA (failure Mode Effects and Analysis) system that identifies all possible risks along the Down’s syndrome screening pathway. We have now developed one for the 18 to 20 weeks six-day scan and this will be shortly available to use.

During this report period we have also seen a tremendous amount of work being undertaken by our ROSCOs,

who were specifically put into place to support improvements to the Nuchal Translucency (NT) and Crown–Rump Lenth (CRL) ultrasound measurement of the combined screening test (CST). They have been very successful in improving the measurements, which is demonstrated in Figures 9 and 10. Our statistical support service DQASS has been at the front of providing analysis and interpretation of the practice and this is explained in more detail in the report. It has allowed us to monitor the service more closely and provide assurance of the quality of the screening test for Down’s syndrome.

A key point for NHS FASP is to demonstrate that we work closely to a process with our projects so that information produced is of the best quality. This year in particular we were very proud to be awarded with the

NICE Accreditation Programme Award for the Model of Best Practice policy document.

Contributors

Introduction


The NHS FASP works within the organisational structure of the UK NSC. It is one of a number of national screening programmes set up by the Department of Health to oversee implementation of an agreed screening programme. The core roles are that of audit, monitoring, developing improvements to the service, patient information, and education and training of staff. Developing and influencing national policy is also a central remit of the programme in conjunction with the UK NSC, who recommends policy to the Department of Health and the Ministers of the four countries. The terms and remit of the UK NSC are available from: www.screening.nhs.uk

The overarching programme director of the UK NSC is Dr Anne Mackie and the programme director of NHS FASP is Mrs Pat Ward. There are a number of steering and working groups that advise the NHS FASP and the UK NSC on the direction and development of the programme. These groups can be seen below. The ultimate responsibility of the NSC sits with the Department of Health. The director and staff working within NHS FASP are hosted by The Royal Devon and Exeter NHS Foundation Trust, with a service-level agreement between that Trust and the Department of Health to deliver the required outputs for the national programme. The base office of NHS FASP is known as the Programme Centre and is situated within the University of Exeter.

The structure of the core team and expert groups at the NHS FASP are outlined below. The membership can be seen in the appendix.

Figure 1 – The structure of the core team and expert groups

Provenance of the programme

Governance of the programme

The structure of the core team and expert groups

Programme CentreBased at the University of Exeter

Core staff – supported by independent consultants

DirectorMrs Pat Ward

Fetal Maternal & Child Health Group(FMCH)

Dr Anne MackieNSC Programmes Director

Fetal Anomaly Screening Programme Steering Group(FASPSG)

ChairProf Peter Soothill

Meets 3 Kmes a year

UK Na>onal Screening Commi?ee DH

Other project workReport from Mrs Pat Ward

NT Management Group

ChairFiona Maddocks

QC Group

ChairAngela Mallard

Public & Professional Informa>on Group

ChairJenny Hewison

DQASS Monitoring OfficeUniversity of Plymouth

Prof Dave Wright

Programme Execu>ve Group

ChairMrs Pat Ward


On 5 April 2012, the National Institute for Health and Clinical Excellence (NICE) announced that NHS FASP had been awarded accreditation for the processes it used to develop the document “Screening for Down’s syndrome: UK National Screening Committee Policy Recommendations 2011–2014: Model of Best Practice”.

The NICE Accreditation Advisory Committee, who reviewed the application for accreditation, found that the process for producing the guidance “used systematic methods to search for evidence of both clinical and cost effectiveness” and ensured the views of healthcare professionals and patient groups were well represented.

As a result of the decision by the independent Accreditation Advisory Committee, the policy document can now be considered as part of the development of NICE quality standards, should ones be developed relevant to these guidelines in future. NICE quality standards are central to supporting the Government’s vision for an NHS focussed on delivering the best possible outcomes for patients, as detailed in the 2010 NHS White Paper “Equity and Excellence – Liberating the NHS”.

NHS FASP will also be able to carry the “Accreditation Mark” (see below) on any new clinical guidelines produced under the accredited process, assuring health and social care professionals that they are accessing some of the best information available online to make informed decisions about patient care.

The Accreditation Advisory Committee concluded that 22 of the 25 criteria for assessment had been met by the NHS FASP.

Donna Kirwan, National Project Officer and Project Lead/Manager for NHS FASP Policy and Standards, said in the news brief:

“We pride ourselves on producing the ‘Model of Best Practice’ policy because it ensures that a better-performing screening test for Down’s syndrome is available for pregnant women. Although we were confident in how we had undertaken our policy setting, both for the Model of Best Practice (MoBP) and in the past, seeking opinion about our processes from an external programme was necessary in terms of further endorsing our work, which in turn would reassure the public that our methods were trusted.

“Overall, we spent a lot of time over an eight-month period preparing a portfolio for review but it was well worth it. Sharing our expertise and collaborating with the NICE Accreditation Programme was certainly a

positive learning experience.”

NHS FASP receives accreditation


Congenital abnormalities still remain one of the leading causes of perinatal morbidity and mortality and a wide variety of structural abnormalities can be detected prenatally by ultrasound scanning. The understanding of the purpose of the scan is variable – from the woman’s perspective it is a chance to see the baby and confirm normality, rather than a screening test to look for abnormalities. From the clinical perspective it is considered a useful tool to identify problems that, if present, allow the clinician to develop management pathways which are likely to optimise outcome. However, the dichotomy appears to have led to confusion over the purpose, limitations and benefits of the use of ultrasound screening over the years.

The core aim of the 18+0 to 20+6 weeks Fetal Anomaly scan is to screen for and/or diagnose, with the woman’s consent, a systematic examination of fetal skeleton, limbs and vital organs for any type of singular or multiple, minor, major or fatal structural malformations before birth.

Primary aims include:

• Ensure access to a uniform screening programme which conforms to an agreed level of quality standards

• Provide appropriate, clear, high-quality information in a range of formats to enable women to make choices and decisions that are right for their pregnancy

• Offer choice to women about their screening options and pregnancy management

• Identify conditions that may benefit for antenatal intervention

• Identify conditions that require early intervention following delivery

Secondary aims include:

• Prompt referral to an obstetric ultrasound specialist or fetal medicine specialist to confirm a diagnosis

• Provision of a seamless care pathway between specialist fetal medicine services and local (secondary) hospital Trusts to provide care for women with difficult or complex fetal disorders as near to their home as possible

• Audit and monitoring of the screening programme against set NHS FASP standards

Overall programme aims and objectivesThe ultrasound screening scan


RemitThe remit of the programme is to set standards and oversee implementation of a screening programme that conforms to an agreed level of quality for all pregnant women in England who choose to undergo screening for Down’s syndrome.

The main aims and objectives of the programme are to:

• Ensure access to a uniform screening programme which conforms to an agreed level of quality

• Provide information for women so they are able to exercise informed choice

• Offer options to women and their partners about the management of their pregnancy

National Programme resources have focussed on refining the quality assurance mechanisms associated with the recommended screening test strategies, and further quality improvements have been demonstrated.

Ensuring the quality of the test result remains a key objective and is underpinned by the “Screening for Down’s syndrome UK NSC Policy Recommendations 2011–2014 Model of Best Practice” and the “Working Standards for Down’s syndrome Screening” (2007). These standards are due to be reviewed during 2012.

From 1 April 2011 up to 31 March 2012 many of the remaining hospitals due to implement combined screening have done so. The charts below show the status of the implementation of combined screening in hospitals in England at the end of March last year and for early April 2012. The last few hospital Trusts due to implement the combined test are expected to complete this in early 2012.

Figure 2 - Implementation of the combined screening test on 1 April 2012

The Down’s syndrome screening test

The roll out of first trimester combined screening

200

150

100

50

0

Implemented

Hos

pita

ls

86%

Due to Implement in 2011

9%

2% 3%


Unknown date


Figure 3 – Implementation of the combined screening test on 31 March 2012

As more hospitals implemented first trimester combined screening and the quadruple test for second trimester screening in 2011, the figures for hospitals meeting the standards set out in the Model of Best Practice improved from 95 per cent at the end of March 2011 to 99 per cent by April 2012. This reflected a shift by those hospitals only offering second trimester triple testing and quadruple testing to first trimester combined screening.

Figure 4 – Primary screening method offered by hospitals in England, April 2011

Meeting the “Model of Best Practice” 2007 – policy statement

200

150

100

50

0

Implemented

Hos

pita

ls

96%


4%0%

Unknown date

Combined

Quad

Integrated

Triple

Combined

Quad

Integrated

Triple

86%86%

9%9% 1%1%4%4%


Figure 5 – Primary screening method offered by hospitals in England, March 2012

All laboratories are required to submit data to the monitoring arm of the NHS FASP – the Down’s Syndrome Screening Quality Assurance Support Service (DQASS). More information on DQASS can be found on our website at: http://www.fetalanomaly.screening.nhs.uk/dqass. This has been in place since October 2006 and provides good comparative data for improvements as well as highlighting any concerns that need addressing. The reports are issued in six-monthly cycles.

The cycle reports provide summary information of all 30 laboratories in the UK and it is not possible to isolate figures for England only.

National programme standards and this year’s performance against them

Down’s syndrome screening – results for cycle 10The summary of cycle 10, from April 2011 to September 2011, is given below in Table 1. The number of first trimester combined tests continued to increase and accounted for 72.9 per cent of all tests in this cycle, compared with 60.7 per cent in cycle 9. Quadruple testing increased and accounted for 72.8 per cent of all second trimester and integrated tests compared with a previous cycle rate of 49.7 per cent.

Overall, age-standardised screen positive rates (SPRs) for the different tests were similar to the previous cycle. The overall standardised SPR of 3.0 per cent reflects the high proportion of combined tests.

PAPP-A and Free β-hCG (first trimester) have shown improvement since cycle 9.

Combined

Quad

Integrated

96%

3% 1%4%


Table 1 – Number of screening tests included in submission, number screened positive and standardised SPRs for this cycle. Laboratories provided data over varying lengths of time so annualised figures are given. Standardised SPRs are estimated from the annualised figures.

Cycle 10 Number screened in data

supplied

Estimated annual number screened

Number screened positive

Estimated annual number screened positive

Standardised SPR (%)

Combined 200,978 366,888 5,928 10,562 2.5

Integrated 2,389 4,700 77 149 2.8

Quad 54,379 119,360 2,244 4,828 4.1

Triple 17,928 54,497 811 2,288 4.5

All 275,674 545,445 9,060 17,827 3

Down’s syndrome screening – results for cycle 11 The summary of cycle 11, from October 2011 to March 2012, is given below in Table 2. The number of first trimester combined tests increased slightly and accounted for 79.4 per cent of all tests in this cycle. Quadruple testing increased and accounted for 87.6 per cent of all second trimester and integrated tests compared with a previous cycle rate of 72.8 per cent.

Overall, age-standardised SPRs for the different tests were similar to the previous cycle. The overall standardised SPR of 2.7 per cent again reflected the high proportion of combined tests.


Cycle 11 Number screened in data

supplied

Estimated annual number screened

Number screened positive

Estimated annual number screened positive

Standardised SPR (%)

Combined 211.464 407,168 5,867 11,334 2.4

Integrated 2,324 4,451 59 114 2.2

Quad 48,157 90,918 2,108 3,927 4.2

Triple 4,464 8,853 220 437 4.4

All 266,409 511,390 8,254 15,812 2.7

Diagnosis of Down’s syndrome pregnancies According to data collected by the NDSCR (National Down Syndrome Cytogenetic Register), in 2010 there were 1,868 diagnoses of Down’s syndrome, 64 per cent of which were made prenatally. In 2010 there were an estimated 715 Down’s syndrome live births, a live birth rate of 1 per 1,000 live births.

Year Total number of tests Number of births Uptake %

2007 367,962 690,013 53

2008 409,436 708,711 57

2009 442,361 706,248 62

2010 508,091 723,165 70

2011 542,312 723,913 74

Uptake of Down’s syndrome screening

Presently we don’t collect national uptake except for knowing what the numbers of samples are compared to overall deliveries in England. This is shown in Table 3. These are the figures for England and Wales.

Table 3 – Uptake rate of Down’s syndrome screening in England and Wales

Table 2 – Number of screening tests included in submission, number screened positive and standardised SPRs for this cycle. Laboratories provided data over varying lengths of time so annualised figures are given. Standardised SPRs are estimated from the annualised figures.


Project development to support improvements

Failure Modes and Effects Analysis (FMEA) tool for the NHS FASP

It cannot be refuted that health screening is complex. It relies on a variety of people to undertake specific actions within a stepped process and doing the right thing, at the right time to the right patient. Care pathways should enable seamless “best practice” for every patient whatever their outcome, but is inevitable that unforeseen problems can occur. Whether small, or of a greater magnitude, “patient harm” of any nature is unacceptable and employing proactive measures is a necessity to minimise future risks.

Originally developed by the American aviation and motor industry, a “Failure Modes and Effects Analysis” (FMEA) is a tool which provides logical, sequential steps for specifying and highlighting potential pitfalls in process areas before they occur and also ensuring that specifications, policies and standards align to care pathways. The FMEA is an additional resource that can be used for investigating serious incidents, reducing the chances of same incidents occurring again, or as a complementary resource when preparing for service redesign.

Since 2008 to date, NHS FASP has created a series of electronic FMEA documents to meet the requirements of quality planning regulations for their ISO 9000 Risk Management Safety Strategy. To start the task, NHS FASP care pathways (from the offer of screening to pregnancy outcome) were drafted and refined, and each step in the care pathway interrogated (see statements below). Responses were substantiated with evidence.

Failure (F) 1. Examine a process in detail and outline every step.

Mode (M) 2. Identify ways in which any of the steps might go wrong: that is, the “failure modes”.

Effects (E) 3. Establish the consequences (effects) of each failure mode.

Analysis (A) 4. Identify what could be the underlying causes (contributory factors). 5. Identify any existing “controls” (factors acting to prevent, detect, monitor or mitigate this risk).

As the FMEA is a “living” document the tool is monitored and updated periodically to reflect any type of change (e.g. policy, service, evidence) within the NHS. All hospital Trusts should be able to access it by the end of 2012 as an online interactive tool.


Standards – T21 National Standards and Guidance for England

The last edition of standards for Down’s syndrome screening was produced in 2007 and since this time the evidence base has progressed significantly to alter the standards and warrant an update. The aim of this project was to produce a set of evidence-based first and second trimester Down’s syndrome screening standards relevant to primary, secondary and tertiary NHS care settings, primarily for NHS staff (maternity and pathology services), but also for people or organisations such as patient support groups and clinical commissioning groups (CCTs).

A multidisciplinary T21 National Standards Working Group was set up to provide a user-friendly, clinical evidence-based suite of standards for the NHS in England that:

a) offers best clinical advice for T21 b) is based on best published evidence and expert consensus c) takes into account maternal choice and informed decision making d) defines the major components of NHS care provision for T21 screening e) indicates areas suitable for clinical audit

The first-draft version of the standards was drawn up by the national working group between July and September 2011. The draft was then submitted for a round of formal public and stakeholder consultation from 19 September to 24 October 2011. From October to April, the group met again on another two occasions to review the consultation feedback and support the editing of the draft document. The second and final public and stakeholder consultation from 6 June to 13 July 2012 will hopefully provide again information to enable the group to refine the document. In brief, key priorities for implementation include:

• The offer of first trimester Combined Screening

• The offer of first trimester Combined Screening for women with a multiple pregnancy

• Referral to expert for accurate diagnosis

• Quality assurance of the CRL and NT measurements

• Ensuring that the new content reflects the “new” NHS

The document will be completed and launched by the beginning of 2013.

Figure 6 – Example of the new layout of the T21 National Standards and Guidance for England

NaKon T21 screening programme standards 2013-‐2016 (DRAFT)







No. 1PS / GS (see footnote)

Standard 2Criteria (see footnote)

Acceptable Achievable Level of Monitoring

Policy and governancePolicy and governancePolicy and governancePolicy and governancePolicy and governancePolicy and governancePolicy and governance1

PS All eligible pregnant women must be offered screening for Down’s syndrome (1-‐7)

The T21 screening window is from 10 weeks, 0 days to 20 weeks, 0 days.The Combined screening test must be undertaken when the crown rump length (CRL) measures from 45mm to 84 mm (10 weeks, 0 days to 14 weeks, 1 day). It must include the ultrasound measurement of the nuchal translucency (NT) and measurement of maternal serum free beta hCG and PAPP-‐A biochemical markers. It is the UK-‐NSC recommended invesKgaKon pathway for both singleton and twin pregnancy regardless of maternal age.The Quadruple screening test which includes the measurement of maternal serum AFP, hCG, uE3 and Inhibin-‐A must be offered to women who are for whatever reason unable to have the Combined screening test and are

97% of eligible pregnant women offered screening for T21 in the first or second trimester of pregnancy. 97% of eligible pregnant women offered the Combined screening test when the ultrasound CRL measures from 45mm to 84mm. 97% of eligible pregnant women offered the Quadruple screening test when the ultrasound CRL is greater than 84.0mm.

100% of eligible pregnant women offered screening for T21 in the first or second trimester of pregnancy.

Collected locally Collected regionally Collected naKonally


Fetal Anomaly ultrasound screeningStandards 18+0 to 20+6 weeks Fetal Anomaly scan: National standards and guidance for EnglandFigure 7 – 18+0 to 20+6 weeks Fetal Anomaly scan: National standards and guidance for England

In 2010, the first official set of obstetric ultrasound standards for England was produced by the NHS FASP. The standards endorsed by the Royal College of Obstetricians and Gynaecologists (RCOG), British Maternal and Fetal Medicine Society (BMFMS) and Society of Radiographers (SoR) were developed over an 18-month period by a small expert group of clinicians and were positively received by hospital Trusts. The aim of the standards was to provide a quality-assured suite of obstetric ultrasound standards to improve the care given for their respective eligible pregnant population.

For this purpose, a group of experts was established with members selected and appointed by the national project lead. Each member of the project national working group is expected to take a broad view of the topic areas and collated evidence presented. Membership reflects the specialist skills and knowledge as well as experience of caring for and working with pregnant women. These individuals are also selected because of their links with other networks. We feel confident that those involved in this project will be true and fair in their decision making.


This project will make use of the existing standards document by updating it using an iterative process of information gathering and considering the social, psychological and practical aspects of how screening programmes will work for both the pregnant population and healthcare professionals in a local maternity Trust. The project cycle includes:

• Four national expert group meetings (June, September, December and January 2013)

• Two national online stakeholder consultations (March, October/November 2012)

The first meeting held in June 2012 will start with specific key aspects; issues generated from 2009 consultation feedback and more recent consultation in spring 2012:

• Project scope

• Product scope of second edition of standards

• Time frame for undertaking the obstetric ultrasound scan

• Re-scanning women

• Appointment schedules

• Referral arrangements to tertiary-level fetal medicine services

From this point and to the end of the project, the expert group will discuss and consider what can be reasonably achieved in terms of new evidence, workforce capacity, financial resources, as well as patient safety.


At ‘first contact’ visit or at ‘booking’ visit with midwife

Offer verbal and written information (‘Screening Tests for You and Your Baby’) about dating scan, Trisomy 21 screening and 18+0 to 20+6 weeks fetal anomaly scan

18+0 to 20+6 weeks fetal anomaly screening scan offered to woman

Provisional offer of screening for fetal anomalies would be given by a midwife at the first contact visit and again at the

booking visit (or just one visit)

Provisional consent obtained by midwife during discussions at either first contact or

booking visit. Pre-scan ‘tear off’ scan leaflet should be given on day of appointment by

clerk or midwife to remind the woman about the purposes of the scan

Women who present beyond 20+6 weeks should be scanned but be informed about the limitations of detecting structural

anomalies later in pregnancy

Woman declines all screening

Record decision in hand-held notes*

Continue and obtain pregnancy outcome

No anomaly identified

Anomaly identified/suspected

Refer to fetal medicine unit (FMU)

Anomaly suspected(‘best practice’ refer to fetal medicine unit)

Anomaly confirmedoffer prenatal investigations

Refer to in-house consultant with fetal anomaly/ultrasound experience

Woman acceptsprenatal

investigations

Obtain consent Record in

hand-held notes*

Go to prenatal diagnosis

pathway

Inform woman Inform woman

Obtain consent Record decision in hand-held notes*

Record In hand-held notes*

Record in hand-held notes*

Continue andobtain pregnancy

outcome

Refer to second sonographer/

consultant

Go to fetal medicine pathway

Obtain consentRecord in hand-held

notes*

No anomaly identified

Declines further management

Woman declines prenatal

investigations


outcome


outcome


outcome

Record decision in hand-held notes*

Record decision in hand-held

notes*

Re-scansecond sonographer/

consultant

Woman accepts all screening

18+0 to 20+6 weeks fetal anomaly scan undertaken with woman’s consent

Nine conditions should be audited:1. Anencephaly2. Bilateral renal agenesis3. Diaphragmatic hernia4. Exomphalos5. Gastroschisis6. Lethal skeletal dysplasia7. Open spina bifida8. Cleft lip9. Serious cardiac

anomalies

Level 3 scan, PND (and maybe intra-uterine treatment) and/or termination of pregnancy may be required

Screening Programmes

Fetal Anomaly

First contact/booking

Screening test

Accepts

Declines

Ultrasound

High risk/anomaly

Prenatal diagnosis

Colour key

*This also includes reporting in an electronic auditable system

Care pathway for Fetal Anomaly scan

Nine conditions should be audited:1. Anencephaly2. Bilateral renal agenesis3. Diaphragmatic hernia4. Exomphalos5. Gastroschisis6. Lethal skeletal dysplasia7. Open spina bifida8. Cleft lip9. Serious cardiac anomalies

Prenatal investigations offered may include:• Maternal blood• karyotyping• MRI

Figure 8 – NHS FASP care pathway for Fetal Anomaly scan


“Incidental markers” indicative of Patau’s syndrome (T13) and Edwards’ syndrome (T18) in the first trimester of pregnancy

The NHS FASP recently finalised the third edition of the Down’s syndrome screening policy “Model of Best Practice”, which builds upon former recommendations to introduce a universal first trimester screening programme. The DQASS Programme reports that 97 per cent of hospital providers in the country have implemented the combined screening test (CST), which essentially means, overall, a better detection rate (compared to second trimester methods) and a reduction in the number of miscarriages due to unnecessary invasive testing.

It is a fact that maternal serum biochemical markers used in T21 screening can also be indicative of other less common conditions such as Patau’s syndrome (T13) and Edwards’ syndrome (T18) if free β-hCG and PAPP-A are decreased and the fetus has an increased NT. Currently, identification of these conditions is usually by second trimester ultrasound.

In 2010, 7 of 24 laboratories declared that as well as providing a risk result for T21, they also included the profile for T13 and T18. This was for several reasons: high mortality is associated with both conditions, including numerous complex anomalies. Thus, knowing about and withholding this information was considered unethical since women may benefit as such information could extend their reproductive choice before 15 weeks of pregnancy.

A recent parent “straw poll” supported the initiation of a national screening policy for T13 and T18.

The UK NSC office is dovetailing this project and will be commissioning an independent organisation to undertake a formal literature review of the evidence. In the meantime the project will continue, moving on to a further consultation round in the autumn.

It is anticipated that the project will complete at the end of 2012 and report to the UK NSC.


Education and training

Regional Obstetric ultrasound Screening Co-ordinator (ROSCO) Group The nine members of the highly skilled and experienced ROSCO group, each operating within a named SHA boundary of England, have continued to offer practical education and training support to ultrasound practitioners within English NHS Trust hospitals. Their remit is to provide guidance on the practical acquisition of accurate measurements as part of the 11+2 to 14+1 week ultrasound scan, which contributes to the “combined” test risk calculation for Down’s syndrome.

Ultrasound practitioners provide their individual measurements to DQASS through the laboratory data and a system has been set up to analyse these against a reference curve. This can be seen in Table 4. In-house practical support is given to those who have a red flag assigned to them by the local screening support sonographer (SSS) and the ROSCO. It can be seen in Figures 9 and 10 that there has been an improvement to measurements with less red flags assigned during three DQASS cycles, which equates to 18 months.

Table 4 – The criteria and subsequent action following assignment of a flag

Flag type Criteria and Action required

Green flag: achievable

No action required. Continue screening. A green flag is assigned when NT bias relative to the FMF reference curve is less than 0.10mm

Amber flag:acceptable

Continue screening. Discuss with SSS to identify areas where some adjustments could be made to improve practice even further. An amber flag is assigned when NT bias relative to the FMF reference curve is between 0.10 mm and 0.49mm

Red flag: action required

Devise a supportive action plan with SSS and ROSCO. This may include a review of theory, further practical sessions, and assessing images against criteria. Document extra training received. Resubmit 25 paired measurements to DQASS when SSS and ultrasound practitioner agree an improvement in practice is demonstrated. Maximum two-month review.

A red flag will be assigned when NT bias relative to the FMF reference curve is 0.50mm or greater


Regional Obstetric ultrasound Screening Co-ordinator (ROSCO) Group continued

Figure 9 – The changes in the flag status assigned for cycle 8, 9 and 10

Cycle 8: 933 Ultrasound practitioners 102689 Scans Cycle 9: 1230 Ultrasound practitioners 131804 Scans

Cycle 10: 1609 Ultrasound practitioners 168528 Scans

Cycle 8 Cycle 9

Cycle 10

35.08%38.77%46.94%

51.90%46.56%42.31%

11.59%13.41%9.77%

1.43%1.26%0.98%

100

90

80

70

60

50

40

30

20

10

0

0.0 0.1 0.2 0.3 04 0.5 0.6 0.7

Prop

ortt

ion

of W

omen

Scr

eene

d

Bias (MM)

National


The development of care pathways for Fetal Anomalies The NHS FASP published two care pathways for fetal neural tube defects in Spring 2011 that covered the antenatal and the postnatal periods. During 2011–2012 work continued on the preparatory stages for developing care pathways for congenital heart disease, congenital diaphragmatic hernia and for cleft lip.

The remit of the care pathways was to commence from the point of first diagnosis up to one year of life and the aim was to set out best practice referral patterns and care for women. The care pathways are intended to provide a framework to enable the NHS to achieve greater standardisation and equity of service delivery for patients along with timely care.

For each Fetal Anomaly condition a literature search was commissioned to review current evidence and key stakeholders were identified to participate in a national meeting to discuss what key elements would be needed for a pathway. In addition, NHS FASP met with relevant support groups to ascertain the views and needs of parents as well as continue our long-established relationships with those groups. Groups included Antenatal Results and Choices (ARC), the Cleft Lip and Palate Association (CLAPA) and CDH-UK (formerly Cherubs UK).

For each care pathway a stakeholder meeting was held of key health professionals, representatives from Royal Colleges, Associations and Societies, support groups and parents. The events included presentations of key evidence in the morning and open forum discussion. In the afternoon small group discussions were facilitated to enable key elements of a care pathway to be drawn out. Following each stakeholder meeting, a report and draft care pathway was produced and reviewed by the attendees. Once the care pathways have been revised they will be available for wide consultation via the NHS FASP website. The consultation period for the cleft lip care pathway commenced in April 2012 and the consultations for congenital diaphragmatic hernia and for congenital heart disease will commence later in 2012.

Figure 10 – Development cycle of NHS FASP care pathways

Publication & distribution to

the NHS

Literature search and stakeholder

analysis

National stakeholder

meeting

Draft care pathway

Consultation Process


Congenital heart disease clinical care pathway project Within the remit of overseeing the implementation of a high-quality Fetal Anomaly screening programme for all pregnant women in England the NHS FASP has identified congenital heart disease (CHD) as one of the 11 key conditions within this screen. This is in part due to the prevalence of major cardiac lesions and also due to the severity, prognosis and life-long care required when a child is born with a significant cardiac defect. Research has demonstrated that prenatal diagnosis affords parents the time and information to make an informed decision regarding their options. It has also been postulated that in the case of ongoing pregnancies, anticipatory care plans can result in an improvement in postnatal morbidity and mortality.

The congenital heart disease clinical care pathway project aims to produce a consolidated, evidence-based national care pathway for women referred for advanced screening and diagnosis of fetal heart disease. The pathway will commence at the point of referral (which may vary due to the reason for referral) and continue through to the end of the first six weeks of neonatal life. The pathway project includes both pre- and postnatal considerations.

The interface between the prenatal and postnatal pathway has facilitated a close collaboration with the NHS Infant Physical Examination Programme (NHS NIPE), which has allowed screening programme team members to integrate and share their expertise. The multifaceted dimensions of the pathway require input from varying clinical service aspects and the collaborative working has also drawn on key stakeholders, such as the British Maternal Fetal Medicine Society (BMFMS), the Safe and Sustainable review of congenital heart services for children in England and Wales and the British Congenital Cardiac Association (BCCA). To date a number of meetings have been held with these key organisations. This has ensured uniformity of the standards and literature produced not only for the screening of CHD but also for use in diagnostic fetal cardiology units across England.

An extensive stakeholder event was also held on the 1 March 2012 in London. The meeting was chaired by Mr Pranav Pandya, Director of Fetal Medicine, University College London Hospitals Foundation Trust. A wide range of stakeholders was present, including clinicians, charities/support groups and parents/lay representation. The event was extremely well received and the facilitated group work ensured the productivity of the day. The outputs from this event included identification of the key themes of the integrated cardiac clinical care pathway, stakeholder opinion and, where possible, consensus regarding the layout, terminology and development of the pathway.

Currently the pathway is undergoing a redrafting exercise and following this a consultation with the event attendees will be held. Following this a nationwide consultation will be undertaken in accordance with NHS FASP policy and protocol. It is envisaged that the pathway will reach completion in August 2012 with endorsement from the key stakeholders as detailed above.


Gastroschisis audit report 2011 The report was commissioned to assess the service in England in relation to screening, diagnosis and referral for fetal gastroschisis, with the intention of identifying variable practice that would inform areas for future development and improvement.

Hospitals of varying size and type completed the survey, which looked at policies, practices and attitudes after the prenatal diagnosis of gastroschisis. There was little perception that management of women with gastroschisis had changed in the last five years. Formal written care pathways, use of written information leaflets and consultants’ attitudes to the offer of termination were found to be variable between different hospitals. In the majority of cases when gastroschisis is diagnosed by ultrasound in a local hospital, second opinions are obtained both in-house and with referral to specialist fetal medicine units. Increasingly, local hospitals have an in-house consultant with specialist fetal medicine interest. Few women are ever offered a termination of pregnancy. However, there are high rates of missing data.

MethodTwo questionnaires were designed for distribution to local general hospitals (DGHs) and regional tertiary fetal medicine centres (FMUs). The questionnaires were distributed electronically to 205 units – 182 DGHs in England and 23 tertiary fetal medicine units. Many questionnaires were returned as a composite response of the hospital Trust, rather than individual maternity units.

Response ratesSurvey forms were received from 81 hospitals, 64 reporting on the experiences of DGHs without specialist fetal medicine units, 9 from units in hospitals with fetal medicine units and 8 from fetal medicine units. Questionnaires were received from 9 of the 10 SHAs. The response rate by SHA varied from 24 per cent to 79 per cent, excluding 0 per cent from one area.

Incidence of gastroschisisFrom the data of number of births and numbers of confirmed diagnoses, an average incidence was calculated of 4.3 cases per 10,000 births. This compares favourably with the figure of 4.7 reported by Boyd et al. (2011 J Med Screen 18 2–7) and gives reported data face validity.

Provision of supporting informationHospitals were asked if they gave women any of three sources of information: the NHS FASP leaflet for parents, information about Antenatal Results and Choices (ARC) and information about the Gastroschisis Exompholos Extrophies Parents Support Network (GEEPs). Information about ARC is given more than other sources. The leaflet for parents produced by FASP is not given widely, although some units commented that the FASP leaflet was only recently available. A number of units use their own or regional information leaflets. Information about GEEPs was the least frequently given.


Where data is available, the comparison of initial prenatal diagnosis with delivery shows 93 per cent confirmation.

Outcome data Table 5 – Outcome of gastroschisis diagnoses

Table 6 – Diagnosis at delivery

Outcome of pregnancy %

Termination 6.2

Miscarriage 1.0

Stillbirth 3.9

Neonatal death 2.0

Live birth 68.5

Don’t know 18.4

Total 100

Diagnosis at delivery %

Confirmed as gastroschisis 63.2

Gastroschisis with additional abnormalities

4.8

Gastroschisis not confirmed 1.3

Don’t know/missing 30.7

Total 100


Options following diagnosis In the majority of all units, regardless of type, it was reported that no consultants would “offer the option of termination”, even before 18 weeks gestation. Termination is reported as not offered at any gestation by any consultant in 63 per cent of units that responded. Five units reported that some, or all, consultants would offer termination after 24 weeks. Comments made suggest two perspectives: a number or respondents in DGHs expressed that termination was not their concern as it is dealt with by FMUs, and others stated that outcomes for babies born with gastroschisis were so good that the offer of termination was unnecessary. Cases of gastroschisis with additional abnormalities appeared more likely to result in the offer of termination.

The NHS FASP has submitted a paper to the White Journal assessing the impact of introducing a national policy for Down’s syndrome screening on the diagnostic invasive procedure rate in England. This paper shows that the implementation of a national Down’s syndrome screening policy based on the CST has significantly reduced the number of invasive tests performed. However, as the CST has become the replacement for second trimester testing and has been almost completely implemented it appears that improvements in screening using current approaches may have reached their limits.

To date, there is no national prospective data about the number of fetal losses following either amniocentesis or chorionic villus sampling (CVS) procedures, unlike Denmark. Nor are there any specific data to assess the possible association between operator performance and miscarriage rates in the UK. Given the Government’s vision for an NHS focussed on delivering the best possible outcomes for patients, as detailed in the 2010 “NHS White Paper Equity and Excellence – Liberating the NHS”, NHS FASP, in partnership with the RCOG, thought it imperative that the activity and outcomes of diagnostic invasive testing were evaluated so that there is a national picture of performance activity which pregnant women can use to assist them with their decision making.

Phase 1 of the project began in the summer of 2010, and from 14 March to 8 April 2011 a suite of auditable data fields for a draft invasive procedure audit form was piloted across England. Eighty-seven clinicians based in 35 hospital Trusts took part, which was a great and surprising result despite these individuals being busy.

The first meeting of Phase 2 occurred in April and during the next six months the group will meet up to complete and finalise the project. During this time, another pilot is scheduled to take place and will involve asking any Phase 1 hospital clinician (obstetrician, ultrasound practitioner, radiographer or midwife) working either in a secondary or tertiary level unit to undertake a retrospective exercise to:

a) trial a specially designed clinical electronic pre-procedure (amnio or CVS) and pregnancy outcome audit form via an internet browser

b) complete a specifically designed post-pilot semi-structured questionnaire about the process and forms

DiagnosticsThe impact of introducing a national policy for Down’s syndrome screening on the diagnostic invasive procedure rate in England

Invasive testing and pregnancy outcome data collection system for England: amniocentesis and chorionic villus sample national audit pilot project (Phase 2)


Specific objectives include:

• The retrieval of 10 consecutive cases of women who had an invasive procedure between August to September 2011

• Entering the details of the procedure (CVS or amniocentesis) and pregnancy outcome data onto the Phase 2 electronic web-based pilot audit form (each form will have an automated unique maternal ID code) and returning this to NHS FASP via the web-based browser

• Completing a post-pilot survey and returning this to the Programme Centre

Based on the pilot findings, the forms may require a little more modification. Upon completing this task, the products of the project will transfer to the Department of Health where the newly designed system can be integrated within the wider 10-year framework for transforming information for the NHS, public health and social care.

Literature searches The following literature search topics were carried out by the Royal Society of Medicine and commissioned by the NHS FASP:

- Trisomies 13 and 18 – October 2011 - Down’s syndrome screening – October 2011

Both of these literature searches are available to download from the website here: http://fetalanomaly.screening.nhs.uk/knowledgeupdates External research activities The following external guidance and policies were published during the period 1 April 2011 to 31 March 2012 and may be of interest.

NICE Guidance

CG132 Caesarean section (CG132), Published in Nov 2011CG129 Multiple pregnancy (CG129), Published in Sep 2011These documents can be downloaded from the NICE website here: http://www.nice.org.uk


National conferences and events 18–19 April 2011: Biochemists conference, University of Exeter, UK. FASP hosted a conference including representatives from a number of laboratories in the UK, with software supplier and regional team representation.

26–30 June 2011: World Fetal Medicine Congress, Malta. The conference was attended by NHS FASP and DQASS staff. A presentation was given by Pat Ward and an abstract was presented by Nancy Chung (Programme Associate) on “Improving quality in the NHS Down’s syndrome screening programme: lessons from developing a decision analytic model as a tool for change”.

15–17 October 2011 BMUS: Annual Scientific Meeting and Congress

7 March 2012: Screening Support Sonographers Workshop and Conference. The focus of the day was on the practical aspects of improving the quality of the ultrasound component of combined screening. The new image guidance tool was evaluated in a workshop setting, a set of FAQs were developed, views were obtained on potential education and training materials for the future and draft documents for consultation were presented.

Programme information systems

One of the major areas we have continued working on has been to extract outcome data and align this with the screening test in order to produce the overall true false positive and detection rates. There is a need to ascertain that the screening programme is working to a set performance level and that is across both the Down’s syndrome and Fetal Anomaly ultrasound. Integrating and interfacing IT to allow data flows through the service at all levels is a challenge. A major piece of work for the NHS FASP has been setting up a project called “The Proof of Concept” to test if the data required to ascertain outcomes of the screening test does sit within the service, and if this can be tied together with the screening results. The proof of concept was therefore aimed at testing these challenges as well as the challenge of compiling the data.

It required data on screen positive and detection rates with analysis of the following five conditions of the ultrasound screening programme. These were chosen because they are the more common and it is known that data should be available. They were:

- Neural tube defects - Gastrochisis - T13 - T18 - Serious cardiac anomalies

A total of six NHS Trusts spread over England and one region (The North East) volunteered to test the concept, which provided a mix of sites and services. The outcome report showed a number of recommendations to take forward, but in principle data was collected and tied together. However, it was apparent that the data collection exercise is hampered by a number of issues:

• Completeness: cross-boundary movement of patients; completeness of outcome data from those pregnancies that were terminated or miscarried; and completeness for cardiac anomalies

• Coding: NHS Number was not available across all sites; clinical information on the anomalies tended to be text-based rather than coded; ICD10 codes were not used

• IT Skills: Fundamentally in most sites there were limited skills to configure, implement and interrogate systems beyond simple capture and query of the screening information

We are now looking at how we can address some of these and have a fully integrated IT system to collect data.


Equity/Equality The NHS FASP continued to develop its first Single Equality Scheme during 2011. The Single Equality Scheme sets out our eight equality objectives and an action plan to achieve them covering all aspects of the programme’s work. Two of NHS FASP expert groups, the Steering group and Professional and Parent Information Development group, reviewed the draft document and made recommendations. Following these amendments, the draft Equality Scheme was released for wide public consultation in early 2012 and all comments were reviewed and incorporated as necessary. The Single Equality Scheme was published on the equality page of the NHS FASP website in early April 2012.

Figure 11 – Equality page on the NHS FASP website


Programme expenditure Programme expenditure for the period 1 April 2011 to 31 March 2012 is outlined in Table 7.

Table 7 – Programme expenditure for the period 1 April 2011 to 31 March 2012

Future work, aims and long-term objectives The following year’s objectives will begin to concentrate on ensuring that our work is in a complete and comprehensive position to transfer into Public Health England and fit comfortably in the long term.

We will continue developing the argument to include screening for T13 and T18 into the first trimester screening for Down’s syndrome. Along with this, we will develop an expert working group to look at the implications to the service if screening was to be introduced at an earlier stage.

The standards which support Down’s syndrome screening will require a substantial review to ensure they are fit for the service. The last review was in 2007 and although they have served the service well, developments mean that these need a full discussion on all aspects.

Alongside this we will be reviewing the ultrasound standards which support the 18 to 20 week six-day ultrasound scan.

The NHS FASP will be working closely with the fetal medicine Commissioning team at the Department of Health to define a “fetal medicine service” and deliver a supporting commissioning framework around it.

There will be a continuation of developing the clinical care pathways for each condition that is screened for, ensuring we work in a collaborative way with all stakeholders.

Ensuring quality and being able to monitor has always been an aim every year, and this will continue as we see more work development of our QC area, particularly for Down’s syndrome. This sits alongside our ever-developing QA system, which can now provide information about improvements to the service.

Programme expenditure 2011/2012 in £

Salary costs 777,277

Non-pay costs 246,585

Education and training 108,937

Public information 125,864

Quality assurance 490,829

Less recharges 33,844

Total 1,715,648


Appendix – The NHS FASP Expert Group Membership

NHS FASP Steering Group (FASPSG)

Name Title

Mr Pran Pandya Consultant in Fetal Medicine and Obstetrics, UCLH

Mrs Pat Ward National Programme Director, NHS FASP

Professor Jenny Hewison Professor of the Psychology of Healthcare, University of Leeds

Ms Jane Fisher Director ARC (Antenatal Results & Choices)

Professor Kevin Spencer Consultant Biochemist, King George Hospital

Dr Dave Worthington Programme Consultant Biochemist

Mr Paul Wood Consultant in Obstetrics and Gynaecology

Ms Rita Phillips Lecturer, University of West of England

Maria Chapman Antenatal Screening Co-ordinator – Wales

Dr Catherine Calderwood Consultant Obstetrician and Gynaecologist – Scotland

Ms Jackie McGeagh Regional Co-ordinator, Antenatal and Newborn Screening – Northern Ireland

Sian Morgan Principal Cytogeneticist, Association of Clinical Cytogeneticists

Dr Tessa Homfray Consultant Medical Genetics, RCP

Mrs Donna Kirwan National Project Officer, NHS FASP

Mrs Fiona Maddocks National Project Officer, NHS FASP

Mr Alastair Kent Director, Genetics Interest Group

Ms Annette McHugh Regional Co-ordinator


Programme Executive Group (PEG)

Laboratory Quality Control Advisory Group (QC Group)

Name Title

Mr Pran Pandya Consultant in Fetal Medicine and Obstetrics, UCLH


Mrs Donna Kirwan National Projects Officer, NHS FASP

Mrs Fiona Maddocks National Projects Officer, NHS FASP

Professor Dave Wright Statistician, DQASS

Miss Sophie Bale National Projects Midwife, NHS FASP

Name Title

Dr Angela Mallard (Chair) Biochemist, Royal Cornwall Hospital

Mr Andy Ellis Deputy Director UK NEQAS

Alan James Biochemist, Royal Devon and Exeter Hospital

Dr Barry Nix Consultant, DQASS

Professor Dave Wright Consultant, DQASS

Dr Dave Worthington Programme Consultant Biochemist


Steve Turner Principal Biochemist, Royal Victoria Infirmary, Newcastle

Dr Tony Hitch Consultant Clinical Scientist, Nottingham University Hospital


Public and Professional Information Group

Name Title

Professor Jenny Hewison Chair of group

Pat Ward National Programme Director, NHS FASP

Alissa Delbarre National Programme Associate, NHS FASP

Louise Swiggs Local Screening Co-ordinator, Royal Devon and Exeter Hospital

Jane McFarlane Antenatal and Newborn Screening Co-ordinator/Supervisor of Midwives, Hull and East Yorkshire Hospitals NHS Trust

David Churchill Consultant Obstetrician, The Royal Wolverhampton Hospitals NHS Trust

Amber Butler Independent Consultant Advisor to NHS FASP

Sally George ARC

Susan Fairgrieve Genetics Counsellor, Newcastle

Jan Fowler Chief Nurse and Director of Clinical Standards, NHS South of England (Central)


Diagnostic Audit Group

Name Title

Professor Peter Soothill (Chair) Head of Obstetrics and Gynaecology, University of Bristol, St Michael’s Hospital


Mrs Donna Kirwan National Projects Officer, NHS FASP

Professor Steve Robson Institute of Cellular Medicine, University of Newcastle

Mrs Charnjit Dhillon Director of Standards RCOG

Dr Tahir Mahmood Vice President of Standards RCOG

Dr Pran Pandya Director of Fetal Medicine

Professor Alan Cameron Consultant Obstetrician and Gynaecologist, Queen Mother’s Hospital

NT Management Group

Name Title

Professor Peter Soothill Head of Obstetrics and Gynaecology, University of Bristol, St Michael’s Hospital


Mrs Fiona Maddocks National Projects Officer, NHS FASP

Professor Dave Wright Statistician, DQASS

Dr Trish Chudleigh Advanced Practitioner Manager The Ultrasound Department, The Rosie Hospital Cambridge

Mrs Amber Butler Independent Midwife Sonographer Adviser, NHS FASP


References Brache AP. Stepping Up: A Game Plan for Leading Your Business to the Next Level. Apb Llc; 2010.

Kepner CH, Tregoe BB. The new rational manager: An updated edition for a new world. Princeton, NJ: Princeton Research Press; 1997.

Kirwan DM, NHS Fetal Anomaly Screening Programme. 18+0 to 20+6 Weeks Fetal Anomaly Scan: National Standards and Guidance for England. 1st edition. Exeter: NHS Fetal Anomaly Screening Programme; 2010.

McDermott RE, Mikulak RJ, Beauregard MR. The basics of FMEA. Productivity Pr; 2008.

National Down’s Syndrome Screening Programme for England. Antenatal screening – Working standards for Down’s syndrome screening 2007. Exeter: NHS FASP; 2007.

NHS National Down’s Syndrome Screening Programme for England. The Down’s syndrome screening Quality Assurance Support Service (DQASS): DQASS Working Structure. Kettering, Northants: NHS National Programme Centre; 2012.

NICE, National Collaborating Centre for Women and Children’s Health. Multiple pregnancy: the management of twin and triplet pregnancies in the antenatal period. London: RCOG Press; 2011.

NICE. NICE Antenatal Care: Routine care for the healthy pregnant woman. London; 2010. Report No.: 6.

NICE. Pregnancy and complex social factors: A model for service provision for pregnant women with complex social factors. London: NICE; 2010. Report No.: 10.

Parliament UK. Equality Act 2010. legislation gov uk 2010;8.

Royal College of Obstetricians and Gynaecologists. Amniocentesis and Chorionic Villus Sampling: Green Top Guideline Number 8. 8, 1–13. 2010. London: RCOG Press; Green Top Guidelines.

Royal College of Obstetricians and Gynaecologists. Standards for Maternity Care: Report of a working party. London: RCOG Press; 2008.

UK National Screening Committee. Fetal anomaly screening programme. Screening for Down’s syndrome: UK NSC policy recommendations 2007–2010: model of best practice. Department of Health Policy Guideline No DH_084731; 2008.

NDSCR (National Down Syndrome Cytogenetic Register). The National Down Syndrome Cytogenetic Register for England and Wales: 2010 Annual Report. Joan Morris. December 2011.


Useful WebsitesDepartment of Health and associated agencies

Care Quality Commission www.cqc.org.uk

Health Technology Assessment www.ncchta.org

Medicines and Healthcare products Regulatory Agency

www.mhra.gov.uk

Office of National Statistics www.ons.gov.uk

Sickle Cell Society www.sicklecellsociety.org

The National Institute for Health and Clinical Excel-lence (NICE)

www.nice.org.uk

The Department of Health www.doh.gov.uk

Cytogenetic

The Association of Clinical Cytogeneticists www.cytogenetics.org.uk

Royal Colleges

The Royal College of General Practitioners www.rcgp.org.uk

The Royal College of Midwives www.rcm.org.uk

The Royal College of Nursing www.rcn.org.uk

The Royal College of Obstetricians and Gynaecologists

www.rcog.org.uk

The Royal College of Pathologists www.rcpath.org

The Royal College of Radiologists www.rcr.ac.uk

Parent support organizations

Antenatal Results and Choices (ARC) www.arc-uk.org

Association for Spina Bifida and Hydrocephalus (ASBAH)

www.shinecharity.org.uk/

Contact a Family www.cafamily.org.uk

Down’s Syndrome Association www.downs-syndrome.org.uk


GEEPS (Gastroschisis Exomphalos ExtrophiesParents Support)

www.geeps.co.uk

Miscarriage Association www.miscarriageassociation.org.uk

SOFT UK www.soft.org.uk

Stillbirth and Neonatal Death Society (SANDS) www.uk-sands.org

Quality assurance

The Association of Clinical Biochemists www.acb.org.uk

Clinical Pathologists’ Accreditation www.cpa-uk.co.uk

DQASS (Down’s Syndrome Quality AssuranceSupport Service)

fetalanomaly.screening.nhs.uk/dqass

NEQAS (National External Quality AssessmentService)

www.ukneqas.org.uk

The Review of Central Returns www.ic.nhs.uk/rocr

Information on screening

Healthtalk online – Videos and texts of patients’experiences

www.healthtalkonline.org

National Library for Health www.evidence.nhs.uk

National Screening Committee www.screening.nhs.uk

Information on Trisomy 21

Down’s Syndrome Medical Interest Group www.dsmig.org.uk

National Down’s syndrome Cytogenetic Register www.smd.qmul.ac.uk/solfson/ndscr

NHS Fetal Anomaly Screening ProgrammeUK National Screening CommitteeTelephone: 0845 527 7910Email: [email protected]

First published 2012 by the UK National Screening Committee Programmes Directorate.

ISBN 978-0-9562084-8-4

British Library Cataloguing in Publication Data.

A catalogue record for this report is available from the British Library.

For further copies and information about this report please tel. 0845 527 7910 or email [email protected].

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