We have recently received several queries from patients who had been tested for transmissible infections at laboratories not associated with the clinic at which they are being treated at. For example, their blood tests may have been carried out at an NHS hospital before they go on to have treatment at a private clinic.
These queries have raised concerns regarding clinics not accepting the results because of lack of sufficient proof of suitable accreditation of the laboratory, which could result in patients having to pay for new blood tests.
License condition T51, which is outlined in guidance note 15 of the HFEA’s Code of Practice, requires that the tests (for HIV 1, HIV 2, hepatitis B and hepatitis C) must be carried out by a qualified laboratory with suitable accreditation such as CPA Ltd or another body accrediting to an equivalent standard.
It is up to clinics to determine their processes for checking that the laboratory is accredited, we do not specify which format documents need to be in to validate accreditation. However, clinics should be aware that we consider that the following can suffice as evidence of accreditation:
- the GP’s letter that referred the patients to have the tests done at the hospital
- a letter from the hospital saying that the patients had the tests done by them
Clinics should advise patients on obtaining the above when proof of accreditation is required.