The National Health Service (Pharmaceutical Services) (Wales) Regulations 2013

Clinical governance

16.—(1) An NHS appliance contractor must, in connection with all the services that he or she provides, participate, in the manner reasonably required by the Local Health Board on whose pharmaceutical list he or she is included, in an acceptable system of clinical governance.

(2) A system of clinical governance is “acceptable” if it provides for—

(a) compliance with the clinical governance components set out in sub-paragraph (3), and

(b) submission of an annual self assessment of compliance (to an approved level) with those clinical governance components via approved data submission arrangements which allow the Local Health Board to access that assessment.

(3) The clinical governance components comprise of the following—

(a) a patient and public involvement programme, which includes—

(i) a requirement that the NHS appliance contractor should produce in an approved manner, and make available in an appropriate manner, a practice leaflet in respect of each of the premises from which he or she provides pharmaceutical services,

(ii) a requirement that the NHS appliance contractor publicises the NHS services that are available at or from the premises from which the NHS appliance contractor provides services,

(iii) a requirement that where the NHS appliance contractor publicises the NHS services that are available at or from premises from which the NHS appliance contractor provides services (whether he or she is producing his or her own publicity material or advertising services in material published by another person), the NHS appliance contractor does so in a manner which makes clear that the services are funded as part of the health service,

(iv) a requirement that the NHS appliance contractor should undertake an approved patient satisfaction survey annually, in an approved manner, including a requirement to publicise the results of the survey and any appropriate action the NHS appliance contractor intends to take,

(v) monitoring arrangements for appliances owed to patients but which are out of stock,

(vi) an approved complaints system (which meets the requirements of this Part),

(vii) a requirement that the NHS appliance contractor co-operates appropriately with Local Community Health Council visits and takes appropriate action following the outcome of such visits,

(viii) a requirement that the NHS appliance contractor co-operates appropriately with any reasonable inspection or review that the Local Health Board or any relevant statutory authority wishes to undertake, and

(ix) monitoring arrangements for compliance with the Equality Act 2010(1);

(b) a clinical audit programme (normally of five days), which includes at least one premises-based audit and one multi-disciplinary audit agreed by the Local Health Board in each financial year;

(c) a risk management programme, which includes—

(i) arrangements for ensuring that all stock is handled in an appropriate way,

(ii) arrangements for ensuring that all equipment used in the provision of pharmaceutical services is maintained appropriately,

(iii) an approved incident reporting system, together with arrangements for analysing and responding to critical incidents, which comprises of—

(aa) a patient safety incident log, and

(bb) a near-miss log,

(iv) arrangements, including record keeping arrangements, for dealing appropriately and timeously with communications concerning patient safety from the Welsh Ministers, the Medicines and Healthcare Products Regulatory Agency and the National Health Service Commissioning Board,

(v) appropriate standard operating procedures, including standard operating procedures in respect of repeatable prescriptions and providing advice and support to people caring for themselves or their families,

(vi) appropriate waste disposal arrangements for clinical and confidential waste,

(vii) a clinical governance lead person for each of the premises from which the NHS appliance contractor provides services, who is knowledgeable about both the procedures of the NHS appliance contractor and the other NHS services that are available in the locality,

(viii) appropriate child protection procedures, and

(ix) monitoring arrangements for compliance with the Health and Safety etc. Act 1974(2);

(d) a clinical effectiveness programme, which includes arrangements for ensuring that appropriate advice is given by the NHS appliance contractor—

(i) in respect of the provision of appliances in accordance with a prescription form or repeatable prescription, or

(ii) to people caring for themselves or their families,

and arrangements for ensuring that the NHS appliance contractor, when giving advice to any patient on a matter mentioned in paragraph (d)(i), has regard to the details contained in the records maintained under paragraph 9(1)(f) in respect of the provision of appliances and the prescribing pattern relating to the patient in question;

(e) a staffing and staff management programme, which includes—

(i) arrangements for appropriate induction training for staff, including any locum,

(ii) appropriate training for all staff in respect of any role they are asked to perform,

(iii) arrangements for the checking of qualifications and references of all staff engaged in the provision of NHS services,

(iv) arrangements for identifying and supporting the development needs of all staff engaged in the provision of services as part of the health service including continuing professional development for registered pharmacists and any necessary accreditation in respect of the provision of directed services,

(v) arrangements for addressing poor performance (in conjunction with the Local Health Board as appropriate), and

(vi) arrangements (which must include a written policy) for ensuring that all staff, including any locum who, arising out of their employment with the NHS appliance contractor—

(aa) make what is a protected disclosure within the meaning given in section 43A of the Employment Rights Act 1996(3) (meaning of protected disclosure) have the rights afforded in respect of such disclosures by that Act, and

(bb) provide information in good faith and not for purposes of personal gain to the General Pharmaceutical Council or to a Local Health Board which includes an allegation of a serious nature which they reasonably believe to be substantially true, but disclosure of it is not a protected disclosure within the meaning given in section 43A, have the right not to be subjected to any detriment or to dismissal as a consequence of that act;

(f) an information governance programme, which provides for—

(i) compliance with approved procedures for information management and security, and

(ii) submission of an annual self assessment of compliance (to an approved level) with those procedures via approved data submission arrangements which allow the Local Health Board to access that assessment; and

(g) a premises standards programme, which includes—

(i) a system for maintaining cleanliness at the premises from which the NHS appliance contractor provides services which is designed to ensure, in a proportionate manner, that the risk to people at the premises of healthcare acquired infection is minimised, and

(ii) arrangements for there to be a clear separation between the areas of the premises which are an appropriate healthcare environment (where patients receive NHS services) and those areas that are a non-healthcare environment.

(1)

2010 c. 15.

(2)

1974 c. 37.

(3)

1996 c. 18; section 43A was inserted by section 1 of the Public Interest Disclosure Act 1998 (c. 23). See also section 43K(1)(c) of the Employment Rights Act 1996 which extends the meaning of “worker” for the Part of that Act that deals with protected disclosures so that it covers all individuals who provide pharmaceutical services in accordance with arrangements made by a Local Health Board under section 80 of the 2006 Act.