Quality assurance looks at the antenatal and newborn screening pathways starting with identifying the eligible population of pregnant women and babies. It also includes the relevant screening tests for each programme. For women and babies with screen positive/higher chance results it will also include the pathways for referral, diagnosis and/or treatment.
The findings in this report relate to the quality assurance visit on 05 and 06 March 2024 to Bedfordshire Hospitals NHS Foundation Trust Screening Service which is commissioned by NHS England (East of England region). Any commissioning findings are outside the scope of this report and will be followed up directly with the commissioner.
We use the term ‘woman’ or ‘mother’ to encompass all gender identities and is intended for anyone who is pregnant. Similarly, where the term ‘parents’ is used, this encompasses anyone who has main responsibility for caring for the baby.
Quality assurance (QA) aims to achieve and maintain national standards, promote continuous improvement in antenatal and newborn (ANNB) screening and support reducing health inequalities. This is to ensure all eligible people have access to a consistent high quality, effective, equitable and safe service wherever they live.
QA visits are carried out by the NHS England Screening Quality Assurance Service (SQAS).
Bedfordshire Hospitals NHS Foundation Trust (BHFT) formed as a new entity in April 2020 following a merger between Luton and Dunstable Hospital NHS Foundation Trust and Bedford Hospitals NHS Trust.
Bedfordshire Hospitals NHS Foundation Trust serves around 700,000 people and offers maternity services for women living in South Bedfordshire, Luton and parts of Hertfordshire and Buckinghamshire. There are two main hospital sites, Luton and Dunstable Hospital and Bedford Hospital. Luton and Dunstable share borders with Milton Keynes, East and North Herts (Lister/Stevenage hospital) and West Herts (Watford). Bedford Hospital borders Milton Keynes, Kettering and East and North Herts. There is a level 3 neonatal intensive care unit at the Luton site and a level 1 unit in Bedford. There is a diverse ethnic population, particularly in the Luton area. The trust is designated as high prevalence for sickle cell and thalassaemia screening.
The East of England Child Health Information Service (CHIS), run by Hertfordshire Community Trust provide services to Bedfordshire.
Cambridgeshire Community Services are commissioned by the trust, to provide the newborn hearing screening programme (NHSP) for Bedfordshire.
This is the first quality assurance visit to BHFT as a merged organisation. Antenatal and newborn (ANNB) screening at BHFT is a patient focused service delivered by a screening team clearly committed to the care of pregnant women and babies.
There are two dedicated and hardworking screening midwives in post, supported by a wider multi-disciplinary team across all programmes. There are skilled and dedicated staff across the screening programmes, including the newborn hearing screening and sonography workforce. There are some identified workforce gaps with a need for greater resilience within the screening teams. There is a good understanding of areas for improvement with some quality improvement plans initiated.
The maternity leadership team are working to develop a whole service approach across the two hospital sites and wider geography of the trust following the 2020 merger. There is a service wide opportunity for shared learning between the sites and a need to unite the different screening services under the maternity management structure. The leadership team is working collaboratively to address limitations within their screening processes with many plans already in place that will support meeting the recommendations.
The QA visit team identified one immediate concern. A letter was sent to the chief executive, on 8 March 2024 asking that the following item(s) is addressed within 7 working days:
A response was received within 7 working days. The trust has provided an action plan to address the immediate concern. NHS England has requested that the obstetric emergency drills are expedited to provide assurance on the safety on the scanning rooms.
The QA visit team identified four urgent recommendations. A letter was sent to the programme manager on 8 March 2024 asking that the following items were addressed:
An action plan was received within 14 working days which assured the visiting QA team the identified concerns were mitigated.
The QA visit team identified a further two urgent recommendations in relation to the NHSP. A letter was sent to the Chief Executive Officer of Cambridgeshire Community Services NHS Trust on 8 March 2024 asking that the following items were addressed.
An action plan was received within 14 working days which assured the visiting QA team the identified concerns were mitigated.
The QA visit team identified 13 high priority findings as summarised in themes below.
It is unclear how FASP related issues are escalated up through the Imaging Directorate on both sites or how issues are escalated between the maternity and sonography departments.
There are some identified workforce and training gaps, with a need for greater resilience within the screening teams:
There are elements of the ANNB screening pathways that do not comply with the national specification:
Audiological services are not currently Improving Quality in Physiological Services (IQIPS) accredited and this is not on a risk register.
The following recommendations are for the provider to action unless otherwise stated.
| Service provider and population served – no recommendations made in this section | ||||||
| Governance and leadership | ||||||
| 08 | Make sure that there is a Trust Board director with overall responsibility for screening | Leadership roles | 1, 2 | 6 months | Standard | Organisational chart (that is signed off) |
09 | (Luton FASP only) Strengthen the oversight and accountability of the sonography service, documenting risks and making sure that there is a clear route of escalation through the Imaging Directorate, linked to maternity governance arrangements and to Trust Board | Leadership roles Escalation | 1 and 2 (FASP) | 3 months | High | Organisation chart (that is signed off) Escalation process (that is signed off) Risk and mitigation plan (that is signed off) |
| 10 | Improve the governance structure for antenatal and newborn screening by embedding the Trust Screening Steering Group (TSSG). This should include representation from Diabetic Eye Screening, Child Health Information Service, Newborn Hearing Screening and the newborn haemoglobinopathy nurse specialist | Screening group | 1, 2 | 6 months | Standard | Organisation chart (that is signed off) Escalation process (that is signed off) Risk and mitigation plan (that is signed off) Risks are documented on the organisation risk register Terms of reference for the Trust Screening Steering Group (that is signed off) including review and learning from incidents from all ANNB programmes Minutes of meetings Business continuity plan (that is signed off) |
11 | Review and update newborn hearing screening service business continuity plan | Risk | 1 and 2 (NHSP) | 12 months | Standard | Business continuity plan (that is signed off) |
12 | Put in place a defined contractual arrangement for the NHSP service | Contracts | 6 months | Standard | Signed document | |
13 | (Luton only) Make sure the sonography service has joint oversight with the maternity service of Fetal Anomaly Screening Programme (FASP) incidents | Incident management | 5, 6 | 6 months | Standard | Incident management policy (that is signed off) to include process for the sonography service to be consistently notified of FASP related incidents Evidence of shared learning with sonographers participating in FASP Evidence of collaborative incident investigation between the maternity and sonography services |
14 | The Public Health Commissioning team should work with the Integrated Care Board (ICB) commissioner to make sure that newborn hearing screening referrals are referred into a United Kingdom Accreditation Service / Improving Quality in Physiological Services (UKAS IQIPS) accredited audiology service (add to trust risk register) | Newborn hearning screening | 1 and 2 (NHSP) | 6 months | High | Risk assessment or action plan |
15 | Change guidelines to cover the end-to-end pathways and to comply with national policy across all six ANNB programmes | Guidelines | 1, 2 | 12 months | High | Guidelines (that are signed off) |
16 | Implement a process for the maternity, sonography and newborn hearing screening services to identify areas of the screening pathway for audit within an agreed audit plan, listed on organisation’s audit schedule with timescales for feedback at the screening group and follow-up of actions and shared learning across the directorates and sites | Audit | 1 and 2 (FASP and NHSP) | 12 months | Standard | Audit plan including timescales Minutes from the screening group and/or programme board |
17 | (Luton only) Undertake quality improvement audits to improve capacity and quality within the Fetal Anomaly Screening Programme (FASP), including a rescan audit | Audit | 1 and 2 (FASP) | 12 months | Standard | Audit schedule, completed audit and action plan Evidence of sharing and collaboration with the maternity service |
18 | Put in place a process to ensure that DQASS findings are understood and acted upon by the team | Leadership roles | 1 and 2 (FASP) | 12 months | Standard | Documented process for management of DQASS reports |
19 | Make sure that there is a collaborative process between the maternity and sonography service for undertaking a clinical review when a baby is born unexpectedly with one of the FASP conditions | Clinical review | 1 and 2 (FASP) | 6 months | Standard | Documented clinical review/minutes of clinical review meeting – using the SQAS clinical review checklist for antenatal and newborn screening Shared learning |
20 | Make sure that the sonography teams on both sites receive the findings of the National Congenital Anomaly and Rare Disease Registration Service (NCARDRS) report and take action if required | Outcomes | 1 and 2 (FASP) | 12 months | Standard | Action plan to address improvement actions outlined in the NCARDRS report if required (fetal anomaly detection rate report) |
21 | Demonstrate that feedback (including complaints) from service users, including those with protected characteristics or from underserved groups is used to develop and/or improve service delivery for antenatal and newborn screening | User feedback | 1, 2 | 12 months | Standard | User feedback findings action plan discussed at the screening group and/or programme board |
| Infrastructure | ||||||
22 | Make sure there is resilience in the service to maintain delivery of screening functions when key members of staff are absent from the screening team (including the failsafe officer at Bedford) | Staffing | 1, 2 | 3 months | High | Business continuity plan (that is signed off) Job description, Structure chart/guideline that outlines the functions of the respective role(s) if relevant |
23 | (Luton only) Put in place an induction pack to support the orientation of new and agency staff that includes FASP e-learning | Staffing | 1 and 2 (FASP) | 3 months | High | Induction pack |
24 | (Luton only) Formalise the role of the screening support sonographer | Staffing | 1 and 2 (FASP), 7 | 3 months | High | Rostered time Job description/ structure chart/guideline (that are signed off) that outlines the functions of the role |
25 | (Luton only) Appoint a deputy screening support sonographer | Staffing | 1 and 2 (FASP), 7 | 6 months | Standard | Job description/ structure chart/guideline (that are signed off) that outlines the functions of the role |
26 | (Luton only) Complete a demand, capacity and workforce audit to improve the resilience of the sonography service, decrease staffing absence, make sure that the service can meet the requirements of FASP and reduce reliance on agency staff | Staffing | 1 and 2 (FASP) | 6 months | Standard | Workforce audit and action plan |
27 | Implement and monitor a process to make sure all ultrasound practitioners delivering the fetal anomaly screening programme complete the required e-Learning resources | Staff training | 1 and 2 (FASP), 7 | 6 months | Standard | Training log / completion of FASP e-Learning resources (with dates) |
28 | Make sure that there is equity in access to the fetal medicine service at Luton for all women booked at Bedfordshire Hospitals NHS FT | Health inequalities | 1 and 2 (FASP) | 6 months | Standard | Audit |
29 | Make sure new newborn hearing screeners complete the External Competency Assessment (ECA) within three months of starting employment | Staff training | 1 and 2 (NHSP), 8 | 6 months | Standard | Certificate of completion (with dates) |
30 | Implement and monitor a process to make sure NHSP screeners complete e-learning every year | Staff training | 1 and 2 (NHSP), 8 | 12 months | Standard | Training log / completion of NHSP e-Learning resource (with dates) |
31 | Make sure new NHSP screeners register for the level 3 diploma within 6 months of starting employment | Staff training | 1 and 2 (NHSP), 8 | 12 months | Standard | Staff registered for diploma within 6 months Documented process (that is signed off) for registering new starters and check diploma is started within 12 months |
32 | (Bedford only) Appoint a designated NIPE lead midwife/nurse and deputy for day to day oversight of the programme | Staffing | 1 and 2 (NIPE) | 6 months | Standard | Job description/ structure chart/guideline (that are signed off) that outlines the functions of the respective role(s) |
33 | Implement and monitor a process to support continuing professional development of practitioners who perform the newborn examination | Staff training | 1 and 2 (NIPE), 9 | 6 months | Standard | Training log/completion of NIPE e-learning resource each year (with dates) |
34 | Implement and monitor a process for NHSP equipment calibration, maintenance and repair as per the manufacturer’s recommendations | Equipment and facilities | 1 and 2 (NHSP), 8 | 6 months | Standard | Maintenance contract/log Calibration log Confirmation that equipment is replaced |
35 | Make sure quality assurance checks are performed on NHSP equipment before screening babies | Equipment and facilities | 1 and 2 (NHSP), 8 | 3 months | Standard | Audit from S4H Documented process |
| Identification of cohort (newborn) | ||||||
36 | Implement a process for notifying key stakeholders about babies who die including updating the baby’s status as deceased on the S4H, S4N and NBSFS national IT system | Babies who die | 1 and 2 (Newborn) | 6 months | Standard | Guideline (that is signed off) Audit Communication templates (if available) |
| Invitation and access | ||||||
No recommendations made in this section | ||||||
| Sickle cell and thalassaemia screening | ||||||
37 | Implement and monitor a plan to meet the acceptable threshold for standard/key performance indicator SCT-S02/ST2 – the proportion of pregnant women having antenatal sickle cell and thalassaemia screening for whom a screening result is available at less than or equal to 10 weeks + 0 days gestation | KPIs/Standards | 1 and 2 (SCT) 4 – Standards 2018 SCT-S02 | 12 months | Standard | Submission of data for standard/key performance indicator SCT-S02/ST2 ST2 check list and action plan that is agreed and monitored by the screening group and programme board |
38 | (Bedford only) Implement and monitor a plan to meet the acceptable threshold for standard/key performance indicator SCT-S03/ST3 – the proportion of antenatal SCT samples submitted to the laboratory accompanied by a completed family origin questionnaire | KPIs/Standards | 1 and 2 (SCT) 4 – Standards 2018 SCT-S03 | 12 months | Standard | Submission of data for standard /key performance indicator SCT-S03/ST3 Action plan that is agreed and monitored by the screening group and programme board |
39 | (Bedford only) Implement a timely process for the laboratory to notify the screening midwives of an incomplete FOQ so that results are not delayed | Laboratory | 1 and 2 (SCT) | 3 months | High | Guideline (that is signed off) |
40 | (Luton only) Implement a laboratory failsafe to make sure that all SCT screen positive results are notified to the screening team | Laboratory | 1 and 2 (SCT) | 3 months | High | Guideline (that is signed off) |
41 | Send an sickle cell and thalassaemia alert card to notify the relevant newborn screening laboratory of the woman’s or couple’s ‘at risk’ screening result | Outcomes | 1 and 2 (SCT and NBS) | 6 months | Standard | Guideline (that is signed off) Feedback at programme board Add requirement to SCT tracker |
42 | Make sure that the screening midwives are informed of the screen positives from newborn blood spot screening for SCT | Outcomes | 1 and 2 (SCT) | 6 months | Standard | Guideline (that is signed off) Access to the Newborn Outcomes Solution |
Infectious diseases in pregnancy screening | ||||||
43 | Change the infectious diseases request form (paper and electronic) to comply with the minimum data fields | Laboratory | 1 and 2 (IDPS), 10 | 3 months | High | Revised request forms (paper and electronic) |
44 | (Luton only) Make sure each woman who declines the initial offer of IDPS screening (HIV, hepatitis B and/or syphilis) is identified, tracked and re-offered screening by 20 weeks of pregnancy or within 2 weeks if greater than or equal to 24 weeks gestation | Declines | 1 and 2 (IDPS), 10 | 3 months | High | Guideline (that is signed off) Tracking system Documentation of decline in maternity notes Audit of declines |
45 | Implement and monitor a process for requesting urgent infectious diseases screening tests for unbooked women or women with no screening results presenting in labour | Unbooked women | 1 and 2 (IDPS), 10 | 3 months | High | Guideline (that is signed off) Audit |
46 | Implement and monitor a plan to meet the acceptable threshold for standard IDPS-S05 – timely communication of confirmed screen-positive or known positive (HIV and hepatitis B) results for S05a (HIV), S05b (hepatitis B) and S05c (syphilis) at Luton and S05c (syphilis) at Bedford | KPIs/Standards | 1 and 2 (IDPS) 4 – Standards 2018 IDPS-S05 | 12 months | Standard | Submission of data for standard IDPS-S05 Action plan that is agreed and monitored by the screening group and programme board |
47 | (Bedford only) Implement a multidisciplinary team IDPS meeting to discuss screen positive cases and formulate birth plans | Clinical review | 1 and 2 (IDPS) | 6 months | Standard | Terms of reference Agenda |
48 | (Bedford only) Make sure that there is a consistent process for paediatric alerts from antenatal screening, to ensure the completion of the screening pathway and referral into clinical services / vaccination for babies identified as at risk following maternal IDPS screening | Clinical review | 1 and 2 (IDPS) | 6 months | Standard | Guideline (that is signed off) |
49 | (Bedford only) Implement and monitor a plan to meet the acceptable threshold for standard IDPS S07a- the proportion of babies born to women with hepatitis B receiving first dose of vaccination at less than or equal to 24 hours of birth | KPIs/Standards | 1 and 2 (IDPS), 15 4 – Standards 2018 IDPS-S07a | 12 months | Standard | Submission of data for standard IDPS-S07a Action plan that is agreed and monitored by the screening group and programme board |
Fetal anomaly screening | ||||||
50 | Implement and monitor a process to make sure women with very high chance results for trisomy screening are given consistent information to make an informed choice about further testing | Screening information | 1 and 2 (FASP) | 3 months | High | Guideline (that is signed off) |
51 | (Luton only) Make sure there is adequate provision for counselling of women and tracking through the referral pathway for women where a suspected fetal anomaly is detected at the weekend | Screening information | 1 and 2 (FASP) | 3 months | High | Guideline (that is signed off) |
52 | (Luton only) Track the screen positive cohort for the fetal anomaly screening programme | Failsafe | 1 and 2 (FASP) | 3 months | High | Tracking process Guideline (that is signed off) |
53 | (Luton only) Implement and monitor a plan to meet the acceptable threshold for standard FASP-S08a – timely referral (local) when an anomaly is suspected or confirmed at the 20-week screening scan, including a process to meet the standard when scanning is completed at weekends | KPIs/Standards | 1 and 2 (FASP) 4 – Standards 2022 FASP-S08a | 12 months | Standard | Submission of data for standard FASP-S08a Action plan that is agreed and monitored by the screening group and programme board |
54 | (Bedford only) Implement and monitor a plan to meet the acceptable threshold for standard FASP-S08b – timely referral (tertiary) when an anomaly is suspected or confirmed at the 20-week screening scan | KPIs/Standards | 1 and 2 (FASP) 4 – Standards 2022 FASP-S08b | 12 months | Standard | Submission of data for standard FASP-S08b Action plan that is agreed and monitored by the screening group and programme board |
| Diabetic eye screening in pregnancy | ||||||
55 | Make sure there is a written guideline for diabetic eye screening in pregnant women that is agreed with the local diabetic eye screening programme (DESP) | DES | 1 and 2 (DES) | 6 months | Standard | Guideline (that is signed off) agreed with local DESP |
56 | Implement and monitor a process to identify and track eligible women – pregnant women with existing type 1 and type 2 diabetes | DES | 1 and 2 (DES) | 6 months | Standard | Guideline (that is signed off) Tracking process |
57 | Implement and monitor a process to inform the local diabetic eye screening programme (DESP) of pregnant women with existing type 1 and type 2 diabetes when they book for maternity care | DES | 1 and 2 (DES) | 6 months | Standard | Guideline (that is signed off) agreed with local DESP |
| Newborn hearing screening | ||||||
No recommendations made in this section | ||||||
| Newborn and infant physical examination | ||||||
58 | (Bedford only) Track the screen positive cohort for the newborn and infant physical examination and make sure that there is timely escalation in place before babies breach the referral timeframes | Failsafe | 1 and 2 (NIPE) | 6 months | Standard | Tracking process Guideline (that is signed off) |
59 | Implement and monitor a plan to meet the acceptable threshold for standard NIPE-S02 – the proportion of babies with a screen positive eye result on newborn physical examination who attend for clinical assessment by an ophthalmology specialist ≤ 2 weeks of the examination | KPIs/Standards | 1 and 2 (NIPE) 4 – Standards 2021 NIPE-S02 | 12 months | Standard | Submission of data for standard NIPE-S02 Action plan that is agreed and monitored by the screening group and programme board |
60 | Implement and monitor a plan to meet the acceptable threshold for standard/key performance indicator NIPE-S03/NP3 – the proportion of babies with a screen positive newborn hip result who attend for ultrasound scan of the hips within the designated timescale | KPIs/Standards | 1 and 2 (NIPE) 4 – Standards 2021 NIPE-S03/NP3 | 12 months | Standard | Submission of data for standard/key performance indicator NIPE-S03/NP3 Action plan that is agreed and monitored by the screening group and programme board |
61 | Implement and monitor a plan to meet the acceptable threshold for standard NIPE-S05 – the proportion of babies identified with bilateral undescended testes detected on newborn physical examination and seen by a consultant paediatrician/ associate specialist within 24 hours of the newborn examination | KPIs/Standards | 1 and 2 (NIPE) 4 – Standards 2021 NIPE-S05 | 12 months | Standard | Submission of data for standard NIPE-S05 Action plan that is agreed and monitored by the screening group and programme board |
| Newborn blood spot screening | ||||||
62 | (Luton only) Implement and monitor a plan to meet the acceptable threshold for standard NBS-S04 – the proportion of first blood spot samples taken on day 5 | KPIs/Standards | 1 and 2 (NBS) 4 – Standards 2021 NBS-S04 | 12 months | Standard | Submission of data for standard NBS-S04 Action plan that is agreed and monitored by the screening group and programme board |
63 | (Luton only) Implement and monitor a plan to meet the acceptable threshold for standard /key performance indicator NBS-S06/NB2 – the proportion of first blood spot samples that require repeating due to an avoidable failure in the sampling process | KPIs/Standards | 1 and 2 (NBS) 4 – Standards 2021 NBS-S06/NB2 | 12 months | Standard | Submission of data for standard /key performance indicator NBS-S06/NB2 NB2 check list and action plan that is agreed and monitored by the screening group and programme board |
The screening service is responsible for developing an action plan in collaboration with the commissioners to complete the recommendations contained within this report.
SQAS will work with commissioners to monitor activity and progress of the recommendations for 12 months after the report is published. After this point SQAS will send a letter to the provider and commissioners summarising progress made and will outline any further action(s) needed.
