NHS England » Screening Quality Assurance visit report – Oxford University Hospitals NHS Foundation Trust

Scope of this report

Service*	Provider	Commissioner	Within the scope of this visit
Sickle cell and thalassaemia screening laboratory services	Full blood count and HPLC: Oxford University Hospitals NHS Foundation Trust	NHS England (South East)	No – interfaces only
Infectious diseases screening laboratory services	HIV, hepatitis B and syphilis: Oxford University Hospitals NHS Foundation Trust	NHS England (South East)	No – interfaces only
Fetal anomaly screening – combined screening services	Dating/NT scan: Oxford University Hospitals NHS Foundation Trust Screening laboratory: Oxford University Hospitals NHS Foundation Trust	NHS England (South East)	Sonography element- yes
Fetal anomaly screening – quadruple screening laboratory services	Dating scan: Oxford University Hospitals NHS Foundation Trust Screening laboratory: Oxford University Hospitals NHS Foundation Trust	NHS England (South East)	Sonography element- yes
Fetal anomaly screening – NIPT screening laboratory services	Birmingham Women’s and Children’s NHS Foundation Trust	NHS England	No
Fetal anomaly screening – 20-week screening scans	Oxford University Hospitals NHS Foundation Trust	NHS England (South East)	Yes
Diabetic eye screening	Oxford University Hospitals NHS Foundation Trust	NHS England (South East)	Yes
Newborn and infant physical examination	Oxford University Hospitals NHS Foundation Trust	NHS England (South East)	Yes
Newborn blood spot screening laboratory services	Oxford University Hospitals NHS Foundation Trust	NHS England (South East)	No – interfaces only
Newborn hearing screening programme	Oxford University Hospitals NHS Foundation Trust	NHS England (South East)	Yes
Child Health Information Service (CHIS)	South, Central and West Commissioning Support Unit	NHS England (South East)	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 23 April 2024 to Oxford University Hospitals NHS Foundation Trust Screening Service which is commissioned by NHS England (South East) Hampshire and Thames Valley 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
discussion with the commissioner in advance of the visit
information shared with SQAS as part of the visit process

The screening service

Oxford University Hospitals NHS Foundation Trust (OUH) provides services for women across Oxfordshire and bordering areas. Both consultant and midwifery led services are provided at John Radcliffe Hospital with 4 additional standalone midwifery led units across the county. The service reports that it has approximately 7500 deliveries per year.

The scope of this review includes screening delivered by the maternity and sonography services based at Oxford University Hospitals NHS Foundation Trust.

Delivery of the screening service involves interdependencies with other providers for parts of the pathway. The laboratory services were outside of the scope of this review, however the interfaces relating to the delivery of screening programmes were examined.

The trust has a tertiary fetal medicine referral centre and a Level 3 neonatal intensive care unit on site at the John Radcliffe Hospital.

Findings

This is the second quality assurance visit to OUH. During the visit there was evidence of a commitment to providing high quality services for women and newborn babies through the screening pathways. The local service was aware of some areas for further development and are already planning some enhancements.

Immediate concerns

The QA visit team identified no immediate concerns.

Urgent recommendations

The QA visit team identified 5 urgent recommendations. A letter was sent to the programme manager on 24 April 2024 asking that the following items were addressed:

implement a process to identify and manage screening safety incidents in line with national guidance ‘Managing safety incidents in NHS screening programmes’
clarify the process for identification and escalation of risk and issues in antenatal and newborn screening within the trust
document the process for identification and tracking of the cohort through the screening programmes
review the mandatory screening training pathway for staff including a process to document compliance against training needs
make sure that community midwives have appropriate training for the delivery of the screen positive pathway for sickle cell and thalassaemia

An action plan was received within 14 working days which assured the visiting QA team the identified concerns were mitigated.

High priority findings

The QA visit team identified 11 high priority findings as summarised in themes below:

There is a requirement for clinical leadership and greater oversight of the antenatal and newborn screening services within the trust.

Elements of the antenatal and newborn screening pathways do not comply with national specifications:

there is no process to inform or follow up women who miscarry or terminate their pregnancy after screening
there is no documented process to inform key stakeholders when a baby dies
there is no process to identify and refer babies with suspected or confirmed meningitis to audiology

Documentation and updates of key processes and guidance would allow the service greater resilience within the screening teams for example:

use of generic emails for communication
implementation of standard operating procedures to describe processes for managing women and babies through the screening pathways

Examples of practice that can be shared

The QA visit team identified several areas of practice for sharing, including:

Provision of SIM cards and mobiles phones to enable digitally excluded women to access key information during their pregnancy
Training pathway for midwives completing newborn physical examinations
The trust meets the achievable level for women completing screening for sickle cell and thalassaemia by 10 weeks gestation

Recommendations

No.	Recommendation	Pathway theme	Reference	Timescale	Priority	Evidence required
Urgent recommendations
01	Implement a process to identify and manage screening safety incidents in line with national guidance ‘Managing safety incidents in NHS screening programmes’	Governance and leadership	2 and 5	14 days	Urgent	Action plan
02	Clarify the process for identification and escalation of risk and issues in antenatal and newborn screening within the trust	Governance and leadership	5 and 9	14 days	Urgent	Action plan
03	Document the process for identification and tracking of the cohort through the screening programmes	Identification of cohort antenatal and newborn	9	14 days	Urgent	Action plan
04	Review the mandatory screening training pathway for staff including a process to document compliance against training needs	Infrastructure	9	14 days	Urgent	Action plan
05	Make sure that community midwives have appropriate training for the delivery of the screen positive pathway for sickle cell and thalassaemia	Infrastructure	9	14 days	Urgent	Action plan

No.	Recommendation	Reference	Timescale	Priority	Evidence required
High and standard recommendations
Governance and leadership
06	Make sure there is a trust director or senior nominated person who is responsible for the antenatal and newborn screening services	9	3 months	Standard	Organisational structure chart (that is signed off)
07	Make sure there is clinical oversight of the antenatal, newborn blood spot and newborn/infant physical examination screening programmes by a clinical lead	9	3 months	High	Organisational structure chart (that is signed off)
08	Update the terms of reference for the ANNB Screening management group to include membership, nominated clinical leads for each screening programme, frequency of meetings, accountability, review of risks and escalation of issues	9	3 months	High	Updated terms of reference
09	Implement an auditable process for the oversight and performance management of Key Performance Indicators and standards data within the trust	1,4 and 9	6 months	Standard	Process for data review (that is signed off)
10	Implement a process to review the antenatal screening pathway where a baby has an unexpected sickle cell or thalassaemia condition detected on newborn blood spot screening or where a baby is born unexpectedly with one of the FASP conditions	9	6 months	Standard	Documented review/minutes of review meeting – using the SQAS clinical review checklist for antenatal and newborn screening Incident reported (if relevant) Shared learning
11	Collect and analyse inequalities data such as demographic data to understand characteristics of the local population	6 and 7	12 months	Standard	Work shared at ANNB Screening management group and programme board and next steps agreed
12	Change and update for all programmes guidelines to comply with national policy and local pathways	9	12 months	Standard	Guidelines (that are signed off)
13	Develop a suite of standard operating procedures to describe processes for managing women and babies through the screening pathways	9	12 months	High	Standard operating procedures (that are signed off)
14	Implement a process to plan an annual audit schedule for ANNB screening, listed within the organisational schedule with timescales and actions on audit findings reported to the ANNB screening management group	9	12 months	Standard	Annual audit schedule Completed audits Confirmation of completed actions in minutes of trust steering group
15	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	9	12 months	Standard	User feedback findings action plan discussed at the ANNB screening management group
Infrastructure
16	Undertake a capacity review for the antenatal and newborn screening service to make sure there is resilience in the service to maintain delivery of screening functions when key members of staff are absent	9	12 months	Standard	Business continuity plan (that is signed off) Structure chart or guideline that outlines the functions of the respective role(s) if relevant
17	Implement and monitor a process to make sure NHSP screeners have competency assessed every year and receive individualised feedback	9	12 months	High	Competency assessments (with dates)
18	Implement a process for allocating NHS numbers for babies in cases where the maternity IT system fails	9	6 months	Standard	Guideline (that is signed off) Business continuity plan (that is signed off)
19	Implement and monitor a process for newborn hearing screening equipment calibration and maintenance or repair as per manufacturers recommendation	9	6 months	High	Maintenance contract/log Calibration log Confirmation that equipment is replaced
20	Document the process to make sure that specified consumables for the relevant newborn hearing screening equipment are available to enable continuous delivery of the screening programme	9	12 months	Standard	Documented process (that is signed off)
Identification of cohort (antenatal)
21	Make sure there is a process in place to follow up women who do not attend screening pathway appointments	9	6 months	Standard	Guideline (that is signed off) Tracking process Audit (if available)
Identification of cohort (newborn)
22	Document a process for notifying stakeholders about deceased babies, that includes updating the baby’s status as deceased on the national screening IT systems	9	6 months	High	Guideline (that is signed off)
23	Make sure there is a process in place to follow up babies who are not brought for screening pathway appointments	9	6 months	Standard	Guideline (that is signed off) Tracking process Audit (if available)
Invitation and access
24	Make sure that all communication pathways are via generic inboxes and not to individuals	9	3 months	High	Standard operating procedure
25	Implement and monitor a process (that meets the accessible information standard) to make sure women and families receive antenatal and newborn screening information in a format that meets their individual needs	6 and 9	12 months	High	Guideline (that is signed off) which should include how the provider identifies women who need: A physical (hard) copy, translated versions, easy read guides, screening animation and digital versions of STFYAYB Interpreting services when English is not the first language Plus, a plan to audit the process within 12 months
26	Make sure all women who miscarry or terminate their pregnancy after screening receive their screening results and are followed up as required	9	6 months	High	Guideline (that is signed off) Tracking system Letter templates
Infectious diseases in pregnancy screening
27	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	9	3 months	High	Guideline or standard operating procedure
28	Document the process for submission of data to the Integrated Screening Outcomes Surveillance Service (ISOSS)	9	12 months	Standard	Guideline (that is signed off) ISOSS provider synopsis report (can be requested from ISOSS team)
Fetal anomaly screening
29	Implement and monitor a plan to meet the acceptable threshold for standard FASP-S06/FA4 – the proportion of inadequate samples received in the laboratory in the reporting period for Down’s syndrome, Edwards’ syndrome and Patau’s syndrome screening	1 and 4	12 months	Standard	Submission of data for standard /key performance indicator FASP-S06/FA4 Action plan that is agreed and monitored by the screening group and programme board
30	Document the process for how women who are pregnant with twins are provided with comprehensive counselling to support decisions in screening for Downs’s syndrome, Edwards’ syndrome and Patau’s	9	6 months	Standard	Documented process (that is signed off)
31	Document the process for submission of data to the National Congenital Anomaly and Rare Disease Registration Service (NCARDRS)	9	12 months	Standard	Documented process (that is signed off)
Diabetic eye screening in pregnancy
32	Implement and monitor a process to identify and track eligible women – pregnant women with existing type 1 and type 2 diabetes	8	6 months	Standard	Guideline (that is signed off) Tracking process
Newborn hearing screening
33	Make sure that current clinical practice complies with national policy for identification and referral for babies with suspected or confirmed meningitis	9	3 months	High	Guideline (that is signed off)
Newborn blood spot screening
34	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	1 and 4	12 months	Standard	Submission of data for standard NBS-S04 Action plan that is agreed and monitored by the ANNB screening management group
35	Implement and monitor a plan to meet the acceptable threshold for standard NBS-S03 – the proportion of blood spot cards received by the laboratory with the baby’s NHS number on a barcoded label	1 and 4	12 months	Standard	Submission of data for standard NBS-S03 Action plan that is agreed and monitored by the ANNB screening management group
36	Implement and monitor a plan to meet the achievable 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	1 and 4	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 ANNB screening management group

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

Key Performance Indicators NHS screening programmes Antenatal, newborn, young person and adult NHS population screening: reporting data definitions
Managing Safety Incidents in NHS Screening Programmes Managing safety incidents in NHS screening programmes
NHS England Serious Incident Framework – Supporting learning to prevent recurrence (March 2015) Serious-incident-framework
NHS population screening standards NHS population screening standards
NHS population screening: pathway requirements specifications and learning from screening incidents Population screening: pathway requirements specifications
PHE Screening inequalities strategy PHE Screening inequalities strategy
Public Health Profiles Public health profiles
Section 7a screening service schedule 2. DESP Schedule 2 2022-23 – NHS Public Health Commissioning & Operations – FutureNHS Collaboration Platform
Section 7a screening service schedules 2. ANNB – NHS Public Health Commissioning & Operations – FutureNHS Collaboration Platform

There is more detailed information on individual screening programmes, including handbooks and operational guidance, that can be access via Population screening programmes: detailed information

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