Care Quality Commission to regulate private providers of non-invasive prenatal testing following Nuffield Council recommendation

The Care Quality Commission (CQC) now considers non-invasive prenatal testing (NIPT) to be within its regulatory remit and has begun inspecting private clinics that offer NIPT. This was prompted by a recommendation made in the Nuffield Council on Bioethics’ 2017 report on the ethics of NIPT.

Private clinics have been offering NIPT to pregnant women and couples since 2012. NIPT is an early pregnancy screening test for conditions such as Down’s syndrome, and costs around £500. These services were previously considered to be exempt from the remit of CQC, which is the regulator of health and social care providers in England.In our report, we highlighted concerns about how NIPT is being offered by private clinics.

There is commonly a lack of good quality information about the limitations of NIPT and the conditions being tested for, and inadequate support for women who receive a high chance result. In addition, some clinics are offering NIPT for an ever increasing number of genetic conditions, where the likelihood of receiving a false positive result is high.

We recommended that the CQC should be inspecting clinics to ensure NIPT is provided to high standards of quality and safety. We believe this involves offering an inclusive package of care that includes pre- and post-test counselling, and follow-up invasive diagnostic testing if required. This would help women and couples make informed decisions about NIPT, and reduce the need for women to seek follow-up services from the NHS.

Catherine Joynson, Assistant Director at the Nuffield Council on Bioethics, said: “We are delighted that the CQC has revised its position and now considers NIPT to be within its remit. This is an important step in ensuring that women and couples are adequately informed and supported when accessing NIPT. However, more could be done to ensure that NIPT is being marketed and offered to women and couples appropriately. We hope that other regulators and professional bodies operating in this field will listen again to our concerns and take action.”

Ted Baker, Chief Inspector of Hospitals at the CQC, said: “As services evolve, we continue to review and update our approach to ensure robust oversight of the quality and safety of care. In recent years the private baby scanning industry has expanded significantly and this has included an increase in the number of private providers offering non-invasive prenatal testing (NIPTs). As a result we have reviewed our approach, taking into account recommendations made by the Nuffield Council on Bioethics around the regulation of these services, and now include NIPT in the activities that are regulated by CQC. “We expect providers of NIPTs to ensure that women fully understand the procedure, know that it is not a diagnostic test, are informed about the possible outcomes, and that appropriate support is made available when delivering the test results. This includes facilitating access to counselling and other relevant services as well as medical follow up where this is needed.“ Last year we began our planned programme of diagnostic and imaging service inspections, which includes those independent providers offering NIPTs. It is wholly unacceptable for women undergoing testing to be left without clear information or support and where we identify concerns we will hold providers to account using our enforcement powers if necessary to protect women using these services. We will continue to talk to key stakeholders, including the Nuffield Council on Bioethics, to keep abreast of developments in this rapidly evolving area and allow us to further refine our approach if necessary.”

Read more on our concerns about NIPT in the private healthcare sector. See today's (8 February) BBC news coverage.