Scope of this report
| Service | Provider | Within the scope of this visit |
|---|---|---|
|
Sickle cell and thalassaemia screening laboratory services | Full blood count: East Cheshire NHS Trust HPLC: University Hospitals of North Midlands NHS Foundation Trust (UHNM) |
No |
|
Infectious diseases screening laboratory services | HIV: UHNM Hepatitis B: UHNM Syphilis: UHNM Some of these samples may be sent to a confirmatory laboratory |
No |
Fetal anomaly screening – combined screening services | Dating/NT scan: East Cheshire NHS Trust Screening laboratory: Birmingham Women and Children’s NHS Foundation Trust |
Yes |
|
Fetal anomaly screening – quadruple screening laboratory services | Dating scan: East Cheshire NHS Trust Screening laboratory: Birmingham Women and Children’s NHS Foundation Trust |
Yes |
Fetal anomaly screening – NIPT screening laboratory services |
Birmingham Women and Children’s NHS Foundation Trust |
No |
|
Fetal anomaly screening – 20- week screening scans |
East Cheshire NHS Trust |
Yes |
|
Diabetic eye screening |
n/a |
No |
Newborn and infant physical examination |
East Cheshire NHS Trust |
Yes |
|
Newborn blood spot screening laboratory services |
Alder Hey Children’s NHS Foundation Trust |
No |
Newborn hearing screening programme |
East Cheshire NHS Trust |
Yes |
|
Child Health Information Service (CHIS) |
South Central and West Commissioning Support Unit |
No |
Screening laboratories are quality assured by the United Kingdom Accreditation Service (UKAS).
Summary
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 02 July 2025 to East Cheshire NHS Trust Screening Service which is commissioned by North West Public Health Commissioning team. 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 purpose and approach
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).
The evidence for this report comes from the following sources:
- monitoring of routine data collected by NHS England
- data and reports from external organisations
- evidence submitted by the provider(s) and external organisations
- discussion with the commissioner in advance of the visit
- information shared with SQAS as part of the visit
The screening service
East Cheshire NHS Trust is a community and acute trust providing services for a population of around 250,000 living in Eastern Cheshire. Maternity services are based at Macclesfield District General Hospital, which has a level 1 neonatal unit. Maternity bookings for 2024/25 were 1484 bookings and 1,256 births.
Acute maternity services were suspended for three years between March 2020 and June 2023. During this time, women could still book for care at East Cheshire but birthed at another nearby maternity unit.
South Central and West Commissioning Support Unit (SCW) provide the Child Health Information Service (CHIS) across Cheshire and Merseyside. CHIS was not included in the scope of the visit.
The scope of the review includes antenatal and newborn screening delivered by the maternity, sonography and newborn hearing screening service based at East Cheshire NHS Trust.
Findings
East Cheshire NHS Trust provide a patient focused ANNB screening service delivered by a small, dedicated screening team across the programmes. There is senior leadership oversight of the screening service.
The trust maintained an ANNB screening service during the period of acute service suspension. Newborn inpatient screening services have been fully restored since reopening.
Capacity issues in the screening team, including sonography, are limiting the quality improvement and audit work within screening. The lack of resilience and administrative support for screening is impacting the failsafe and cohort tracking functions. The maternity IT system has limited functionality to support these processes digitally.
The newborn hearing screening service is a well managed and high performing service.
Immediate concerns
The QA visit team identified no immediate concerns.
High priority findings
The QA visit team identified 3 high priority findings as summarised below:
- There is not enough protected time for the screening midwife for full completion of the role including audit and quality improvement. There is a lack of resilience to cover screening midwife absence/
- The limited capacity in the screening team is compromising the ability to fully failsafe the antenatal and newborn screening cohort/
- There is no dedicated time for the screening support sonographer and deputy for fetal anomaly screening programme oversight and completion of audit and learning/
Example of practice that can be shared
The QA visit team identified 1 area of practice for sharing:
- The co-located scan and blood sampling process for screening for Down’s syndrome, Edwards’ syndrome and Patau’s syndrome supports efficient completion of the screening pathway.
Recommendations
The following recommendations are for the provider to action unless otherwise stated.
| No. | Recommendation | Reference | Timetable | Priority | Evidence required |
|---|---|---|---|---|---|
|
Service provider and population served | |||||
|
No recommendations made in this section | |||||
|
Governance and leadership | |||||
|
01 |
Put in place formal reporting from screening into the clinical governance group |
1, 2 |
3 months |
Standard |
Evidence such as minutes from the clinical governance group |
|
02 |
Update the terms of reference of the screening group and improve the functioning of the group with greater participation from senior clinicians and provision of administrative support to the chair |
1, 2 |
12 months |
Standard |
Terms of reference signed off by the ANNB screening group Attendance log for senior clinicians |
|
03 |
Formalise a trust level process to improve the consistency of senior leadership oversight for ANNB screening incidents |
1, 2, 5 |
6 months |
Standard |
Documented process (that is signed off) |
|
04 |
Make sure guidelines refer to managing safety incidents in NHS screening programmes |
5, 6 |
6 months |
Standard |
Guideline (that is signed off) |
|
05 |
Make sure that newborn hearing screening programme (NHSP) and sonography risks shared with maternity are documented on the maternity risk register in addition to departmental registers |
1, 2 |
3 months |
Standard |
Copy of risk register |
|
06 |
Document a business continuity plan for screening that includes NHSP |
1, 2 |
6 months |
Standard |
Business continuity plan |
|
07 |
Complete a health equity audit |
1, 2 |
12 months |
Standard |
Completed audit Action plan |
|
08 |
Change guidelines to comply with national policy |
1, 2, 7, 8, 9, 11, 12 |
12 months |
Standard |
Guidelines (that are signed off) |
|
09 |
Implement an audit programme for ANNB screening |
1, 2 |
6 months |
Standard |
Audit plan including timescales |
|
Infrastructure | |||||
|
10 |
Make sure that the screening midwife has sufficient dedicated time for completion of the role including audit and quality improvement and that there are cross-cover arrangements in place for their absence |
1, 2 |
6 months |
High |
Written confirmation that there is protected time for all aspects of screening midwife role |
|
11 |
Formalise the deputy SSS role and make sure there is dedicated time for the functions of the role |
1, 2, 9, 16 |
6 months |
Standard |
Job description Written evidence of rostered time |
|
No. |
Recommendation |
Reference |
Timescale |
Priority |
Evidence required |
|
12 |
Make sure the screening support sonographer (SSS) is supported in carrying out the functions of the role |
1, 2, 9, 16 |
3 months |
High |
Written evidence of rostered time |
|
Identification of cohort (antenatal) | |||||
|
13 |
Confirm adequate week day capacity is in place to maintain administrative function of failsafe processes |
1, 2 |
3 months |
High |
Written confirmation of failsafe cover |
|
Identification of cohort (newborn) | |||||
|
No recommendations made in this section | |||||
|
Invitation and access | |||||
|
No recommendations made in this section | |||||
|
Sickle cell and thalassaemia screening | |||||
|
14 |
Document a process for direct referral for counselling and offer of prenatal diagnosis for couples or women known to be at risk of sickle cell or thalassaemia |
1, 2 7 |
6 months |
Standard |
Documented process (that is signed off) |
|
Infectious diseases in pregnancy screening | |||||
|
15 |
Document the process for the Perinatal Infectious Diseases Multi-Disciplinary Team (PID MDT) meetings |
1, 2, 8 |
6 months |
Standard |
Documented process (that is signed off) |
|
No. |
Recommendation |
Reference |
Timescale |
Priority |
Evidence required |
|
Fetal anomaly screening | |||||
|
16 |
Document the process for the review of unexpected conditions identified at birth |
1, 2, 9 |
12 months |
Standard |
Documented process (that is signed off) |
|
Diabetic eye screening in pregnancy | |||||
|
No recommendations made in this section | |||||
|
Newborn hearing screening | |||||
|
17 |
Make sure NHSP guidelines are ratified through the trust process for review and approval |
1, 2, 10 |
6 months |
Standard |
Guidelines (that are signed off) |
|
Newborn and infant physical examination | |||||
|
No recommendations made in this section | |||||
|
Newborn blood spot screening | |||||
|
No recommendations made in this section | |||||
Next steps
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
Appendix G: References
- NHS Section 7a screening service schedules 2 and 4 2024-25
- NHS population screening: pathway requirements specifications and learning from screening incidents
- NHS population screening standards
- NHS population screening: reporting data definitions for key performance indicators
- NHS Managing Safety Incidents in NHS Screening Programmes https://www.gov.uk/government/publications/managing-safety-incidents-in- nhs-screening-programmes (last updated 2024)
- NHS England (2022) Patient Safety Incident Response Framework
- NHS Sickle cell and thalassaemia screening programme handbooks (last updated 2022)
- NHS Infectious diseases in pregnancy screening programme clinical guidance (last updated 2023)
- NHS Fetal anomaly screening programme handbook (last updated 2024)
- NHS Newborn hearing screening programme operational guidance (last updated 2024)
- NHS Newborn and infant physical examination: programme handbook (last updated 2024)
- NHS Newborn blood spot screening guidance (last updated 2023)
- NHS England population screening: pathway requirements specification Diabetic eye screening pathway requirements specification
- NHS Screening inequalities strategy
- Department of Health and Social Care Public Health Profiles
- The Society and College of Radiographers and The Royal Collage of Radiologists (2017) Standards for the provision of an ultrasound service
- UK Health Security Agency Immunisation against infectious disease (last updated 2024)
- https://fingertips.phe.org.uk/
- Hinton et al (2023). A qualitative study of the dynamics of access to remote antenatal care through the lens of candidacy
- Hinton et al (2022) Quality framework for remote antenatal care
There is more detailed information on individual screening programmes that can be accessed via Population screening programmes: detailed information