The National Health Service (Pharmaceutical Services) (Appliances) (Amendment) Regulations 2009

Insertion of new paragraph 13A

20.  After paragraph 13 insert—

“Clinical governance

13A.— (1) A supplier of appliances shall, in connection with all the pharmaceutical services the supplier of appliances provides, participate, in the manner reasonably required by the Primary Care Trust, 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 Secretary of State and comprises the following components—

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

(i) a requirement that the supplier of appliances 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 the supplier of appliances publicises the NHS services that are available at or from such premises,

(iii) a requirement that the supplier of appliances undertakes an approved patient satisfaction survey annually, in an approved manner,

(iv) the monitoring arrangements of the supplier of appliances in respect of appliances owed to patients but which are out of stock,

(v) an approved complaints system (which meets the requirements of this Schedule),

(vi) a requirement that the supplier of appliances co-operates appropriately with visits by an authorised representative of any relevant local involvement network and takes appropriate action following the outcome of such visits,

(vii) a requirement that the supplier of appliances co-operates appropriately with any reasonable inspection or review that the Primary Care Trust or any relevant statutory authority wishes to undertake, and

(viii) the monitoring arrangements of the supplier of appliances in respect of the supplier’s compliance with the Disability Discrimination Act 1995(1);

(b) a clinical audit programme (normally of five 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 the premises from which the supplier provides pharmaceutical services,

(vii) appropriate child protection procedures, and

(viii) the monitoring arrangements of the supplier of appliances in respect of the supplier’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 a supplier of appliances—

(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 supplier, 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 8(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 and 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 services as part of the health service, 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 a Primary Care Trust as appropriate); and

(f) a use of information programme, which includes—

(i) appropriate arrangements (having regard to issues both of rights of access to information and of confidentiality) to support both health care delivery and clinical governance,

(ii) appropriate arrangements in respect of compliance with “Confidentiality: the National Health Service Code of Practice”(3),

(iii) the monitoring arrangements of the supplier of appliances in respect of the supplier’s compliance with the Data Protection Act 1998(4) and with regard to patient confidentiality, and

(iv) appropriate training for staff with regard to compliance with the Data Protection Act 1998 and patient confidentiality.

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

(1)

1995 c. 50.

(2)

1974 c. 37.

(3)

This Code of Practice is available on the Department of Health’s website, www.dh.gov.uk.

(4)

1998 c. 29.