The fit and proper person test for healthcare directors could lead to the creation of an ‘informal blacklist’ of senior managers and put regulators at risk of legal challenge, senior lawyers have warned.

The test, which will be overseen and enforced by the Care Quality Commission, will apply to the NHS from October.

It hands the CQC powers to refuse to register a provider and require the removal of directors it deems to be “unfit”, when they have been involved in serious misconduct or mismanagement, for example.

The lawyers’ concerns come after the regulator published a consultation setting out how it expects the test to be applied.

Paul Spencer, employment partner at Hempsons Solicitors, told HSJ there were serious questions about what would constitute an unfit person.

“That is probably going to be the area of biggest challenge,” he said.

“Is a trust financially unsound because central government has not provided sufficient funds or is it because a director has been negligent in their management?”

“What is going to happen in practice is an informal blacklist of managers.”

Mr Spencer said that the test’s regulations left employees vulnerable and could “force them down a route of challenging them through judicial review or Human Rights Act claims, which are very public and very visible”.

Corinne Slingo, partner at DAC Beachcroft, also raised concerns about the CQC’s “subjective analysis” of what would amount to serious mismanagement.

She said: “We all understand what the intention is, but providers need more detail to implement this effectively.

“The stakes are high for individual directors and equivalents, as the regulations do not appear to contain a suggestion that concerns that reach the threshold will ever be ‘spent’, and thus individuals could, in theory, be unable to work for a registered provider under the CQC again in a director role.”

The CQC’s consultation on the duty of candour has also sparked concerns after it said the CQC would “mainly use the new regulations to confirm or encourage good practice… rather than to enforce them directly”.

Peter Walsh, from Action against Medical Accidents, told HSJ: “We will be asking the CQC to be more proactive in monitoring and enforcing compliance with the duty of candour, and would urge others to do so also during the consultation period.

“We haven’t fought so hard for so long for this to allow it to be paid lip service to.”

A spokeswoman for the CQC said the regulator was still working on what tools it would use to assess an individual’s fitness.

In relation to the duty of candour David Behan, chief executive of the CQC, said: “What is now very clear is that the best organisations – the ones with open and honest cultures – tell people when incidents have occurred, communicate effectively, apologise when necessary and support as appropriate.

“Where organisations are failing to apply this duty we will take enforcement action.”