HEALTH AND PERSONAL SOCIAL SERVICES PART I GENERAL Citation, commencement and extent 1 These Regulations may be cited as the Independent Health Care Regulations (Northern Ireland) 2005 and shall come into operation on 1st April 2005. Interpretation 2 1 In these Regulations – “agency” means an independent medical agency; “ bankruptcy restrictions order ” means an order made under Schedule 2A of the Insolvency (Northern Ireland) Order 1989 or Schedule 4A of the Insolvency Act 1986; “debt relief order” means an order made by the Official Receiver under Part 7A of the Insolvency (Northern Ireland) Order 1989, or Part 7A of the Insolvency Act 1986; “debt relief restrictions order” means an order made under Schedule 2ZB to the Insolvency (Northern Ireland) Order 1989, or Schedule 4ZB to the Insolvency Act 1986; “dentist” means dental practitioner; “establishment” means an independent hospital, or an independent clinic; “ ethics committee ” means a group of persons which assesses the ethics of research involving individuals and which is recognised for that purpose by or on behalf of the Department of Health, Social Services and Public Safety; “ Fire Authority ” means the Fire Authority for Northern Ireland within the meaning of the Fire Services (Northern Ireland) Order 1984 ; “general practitioner” means a medical practitioner providing primary medical services; “health care professional” means a person who is registered as a member of any profession which is regulated by a body mentioned in section 25(3) of the National Health Service Reform and Health Care Professions Act 2002 or who is a clinical psychologist or child psychotherapist ; “insurance provider” means— a person regulated by the Financial Conduct Authority or the Prudential Regulation Authority who sells insurance, or underwrites the risk of such an insurance, or the agent of such a person; “medical device” has the same meaning as in the Medical Devices Regulations 2002 ; “ the Order ” means the Health and Personal Social Services (Quality, Improvement and Regulation) (Northern Ireland) Order 2003; “the 1972 Order ” means the Health and Personal Social Services (Northern Ireland) Order 1972 ; “organisation” means a body corporate or any unincorporated association other than a partnership; “patient”, in relation to any establishment or agency, means a person for whom treatment is provided in or for the purposes of the establishment, or for the purposes of the agency; “patient’s guide” means the guide compiled in accordance with regulation 8; “personal dental services” has the same meaning as in Article 3(7) of the Health Services (Primary Care) (Northern Ireland) Order 1997 ; “practising privileges” in relation to a medical practitioner, refers to the grant to a person who is not employed in an independent hospital of permission to practise in that hospital; “registered manager”, in relation to an establishment or agency, means a person who is registered under Part III of the Order as the manager of the establishment or agency; “registered person”, in relation to an establishment or agency, means any person who is the registered provider or the registered manager of the establishment or agency; “registered provider” in relation to an establishment or agency, means a person who is registered under Part III of the Order as the person carrying on the establishment or agency; “ RQIA ” means the Health and Social Care Regulation and Quality Improvement Authority; “responsible individual” shall be construed in accordance with regulation 10(2)(c)(i); “statement of purpose” means the written statement compiled in accordance with regulation 7; “treatment” includes palliative care and nursing and listed services within the meaning of Article 2 of the Order. 2 In these Regulations, references to employing a person include employing a person whether under a contract of service or a contract for services. Exceptions to the definition of independent hospital 3 For the purposes of Article 2 of the Order, establishments of the following descriptions are excepted from being independent hospitals – a an establishment which is a hospital by virtue of Article 2(2) of the Order solely because its main purpose is to provide medical or psychiatric treatment for illness or mental disorder but which provides no overnight beds for patients; b an establishment which is a service hospital within the meaning of section 13(9) of the Armed Forces Act 1981 ; c an establishment which is, or forms part of, a prison, within the meaning of the Prison Act (Northern Ireland) 1953 or a Remand Centre or Young Offenders Centre within the meaning of the Treatment of Offenders Act (Northern Ireland) 1968 ; d an establishment which is an independent clinic by virtue of regulation 5; e an establishment (not being a hospital which is vested in the Department or managed by an HSS trust) which has as its sole or main purpose the provision by a general practitioner of primary medical services; and such an establishment shall not become an independent hospital as a result of the provision of listed services to a patient by such a general practitioner; f the private residence of a patient in which treatment is provided to such patient, but to no one else; g sports grounds and gymnasia where health professionals provide treatment to persons taking part in sporting activities and events; ... h a surgery or consulting room (which is not part of a hospital) in which a medical practitioner provides medical services only under arrangements made on behalf of the patients by — i their employer; ii a Northern Ireland department; iii a prison or other establishment in which the patients are held in custody, other than pursuant to any provision of the Mental Health Order (Northern Ireland) 1986; or iv an insurance provider with whom the patients hold an insurance policy, other than a insurance policy which is solely or primarily intended to provide benefits in connection with the diagnosis or treatment of physical or mental illness, disability or infirmity; and i an establishment which has as its sole purpose the provision by a dental practitioner of general dental services , or personal dental services and such an establishment shall not become an independent hospital as a result of the provision of listed services to a patient by such a dental practitioner Prescribed techniques or technology 4 1 Subject to paragraph (2), for the purposes of Article 2 of the Order, “listed services” include treatment using any of the following techniques or technology – a a Class 3B or Class 4 laser product, as defined in Part I of British Standard EN 60825-1 (Radiation safety of laser products and systems) ; b an intense light, being broadband non-coherent light which is filtered to produce a specified range of wavelengths; such filtered radiation being delivered to the body with the aim of causing thermal, mechanical or chemical damage to structures such as hair follicles and skin blemishes while sparing surrounding tissues; c endoscopy; ... d in vitro fertilisation techniques, being treatment services for which a licence may be granted under paragraph 1 of Schedule 2 to the Human Fertilisation and Embryology Act 1990 . e haemodialysis or peritoneal dialysis; and f hyperbaric therapy, being the administration of oxygen (whether or not combined with one or more other gases) through a mask to a patient who is in a sealed chamber which is gradually pressurised with compressed air, where such therapy is carried out by or under the supervision or direction of a medical practitioner, except where the primary use of that chamber is— i pursuant to regulation 6(3)(b) of the Diving at Work Regulations (Northern Ireland) 2005 or regulation 8 or 12 of the Work in Compressed Air Regulations (Northern Ireland) 2004; or ii otherwise for the treatment of workers in connection with the work which they perform. 2 Listed services shall not include treatment using the following techniques or technology – a treatment for the relief of muscular and joint pain using an infra-red heat treatment lamp; b treatment using a Class 3B laser where such treatment is carried out by or under the supervision of a health care professional; and c the use of an apparatus (not being an apparatus falling within paragraph (1)(b), for acquiring an artificial suntan, consisting of a lamp or lamps emitting ultraviolet rays. 3 Paragraph (7) of Article 2 of the Order shall be modified by adding at the end of sub-paragraph (d) (cosmetic surgery) the following – other than – ear and body piercing; tattooing; the subcutaneous injection of a substance into the skin for cosmetic purposes; and the removal of hair roots or small blemishes on the skin by the application of heat using an electric current. Modification of Article 2(7) of the Order 4A Paragraph (7) of Article 2 of the Order shall be modified by substituting for sub-paragraph (b), the following sub-paragraph— b dental treatment; . Meaning of independent clinic 5 1 For the purposes of the definition of independent clinic under Article 2(2) of the Order, establishment of the following kinds are prescribed – a a walk-in centre, in which one or more medical practitioners provide services of a kind which, if provided in pursuance of the 1972 Order, would be provided as primary medical services; and b unless paragraph (1A) applies, a surgery or consulting room in which a medical practitioner who provides no services in pursuance of the 1972 Order provides medical services of any kind (including psychiatric treatment). 1A Paragraph (1)(b) does not apply to an establishment where medical services are provided only under arrangements made on behalf of the patients by— a their employer; b a Northern Ireland department; c a prison or other establishment in which the patients are held in custody, other than pursuant to any provision of the Mental Health Order (Northern Ireland) 1986; or d an insurance provider with whom the patients hold an insurance policy, other than an insurance policy which is solely or primarily intended to provide benefits in connection with the diagnosis or treatment of physical or mental illness, disability or infirmity 2 Where two or more medical practitioners use different parts of the same premises as a surgery or consulting room, or use the same surgery or consulting room at different times, each of the medical practitioners shall be regarded as carrying on a separate independent clinic unless they are in practice together. Exception of undertaking from the definition of independent medical agency 6 For the purposes of the Order, any undertaking which consists of the provision of medical services by a medical practitioner only under arrangements made on behalf of the patients by— a their employer; b a Northern Ireland department; c a prison or other establishment in which the patients are held in custody, other than pursuant to any provision of the Mental Health Order (Northern Ireland) 1986; or d an insurance company with whom the patients hold an insurance policy, other than an insurance policy which is solely or primarily intended to provide benefits in connection with the diagnosis or treatment of physical or mental illness, disability or infirmity, shall be excepted from being an independent medical agency. Statement of purpose 7 1 The registered person shall compile in relation to the establishment or agency written statement which shall consist of a statement as to the matters listed in Schedule 1. 2 The registered person shall supply a copy of the statement of purpose to the RQIA and shall make the statement available for inspection by every patient and any person acting on behalf of a patient. 3 Nothing in regulation 15(1) or 25(1) and (2) shall require or authorise the registered person to contravene, or not to comply with – a any other provision of these Regulations; or b the conditions for the time being in operation in relation to the registration of the registered person under Part III of the Order. Patient’s guide 8 1 The registered person shall produce a written guide to the establishment or agency which shall consist of – a a summary of the statement of purpose; b the terms and conditions in respect of services to be provided for patients, including as to the amount and method of payment of charges for all aspects of their treatment; c a standard form of contract for the provision of services and facilities by the registered provider to patients; d a summary of the complaints procedure established under regulation 23; e a summary of the results of the consultation conducted in accordance with regulation 17(3); f the address and telephone number of the RQIA ; and g the most recent inspection report prepared by the RQIA or information as to how a copy of that report may be obtained. 2 The registered person shall supply a copy of the patient’s guide to the RQIA , and shall make the patient’s guide available for inspection by every patient and any person acting on behalf of a patient. Review of statement of purpose and patient’s guide 9 The registered person shall – a keep under review and, where appropriate, revise the statement of purpose, and the content of the patient’s guide; and b notify the RQIA of any such revision. Requirements for statements of policies & procedures 9A 1 The registered person shall implement written statements of the policies to be applied and the procedures to be followed in or for the purposes of an establishment in relation to— a the arrangements for admission or acceptance of patients, their transfer to a hospital where required and, in the case of an establishment which admits in-patients, their discharge; b the arrangements for assessment, diagnosis and treatment of patients; c ensuring that the premises used by or for the purpose of an establishment are at all times fit for the purpose for which they are used; d monitoring the quality and suitability of facilities and equipment; e identifying, assessing and managing risks to employees, patients and visitors associated with the operation of the establishment; f the creation, management, handling and storage of records and other information; g the provision of information to patients and others; h the recruitment, induction and retention of employees and their employment conditions; i the grant and withdrawal of practising privileges to medical practitioners in establishments where such privileges are granted; and j ensuring that, where research is carried out in an establishment, it is carried out with the consent of any patient or patients involved, is appropriate for the establishment concerned and is conducted in accordance with up-to-date and authoritative published guidance on the conduct of research projects. 2 The registered person shall prepare and implement a written statement of the policies to be applied and the procedures to be followed for the purposes of an agency in relation to— a the arrangements for transfer to a hospital, where required; and b each of the matters specified in sub-paragraphs (b), (f), (g) and (h) of paragraph (1) 3 The registered person shall prepare and implement written statements of policies to be applied and procedures to be followed in or for the purposes of an establishment, or for the purpose of an agency, which ensure that— a the competence of each patient to consent to treatment is assessed; b in the case of a competent patient, properly informed consent to treatment is obtained; c in the case of a patient who is not competent, he is, so far as practicable, consulted before any treatment proposed for him is administered; and d information about a patient’s health and treatment is disclosed only to those persons who need to be aware of that information in order to treat the patient effectively or minimise any risk of the patient harming himself or another person, or for the purpose of the proper administration of the establishment or agency. 4 The registered person shall review the operation of each policy and procedure implemented under— a this regulation b regulation 23; and c in so far as they apply to him, regulations 35, 39C and 39D at intervals of not more than three years and shall, where appropriate, prepare and implement revised policies and procedures. 5 The registered person shall make a copy of all written statements prepared in accordance with this regulation available for inspection by the RQIA . PART II REGISTERED PERSONS Fitness of registered person provider 10 1 A person shall not carry on an establishment or agency unless he is fit to do so. 2 A person is not fit to carry on an establishment or agency unless the person – a is an individual, who carries on the establishment or agency – i otherwise than in partnership with others, and he satisfies the requirements set out in paragraph (3); ii in partnership with others, and he and each of his partners satisfies the requirements set out in paragraph (3); b is a partnership, and each of the partners satisfies the requirements set out in paragraph (3); c is an organisation and – i the organisation has given notice to the RQIA of the name, address and position in the organisation of an individual who is a director, manager, secretary or other officer of the organisation and is responsible for supervising the management of the establishment or agency; and ii that individual satisfies the requirements set out in paragraph (3). 3 The requirements are that – a he is of integrity and good character; b he is physically and mentally fit to carry on the establishment or agency; and c full and satisfactory information is available in relation to him in respect of each of the matters specified in Schedule 2. 4 A person shall not carry on an establishment or agency if – a he has been adjudged bankrupt or sequestration of his estate has been awarded and (in either case) he has not been discharged and the bankruptcy order has not been annulled or rescinded; or ab he is the subject of a bankruptcy restrictions order; or ac he is a person in relation to whom a moratorium period under a debt relief order applies or he is the subject of a debt relief restrictions order ; or b he has made a composition or arrangement with his creditors and has not been discharged in respect of it. Appointment of manager 11 1 The registered provider shall appoint an individual to manage an establishment or agency if – a there is no registered manager in respect of the establishment or agency; and b the registered provider – i is an organisation or a partnership; ii is not a fit person to manage an establishment or agency; or iii is not, or does not intend to be, in full-time day-to-day charge of the establishment or agency. 2 Where the registered provider appoints a person to manage the establishment or agency, he shall forthwith give notice to the Registration and Inspection Authority of – a the name of the person so appointed; and b the date on which the appointment is to take effect. Fitness of registered manager 12 1 A person shall not manage an establishment or agency unless he is fit to do so. 2 A person is not fit to manage an establishment or agency unless – a he is of integrity and good character; b having regard to the size of the establishment or agency, the statement of purpose, and the number and needs of the patients – i he has the qualifications, skills and experience necessary to manage the establishment or agency; and ii he is physically and mentally fit to do so; and c full and satisfactory information is available in relation to him in respect of each of the matters specified in Schedule 2. Registered person: general requirements 13 1 The registered provider and the registered manager shall, having regard to the size of the establishment or agency, the statement of purpose and the number and needs of the patients, carry on or (as the case may be) manage the establishment or agency with sufficient care, competence and skill. 2 If the registered person provider is – a an individual, he shall undertake; b an organisation, it shall ensure that the responsible individual undertakes; c a partnership, it shall ensure that one of the partners undertakes, from time to time such training as is appropriate to ensure that he has the skills necessary for carrying on the establishment or agency. 3 The registered manager shall undertake from time to time such training as is appropriate to ensure that he has the skills necessary for managing the establishment or agency. Registered person: notification of offences 14 Where the registered person or the responsible individual is convicted of any criminal offence whether in Northern Ireland or elsewhere, he shall forthwith give notice in writing to the RQIA of – a the date and place of the conviction; b the offence of which he was convicted; and c the penalty imposed on him in respect of the offence. PART III CONDUCT OF HEALTH CARE ESTABLISHMENTS AND AGENCIES QUALITY OF SERVICE PROVISION Quality of treatment and other service provision 15 1 Subject to regulation 7(3), the registered person shall provide treatment and any other services to patients in accordance with the statement of purpose, and shall ensure that the treatment and any other services provided to each patient – a meet his individual needs; b reflect published research evidence and guidance issued by the appropriate professional and expert bodies, as to good practice in the treatment of the condition from which the patient is suffering; and c are (where necessary) provided by means of appropriate equipment. 2 The registered person shall ensure that all equipment used in or for the purposes of the establishment, or for the purposes of the agency is – a suitable for the purposes for which it is to be used; and b properly maintained in accordance with the manufacturer’s guidance and in good working order. 3 Where reusable medical devices are used in an establishment or agency, the registered person shall ensure that appropriate procedures are implemented in relation to cleaning, disinfection, inspection, packaging, sterilisation, transportation and storage of such devices. 4 The registered person shall ensure that medical devices designated for single use only are not re-used under any circumstances. 5 The procedures implemented in accordance with paragraph (3) shall be such as to ensure that reusable medical devices are handled safely and decontaminated effectively prior to re-use. 6 The registered person shall make suitable arrangements for the ordering, recording, handling, safe keeping, safe administration and disposal of medicines used in or for the purposes of the establishment, or for the purposes of the agency. 7 The registered person shall make suitable arrangements to minimise the risk of infection and toxic conditions and the spread of infection between patients and staff (including medical practitioners with practising privileges). 8 The registered person shall ensure that patients receive a comprehensive outpatient service. 9 If an establishment provides food for patients, the registered provider shall ensure that it is – a provided in adequate quantities and at appropriate intervals; b properly prepared, wholesome and nutritious; and c suitable for the needs of patients, and that the menu is varied at suitable intervals. Care and welfare of patients 16 1 The registered person shall, so far as practicable, enable each patient to make decisions about matters affecting the way in which he is cared for and his general welfare. 2 The registered person shall ensure that patients are permitted to control their own money, except where a patient does not wish, or lacks the capacity, to do so, in which case the registered person shall ensure that patient monies are properly held and recorded and that receipts are issued as appropriate. 3 The registered person shall, so far as practicable, ascertain and take into account the wishes and feelings of all patients in determining the manner in which they are cared for and services are provided to them. 4 The registered person shall make suitable arrangements to ensure that the establishment or agency is conducted – a in a manner which respects the privacy and dignity of patients; and b with due regard to the sex, religious and spiritual needs, ethnic origin, and cultural and linguistic background and any disability of patients. 5 The registered provider and the registered manager (if any) shall each take all reasonable steps to ensure that the establishment or agency is conducted on the basis of good personal and professional relationships – a between each other; and b between each of them and the patients and staff. 6 The registered person shall ensure that the patient’s general practitioner is kept informed of relevant developments including significant family distress and this action is documented. 7 The registered person shall ensure that the information and communication procedures for the establishment or agency meet the needs of patients, their families and staff Review of quality of treatment and other services 17 1 The registered person shall introduce and maintain a system for reviewing at appropriate intervals the quality of treatment and other services provided in or for the purposes of an establishment or for the purposes of an agency. 2 The registered person shall supply to the RQIA a report in respect of any review conducted by him for the purposes of paragraph (1) and make a copy of the report available to patients. 3 The system referred to in paragraph (1) shall provide for consultation with patients and their representatives. 4 Where shortcomings in systems are highlighted as a result of an investigation, additional safeguards are put in place. 5 The registered person shall ensure there are arrangements for identifying, recording, analysing and learning from adverse incidents. Staffing 18 1 The registered person shall, having regard to the nature of the establishment or agency, the statement of purpose and the number and needs of patients, ensure that there is at all times an appropriate number of suitably qualified, skilled and experienced persons employed in or for the purposes of the establishment or, as the case may be, for the purposes of the agency. 2 The registered person shall ensure that each person employed in or for the purposes of the establishment or, for the purposes of the agency – a receives mandatory training and other appropriate training, supervision and appraisal; b is enabled from time to time to obtain further qualifications appropriate to the work he performs; and c is provided with a job description outlining his responsibilities. 3 The registered person shall ensure that each person employed in or for the purposes of the establishment, or for the purposes of the agency and any medical practitioner with practising privileges, receives regular and appropriate appraisal and shall take such steps as may be necessary to address any aspect of – a a health care professional’s clinical practice; or b the performance of a member of staff who is not a health care professional, which is found to be unsatisfactory. 4 The registered person shall take reasonable steps to ensure that any person working in an establishment or agency who is not employed by him and to whom paragraph (2) does not apply, is appropriately supervised while carrying out his duties. 5 The registered person shall maintain a record of the rostered shifts for each employee and a record of the hours worked by each person. Fitness of workers 19 1 The registered person shall ensure that – a no person is employed to work in or for the purpose of the establishment or for the purpose of the agency; b no medical practitioner is granted consulting or practising privileges, unless that person is fit to work in or for the purpose of the establishment, or for the purposes of the agency; and c there is evidence that all professional registration and revaluation requirements are met. 2 A person is not fit to work in or for the purposes of an establishment, or for the purposes of an agency unless – a he is of integrity and good character. b he has the qualifications, skills and experience which are necessary for the work which he is to perform; c he is physically and mentally fit for that work; and d full and satisfactory information is available in relation to him in respect of each of the matters specified in Schedule 2. 3 The registered person shall ensure that all healthcare professionals are covered by appropriate professional indemnity. Guidance for health care professionals. 20 The registered person shall ensure that any code of ethics or professional practice prepared by a body which is responsible for regulation of members of a health care profession is made available in the establishment or agency to members of the health care profession in question. Records 21 1 The registered person shall ensure that – a a comprehensive medical record is maintained in relation to each patient, which includes – i a contemporaneous note of all treatment provided to him; ii his medical history and all other notes prepared by a health care professional about his case; and b the record is retained for a period which is not less than that specified in Part I of Schedule 3 in relation to the type of patient in question or, where more than one such period could apply, the longest of them. 2 The registered person shall ensure that – a the medical record for a person who is currently a patient is kept in a secure place in the establishment or the agency premises; and b the medical record for a person who is not currently a patient is stored securely (whether in the establishment or the agency premises or elsewhere) and that it can be located if required. 3 The registered person shall ensure that the records specified in Part II of Schedule 3 are maintained and that they are – a kept up to date; b at all times available for inspection in the establishment or the agency premises by any person authorised by the RQIA to enter and inspect the establishment or agency premises; and c retained for a period of time not less than three years beginning on the date of the last entry. Staff views as to conduct of establishment or agency 22 1 This regulation applies to any matter relating to the conduct of the establishment or agency so far as it may affect the health and welfare of patients. 2 The registered person shall make arrangements to enable any person employed in or for the purposes of the establishment, or for the purposes of the agency, and any medical practitioner with practising privileges to inform the registered person and the RQIA of their views about any matter to which this regulation applies. Complaints 23 1 The registered person shall establish a procedure (in these Regulations referred to as “the complaints procedure”) for receiving, managing and responding to complaints made to the registered person by a patient or a person acting on behalf of a patient. 2 The complaints procedure shall be appropriate to the needs of patients. 3 The registered person shall ensure that any complaint made under the complaints procedure is fully investigated. 4 The registered person shall, within 28 days after the date on which the complaint is made, or such shorter period as may be reasonable in the circumstances, inform the person who made the complaint of the investigative process, outcome and action (if any) that is to be taken. 5 The registered person shall supply a written copy of the complaints procedure to every patient and, upon request, to – a any person acting on behalf of a patient; and b any person who is considering whether to become a patient. 6 The copy of the complaints procedure shall include – a the name, address and telephone number of the RQIA ; and b the procedure (if any) which has been notified by the RQIA to the registered person for making complaints to the RQIA relating to the establishment or agency. 7 The registered person shall maintain a record of each complaint, including details of the investigations made, the outcome and any action taken in consequence and the requirements of regulation 21(3)(b) and (c) shall apply to that record. 8 The registered person shall supply to the RQIA annually a statement containing a summary of the complaints made during the preceding twelve months and the action taken in response. Clinical trials and research 24 The registered person shall ensure that – a before any research involving patients, information about patients is undertaken in or for the purposes of the establishment or agency, a research proposal is prepared and approval is obtained from the appropriate Ethics Committee; b any clinical trial to be conducted in the establishment or agency has been authorised in accordance with the Medicines for Human Use (Clinical Trials) Regulations 2004 . PREMISES Fitness of premises 25 1 Subject to regulation 7(3), the premises used as an establishment or agency must be in a location and of a physical design and layout, which are suitable for the purpose of achieving the aims and objectives set out in the statement of purpose. 2 The registered person shall ensure that – a the premises are of sound construction and kept in a good state of repair externally and internally; b the size and layout of rooms are suitable for the purposes for which they are to be used and are suitably equipped and furnished; c all parts of the establishment or agency are kept clean and meet appropriate standards of hygiene; d all parts of the establishment or agency to which patients have access are so far as reasonably practicable free from hazards to their safety; and e if surgical procedures are undertaken, life support systems are used, and such electrical supply is provided during the interruption of public supply as is needed to safeguard the lives of the patients. 3 The registered person shall provide for employees and medical practitioners with practising privileges – a suitable facilities and accommodation, other than sleeping accommodation, including – i facilities for the purpose of changing; and ii storage facilities; and b where the provision of such accommodation is needed by employees in connection with their work, sleeping accommodation. 4 The registered person shall, after consultation with the Fire Authority – a take adequate precautions against the risk of fire, including the provision and maintenance of suitable fire equipment; b provide adequate means of escape in the event of fire; c make arrangements for persons employed in the establishment or for the purposes of the agency and medical practitioners to whom practising privileges have been granted to receive suitable training in fire prevention; d ensure, by means of fire drills and practices at suitable intervals, that the persons employed in the establishment or for the purposes of the agency and, so far as practicable, patients and medical practitioners to whom practising privileges have been granted, are aware of the procedure to be followed in case of fire; and e review fire precautions, the suitability of fire equipment and the procedure to be followed in case of fire at intervals not exceeding twelve months; f carry out a fire risk assessment of the premises and identify the significant findings of the risk assessment and the details of anyone who might be especially at risk. MANAGEMENT Visits by registered provider 26 1 Where the registered provider is an individual but is not in day-to-day charge of the establishment or agency, he shall visit the establishment or agency premises in accordance with this regulation. 2 Where the registered provider is an organisation or a partnership, the establishment or agency shall be visited in accordance with this regulation by – a the responsible individual or one of the partners, as the case may be; b another of the directors or other persons responsible for the management of the organisation or partnership; or c an employee of the organisation or partnership who is not directly concerned with the conduct of the establishment or agency. 3 Visits under paragraph (1) or (2) shall take place at least once every six months and shall be unannounced. 4 The person carrying out the visit shall – a interview, with their consent and in private (if necessary, by telephone), such of the patients and their representatives and such employees as appears to him to be necessary in order to form an opinion of the standard of treatment and other services provided in or for the purposes of the establishment, or for the purposes of the agency; b inspect records of any complaints and, in the case of an establishment, its premises; and c prepare a written report on the conduct of the establishment or agency. 5 The registered provider shall maintain a copy of the report required to be made under paragraph (4)(c) on the establishment or agency and make it available on request to – a the RQIA ; b the registered manager; c the patient or their representative. 6 In the case of a visit under paragraph (2) – i where the registered provider is an organisation, to each of the directors or other persons responsible for the management of the organisation; and ii where the registered provider is a partnership, to each of the partners. Financial position 27 1 The registered provider shall carry on the establishment or agency in such manner as is likely to ensure that the establishment or agency will be financially viable for the purpose of achieving the aims and objectives set out in the statement of purpose. 2 The registered person shall, if the RQIA so requests, provide the RQIA with such information and documents as it may require for the purpose of considering the financial viability of the establishment or agency, including – a the annual accounts of the establishment or agency, certified by an accountant; or b the annual accounts of the organisation which is the registered provider of the establishment or agency, certified by an accountant, together with accounts relating to the establishment or agency itself. 3 The registered person shall also provide the RQIA with such other information as it may require in order to consider the financial viability of the establishment or agency, including – a a reference from a bank expressing an opinion as to the registered provider’s financial standing; b information as to the financing and financial resources of the establishment or agency; c where the registered provider is a company, information as to any of its associated companies; and d a certificate of insurance for the registered provider in respect of liability which may be incurred by him in relation to the establishment or agency in respect of death, injury, public liability, damage or other loss. 4 In this regulation, one company is associated with another if one of them has control of the other, or both are under the control of the same person. NOTICES TO BE GIVEN TO THE RQIA Notification of deaths and other events 28 1 The registered person shall give notice to the RQIA of – a the death of a patient – i in an establishment; ii during treatment provided by an establishment or agency; or iii as a consequence of treatment provided by an establishment or agency within the period of seven days ending on the date of the death, and the circumstances of his death; b any serious injury to a patient; c the outbreak in an establishment of any infectious disease, which in the opinion of any medical practitioner employed in the establishment is sufficiently serious to be so notified; d any event in the establishment or agency which adversely affects the well-being or safety of any patient; e any allegation of misconduct resulting in actual or potential harm to a patient by the registered person, any person employed in or for the purposes of the establishment or for the purposes of the agency, or any medical practitioner with practising privileges; f any theft, burglary or accident in the establishment or agency. 2 Notice under paragraph (1) shall be given within the period of 24 hours beginning with the event in question and, if given orally, shall be confirmed in writing as soon as practicable. Notice of absence 29 1 Where – a the registered provider, if he is the person in day-to-day charge of the establishment or agency; or b the registered manager, proposes to be absent from the establishment or agency for a continuous period of 28 days or more, the registered person shall give notice in writing to the RQIA of the proposed absence. 2 Except in the case of an emergency, the notice referred to in paragraph (1) shall be given no later than one month before the proposed absence commences or within such shorter period as may be agreed with the RQIA and the notice shall specify with respect to the proposed absence – a its length or expected length; b the reason for it; c the arrangements which have been made for running the establishment or agency; d the name, address and qualifications of the person who will be responsible for the establishment or agency during that absence; and e in the case of the absence of the registered manager, the arrangements that have been, or are proposed to be, made for appointing another person to manage the establishment or agency during that absence, including the proposed date by which the appoint is to be made. 3 Where the absence arises as a result of an emergency, the registered person shall give notice of the absence within one week of its occurrence specifying the matters set out in sub-paragraphs (a) to (e) of paragraph (2). 4 Where – a the registered provider, if he is the person in day-to-day charge of the establishment or agency; or b the registered manager; has been absent from the establishment or agency for a continuous period of 28 days or more, and the RQIA has not been given notice of the absence, the registered person, shall, without delay, give notice in writing to the RQIA of the absence, specifying the matters set out in paragraph (2)(a) to (e). 5 The registered person shall notify the RQIA of the return to duty of the registered provider or (as the case may be) the registered manager not later than 7 days after the date of his return. Notice of changes 30 The registered person shall give notice in writing to the RQIA as soon as it is practicable to do so if any of the following events take place or are proposed to take place – a a person other than the registered person carries on or manages the establishment or agency; b a person ceases to carry on or manage the establishment or agency; c where the registered provider is an individual, he changes his name; d where the registered provider is a partnership, there is any change in the membership of the partnership; e where the registered provider is an organisation – i the name or address of the organisation is changed; ii there is any change of director, manager, secretary or other similar officer of the organisation; iii there is any change in the identity of the responsible individual; f where the registered provider is an individual, a trustee in bankruptcy is appointed; fa where the registered provider is an individual, a debt relief order is made in respect of him; g where the registered provider is a company or partnership, a receiver, manager, liquidator or provisional liquidator is appointed; or h the premises of the establishment or agency are significantly altered or extended, or additional premises are acquired. Appointment of liquidators etc 31 1 Any person to whom paragraph (2) applies must – a forthwith notify the RQIA of his appointment indicating the reasons for it; b appoint a manager to take full-time day-to-day charge of the establishment or agency in any case where there is no registered manager; and c before the end of the period of 28 days beginning on the date of his appointment, notify the RQIA of his intentions regarding the future operation of the establishment or agency. 2 This paragraph applies to any person appointed as – a the receiver or manager of the property of a company or partnership which is a registered provider of an establishment or agency; b liquidator or provisional liquidator of a company which is the registered provider of an establishment or agency; c the trustee in bankruptcy of a registered provider of an establishment or agency. Death of registered person 32 1 If more than one person is registered in respect of an establishment or agency, and a registered person dies, the surviving registered person shall without delay notify the RQIA of the death in writing. 2 If only one person is registered in respect of an establishment or agency, and he dies, his personal representatives must notify the RQIA in writing – a without delay of the death; and b within 28 days of their intentions regarding the future running of the establishment or agency. 3 The personal representatives of the deceased registered provider may carry on the establishment or agency without being registered in respect of it – a for a period not exceeding 28 days; and b for any further period as may be determined in accordance with paragraph (4). 4 The RQIA may extend the period specified in paragraph (3)(a) by such further period, not exceeding one year, as the RQIA shall determine, and shall notify any such determination to the personal representatives in writing. 5 The personal representatives shall appoint a person to take full-time day-to-day charge of the establishment or agency during any period in which, in accordance with paragraph (3), they carry on the establishment or agency without being registered in respect of it. PART IV ADDITIONAL REQUIREMENTS APPLYING TO INDEPENDENT HOSITALS PATHOLOGY SERVICES, RESUSCITATION AND TREATMENT OF CHILDREN IN INDEPENDENT HOSPITALS Application of regulations 34 to 36 33 1 Regulations 34 to 36 apply to independent hospitals of the following kinds – a those defined in Article 2(2) of the Order except establishments excepted by regulation 4(2); and b those in which medical treatment, including cosmetic surgery, is provided under anaesthesia or sedation. 2 Regulation 34 also applies to any establishment or agency which provides pathology services. Pathology services 34 The registered person shall ensure that – a an adequate range of pathology services is available to meet the needs of the independent hospital; b those services are provided to an appropriate standard; c appropriate arrangements are made for the collection, and (where pathology services are provided outside the hospital) transportation of pathology specimens; and d the patient from whom a specimen was taken and such specimen, is identifiable at all times. Resuscitation 35 1 The registered person shall prepare and implement a written statement of the policies to be applied and the procedures to be followed in the hospital in relation to resuscitation of patients, and shall review such statement annually. 2 The registered person shall ensure that policies and procedures implemented in accordance with paragraph (1) – a take proper account of the right of all patients who are competent to do so to give or withhold consent to treatment; b are available on request to every patient and any person acting on behalf of a patient; and c are communicated to and understood by all employees and all medical practitioners with practising privileges who may be involved in decisions about resuscitation of a patient. Treatment of children 36 The registered person shall ensure that, where a child is treated in an independent hospital – a he is treated in accommodation which is separate from accommodation in which adult patients are treated; b particular medical, physical, psychological, social, educational and supervision needs arising from his age are met; c his treatment is provided by persons who have appropriate qualifications, skills and experience in the treatment of children; d his parents are kept fully informed of his condition and so far as is practicable consulted about all aspects of his treatment, except where the child is himself competent to consent to treatment and does not wish his parents to be so informed and consulted. INDEPENDENT HOSPITALS IN WHICH CERTAIN LISTED SERVICES ARE PROVIDED Surgical procedures 37 1 Where medical treatment (including cosmetic surgery) is provided under anaesthesia or sedation in an independent hospital, the registered person shall ensure that – a each operating theatre is designed, equipped and maintained to an appropriate standard for the purposes for which it is to be used; b all surgery is carried out by, or under the direction of, a suitable qualified, skilled and experienced medical practitioner; c an appropriate number of suitably qualified, skilled and experienced employees are in attendance during each surgical procedure; and d the patient receives appropriate treatment – i before administration of an anaesthetic or sedation; ii whilst undergoing a surgical procedure; iii during recovery from general anaesthesia; and iv post-operatively. 2 The registered person shall ensure that before a patient consents to any surgery offered by the independent hospital, he has received clear and comprehensive information about the procedure and any risks associated with it. 3 In the case of a patient who is not competent to consent to surgery, the information mentioned in paragraph (2) shall, wherever possible, be provided to his representative. Dental treatment under general anaesthesia or sedation 38 Where the treatment provided in an independent hospital includes dental treatment under general anaesthesia or sedation, the registered person shall ensure that – a the dentist and any employees assisting him are suitable, qualified, skilled and experienced to deal with any emergency which occurs during or as a result of the general anaesthesia, sedation or treatment; and b adequate facilities, drugs and equipment are available to deal with any such emergency. Use of certain techniques or technology 39 1 The registered person shall ensure that no Class 3B or Class 4 laser or intense light source (within the meaning of regulation 4(1)), is used in or for the purposes of an independent hospital unless that hospital has in place a professional protocol drawn up by a trained and experienced medical practitioner or dentist from the relevant discipline in accordance with which treatment is to be provided, and is so provided. 2 The registered person shall ensure that such a laser or intense light source is used in or for the purposes of the hospital only by a person who has undertaken appropriate training and has demonstrated an understanding of – a the correct use of the equipment in question; b the risks associated with using a laser or intense light source; c its biological and environmental effects; d precautions to be taken before and during use of a laser or intense light source; and e action to be taken in the event of an accident, emergency, or other adverse incident. ”INDEPENDENT HOSPITALS THE MAIN PURPOSE OF WHICH IS TO PROVIDE MEDICAL OR PSYCHIATRIC TREATMENT FOR MENTAL DISORDER 39A Regulations 39B to 39E apply to independent hospitals the main purpose of which, is to provide medical or psychiatric treatment for mental disorder. Safety of patients and others 39B 1 In addition to the statement of policies and procedures to be prepared in accordance with regulation 9A, the registered person shall prepare and implement written statements addressing policies and procedures in relation to— a assessment of a patient’s propensity to violence and self harm; b the provision of information to employees as to the outcome of such an assessment; c assessment of the effect of the layout of the hospital premises, and its policies and procedures, on the risk of a patient harming himself or another person; and d the provision of training to enable employees to minimise risk of a patient harming himself or another person. 2 The registered person shall in particular prepare and implement a suicide protocol, which requires— a a comprehensive examination of the mental condition of each patient; b an evaluation of the patient’s history of mental disorder, including identification of suicidal tendencies; c an assessment of the patient’s propensity to suicide; d if necessary, appropriate action to reduce the risk of the patient committing suicide. Management of disturbed behaviour 39C The registered person shall prepare and implement a written statement of policy setting out— a how disturbed behaviour exhibited by a patient is to be managed; b permitted measures of restraint and the circumstances in which they may be used; c requirements for employees to report serious incidents of violence or self harm, including guidance as to how those incidents should be classified; and d the procedure for review of such incidents and determination of the action which is to be taken subsequently. Visitors 39D The registered person shall prepare and implement written policies and procedures in relation to patients receiving visitors. Mental health records 39E The registered person shall ensure that any records which are required to be made under the Mental Health (Nurses, Guardianship, Consent to Treatment and Prescribed Forms) Regulations (Northern Ireland) 1986, and which relate to the treatment of a patient in an independent hospital, are kept for a period of not less than ten years beginning on the date on which the person to whom they relate ceases to be a patient in the hospital. PART V ADDITIONAL REQUIREMENTS APPLYING TO INDEPENDENT MEDICAL AGENCIES Independent medical agencies 40 The registered person shall ensure that the register of patients to be maintained in relation to an independent medical agency under Part II of Schedule 3 includes the name of the medical practitioner by whom each patient is treated. PART VI MISCELLANEOUS Compliance with regulations 41 Where there is more than one registered person in respect of an establishment or agency, anything which is required under these Regulations to be done by the registered person shall, if done by one of the registered persons, not be required to be done by any of the other registered persons. Offences 42 1 A contravention of any of the provisions of regulations 7, 8, 9A, 14, 15, 16(1) to (4), 17 to 32 and 34 to 40 shall be an offence. 2 The RQIA shall not bring proceedings against a person in respect of any contravention of these regulations unless – a subject to paragraph (4), he is a registered person; b notice has been given to him in accordance with paragraph (3); c the period specified in the notice beginning with, and including the date of the notice has expired; and d the person contravenes any of the provisions of the regulations mentioned in the notice. 3 Where the RQIA considers that the registered person has contravened any of the provisions of the regulations mentioned in paragraph (1), it may serve a notice on the registered person specifying – a in what respect in its opinion the registered person has contravened the requirements of any of the regulations; b what action, in the opinion of the RQIA , the registered person should take so as to comply with any of these regulations; and c the period, not exceeding three months beginning on and including the date on which the notice is given, within which the registered person should take action. 4 The RQIA may bring proceedings against a person who was once, but no longer is a registered person, in respect of a failure to comply with regulation 21 and for this purpose, references in paragraphs (2) and (3) to a registered person shall be taken to include such a person. Sealed with the Official Seal of the Department of Health, Social Services and Public Safety on 25th March 2005. N. McCann Senior Officer of the Department of Health, Social Services and Public Safety