A consultation paper on proposed Regulation of Care (Requirements as to Independent Healthcare Services) (Scotland) Regulations 2008

Primary and Community Care Directorate

4 July 2008

Contents

Introduction

Background to legislation

Reason for change

What the change will do

Responding to the consultation paper

Handling your response

Annex A - definitions of independent healthcare services

Annex B - proposed regulations

Annex C - questions

Annex D - Respondent Information Form

Introduction

1. This consultation document seeks views on proposals for a suite of regulations which will apply to all independent healthcare services regulated by the Care Commission. The proposed regulations would replace SSI 114 Regulation of Care (Scotland) Requirements as to Care Services Regulations 2002 (the 2002 regulations) for all independent healthcare services.

Background

2. The Care Commission was established on 1 April 2002 under the Regulation of Care (Scotland) Act 2001 ("the Act") to regulate a wide range of care services defined in section 2 of the Act, including independent healthcare services.

3. An independent healthcare service is defined in the Act as any of the following:

(a) an independent hospital;

(b) a private psychiatric hospital;

(c) an independent clinic; and

(d) an independent medical agency

4. . A note of those definitions and how they are interpreted in the Act is set out in Annex A.

Reason for change

5. The Care Commission has now had six years operational experience of regulating those independent healthcare services for which regulation commenced on 1 April 2002, including assessing their compliance with the 2002 Regulations. On the basis of the Commission's experience we now consider that further specific regulations need to be made. This will ensure effective regulation of independent healthcare services before commencing regulation of any further independent healthcare services.

What the change will do

6. These proposed regulations help further clarify for providers the extent of the Care Commission's regulatory requirements in respect of independent health care services.

Responding to this consultation paper

7. Comments on the contents of this paper are invited by 26 September 2008. Electronic responses may be sent to:

standardsandsponsorship@scotland.gsi.gov.uk.

or in writing to:

Stephen Mitchell

Primary and Community Care Directorate | Community Care Division

Care Standards and Sponsorship Branch

2E(S), St Andrew's House

Regent Road

Edinburgh EH1 3DG.

Telephone 0131 244 5387

8. You are invited to consider and comment on all/any of the proposed regulations, which are attached at Annex B except those relating to fitness of providers (regulation 6), managers (regulation 7) and employees (regulation 9). The regulations relating to fitness were recently consulted on and these independent healthcare regulations will reflect the revised fitness regulations once these have been finalised. A list of specific questions on the draft regulations which you are also invited to consider is attached at Annex C.

9. This consultation, and all other SG consultation exercises, can be viewed online at http://www.scotland.gov.uk/consultations. You can telephone Freephone 0800 77 1234 to find out where your nearest public internet access point is.

10. The SG now has an email alert system for consultations. (SEconsult: http://www.scotland.gov.uk/consultations/seconsult.aspx. This system allows stakeholder individuals and organisations to register and receive a weekly email containing details of all new consultations (including web links). SEconsult complements, but in no way replaces SG distribution lists, and is designed to allow stakeholders to keep up to date with all SG consultation activity, and therefore be alerted at the earliest opportunity to those of most interest. We would encourage you to register.

Handling your response

11. We need to know how you wish your response to be handled and, in particular, whether you are happy for your response to be made public. Please complete the Respondent Information Form at Annex D along with your response as this will ensure that we treat your response appropriately. All respondents should be aware that the SG is subject to the provisions of the Freedom of Information (Scotland) Act 2002 and would therefore have to consider any request made to it under the Act for information relating to responses made to this consultation exercise.

12. Where respondents have given their permission for their responses to be made public these will be made available to the public in the Scottish Government Library by late Autumn and a report will be published on the Scottish Government consultation web pages by the same date. We will check all responses where agreement to publish has been given for any potentially defamatory material before logging them in the library or placing them on the website. You can make arrangements to view responses by contacting the SG Library on 1031 244 4552. Responses can be copied and sent to you, but a charge may be made of this service.

Scottish Government

Primary and Community Care Directorate | Community Care Division

4 July 2008

DEFINITIONS

The independent healthcare services set out in section 2(5) of the Regulation of Care (Scotland) Act 2001 ("the Act") are further defined in sections 77(1) and (2) of the Act. A note of those definitions is set out below.

Independent Hospital

A hospital which is neither a health service hospital nor a private psychiatric hospital. A part of a health service hospital is an independent hospital if:

(i) it is carried on as a separate unit;

(ii) it does not provide treatment or nursing in pursuance of the National Health Service (Scotland) Act 1978; and

(iii) no part of it is contained within the same building as any such part which does provide treatment or nursing in pursuance of the Act.

All independent hospitals have been regulated by the Care Commission since 1st April 2002.

Private Psychiatric Hospital

Means a private hospital as defined in section 12 (2) of the Mental Health (Scotland) Act 1984

All private psychiatric hospitals have been regulated by the Care Commission since 1st April 2002.

Independent Clinic

A clinic which is not comprised in a hospital and in and from which services are provided, other than in pursuance of the National Health Service (Scotland) Act 1978, by a registered medical practitioner or registered dentist.

Only clinics which were registered before the 1st April 2002 under the Nursing Homes Registration (Scotland) Act 1938 are currently regulated under this heading.

Independent Medical Agency

An undertaking which is neither an independent clinic nor an undertaking comprised in a hospital and which consists of or includes the provision of services, other than in pursuance of the National Health Service (Scotland) Act 1978, by a registered medical practitioner.

Medical agencies have not yet been commenced for regulation by the Care Commission.

The Regulation of Care (Requirements as to Independent Health Care Services) (Scotland) Regulations 2008

Made - - - - 2008

Laid before the Scottish Parliament 2008

Coming into force - - 2008

The Scottish Ministers make the following Regulations in exercise of the powers conferred by section 29(1) of the Regulation of Care (Scotland) Act 2001( [1]) ("the Act") and all other powers enabling them to do so.

In accordance with section 29(12) of the Act they have consulted with such persons and groups of persons as they consider appropriate.

Citation, commencement and interpretation

1.-(1)(1) These Regulations may be cited as the Regulation of Care (Requirements as to Independent Health Care Services) (Scotland) Regulations 2008 and shall come into force on [date to be confirmed].

(2) In these Regulations-

"care service" means independent health care service;

"health care professional" means-

(a) a registered medical practitioner;

(b) a registered dentist or dental practitioner registered with the General Dental Council;

(c) a registered pharmacist, as defined in section 108(1) of the National Health Service (Scotland) Act 1978( [2]);

(d) an ophthalmic optician, as defined in section 108(1) of the National Health Service (Scotland) Act 1978 but excluding a body corporate enrolled in the list kept under section 9 of the Opticians Act 1989( [3]);

(e) a registered nurse, midwife or health visitor;

(f) a person who is registered as a member of a profession to which the Health Professions Order 2001( [4]) extends;

(g) a registered chiropractor as defined by section 43 of the Chiropractors Act 1994( [5]); or

(h) a registered osteopath as defined by section 41 of the Osteopaths Act 1993( [6]).

"manager" in relation to a care service means the person for the time being appointed to manage that service in accordance with regulation 17 of the Regulation of Care (Requirements as to Care Services) (Scotland) Regulations 2002( [7]);

"provider" in relation to a care service means the person for the time being providing that service;

"representative" means any person having legal authority, or the consent of the service user, to act on the service user's behalf;

"service user" in relation to a care service means any person to whom that service is provided; and

"statement of aims and objectives" means the written statement compiled in accordance with regulation 3.

(3) In these Regulations, references to employing a person include employing a person whether or not for payment and whether under a contract of service, a contract for services or otherwise than under a contract, and allowing a person to work as a volunteer; and references to an employee or to a person being employed shall be construed accordingly and shall include a registered medical practitioner or registered dentist having practising privileges who provides medical or dental care within the care service, and dental associates who provide dental care within the care service.

Principles

2. A provider of a care service shall provide the service in a manner which promotes and respects the independence of service users and, so far as it is practicable to do so, affords them choice in the way in which the service is provided to them.

Statement of Aims and Objectives

3. A provider shall prepare a written statement which shall include-

(a) the aims and objectives of the care service;

(b) the name and address of the provider and, if one has been appointed, the manager;

(c) the relevant qualifications and experience of the provider (where the provider is an individual) and, if one has been appointed the manager;

(d) the number of staff working in the care service, their experience and relevant qualifications;

(e) the organisational structure of the care service;

(f) a list of the treatments and other services provided by the care service;

(g) the range of needs which the care service is intended to meet and the facilities which are available for the benefit of service users;

(h) the arrangements made for consultation with service users about the operation of the care service; and

(i) the arrangements made for contact between any in-patients and their relatives, friends and representatives.

Welfare of users

4. Providers shall-

(a) make proper provision for the health and welfare of service users;

(b) provide services in a manner which respects the privacy and dignity of service users;

(c) ensure that no service user is subject to restraint unless it is the only practicable means of securing the welfare of that or any other service user and there are exceptional circumstances; and

(d) have appropriate procedures for the control of infection, decontamination and the management of clinical waste, including, in particular, the following:-

(i) where reusable medical devices are used in a care service, the provider shall ensure that appropriate procedures are implemented in relation to cleaning, disinfection, inspection, packaging, sterilisation, transportation storage and disposal of such devices, sufficient to ensure that reusable medical devices are handled safely and decontaminated effectively prior to re-use, and disposed of safely;

(ii) where non-reusable medical devices are used in a care service, the provider shall ensure that appropriate procedures are implemented in relation to transportation, storage, use and inspection, sufficient to ensure that such medical devices are handled and disposed of safely;

(iii) the provider 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 independent health care service and the recording of these processes;

(iv) the provider shall make suitable arrangements to minimise the risk of infection and the spread of infection between service users, carers and employees of the care service.

Patient Care Record

5.-(1)(1) A provider shall, after consultation with each service user and, where it appears to the provider to be appropriate, any representative, within 24 hours of the time at which the service user first received the service prepare a Patient Care Record ("PCR") which sets out how the service user's health and welfare needs are to be met.

(2) A provider shall ensure record is made in the PCR, as closely as possible to the time of the relevant event, the following matters.

(a) the date and time of every consultation with, or examination of, the service user by a health care professional and the name of that health care professional;

(b) the outcome of that consultation or examination;

(c) [details of] every treatment provided to the service user [including the place, date and time that treatment was provided and the name of the health care professional responsible for providing it]; and

(d) every drug ordered for the service user and the date and time at which it was administered or otherwise disposed of.

(3) A provider shall-

(a) make the PCR available to the service user and to any relevant representative of the service user;

(b) ensure that the PCR is readily available to all relevant health care staff involved in meeting the service user's health and welfare needs; and

(c) where appropriate, and after consultation with the service user and, where it appears to the provider to be appropriate, any representative, revise the PCR;

Fitness of providers

6.-(1)(1) A person shall not provide a care service unless that person is fit to do so.

(2) The following persons are unfit to provide a car service:-

(a) a person who is not of integrity and good character;

(b) a person who has been convicted whether in the United Kingdom or elsewhere of any offence which is punishable by a period of imprisonment (whether or not suspended or deferred) for any period without the option of a fine;

(c) a person whose estate has been sequestrated in Scotland or who has been adjudged bankrupt elsewhere in Scotland or in relation to whose estate a judicial factor has been appointed or who has granted a trust deed for the benefit of the person's creditors;

Provided that-

(i) the unfitness attaching to a person whose estate has been sequestrated shall cease if and when-

(aa) the sequestration is recalled or reduced; or

(bb) the sequestration is discharged;

(ii) the unfitness attaching to a person by reason of having been adjudged bankrupt shall cease if and when-

(aa) the bankruptcy is annulled; or

(bb) the person is discharged;

(iii) the unfitness attaching to a person in relation to whose estate a judicial factor has been appointed shall cease if and when-

(aa) that appointment is recalled; or

(bb) the judicial factor is discharged; or

(iv) the unfitness attaching to a person who has granted a trust deed shall cease if and when the person pays the creditors in full or on the expiry of 5 years from the date of grant of the deed.

(3) For the purposes of paragraph 92)(b)-

(a) the date of conviction shall be deemed to be the date on which the ordinary period allowed for making an appeal or application with respect to the conviction expires or, if such an appeal or application is made, the date on which the appeal or application is finally disposed of or abandoned or fails by reason of its not being prosecuted; and

(b) any conviction by or before a court outside the United Kingdom for an offence in respect of conduct which, if it had taken place in any part of the United Kingdom, would not have constituted an offence under the law in force in that part of the United Kingdom, shall be disregarded.

(4) A provider shall inform the Commission immediately in writing where a provider becomes a person who is unfit to provide a care service in terms of this regulation.

Fitness of managers

7.-(1)(1) A person shall not act as a manager in relation to a care service unless the person is fit to do so.

(2) The following persons are unfit to act as a manager in relation to a care service-

(a) any person to whom regulation 6(2)(a) applies;

(b) any person to whom regulation 6(2)(b) applies;

(c) a person who is not physically and mentally fit to manage the care service;

(d) a person who does not have the skills knowledge and experience necessary for managing the care service;

(e) a person who, in order to perform the duties for which the person is employed in the care service, is required by any enactment to be registered with any person or body and is not so registered.

Notification of unfitness

8.-(1)(1) Where a provider of a care service is, or becomes aware that a person acting as a manager in relation to the car service, has been convicted of any criminal offence whether in the United Kingdom or elsewhere, the provider shall immediately given notice to the Commission of-

(a) the date and place of conviction;

(b) the offence of which the provider or manager was convicted; and

(c) the penalty imposed in respect of the offence.

(2) Where a provider of a care service becomes aware that a person acting as manager in relation to that service is unfit to do so in terms of regulation 7, the provider shall immediately notify the Commission in writing of that fact.

Fitness of employees

9.-(1)(1) A provider shall not employ any person in the provision of a care service unless that person is fit to be so employed.

(2) The following persons are unfit to be employed in the provision of the care service:-

(a) a person who is not physically and mentally fit for the purposes of the work for which the person is employed in the care service;

(b) a person who does not have the qualifications, skills and experience necessary for the work that the person is to perform; and

(c) any person to whom regulation 7(2)(e) applies.

Fitness of premises

10.-(1)(1) A provider shall not use premises for the provision of a care service unless they are fit to be so used.

(2) Premises are unfit to be used for the provision of a care service unless-

(a) they are in a location and of a physical design and layout suitable for the purpose of achieving the aims and objectives of the care service which are set out in the statement of aims and objectives;

(b) they are of sound construction and kept in a good state of repair both externally and internally;

(c) they have adequate and suitable ventilation, heating and lighting;

(d) the size and layout of all rooms including operating theatres and treatment rooms are suitable for the purposes for which they are to be used and are suitably equipped and furnished;

(e) all parts of the premises used in the delivery of the service are clean and meet appropriate standards of hygiene, infection control and decontamination;

(f) all parts of the premises to which service users have access are, so far as reasonably practicable, free from hazards to their safety;

(g) such electrical supply is provided during the interruption of public supply as is needed to ensure the safety of the service users; and

(h) there are provided at appropriate places sufficient numbers of toilets, and of wash-basins, baths and showers fitted with a hot and cold water supply.

Facilities

11. Providers shall provide-

(a) where both adult, and child service users are provided with accommodation within the care service's premises, a separate area for the overnight accommodation of child and adult service users;

(b) a place where the money and valuables of service users may be deposited for safe keeping, and arrangements for service users to acknowledge in writing the return to them of any money or valuable so deposited.

(c) for employees, suitable facilities and accommodation, other than sleeping accommodation, including-

(i) changing room facilities; and

(ii) storage facilities; and

(d) where the provision of such accommodation is needed by employees in connection with their work, sleeping accommodation.

Staffing

12. A provider shall, having regard to the size and nature of the service, the statement of aims and objectives and the number and needs of service users-

(a) ensure that at all times suitably qualified and competent persons are working in the care service in such numbers as are appropriate for the health and welfare of service users;

(b) ensure that at all times a suitably qualified health care professional is working at the independent health care service whilst service users are present;

(c) ensure that each person employed in the provision of the care service receive-

(i) regular and appropriate appraisal performance review and validation;

(ii) education and training appropriate to the work they are to perform; and

(iii) suitable assistance, including time off work, for the purpose of obtaining further qualifications appropriate to such work.

(iv) take such steps as may be necessary to address any aspect of-

(aa) a health care professional's clinical practice; or

(bb) the performance of a member of staff who is not a health care professional which is found to be unsatisfactory.

(d) ensure that any person working in the care service who is not employed by the provider and to whom paragraph (c)(iv) does not apply, is appropriately supervised and has undergone an appropriate induction programme while carrying out their duties.

Quality of independent health care

13.-(1)(1) The provider of a care service shall make such arrangements as are necessary for securing that any treatment or services provided by the care service are of a quality which is appropriate to meet the needs of service users.

(2) The provider shall-

(a) introduce and maintain a system to manage risk associated with or arising from the care and treatment of service users;

(b) can evidence review of the quality of treatment and other services provided by the care service, which review shall involve consultation with service users and their carers where relevant; and

(c) produce a written record of the review carried out under sub-paragraph (b) above and make this record available to the Commission and service users.

Financial position

14.-(1)(1) Subject to paragraph (3), a provider shall provide the Commission with such information and documents as it may require in order to consider the financial viability of the care service, including-

(a) the annual accounts of the care service certified by an accountant;

(b) a reference from a bank expressing an opinion as to the provider's financial standing;

(c) information as to the financing and financial resources of the care service;

(d) where the provider is a company, information as to any of its associated companies; and

(e) a certificate of insurance for the provider in respect of liability which may be incurred by the provider in relation to the care service in respect of death, injury, public liability, damage or other loss.

(2) A provider, other than a person to whom paragraph (3) applies, shall-

(a) ensure that adequate accounts are maintained in respect of the care service;

(b) ensure that accounts give details of the running costs of the care service, including any rent, payments under a mortgage and expenditure on food, heating and payments to employees; and

(c) supply a copy of the accounts to the Commission at its request.

(3) In this regulation a company is an associated company of another if one of them has control of the other or both are under the control of the same person.

Appointment to manager

15.A provider who-

(a) is not an individual;

(b) is not a fit person to manage a care service; or

(c) is not, or does not intend to be, in full time day to day charge of the care service;

shall appoint an individual to be the manager of the care service.

(2) Where a provider appoints a person to manage the care service, the provider shall forthwith give notice to the Commission of-

(a) the name of the person so appointed; and

(b) the date on which the appointment is to take effect.

Appointment of liquidators etc

16. Any person to whom section 29(3) of the Regulation of Care (Scotland) Act 2001 applies must-

(a) forthwith notify the Commission of that person's appointment; and

(b) where no person has been appointed to manage the care service, appoint such a person.

Records

17. A provider shall keep a record of the matters set out in the schedule to these Regulations.

Notification of death, illness and other events

18.-(1)(1) A provider shall give notice to the Commission without delay of the death of any service user who has died while the care service was being provided to the service user, and of the circumstances of the death.

(2) A provider shall give notice to the Commission without delay in the occurrence of-

(a) an outbreak in the care service of any serious infection or infectious disease which in the opinion of any registered medical practitioner attending persons in the care service is sufficiently serious to be so notified;

(b) any serious injury to a service user;

(c) any theft or accident;

(d) any allegation of misconduct by the provider or any person who is employed in the care service; or

(e) significant clinical incidents which have affected or may affect the clinical safety and welfare of the service user.

Notice of changes

19. A provider shall given notice in writing to the Commission as soon as it is practicable to do so if any of the following events takes place or is proposed to take place:-

(a) any change of provider;

(b) any change of manager;

(c) any change, alteration or extension to or of, or acquisition of premises which are or will be used in the provision of the care service;

(d) where the provider is an individual, that person's name is changed;

(e) where the provider is a body corporate, any change in the ownership of the entire body, or a controlling interest therein or any change in the identity of its officers; or

(f) where the provider is a firm, any change in the identity of the persons who are its partners.

Pathology services

20. The provider shall ensure that-

(a) an adequate range of pathology services are available to meet the needs of the care service;

(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 care service's premises) transportation of pathology specimens; and

(d) any specimen taken from a service user is, at all times, identifiable as having been taken from that service user.

Resuscitation

21.-(1)(1) The provider shall prepare and implement a written statement of the policies to be applied and the procedures to be followed in the care service in relation to resuscitation of service users, and shall review such statement annually.

(2) The provider shall ensure that the policies and procedures implemented in accordance with paragraph (1)-

(a) take proper account of the rights of all service users who have capacity to give or withhold consent to treatment and take proper account of the rights of all service users who do not have capacity;

(b) are available on request to every service user and any representative; 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 service user.

Treatment of children

22. The provider shall ensure that, where a child is treated and cared for in a care service-

(a) treatment and care is provided in accommodation which is appropriate and normally separate from accommodation in which adult patients are treated;

(b) particular medical, physical, psychological, emotional, spiritual, social, educational and supervision needs arising from the child's age are met;

(c) treatment and care is provided by persons who have appropriate qualifications, skills and experience in the treatment and care of children;

(d) the child's parents or guardians are kept fully informed of the child's condition and so far as is practicable consulted about all aspects of treatment, except where the child is competent to consent to treatment and does not wish their parents and guardians to be so informed and consulted.

Dental treatment under general anaesthesia and/or conscious sedation

23. Where the treatment provided in a care service includes dental treatment under general anaesthesia or conscious sedation, the provider shall ensure that-

(a) the dentist and any employees assisting the dentist are suitably 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

24.-(1)(1) The provider shall ensure that no Class 3B or Class 4 laser or intense light source is used in or for any treatment unless there is in place a professional protocol drawn up by a trained and experienced medical practitioner or registered dentist from the relevant discipline in accordance with which treatment is to be provided, and is so provided.

(2) The provider shall ensure that such a laser or intense light source is used in or for the purposes of the care service 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) the biological and environmental effects of a laser or intense light source;

(d) precautions to be taken before and during use of a laser or intense light source;

(e) action to be taken in the event of an accident, emergency, or other adverse incident associated with the provision of treatment using a laser or intense light source; and

(f) the need to identify a laser protection adviser and supervisor.

Notice of absence

25.-(1)(1) Where a manager proposes to be absent from the duties of manager of the care service for a continuous period of 28 days, or more, the provider shall give notice to the Commission of the proposed absence.

(2) Except in the case of an emergency, the notice referred to in paragraph (1) above shall be given no later than 14 days before the proposed absence or within such shorter period as may be agreed with the Commission and the notice shall specify-

(a) the length or expected length of the proposed absence;

(b) the reason for that absence;

(c) the arrangements which have been made for the running of the care service during that absence; and

(d) the name, address and qualifications of the person who will manage the care service during that absence.

(3) Where the absence arises as a result of an emergency, the provider shall give notice of the absence within one week of its occurrence specifying the matters in sub-paragraphs (a) to (d) of paragraph (2).

Notice of changes

26. A provider shall give notice in writing to the Commission as soon as it is practicable to do so if any of the following events take place or is proposed to take place:-

(a) any change of provider of the care service;

(b) any change of manager of the care service;

(c) any change of premises which are used in the provision of the care service;

(d) where the provider is an individual, any change in that person's name;

(e) where the provider is a body corporate, any change in the ownership of the body or of the identity of its officers; or

(f) where the provider is a firm, any change in the identity of the persons who are its partners.

Death of provider

27. Where a provider who is an individual dies, and there is no other provider, the personal representatives of the provider shall, without delay give notice of the death to the Commission.

Complaints

28.-(1)(1) A provider shall establish a procedure ("the complaints procedure") for considering complaints made to the provider by a service user or person acting on the service user's behalf.

(2) The complaints procedure shall be appropriate to the needs of the service users.

(3) The provider shall ensure that any complaint made under the complaints procedure is fully investigated.

(4) The provider 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 any action (if any) that is to be taken.

(5) The provider shall supply a written copy of the complaints procedure to every service user and to any person acting on behalf of a service user if that person so requests.

(6) The written copy of the complaints procedure shall include-

(a) the name and address of the Commission, and

(b) the procedure (if any) that has been notified by the Commission to the provider for the making of complaints to the Commission relating to the care service.

(7) The provider shall supply to the Commission at its request a statement containing a summary of the complaints made during the preceding twelve months and the action that was taken.

Offences

29. A contravention of or failure to comply with any of the provisions of regulations 5(1), 7(1), or 8(1) shall be an offence.

SCHEDULE

Records to be maintained for inspection

1. A register of service users, including:-

(a) the name, address, telephone number and date of birth of each service user;

(b) the name, address and telephone number of the service user's next of kin or any person authorised to act on their behalf;

(c) the name, address and telephone number of the service user's general practitioner;

(d) where a service user has been received into guardianship under the Mental Health (Care and Treatment) (Scotland) Act 2003, the name, address and telephone number of the guardian;

(e) the name and address of any body which arranged the service user's admission to or treatment by the care service;

(f) the date on which the service user was admitted to an establishment or first received treatment provided for the purposes of an establishment or agency;

(g) the nature of the treatment for which the service user was admitted and which was received;

(h) where the service user has been an in-patient in an independent hospital, the date of discharge;

(i) if the service user has been transferred to a hospital (including a health service hospital), the date of the transfer, the reasons for it and the name of the hospital to which the service user was transferred;

(j) if the service user dies whilst in an establishment or during treatment provided for the purposes of an establishment or agency, the date, time and cause of the service user's death.

2. A record of-

(a) any occasion on which restraint or control has been applied to a service user, with details of the form of restraint or control, the reason why it was necessary and the name of the person authorising it;

(b) the procedure which is to be followed in the event of a fire or other emergency;

(c) all fire drill sand alarm tests which have been conducted;

(d) any incident which is detrimental to the health or welfare of a service user;

(e) any maintenance of equipment which is used in the provision of the service;

(f) any complaint made by a service user, representative or relative of a service user or a person employed in the care service about the operation of the care service, the outcome of such complaint and the action taken;

(g) the rostered shifts for each employee and a record of the hours actually worked by each employee;

(h) medicines [for the use of service users which are] kept on the premises from which the care service is provided; and

(i) details of any instance in which medication has been administered to a service user without the consent of that service user or a person duly authorised to consent on the service user's behalf.

3. A record of all surgical operations performed in an establishment or by an agency, including-

(a) the name of the service user on whom the operation was performed;

(b) the nature of the surgical procedure and the date and time of the procedure;

(c) the name of the medical practitioner or dentist by whom the operation was performed;

(d) the name of the anaesthetist in attendance;

(e) the name and signature of the person responsible for managing the equipment, swabs and needles throughout the operation;

(f) details of all implanted medical devices, except where this would entail the disclosure of information contrary to the provisions of section 33(5) of the Human Fertilisation and Embryology Act 1990 (restrictions on disclosure of information).

4. A record of each occasion on which a technique or technology to which regulation 0 applies has been used; including-

(a) the name of the service user in connection with whose treatment the technique or technology was used;

(b) the nature of the technique or technology in question and the date on which it was used; and

(c) the name of the person using it.

5. A record of all mechanical and technical equipment used for the purposes of treatment provided by the establishment or agency including-

(a) the date of purchase of the equipment;

(b) the date of installation of the equipment;

(c) details of maintenance of the equipment and the dates on which maintenance work was carried out.

6. A record of all events which must be notified to the Commission in accordance with regulation 0.

7. A record of the rostered shifts for each employee and a record of the hours actually worked by each person.

8. A record of each person employed in or for the purposes of the care service, including-

(a) their name and date of birth;

(b) positions which they have held in the care service;

(c) the dates of their employment in the care service;

(d) in respect of a health care professional, details of their professional qualifications and registration with the relevant professional regulatory body; and

(e) any disciplinary action taken by the care service against them, including the outcome of any such action.

QUESTIONS ON THE PROPOSED REGULATIONS

Personal plans

The term 'personal plan' is used in the 2002 regulations. Our preference for independent healthcare services is to use 'patient care record' (PCR). This term is used in the National Care Standards and is defined as 'A multi-disciplinary record of all care assessment and treatment, including the medical component'

Q: Is patient care record the correct term. If not what term should be used and why?

Reviewing the personal plan

The 2002 regulations there is a requirement to review personal plans in care homes when requested to do so by the service user or any representative; and at least once in every six month period.

Independent healthcare services provide a broad range of services from clinics where the service user may visit only once or twice to those where service users are resident for long periods of time.

Q: Should PCRs be regularly reviewed and if so how often?

Research

There are safeguards in place for research conducted in or through the NHS in Scotland. This research is governed by the Research Governance Framework for Health and Community Care in Scotland which sets standards to improve research quality and safeguard the public.

It is not the function of the Care Commission to regulate any research being carried out in the independent sector. However, safeguarding the people who use care services is included in the role of the regulator.

Q: With that in mind should regulations be included to put safeguards in place for individuals who may be invited to participate in research:

· to ensure that the purpose and scope of any research is clearly defined and understood; and

· that there are appropriate consents in place and clarity as to what may or may not take place, including the publication of results, the use and retention of samples, etc.?

General

Q: Have we covered all appropriate aspects in these draft regulations? If not please say what we have missed and why you think regulations are needed.

([1]) 2001 asp 8.

([2]) 1978 c.29.

([3]) 1989 c.44.

([4]) S.I. 2001/254.

([5]) 1994 c.17.

([6]) 1993 c.21.

([7]) S.S.I. 2002/114.