The National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013

Clinical governance

18.—(1) An NHS appliance contractor (C) must, in connection with the pharmaceutical services provided by C, participate, in the manner reasonably required by the NHSCB, in an acceptable system of clinical governance.

(2) For these purposes a system of clinical governance is “acceptable” if it is considered acceptable by the NHSCB and comprises the following components—

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

(i) a requirement that C produces in an approved manner a practice leaflet containing approved particulars in respect of each of the premises from which the supplier provides pharmaceutical services,

(ii) a requirement that C publicises the NHS services that are available at or from C’s appliance contractor premises,

(iii) a requirement that C undertakes an approved patient satisfaction survey annually, in an approved manner,

(iv) C’s monitoring arrangements in respect of appliances owed to patients but which are out of stock,

(v) an approved complaints system (which meets the requirements of paragraph 24),

(vi) a requirement that C co-operates appropriately with visits by an authorised representative of any relevant Local Healthwatch organisation and takes appropriate action following the outcome of such visits,

(vii) a requirement that C co-operates appropriately with any reasonable inspection or review that the NHSCB or any relevant statutory authority wishes to undertake, and

(viii) C’s monitoring arrangements in respect of C’s compliance with the Equality Act 2010(1);

(b) a clinical audit programme (normally of 5 days) twice in each financial year;

(c) a risk management programme, which includes—

(i) arrangements for ensuring that all stock is procured and 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,

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

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

(vi) identifying a clinical governance lead person in respect of each of C’s appliance contractor premises,

(vii) C’s monitoring arrangements of C’s compliance with the Health and Safety at Work etc. Act 1974(2);

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

(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 C, 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 prescribing pattern relating to the patient in question;

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

(i) arrangements for appropriate induction for staff (including locums),

(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 NHS services, including continuing professional development for registered pharmacists, registered nurses and registered pharmacy technicians and any necessary accreditation in respect of the provision of directed services, and

(v) arrangements for addressing poor performance (in conjunction with the NHSCB as appropriate); and

(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 NHSCB to access that assessment.

(3) For the purposes of sub-paragraph (2), “approved” means approved by the NHSCB.

(1)

2010 c. 15.

(2)

1974 c. 37.