The National Health Service (Concerns, Complaints and Redress Arrangements) (Wales) Regulations 2011

Made: 8 March 2011

Coming into force in accordance with the provisions of regulation 1(2)

A draft of these Regulations was laid before, and approved by resolution of, the National Assembly for Wales in accordance with section 11(6) of the NHS Redress (Wales) Measure 2008.

PART 1 — GENERAL

Title, commencement and application

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• (1) The title of these Regulations is the National Health Service (Concerns, Complaints and Redress Arrangements) (Wales) Regulations 2011.

• (2) Parts 1 to 6 and 8 to 10 come into force on 1 April 2011 and Part 7 comes into force on 1 October 2011.

• (3) These Regulations apply to services provided as part of the health service in Wales.

Interpretation

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• (1) In these Regulations—

• “the 2006 Act” (“Deddf 2006”) means the National Health Service (Wales) Act 2006[^f00001];

• “the 2020 Act” (“Deddf 2020”) means the Health and Social Care (Quality and Engagement) (Wales) Act 2020;

• “the 2023 Regulations” (“Rheoliadau 2023”) means the Duty of Candour Procedure (Wales) Regulations 2023;

• “alternative dispute resolution” (“dull amgen o ddatrys anghydfod”) means mediation, conciliation or facilitation;

• “child” (“plentyn”) means a person who has not attained the age of eighteen years;

• “complaint” (“cwyn”) means any expression of dissatisfaction;

• “concern” (“pryder”) means any complaint; notification of an incident concerning patient safety or, save in respect of concerns notified in respect of primary care providers or independent providers, a claim for compensation;

• “disciplinary proceedings” (“achos disgyblu”) means any procedure for disciplining employees adopted by a responsible body for disciplining employees;

• “executive director” (“cyfarwyddwr gweithredol”) means a member of the Board of a National Health Service Trust who is an employee of that body;

• “general dental services contractor” (“contractwr gwasanaethau deintyddol cyffredinol”) means a person who has entered into a contract to provide general dental services with a Local Health Board in accordance with section 57 of the 2006 Act;

• “general medical services contractor” (“ contractwr gwasanaethau meddygol cyffredinol”) means a person who has entered into a contract to provide general medical services with a Local Health Board in accordance with section 42 of the 2006 Act;

• “health care professional” (“proffesiynolyn gofal iechyd”) means a member of a profession (whether or not regulated by, or by virtue of, any enactment) which is concerned (wholly or partly) with the physical or mental health of individuals;

• “incident concerning patient safety” (“digwyddiad sy'n ymwneud â diogelwch claf”) means any unexpected or unintended incident which did lead to or could have led to harm for a patient;

• “independent provider” (“darparwr annibynnol”) means a person or body who—provides health care in Wales under arrangements made with a Welsh NHS body; andis not an NHS body or a primary care provider;

• “individual patient treatment request” (“cais am driniaeth i glaf unigol”) means a request to a Local Health Board to fund health care for an individual patient that falls outside the range of services and treatments that the Local Health Board provides including those specialist services secured through the Welsh Health Specialist Services Committee;

• “Local Health Board” (“Bwrdd Iechyd Lleol”) means a Local Health Board established in accordance with section 11(2) of the 2006 Act;

• “moderate or severe harm” (“niwed cymedrol neu ddifrifol”) means moderate or severe harm determined in accordance with guidance issued for the purpose of these Regulations by the Welsh Ministers;

• “non-executive director” (“cyfarwyddwr anweithredol”) means a member of the Board of a National Health Service Trust who is not an employee of that body;

• “non-officer member” (“aelod nad yw'n swyddog”) means a member of the Board of a Local Health Board who is not an employee of that body;

• “officer member” (“aelod sy'n swyddog”) means a member of the Board of a Local Health Board who is an employee of that body;

• “patient” (“claf”) means the person who receives or has received services from a responsible body;

• “primary care provider” (“darparwr gofal sylfaenol”) means a person or body who—is a general medical services contractor;provides primary medical services in accordance with arrangements made under sections 41(2)(b) and 50 of the 2006 Act;is a general dental services contractor;provides primary dental services in accordance with arrangements under section 64 of the 2006 Act;provides ophthalmic services, including primary ophthalmic services, in accordance with arrangements under the 2006 Act;provides pharmaceutical services in accordance with arrangements under section 80 of the 2006 Act;provides local pharmaceutical services under pilot schemes pursuant to section 92 of the 2006 Act; orprovides local pharmaceutical services pursuant to paragraph 1 of Schedule 7 to the 2006 Act;

• “primary ophthalmic services” (“gwasanaethau offthalmig sylfaenol”) has the meaning given in regulation 4 of the National Health Service (Ophthalmic Services) (Wales) Regulations 2023;

• “qualifying liability” (“atebolrwydd cymwys”) means a liability in tort owed in respect of, or consequent upon, personal injury or loss arising out of or in connection with breach of a duty of care owed to any person in connection with the diagnosis of illness, or in the care or treatment of any patient—in consequence of any act or omission by a health care professional; andwhich arises in connection with the provision of qualifying services;

• “relevant complaints procedure” (“gweithdrefn gwynion berthnasol”) means—any arrangements for the handling and consideration of complaints that are required or have been required to be established and operated respectively by any of the following directions—Directions to NHS Trusts and Local Health Boards on Hospital Complaints Procedures signed on 27 March 2003;Directions to Local Health Boards on Dealing with Complaints about Family Health Services Practitioners, Providers of Personal Medical Services and Providers of Personal Dental Services other than Personal Dental Services Provided by NHS Trusts signed on 27 March 2003;Miscellaneous Directions to Local Health Boards for Dealing with Complaints signed on 27 March 2003[^f00002];any arrangements for the handling and consideration of complaints that may at any time be or have been required by paragraph 28 of Schedule 2 to the National Health Service (Pharmaceutical Services) Regulations 1992[^f00003];any arrangements for the handling and consideration of complaints that may at any time be or have been required to be established and operated respectively by any of the following provisions—paragraph 39 of Schedule 2 to the National Health Service (Pharmaceutical Services) Regulations 1992;paragraph 22 of Schedule 2A to the National Health Service (Pharmaceutical Services) Regulations 1992;paragraph 90 of Schedule 6 to the National Health Service (General Medical Services Contracts) (Wales) Regulations 2004[^f00004];paragraph 19 of Schedule 4 to the National Health Service (Ophthalmic Services) (Wales) Regulations 2023;paragraph 47 of Schedule 3 to the National Health Service (General Dental Services Contracts) (Wales) Regulations 2006[^f00006];paragraph 47 of Schedule 3 to the National Health Service (Personal Dental Services Agreements) (Wales) Regulations 2006[^f00007];

• “representative” (“cynrychiolydd”) has the meaning given in regulation 12(2);

• “responsible body” (“corff cyfrifol”) means—a Welsh NHS body;a primary care provider; oran independent provider;

• “Special Health Authority” (“Awdurdod Iechyd Arbennig”) means a body established by an order made under section 22 of the 2006 Act; but does not include any cross-border Special Health Authority (within the meaning of section 8A(5) of the 2006 Act);

• “staff” (“staff”) means any person who is employed by or engaged to provide health care services for a responsible body;

• “Welsh NHS body” (“corff GIG Cymru”) means—a Local Health Board; ...a National Health Service Trust managing a hospital or other establishment or facility wholly or mainly in Wales; or a Special Health Authority;

• “working day” (“diwrnod gwaith”) means a day except Saturday or Sunday, Christmas Day, Boxing Day, Good Friday, or a day which is a bank holiday in Wales under the Banking and Financial Dealings Act 1971[^f00008].

• (2) For the purposes of Part 7, “qualifying services” (“gwasanaethau cymwys”) means services provided in the United Kingdom as part of the health service in Wales (this does not include services provided in Wales commissioned as part of the health service in England, Scotland or Northern Ireland).

• (3) For the purposes of regulation 3 and Parts 5 and 6, “qualifying services” (“gwasanaethau cymwys”) means services provided in Wales as part of the health service in Wales (this does not include services provided in Wales commissioned as part of the health service in England, Scotland or Northern Ireland).

General principles for the handling and investigation of concerns

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• (1) Any arrangements set up under these Regulations for the handling and investigation of concerns must be such as to ensure that—

• (a) there is a single point of entry for the submission of concerns;

• (b) concerns are dealt with efficiently and openly;

• (c) concerns are properly investigated;

• (d) provision should be made to establish the expectations of the person notifying the concern and to seek to secure their involvement in the process;

• (e) persons who notify concerns are treated with respect and courtesy;

• (f) persons who notify concerns are advised of—

• (i) the availability of assistance to enable them to pursue their concern;

• (ii) advice as to where they may obtain such assistance, if it is required; and

• (iii) the name of the person in the relevant responsible body who will act as their contact throughout the handling of their concern;

• (g) a Welsh NHS body must give consideration to the making of an offer of redress in accordance with Part 6 where its investigation into the matters raised in a concern reveal that there is a qualifying liability;

• (h) persons who notify concerns receive a timely and appropriate response;

• (i) persons who notify concerns are advised of the outcome of the investigation;

• (j) appropriate action is taken in the light of the outcome of the investigation; and

• (k) account is taken of any guidance that may be issued from time to time by the Welsh Ministers.

• (2) In complying with its obligations under these Regulations, a responsible body must not disclose personal data to a person who is not the data subject, unless that person is a representative of the data subject.

• (3) In paragraph (2), “data subject” and “personal data” have the same meaning as in the Data Protection Act 2018 (see section 3 of that Act).

PART 2 — DUTY TO MAKE ARRANGEMENTS FOR THE HANDLING AND INVESTIGATION OF CONCERNS

Duty to make arrangements

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A responsible body must make arrangements in accordance with these Regulations for the handling and investigation of concerns (“arrangements for dealing with concerns”).

Arrangements to be published

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The arrangements for dealing with concerns must be published in a variety of media, formats and languages and a copy of the arrangements must be given free of charge to any person who requests it, in the format that has been requested.

Strategic oversight of the arrangements

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• (1) Each responsible body must designate a person to be responsible for maintaining a strategic overview of its operation of the arrangements under these Regulations, in particular to—

• (a) ensure that the responsible body complies with its arrangements for dealing with concerns; and

• (b) undertake the functions set out in Part 8.

• (2) Where the responsible body is a Welsh NHS body, this person must be one of its non-officer members or non-executive directors, as appropriate.

Responsible officer

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• (1) Each responsible body must designate a person in these Regulations referred to as the responsible officer, to take overall responsibility for the effective day to day operation of the arrangements for dealing with concerns in an integrated manner.

• (2) For the purposes of this regulation “integrated manner” means that the process for dealing with concerns, and, if there is a duty under the Regulations to consider qualifying liabilities, claims management reporting are dealt with under a single governance arrangement.

• (3) The responsible officer is to be—

• (a) in the case of a Welsh NHS body, a person who is an officer member or executive director of that body, as appropriate;

• (b) in the case of any other responsible body, the person who acts as the chief executive officer of that body or, if there is none—

• (i) the person who is the sole proprietor of the responsible body;

• (ii) where the responsible body is a partnership, a partner; or

• (iii) in any other case, a director of the responsible body, or a person who is responsible for managing the responsible body.

• (4) The functions of the responsible officer may be performed by that person or by any person authorised by the responsible body to act on his or her behalf provided that the person so authorised is under the direct control and supervision of the responsible officer.

Senior investigations manager

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• (1) Each responsible body must designate at least one person, in these Regulations referred to as a senior investigations manager, to undertake responsibility for the handling and consideration of concerns notified in accordance with the arrangements for handling concerns and in particular to—

• (a) perform the functions of a senior investigations manager under the arrangements for dealing with concerns;

• (b) perform such other functions relating to the handling and consideration of concerns as the responsible body may require; and

• (c) co-operate with such other persons or bodies as may be necessary to facilitate the handling and consideration of concerns.

• (2) The responsible body must ensure that the senior investigations manager appointed by that body has a sufficient number of staff of the required level of seniority to assist in the carrying out of his or her functions and that such members of staff receive adequate training to enable them to fulfil their responsibilities under the arrangements for dealing with concerns.

• (3) The functions of a senior investigations manager under paragraph (1) may be performed personally or by a person or persons authorised by the responsible body to act on behalf of the senior investigations manager.

• (4) The functions of a senior investigations manager may be carried out by the senior investigations manager designated by another responsible body under paragraph (1).

Information and training for staff

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Each responsible body must ensure that its staff are informed about and receive appropriate training in respect of the operation of the arrangements for the reporting, handling and investigation of concerns.

PART 3 — NATURE AND SCOPE OF THE ARRANGEMENTS FOR HANDLING CONCERNS

Requirement to consider concerns

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Subject to regulation 14, a responsible body must handle a concern in accordance with the arrangements for handling concerns set out in these Regulations if it is notified on or after the 1 April 2011—

• (a) in accordance with regulation 11;

• (b) by a person specified in accordance with regulation 12;

• (c) about a matter specified in regulation 13; and

• (d) within the period specified in regulation 15.

Notification of concerns

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• (1) A concern may be notified—

• (a) in writing;

• (b) electronically; or

• (c) verbally, either by telephone or in person, to any member of the staff of the responsible body, the exercise of whose functions is the subject of the concern.

• (2) Subject to regulation 14(1)(f), where a concern is notified verbally, the member of staff of the responsible body to whom the concern has been notified must—

• (a) make a written record of the concern; and

• (b) provide a copy of the written record to the person who notified the concern.

Persons who may notify concerns

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• (1) A concern may be notified by—

• (a) a patient in relation to the services being received or having been received;

• (b) any person who is affected, or likely to be affected by the action, omission or decision of a responsible body the exercise of whose functions is the subject of the concern;

• (c) a non-officer member or a non-executive director of a responsible body;

• (d) a member of the staff of a responsible body; or

• (e) a partner in a responsible body.

• (2) A concern may be notified by a person (in this regulation referred to as a representative) acting on behalf of a person mentioned in paragraph (1) who—

• (a) has died;

• (b) is a child;

• (c) is unable to notify the concern themselves because they lack capacity within the meaning of the Mental Capacity Act 2005[^f00009]; or

• (d) has requested the representative to act on their behalf.

• (3) Where a representative notifies a concern on behalf of a child, the responsible body to which the concern has been notified—

• (a) must not consider the concern unless it is satisfied that there are reasonable grounds for the concern being notified by a representative instead of the child; and

• (b) if it is not so satisfied, must notify the representative in writing and state the reason for its decision.