PART 5E+WHANDLING AND INVESTIGATION OF CONCERNS

Procedure before investigationE+W

22.—(1) Except where regulation F1... 18 applies, a responsible body must acknowledge receipt of the notification of the concern not later than [F2five] working days after the day on which it receives it.

(2) The acknowledgement may be made in writing or electronically, depending upon how the concern was notified.

(3) Where a concern was notified verbally, the acknowledgement must be in writing.

(4) At the time it acknowledges notification of a concern, the responsible body must offer to discuss with the person who notified the concern, at a time to be agreed with that person—

(a)the manner in which the investigation of the concern will be handled, including consent to the use of medical records;

(b)the availability of advocacy and support services which may be of assistance to that person in their pursuit of the concern;

(c)the period within which—

(i)the investigation of the concern is likely to be completed; and

(ii)the response required by regulation 24 is likely to be sent to that personF3...[F4;

(d)the resolution or outcome they desire in relation to the concern they have notified;

(e)their understanding of, and perspective on, the facts and circumstances of the concern they have notified;

(f)the person’s preferred method of communication and whether they have any specific communication requirements;

(g)except where an investigation under regulation 23 has begun in relation to the concern, the early resolution procedure, including—

(i)whether the responsible body considers that the early resolution procedure is appropriate in the circumstances, and

(ii)if the responsible body considers that the early resolution procedure is not appropriate (for example due to complexity or severity), the reason for this;

(h)that an assessment of whether a qualifying liability exists in relation to the concern notified can only take place where an investigation under regulation 23 is undertaken;

(i)where the responsible body considers that the early resolution period is appropriate in the circumstances, whether the person who notified the concern consents to the responsible body attempting to resolve the concern in accordance with the early resolution procedure.]

[F5(4A) Where the person who notified the concern accepts the offer of a discussion under paragraph (4), such discussion must be by in-person communication.

(4B) Where the responsible body is notified that any services mentioned in paragraph (4)(b) are required by the person who notified the concern, when arranging a discussion under paragraph (4), the responsible body must take into account the need to ensure that such services are provided at that discussion.

(4C) The responsible body must keep a record of—

(a)whether or not the offer of a discussion under paragraph (4) is accepted, and

(b)if the offer is accepted, the matters discussed.]

(5) If the person who notifies the concern does not accept the offer of a discussion under paragraph (4), the responsible body must consider and make a decision upon the matters set out in sub-paragraphs (a) to (c) of that paragraph and write to the person accordingly.

(6) [F6Subject to paragraph (7), the] responsible body must send a copy of the notification of a concern to any person who is the subject of that concern unless—

(a)this has already been done; or

(b)provision of a copy of the notification to such a person at that time would, in the reasonable opinion of the responsible body, prejudice its consideration of the matters raised by the concern.

[F7(7) Where the duty of candour under section 3 of the 2020 Act has come into effect in relation to the subject matter of the concern and notification under regulations 4(1) and 5(1) of the 2023 Regulations has been given, the responsible body is not required to send a copy of the notification of the concern to the patient or his or her representative.]

Textual Amendments

Commencement Information

I1Reg. 22 in force at 1.4.2011, see reg. 1(2)