ANNB screening: programme specific operating model

Question 1

Overview of quality assurance activities

Accepted Answer

Service engagement

A named senior quality assurance advisor (SQAA) or quality assurance advisor (QAA) will be linked to each screening service and NHS England and NHS Improvement (NHSEI) public health commissioning team (PHCT).

Throughout the remainder of the document the named SQAS visit lead will be referred to as S/QAA.

The S/QAA or deputy will attend screening service steering or programme boards to:

identify and monitor screening issues
support the identification of risks and potential incidents
monitor progress against QA recommendations
support service improvement including work to reduce screening inequalities
update screening services on changes in national policy
share learning

Analysis of data and intelligence

PHE Screening and SQAS will collect and/or review data in specified time periods. See data and intelligence for quality assurance.

Services are benchmarked using set national screening standards.

Annually, SQAS and, where applicable, professional clinical advisors (PCAs) review data and intelligence at a national, regional or sub regional level. This data and intelligence is used to prioritise SQAS activities.

Further information and intelligence may be obtained from attendance at screening service steering or programme boards and by other means including regular PHE screening reports, published studies, discussions with screening services and national screening programmes.

Visits and reviews

The QA visit process includes all screening services delivering the full screening pathway or part of it. This includes private providers commissioned to deliver NHS screening programmes.

Visit schedules and other QA activities will be decided by assessment against an agreed set of criteria each year to align SQAS resource according to services’ needs. SQAS will evaluate this approach and consider the impact on the average visit interval, findings at QA interventions and SQAS capacity.

SQAS may undertake a focussed visit or assessment of any individual discipline or group of disciplines of the screening programme that require more detailed investigation or intervention outside the routine QA visit process. The level of intervention and most appropriate approach will be informed by the prioritisation assessment. A set of principles links to a set of QA interventions, to support consistency of this approach. A review of the number, rationale and outcome of non-routine visit interventions will be undertaken as part of the evaluation of QA visit activities.

The QA visit and review of screening services will include:

programme management and governance
the screening pathway
referral to relevant diagnostic or treatment services
public health system leadership and commissioning

The screening programmes covered are:

fetal anomaly screening programme (FASP)
sickle cell and thalassaemia (SCT)
infectious diseases in pregnancy screening (IDPS)
newborn blood spot (NBS)
newborn hearing screening programme (NHSP)
newborn and infant physical examination (NIPE)

In addition, SQAS will look at the maternity pathway and communication aspects of diabetic eye screening (DES) in pregnancy.

Laboratory QA

The United Kingdom Accreditation Service (UKAS) will assess both internal organisation for standardisation (ISO) 15189 requirements and the screening QA requirements as an integrated process over the 4-year cycle of laboratory accreditation. UKAS will share the screening assessments in reports to PHE and manage non-conformance. The reports will take the form of a summary of findings as an appendix to the UKAS assessment report. PHE and UKAS will collaborate to support improvement, to escalate and remedy any serious problems, to identify areas of merit and to develop screening laboratory policy.

NHSEI and screening services are informed of scheduled visits or targeted interventions to give adequate preparation time.

Following a QA visit or targeted intervention a report is produced and sent to the screening service and commissioner(s). Where recommendations are made the screening service should develop an action plan with the commissioner.

The QA report executive summary is published on GOV.UK unless consent is withdrawn by either the screening service or commissioners.

The QA visit process is described in detail in the QA visit preparation section.

Support with incidents

The role of SQAS in screening safety incidents is set out in the managing safety incidents in NHS screening programmes guidance. The role includes:

developing guidance and processes for managing and monitoring screening safety incidents and serious incidents
developing resources and training packages to support the management of screening incidents
collating and disseminating the learning from incidents at national, regional and local level

SQAS supports patient safety by:

providing expert advice to screening services and public health commissioning teams so that safety concerns, safety incidents and serious incidents are assessed, investigated and managed effectively
accessing specialist clinical and policy advice for specific incidents from PHE Screening’s national programme team and from PCAs who work with regionally based SQAS teams
working with the public health commissioning and operations team in NHSEI on incidents that require a national response

Networking and support

A variety of approaches to networking are used across SQAS. Feedback from attendees shows these events are valued by both SQAS and screening service representatives.

SQAS uses network meetings to share information relating to screening standards, guidance and national programme developments. They provide an opportunity to share data, discuss support needs, and enable feedback. They help identify quality issues and potential risks which could inform future QA activity.

Meetings allow staff working in screening services to develop networks and share tasks such as development of protocols.

Meetings may have input from external speakers or include sharing of audit information. SQAS and the national screening programme manager work together where applicable to develop a joint agenda for these meetings.

The frequency of meetings will vary by professional group. There will be a minimum of 3 per year per region. They will involve different staff groups depending on prioritisation and current issues.

Question 2

Data and intelligence

Accepted Answer

Data sources

The main source of data for quality assuring the 6 antenatal and newborn screening programmes are the screening standards. A number of these standards are also key performance indicators (KPIs).

Key performance indicators (KPIs)

Screening KPIs define consistent performance measures for a selection of public health priorities, using terminology that is clear and common across all NHS screening programmes, so performance can be understood, assessed and compared. They are a subset of screening standards and relate to a limited range of screening priorities that are not in themselves sufficient to quality assure or performance manage screening services. The KPIs reflect areas where consistency and an understanding of variation across England are important.

KPIs are collated and reported quarterly, unless numbers are small, in which case aggregated data is reported in the public domain annually. Small number KPIs are available for PHE Screening staff for quality assurance purposes. These KPIs are contained within the Section 7a agreements between the Department of Health and Social Care (DHSC) and NHSEI and in the public health outcomes framework (PHOF). Further information about screening standards, screening pathway requirements and screening service specifications is available.

Screening pathway reporting

PHE Screening is committed to publishing data required to support QA of screening standards. Standards are reported annually unless they are also KPIs in which case they are usually reported on quarterly and annual figures are aggregated. PHE screening co-ordinates an annual collection and analysis of standards data. The submitting organisation is responsible for timely submission of data and making sure that only accurate data is submitted.

Good quality data is important for monitoring and improving screening services. Screening providers may want to refer to the guidance for providers on the false or misleading information FOMI offence, which sets out the responsibility of providers to supply and publish accurate data.

The current list of outline reports and frequency are:

KPI confidential data file – quarterly
NHSP EQA funnel plots (contains 2 KPIs) – quarterly
FASP standards – annually
IDPS standards – annually
NIPE standards – annually
NHSP standards – annually
SCT standards/data – annually
NBS standards/data – annually
Downs syndrome quality assurance support service (DQASS) laboratory summary report – 6 monthly
DQASS ultrasound sonography (USS) department and individual practitioner report (red flags) – 6 monthly

National reporting systems

There are a small number of standards that are reported at a national level. Data is usually collected and reported by other bodies such as the Association for Clinical Genetic Science, the National Congenital Anomaly and Rare Disease Registration Service (NCARDRS) and the Institute of Child Health (ICH) to PHE screening.

Reports are also produced by DQASS for laboratory and ultrasound practitioners. DQASS assigns each ultrasound data set with a flag status for bias and throughput as outlined in the USS practitioner’s handbook.

Data analysis

SQAS will comply with the set national screening methodologies as these are developed.

Data quality and completeness of data is reviewed using national guidance and other data validation operating procedures (manual and/or automatic).

Data analysis is undertaken by national or regional data analysts and the national data and information team in the case of KPIs and screening standards as required.

Data reporting

Reporting and analysis is done once, nationally where possible. Dissemination of data not already in the public domain to screening services is done via SQAS regional teams.

Routine data sharing between PHE screening and NHSEI for all 11 NHS screening programmes is underpinned by the memorandum of understanding (MoU) signed by both organisations. This MoU extends to any onward sharing to any third party, for example, PHE centre directors, providers of screening services, local authority, clinical commissioning groups (CCGs), voluntary organisations and other health professionals using screening data to improve and monitor services. This is for the purpose of improving the quality of screening services.

The set of data items covered by the MoU is shared prior to publication and for management purposes only. Data flows, schedules and the list of data items shared are managed by the national data and information team. All data shared under the MoU is also available to PHE screening staff.

Non routine data requests from commissioners and service providers should be discussed with SQAS regional teams and/or Research Advisory Committees (RACs) who will consider requests in line with data release principles including, but not limited to, asking:

Has the data already been shared via the MoU or is it available in the public domain?
Is the data likely to support population health improvement?
Is the data likely to improve the quality of screening services?
What is the level of anonymisation required (open government licence to potentially identifiable and identifiable information)?
What are the resources and costs required to extract, collate, quality assure and release the data set?

SQAS regional teams will, if necessary, involve national programme managers and the national data and information team in the initial discussion of non-routine data requests and seek advice from RACs where appropriate. All requests for data not aggregated to the information standards board (ISB) anonymisation standard is discussed with the PHE Office for Data Release.

The RAC application process and a detailed flowchart are available.

All data requests and releases will be centrally logged and tracked.

Information governance

PHE acts as the sole or joint data controller for certain data. This includes data within national information communication technology (ICT) systems which is used to deliver the call recall part of the screening pathway. It also includes data which is processed to assure the quality, safety and efficacy of screening. These systems are usually ones that PHE has directly commissioned or has a role in establishing.

PHE holds a responsibility to ensure that any data we control is processed in line with the relevant legal and ethical requirements. Because we process personal confidential data without gaining prior consent from patients, PHE requires permission to set aside the legal duty of confidence (this is the obligation that medical services have to keep information they hold on patients secure and confidential and not share it with third parties, such as PHE).

The legal authority to set aside the duty of confidence comes from approval by the Health Research Authority’s confidentiality advisory group (HRA CAG). This is commonly referred to as Section 251 (S251) support. PHE has approval to process confidential data for a specific set of circumstances required to deliver safe, effective screening. Specifically, PHE has S251 support to discharge its duty to oversee the delivery of screening, its quality assurance and its evaluation.

PHE does not have S251 support to undertake research. Researchers cannot claim PHE’s S251 support as their own without an explicit data processing agreement between PHE and the processor and a letter of amendment from the HRA CAG.

Question 3

QA visit preparation

Accepted Answer

Objectives

The objectives of the QA visit are to:

examine the performance of the screening service
confirm if national screening standards are met
identify variance from screening standards
support professionals working in the screening service to maintain and improve performance against screening standards
identify areas for shared learning and disseminate these to all screening services
share experiences and understanding of current problems or concerns in NHS ANNB screening services and contribute to national development

The QA visit team

The QA visit team is selected by SQAS, led by the visit chair and supported by the:

SQAA and/or
QAA/quality assurance facilitator (QAF)

Members of the team may include:

public health and commissioning
head of midwifery
local screening co-ordinator
laboratory lead (where applicable)
hearing screening local manager or team leader
screening support sonographer
child health information service manager

QA visit team members are asked to declare conflicts of interest before the visit. If this raises concerns about the use of a PCA for a visit, SQAS will take advice within PHE.

A maximum of 2 observers may be present at a QA visit, for training and education purposes. The observers are not involved with providing feedback and will not input into the interviews or decision-making processes.

Role of the QA visit chair and QA advisor

For ANNB screening, the visit chair is the regional portfolio lead (RPL) or a PCA who has received specific training to perform this role. If the visit chair is also a PCA they are not expected to act in their usual PCA role during the QA visit unless agreed in advance.

The visit chair is responsible for:

chairing and directing the conduct of the QA visit
providing considered, consistent feedback on the QA visit findings
managing sensitively and appropriately any serious issues or concerns raised prior to or on the day of the QA visit
facilitating the exchange of knowledge and ideas and encouraging productive networking

The S/QAA supporting the visit chair is responsible for adequate preparation before the QA visit including:

notification of the visit date to the provider organisation chief executive (CE) and commissioner 6 months before the visit
making sure the screening service knows what to prepare for the QA visit
arranging any preliminary meetings between SQAS and the screening service
acting as a point of contact for any queries relating to organising and co-ordinating the QA visit
identifying and managing the QA visit team who are accountable to the QA visit chair up to and including production of the final report and executive summary
making sure PCAs are contracted appropriately and agreements are signed prior to undertaking QA activity
making sure all PCAs selected have completed the required training
making sure the evidence to support the QA visit is submitted via the screening division’s Marvin IT system and any observational pre-visits are completed
identifying late submission or missing evidence and escalating as appropriate
reviewing the evidence submitted and identifying areas for discussion
developing agendas for the pre meeting, QA visit and feedback sessions
making sure adequate preparatory work is complete
supporting the visit chair to collate feedback during the QA visit

After the visit, the S/QAA is responsible for:

making sure PCAs provide feedback in a timely manner to allow drafting of the factual accuracy report within the agreed timescales
making sure an accurate final report of the QA visit is issued within the agreed timescale and sent to provider CE(s) and NHSEI screening and immunisation leads (SILs)
making sure recommendations are followed up and monitored within the agreed timescale and escalated where progress is not made
making sure the executive summary is uploaded to GOV.UK in accordance with SQAS guidance

Skills and experience of QA visit team

Members of the QA visit team need skills in:

report writing
interview techniques
an understanding of screening incident identification and management
analytical skills

They should also:

have programme specific QA training
understand public health aspects of screening
have the opportunity to observe a QA visit

Specialist skills required of the individual PCAs are documented in the ANNB screening PCA person specification or role description.

Locations to be visited

The QA visit will assess the screening service and screening pathway(s). If a service has sites located away from the main provider unit it may not be possible to visit all screening sites on the same day. Where needed, the S/QAA will arrange visits to other sites before the main provider unit QA visit takes place.

Screening service personnel

Depending on service configuration the QA visit should be attended by:

public health/commissioner
head of midwifery
local screening co-ordinator
laboratory lead (where applicable)
hearing screening local manager/team leader
screening support sonographer
child health information service manager

Evidence considered at QA visits

The QA team review:

pre-visit questionnaires completed by the screening service (where applicable)
commissioning
supporting evidence and documents submitted to SQAS
interviews undertaken during the QA visit
observational visits (where applicable)
case reviews (where applicable)
analysis of annual report data and routine data for the preceding 12-month period
analysis of audit reports
UKAS reports

Preparation for a QA visit

SQAS will agree the QA visit date with the screening service and commissioners. At least 6 months’ notice is given. The screening service should identify a contact person to co-ordinate arrangements. They are responsible for evidence submission, booking meeting rooms for interviews on the day and providing relevant contact details.

The date of the QA visit will not be changed once it is agreed, except in exceptional circumstances, and only with the agreement of both parties.

SQAS informs the CE(s) of the host trust, stakeholder trusts, providers of any associated services and commissioners of the QA visit. They are required to attend or send a suitable representative to the QA visit feedback session and subsequent discussions as appropriate.

Preliminary meeting

A preliminary meeting between SQAS and the screening service or commissioners may take place. This will vary by programme, for example, SQAS may attend the next scheduled screening service steering or programme board meeting or operational group meeting once the QA visit date is agreed.

If no meeting is scheduled prior to the QA visit, SQAS may request a bespoke meeting around 3 months before the QA visit date.

SQAS will use the meeting to inform the screening service about arrangements for the QA visit. This includes arrangements for any observational visits, an outline of the agenda and answering any questions the screening service and its stakeholders may have.

Information to provide

In preparation for a QA visit the screening service is asked to provide:

action plans from previous QA recommendations (where not already available to SQAS)
action plans from pre-visit questionnaire or desk top review (where applicable)
completed pre-visit questionnaire (where applicable)
supporting documents and protocols as outlined in the pre-visit questionnaire or documentation
performance reports as requested
information on any incidents that have occurred in the last 12 to 24 months
information on venue organisation, the location of the QA visit including rooms for interviews and feedback sessions
other relevant information requested by SQAS

This information should be provided to SQAS at least 10 weeks prior to the QA visit date. There is no flexibility to extend the deadline for evidence submission unless it is agreed by the S/QAA, RPL and visit chair.

Evidence should be submitted via the screening division IT system known as Marvin. SQAS will provide details of how to upload evidence.

Evidence transfer must conform to information governance rules. No patient identifiable or sensitive information should be transferred to SQAS. SQAS information governance protocols should be followed.

Evidence submitted that is out of date, for example policies or guidelines, is not assessed, but is used to inform decisions about screening service governance.

Where needed the S/QAA leading the QA visit will request clarification of evidence submitted or for further evidence to be provided.

Where evidence is not submitted, the S/QAA will escalate within the screening service and with the commissioner or SIL.

Review of evidence to inform the QA visit

The evidence is reviewed by the visit chair, lead S/QAA and PCAs.

The lead S/QAA completes the context grid (summary document) and reviews the evidence with the visit chair to determine initial key lines of enquiry (KLOE). The final KLOE are agreed with the PCAs following the evidence review meeting. The visit chair and S/QAA will decide which PCAs are required for the QA visit.

Use of UKAS reports for QA

SQAS may conduct their own investigations where:

the laboratory has not applied to UKAS to be assessed for its ANNB screening functions or declines to be assessed against the screening requirements document
the laboratory has declined to sign the confidentiality waiver allowing UKAS to share the report of screening findings with PHE
the laboratory has problems related to conformity which would benefit from a QA visit
a serious concern arises outside the UKAS cycle of laboratory accreditation and surveillance visits

SQAS regional teams will:

review the UKAS reports prior to a QA visit and may refer to them as part of other QA activities focusing on the interface between the laboratory user and the laboratory
cross-reference the UKAS assessment in QA visit reports produced following visits to the provider(s) that use the screening laboratory

PCAs

PCAs are given at least 6 weeks’ notice if they are not needed to attend the QA visit. PCAs may perform a number of tasks, including scrutiny of evidence, development of KLOEs and telephone interviews.

The minimum visit team consists of the visit chair and S/QAA who will meet with the head of midwifery and lead commissioner. A full QA visit will take place where necessary. The lead S/QAA informs PCAs of any required actions.

Information for the QA visit team

The information pack includes:

contact details of visiting PCAs
list of screening service personnel
agenda for the QA visit day (including details of venue and rooms booked)
overview of the screening service (context grid where applicable)
copy of last QA visit report and progress against action plan (where applicable)
all documents submitted by the screening service
data relating to performance of the screening service
UKAS reports

The information pack is available at least 2 weeks before the QA visit.

Briefing for visit chair, PCAs and S/QAA

The QA visit team meets either before or on the day of the QA visit and will:

introduce the members of the QA visit team
give PCAs an accurate overview of the main elements of the screening service
initiate discussions and highlight potential areas of concern
triangulate initial findings from pre-visit evidence review such as KLOEs generated by the PCAs and SQAS
make sure the visiting QA team are aware of their roles and responsibilities

Question 4

QA visit day

Accepted Answer

Presentation from the screening service

The local screening co-ordinator or designated representative is asked to give a short 10 to 15-minute presentation which outlines the service, including:

changes since the last QA visit
activity
achievements
any challenges or particular issues

Individual interviews

Each PCA ideally meets their professional counterpart(s) in the screening service. The PCA uses the interview to help determine whether national screening standards are met. They may also assess the relationships within the screening service. The PCA summarises the discussion, feeds back the main issues and checks for mutual understanding at the end of the interview.

Preparation for the feedback session

The QA visit team meets to discuss and triangulate the findings from interviews. They focus on areas of risk, recommendations and shared learning. Findings are summarised and fed back to the screening service.

Feedback session

Feedback on the day may be given in 2 sessions.

The visit chair and S/QAA meet with the provider CE9(s) and NHSEI PHCT representative, for example SIL, to give a verbal summary of risks, high level findings and recommendations. This session may be used to raise concerns regarding performance of an individual, or concerns for patient safety which would not be appropriate to raise in a wider audience.

This session usually, but not always, takes place before the main feedback session and is likely to last no longer than 15 minutes.

All interviewees are invited to the main feedback session where the visit chair gives a summary of the main findings and recommendations. All screening service staff and invited stakeholders are welcome to attend.

Senior management representatives of the provider trust or organisation(s), CE(s), CCG representatives (where applicable), NHSEI PHCT representatives and other stakeholders identified by the screening service are also invited to attend this session. Directors of public health (DoPH) or their nominated representative can be invited to attend by the PHCT.

The feedback session usually lasts no longer than 30 minutes and highlights:

areas for shared learning
risks
high level recommendations
the intention to publish the executive summary of the QA visit report on GOV.UK

Where immediate safety concerns are raised the S/QAA informs the RPL. Within 2 working days the RPL writes to the CE of the screening service and the lead commissioner outlining the main concerns and required actions. The letter is copied to the regional head of QA (RHQA) and to the national lead SQAS. PHE screening division director and national programme manager may also be informed. The provider is asked to send a written response within 7 working days.

Where urgent recommendations are made, the RPL writes to the programme manager and commissioner within 2 working days outlining the main concerns and required actions. The provider is asked to send a written response within 14 working days with an action plan to resolve the urgent recommendation within 3 months or sooner.

Question 5

Post QA visit

Accepted Answer

Feedback questionnaire

Screening services are asked to complete online feedback questionnaires to evaluate the QA visit process and provide feedback for SQAS to help improve processes.

QA visit report

The QA visit team submits a summary of their findings to the lead S/QAA within one week of the QA visit (or earlier as agreed). The lead S/QAA produces a draft report for factual accuracy checking by the screening service and commissioners within 30 working days of the QA visit. Day one is the first working day after the QA visit takes place.

The final report is completed within 10 weeks of the QA visit.

The QA visit report is completed using the agreed report template, written in plain English and conforms to the PHE style guide. It includes:

summary descriptions of screening service organisation and leadership arrangements
comments on the adequacy of resource, accommodation, and equipment to meet national screening standards
areas of shared learning
variance from national screening standards
strengths and weaknesses within the screening service
recommendations to address issues identified and improve quality

Circulation of the final report

A copy of the report is sent via email (copying in the head of midwifery) to:

provider CE(s)
NHSEI PHCT representative, for example SIL and the head of public health commissioning (HoPHC)

The CE and SIL are asked to share the report with relevant colleagues including those in the local health economy and public health centres who have a responsibility for screening services. Details of where the executive summary will be published is shared.

Unless consent is withdrawn, the executive summary of the QA visit report is published on the GOV.UK website 8 weeks after the final report is issued (18 weeks after the QA visit).

Where consent is not given SQAS will publish an acknowledgement that a QA visit took place to the named provider however consent to publish the executive summary was declined. A similar note is placed on GOV.UK if NHSEI commissioners decline publication.

The full report can be requested by a member of the public using a Freedom of Information request and may be released by PHE if requested.

Action plan

SQAS supports the screening service and commissioner through the action planning process.

SQAS specifies the evidence used to check whether screening services have met nationally agreed screening standards and any statutory or national guidance or guidelines that apply at the time of the visit.

Recommendations are written so that action plans can be developed. They include the evidence needed to show the action is complete and the criteria for closure.

Timescales for recommendations should be specific, with clear completion dates.

It is the responsibility of the NHSEI PHCT SIL (the commissioner) to make sure the recommendations made in the QA visit report are implemented. It is the responsibility of the screening service to develop an action plan to address the recommendations made.

The action plan is agreed with the SIL or HoPHC within 4 weeks of receipt of the final report. It is good practice for this to be submitted to the next screening service programme board or equivalent governance structure within 3 months of the QA visit.

The SIL makes sure progress against the action plan is maintained using relevant commissioner oversight mechanisms and levers. SQAS should be kept informed via screening service programme boards and direct contact with the providers and commissioners.

SQAS works with commissioners to monitor activity and progress in response to the recommendations for 12 months from receipt of the final report. This enables enough time for at least one response to all recommendations. SQAS sends a letter to the provider CE and commissioners summarising progress made and asking for their direct intervention to address any remaining issues.

Escalation process

SQAS escalates if progress against recommendations is not made. Initially this is through the screening service programme boards or equivalent governance structure and NHSEI PHCT, including to the HoPHC where necessary.

Question 6

Training and development

Accepted Answer

All staff taking part in QA activity have training related to the role. SQAS staff and PCAs should have the skills and knowledge needed to address inequalities. The training requirements for PCAs are set out in the relevant role outlines which are available from SQAS.

Continuous improvement

SQAS is committed to improving processes and measuring the impact of QA. SQAS therefore requests feedback from screening services and commissioners on the QA process and QA visit. Feedback will be requested within 2 weeks via an online Select Survey following the QA visit. Feedback received is shared in relevant forums, or individually where applicable, to improve the QA process.

Question 7

Purpose and scope

Accepted Answer

The operating model outlines the agreed QA process for the NHS ANNB screening programmes. SQAS staff and any PCA supporting the SQAS team must follow the PSOM to make sure the approach to QA is consistent across all screening services.

The NHS ANNB screening programmes begin with the identification of eligible women and babies and relevant tests as per each screening programme. They include acknowledgement of the referral to treatment or diagnostic services for individuals or families with screen-positive results, or the completion of the screening pathway.