Build it right the first time
Adding a specialty service, such as molecular diagnostics, immunohistochemistry or flow cytometry, is a larger step than adding a test. It brings new space and environmental requirements, new equipment, new methods to validate and staff who need new competencies, all of which an assessor will expect to see controlled.
We support laboratories from planning to go-live: laying out the space and workflow, selecting and validating equipment, defining the test menu, writing the procedures and training the team. Building the quality requirements in from the start is far simpler than retrofitting them before an assessment.
The work suits hospital laboratories adding a new department, private laboratories launching a specialty service line and reference laboratories extending their scope.
How it works
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Lab design and space planning
Layout, direction of workflow and separation of areas, planned around the tests you will run and the containment and environmental conditions they need.
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Equipment selection and validation
Specifications and comparison of offers, then installation checks and method validation before any instrument is used for patient testing.
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Test menu establishment
Which tests to offer first, based on clinical demand, expected sample volumes and what your staff and equipment can support.
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Workflow and SOP development
Pre-analytical, analytical and post-analytical procedures for the new service, issued through your existing document control.
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Staff training and competency
Technical training in the new discipline, and documented competency assessment before staff report patient results.
What you receive
Layout and workflow plan
A floor plan and workflow for the new area, with its environmental and biosafety requirements.
Equipment specifications and records
Specifications, comparison of offers, and installation and validation records for each instrument.
Procedure set
SOPs covering the new service end to end, issued under your document control.
Training and competency records
Training delivered and competency assessed for each staff member, ready to show as evidence at assessment.
Common questions
Which specialty disciplines do you support?
These include molecular PCR diagnostics and NGS, immunohistochemistry, flow cytometry, allergy and autoimmune testing, and biobanking. Tell us the service you are planning and we will confirm how we can help.
Can you help with a laboratory that is still being built?
Yes, and that is the best time to involve us. Layout and workflow decisions are much easier to get right on the plan than after construction.
Will the new service be ready for accreditation?
Setup is planned against ISO 15189:2022 from the outset, so the documentation, validation and competency evidence an assessor expects is produced as the service is built. When you apply to extend your accredited scope, that evidence is already in place.
Do you choose the equipment supplier for us?
We help you set specifications and compare offers against them, so the decision rests on your requirements. The purchasing decision stays with you.