A Guide to Implementing a POC Service or Device

This article outlines the steps required to implement a new service or device at the point of care (POC) or other healthcare delivery point. This approach can be applied to the introduction of any diagnostic tool. A simple flowchart is provided here to accompany the following narrative.

The Essential Steps

• Understand the Issue
• Identify the stakeholders
• Engage early
• Establishing the Clinical Need
• Identify the available solutions
• Submit proposals for approval
• Ensure the project is appropriately resourced and managed

Understand the Issue

It is essential to understand from the outset which patient groups, staff groups or services are affected by the issue and what might be impacted by the change. In some instances process mapping tools may be useful in illustrating the problems which are drivers for the change, and allow individuals to visualise where the improvements might be made through the introduction of new technologies or updated processes. The outputs may serve as evidence further into the project, demonstrating what considerations were made from the start.

Identify the Stakeholders

Identifying the individuals who will review what is required fully depends on the clinical issue being addressed. For instance, if a solution is required to support patient flow through Emergency Medicine, the range of stakeholders will include the point of care team plus clinical leads not only in emergency medicine, but also the downstream clinical specialties impacted by the improvements. Complex IT work may be required to implement new devices so stakeholders need to engage with local IM&T services so that resource can be dedicated and a work plan drawn up.

If funding is required to make the change then finance and procurement leads should be made aware at the earliest opportunity, and if patient flow is to be impacted with associated improvements in hospital pressures, the Executive Team should be notified. This will mean the project will have appropriate oversight and support.

Engage Early

The best approach is to engage as early as possible with the key stakeholders, holding structured meetings to discuss the problem and potential solutions. Time can be lost if each stakeholder is met individually as this can lead to one sided discussions which are out of consensus with the wider stakeholder group.

The advice is to set up a number of early-scoping meetings, focus the discussion on the problem itself and leave identifying the solutions to future meetings. At these meeting a list of drivers for change must be drawn up and an agreement made to progress in a linear fashion.

These meetings must be well led, expertly chaired and all sides of the discussion heard and responded to in a positive way, to ensure ongoing engagement. Projects often fail or experience unnecessary barriers when stakeholders become disengaged in the process. Excellent communication, feedback and ongoing updates are essential for these projects to succeed.

Establishing the Clinical Need

The most important factor in the change process is to establish what the clinical problem is that needs solving. Often there can be adjustments made to existing laboratory services or other processes in medical specialties. Where those changes do not bring about the desired improvements, it would then be appropriate to consider non-laboratory solutions.

Once the clinical need has been established by qualified medical personnel, and agreed with clinical leads in laboratory medicine, the process of identifying potential solutions can start. Some of these may already be known but it is important to pay particular attention to emerging technologies and innovative solutions. A pilot of these solutions may yield a better outcome than adopting an older, more established solution, but this is an internal decision and may come with additional risk.

All service changes should be, where possible, backed up by clinical data that illustrates the need to improve patient care as well as patient and clinician experience. Cases submitted with anecdotal narratives are far less compelling than a case submitted with clinical data, especially if that data comes from organisations where a similar problem has been solved and positive patient outcomes published.

Identifying the Solutions

As with any technical or analytical change, the stakeholders must be aware of the potential solutions on the market so that an option appraisal can take place. This can only be achieved if key stakeholders engage with commercial partners to understand the portfolios available. A literature review or internet search must also be undertaken to ensure the diagnostic landscape is understood. This may be undertaken by the point of care team or appointed individual.

Depending on the value of the overall service, there may need to be a tender process or a small competitive process based on a specification written by the stakeholders who have the appropriate expertise for each of the elements of the service. This will include the analytical component (methodology/technology/accuracy of results/interferences and limitations), the IT component and clinical interpretation of results.

Try before you buy

Once the potential solutions have been identified, there should be a round of elimination in order to focus on a manageable number. If the change is purely device or test driven, an appraisal of the performance characteristics of the manufacturer’s device is a good start. There may be an industry standard solution, or even a single solution that addresses the issues concerned. If so then this may change the approach to procurement and adoption. If multiple solutions can meet the challenge, a more formalised procurement process will be required to differentiate between them.

As part of the process the opportunity should be taken to trial equipment from each vendor of interest. At this point the end adopter must be involved in using the equipment so that end user feedback is captured. This is by far one of the most important steps required for the successful long term adoption of the new service. Losing the end user because they weren’t involved in technology selection is a major root cause of failure.

Demonstrations from the vendors should be encouraged along with face to face training where achievable. This will lead to some preliminary evaluations of equipment performance along with capturing feedback from users. Laboratory staff (non-POCT) may be involved in comparison work if the point of care test has a comparable assay in the laboratory. At this stage a full validation or verification is not required.

Submit Proposals for Approval

Once the number of potential solutions has been identified through the option appraisal phase, an overview document establishing the need should be submitted to the POCT management group, committee or governance group for high level approval. At this stage some further supporting evidence or work may be requested before agreement to proceed is received.

Once approved at this level a more detailed paper will need to be produced which includes cost benefit analysis to inform an outline business case. Things to identify include capital funding requirements, ongoing revenue costs and also any income or cost avoidance that may be a consequence of delivering the new service. This is important to understand the commitment being made by the budget holders in the areas affected by the change. If there are savings to be made in other areas of healthcare based on the new service, the values must be included and discussions held around budget transfer to support the start up and running costs. In some cases a full business case will be required.

Approval and Procurement

If approved a project team needs to be appointed to deliver the solution in an agreed timeframe, where all stakeholders are primed and engaged to deliver the outcome. The requirements should be clearly laid out in a GANTT chart or work plan where all participants agree in an official capacity to divert resource to the project. This agreement can be captured in a project brief which is signed off by the work group.

The project team will liaise with procurement in purchasing the equipment and services (such as maintenance contracts) and also arrange delivery lead times, installation and testing of any interfaces. Once the installation is signed off the point of care team will coordinate the full validation or verification of the equipment. For this a validation/verification plan must be produced stating the acceptance criteria, and have clinical sign off by the laboratory clinical lead or designated individual. Any deviations from the acceptance criteria must be communicated to, and understood by, those individuals interpreting and acting on the results.

Implementing the Change

At this stage there will be many steps that need to be undertaken to reach the final goal of full implementation. The accompanying flowchart helps to illustrate the individual elements that require addressing as part of the project plan. Some of the key requirements are listed here:

• Undertake changes to the clinical area – Electrics, IT data points, storage (including refrigeration/ambient areas), benching, waste disposal, temperature monitoring
• Undertake training and competency assessments for POCT team members, clinical educators and users
• Set up all required documentation – Standard Operating Procedures (SOPs), Service Level Agreements (SLAs), quick guides, training syllabi
• All quality aspects implemented – IQC and EQA processes, error monitoring, clinical incident reporting, Key Performance Indicators (KPIs), Quality Indicators (QIs), etc.
• An audit programme should be set up to review the effectiveness of the service, impact on care, ongoing issues. This may be monthly in the first quarter of year one, moving to quarterly for the rest of year one, and yearly beyond year one as a part of the annual service review.
• Include the service in the scope of accreditation, if applicable

Once these elements are in place and effective, the service can be monitored as part of ‘Business as Usual’ allowing the next challenge to be undertaken.

This article is intended to serve as a reference document, and some projects may require additional steps depending on the complexity.

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