any nomination or appointment by it in under paragraph (1) as soon as practicable; and

the removal of an accountable officer by it (whether or not under regulation 6) as soon as practicable.

the person does not routinely supply, administer or dispose of controlled drugs as part of his or her duties.

is registered as manager in relation to both or all of the hospitals; and

does not routinely supply, administer or dispose of controlled drugs as part of his or her duties.

the person does not routinely supply, administer or dispose of controlled drugs as part of his or her duties.

the person satisfies paragraph (3)(a) in relation to one of the designated bodies;

each designated body is satisfied that the person can properly discharge his or her responsibilities in relation to it; and

the person does not routinely supply, administer or dispose of controlled drugs as part of his or her duties.

no longer satisfies the conditions set out in regulation 5; or

is unfit to be an accountable officer.

establish or ensure that his or her designated body (and any body or person acting on behalf of, or providing services under arrangements made with, his or her designated body) establishes appropriate arrangements to comply with the misuse of drugs legislation; and

ensure that his or her designated body (and any body or person acting on behalf of, or providing services under arrangements made with, his or her designated body) has adequate and up-to-date standard operating procedures in place in relation to the management and use of controlled drugs.

who has access to the controlled drugs;

where the controlled drugs are stored;

security in relation to the storage and transportation of controlled drugs as required by the misuse of drugs legislation;

disposal and destruction of controlled drugs;

who is to be alerted if complications arise; and

establish and operate, or ensure that his or her designated body establishes and operates, appropriate arrangements for monitoring and auditing the designated body’s management and use of controlled drugs; and

ensure that a body or person acting on behalf of, or providing services under arrangements made with, his or designated body establishes and operates appropriate arrangements for monitoring and auditing the person or body’s management and use of controlled drugs (that is, their management and use of controlled drugs under their arrangements with the designated body, not under any other arrangements).

monitoring and analysing health service and private prescribing of controlled drugs through the use of data relating to the prescribing and dispensing of prescriptions in Wales available from Health Solutions Wales.

ensuring that the designated body (and any body or person acting on behalf of, or providing services under arrangements made with, the designated body) has systems in place to alert the accountable officer of any complaints or concerns involving the management or use of controlled drugs;

ensuring that the designated body (and any body or person acting on behalf of, or providing services under arrangements made with, the designated body) has an incident reporting system in place for untoward incidents involving the management or use of controlled drugs; and

ensuring that the designated body (and any body or person acting on behalf of, or providing services under arrangements made with, the designated body) has appropriate arrangements in place for analysing and responding to untoward incidents involving the management or use of controlled drugs.

whether the practitioner uses controlled drugs at any of the premises from which he or she provides primary medical services as part of the health service; and

how the practitioner manages and uses controlled drugs at those premises.

an NHS Trust, or a person registered with that NHS Trust who provides health care; and

a Local Health Board.

establish and operate, or ensure that his or her designated body establishes and operates; and

ensure that a body or person acting on behalf of, or providing services under arrangements made with, his or her designated body establishes and operates,

as regards the designated body, relevant individuals

The expression “relevant individual” is defined in section 17(8)(b) of the Health Act 2006

involved in prescribing, supplying, administering or disposing of controlled drugs,

to receive information and, where appropriate, training on local standard operating procedures for controlled drugs when they first become involved in prescribing, supplying, administering or disposing of controlled drugs; and

to be informed when any local standard operating procedures for controlled drugs are subsequently reviewed or amended.

establish and operate, or ensure that his or her designated body establishes and operates; and

ensure that a body or person acting on behalf of, or providing services under arrangements made with, his or her designated body establishes and operates,

for monitoring and auditing the management and use of controlled drugs by a person who is, as regards the designated body, a relevant individual; and

for monitoring and assessing the performance of persons who are, as regards the designated body, relevant individuals, in connection with the management and use of controlled drugs.

recording, in accordance with regulation 15, any concerns raised in relation to the management or use of controlled drugs by a relevant individual;

assessing and investigating, in accordance with regulation 16, any concerns raised regarding the management or use of controlled drugs by a relevant individual; and

determining whether there are concerns in relation to the management or use of controlled drugs by a relevant individual which the designated body reasonably considers should be shared with a responsible body under regulation 25.

establish and operate, or ensure that his or her designated body establishes and operates, appropriate arrangements for recording concerns expressed about incidents that involved, or may have involved, improper management or use of controlled drugs by a person who is, as regards his or her designated body, a relevant individual; and

ensure that any body or person acting on behalf of, or providing services under arrangements made with, his or her designated body establishes and operates appropriate arrangements for recording concerns expressed about incidents that involved, or may have involved, improper management or use of controlled drugs by a person who is, as regards his or her designated body, a relevant individual.

the date on which the concern was made known to the accountable officer;

any dates on which the matters that led to the concern took place;

details regarding the nature of the concern;

details of the relevant individual in relation to whom the concern was expressed;

details of the person who, or body which, made known the concern;

details of any action taken by the designated body (or a body or person acting on behalf of, or providing services under arrangements made with, the designated body) in relation to the concern;

the assessment of whether information in relation to the concern should be disclosed to another responsible body under regulation 25 or 26; and

if information regarding the concern is disclosed to another responsible body under regulation 25 or 26, the details of any such disclosure, including the name of the responsible body to which the disclosure was made and the nature of the information disclosed to the body.

the accountable officer and his or her staff; and

others who need to have access for the purposes of ensuring the safe management or use of controlled drugs.

assessing concerns expressed about incidents that involved, or may have involved, the improper management or use of controlled drugs by a person who is, as regards his or her designated body, a relevant individual; and

investigating such concerns.

carry out that investigation personally;

make a written request for another officer or employee of his or her designated body to carry out the investigation; or

a designated body;

HIW;

the Counter Fraud and Security Management Service Division of the NHS Business Services Authority;

CSSIW;

a police force;

a regulatory body.

any request made to an accountable officer from another designated body, or to another responsible body, under paragraph (2)(c) to investigate a concern that involved, or may have involved, the improper management or use of controlled drugs;

any assessment or investigation of a concern that involved, or may have involved, improper management or use of controlled drugs by a relevant individual that the accountable officer or his or her designated body carried out; and

any notification given to another responsible body or accountable officer under regulation 25(4).

implementation of a serious untoward incident procedure;

referral of the concerns to a regulatory body;

referral of the concerns to a police force;

in a case of possible fraud in relation to the health service, referral of the concerns to the Counter Fraud and Security Management Service Division of the NHS Business Services Authority;

sharing information with, and requesting information from, other responsible bodies, in accordance with regulation 25 or 26; or

if the accountable officer is an accountable officer nominated or appointed by a Local Health Board, convening an incident panel, made up of officers from any of the bodies that are responsible bodies for the purposes of Part 4, to investigate the concern and make recommendations as mentioned in paragraph (3).

ongoing monitoring of the relevant individual;

referral of the concerns to another accountable officer;

referral of the concerns to a regulatory body;

referral of the concerns to a police force; or

implementation of a serious untoward incident procedure.

a Local Health Board;

an NHS trust;

HIW;

CSSIW;

the Counter Fraud and Security Management Service Division of the NHS Business Services Authority;

a regulatory body;

a police force; and

a local authority.

used in connection with management or use of controlled drugs; and

the premises of the Local Health Board for which he or she is the accountable officer or (where appropriate) of which he or she is a member of staff;

the premises of a body or person acting on behalf of, or providing services under arrangements made with, that Local Health Board, unless those arrangements are with an NHS trust or a Welsh independent hospital; and

any other premises which are covered by arrangements established by virtue of regulation 19(1) but which are not mentioned in sub-paragraphs (a) or (b).

the premises of the NHS trust for which he or she is the accountable officer or (where appropriate) of which he or she is a member of staff; and

the premises of a body or person acting on behalf of, or providing services under arrangements made with, that NHS trust, unless those arrangements are with a Local Health Board or a Welsh independent hospital.

the premises of the independent hospital for which he or she is the accountable officer; and

the premises of a body or person acting on behalf of, or providing services under arrangements made with, that independent hospital, unless those arrangements are with a Local Health Board or an NHS trust.

the premises of the designated body of the first accountable officer; or

the premises of a body or person acting on behalf of, or providing services under arrangements made with the designated body of the first accountable officer,

a Local Health Board;

an NHS trust;

the Welsh Ambulance Services NHS Trust;

a Welsh independent hospital;

HIW;

CSSIW;

the NHS Business Services Authority, in relation to the performance of its functions by the Counter Fraud and Security Management Service Division;

Health Solutions Wales

a police force;

a local authority; and

a regulatory body.

identifying cases in which action may need to be taken in respect of matters arising in relation to the management or use of controlled drugs by a relevant person;

the consideration of issues relating to the taking of action in respect of such matters;

the taking of action in respect of such matters.

contains confidential information which relates to and can identify a patient; and

that confidential information is not required for the purposes of identifying cases in which action may need to be taken in respect of matters arising in relation to the management or use of controlled drugs by a relevant person, or for considering or taking action in such a case,

is unable, under paragraph (2), to remove from any information to be disclosed any confidential information which relates to and can identify a patient; or

considers it necessary to disclose information which contains the confidential information that relates to and can identify the patient,

commenced an assessment of or an investigation into a matter of concern in relation to the management or use of controlled drugs by a relevant individual under regulation 16 (that individual being a relevant person for the purposes of this Part); or

completed an assessment of or an investigation into a matter of concern under regulation 16,

if the responsible body has an accountable officer and he or she is unaware of the action taken, that accountable officer;

the accountable officer nominated or appointed as accountable officer for any Local Health Board in whose area the relevant individual lives or provides health care or services related to health care; and

any other responsible body that it considers it appropriate to notify.

any investigation being conducted by the responsible body, or any other responsible body, under any enactment; or

any civil or criminal proceedings.

it must determine within a reasonable period of time whether or not to comply with the request; and

it may disclose any information relating to the management or use of controlled drugs by a relevant person which it reasonably considers to be relevant to the request.

is unable, under paragraph (3), to remove from any information to be disclosed any confidential information which relates to and can identify a patient; or

considers it necessary to disclose information which contains the confidential information that relates to and can identify the patient,

would prejudice, or would be likely to prejudice, any investigation being conducted by the responsible body, or by any other responsible body, under any enactment;

would prejudice, or would be likely to prejudice, any civil or criminal proceedings; or

would involve disproportionate cost.

identifying cases in which action may need to be taken in respect of matters arising in relation to the management or use of controlled drugs by a relevant person;

considering issues relating to the taking of action in respect of such matters; or

taking action in respect of such matters.

not allow any person access to that information unless he or she is a person who, by virtue of his or her contract of employment or otherwise, is aware of the purposes for which the information may be processed; and

ensure that appropriate organisational measures are taken to prevent unauthorised disclosure or processing of the information.

a decision to disclose information under regulation 25;

details of the nature of the information disclosed;

details of the responsible body to which information was disclosed; and

any other details which the responsible body considers to be relevant to the disclosure.

any request received from another responsible body to disclose information under regulation 26;

details of the nature of any information disclosed;

details of the responsible body to which the information was disclosed; and

any other details which the responsible body considers to be relevant to the disclosure.

details of any concerns that his or her designated body has regarding its management or use of controlled drugs; or

confirmation by his or her designated body that it has no concerns to report regarding its management or use of controlled drugs.

entering into any arrangements with the relevant person; or

entering into any arrangements with any other person or body, under which the relevant person provides or may provide services,

seek to take reasonable steps to protect the safety of patients or the general public; and

where appropriate, refer the matter to a relevant responsible body (for example, a regulatory body or a police force).