6 How to implement this guidance

NHS contributors to this resource have worked with NICE to develop practical suggestions for how to consider implementing NICE guidance on molecular testing strategies for Lynch syndrome in people with colorectal cancer. Local organisations will need to assess their applicability taking into consideration the time, resources and costs of an implementation programme in the context of their current practice.

Project management

Molecular testing strategies can be best adopted using a project management approach. NICE has produced the into practice guide which includes a section on what organisations need to have in place to support the implementation of NICE guidance in this way.

Project team

The first step is to form a local project team who will work together to support implementation and manage any changes in practice.

Individual NHS organisations will determine the membership of this team. Consider the following membership of the team:

  • Clinical champion(s): could be a clinician within the colorectal MDT, for example, a colorectal surgeon or gastroenterologist. They should have the relevant knowledge and understanding to be able to drive the project, answer any clinical queries and champion the project at a senior level. It may be helpful to have a clinical geneticist to support this role.

  • Project manager: could be someone in a clinical or managerial role who will be responsible for the day-to-day running of the project, co‑ordinating the project team and ensuring the project is running as planned. Examples of roles that may act as project managers include pathologists and clinical scientists. Depending on current service provision, a dedicated project manager may be needed to support adoption of this guidance.

  • Management sponsor: will be able to help assess the financial viability of the project, drive the formulation of a business case and help to show the benefits achieved. This member of the team may be based in a laboratory or clinical genetics service because this is where the costs will be incurred.

  • Genetic counsellors, colorectal nurses, histopathology laboratory staff and molecular genetics laboratory staff: will be valuable members of the project team because they will be providing the service.

  • Clinical audit facilitator: to help set up mechanisms to ensure that every patient is tested and that their test results are discussed as well as collecting and analysing local data related to the project metrics and audit needs.

Care pathway development

Care pathway stages that may need to be considered or developed are as follows:

  • Attendance at colorectal cancer MDT meetings or liaising with people who attend them. Representatives from the local pathology laboratory, specialist clinical laboratory and clinical genetics services may organise regular communication with a lead member of the MDT. Contributors advised that attendance at weekly MDT meetings was helpful at the start of the project. After this, electronic communication and attendance at the annual MDT meeting is enough.

  • Automatic MMR testing of all CRCs (if service capacity allows) using either immunohistochemistry (IHC) or microsatellite instability (MSI) and inclusion of this in the standard pathology report requested by oncology. If service capacity will not allow for MMR testing of all CRCs, a decision may need to be made on those to prioritise in the early stages of implementing a strategy (phased introduction). If a phased introduction to testing is deemed appropriate locally, plans should be in place to expand this to testing all CRCs in the future.

  • Identifying when people with abnormal results for MMR testing should be referred to a clinical genetics service and establishing robust referral mechanisms for this. The MDT may be best placed to make this referral after collation of all test results.

  • The point at which to get patient consent for genetic testing and for sharing information with relatives.

  • Providing further sequential testing within a regional molecular genetics laboratory or other specialist service depending on results.

  • Feedback of test results to all services involved and to patients.

Measuring success

In order to show the benefits of adopting molecular testing strategies it is important to take measurements before, during and after implementation. Some of these measures will not be routinely collected and trusts should consider a data-collection methodology that is appropriate to the service. Inclusion within local and regional audit linked to peer review may help with this. Suggested measures from the sites involved in developing this resource are:

  • Proportion of people with CRCs having MMR testing carried out.

  • Proportion of people with CRCs that have an MMR deficient result. If this is over 40%, there may be an issue with laboratories reporting false positives.

  • Number of further sequential tests that are carried out in people with a positive MSI or an abnormal IHC result.

  • Proportion of patients that have an MMR deficient result that are referred to clinical genetics services either at this point or following further sequential tests (depending on point of referral in the local patient pathway).

  • Proportion of patients who attend their appointment when referred to clinical genetics services.

  • Number of people with CRC who are diagnosed as having Lynch syndrome.

  • Number of relatives tested for Lynch syndrome.

  • Longer term: number of surveillance detected cancers in patients and relatives diagnosed with Lynch syndrome.

Overcoming implementation challenges

This section shows the challenges which contributors to this resource reported may be experienced by NHS sites when implementing molecular testing strategies.

Capacity

The volume of requests to pathology and specialist clinical laboratories for tests will increase and more clinical genetics appointments will be needed.

  • Prepare a business case including full cost considerations of the increased capacity needed for testing all CRCs compared with the current service model. Depending on the current service model, a phased introduction may need to be considered possibly focussing on the highest risk in the first instance. The infrastructure of the service should be designed to ensure equity of access to consistent and quality assured testing strategies. Consolidation of service models may help to achieve this and ensure smaller organisations are able to offer testing to patients.

Quality assurance

It is vital to ensure the tests are done and interpreted correctly.

  • Staff in laboratories doing MSI or IHC testing should have training on how to carry out and interpret results and should take part in a recognised external quality assurance programme.

Governance

Testing involves multiple steps that may occur at different sites. It is crucial that there is clear ownership of testing and results at each stage.

  • Establish champions (named individuals with a specialist interest and up-to-date knowledge) in each department and within each colorectal cancer MDT to whom questions and requests can be addressed.

  • When testing is carried out in more than 1 laboratory, arrange to contact the colorectal MDT lead electronically or set up a service delivery group to discuss collated test results. This can help with decisions on further sequential testing and referral.

  • Ensure that the correct samples are sent from histopathology laboratories to specialist clinical laboratories for testing. This could be done by clarifying what is needed on export request forms and by raising awareness in histopathology laboratories about the tissues and formats needed to carry out relevant tests (see developing local documentation and Central Manchester University Hospitals NHS Foundation Trust's website for example letters to pathology detailing how tumour samples need to be prepared and labelled for testing).

Raising awareness

People with Lynch syndrome may not be identified because of a lack of awareness among healthcare professionals both of the condition and the referral mechanism to clinical genetics services. To raise awareness:

  • Clinical genetics specialists may want to liaise with the colorectal cancer MDT lead within their local services.

  • Develop a clear flow diagram that shows what testing and onward referral is needed and signposts to whom that referral should go to at local level.

  • Identify clinical champion(s) for education who can offer training and awareness-raising initiatives, particularly to colorectal surgeons and specialist cancer nurses to increase their identification of people who may have Lynch syndrome.

  • Use the resources to support awareness raising developed by Lynch Syndrome UK.

Laboratory staff training

  • Laboratory staff may need training on how to carry out and interpret the tests covered by this guidance. The sites that have contributed to this resource reported that colleagues with experience of doing these tests may be able to help with this.

  • Consider providing training for pathologists as part of a molecular pathology attachment done during their training period, which could include correct preparation and marking of tumour samples.

Information for patients

People need to make informed decisions about both testing and further screening and treatment.

  • Develop resources and information for patients that explain why they have been referred to clinical genetic services because of the results of their tumour tests (see developing local documentation).

  • At the review appointment with the oncologist or colorectal surgeon, explain the benefits both for them and possibly their relatives.

Business case

Developing a business case should be a priority for the implementation team. Local arrangements for developing and approving business plans will vary from trust to trust, and each organisation is likely to have its own process in place.

In developing a business case for molecular testing strategies, consider the following:

  • The need to develop this in co-ordination with all services involved because the adoption of this guidance is likely to have benefits at hospital and societal level as a result of earlier identification of some associated cancers and cancers in relatives.

  • Clinical rationale for testing all people with CRC: include an evidence summary showing treatment pathways, clinical outcomes and reduction in mismanaged patients.

  • The increased cost of staff and resources needed in histopathology and specialist clinical laboratories and clinical genetics services to comply with the NICE recommendation to test all people with CRC. For an example approach to histopathology reporting and invoicing, see the Central Manchester University Hospitals Trust website. Take into account that this trust was not testing all CRCs at the time of writing this resource.

  • The increased cost of testing relatives and of the screening they may have if diagnosed with Lynch syndrome. See the NICE resource impact report and template to help identify the resource implication within your organisation.

  • Potential benefits because of the prevention of early onset of associated cancers and of CRC for relatives of people diagnosed with Lynch syndrome.

Resource Impact

A resource impact report and template have been prepared to support the implementation of the guidance. The guidance may have resource implications at a local level because of variation in clinical practice across the country. Therefore, organisations are encouraged to evaluate their own practice against the recommendations in the NICE guidance and assess resource impact locally.

Developing local documentation

These are examples of tools developed by NHS services using molecular testing strategies, which can be used to inform the development of local documentation. They have not been produced, commissioned or sanctioned by NICE. Take into account that some of these trusts were not testing all CRCs at the time of writing this resource.

Oxford University Hospitals NHS Foundation Trust – Information pack for specialist team to support referral to clinical genetics

Oxford University Hospitals NHS Foundation Trust – Abnormal MMR management flow chart

Cambridge University Hospitals NHS Foundation Trust – Letter to pathology laboratory requesting tumour samples for MLH1 methylation studies

Leeds Teaching Hospitals NHS Trust – Letter to pathology laboratory detailing how tumour samples need to be prepared and labelled for MSI testing

London North West Healthcare NHS Trust – Letter for first degree relatives of patients with CRC who have a normal IHC result

Cambridge University Hospitals NHS Foundation Trust – Information for people with a family history of bowel cancer


This page was last updated: 22 February 2017