10.—(1) The registered person must protect service users, and others who may be at risk, against the risks of inappropriate or unsafe care and treatment, by means of the effective operation of systems designed to enable the registered person to—
(a)regularly assess and monitor the quality of the services provided in the carrying on of the regulated activity against the requirements set out in this Part of these Regulations; and
(b)identify, assess and manage risks relating to the health, welfare and safety of service users and others who may be at risk from the carrying on of the regulated activity.
(2) For the purposes of paragraph (1), the registered person must—
(a)where appropriate, obtain relevant professional advice;
(b)have regard to—
(i)the complaints and comments made, and views (including the descriptions of their experiences of care and treatment) expressed, by service users, and those acting on their behalf, pursuant to sub-paragraph (e) and regulation 19,
(ii)any investigation carried out by the registered person in relation to the conduct of a person employed for the purpose of carrying on the regulated activity,
(iii)the information contained in the records referred to in regulation 20,
(iv)appropriate professional and expert advice (including any advice obtained pursuant to sub-paragraph (a)),
(v)reports prepared by the Commission from time to time relating to the registered person's compliance with the provisions of these Regulations, and
(vi)periodic reviews and special reviews and investigations carried out by the Commission in relation to the provision of health or social care, where such reviews or investigations are relevant to the regulated activity carried on by the service provider;
(c)where necessary, make changes to the treatment or care provided in order to reflect information, of which it is reasonable to expect that a registered person should be aware, relating to—
(i)the analysis of incidents that resulted in, or had the potential to result in, harm to a service user, and
(ii)the conclusions of local and national service reviews, clinical audits and research projects carried out by appropriate expert bodies;
(d)establish mechanisms for ensuring that—
(i)decisions in relation to the provision of care and treatment for service users are taken at the appropriate level and by the appropriate person (P), and
(ii)P is subject to an appropriate obligation to answer for a decision made by P, in relation to the provision of care and treatment for a service user, to the person responsible for supervising or managing P in relation to that decision; and
(e)regularly seek the views (including the descriptions of their experiences of care and treatment) of service users, persons acting on their behalf and persons who are employed for the purposes of the carrying on of the regulated activity, to enable the registered person to come to an informed view in relation to the standard of care and treatment provided to service users.
(3) The registered person must send to the Commission, when requested to do so, a written report setting out how, and the extent to which, in the opinion of the registered person, the requirements of paragraph (1) are being complied with, together with any plans that the registered person has for improving the standard of the services provided to service users with a view to ensuring their health and welfare.