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Private service providers must have a licence to provide healthcare services before they can apply for a licence for clinical microbiology laboratory operations.
Licence to provide healthcare services
Service providers can be limited companies, limited or general partnerships, cooperatives, foundations or non-governmental organisations.
Healthcare services refer to healthcare and medical services based on generally accepted methods and empirical medical research and treatment.
Microbiological testing requires:
Public service providers only need a licence for a clinical microbiology laboratory. The licences for operating a clinical microbiology laboratory are always specific to the tests carried out.
Send the application to the Regional State Administrative Agency for the region where the laboratory carrying out the tests is located. For near-patient testing, the supervising laboratory submits a notice to the Regional State Administrative Agency for the region where the supervising laboratory has its head office.
Instructions and forms for applying for a licence for a clinical microbiology laboratory are available on the website of the Finnish Institute for Health and Welfare (THL).
If you apply for a licence for a small laboratory and your company’s microbiological expertise has been gained through special arrangements (supervision agreement with a large clinical microbiology laboratory), you must send us the written supervision agreement and a (self) regulation plan drawn up jointly by the company and the supervising laboratory.
Taking a sample only, after which the sample is sent elsewhere for testing, does not require a licence or notice for clinical microbiology. However, you will need a private healthcare licence for taking samples.
You will need appropriate facilities and equipment for providing healthcare services. The company must also have the necessary staff with appropriate training to carry out its activities. The operations must be medically appropriate and take into account patient safety.
The service provider must have a healthcare service director approved by the licensing authority. The director responsible for healthcare services must be a healthcare professional who has training and sufficient practical experience to enable successful performance of the task.
COVID-19 tests are microbiological tests. This means that private service providers conducting tests must have a licence to carry out clinical microbiological studies and a licence to provide private healthcare services. In addition, microbiological testing requires a licence for a microbiology laboratory or a supervision agreement concluded with the supervising laboratory for carrying out microbiological near-patient testing. Public operators also need a licence for a clinical microbiology laboratory. You may not start diagnostic testing for COVID-19 before you have been granted a licence.
If you apply for a licence for a small laboratory and your company’s microbiological expertise has been gained through special arrangements (supervision agreement with a large clinical microbiology laboratory), you must send us the written supervision agreement and a (self) regulation plan drawn up jointly by the company and the supervising laboratory.
If your company already has a valid licence for microbiology (licence for a large microbiology laboratory and a private healthcare licence) and the setting of diagnostic testing for COVID-19 has been completed in cooperation with the Finnish Institute for Health and Welfare by 27 March 2020, you can continue your operations as usual.
If COVID-19 testing is not included in the range of tests conducted by your company, notify the Regional State Administrative Agency which granted your microbiology licence of starting COVID-19 testing to expand the range. There is no form for the notice, but it must include information on the test number and title, an estimate of the maximum number of weekly tests (number of tests per week) and whether the laboratory will participate in external quality control. The same information must be provided for all subcontracted tests. In addition, we need details of any subcontracting laboratories and the arrangements for sample and response transport. You can send the notice to our registry. A link to the contact information of Regional State Administrative Agency registries is provided at the bottom of this page.
You can only start diagnostic testing for COVID-19 once adding the test to the test menu has been approved.
In this exceptional situation, licence and supervisory authorities process licence applications related to COVID-19 testing as a matter of urgency.
Instructions and forms for applying for a licence for a clinical microbiology laboratory (in Finnish)
