Screening quality assurance
Activities to assess the quality of screening programmes, monitor compliance with standards and support quality improvement.
Quality assurance (QA) is a set of activities aimed at ensuring and supporting adherence to complex programmes.
Systematic health screening programmes are complex, include risks as well as benefits, are high profile and cross many organisational boundaries. This means they rely heavily on QA to minimise harm and maximise benefit. Considerations of quality dimensions (for example safety, effectiveness, equity and acceptability) are critical to the design, implementation, safety and acceptable functioning of a screening programme.
A screening QA system is both proactive and reactive.
Proactive QA
Proactive QA supports the delivery of a screening programme to reach agreed standards and follow a published screening pathway. This helps to maintain and improve quality and is ideally done by working both:
- alongside the screening provider, aimed at supporting, educating and improving the service
- outside the health service (often known as external quality assessment (EQA)) – this usually results in a report which the service receives formally and should use to learn and improve
EQA can be done using data and/or a formal QA visit.
Reactive QA
This is to monitor and advise on problems that can be predicted (for example, a change in IT systems), or which have arisen in a programme (for example a missed referral of a screen positive case). These might be called screening incidents.
Screening benefits and harms
Screening invitations are proactively offered, rather than requested by individuals. It is important to ensure screening programmes minimise harm, maximise benefit, and provide invitees with appropriate information.
There are inevitable harms related to population screening, including false positive results, anxiety, and treatment for risks or illnesses that would never have become symptomatic. QA is critical to minimising these harms.
Public policy and delivery should work to ensure the benefits of screening outweigh the harms, and risks are clearly communicated to participants to support them to make an informed choice about whether to have screening (see chapter on informed choice).
QA helps make sure a screening programme is delivered in a way that actively reduces harms and increases benefits. The balance of harms and benefits should be identified as part of the screening recommendation process (see the UK NSC evidence review criteria).
Programme harms can be reduced, and benefits increased by:
- having a clear programme description with an evidence-based screening pathway that describes what should happen at each point of the pathway (see English screening programme pathway requirements). This reduces the risk of inconsistent service delivery
- agreeing written and numerical standards across the screening pathway, against which performance can be monitored and checked – standards should cover programme effectiveness and safety, acceptability, equity, workforce and equipment (see Screening standards chapter)
- having a comprehensive framework of quality assurance which sets out a systematic process for checking that programme standards are being met and covering what to do when they are not
- providing comprehensive, up to date, evidence-based clinical guidance which informs the optimal delivery of a screening programme and identifies continuous professional development expectations
- clear governance and accountability within both national oversight and local delivery - including escalation routes for the identification, notification and management of serious incidents
- establishing a screening safety incidents system so that actual or potential errors can be identified and reported without blame and in a timely manner, acted on, and shared across the programme to support pathway, staff or service improvements as appropriate
- establishing end to end IT systems to hold the necessary information to ensure all eligible people are identified, invited and properly managed through the screening pathway, and that failsafes are in place (see the manual chapter on IT and data)
- agreeing and publishing data definitions (a minimum data set) for effective programme monitoring and to support performance reporting, including regular and timely publication of annual reports (see the manual chapter on IT and data)
- providing or signposting to training, ensuring all staff identify and complete continuous professional development (CPD) (see the manual chapter on workforce)
- ensuring any pathway variations (for example due to research or pilots) are planned, agreed and run with minimum disruption to services and so that appropriate evidence is gathered and available for policy and pathway decisions
A well-functioning programme needs central or national functions for:
- developing pathways and standards
- defining standards data and collecting, analysing, reporting and acting on them
- reviewing the quality and consistency of service delivery and identifying mitigations to identified risks and opportunities for improvement
- sharing learning and good practice across providers to support continual improvement and consistent delivery
- investigating, mitigating for, and learning from incidents
- supporting staff and working with training and educational establishments
- supporting consistent quality improvement across the entire screening programme
- identifying and assessing new evidence and research proposals
Successful screening quality assurance
In 1998, Gray JAM and Austoker J [footnote 1] set out 5 preconditions for successful QA, which are:
- the right culture
- the existence of explicit standards of good performance
- an information system that allows each professional and programme to compare their performance with that of others and with the explicit standards
- the authority to take action if a quality problem is identified
- clear lines of responsibility in managing the process of QA itself
Screening QA is applicable to population screening, stratified screening and targeted screening.
Screening QA has 2 main functions, which are to:
- assess screening programmes and assure stakeholders that they are safe and effective
- support continuous improvement within screening
Screening stakeholders can include screening staff, commissioners (the organisation that pays for screening services), policy makers, the public, academics and the media.
QA staff, working alongside other experts, assess the performance of screening programmes against agreed quality standards, and provide expert advice or investigation as required.
QA functions can conflict with financial considerations or the routine delivery and priorities of screening services. Formal separation of the QA process from the organisation responsible for the delivery and financial responsibility for screening is therefore vital for ensuring that quality concerns or improvements can be identified and raised.
The balance of internal and external QA will be decided by those who set policy, pay for services and deliver the programmes.
QA provides an assessment of screening provision against published and agreed programme standards and pathways. QA activity may include data monitoring, reviewing service user feedback, incident management and onsite QA visits. An onsite visit is a quality ‘health check’ where an independent team of peers led by a trained QA professional provides external assurance that:
- the screening service’s processes and procedures meet or exceed the published programme standards and guidance
- internal assurance and governance are appropriate to support safe provision of screening, including escalation of issues
- the different parts of the screening pathway work effectively together, ensuring an end-to-end service for the screening participant in line with national guidance
The definition, collection and reporting of data and information that can provide evidence for quality assurance should be considered early in the development of a screening pathway.
QA activity also provides an opportunity to assess and report actions taken to reduce health inequalities and identify areas for improvement.
In some jurisdictions formal QA visits are carried out in addition to data and information analysis. Visits allow more detailed and peer to peer understanding of the programme. They can be used, for instance, to learn how a programme operates alongside other activities of the health service provider or hear from staff and public using the services.
Established practice suggests that the programme areas to be visited, questions to be asked, and which policies to be looked at, should all be agreed beforehand. QA visit practices should be the same across all providers. Data reports comparing local performance of the provider against programme standards and specifications (and including comparison with national performance if applicable) are obvious elements to cover.
Other practical aspects of a QA visit could include:
- talking through data recording processes to make sure they are accurate, complete and mitigate for known risks (such as duplicate names)
- talking through the screening pathway to check that all screening individuals are moving through the pathway appropriately and in a timely way
- a review of materials such as slides or case notes
- an observation of a screening test being carried out
All processes must be agreed before designing and carrying out a QA visit to ensure the visit is objective and relies on published evidence. This means that if inconsistencies are found via a visit, they are more likely to be considered valid by the screening provider.
The visit should be followed up with a report to the screening programme detailing:
- the main findings, with any significant concerns clearly identified
- points of good practice
- any recommendations to improve the quality of the service
A summary report should also be published and available to the public.
Following the visit, the QA team should be available to provide expert advice and guidance to the screening provider on how the identified recommendations may be met.
Peer-to-peer professional assessment
To maximise the effectiveness of a QA visit, established practice has found that the visiting QA team should include trained professional peers for each of the professional disciplines covered by the visit process. This peer-to-peer model maximises not just the ability to identify suboptimal processes, but also increases the opportunity to identify instances of good practice which could and should be shared more widely.
The peer-to-peer model should not be used to provide a second opinion on challenging cases, nor to make decisions on the clinical management of an individual case. These responsibilities remain with the screening provider.
An EQA scheme may be included as part of QA activity. These are schemes run by specific organisations and focus on a particular aspect of the screening pathway, for example pathology or image interpretation.
Examples of EQA schemes include:
- UK National Breast Pathology Interpretive EQA Scheme
- PERFORMS – NHS Breast Screening Programme scheme for image readers and radiographers (UK)
- DetectedX – medical imaging for breast and chest (USA and Australia)
- UK cervical screening EQA and a technical EQA scheme (TEQA)
- PERFECTS EQA – PERFormance Evaluation for CT Screening (UK)
Quality should not be assumed. Nor should definitions of quality remain unchanged. There are always opportunities to improve service delivery. QA activities should incorporate:
- provision of external assurance that the quality being delivered meets or exceeds expected standards
- identification, championing and sharing of quality improvements
QA activities should include the independent and timely sharing of examples of good practice across screening providers so opportunities to improve service delivery can be taken. QA activities, visits or reports should lead to the identification of actions to improve quality.
Screening programmes are large and complex, and it is inevitable that some errors will occur. Without scrutiny, these errors risk being either missed or not investigated, and important lessons will not be learned and acted on, leading to repeated similar errors.
This can result in:
- poor care or harm to people eligible for screening
- damage to the reputation of the screening service
- damage to the reputation of screening for a particular condition
Inevitably, the standards or pathway processes laid out in programme guidance are not always met. It is essential to have central programme guidance on the identification, investigation, resolution and prevention of incidents as part of the programme implementation process. This guidance should be updated as necessary.
Incidents may involve single or multiple providers and can affect small or large numbers of people. The severity of the impact of incidents also varies. What appears to be a relatively minor incident can result in screening harming or failing to help many people. Understanding and tackling the root cause of all incidents is therefore essential.
There should be a process that enables the provider to raise any identified or suspected programme delivery problem with the QA team as soon as possible. The QA incident process should then begin. The immediate objective at this first contact between service provider and QA is to assess the safety of the service. Once that is established, the QA team should then work with the provider, and give independent advice to both the provider and the commissioner to resolve the issue and assure the future safety and quality of the service.
Examples of programme incidents
A screening programme IT system fails to identify and invite all eligible people. This could lead to:
- some people missing the opportunity to be screened
- delayed diagnosis for people who have the condition being screened for
- potentially less effective treatment following a delayed diagnosis
An unexpected rise, fall or other unusual variation in types of screening results is noticed, possibly indicating a testing issue at a laboratory. This could lead to:
- assessment of any equipment used in the analysis of screening tests, plus investigation of individuals’ working practices
- the need to re-process tests, potentially causing capacity issues for the service
- issuing revised results to those screened, potentially causing anger, anxiety, and reduced public confidence in the programme’s effectiveness
Someone involved in reporting screening test results is found to be performing poorly. This could lead to:
- their work being investigated to check on the accuracy of their reported results
- revisiting the individual’s work and issuing revised results
- a consideration of the wider workplace context, to identify any external factors impacting on personal performance
Note that in the case of underperformance, the service should provide support for individuals to attain (or regain) the required or desired standards or levels of practice.
Learning from incidents
Incidents should be used as valuable learning opportunities. Where lessons learned may impact across the whole screening programme (not just one local screening provider or service), this information should be shared as quickly as possible. Clear advice and action points should be included in a rapid communication so each service can assess its own risk.
The QA service should produce an annual report of incidents. This information can help inform revisions to screening guidance, including effective mitigations to address specific risk points. Future QA activities can then be used to ensure the identified mitigations are working, and screening participants are no longer being adversely affected.
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Gray J A M and Austoker J (1998). Quality assurance in screening programmes. British Medical Bulletin 54 (no. 4): 983-992. ↩