6 How to implement NICE's guidance on Spectra Optia for automated red cell exchange

6 How to implement NICE's guidance on Spectra Optia for automated red cell exchange

The experiences of NHS trusts have been used to develop practical suggestions for how to implement NICE guidance on the use of Spectra Optia for automated red cell exchange.

Project management

This technology 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 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): could be a senior clinician (consultant haematologist or nurse specialist) with an interest in sickle cell disease. 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.

  • 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. This could be a sickle cell nurse specialist, day unit sister or matron.

  • Management sponsor: 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. Involve a member of the finance staff, for example the directorate accountant, from the start.

  • Day unit nurses and doctors and departmental vascular access teams will be valuable members of the project team because they will be providing the service.

  • Clinical audit facilitator: to help set up mechanisms to collect and analyse local data related to the project metrics and audit needs. A nurse specialist, specialist registrar or senior house officer with interest in a project in this area could support this role.

Early questions that the team may wish to consider are:

  • Which patients will be offered automated red cell exchange and from what geographical area?

  • Are there enough eligible patients to warrant development of the service?

  • Are there Spectra Optia machines already in use within the organisation and do they have spare capacity? The manufacturer has identified that in England there are 53 machines in use but 19 of these are not used for automated red cell exchange.

  • How many machines will be needed to run an efficient and effective service?

  • How will the necessary education (using the device and venous access) be provided?

  • How will timely venous access be achieved?

  • How will the project be funded?

  • How will local metrics be identified and measured?

  • Who will be responsible for collecting clinical data?

  • What are the criteria for starting, continuing and stopping treatment?

  • Are there any obvious challenges and how can these be overcome?

Care pathway mapping

Patient selection

The sites reported offering regular automated red cell exchange to patients in line with the BSCH guideline (2015) and including patients at high risk of stroke or with history of stroke and patients in whom hydroxycarbamide is not effective or is not tolerated and who have:

  • recurrent painful crisis or acute chest syndrome

  • pulmonary hypertension or sickle cell related kidney disease

  • leg ulcer or severe priapism

  • significant cardio respiratory problems where it is believed a sickle crisis would be particularly detrimental

  • sickle cell related complications in pregnancy.

Maximising capacity

It is important for developing a service to be able to meet demand. Some sites were able to increase capacity to complete 2 procedures per day on 1 machine, where clinically safe to do so, by:

  • Analysing the demand and capacity of the day unit to decide whether a standalone or integrated service would be most suitable.

  • Addressing sources of delays:

    • Considering ways to ensure patients arrive on time.

    • Ensuring pre procedure blood tests and cross‑match samples are taken with enough time to allow results and blood to be available.

    • Formally agreeing responsibility for line insertion. Ensure someone with the appropriate skills is available at the right time (see education). Using peripheral access may reduce delays as there is not a dependence on staff trained to insert femoral lines.

    • Ensuring staff can effectively troubleshoot the machine.

    • Reducing the impact of delays from other areas of the day unit.

  • Developing a scheduling system with a staff plan:

    • Staggering procedure starts to maintain constant activity.

    • Planning nurse cover for the busiest times and if a procedure is delayed.

  • Monitoring and regularly reviewing all patients to ensure treatment is beneficial. Protocols and criteria should be in place to guide stopping decisions.

Measuring success

In order to demonstrate the benefits of adopting Spectra Optia for automated red cell exchange it is important to take measurements before, during and after implementation. Some of these measures will not be routinely collected and sites must consider a data collection methodology that is appropriate to the service.

Homerton University Hospital NHS Foundation trust have developed a data sheet for automated red cell exchange transfusion: a real-world example to help monitor each of the patients on their programme.

Suggested measures from the sites involved in developing this resource include:

  • patient demographics

  • indications for starting treatment and related outcomes

  • admissions rates (days in hospital)

  • iron levels

  • previous transfusions

  • patient start date on the programme and any gaps

  • haematological and biochemical parameters pre‑ and post‑transfusion (including haemoglobin, haematocrit and haemoglobin 'S' percentage and pre procedure ferritin)

  • side effects of the treatment and safety markers for example incidences of allo‑immunisation

  • sites of access.

All patients will undergo regular detailed clinical review which is documented in their medical notes and are frequently discussed at team progress meetings.

Overcoming implementation challenges

The table below shows the implementation challenges reported by NHS sites using Spectra Optia for automated red cell exchange.

Table 1: Reported implementation challenges when using Spectra Optia for automated red cell exchange

Implementation challenge

Solution

Capital and ongoing revenue costs.

Prepare a business case including full cost considerations for Spectra Optia for automated red cell exchange compared with the current service model. There is variation across the country in funding arrangements. Commissioners and providers are advised to work together to realise anticipated savings.

See service commissioning.

Clinical confidence

Select appropriate metrics to demonstrate cost and clinical benefits, safety and demand.

Training in vascular access and using the machine.

Seek expertise and support from within the organisation, other external sites who offer the service and the manufacturer.

Develop an in‑house training programme, using cascade training. See education.

Maximising capacity from the machines available

Undertake care pathway mapping to identify how delays can be reduced and procedures and staffing scheduled to maximise capacity.

Developing a business case

Cost savings

Some NHS trusts reported that using Spectra Optia for automated red cell exchange saved money through reduced use of iron chelation therapy and fewer emergency inpatient bed days.

NICE has published a resource impact report and template that can be used by NHS commissioners and providers to better understand the costs associated with adopting Spectra Optia for automated red cell exchange. The resource impact products can help guide commissioners and providers in making the service financially viable. The national assumptions used in the template can be altered to reflect local circumstances.

Service commissioning

Sickle cell and thalassaemia services fall under the remit of the direct specialised services function of NHS England, specifically Cancer and Blood Programme of Care (B08 – Haemoglobinopathies).

The West Midlands Quality Review Service overview report 2012/13 for adults with haemoglobin disorders recommends that NHS England should ensure that commissioning of specialist haemoglobinopathy centres includes access to automated red blood cell exchange for at least routine care and, ideally, also emergency care.

NHS England commissions the specialised services in these case studies.

When considering the most appropriate commissioning model, services may wish to explore the therapeutic apheresis services offered by NHS Blood and Transplant.

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.

The business case will need to consider the number of patients who could benefit from the treatment, potential savings from this treatment, optimal volumes of activity for capacity (number of machines needed and current availability of machines in the trust), costs and benefits of using the machine for other treatments and the financial viability of the service.

National drivers

When developing a business case, NHS trusts may find it useful to refer to table 2 below for details of publications at a national level which encourage implementing Spectra Optia for automated red cell exchange.

Table 2: National drivers related to Spectra Optia for automated red cell exchange

Driver

Significance or measure

British Committee for Standards in Haematology guideline on the clinical use of apheresis procedures for the treatment of patients and collection of cellular therapy products.

Provides healthcare professionals with clear guidance on the use of clinical apheresis.

West Midlands Quality Review Service, Services for Adults with Haemoglobin Disorders. Peer Review Programme 2012-13 Overview Report.

Summarises the findings of visits to services for adults with haemoglobin disorders in England.

NHS screening programmes Sickle Cell and Thalassaemia Sickle cell disease in childhood: standards and guidelines for clinical care.

Sets out standards and guidelines for clinical care and recommendations for how care for children with sickle cell disease should be delivered.

NICE guideline on the management of an acute painful sickle cell episode in hospital.

Addresses the management of an acute painful sickle cell episode in patients presenting to hospital until discharge.

National service framework for children, young people and maternity services: Children and young people who are ill.

Sets out the government's quality standards for children, young people and maternity standards.

Education

Vascular access

Because of difficulties in vascular access for patients with sickle cell disease and Spectra Optia's need for a high blood flow, it is important that practitioners inserting the venous access (peripheral and femoral) have the skills and experience to gain access quickly, minimising damage to veins and patient discomfort.

When sites first adopted Spectra Optia for red cell exchange, most venous access was via femoral line. Training small specialist teams to do this involved:

  • femoral line‑insertion policies for patients with sickle cell disease

  • in‑house training, including anatomy and physiology, from experts

  • observation, supervision and completion of competencies.

All sites aimed to increase access through peripheral lines in a large arm vein (sited using ultrasound). Training programmes were devised for nurses using Spectra Optia who already had phlebotomy and cannulation skills. These programmes involved peer training both from within the trust and from external practitioners using the technique in other automated red cell exchange services, and support from the ultrasound manufacturer. Cascade training was then delivered to other nurses along with frequent opportunities to practice.

Sites had a number of current models for vascular access. The following healthcare professionals were responsible for femoral line insertion at the different sites:

  • haematology and oncology vascular access nursing team (booked slots)

  • sickle cell nurse specialists, apheresis nurse specialists or day senior day unit nurses

  • hospital's vascular access team

  • dedicated day‑unit doctors.

The following healthcare professionals were responsible for peripheral line insertion under ultrasound guidance at the different sites

  • haematology and oncology vascular access nursing team (booked slots)

  • nurses responsible for using the Spectra Optia machines.

Using Spectra Optia

Governance of this procedure is important therefore training and experience so that users can competently set up, programme individual patient requirements and troubleshoot the machine is essential. Training involves:

  • the manufacturer's 'Essentials' training package, comprising on‑site training and a workbook on how to work the machine (not including managing a patient having the procedure)

  • taking account of in‑house skills for Spectra Optia

  • completion of in‑house developed competencies and sign‑off by a senior nurse experienced in apheresis at the trust

  • a session about the treatment purpose with an in‑house expert

  • a system of observing and supervision.

The cover needed to maintain the service and existing staff skills should guide the number of nurses trained to use the machine.

Developing local documentation

Sites have developed individualised patient records to be used as the patient's prescription and accessible from the day unit (either in paper or digital format). These records are updated regularly following team monitoring review meetings (see measuring success) and consist of:

  • indications for treatment

  • physical measurements (height, weight)

  • current medications

  • a prescription for red cell exchange (calculations for that procedure)

  • frequency of treatments (how frequently consented)

  • target levels (haemoglobin, haematocrit and haemoglobin 'S' percentage after the procedure)

  • blood results before and after previous procedures

  • specific transfusion instructions or requirements, sites of access

  • documentation of incidences.

The following are examples from the sites that can be used to inform the development of local documentation.


This page was last updated: 02 March 2016