6 How to implement NICE's guidance on viscoelastometric point-of-care testing

Thromboelastography/thromboelastometry toolkit

A toolkit to support the implementation of thromboelastography and thromboelastometry in NHS trusts has been developed by a working group of the North West Regional Transfusion Committee.

The toolkit includes a variety of documents, educational resources, templates for funding bids, a literature review, manufacturers' technical specifications, contact details, factsheets and audit and competency documentation. All the resources are free to download and can be adapted to suit local requirements.

Education

The successful adoption of this technology is reliant upon the knowledge and skills of those staff maintaining and quality controlling the device, undertaking the tests and interpreting the results.

All manufacturers of viscoelastometric point-of-care testing devices offer comprehensive training packages which include online resources, face-to-face theoretical education and hands-on sessions. Initial training is usually included in the cost of the equipment with further training sessions either free or at an additional cost.

The following educational resources are available as part of the toolkit.

Factsheets	Factsheet 1: Sample collection Factsheet 2: Operating procedure Factsheet 3: Interpretation
TEG learning module	www.transfusionguidelines.org.uk/uk-transfusion-committees/regional-transfusion-committees/north-west/policies/thromboelastography-thromboelastometry-toolkit
TEM learning module	http://learning.rotem.de
Examples training and competency records which can be used to inform the development of local documentation	Liverpool Women's NHS Foundation Trust Competency Statement East Lancashire Hospitals NHS Trust Competency Assessment Central Manchester University Hospitals NHS Foundation Trust Training Record

Patient blood management

According to the National Blood Transfusion Committee, patient blood management is defined as "a multidisciplinary, evidence-based approach to optimising the care of patients who might need blood transfusion."

NHS Blood and Transplant is working with the Department of Health and the National Blood Transfusion Committee to support NHS trusts in effective blood use management, and to ensure that inappropriate use of blood and blood components is minimised.

Viscoelastometric point-of-care testing can be used as an element of a patient blood management approach. Other elements include the use of blood-tracking, automated dispensing and peri-operative cell salvage devices.

Patient Blood Management recommendations prepared by the National Blood Transfusion Committee and supported by NHS England and NHS Blood and Transplant were published in June 2014.

A further table of national drivers for change is included in the Business Case Development section.

Quality control

Tests performed in a point-of-care setting need quality control procedures to be in place in just the same way as tests carried out in a laboratory setting.

The aim of quality assurance is to ensure reliable, accurate results when testing patient samples. It is also important that quality assurance records are well documented and records retained so they may be consulted should any queries arise.

The process of quality control requires a combination of internal quality control and external quality assessment.

IQC is a process controlled by the test user and is a way of checking the day-to-day precision (reproducibility) of the method. Test material for internal quality control is usually purchased from the manufacturer of the test device. The test sample will have a pre-assigned acceptable range and the operator should have a procedure in place should the results fall outside this range.

In contrast, external quality assessment is provided by an external organisation and is a spot check which occurs at a number of set times in the year. The basis of external quality assessment testing is that centres testing the same sample in the same way should all get a similar result. If a centre records a result outside of the acceptable or target range (as determined by analysis of the results submitted by the group of testers using the same method), there may be a problem with that centre's test systems. In practice, for each external quality assessment exercise, the provider sends aliquots of the same sample to centres performing the same test. External quality assessment samples do not have a pre-assigned target value or range and only after all centres have tested the sample and the results analysed is a target range calculated.

Both internal quality control and external quality assessment processes are required to ensure that a system of testing is working reliably.

The United Kingdom National External Quality Assessment Service (UK NEQAS) has a formal external quality assessment programme for both TEG and Rotem systems which consists of 3 surveys per year, with 1 sample per survey.

Registration with the programme is made by contacting UK NEQAS Blood Coagulation by phone: 0114 267 3300, Fax: +44(0)114 267 3309 or email: neqas@coageqa.org.uk

Overcoming implementation hurdles

NHS sites currently using viscoelastometric point-of-care testing reported a number of implementation hurdles, as set out in the table below.

Implementation hurdle

Solution

Capital and ongoing revenue costs

Preparation of business case.

Selection of appropriate metrics to demonstrate cost benefit.

Investigate alternative purchase options.

Educational requirements of staff

Ensure all staff are available for training sessions.

Ensure staff chosen to carry out tests and interpret results do so often enough to maintain knowledge and skills.

Keep accurate training records.

Ensure only trained staff use equipment.

Consistency of interpretation of results

Try to gain consensus from clinicians regarding interpretation of results and how they influence transfusion protocols.

Ensure the use of the technology is included as part of all relevant care pathways and transfusion protocols.

Finding a suitable location for the device

Ensure the location is free from undue interference.

Ensure there is adequate space available to store (refrigerated) and prepare reagents and to conduct tests.

Need to maintain high standards of quality and governance

Ensure that quality control regimes are adhered to.

Include the local blood transfusion committee and laboratories/point-of-care committee in the adoption of the technology.

Connectivity with laboratory reporting systems

Discuss connectivity with the manufacturer and local network manager prior to procurement of technology. Remote viewing of tests as they develop may be required by, for example, laboratory staff.

Business case development

Cost savings

Some NHS trusts reported that using viscoelastometric point-of-care testing reduced their use of blood and blood components and saved money. Further details of these examples can be found within the Insights from the NHS section.

Expert clinical opinion is that both the ROTEM and TEG tests are already widely used in cardiac centres, therefore we do not expect there to be a significant cost impact to the NHS following the publication of the guidance 'Detecting, managing and monitoring haemostasis: viscoelastometric point-of-care testing (ROTEM, TEG and Sonoclot systems)'. Costing information for these tests has been included throughout this document and can be used to advise cardiac centres which do not currently use ROTEM or TEG but are considering using them in the future.

Business case

The implementation team should treat the development of a robust business case as an early priority in the life of the implementation project.

A fully worked example of a business case for the adoption of viscoelastometric point-of-care testing is available as part of the North West Regional Blood Transfusion Committee thromboelastography/ thromboelastometry toolkit and includes information that you can copy and paste into your own business case documentation.

Local arrangements for developing and approving business plans will vary from trust to trust, and each organisation is likely to have its own template and process in place.

National drivers

When developing a business case, NHS trusts may find it useful to refer to the following national drivers for implementing viscoelastometric point-of-care testing.

Driver	Significance or measure
NHS outcomes framework 2014 to 2015	Domain 3 – improving outcomes from planned treatments and from injuries and trauma. Domain 4 – ensuring that people have a positive experience of care. Domain 5 – treating and caring for people in a safe environment and protecting them from avoidable harm/reducing the incidence of avoidable harm.
European Society of Anaesthesiology	Management of bleeding and coagulopathy following major trauma: an updated European guideline (2013) recommends that viscoelastic methods also be performed to assist in characterising the coagulopathy and in guiding haemostatic therapy.
The Royal College of Anaesthetists	Cardiac and thoracic anaesthesia services (2013). In cardiac surgery, there should be satellite or point-of-care laboratory facilities in or near the operating room for the measurement of blood gases, electrolytes, haemoglobin and anticoagulation (including thromboelastography or thromboelastometry).
The Association of Anaesthetists of Great Britain and Ireland	Blood transfusion and the anaesthetist: management of massive haemorrhage (2010). Immediate actions in dealing with a patient with massive haemorrhage; if available, carry out near-patient testing such as through thromboelastography (TEG) or thromboelastometry (ROTEM). Guidelines for Obstetric Anaesthetic Services (2013). It is strongly recommended that there should be equipment to enable bedside estimation of coagulation such as thromboelastography (TEG) or thromboelastometry (ROTEM).

Project management

It is the experience of the Health Technologies Adoption Programme that in order to gain maximum benefit, the adoption of this technology should be carried out using a project management approach.

Project team

A systematic and collaborative approach will support the successful adoption of viscoelastometric point-of-care testing in line with NICE guidance.

The first step in this approach is to form a local project team who will work together to implement the technology and manage any changes in practice. Individual NHS organisations will determine the membership of this team and how long the project will last.

In order to implement this guidance in an effective and sustainable way, consider the following membership of the team:

Clinical champion(s): this person could be an anaesthetist with an interest in this area, a clinical scientist or another suitably qualified and experienced individual. 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.
Point-of-care committee representative: this person will be a vital link to the laboratories and will be able to provide advice and guidance on maintenance, quality control, educational issues and standard operating procedures.
Blood transfusion representative: this will help to establish baseline metrics, ensure that use of the technology is integrated into blood transfusion protocols, and help to monitor the ongoing use of blood and blood components.
Management sponsor: this person will be able to help assess the financial viability of the project, drive the formulation of a business case and help to demonstrate the cost savings achieved.
Project manager: this person could be someone in a clinical or managerial role and will be responsible for the day-to-day running of the project, coordinating the project team and ensuring the project is running as planned.
Clinical audit facilitator: to help set up mechanisms to collect and analyse local data related to the project metrics.
Other staff: theatre nurses, operating department practitioners, and clinical perfusion staff and nurses may also be valuable members of the implementation team.

Early questions that the implementation team may wish to consider are as follows:

Which technology will be selected and why?
How will the project be funded?
How to best measure both financial impact and clinical outcomes of implementing this technology?
How will local metrics be identified and measured?
Who will be responsible for collecting clinical data?
How will the required education be provided?
Are there any obvious challenges and how can these be overcome?
How can effective communication with all involved be ensured?

Communication and collaborative working

Experience shared by NHS sites has indicated that when implementing viscoelastometric testing, it is important that there is good communication between all stakeholders. This will include surgeons, anaesthetists, clinical perfusion staff, laboratory staff/point-of-care committee, blood bank/transfusion committee, managers and procurement staff.

In order to achieve the desired aims of the project, clear written and verbal communication between staff should include:

keeping staff updated on the project aims, project plans and updates
highlighting implementation hurdles and proposed solutions to staff
listening to staff so that team members are able to report problems or issues, share success and useful experiences.

Measuring success

In order to demonstrate the benefits of adopting viscoelastometric point-of-care testing it is important to take measurements before, during and after implementation. This will enable the benefits and impact achieved at a local level to be measured and built upon.

When implementing viscoelastometric point-of-care testing, the following metrics are suggested:

Use of blood and blood components, specifically red blood cells, fresh frozen plasma, cryoprecipitate and platelets.
Costs associated with the use of blood and blood components.
Re-operation rates.
Length of stay in intensive care.
Staff experience and satisfaction.

Detecting, managing and monitoring haemostasis: viscoelastometric point‑of‑care testing (ROTEM, TEG and Sonoclot systems)

Tools and resources

Adoption support resource – insights from the NHS