Provider requirements5
1
A test provider must meet the following requirements in respect of any applicable test that they provide.
2
The test provider must ensure that a registered medical practitioner has oversight and approval of medical practices undertaken by the test provider, and responsibility for reporting medical issues.
3
The test provider must have an effective system of clinical governance in place which includes appropriate standard operating procedures in relation to the carrying out of applicable tests.
4
The test provider must ensure that a registered clinical scientist has oversight of clinical practices undertaken by the test provider, and responsibility for reporting clinical issues.
5
The test provider must have systems in place to—
a
identify any adverse incidents or quality control issues in relation to applicable tests, and
b
report any such incidents or issues as soon as reasonably practicable to the Secretary of State.
6
If the test provider arranges with another person (“X”) for X to carry out any element of the testing service on their behalf, the test provider must ensure that X complies with any provision of this regulation that is relevant to the carrying out of that element.
7
In this regulation “registered clinical scientist” means a person registered as a clinical scientist with the Health and Care Professions Council pursuant to article 5 of the Health Professions Order 20018.