Journey
Set up a clinical laboratory service
Open a laboratory that tests patient samples. Register with the CQC, work towards UKAS accreditation to ISO 15189, check whether you need an HTA licence or MHRA blood authorisation, employ registered staff and protect patient data.
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Register with the CQC
Testing patient samples and reporting the results is a regulated activity in England.
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Work towards UKAS accreditation
Accreditation to ISO 15189 shows that your laboratory is competent and impartial.
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Check whether you need an HTA licence
Keeping human tissue for research, transplantation or other scheduled purposes needs a Human Tissue Authority licence.
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Check whether you need MHRA blood authorisation
Collecting, testing or processing blood for transfusion needs authorisation from the MHRA.
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Employ registered staff
Biomedical scientists and clinical scientists must be registered with the HCPC.
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Protect patient data
Health and genetic data are special category data under UK GDPR.
Official guidance
Professions and protected titles (HCPC) (opens in a new tab)
www.hcpc-uk.org
Human Tissue Authority licensing (opens in a new tab)
GOV.UK
ISO 15189 medical laboratory accreditation (UKAS) (opens in a new tab)
www.ukas.com
Care Quality Commission (England) (opens in a new tab)
www.cqc.org.uk · England
Blood: authorisations and safety reporting (opens in a new tab)
MHRA
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