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The National Health Service (Primary Medical Services Section 17C Agreements) (Scotland) Regulations 2018

Type Scottish-Statutory-Instrument

Publication 2018-02-15

Last updated 2026-03-14

State In force

Jurisdiction Scotland

Department King's Printer for Scotland

Source legislation.gov.uk

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(ii) is no longer a person to which the provider has agreed to provide the service.

(3) A provider who wishes to terminate its responsibility for a patient under sub-paragraph (2) (b) or (c) must notify the patient of the termination and the reason for it.

(4) The provider must keep a written record of terminations under this paragraph and of the reason for them and must make this record available to the Health Board on request.

(5) A termination under—

(a) sub-paragraph (2)(b) will take effect 14 days from the date on which notice is given; and

(b) sub-paragraph (2)(c) will take effect from the date on which notice is given.

PART 3 — PRESCRIBING AND DISPENSING

Prescribing

11

The provider must ensure that any prescription form for drugs, medicines or appliances issued or created by a prescriber complies as appropriate with the requirements in paragraphs 12 to 14.

Prescribing

12

(1) Subject to paragraphs 13 and 14, a prescriber must order any drugs, medicines or appliances which are needed for the treatment of any patient who is receiving treatment under the agreement by—

(a) issuing to that patient a non-electronic prescription form; or

(b) creating and transmitting an electronic prescription form,

and such a non-electronic prescription form or electronic prescription form must not be used in any other circumstances.

(2) In issuing any non-electronic prescription form, the prescriber must sign the prescription form in ink with the prescriber’s initials, or forenames, and surname in the prescriber’s own handwriting and not by means of a stamp and must so sign only after particulars of the order have been inserted in the prescription form.

(3) A prescription form must not refer to any previous prescription form.

(4) A separate prescription form must be used for each patient.

(5) In a case of urgency a prescriber may request a pharmacist to dispense a drug or medicine before a prescription form is issued or created , only if—

(a) that drug or medicine is not a Scheduled drug;

(b) that drug is not a controlled drug within the meaning of the Misuse of Drugs Act 1971⁶² other than a drug which is for the time being specified in schedules 4 or 5 of the Misuse of Drugs Regulations 2001⁶³; and

(c) the prescriber undertakes to furnish the pharmacist, within 72 hours, with a prescription form completed in accordance with sub-paragraph (2) or with an electronic prescription form.

(6) In a case of urgency a prescriber may request a pharmacist to dispense an appliance before a prescription form is issued or created only if—

(a) that appliance does not contain a Scheduled drug or a controlled drug within the meaning of the Misuse of Drugs Act 1971, other than a drug which is for the time being specified in schedule 5 of the Misuse of Drugs Regulations 2001;

(b) in the case of a restricted availability appliance, the patient is a person, or it is for a purpose, specified in the Drug Tariff; and

(c) the prescriber undertakes to furnish the pharmacist, within 72 hours, with a prescription form completed in accordance with sub-paragraph (2) or with an electronic prescription form.

(7) A prescriber may only order drugs, medicines or appliances by means of an electronic prescription form if the prescription is not for a controlled drug within the meaning of the Misuse of Drugs Act 1971, other than a drug which is for the time being specified in schedule 4 or 5 of the Misuse of Drugs Regulations 2001.

(8) A prescriber who orders drugs, medicines or appliances by means of an electronic prescription form must issue the patient with a written record of the prescription which has been created.

Restrictions on prescribing by medical practitioners

13

(1) In the course of treating a patient to whom a medical practitioner is providing treatment under the agreement, the medical practitioner must not order on a prescription form a drug, medicine or other substance specified in any directions given by the Scottish Ministers under section 17N(6) of the Act⁶⁴ as being drugs, medicines or other substances which may not be ordered for patients in the provision of primary medical services under a general medical services contract but may, subject to regulation 24(1)(b), prescribe such a drug, medicine or other substance for that patient in the course of that treatment under a private arrangement.

(2) In the course of treating a patient to whom a medical practitioner is providing treatment under the agreement, the medical practitioner must not order on a prescription form or repeatable prescription a drug, medicine or other substance specified in any directions given by the Scottish Ministers under section 17N(6) of the Act as being a drug, medicine or other substance which may only be ordered for specified patients and specified purposes in the provision of primary medical services under a general medical services contract unless:

(a) that patient is a person of the specified description;

(b) that drug, medicine or other substance is prescribed for that patient only for the specified purpose; and

but may, subject to regulation 24(1)(b), prescribe such a drug, medicine or other substance for that patient in the course of that treatment under a private arrangement.

(3) In the course of treating a patient to whom a medical practitioner is providing treatment under the agreement, the medical practitioner must not order on a prescription form a restricted availability appliance unless—

(a) the patient is a person, or it is for a purpose, specified in the Drug Tariff; and

(b) the practitioner includes on the prescription form the reference “SLS”,

but may, subject to regulation 24(1)(b), prescribe such an appliance for that patient in the course of that treatment under a private arrangement.

Restrictions on prescribing by supplementary prescribers

14

(1) The provider must have arrangements in place to secure that a supplementary prescriber will—

(a) issue or create a prescription for a prescription only medicine;

(b) administer a prescription only medicine for parenteral administration; or

as a supplementary prescriber under the conditions set out in sub-paragraph (2).

(2) The conditions referred to in sub-paragraph (1) are that—

(a) the supplementary prescriber satisfies the applicable conditions set out in regulation 215 of the Human Medicines Regulations 2012⁶⁵ (prescribing and administration by supplementary prescribers), unless those conditions do not apply by virtue of any of the exemptions set out in the subsequent provisions of those Regulations;

(b) the drug, medicine or other substance is not specified in any directions given by the Scottish Ministers under section 17N(6) of the Act as being a drug, medicine or other substance which may not be ordered for patients in the provision of primary medical services under a general medical services contract;

(c) the drug, medicine or other substance is not specified in any directions given by the Scottish Ministers under section 17N(6) of the Act as being a drug, medicine or other substance which can only be ordered for specified patients and specified purposes in the provision of primary medical services under a general medical services contract unless—

(i) the patient is a person of the specified description;

(ii) the medicine is prescribed for that patient only for the specified purposes; and

(iii) if the supplementary prescriber is issuing or creating the prescription, the supplementary prescriber includes on the prescription form the reference “SLS”.

(3) Where the functions of a supplementary prescriber include prescribing, the provider must have arrangements in place to secure that that person will only issue or create a prescription for—

(a) an appliance; or

(b) a medicine which is not a prescription only medicine,

as a supplementary prescriber under the conditions set out in sub-paragraph (4).

(4) The conditions referred to in sub-paragraph (3) are that—

(a) the supplementary prescriber acts in accordance with a clinical management plan which is in effect at the time the supplementary prescriber acts and which contains the following particulars—

(i) the name of the patient to whom the plan relates;

(ii) the illness or conditions which may be treated by the supplementary prescriber;

(iii) the date on which the plan is to take effect, and when it is to be reviewed by the medical practitioner or dentist who is a party to the plan;

(iv) reference to the class or description of medicines or types of appliances which may be prescribed or administered under the plan;

(v) any restrictions or limitations as to the strength or dose of any medicine which may be prescribed or administered under the plan, and any period of administration or use of any medicine or appliance which may be prescribed or administered under the plan;

(vi) relevant warnings about known sensitivities of the patient to, or known difficulties of the patient with, particular medicines or appliances;

(vii) the arrangements for notification of—

(aa) suspected or known adverse reactions to any medicine which may be prescribed or administered under the plan, and suspected or known adverse reactions to any other medicine taken at the same time as any medicine prescribed or administered under the plan; and

(bb) incidents occurring with the appliance which might lead, might have led or has led to the death or serious deterioration of state of health of the patient; and

(viii) the circumstances in which the supplementary prescriber should refer to, or seek the advice of, the medical practitioner or dentist who is a party to the plan;

(b) the supplementary prescriber has access to the health records of the patient to whom the plan relates which are used by any medical practitioner or dentist who is a party to the plan;

(c) if it is a prescription for a drug, medicine or other substance, that drug, medicine or other substance is not specified in any directions given by the Scottish Ministers under section 17N(6) of the Act as being a drug, medicine or other substance which may not be ordered for patients in the provision of primary medical services under a general medical services contract;

(d) if it is a prescription for a drug, medicine or other substance, that drug, medicine or other substance is not specified in any directions given by the Scottish Ministers under section 17N(6) of the Act as being a drug, medicine or other substance which can only be ordered for specified patients and specified purposes in the provision of primary medical services under a general medical services contract unless—

(i) the patient is a person of the specified description;

(ii) the medicine is prescribed for that patient only for the specified purposes; and

(iii) when issuing or creating the prescription, the supplementary prescriber includes on the prescription form the reference SLS;

(e) if it is a prescription for an appliance, the appliance is listed in Parts 2 to 6 or 8 to 10 of the Drug Tariff; and

(f) if it is a prescription for a restricted availability appliance—

(i) the patient is a person of a description mentioned in the entry in Part 3 of the Drug Tariff in respect of that appliance;

(ii) the appliance is prescribed only for the purposes specified in respect of that person in that entry; and

(iii) when issuing or creating the prescription, the supplementary prescriber includes on the prescription form the reference “SLS”.

(5) In sub-paragraph (4)(a), “clinical management plan” means a plan (which may be amended from time to time) relating to the treatment of an individual patient agreed by—

(a) the patient to whom the plan relates;

(b) the medical practitioner or dentist who is a party to the plan; and

Excessive prescribing

15

(1) The provider must not prescribe drugs, medicines or appliances whose cost or quantity, in relation to any patient, is, by reason of the character of the drug, medicine or appliance in question in excess of that which is reasonably necessary for the proper treatment of that patient.

(2) In considering whether a provider has breached its obligations under sub-paragraph (1), the Health Board must seek the views of the area medical committee for its area.

Provision of dispensing services

16

(1) A provider may secure the provision of dispensing services to its patients under the agreement only if it is authorised or required to do so by the Health Board in accordance with the following provisions of this paragraph.

(2) Where the Health Board is satisfied, after consultation with the area pharmaceutical committee that a person, by reason of—

(a) distance;

(b) inadequacy of means of communication; or

will have serious difficulty in obtaining from a pharmacist any drugs, medicines or appliances, other than Scheduled drugs, required for that person’s treatment, the Health Board must require or authorise the provider with whom the person is a registered patient to supply such drugs, medicines and appliances to that person until further notice.

(3) Notwithstanding anything in sub-paragraph (2)—

(a) a provider will not be required to undertake the supply of drugs, medicines and appliances under sub-paragraph (2) if the provider satisfies the Health Board that the provider is not in the habit of dispensing drugs, medicines and appliances for the provider’s patients;

(b) a provider will be entitled to receive reasonable notice from the Health Board that the provider is required to undertake the supply of drugs, medicines and appliances under sub-paragraph (2) or that such supply is to be discontinued.

(4) A provider must receive the support of an appropriately qualified pharmacist independent prescriber provided by the Health Board, where the Health Board considers that the health outcomes of patients are likely to be improved by the provider and pharmacist independent prescriber working together with the aim of ensuring that the patient gets the best clinical benefit from their prescribed medicines.

(5) Subject to sub paragraph (7), a provider, who is required by the Health Board to supply drugs, medicines and appliances under sub-paragraph (2) to a patient, in the course of treating that patient under these Regulations—

(a) must, subject to sub-paragraph (8), record on a prescription form completed in accordance with paragraph 12, an order for supply of any drugs, medicines or appliances which are needed for the treatment of that patient, but will not be required to issue that form to that patient;

(b) must supply those drugs, medicines or appliances for that patient under sub paragraph (2) but—

(i) must not supply under sub paragraph (2) for that patient any Scheduled drug specified as being a drug, medicine or other substance which may not be ordered for patients in the provision of primary medical services under a general medical services contract, except that, where the provider has ordered a drug which has an appropriate non proprietary name either by that name or by its formula, the provider may supply a drug which has the same specification notwithstanding that it is such a Scheduled drug (but, in the case of a drug which combines more than one drug, only if the combination has an appropriate non proprietary name);

(ii) must supply under sub paragraph (2) for that patient any Scheduled drug specified as being a drug, medicine or other substance which may only be ordered for specific patients and purposes in the provision of primary medical services under a general medical services contract, only where—

(aa) that patient is a person of the specified description; and

(bb) that drug, medicine or other substance is supplied to that patient only for the specified purpose;

(iii) must supply under sub paragraph (2) for that patient a restricted availability appliance only if it is for a patient in a category of person or a purpose specified in the Drug Tariff;

(c) may supply for that patient with the provider’s consent, in respect of that treatment but otherwise than under sub paragraph (2), any Scheduled drug.

(6) A provider must comply with any arrangements made by the Scottish Ministers, or made by the Health Board after consultation with the area medical committee and the area pharmaceutical committee and approved by the Scottish Ministers, under which the provider may obtain and have available any drugs, medicines or appliances which the provider is required or entitled to supply in terms of this paragraph.

(7) Sub-paragraph (5) does not apply to drugs, medicines or appliances ordered on a prescription form by a supplementary prescriber, or an independent prescriber.

(8) Where a patient presents an order on a non-electronic prescription form for listed drugs or medicines, or appliances, signed by a supplementary prescriber, or an independent prescriber, to a provider who is required under sub-paragraph (2) to provide drugs or appliances to that patient, or a provider who is required under sub-paragraph (2) to provide drugs or appliances to a patient receives from the ePharmacy service an electronic prescription form which contains an order for listed drugs or medicines, or appliances in respect of that patient, signed by a supplementary prescriber, or an independent prescriber, the provider may provide to the patient such drugs, medicines or appliances so ordered as the provider supplies in the normal course of the provider’s practice.

(9) A drug supplied by a provider unless administered in person must be supplied in a suitable container.

(10) Nothing in this paragraph must prevent a provider providing a Scheduled drug or a restricted availability appliance in the course of treating a patient under a private arrangement.

(11) A provider who is required or authorised by the Health Board to supply drugs, medicines and appliances under sub-paragraph (2) may do so in accordance with a Scottish SSP.

Provision of drugs, medicines and appliances for immediate treatment or personal administration

17

(1) Subject to sub-paragraph (2), a provider—

(a) must provide to a patient any drug, medicine or appliance, not being a Scheduled drug, where such provision is needed for the immediate treatment of that patient before a provision can otherwise be obtained; and

(b) may provide to a patient any drug, medicine or appliance, not being a Scheduled drug, which the provider personally administers or applies to that patient,

but may, in either case, provide a restricted availability appliance only if it is for a person or a purpose specified in the Drug Tariff.

(2) Nothing in sub-paragraph (1) authorises a person to supply any drug or medicine to a patient otherwise than in accordance with Part 3 of the Medicines Act 1968⁶⁶ or any regulations or orders made thereunder.

PART 4 — PERSONS WHO PERFORM SERVICES

Qualifications of performers

18

(1) Subject to sub-paragraph (2), no medical practitioner may perform medical services under the agreement unless the practitioner is—

(a) included in the primary medical services performers list for the Health Board which is under a duty to provide or secure the provision of the service to be performed;

(b) not suspended from that list or from the Medical Register; and

(2) Sub-paragraph (1)(a) will not apply in the case of—

(a) a medical practitioner employed in Scotland by a Health Board, in England and Wales by an NHS trust, or in Northern Ireland by a Health and Social Care trust who is providing services other than primary medical services at the practice premises;

(b) a person who is provisionally registered under section 15 (provisional registration), 15A (provisional registration for EEA nationals) or 21 (provisional registration) of EEA nationals with certain overseas qualifications of the Medical Act 1983⁶⁸ acting in the course of the person’s employment in a resident medical capacity in an approved medical practice within the meaning of section 44D of the Medical Act 1983 (approved practice settings)⁶⁹; or

(c) a GP Registrar who has applied to the Health Board to have the GP Registrar’s name included in the primary medical services performers list of the Health Board, until the first of the following events arises:—

(i) the Health Board notifies the GP Registrar of the Board’s decision on that application;

(ii) the end of a period of 2 months, starting with the date on which the GP Registrar’s vocational training scheme begins.

(3) In this paragraph, “vocational training scheme” has the meaning given in regulation 2 (interpretation) of the National Health Service (Primary Medical Services Performers Lists) (Scotland) Regulations 2004⁷⁰.

Qualifications of performers

19

No health care professional other than one to whom paragraph 18 applies may perform clinical services under the agreement unless the health care professional is appropriately registered with the health care professional’s relevant professional body and the health care professional’s registration is not currently suspended.

Qualifications of performers

20

Where the registration of a health care professional or, in the case of a medical practitioner, the practitioner’s inclusion in a list, is subject to conditions, the provider must ensure compliance with those conditions insofar as they are relevant to the agreement.

Qualifications of performers

21

No health care professional may perform any clinical services unless the health care professional has such clinical experience and training as are necessary to enable the health care professional properly to perform such services.

Conditions for employment and engagement

22

(1) Subject to sub-paragraphs (2) and (3), a provider must not employ or engage a medical practitioner (other than one falling within paragraph 18(2)) unless—

(a) that practitioner has provided the provider with the name and address of the Health Boards on whose primary medical services performers lists the practitioner appears; and

(b) the provider has checked that the practitioner meets the requirements in paragraph 18.

(2) Where the employment or engagement of a medical practitioner is urgently needed and it is not possible for the provider to check the matters referred to in paragraph 18 in accordance with sub-paragraph (1)(b) before employing or engaging that practitioner, the practitioner may be employed or engaged on a temporary basis for a single period of up to 7 days whilst such checks are undertaken.

(3) Where the prospective employee is a GP Registrar, the requirements set out in sub-paragraph (1) must apply with the modifications that—

(a) the name and address provided under sub-paragraph (1) may be the name and address of the Health Boards on whose primary medical services performers lists the GP Registrar Scheme Guidance has applied for inclusion; and

(b) confirmation that the GP Registrar’s name appears on those lists will not be required until the end of the first two months of the GP Registrar’s training period.

(4) The provider may only offer employment to a general medical practitioner on terms and conditions which are no less favourable than those contained in the “Model terms and conditions of service for a salaried general practitioner employed by a GMS practice” published by the British Medical Association and the NHS Confederation as item 1.2 of the supplementary documents to the GMS contract 2003⁷¹.

Conditions for employment and engagement

23

(1) A provider must not employ or engage—

(a) a health care professional (other than one to whom paragraph 18 applies) unless the provider has checked that the health care professional meets the requirements in paragraph 19;

(b) a health care professional to perform clinical services unless the provider has taken reasonable steps to satisfy the provider that the health care professional meets the requirements in paragraph 21.

(2) Where the employment or engagement of a health care professional is urgently needed and it is not possible to check the matters referred to in paragraph 19 in accordance with sub-paragraph (1) before employing or engaging the health care professional, the health care professional may be employed or engaged on a temporary basis for a single period of up to 7 days whilst such checks are undertaken.

(3) When considering a health care professional’s experience and training for the purposes of sub-paragraph (1)(b) the provider must have regard in particular to—

(a) any post-graduate or post-registration qualification held by the health care professional; and

(b) any relevant training undertaken by the health care professional and any relevant clinical experience gained by the health care professional.

Conditions for employment and engagement

24

(1) A provider must not employ or engage a health care professional to perform medical services under the agreement unless—

(a) that person has provided two clinical references, relating to two recent posts (which may include any current post) as a health care professional which lasted for three months without a significant break, or where this is not possible, a full explanation and alternative referees; and

(b) the provider has checked and is satisfied with the references.

(2) Where the employment or engagement of a medical practitioner is urgently needed and it is not possible to obtain and check the references in accordance with sub-paragraph (1)(b) before employing or engaging the practitioner, the practitioner may be employed or engaged on a temporary basis for a single period of up to 14 days whilst the practitioner’s references are checked and considered, and for an additional single period of a further 7 days if the provider believes the person supplying those references is ill, on holiday or otherwise temporarily unavailable.

(3) Where the provider employs or engages the same person on more than one occasion within a period of three months, it may rely on the references provided on the first occasion, provided that those references are not more than twelve months old.

Conditions for employment and engagement

25

(1) Before employing or engaging any person to assist the provider in the provision of services under the agreement, the provider must take reasonable care to satisfy itself that the person in question is both suitably qualified and competent to discharge the duties for which the person is to be employed or engaged.

(2) The duty imposed by sub-paragraph (1) is in addition to the duties imposed by paragraphs 22 to 24.

(3) When considering the competence and suitability of any person for the purpose of sub-paragraph (1), the provider must have regard, in particular, to—

(a) that person’s academic and vocational qualifications;

(b) the person’s education and training; and

Training

26

(1) Subject to sub-paragraph (2) the provider must ensure that for any health care professional who is—

(a) performing clinical services under the agreement; or

(b) employed or engaged to assist in the performance of such services,

there are in place arrangements for the purpose of maintaining and updating the health care professional’s skills and knowledge in relation to the services which the health care professional is performing or assisting in performing.

(2) Sub-paragraph (1) does not apply in respect of a health care professional who is—

(a) employed by the Health Board, and

(b) performing clinical services under the agreement solely as part of the support which the Health Board is required to provide under paragraph 6A(1) (Health Board support for providers: community treatment and care services) or paragraph 6B(1) (Health Board support for providers: pharmacotherapy services).

Training

27

The provider must afford to each employee reasonable opportunities to undertake appropriate training with a view to maintaining that employee’s competence.

Arrangements for GP registrars

28

(1) The provider may only employ or engage a GP Registrarsubject to the conditions in sub-paragraph (2).

(2) The conditions referred to in sub-paragraph (1) are that the provider must not, by reason only of having employed or engaged a GP Registrar, reduce the total number of hours for which other medical practitioners perform primary medical services under the agreement or for which other staff assist them in the performance of those services.

(3) A provider which employs or engages a GP Registrar must—

(a) offer the GP Registrar terms of employment in accordance with the rates and subject to the conditions contained in any directions given by the Scottish Ministers to NHS Education for Scotland⁷² concerning the grants, fees travelling and other allowances payable to GP Registrars; and

(b) take into account any guidance issued by the Scottish Ministers in relation to the GP Registrar Scheme ⁷³.

Independent prescribers and supplementary prescribers

29

(1) Where—

(a) a provider employs or engages a person who is an independent prescriber or a supplementary prescriber whose functions will include prescribing;

(b) a party to the agreement is an independent prescriber or a supplementary prescriber whose functions will include prescribing;

(c) a partner or member as the case may be of a partnership or limited liability partnership that is a party to the agreement, is an independent prescriber or a supplementary prescriber whose functions will include prescribing;

(d) the member of a company that is a party to the agreement is an independent prescriber or a supplementary prescriber whose functions will include prescribing; or

(e) the functions of a person who is an independent prescriber or a supplementary prescriber whom it already employs or has already engaged are extended to include prescribing,

it must notify the Health Board in writing within the period of seven days beginning with the date on which the provider employed or engaged the person, the person became a party to the agreement, the person became a partner or member as the case may be of the partnership, limited liability partnership or company that is a party to the agreement (unless, immediately before becoming such a party, or partner or member of that partnership, limited liability partnership or company that is such a party, the person fell under sub-paragraph (1)(a)) or the person’s functions were extended as the case may be.

(2) Where—

(a) the provider ceases to employ or engage a person who is an independent prescriber or a supplementary prescriber, whose functions included prescribing in the provider’s practice;

(b) the party to the agreement, who is an independent prescriber or a supplementary prescriber, whose functions include prescribing, ceases to be a party to the agreement;

(c) the partner or member, as the case may be in a partnership or limited liability partnership who is an independent prescriber or a supplementary prescriber, whose functions include prescribing, ceases to be a partner or member of the partnership or limited liability partnership;

(d) the member of a company that is a party to the agreement, who is an independent prescriber or a supplementary prescriber whose functions include prescribing, ceases to be a member of the company;

(e) the functions of a person who is an independent prescriber or a supplementary prescriberwhom the provider employs or engages in its practice are changed so that they no longer include prescribing in its practice; or

(f) the provider becomes aware that a person who is an independent prescriber or a supplementary prescriber whom the provider employs or engages has been removed or suspended from the relevant register,

it must notify the Health Board in writing by the end of the second day after the day when the event occurred.

(3) The provider must provide the following information when it notifies the Health Board in accordance with sub-paragraph (1).

(a) the person’s full name;

(b) the person’s professional qualifications;

(d) the date on which the person’s entry in the relevant register was annotated to the effect that the person was qualified to order drugs, medicines and appliances for patients;

(e) the date on which—

(i) the person was employed or engaged, if applicable;

(ii) the person became a party to the agreement, if applicable;

(iii) the person became a partner or member, as the case may be in the partnership or limited liability partnership that is a party to the agreement, if applicable;

(iv) the person became a member of a company that is a party to the agreement, if applicable; or

(v) one of the person’s functions became to prescribe in its practice.

(4) The provider must provide the following information when it notifies the Health Board in accordance with sub-paragraph (2):—

(a) the person’s full name;

(b) the person’s professional qualifications;

(d) the date on which—

(i) the person ceased to be employed or engaged in its practice;

(ii) the person ceased to be a party to the agreement;

(iii) the person ceased to be a partner or member, as the case may be, in a partnership or limited liability partnership that is a party to the agreement;

(iv) the person ceased to be a member of a company that is a party to the agreement,

(v) the person’s functions changed so as no longer to include prescribing; or

(vi) on which the person was removed or suspended from the relevant register.

Signing of documents

30

(1) In addition to any other requirements relating to such documents whether in these regulations or otherwise, the provider must ensure that the documents specified in sub-paragraph (2) include—

(a) the clinical profession of the health care professional who signed the document; and

(b) the name of the provider on whose behalf it is signed.

(2) The documents referred to in sub-paragraph (1) are—

(a) certificates issued in accordance with regulation 20, unless regulations relating to particular certificates provide otherwise;

(b) prescription forms; and

Level of skill

31

The provider must carry out its obligations under the agreement with reasonable skill and care.

Appraisal and assessment

32

(1) The provider must ensure that any medical practitioner performing services under the agreement—

(a) participates in the appraisal system provided by the Health Board unless the practitioner participates in an appropriate appraisal system provided by another health service body or is an armed forces GP; and

(b) co-operates with any assessment process which the Health Board operates in relation to poorly performing doctors, as set out in NHS circular PCA(M) (2001)17⁷⁴.

(2) The Health Board must provide an appraisal system for the purposes of sub-paragraph (1)(a) after consultation with the area medical committee and such other persons as appear to it to be appropriate.

(3) In sub-paragraph (1)—

“armed forces GP” means a medical practitioner who is employed on a contract of service by the Ministry of Defence, whether or not as a member of the United Kingdom Armed Forces of Her Majesty; and

“health service body” does not include any provider who is to be treated as a health service body in accordance with regulation 10.

Sub-contracting of clinical matters

33

(1) Subject to sub-paragraph (2) the provider must not sub-contract any of its rights or duties under the agreement in relation to clinical matters unless—

(a) in all cases, it has taken reasonable steps to satisfy itself that—

(i) it is reasonable in all the circumstances; and

(ii) that person is qualified and competent to provide the service; and

(b) it has notified the Health Board of its intention to sub-contract as soon as reasonably practicable before the date on which the proposed sub-contract is intended to come into force.

(2) Sub-paragraph (1)(b) must not apply to an agreement for services with a health care professional for the provision by that person of clinical services.

(3) The notification referred to in sub-paragraph (1)(b) must include—

(a) the name and address of the proposed sub-contractor;

(b) the duration of the proposed sub-contract;

(d) the address of any premises to be used for the provision of services; and

(e) in the case of an agreement entered into on or after 22nd December 2010, whether the sub-contractor, if that sub-contractor were a provider, would have sufficient involvement in patient care in terms of section 17CA(3) and (4) of the Act⁷⁵.

(4) Following receipt of a notice in accordance with sub-paragraph (1)(b), the Health Board may request such further information relating to the proposed sub-contract as appears to it to be reasonable and the provider must supply such information promptly.

(5) The provider must not proceed with the sub-contract or, if it has already taken effect, must take appropriate steps to terminate it, where, within 28 days of receipt of the notice referred to in sub-paragraph (1)(b), the Health Board has served notice of objection to the sub-contract on the grounds that—

(a) the sub-contract would—

(i) put at serious risk the safety of the provider’s patients; or

(ii) put the Board at risk of material financial loss;

(b) the sub-contractor would be unable to meet the provider’s obligations under the agreement; or

(c) in the case of an agreement entered into on or after 22nd December 2010, if the sub-contractor were a provider, that sub-contractor would not have sufficient involvement in patient care in terms of section 17CA(3) and (4) of the Act.

(6) Where the Health Board objects to a proposed sub-contract in accordance with sub-paragraph (5), it must include with the notice of objection a statement in writing of the reasons for its objection.

(7) Sub-paragraphs (1) and (3) to (6) must also apply in relation to any renewal or material variation of a sub-contract in relation to clinical matters.

(8) Where a Health Board does not object to a proposed sub-contract under sub-paragraph (5), the parties to the agreement will be deemed to have consented to a variation of the agreement which has the effect of adding to the list of practice premises any premises whose address was notified to it under sub-paragraph (3)(d) and paragraph 61 must not apply.

(9) A contract with a sub-contractor must prohibit the sub-contractor from sub-contracting the clinical services it has agreed with the provider to provide.

(10) The provider, if it has a provider’s list of patients, must not sub-contract any of its rights or duties under the agreement in relation to the provision of essential services to a company, partnership or limited liability partnership—

(a) owned wholly or partly by the provider or a party to the agreement, or by any former or current employee of the provider, or any partner or member of a party to the agreement;

(b) formed by or on behalf of the provider or a party to the agreement, or from which the provider or a party to the agreement derives or may derive a pecuniary benefit; or

(c) formed by or on behalf of a former or current employee of the provider, or a partner or member of a party to the agreement, or from which such a person derives or may derive a pecuniary benefit,

where that company, partnership or limited liability partnership is or was formed wholly or partly for the purpose of avoiding the restrictions on the sale of goodwill of a medical practice in section 35 of the Act⁷⁶ or any regulations made wholly or partly under that section.

PART 5 — DATA PROTECTION, RECORDS, INFORMATION, NOTIFICATIONS AND RIGHTS OF ENTRY

Interpretation

34

(1) ... for the purposes of this Part—

(za) “controller” has the same meaning as in Parts 5 to 7 of the Data Protection Act 2018 (see section 3(6) and (14) of that Act);

(zb) “data protection officer” means a person designated as a data protection officer under the data protection legislation;

(a) “electronic patient records” means records of the provider’s attendance on its patients created by way of data entries on a computer and electronically held and controlled by the provider;

(b) “patient records” means records of the provider’s attendance on and treatment of its patients by way of electronic patient records or on forms supplied by the Health Board to the provider;

(c) “practice data” means data about a provider’s practice and which may include any information or data about employees, sub-contractors, remuneration, finances, workloads, and contracts other than personal data within patient records; and

(e) “personal data” and “processing” have the same meaning as in Parts 5 to 7 of the Data Protection Act 2018 (see section 3(2), (4) and (14) of that Act).

(2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(4) No provision of this Part is to be construed as creating a duty, obligation or right which is contrary to any duty, obligation or right created by—

(a) the data protection legislation, or

(b) any directly applicable EU legislation which is not part of the data protection legislation but which relates to data protection.

(5) The Health Board and the provider, when processing any data under this Part, must comply with any relevant direction, or guidance issued by the Scottish Ministers.

(6) The Health Board and the provider must include within the agreement—

(a) terms which have the effect of the obligations mentioned in paragraph 35; and

(b) a term that requires the Health Board and the provider to act jointly as controllers in relation to the processing of patient records.

Provider and Health Board Obligations

35

(1) The provider must—

(a) take all reasonable steps to ensure the accuracy of patient records;

(b) verify the accuracy of any templates and notices provided to it by the Health Board in accordance with sub-paragraph (2)(b), and once verified, use such templates and notices;

(c) comply with the Health Board’s current policies concerning data security, personal data or IT security notified by the Health Board to the provider under sub-paragraph (2)(c);

(d) maintain a record of all of the provider’s processing activities carried out in performance of the agreement and make the records available to the Health Board on request;

(e) where the Health Board and the provider have not appointed a jointly designated data protection officer; the provider must nominate a person with responsibility for working together with the Health Board’s data protection officer in matters relating to the protection of personal data and the implementation of the Health Board’s guidance, templates and policies on such matters set out under paragraph (2)(b); and

(f) ensure that any person under its direction who has access to patient records has undergone adequate data protection training.

(2) The Health Board must—

(a) take all reasonable steps to confirm the accuracy of patient records provided to or accessed by it;

(b) provide to the provider, guidance, templates, and privacy notices, relating to the provider’s processing of personal data and the provider’s maintenance of a record in accordance with sub-paragraph (1)(d);

(c) notify the provider timeously of its current policies regarding data security, personal data security and IT security processes;

(d) maintain a record of its processing activities carried out in relation to a provider’s patient records;

(e) where the Health Board and provider agree, appoint a jointly designated data protection officer;

(f) ensure that any of its employees who have access to the provider’s patient records and practice data has undergone adequate data protection training; and

(g) make available appropriate data protection training to the provider and its employees.

Records

36

(1) The provider must keep adequate patient records of its attendance on and treatment of its patients and must do so—

(a) on forms to be supplied to it for that purpose by the Health Board; or

(b) with the written consent of the Health Board, by way of electronic patient records; or

(2) The provider must include in patient records referred to in sub-paragraph (1), clinical reports sent in accordance with paragraph 6 of schedule 1 or from any other health care professional who has provided clinical services to a person on its list of patients.

(3) The consent of the Health Board required by sub-paragraph (1)(b) must not be withheld or withdrawn provided the Health Board is satisfied, and continues to be satisfied, that—

(a) the provider ensures that the computer system upon which the provider proposes to keep the electronic patient records is accredited by the Scottish Ministers or another person on their behalf as suitable for that purpose in accordance with a relevant standard issued by the Scottish Ministers;

(b) the security measures, audit and system management functions incorporated into the computer system as accredited in accordance with sub-paragraph (a) have been enabled; and

(c) the agreement signed by the provider contains an obligation requiring the provider to have regard to any guidelines issued by the Scottish Ministers and notified in writing, to the provider by the Health Board concerning good practice in the keeping of electronic patient records.

(4) Where a patient’s records are electronic patient records, the provider must, as soon as possible following a request from the Health Board, allow the Health Board to access the information recorded on the provider’s computer system by means of the audit function referred to in sub‑paragraph (3)(b) to the extent necessary for the Health Board to confirm that the audit function is enabled and functioning correctly.

(5) The provider must send the complete patient record relating to a person mentioned in sub-paragraph 5(a) or (b) to the Health Board—

(a) where a person on its list dies, before the end of the period of 14 days beginning with the date on which it was informed by the Health Board of the death, or (in any other case) before the end of the period of one month beginning with the date on which it learned of the death; or

(b) in any other case where the person is no longer registered with the provider, as soon as possible, at the request of the Health Board.

(6) To the extent that a patient’s records are electronic patient records, the provider complies with sub-paragraph (5) if it sends to the Health Board a copy of those records—

(a) in written form; or

(b) with the written consent of the Health Board, in any other form.

(7) The consent of the Health Board to the transmission of information other than in written form for the purposes of sub-paragraph (6)(b) must not be withheld or withdrawn provided it is satisfied, and continues to be satisfied, with—

(a) the provider’s proposals as to how the record will be transmitted;

(b) the provider’s proposals as to the format of the transmitted record;

(d) how a written copy of the record can be produced by the Health Board.

(8) A provider with electronic patient records must not disable, or attempt to disable, either the security measures or the audit and system management functions referred to in sub‑paragraph (3)(b).

Processing and access of data

37

(1) Subject to paragraphs (2) and (4), the provider must on the request of the Health Board—

(a) allow the Health Board to access practice data and patient records;

(b) produce or disclose practice data and data within patient records to the Health Board or to any person authorised in writing by the Health Board; and

(c) produce or disclose any other information to the Health Board which is reasonably required in connection with the Health Board’s functions.

(2) A request under sub-paragraph (1) must be made—

(a) after consideration of whether the relevant information could be so provided in compliance with—

(i) the data protection legislation, and

(ii) any directly applicable EU legislation which is not part of the data protection legislation but which relates to data protection;

(b) in accordance with directions given to the Health Board by the Scottish Ministers under section 2(5) of the Act that have been consulted upon by a body representative of general medical practitioners providing primary medical services in accordance with a general medical services contract or a section 17C arrangement; and

(3) The purposes mentioned in sub-paragraph (2)(c) are—

(a) medical diagnosis of or provision of healthcare to patients;

(b) the planning, including workforce planning, and management of health and social care services; or

(4) The provider must produce any information relating to a request made in accordance with sub-paragraph (1)(b)—

(a) by such date as has been agreed as reasonable between the provider and the Health Board; or

(b) in the absence of such agreement, within 28 days of the request being made.

(5) In this paragraph—

(a) “access” includes access by way of any computerised system, information management & technology system or software; and

(b) “disclose” includes the provision of information by electronic means.

Confidentiality of personal data

38

The provider must nominate a person with responsibility for practices and procedures relating to the confidentiality of personal data held by it and also data protection generally.

GP IT Services

39

(1) The Health Board will provide, maintain and where necessary, upgrade any integrated information management and technology systems used by the provider for provision of services under the agreement and any telecommunication links between these systems and the systems used by the Health Board, a Special Health Board, the Agency, or Healthcare Improvement Scotland, in accordance with any relevant guidance (including standards) issued from time to time by the Scottish Ministers.

(2) The Health Board and provider must take into account any relevant guidance issued by the Scottish Ministers for the purposes of this paragraph and this Part.

(3) On the expiry or termination of the agreement, the provider must immediately return to the Health Board any integrated information management and technology systems and telecommunication links purchased or provided by the Health Board for the purposes of this paragraph in its possession unless otherwise agreed between the Health Board and provider.

Patient online appointment services

40

(1) A provider must provide its registered patients with—

(a) an ... online appointment service; ...

(b) an ... online repeat prescription service; and

in a manner which is capable of being electronically integrated with the computer systems of the provider’s practice and using appropriate systems authorised by the Health Board .

(2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(3) ... The provider must regularly consider whether it is desirable, in order to meet the reasonable needs of its registered patients, to increase the proportion of appointments which are made available to registered patients through that service and if it is so desirable, to increase the proportion of appointments accordingly.

(4) The provider must promote the services referred to in sub-paragraph (1) to its registered patients—

(a) in practice leaflets in accordance with paragraph 11 of schedule 6; and

(b) on the practice website.

(5) In this paragraph—

(a) “online appointment service” means a facility which allows patients to book, view, amend and cancel appointments online;

(b) “repeat prescription service” means a facility which allows patients to order repeat prescriptions for drugs, medicines or appliances online; and

(c) “online repeat prescription information service” means a facility which allows patients to view online, and print, a list of any drugs, medicines or appliances in respect of which the patient has a repeat prescription.

Practice leaflet

41

The provider must—

(a) compile a document (in this paragraph called a practice leaflet) which includes the information specified in schedule 6;

(b) review its practice leaflet at least once in every period of twelve months and make any amendments necessary to maintain its accuracy; and

Inquiries about prescriptions and referrals

42

(1) The provider must, subject to sub-paragraphs (2) and (3), sufficiently answer any inquiries whether oral or in writing from the Health Board concerning—

(a) any prescription form issued by a prescriber;

(b) the considerations by reference to which prescribers issue such forms;

(d) the considerations by which the provider makes such referrals or provides for them to be made on its behalf.

(2) An inquiry referred to in sub-paragraph (1) may only be made for the purpose either of obtaining information to assist the Health Board to discharge its functions or of assisting the provider in the discharge of its obligations under the agreement.

(3) The provider will not be obliged to answer any inquiry referred to in sub-paragraph (1) unless it is made—

(a) in the case of sub-paragraph (1)(a) or (1)(b), by an appropriately qualified health care professional;

(b) in the case of sub-paragraph (1)(c) or (1)(d), by an appropriately qualified medical practitioner,

appointed in either case by the Health Board to assist the Board in the exercise of its functions under this paragraph and that person produces, on request, written evidence that the person is authorised by the Health Board to make such an inquiry on its behalf.

Provision of information to a medical officer etc.

43

(1) The provider must, if satisfied that the patient has given explicit consents—

(a) supply in writing to any person specified in sub-paragraph (3), within such reasonable period as that person may specify, such clinical information as any of the persons mentioned in sub-paragraph (3)(a) to (d) considers relevant about a patient to whom the provider or a person acting on behalf of the provider has issued or has refused to issue a medical certificate; and

(b) answer any inquiries by any person mentioned in sub-paragraph (3) about—

(i) a prescription form or medical certificate issued or created by, or on behalf of, the provider; or

(ii) any statement which the provider or a person acting on behalf of that provider has made in a report.

(2) For the purposes of being satisfied that a patient has given explicit consent, a provider may rely on an assurance in writing from any person mentioned in sub-paragraph (3) that the explicit consent of the patient has been obtained, unless the provider has reason to believe that the patient does not consent.

(3) For the purposes of sub-paragraph (1) and (2), the persons are—

(a) a medical officer;

(b) a nursing officer;

(d) a physiotherapist; or

(e) an officer of the Department for Work and Pensions who is acting on behalf of, and at the direction of, any person specified in sub-paragraphs (a) to (d).

(4) In this paragraph—

(a) “medical officer” means a medical practitioner who is—

(i) employed or engaged by the Department for Work and Pensions; or

(ii) provided by an organisation under a contract entered into with the Secretary of State for Work and Pensions;

(b) “nursing officer” means a health care professional who is registered on the Nursing and Midwifery Register and—

(i) employed or engaged by the Department for Work and Pensions; or

(ii) provided by an organisation under a contract entered into with the Secretary of State for Work and Pensions;

(c) “occupational therapist” means a health care professional who is registered in the part of the register maintained by the Health and Care Professions Council under article 5 of the Health Professions Order 2001 relating to occupational therapists and—

(i) employed or engaged by the Department for Work and Pensions; or

(ii) provided by an organisation under a contract entered into with the Secretary of State for Work and Pensions; and

(d) “physiotherapist” means a health care professional who is registered in the part of the register maintained by the Health and Care Professions Council under article 5 of the Health Professions Order 2001 relating to physiotherapists and—

(i) employed or engaged by the Department for Work and Pensions; or

(ii) provided by an organisation under a contract entered into with the Secretary of State for Work and Pensions.

Annual return and review

44

(1) The provider must submit an annual return relating to the agreement to the Health Board.

(2) One such return may be requested by the Health Board at any time during each financial year in relation to such period (not including any period covered by a previous annual return) as may be specified in the request.

(3) The provider must submit the completed return to the Health Board—

(a) by such date as has been agreed as reasonable between the provider and the Health Board; or

(b) in the absence of such agreement, within 28 days of the request being made.

(4) Without prejudice to the generality of sub-paragraph (1)—

(a) in the case of agreements entered into on or after 22nd December 2010, the provider must include in the annual return a statement confirming that the provider meets the conditions of section 17CA(3) and (4) of the Act⁷⁷; and

(b) in all cases the provider must include in the annual return a statement confirming that any sub-contractor satisfies the requirements of paragraph 33(3)(e), and such details as the Health Board considers appropriate.

(5) Following receipt of the return referred to in sub-paragraph (1), the Health Board must arrange with the provider an annual review of its performance in relation to the agreement.

(6) Either the provider or the Health Board may, it if wishes to do so, invite the area medical committee for the area of the Health Board to participate in the annual review.

(7) The Health Board must prepare a draft record of the review referred to in sub-paragraph (5) for comment by the provider and, having regard to such comments, must produce a final written record of the review.

(8) A copy of the final record referred to in sub-paragraph (7) must be sent to the provider.

(9) In this paragraph, “financial year” means a period of twelve months ending with 31st March.

Notifications to the Health Board

45

In addition to any requirements of notification elsewhere in these Regulations, the provider must notify the Health Board in writing, as soon as reasonably practicable, of—

(a) any serious incident that in the reasonable opinion of the provider affects or is likely to affect the provider’s performance of its obligations under the agreement;

(b) any circumstances which give rise to the Health Board’s right to terminate the agreement under paragraph 68, 69 and 70;

(d) where the provider has a provider’s list of patients, any change of which it is aware in the address of a registered patient; and

(e) the death of any patient of which it is aware.

Notifications to the Health Board

46

The provider must, unless it is impracticable for it to do so, notify the Health Board in writing within 28 days of any occurrence requiring a change in the information about it published by the Health Board in accordance with regulations made under section 2C(3) of the Act (functions of Health Boards: primary medical services)⁷⁸.

Notice provisions specific to agreements with one or more companies limited by shares

47

(1) This paragraph applies to agreements entered into prior to 22nd December 2010.

(2) Where a company limited by shares is a party to the agreement, the provider must give notice to the Health Board forthwith when—

(a) any share in the company is transmitted or transferred (whether legally or beneficially) to another person on a date after the agreement has come into force;

(b) a new director or secretary is appointed;

(c) the company passes a resolution or a court of competent jurisdiction makes an order that one or more of those companies be wound up;

(d) circumstances arise which might entitle a creditor or a court to appoint a receiver, administrator or administrative receiver for the company;

(e) circumstances arise which would enable the court to make a winding up order in respect of the company; or

(f) the company is unable to pay its debts within the meaning of section 123 of the Insolvency Act 1986⁷⁹.

(3) A notice under sub-paragraph (2)(a) must confirm that the new shareholder, or, as the case may be, the personal representative of a deceased shareholder—

(a) where the company is a qualifying body, within the meaning of section 17D(2)⁸⁰ of the Act, is a person falling within section 17D(1)(a) to (d) of the Act as in force at 21st December 2010 (persons with whom agreements may be made); and

(b) satisfies the condition imposed on shareholders by virtue of regulation 4 (general conditions relating to providers).

(4) A notice under sub-paragraph (1)(b) must confirm that the new director or, as the case may be, secretary meets the conditions imposed on directors and secretaries by virtue of regulation 4.

Notice provisions specific to an agreement with one or more companies

48

(1) This paragraph applies to agreements entered into on or after 22nd December 2010.

(2) Where a company is a party to the agreement, the provider must give notice in writing to the Health Board forthwith when—

(a) a member, director or secretary of the company ceases to be a member, director or secretary of the company or informs the other members of the company that that person intends to cease to be a member, director or secretary of the company, and the date upon which he or she ceased, or will cease, to be a member, director or secretary of the company;

(b) a new member, director or secretary becomes a member, director or secretary of the company;

(d) circumstances arise which might entitle a creditor or a court to appoint a receiver, administrator or administrative receiver for the company;

(e) circumstances arise which would enable the court to make a winding up order in respect of the company; or

(f) the company is unable to pay its debts within the meaning of section 123 of the Insolvency Act 1986.

(3) A notice under sub-paragraph (2)(b) must—

(a) state the date the new member, director or secretary became a member, director or secretary of the company;

(b) confirm that the new member is an individual who satisfies the conditions imposed on members by virtue of section 17CA(3) and (4) of the Act⁸¹ and the conditions imposed by regulations 4 and 5; and

(c) confirm that the new director or, as the case may be, secretary satisfies the conditions imposed on directors and secretaries by virtue of regulation 4.

Notice provisions specific to an agreement with one or more companies

49

(1) Where a partnership is party to the agreement, the provider must give notice to the Health Board without delay—

(a) when a partner leaves or informs the other members of the partnership of which they are a member, that the partner intends to leave the partnership, and the notice must state the date upon which the partner left or will leave the partnership;

(b) when a new partner joins a partnership.

(2) A notice under sub-paragraph (1)(b) must—

(a) state the date that the new partner joined the partnership;

(b) in the case of an agreement entered into prior to 22nd December 2010—

(i) confirm that the new partner satisfies the conditions imposed by regulation 3 of the 2004 Regulations (general conditions relating to providers) as in force at 21st December 2010; and

(ii) state whether the new partner is a general or a limited partner;

(i) confirm that the new partner is an individual who satisfies the conditions imposed on members by virtue of section 17CA(3) and (4) of the Act; and

(ii) satisfies the conditions imposed by regulations 4 and 5; and

(d) state whether the new partner is a general or a limited partner.

Notice provisions specific to an agreement with one or more partnerships

50

(1) Where a limited liability partnership is party to the agreement, the provider must give notice to the Health Board without delay—

(a) when a member ceases to be a member, or informs the other members of the limited liability partnership that the member intends to cease to be a member, of the limited liability partnership, and the notice must state the date upon which the member ceased, or will cease, to be a member of the limited liability partnership;

(b) when a new member joins the limited liability partnership.

(2) A notice under sub-paragraph (1)(b) must—

(a) state the date that the new member joined the limited liability partnership; and

(b) confirm that the new member is an individual who satisfies the conditions imposed on members by virtue of section 17CA(3) and (4) of the Act and the conditions imposed by regulations 4 and 5.

Notification of deaths

51

(1) The provider must report, in writing, to the Health Board, the death on the provider’s practice premises of any patient no later than the end of the first working day after the date on which the death occurred.

(2) The report must include—

(a) the patient’s full name;

(b) the patient’s National Health Service number where known;

(d) a brief description of the circumstances, as known, surrounding the death;

(e) the name of any medical practitioner or other person treating the patient whilst on the practice premises; and

(f) the name, where known, of any other person who was present at the time of the death.

(3) The provider must send a copy of the report referred to in sub-paragraph (1) to any other Health Board in whose area the deceased was resident at the time of the patient’s death.

Notifications to patients following variation of the agreement

52

Where the agreement is varied in accordance with Part 8 of this schedule and, as a result of that variation—

(a) there is to be a change in the range of services provided to the provider’s patients; or

(b) where the provider has a provider’s list of patients, patients who are on that list are to be removed from that list,

the Health Board must notify those patients in writing of the variation and its effect and inform them of the steps they can take to obtain elsewhere the services in question or, as the case may be, register elsewhere for the provision of essential services (or their equivalent).

Entry and inspection by the Health Board

53

(1) Subject to the conditions in sub-paragraph (2), the provider must allow persons authorised in writing by the Health Board to enter and inspect the practice premises at any reasonable time.

(2) The conditions referred to in sub-paragraph (1) are that—

(a) reasonable notice of the intended entry has been given;

(b) written evidence of the authority of the person seeking entry is produced to the provider on request; and

(c) entry is not made to any premises or part of the premises used as residential accommodation without the consent of the resident.

(3) Either the provider or the Health Board may, if it wishes to do so, invite the area medical committee for the area of the Board to be present at an inspection of the practice premises which takes place under this paragraph.

PART 6 — COMPLAINTS

Complaints procedure

54

The provider must have arrangements in place which operate in accordance with section 15 of the Patient Rights (Scotland) Act 2011⁸², and any regulations or directions made under that Act.

Co-operation with investigations

55

(1) The provider must co-operate with—

(a) any investigation of a complaint in relation to any matter reasonably connected with the provision of services under the agreement undertaken by—

(i) the Health Board; and

(ii) the Scottish Public Services Ombudsman; and

(b) any investigation of a complaint by an NHS body or local authority which relates to a patient or former patient of the provider.

(2) In sub-paragraph (1)—

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