Diabetic eye 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) acts as visit lead and will be linked to each screening service and the NHS England and 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 national screening standards.

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

Quarterly, SQAS review participation, sensitivity and specificity of programme grading through the monthly test and training online sets and analysis of atypicality outcomes.

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

NHSEI and screening services are informed of scheduled visits/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 PHE’s guidance Managing safety incidents in NHS screening programmes. 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 professional and clinical advisors 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.

Network meetings are used by SQAS to share information relating to new 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 local audit information. SQAS and the national screening programme manager work together where applicable to develop a joint agenda for these meetings.

There will be a minimum of one network meeting 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

There are 2 approved software systems available to local diabetic eye screening services: Optimize and Spectra. Each screening service has a local database with a nationally specified minimum dataset. This is used for the call and recall of eligible people with diabetes, the grading of images and reporting.

The DES programme database is sourced from GP practice systems and there is a mixture of manual referrals, GP list validation and electronic extracts to obtain the eligible population.

Local services are required to provide data to the PHE national programme team through the production of a performance report on a quarterly and annual basis. The performance report in each software package adheres to a national specification and calculation document.

Key performance indicators (KPIs)

Screening key performance indicators (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 publish data required to support quality assurance 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:

pathway standards – quarterly
key performance indicators – quarterly
pathway standards – annually

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.

The programme performance report is used by the national screening programmes data team to calculate the pathway standards and KPIs on a quarterly and annual basis. Screening services are then able to validate and agree the figures.

Data reporting

Reporting and analysis is done once and nationally, where possible. Dissemination of data not already in the public domain to screening services is via SQAS regional teams. Additional data items have been added to the pathway standards report by NHSEI for completion by the provider.

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 diabetic eye 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
clinical lead (who may be a diabetologist or ophthalmologist) - if the clinical lead is not an ophthalmologist, an ophthalmologist PCA may also be required
programme manager
screener or grader
screening or grading
optometrist where the local programme is optometry based
administration/failsafe – the decision to have a separate administration/failsafe PCA will be taken by the S/QAA responsible for the visit and will be dependent on programme complexities

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 diabetic eye screening, the visit chair is the regional portfolio lead (RPL) for diabetic eye screening 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 IT system known as Marvin 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

Following the QA 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 diabetic eye screening PCA person specification or role description.

Locations to visit

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:

screening service clinical lead
programme manager
screening staff
grading staff
administration staff, including failsafe officer(s)
public health leads
commissioning leads
lead ophthalmologists from linked hospital eye services (HES)

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 (the previously validated released quarter from NDESP)
analysis of audit reports
programme specific inequalities evidence guide to identify inequalities in the screening pathway

Preparation

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, treatment providers 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 that 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/SIL.

Observation of clinical practice and premises

The lead S/QAA will arrange a time for the screener/grader PCA to visit agreed screening and grading locations to observe premises and clinical practice as an ‘observation of clinical practice’ visit. This will take place approximately 8 weeks before the QA visit.

Observation of failsafe/administration practices

The programme manager PCA or administration/failsafe PCA along with the designated administration reviewer (S/QAA) will arrange to visit the local screening service in advance of the visit to examine policies and evidence as an ‘observation of local screening service administration’ visit. This will take place before the QA visit and the S/QAA will liaise with the local screening service regarding when and where this visit will take place.

Review of evidence

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.

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 KLOE and telephone interviews.

The minimum visit team consists of the visit chair and S/QAA who will meet with the programme manager, clinical lead and lead commissioner. A full QA visit will take place where necessary. The lead S/QAA will inform 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
outcome of the observation of clinical practice and premises (where applicable)
outcome of the observation of administration practice (where applicable)
data relating to performance of the screening service

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 KLOE(s) 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 clinical lead 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 CE(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/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 highlights:

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

This feedback session usually lasts no longer than 30 minutes.

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 an online feedback questionnaire 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 1 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 1 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 the clinical lead and programme manager) 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 professional and clinical advisors 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 diabetic eye screening programme. SQAS staff and any professional clinical advisors (PCAs) supporting the SQAS team must follow the PSOM to make sure the approach to QA is consistent across all screening services.

Diabetic eye screening QA begins with the identification of eligible people and includes routine digital photography and digital surveillance. It also includes assessment of ungradeable images through slit lamp biomicroscopy and referral to hospital eye services following notification of a positive test.

QA of local diabetic eye screening includes:

identification of eligible people
call and recall
the screening test
surveillance
timely referral