The National Health Service (Pharmaceutical Services) Regulations 2012

Clinical governance

28.—(1) An NHS pharmacist (P) must, in connection with the pharmaceutical services provided by P, 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 P produces in an approved manner, and makes available in an appropriate manner, a practice leaflet containing approved particulars in respect of P’s pharmacy premises,

(ii) a requirement that the pharmacist publicises the essential services and any advanced services that are available at or from the pharmacist’s pharmacy,

(iii) a requirement that where a pharmacist publicises the essential services or any directed services that are available at or from the pharmacist’s pharmacy (whether the pharmacist is producing their own publicity material or advertising services in material published by another person), the pharmacist does so in a manner which makes clear that the services are funded as part of the health service,

(iv) a requirement that P undertakes an approved patient satisfaction survey annually, in an approved manner,

(v) P’s monitoring arrangements for drugs or appliances owed to patients but which are out of stock,

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

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

(b) a clinical audit programme (normally of 5 days), which includes at least one pharmacy-based audit and one other audit agreed by P’s Primary Care Trust 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) arrangements, including record keeping arrangements, for dealing appropriately and timeously with any communications concerning patient safety from the Secretary of State(2) and the National Health Service Commissioning Board,

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

(vi) appropriate waste disposal arrangements (in addition to those required under Part 2) for clinical and confidential waste,

(vii) a clinical governance lead person for each pharmacy, appointed as such by the pharmacist (or that is the pharmacist), who is knowledgeable about both the pharmacy procedures of that pharmacy and the other NHS services that are available in the locality of that pharmacy,

(viii) appropriate child protection procedures,

(ix) appropriate vulnerable adult (as construed in accordance with section 59 of the Safeguarding Vulnerable Groups Act 2006(3) (vulnerable adults)) protection procedures, and

(x) P’s monitoring arrangements in respect of P’s compliance with the Health and Safety at Work etc. Act 1974(4);

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

(i) in respect of the provision of drugs in accordance with a repeatable prescription,

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

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

and arrangements for ensuring that P, when giving advice to any patient on a matter mentioned in paragraph (d)(ii), has regard to the details contained in the records maintained under paragraph 10(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 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 and registered pharmacy technicians, and any necessary accreditation in respect of the provision of directed services,

(v) arrangements for addressing poor performance (in conjunction with the Primary Care Trust as appropriate), and

(vi) arrangements (which must include a written policy) for ensuring that all staff and locums who, arising out of their employment with the pharmacist—

(aa) make what is a protected disclosure within the meaning given in section 43A of the Employment Rights Act 1996(5) (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 Primary Care Trust 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 Primary Care Trust to access that assessment; and

(g) a premises standards programme, which includes—

(i) a system for maintaining cleanliness at the pharmacy which is designed to ensure, in a proportionate manner, that the risk to people at the pharmacy of health care acquired infection is minimised, and

(ii) arrangements for compliance, in the areas of the pharmacy in which patients receive NHS services, with any approved particulars that are designed to ensure, in a proportionate manner, that those areas are an appropriate environment in which to receive health care,

and for the purposes of this sub-paragraph, “approved” means approved by the Secretary of State.

(1)

2010 c. 15.

(2)

The Medicines and Healthcare Products Regulatory Agency, which is an executive agency of the Department of Health, issues safety advice, warnings, alerts and recalls in respect of medical devices on behalf of the Secretary of State, and also safety advice, warnings, alerts and recalls in respect of medicines on behalf of the Secretary of State and the Minister for Health, Social Services and Public Safety, acting jointly. The Department of Health also, separately, issues other communications concerning patient safety, on behalf of the Secretary of State.

(3)

2006 c. 47; section 59 has been amended by: the Education and Skills Act 2008 (c. 25), section 147(8); the Health Act 2009 (c. 21), Schedule 1, paragraphs 12 and 15, and Schedule 6; and S.I. 2008/912.

(4)

1974 c. 37.

(5)

1996 c. 18; section 43A was inserted by the Public Interest Disclosure Act 1998 (c. 23), section 1. See also section 43K(1)(c) (i) of the Employment Rights Act 1996 (inserted by the Public Interest Disclosure Act 1998, section 1, and amended by: the National Health Service Reform and Health Care Professions Act 2002 (c. 17), Schedule 2, paragraph 63; the National Health Service (Consequential Provisions) Act 2006 (c. 43), Schedule 1, paragraphs 177 and 178(b); and S.I. 2007/961), 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 Primary Care Trust under section 126 of the National Health Service Act 2006.