Implementation Project

NTAC project implementation and mentor sites in partnership with their PCT's have implemented the intra-operative test into their clinical practice as a result of following the technology implementation project. This process has involved significant changes to the way that services have been structured and the way in which healthcare has been delivered within these Trusts.

On this page, you will have unprecedented access to the learning gathered from the teams and there are contact details available so you can make contact and hear from them directly about what really happened and the challenges they encountered. In addition there are support tools and resources for you to download, adapt and use, which all stem from the work completed at each participating Trust.

To explore this section please click on the headings below:

• Project background - gives an overview of the NTAC breast cancer project, where you will be able to gain access to the data we collected as part of this process.
• Project sites - gives an overview of the NHS Trusts who were involved in the project and what their biggest achievement was following their robust implementation processes.
• mandade for change - provides you with a step by step checklist of the essential questions that need to be answered to enable and plan for a change to clinical practice.
• implementation process - provides all of the information and resources that you may find useful when planning the implementation process for insulin pump therapy at a local level.
• Implementation - has been designed to help Trusts understand what implementation will mean locally and what needs to be put in place in order to make it happen.
• patient pathway - provides full and complete patient pathway diagrams that can be tailored as appropriate. These are currently being followed in the NHS Trusts that we worked with on this project.
• Impact on pathology and theatres - this section explores the impact on theatres that may be required for Trusts in order to successfully implement this test.
• evaluate success - provides a number of questions around evaluating success and advocates the need to continually monitor and maintain progress being made as implementation filters through.
• measurements of success - details what Trusts need to put in place to ensure that a sustainable insulin pump therapy service can remain in place for future years.

Project Background

Three NHS hospitals across England are now implementing the intra-operative test into their routine clinical practice. The teams agreed and secured the funding for this service improvement on the foundation of improving quality of life for patients whilst reducing the number of second operations and overall length of stay in hospital. Most importantly, a robust implementation process was followed to allow a greater number of patients to receive only one surgical procedure and therefore reducing the risk of co-morbidities and unnecessary length of stay.

After following this structured implementation process, patient outcomes and the effect on local health economies (clinical and non clinical) were measured in a total of 300 patients across four project sites (NOTE four sites: University Hospital of North Staffordshire is still working through its implementation plan and will be implementing the technology in September 2010. However, data was collected during a trial period that took place at the Trust last year - this is detailed in the project data report which can be found in the evidence base section). Impact on service, financial consequences and the required clinical and patient support needed within the initiation phase was evaluated.

The evaluation measures and values were subjected to independent analysis undertaken by the NHS Technology Adoption Centre and York Health Economics Consortium. The data was also reviewed by the NHS Information Centre for Health and Social Care.

• Click here to access summary data presentation in a pdf file.
• NTAC project data to access the full project data report in a pdf file.

Project Sites

The Princess Alexandra Hospital NHS Trust
Clinical Implementation Lead: Dr Jolanta McKenzie

The Princess Alexandra Hospital NHS Trust is located in Harlow, Essex and is a 501 bedded District General Hospital providing a comprehensive range of safe and reliable acute and specialist services to a local population of 258,000 people.

The Trust is committed to the core principles of the NHS which are to provide services that meet the health needs of everyone and are free at the point of delivery.

A great deal of innovative and exciting work takes place here at The Princess Alexandra Hospital NHS Trust. The Trust has been awarded a double 'Good' rating by the Care Quality Commission for the quality of its services and the way it uses its money. This places the Trust alongside only a handful of Trusts nationally to achieve this dual score.

*** The Trust has recently won a Health and Social Care Award for the introduction of this technique. Click here to find out more. ***

University Hospital of North Staffordshire
Clinical Implementation Lead: Dr James Adjogatse

University Hospital currently runs three hospital sites: the North Staffordshire Royal Infirmary, the City General and Central Out-patients. From these sites the Trust provides an extensive portfolio of emergency, general and specialist hospital services.

The Trust is part way through a major re-development of its hospitals, and a brand new 370 million pound hospital will be fully open in 2012.

Whilst continuing to ensure sustained financial viability to support, maintain and develop the Trusts services, it pledges to continue to improve the clinical care our patients receive through aggressively reducing hospital acquired infections, ensuring all patients are treated with privacy and dignity and ensuring patients do not experience unnecessary delays by achieving the 18 week referral to treatment target.

University Hospitals of Morecambe Bay NHS Trust
Clinical Implementation Lead: Dr Jorien Bonnema

The Trust operates from three main hospital sites - Furness General Hospital in Barrow, the Royal Lancaster Infirmary and Westmorland General Hospital in Kendal and two centres - Queen Victoria Hospital in Morecambe and Ulverston Community Health Centre.

Each main hospital site has a range of 'General Hospital' services, with full Emergency Departments, Critical/Coronary care units and consultant led beds at both Furness General Hospital and the Royal Lancaster Infirmary, plus a Primary Care Assessment Service (PCAS) at Westmorland General Hospital.

City Hospitals Sunderland NHS Foundation Trust
Clinical Implementation Lead: Mr Obi Iwuchukwu

City Hospitals is the leading acute healthcare provider in Sunderland, operating from Sunderland Royal Hospital, Eye Infirmary and Ryhope General Hospital. City Hospitals offers a range of services from two main sites within Sunderland, Sunderland Royal Hospital and Sunderland Eye Infirmary. The Trusts most recent additions are the Cardiac Centre and the Surgical Day Case Unit, its aim is to treat patients promptly and with care in all hospital settings. The Trust has a number of specialist services and Sunderland Eye Infirmary is the leading regional eye treatment centre, with a recently opened second cataract theatre. It has recently launched our new vision for Excellence in Health, Putting People first. The Trust is committed to high quality, safe and personal care for each patient.

Mentor Sites

The Royal Surrey County Hospital NHS Trust
Clinical Implementation Lead: Mr Mark Kissin

The Royal Surrey County Hospital is a leading General Hospital and specialist tertiary centre for cancer, Oral and Maxillo-facial surgery and pathology. The hospital serves a population of 320,000 for emergency and general hospital services and is the lead specialist centre for cancer patients in Surrey, West Sussex and Hampshire, serving a population of 1.2 million.

It has 527 beds and 14 operating theatres. The Trust has a very strong reputation for minimally invasive surgery and laparoscopic surgery is used widely across the surgical specialties. The Trust is a national leader in surgical training and laparoscopic surgery and MATTU (Minimal Access Therapy Training Unit) is one of the most advanced training centres for this type of surgery. It has also been designated as a national training centre for laparoscopic colorectal surgery.

Portsmouth Hospitals NHS Trust
Clinical Implementation Lead: Prof Ian Cree

Portsmouth Hospitals NHS Trust provides a range of acute services across two sites including Queen Alexandra Hospital and St Mary's Hospital.

The Queen Alexandra Hospital site has gone through a major redevelopment to create a modern and 'fit for purpose' hospital, which has been completed in 2009. The majority of the Trust's acute services are now provided at Queen Alexandra following the opening phase of the new state-of-the-art facilities.

The 'Emergency Department' at Queen Alexandra Hospital is one of the busiest in the UK treating in excess of 100,000 patients each year. The 'Medical Assessment Unit' (MAU) and 'Surgical Assessment Unit' (SAU) provide rapid diagnostic assessment for patients admitted as emergencies. These can then be directed to the clinical areas most appropriate for their condition.

The Trust is also home to the Wessex Renal and Transplant Unit and it holds prestigious Cancer Beacon Status for the Head and Neck Cancer Services. Hosting the largest Ministry of Defence Hospital Unit (MDHU) in the country, the Trust enjoys strong military connections and is proud of this association.

Mandate for Change

According to the NHS Information Centre for Health and Social Care, the number of women diagnosed with breast cancer has risen steadily in recent years. As a result there was a 37% increase in the total number of operations performed for breast cancer in the NHS in England between 1997 (24,684) and 2006 (33,814). Thus there is a need to address the problems presented by breast cancer surgery in order to streamline the overall model of care for patients.

Existing breast surgery services (set up and infrastructure) within provider organisations is going to shift as a result of implementation of the intra-operative test. Realising the medical and nursing staff aware of the impact it will have on them that this test can bring to your Trust, and understanding the change required to achieve these benefits is essential in order to answer the following questions:

1. Why is this test important at a local level?
2. Why should we be implementing it?
3. What would the impact be of not implementing it?

Engagement with more than one PCT provider may be required in order to answer these questions sufficiently and plan your mandate for change. If more than one PCT provider needs to be involved, this will undoubtedly expand the overall scale of change locally. This was the case at the University Hospitals of Morecambe Bay NHS Trust who had to navigate around two PCT organisations before implementation discussions could begin. A strong and clear mandate for change sets the precedent for the entire implementation process

There are three underlying principles that underpinned the mandate for change in the NTAC project implementation and mentor sites, which include:

• The speed of adoption (e.g. how quickly can this change be achieved),
• Ultimate utilisation (e.g. how many people within the organisation need to be involved to see the technology successfully embraced) and
• Proficiency (e.g. are the relevant skills in place to deliver this service).

Click here to be taken to the Benefits vs. Barriers section, where the scale of the change that will be possible through implementing this technology can be found.

Planning for Implementation

A systematic and team based approach to implementation is essential if the intra-operative test is to be successfully adopted, and part of this approach involves establishing a core implementation teams representative of all stakeholders who can drive forward the changes required and fulfil the mandade for change. 'Buy in' from the entire Multidisciplinary Team (MDT) from the outset must be a long-term commitment and only then can improved patient outcomes be achieved. Once an implementation team has been formed, the following questions need to be answered:

1. Does the Trust understanding the technology and how it will impact on the local health economy?
2. Can the Trust identify its own potential adoption barriers and benefits at this early stage?
3. Is it possible to overcome these barriers and resolve them quickly and can opportunities be harnessed?
4. Are your commissioners engaged?

The long term sustainability of this service improvement will stem from understanding these issues. Having an awareness of what adoption 'on the ground' will look like in order to work towards a detailed implementation plan is an important step in the planning process.

Understanding the technology and its impact on the local health economy is not always straight forward but it will be the precedent for moving forward. The NTAC project data showed that carrying out an analysis of your patient throughput before implementation is essential (e.g. how many primary operations currently take place and how many of these would otherwise have been saved a second operation if the technology was in place). If you are not aware of your patient numbers and projected impact that the technology will go on to have, implementation will prove to be difficult. This is an essential step in planning for implementation.

Implementation

Trusts and respective PCTs will have to continually re-think and revise local objectives, priorities, and strategies in order to effectively implement an intra-operative service into breast surgery. The experience of the NTAC implementation sites suggests that the initiation, implementation and 'go live' process will take approximately 6-8 months. The following questions were explored in the NTAC implementation sites which facilitated a successful implementation phase:

1. Has a clinical and board level champion been identified?
2. Has an implementation team been created that will initiate, oversee and evaluate success?
3. Can the team understand the dynamics of what is required to take the plan forward, and has it experience of similar adoption issues?
4. Have the key tasks been identified?
5. Have the measurements of success been identified?
6. Do the resource and cost requirements (time, money, people, equipment,) appear reasonable and consistent with existing best practice?
7. Have the key risks of each of the main components been identified and managed (designed out, shared, and mitigated)?
8. Has the revised patient pathway been agreed?
9. Has the team got a review mechanism in place for managing and communicating delivery against the implementation plan and for identifying and managing risk?

Once implementation begins, the service demands will be real and the new infrastructure surrounding financial agreements and clinical time will be in place - there is no going back.

NTAC project experience showed that sites implementing the intra-operative test need to be well trained and prepared not only for technical use of the system but also for efficient and optimised handling of the test in an intra-operative setting. Following initial training, the staff using the method should have the opportunity to get used to using the technique (this may be achieved using non-clinical samples). Once staff are comfortable with the practical methodology, routine intra-operative testing can begin. A defined number of cases and/or nodes to be tested alongside conventional testing will need to be decided by local teams. External support may be available during the implementation period to assist staff during this time.

Standard Operating Procedure for Pathology:

hUniversity Hospital of North Staffordshire have developed a set of Standard Operating Procedures which can be utilised within pathology departments when implementation first begins. This will ensure that there is a governance regime in place to record clinical activity as nodes arrive and are subsequently analysed within pathology. The team at University Hospital of North Staffordshire advocates that these documents are to be used as a guide only, and are only appropriate in the first stages of implementation. It is for local teams to establish an appropriate clinical governance framework, and most Trusts will have their own methods of recording such activity.

• Sentinel Lymph Node Proforma (for attachment to SLN histology request card)
• Sentinel Lymph Node Assay - to prepare a SLN specimen for transport to the histology department (theatre checklist).
• Form to complete prior to SLN procedure - theatre checklist.

Procurement is also an essential part to implementation, and the purchasing of the intra-operative technology can be complex and time consuming - but it doesn't need to be. The procurement section of this How to Why to Guide will explain what processes need to be followed for purchasing this technology, which should be discussed as an implementation teams. The protocols that underpin procurement will also impact on the speed at which implementation can take place locally.

The Pathway: how will it change?

The experience from the NTAC project implementation and mentor sites suggests that there are five core areas of consideration when thinking about how the patient pathway will change:

1. Method of referral to the breast service - Will this change as a result of implementation? Will patient demand increase? How will the Trust manage a possible increase in referrals?
2. Patient assessment and selection - how will the Planning the case mix as a result of implementation?
3. Provision of appropriate structured training and clinical education.
4. Managing patient support and the consent process - what local plans are currently in place locally? Does anything need to be amended?
5. Increased awareness of the technology and the impact it may have on other members of the clinical team - e.g. who will see a change to clinical practice as a result of implementation? For example, are medical and nursing staff aware of the impact it will have on them?

Each Trust will have different needs and demands from what it wants an enhanced breast surgery service to deliver, which is going to be important when pulling together an analysis of how local pathways of care are currently being delivered. However, it is hoped that the patient and clinical staff pathway documents, which have been formulated as part of the NTAC implementation project, will provide Trusts with a clear insight into what needs to change and why.

Three pathways were developed as part of the implementation process:

One: Patient Pathway:

BLNA Patient Pathway (PRE and POST Implementation) - this illustrates how the patient pathway will change as a result of implementing this technology. Two pathway diagrams appear:

• Pre implementation (e.g. the Trust is not intra-operatively analysing sentinel lymph nodes).
• Post implementation (e.g. the Trust is now 'live' and the patient journey has been altered. It will be important for Trusts to understand how implementation of pathway two will impact on the overall service.

Two: Nursing and Medical Staff Pathway:

Breast Pathway for Nursing and Medical Staff - Peer Review. This was developed by City Hospitals Sunderland NHS Foundation Trust, and explains how the workload of nursing and medical teams will alter as a result of implementing pathway one. The activities and interventions stated are site specific and therefore will required amendment as per local protocol.

Three: Pathology Pathway:

Pathology Pathway. This explains the process of analysing nodal material in pathology (post implementation).

Each pathway provides guidance and thoughts as to how you might structure your service - but it is for local implementation teams to decide on which pathway (or which parts of the pathways provided) is right for them and the local health economy they serve. Discussing these pathways as an implementation team to assess their impact at a local Trust level is crucial.

NTACs economic analysis of this technology showed that a saving of £4.09m per annum could be achieved from ward costs if this was implemented across the entire NHS.

Impact on Pathology and Theatres

Pathology

Introducing this technology into the organisation is going to require some reconfiguration of pathology staff and potentially the hiring of additional breast care nurses ( click here for a job description that The Princess Alexandra Trust created and implemented) to oversee the introduction of the technology and thus the revised patient pathway that it introduces.

The Department of Health has recently commissioned a toolkit which was followed in two of the NTAC implementation sites, which supports 'the changing needs of services and pathways of care. It aims to ensure that the right people with the right skills are in place, rather than constraining the service by limiting it to traditional established roles'. Source: Department of Health. NTACs implementation sites recommend using this tool when considering service improvement across pathology but in particular to ensure a methodical approach to successfully implement this particular test / technology.

can be found here to access the workforce planning in pathology toolkit.

The tool may be particularly useful in helping to determine the skill mix of pathology personnel, so that dedicated staff can be assigned to carrying out the analysis once implementation has taken shape. At present, dissection of lymph nodes from surrounding fat and sectioning and sampling is usually undertaken by a consultant pathologist or consultant. However, NTAC project implementation and mentor sites advocate that with experience, there is potential for a bio-medical scientist with extended skills in dissection could perform this task (at a band 6/7).

Dissection of nodal material is performed by a Consultant Surgeon or Consultant Pathologist, or experienced Biomedical Scientist (band 6/7). NTAC project implementation and mentor sites advocate that the core competencies that are required include:

• Radiation training - monitoring radiation levels and taking readings before/after process.
• Accurate pipetting skills.
• Laboratory experience working to a high level - able to eliminate RNA contamination.
• Methodical laboratory practical experience.
• Able to work in a calm and controlled environment with good record keeping. This will ensure that a robust system is in place which will minimise delays of sample delivery.

Click here to access a staff profile checklist, which pathology departments may find useful when assessing the possible impact of implementing the technology within pathology.

Theatres

Whilst it is essential to have dedicated and fully qualified personnel within pathology to be able to effectively operate the intra-operative technology, theatres will have a big part to play in the successful delivery of this improved service model. The following are areas which will need to be carefully thought about in relation to theatres:

• The proximity theatres to pathology - e.g. will this impact on the turnaround time for a result? Will a dedicated 'runner' be required?
• Can and is it appropriate for theatres to be reconfigured so that the technology can be housed there instead of pathology? This will be an option for those Trusts who are working on different sites.
• How will the reduced activity in theatres be reassigned? If second operations are being removed, capacity within theatres will increase.

These questions need to be discussed as an implementation team and careful thought given to the logistics surrounding the careful relationship between theatre and pathology.

Planning the case mix is also an important part of theatre planning. It is important to ensure that those cases that you predict will be node positive (e.g. level 3) are operated on first, and those who you predict will be node negative (e.g. level 1 or 2) are operated on later in the day. Whilst it is not always possible to predict which patients will be node positive, a realistic theatre schedule needs to be planned to ensure that potential node positive patients are split across the various lists.

This will need to be discussed as an implementation team, however, if careful thought is not given to case mix and planning theatre capacity, successful embedment of this technology could be significantly hampered in the embryonic stages of implementation.

Evaluation of Effectiveness

Technology implementation is a continuous process that will by its very nature adapt to the Trusts changing circumstances and the needs of the local health economy. It is important however to continually evaluate the effectiveness on a technology in terms of efficiency and impact.

Effective evaluation will allow commissioners and Trust Management to rethink and adapt local objectives, priorities, and strategies as 'implementation proceeds'. Continuous evaluation also facilitates making changes if aspects of the plan are not working. The following questions should be addressed when planning the evaluation of implementation. They can also assist in planning and agreeing infrastructural changes within the acute setting:

1. How and when will you evaluate the impact that implementation has had on patient care and service efficiency?
2. Who will be responsible for collecting ongoing data to assess the effectiveness of the plan and its implementation? ( Click here for a potential job description and person specification that Trusts may consider building into the business case).
3. What windows of opportunity exist for reviewing the impact of implementation? (For example, the plan might be reviewed as part of the Trusts/Departments regular performance review meetings.)
4. How will accountability for implementation be assessed?
5. How will the level of technological proficiency gained by pathology staff be reviewed? (The Department of Health's workforce redesign tool for pathology can be found here).
6. How will the Trust use the technology to evaluate teaching and learning?
7. What Trust-wide mechanism will be created to allow changes in the implementation of the technology and the plan itself?

A major commitment in the Cancer Reform Strategy (2007) is to improve inpatient care by shifting care from inpatients to an ambulatory care setting. There is considerable potential to streamline care, avoid unnecessary emergency admissions, reduce non-value adding lengths of stay, across elective and emergency pathways.

The Transforming Inpatient Cancer Care programme has tried and tested different models of care that improves the patients' experience, value patients' time by identifying the appropriate length of stay and releases bed capacity. The evidence from the programme tackles the Quality & Productivity Challenge.

Referred to in the recent letter from David Nicholson, NHS Chief Executive (gateway ref: 12396) Implementing the next stage review visions:the quality and productivity challenge, this publication "highlights a set of simple improvements which could save a million bed days if adopted across England".

More information on the Transforming Inpatient Care Programme can be found here.

Measurements of success

The primary task of implementing this technology is to improve patient outcomes during and following breast cancer surgery. A fundamental goal for Trusts moving forward is to measure the impact of this technique and identify the potential benefits, costs and practical issues associated with the routine implementation of the intra-operative test.

The following measurements may be used to assess patient outcomes and impact on productivity and the use of resources, which will allow Trusts to provide relevant information to help providers and commissioners make informed choices about how the adoption of this technique and to assess how it could make a positive difference to NHS performance and the well being of patients:

• Post operative morbidity and mortality,
• Length of overall hospital stay,
• Readmission and reoperation rates,
• The use of the technology (and its financial implications),
• Patient impact,
• Outpatient capacity / changes to waiting lists.

Another mechanism for evaluating the effectiveness of implementation is through some of the concepts laid out by the Improving Surgical Outcomes Group (ISOG).

ISOG is an independent medical group comprising surgeons, anaesthetists, critical care consultants and others involved in operative management and care. The group is concerned with improving patient outcomes and modernising care for patients undergoing major surgery.

In June 2005 the Group produced a report entitled 'click here'. It highlights that 20,000 patients die every year in the NHS following surgery. The report also includes recommendations for how surgical care should be modernised.

The report stated that: "It is recognised that more patients need to be transferred directly to ICU and HDU following surgery than current NHS bed numbers allow, and a combination of improvements in intra-operative care and increasing planned critical care admission for those at increased risk of complications is now known to reduce the overall number of ICU and HDU bed days used".

To review the ISOG report click here.

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