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STATUTORY INSTRUMENTS

2006 No. 490 (W.59)
NATIONAL HEALTH SERVICE, WALES
The National Health Service (General Dental Services Contracts) (Wales) Regulations 2006

	Made	28 February 2006
	Coming into force	1 March 2006

ARRANGEMENT OF REGULATIONS

PART 1
GENERAL

1.	Title, commencement and application

2.	Interpretation

PART 2
CONTRACTORS

3.	Conditions: introductory

4.	General prescribed conditions relating to all contracts

5.	Additional prescribed conditions relating to contracts with dental corporations

PART 3
PRE-CONTRACT DISPUTE RESOLUTION

8.	Pre-contract disputes

PART 4
HEALTH SERVICE BODY STATUS

9.	Health service body status

PART 5
CONTRACTS: REQUIRED TERMS

10.	Parties to the contract

11.	NHS contracts

12.	Contracts with individuals practising in partnership

13.

Duration

14.	Mandatory services

15.	Additional services

16.	Services: general

17.	Units of dental activity

18.	Units of orthodontic activity

19.	Under provision of units of dental activity or units of orthodontic activity

20.	Domiciliary services and sedation services

21.

Finance

22.	Fees, charges and financial interests of the contractor

23.	Arrangements on termination

24.	Other contractual terms

PART 6
TRANSITIONAL PROVISION

25.	Commencement of contract

SCHEDULE 1 —

ADDITIONAL SERVICES

	PART 1 —
	PART 2 —
	SCHEDULE 2 —	PROVISION OF SERVICES: UNITS OF DENTAL ACTIVITY AND UNITS OF ORTHODONTIC ACTIVITY

	PART 1 —
	PART 2 —
	SCHEDULE 3 —	OTHER CONTRACTUAL TERMS

	PART 1 —
	PART 2 —
	PART 3 —
	PART 4 —
	PART 5 —
	PART 6 —
	PART 7 —
	PART 8 —
	PART 9 —
	PART 10 —
	SCHEDULE 4 —	PATIENT INFORMATION LEAFLET

The National Assembly for Wales makes the following Regulations in exercise of the powers conferred by sections 28L, 28M, 28O, 28P and 126(4) of the National Health Service Act 1977[1] and section 4(5) of the National Health Service and Community Care Act 1990[2].

PART 1
GENERAL
Title, commencement and application
     1. —(1) The title of these Regulations is the National Health Service (General Dental Services Contracts) (Wales) Regulations 2006 which come into force on 1 March 2006.

    (2) These Regulations apply in relation to Wales.

Interpretation
     2. —(1) In these Regulations—

"the Act" means the National Health Service Act 1977;

"Assembly" means the National Assembly for Wales;

"the 1990 Act" means the National Health Service and Community Care Act 1990;

"additional services" means one or more of—

"adjudicator" means the Assembly or a person or persons appointed by the Assembly under section 4(5) of the 1990 Act (NHS contracts) or paragraph 55(4) of Schedule 3 (NHS dispute resolution procedure);

"advanced mandatory services" means any primary dental service that would fall within the services described in regulation 14 (mandatory services), but by virtue of the high level of facilities, experience or expertise required in respect of a particular patient, the service is provided as a referral service;

"Band 1 course of treatment" means a course of treatment, including a course of treatment consisting of urgent treatment, provided to a patient in respect of which a Band 1 NHS Charge is payable pursuant to the NHS Charges Regulations, or would be payable if the patient was not an exempt person;

"Band 2 course of treatment" means a course of treatment provided to a patient in respect of which a Band 2 NHS Charge is payable pursuant to the NHS Charges Regulations, or would be payable if the patient was not an exempt person;

"Band 3 course of treatment" means a course of treatment provided to a patient in respect of which a Band 3 NHS Charge is payable pursuant to the NHS Charges Regulations, or would be payable if the patient was not an exempt person;

"banded course of treatment" means a Band 1, Band 2 or Band 3 course of treatment;

"bank holiday" means any day that is specified or proclaimed as a bank holiday in Wales pursuant to section 1 of the Banking and Financial Dealings Act 1971[

3

"bridge" means a fixed or removable bridge which takes the place of any teeth;

"case assessment", in respect of an orthodontic course of treatment, means a clinical examination of the patient, including the taking of such radiographs, colour photographs and models as are required in order to determine what orthodontic treatment (if any) is to be provided to the patient;

"charge exempt course of treatment" means a course of treatment that involves the examination and assessment of a patient leading to—

which, by virtue of regulation 3(2)(d) or (f) of the NHS Charges Regulations, is provided free of charge to the patient;

"charity trustee" means one of the persons having the general control and management of the administration of a charity;

"child" means a person who has not attained the age of 16 years;

"complete", in relation to—

(b) an orthodontic course of treatment, means that—

and "completed" will be construed accordingly;

4

"course of treatment" means—

provided by, except where expressly provided otherwise, one or more providers of primary dental services, but it does not include the provision of any orthodontic services or dental public health services;

"dental appliance" means a denture or bridge and for the purposes of this definition, a denture includes an obturator;

5

"dental corporation" means a body corporate carrying on the business of dentistry in accordance with the Dentists Act;

"domiciliary services" means a course of treatment, or part of a course of treatment, provided at a location other than—

11

"family member" means—

12

(h) a grandparent;

13

"financial year" means a period of 12 months ending with 31 March in any year;

14

15

"licensing body" means any body that licenses or regulates any profession;

16

"Local Health Board" means, unless the context otherwise requires, the Local Health Board which is a party, or a prospective party, to the contract;

"mandatory services" means the services described in regulation 14;

"mobile surgery", except where expressly provided otherwise in these Regulations, means any vehicle in which services under the contract are to be provided;

"national disqualification" means—

17

18

19

"NHS Charge" means a charge made to the patient for provision of services pursuant to the NHS Charges Regulations;

20

"NHS contract" has the meaning assigned to it in section 4(1) of the 1990 Act;

"NHS dispute resolution procedure" means the procedure for disputes specified in paragraphs 55 and 56 of Schedule 3;

21

22

"normal surgery hours" means the times at which the contractor has agreed with the Local Health Board (and specified in the contract) that the surgery will be open to patients for the provision of services;

23

"orthodontic appliance" means a device used in the mouth to move or immobilise the teeth in order to correct or prevent malocclusion;

"orthodontic course of treatment" means—

"orthodontic services" means the provision of orthodontic courses of treatment or the services referred to in paragraph 5(2) of Schedule 1 (repairs);

"orthodontic treatment" means treatment of, or treatment to prevent, malocclusion of the teeth and jaws, and irregularities of the teeth;

"parent" , in relation to any child, means a parent or other person who has parental responsibility for that child;

"patient" means, unless the context otherwise requires, a person to whom the contractor is providing services under the contract;

"patient record" means a form supplied by a Local Health Board for the purpose of maintaining a record of treatment;

"practice" means the business operated by the contractor for the purpose of delivering services under the contract;

"practice premises", except where expressly provided otherwise in these Regulations, means an address specified in the contract as one at which services are to be provided under the contract but does not include a mobile surgery;

"prescriber" means a dental practitioner who is either engaged or employed by the contractor or is a party to the contract;

"primary care list" means—

"prison" includes a young offender institution but not a secure training centre or a naval, military or air force prison, and for the purposes of this definition—

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"private", in the context of services or treatment, means otherwise than under the contract or Part 1 of the Act, and "privately" will be construed accordingly;

"professional registration number" means the number against a dental practitioner's name in the Dentists Register;

"referral notice" means the notice referred to in paragraph 9(2)(a) of Schedule 3 (referral to another contractor, a hospital or other relevant service provider for advanced mandatory, domiciliary or sedation services);

"referral service" means one or more of advanced mandatory services, domiciliary services or sedation services provided by the contractor to a patient who has, during a course of treatment, been referred to the contractor by—

for the provision of one or more of those services as part of that course of treatment;

"referral treatment plan" means a treatment plan provided pursuant to paragraph 2(1) of Schedule 1 or that plan as varied in accordance with paragraph 2(3) of that Schedule;

30

"sedation services" means a course of treatment provided to a patient during which the contractor administers one or more drugs to a patient, which produce a state of depression of the central nervous system to enable treatment to be carried out, and during and in respect of that period of sedation—

"trauma" means damage to teeth, gingival tissues or alveoli caused by a force arising outside the mouth, resulting in mobility, luxation, subluxation or fracture of the hard tissues or injury to the soft tissues;

"unit of dental activity" means the unit of activity which is in the contract used to—

mandatory services and advanced mandatory services provided under the contract;

"unit of orthodontic activity" means the unit of activity which is in the contract used to—

orthodontic services provided under the contract;

"urgent treatment" means a course of treatment that consists of one or more of the treatments listed in Schedule 4 to the NHS Charges Regulations (urgent treatment under Band 1 charge) that are provided to a person in circumstances where—

"working day" means any day apart from Saturday, Sunday, Christmas Day, Good Friday or a bank holiday.

(2) In these Regulations—

PART 2
CONTRACTORS
Conditions: introductory
3. Subject to the provisions of any order made by the Assembly under section 173 of the Health and Social Care (Community Health and Standards) Act 2003[31] (general dental services: transitional), a Local Health Board may only enter into a contract if the conditions set out in—

are met.

General prescribed conditions relating to all contracts
     4. —(1) For the purposes of section 28M of the Act (conditions upon which a general dental services contract may be entered into) the prescribed condition is that a person must not fall within paragraph (3).

    (2) The reference to person in paragraph (1) includes any director, chief executive or secretary of a dental corporation.

    (3) A person falls within this paragraph if—

(a) he, she or it is the subject of a national disqualification;

(b) subject to paragraph(4), he, she or it is disqualified or suspended (other than by an interim suspension order or direction pending an investigation) from practising by any licensing body anywhere in the world;

(c) within the period of five years prior to the date the contract is to be commenced or, if earlier, the date on which the contract is to be signed—

(i) he or she has been dismissed (otherwise than by reason of redundancy) from any employment by a health service body, unless he or she has subsequently been employed by that health service body or another health service body and paragraph (5) applies to him or her or that dismissal was the subject of a finding of unfair dismissal by any competent tribunal or court; or

(ii) he, she or it has been removed from, or refused admission to, a primary care list by reason of inefficiency, fraud or unsuitability (within the meaning of section 49F(2), (3) and (4) of the Act respectively[

32

(d) he or she has been convicted in the United Kingdom of—

(e) subject to paragraph (6), he or she has been convicted outside the United Kingdom of an offence—

(f) he or she has been convicted of an offence referred to in Schedule 1 to the Children and Young Persons Act 1933[33] (offences against children and young persons with respect to which special provisions of this Act apply) or Schedule 1 to the Criminal Procedure (Scotland) Act 1995[34] (offences against children under the age of 17 years to which special provisions apply) committed on or after 1 April 2006;

(g) he, she or it has—

35

(h) an administrator, administrative receiver or receiver is appointed in respect of it;

(i) he or she has within the period of five years prior to the date the contract is to be commenced or, if earlier, the date on which the contract is to be signed—

36

(j) he or she is subject to a disqualification order under the Company Directors Disqualification Act 1986[37], the Companies (Northern Ireland) Order 1986[38] or to an order made under section 429(2)(b) of the Insolvency Act 1986[39] (failure to pay under county court administration order).

(4) A person does not fall within paragraph (3)(b) where the Local Health Board is satisfied that the disqualification or suspension from practising is imposed by a licensing body outside the United Kingdom and it does not make the person unsuitable to be—

40

as the case may be.

(5) Where a person has been employed as a member of a health care profession any subsequent employment must also be as a member of that profession.

(6) A person does not fall within paragraph (3)(e) where the Local Health Board is satisfied that the conviction does not make the person unsuitable to be—

as the case may be.

Additional prescribed conditions relating to contracts with dental corporations
5. —(1) Subject to paragraph (2), it is a condition in the case of a contract to be entered into with a dental corporation on or after the date of the coming into force for all purposes of article 39 of the Dentists Act Order that no—

(a) offence has been or is being committed under section 43 of the Dentists Act; or

(b) financial penalty has been imposed under section 43B or 44 of the Dentists Act .

    (2) Paragraph (1) will not apply if the Local Health Board is satisfied that any offence under section 43 or penalty imposed under section 43B or 44 of the Dentists Act does not make the dental corporation unsuitable to be a contractor, whether by virtue of the time that has elapsed since any conviction or penalty was imposed, or otherwise.

Reasons
     6. —(1) Where a Local Health Board is of the view that the conditions in regulation 4 or 5 for entering into a contract are not met it will notify in writing the person or persons intending to enter into the contract of its view and its reasons for that view and of his, her, its, or their right of appeal under regulation 7.

    (2) The Local Health Board will also notify in writing of its view and its reasons for that view, a director, chief executive or secretary of a dental corporation that is notified under paragraph (1) where its reason for the decision relates to that person or those persons.

Appeal
     7. A person who has been served with a notice under regulation 6(1) may appeal to the FHSAA against the decision of the Local Health Board that the conditions in regulation 4 or 5 are not met by giving notice in writing to the FHSAA within the period of 28 days beginning on the day that the Local Health Board served its notice.

PART 3
PRE-CONTRACT DISPUTE RESOLUTION
Pre-contract disputes
     8. —(1) Subject to paragraphs (2) and (3), if, in the course of negotiations intending to lead to a contract, the prospective contracting parties are unable to agree on a particular term of the contract, either party may refer the dispute to the Assembly to consider and determine the matter in accordance with the procedure provided for in paragraphs 55(2) and (3) of Schedule 3.

    (2) Paragraph (1) does not apply in the case where both parties to the prospective contract are health service bodies (in which case section 4(4) of the 1990 Act (NHS contracts) applies).

    (3) Before referring the dispute for consideration and determination under paragraph (1), both parties to the prospective contract must make every reasonable effort to communicate and co-operate with each other with a view to resolving it.

    (4) Disputes referred to the Assembly in accordance with paragraph (1), or section 4(4) of the 1990 Act, will be considered and determined in accordance with the provisions of paragraphs 55(4) to 55(13) and 56(1) of Schedule 3, and paragraph (5) (where it applies) of this regulation.

    (5) In the case of a dispute referred to the Assembly under paragraph (1), the determination—

PART 4
HEALTH SERVICE BODY STATUS
Health service body status
     9. —(1) Where a proposed contractor elects in a written notice served on the Local Health Board at any time prior to the contract being entered into to be regarded as a health service body for the purposes of section 4 of the 1990 Act, it will be so regarded from the date on which the contract is entered into.

    (2) If, in accordance with paragraph (1) or (5), a contractor is to be regarded as a health service body, that fact will not affect the nature of, or any rights or liabilities arising under, any other contract with a health service body entered into by that contractor before the date on which the contractor is to be so regarded.

    (3) Where a contract is made with an individual dental practitioner or two or more persons practising in partnership, and that individual, or that partnership is to be regarded as a health service body in accordance with paragraph (1) or (5), the contractor will, subject to paragraph (4), continue to be regarded as a health service body for the purposes of section 4 of the 1990 Act for as long as that contract continues and irrespective of any change in—

(4) A contractor may at any time request a variation of the contract to include or remove provision from the contract that the contract is an NHS contract, and if it does so—

(5) Where, pursuant to paragraph (4), the Local Health Board agrees to a variation of the contract, the contractor will—

as a health service body for the purposes of section 4 of the 1990 Act from the date that variation takes effect pursuant to paragraph 60(1) of Schedule 3.

(6) Subject to paragraph (7), a contractor will cease to be regarded as a health service body for the purposes of section 4 of the 1990 Act if the contract is terminated.

(7) Where a contractor ceases to be a health service body pursuant to—

for which purposes it ceases to be such a body on the conclusion of that procedure.

PART 5
CONTRACTS: REQUIRED TERMS
Parties to the contract
10. A contract must specify—

(c) in the case of each party, the postal address to which official correspondence and notices should be sent.

NHS contracts
     11. In the case of a contractor who is to be regarded as a health service body pursuant to regulation 9, the contract must state that it is an NHS contract.

Contracts with individuals practising in partnership
     12. —(1) Where the contract is with two or more individuals practising in partnership, the contract will be treated as made with the partnership as it is from time to time constituted, and the contract will make specific provision to this effect.

    (2) Where the contract is with two or more individuals practising in partnership, the contractor must be required by the terms of the contract to ensure that any person who becomes a member of the partnership after the contract has come into force is bound automatically by the contract whether by virtue of a partnership deed or otherwise.

Duration
     13. —(1) Except in the circumstances specified in paragraph (2), a contract must provide for it to subsist until it is terminated in accordance with the terms of the contract or the general law.

    (2) The circumstances referred to in paragraph (1) are that the Local Health Board has terminated the contract of another provider of primary dental services, and as a result of that termination, it wishes to enter into a temporary contract for a period specified in the contract for the provision of services.

    (3) Where a contract is entered into pursuant to paragraph (2)—

(a) paragraph 66 (termination by the contractor) of Schedule 3 will not apply to the contract; and

(b) the parties to the temporary contract may include such terms as to termination by notice as they may agree.

Mandatory services
14. —(1) For the purposes of section 28L of the Act[41] (requirement to provide certain primary dental services), the services which must be provided under a general dental services contract ("mandatory services") are described in paragraphs (2) to (4).

(2) A contractor must provide to its patients, during the period specified in paragraph (3), all proper and necessary dental care and treatment which includes—

(3) A contractor must provide—

that are necessary to meet the reasonable needs of its patients during normal surgery hours.

(4) The dental care and treatment referred to in paragraph (2) includes—

but it does not include additional services.

Additional services
15. In the case where a contract includes the provision of additional services, that contract must contain, in relation to each such service as is included in the contract, terms that have the same effect as those specified in Schedule 1 in so far as they are relevant to that service.

Services: general
16. —(1) A contract must specify—

(a) the services to be provided by the contractor;

(b) the address of each of the premises to be used by the contractor or any sub-contractor for the provision of such services, or, if the contractor is to provide services from a mobile surgery, that fact; and

(c) the hours during which services that are not mandatory services are to be provided.

(2) The reference to premises in paragraph (1)(b) does not include any place in which a patient is residing.

Units of dental activity
17. —(1) The contract must specify the number of units of dental activity to be provided by the contractor—

(a) where the contract begins on 1 April, in each financial year; or

(b) where the contract begins on a date other than 1 April, in the remainder of the financial year in which the contract begins, and in each financial year thereafter.

(2) A contract must contain terms which have the effect of those specified in Part 1 of Schedule 2 in relation to the calculation of the number of units of dental activity that the contractor will provide under the contract.

Units of orthodontic activity
18. —(1) Where a contract includes the provision of orthodontic services, the contract must specify the number of units of orthodontic activity to be provided by the contractor—

(a) where the contract begins on 1 April, in each financial year; or

(b) where the contract begins on a date other than 1 April, in the remainder of the financial year in which the contract begins, and in each financial year thereafter.

    (2) Where paragraph (1) applies, the contract must also contain terms which have the effect of those provisions specified in Part 2 of Schedule 2 in relation to the calculation of the number of units of orthodontic activity that the contractor will provide under the contract.

Under provision of units of dental activity or units of orthodontic activity
     19. —(1) The contract will provide that the Local Health Board will not pursuant to Part 9 of Schedule 3 (variation and termination of contracts) be entitled to take any action for breach of a term of the contract giving effect to regulation 17 or 18 (including termination of the contract) where paragraph (2) applies.

    (2) Subject to paragraph (4), this paragraph applies where the contractor has failed to provide—

(a) the number of units of dental activity; or

(b) the number of units of orthodontic activity,

it is contracted to provide pursuant to a term of the contract giving effect to regulation 17 or 18 (as the case may be) where—

(i) that failure amounts to 5 per cent or less of the total number of units of dental activity or units of orthodontic activity (as the case may be) that ought to have been provided during a financial year, and

(ii) the contractor agrees to provide and does so provide the units it has failed to provide within such time period as the Local Health Board specifies in writing, such period to consist of not less than 60 days.

    (3) Paragraphs (1) and (2) will not prevent the Local Health Board from taking action under Part 9 of Schedule 3 for breach of contract (including terminating the contract) on other grounds.

    (4) In the case of a temporary contract the reference to a period of not less than 60 days in paragraph (2)(ii) may not apply if the Local Health Board considers it not appropriate or considers another period of less than 60 days should apply.

Domiciliary services and sedation services
     20. Where a contract includes the provision of domiciliary services or sedation services, the contract must specify the number of courses of treatment that the contractor is—

(a) to provide; or

(b) to contribute to where provided as a referral service,

that involve the provision of domiciliary services or sedation services—

(i) where the contract begins on 1 April, in each financial year; or

(ii) where the contract begins on a date other than 1 April, in the remainder of the financial year in which the contract begins, and in each financial year thereafter.

Finance
21. —(1) The contract must contain a term which has the effect of requiring—

(a) the Local Health Board to make payments to the contractor under the contract promptly and in accordance with both the terms of the contract and any other conditions relating to the payment contained in directions given by the Assembly under section 28N of the Act[

42

(2) The obligation referred to in paragraph (1) is subject to any right the Local Health Board has to set off against an amount payable to the contractor an amount that—

    (3) The contract must contain a term to the effect that where, pursuant to directions under section 16BB(4)[43] (Local Health Boards: Functions) or 28N of the Act, a Local Health Board is required to make a payment to a contractor under a contract but subject to conditions, those conditions are to be a term of the contract.

Fees, charges and financial interests of the contractor
     22. —(1) The contract must contain terms relating to fees, charges and financial interests which have the same effect as those set out in paragraphs (2) to (4).

    (2) The contractor will not, either itself or through any other person, demand or accept a fee or other remuneration for its own or another's benefit from—

(a) any patient of its for the provision of any treatment under the contract, except as otherwise provided in the NHS Charges Regulations; and

(b) any person who has requested services under the contract for himself or herself or a family member, as a prerequisite to providing services under the contract to that person or his or her family member.

(3) The contract must contain a term that—

(a) only permits the contractor to collect from any patient of its any charge that that patient is required to pay by virtue of the NHS Charges Regulations, in accordance with the requirements of those Regulations; and

(b) provides for obligations imposed on the contractor by virtue of the NHS Charges Regulations to be terms of the contract.

(4) The contract must contain a term that requires the contractor in making a decision—

(a) as to what services to recommend or provide to a patient who has sought services under the contract; or

(b) to refer a patient for other services by another contractor, hospital or other relevant service provider under Part 1 of the Act,

to do so without regard to its own financial interests.

    (5) The term "patient" in paragraph (3) will have the same meaning as in regulation 2(1) of the NHS Charges Regulations.

Arrangements on termination
     23. A contract will make suitable provision for arrangements on termination of a contract including the consequences (whether financial or otherwise) of the contract ending.

Other contractual terms
     24. —(1) A contract must, unless it is of a type or nature to which a particular provision does not apply, contain other terms which have the same effect as those specified in Schedule 3 except paragraphs 55(4) to 55(13) and 56.

    (2) The paragraphs specified in paragraph (1) will have effect in relation to the matters set out in those paragraphs.

    (3) Where a contract does not commence on 1 April in any financial year, there must be a contractual term—

(a) specifying the date and periods for the purposes of a mid-year review of the services provided; and

(b) which, other than as to the date and periods, have similar effect as those specified in paragraphs 58(3) to (8) and 59 of Schedule 3 in respect of the requirement and procedure for carrying out mid-year reviews.

PART 6
TRANSITIONAL PROVISION
Commencement of contract
25. The contract will provide for services to be provided under it from any date after 31 March 2006.

Signed on behalf of the National Assembly for Wales under section 66(1) of the Government of Wales Act 1998[44]

D. Elis-Thomas
The Presiding Officer of the National Assembly

28 February 2006

SCHEDULE 1Regulations 2 and 15 and paragraph 32 of Schedule 3

ADDITIONAL SERVICES

PART 1
ADVANCED MANDATORY SERVICES, DOMICILIARY SERVICES AND SEDATION SERVICES
Provision of advanced mandatory services, domiciliary services and sedation services by the contractor
1. —(1) A contractor which provides domiciliary services or sedation services under the contract may only provide those services—

(2) A contractor may only provide advanced mandatory services under the contract as a referral service.

In this paragraph, "entire course of treatment" means a course of treatment provided by only the contractor.

Referral services
2. —(1) A contractor which provides one or more of the additional services specified in paragraph 1 as a referral service will, at the time of the first examination of the patient, ensure that the patient is provided with a referral treatment plan on a form supplied for that purpose by the Local Health Board which will specify—

    (2) If the patient having considered the referral treatment plan provided in accordance with sub-paragraph (1), decides to accept the provision of private services in place of all or part of services under the contract, the contractor will ensure that the patient signs that plan in the appropriate place to indicate that he or she has understood the nature of private services to be provided and his or her acceptance of those private services.

    (3) Where the services included in the referral treatment plan need to be varied for clinical reasons, the contractor will provide the patient with a revised referral treatment plan in accordance with sub-paragraph (1).

    (4) The contractor will, subject to the termination of the contract, or being unable to complete a course of treatment in accordance with paragraph 6(5) or (6) of Schedule 3 (course of treatment), provide the services which are detailed in the referral treatment plan, or where a revised treatment plan is provided pursuant to sub-paragraph (3), pursuant to that revised treatment plan.

    (5) This paragraph will not apply where a patient has been referred to the contractor for advanced mandatory services limited only to examination and advice, and the contractor only provides examination and advice in respect of that patient.

Sedation services
     3. The contractor will provide sedation services to a patient in accordance with the recommendations contained in the report of the Standing Dental Advisory Committee entitled "Conscious Sedation in the Provision of Dental Care"[45], in so far as those recommendations and guidelines are relevant to—

PART 2
ORTHODONTIC SERVICES
Patients to whom orthodontic services may be provided
4. —(1) A contract that includes the provision of orthodontic services will specify that orthodontic services may be provided to—

(2) Where a contract specifies the matters referred to in sub-paragraph (1)(b) or (1)(c), it will in addition specify the circumstances in which orthodontic services may be provided to a person over the age of 18 years at the time of a case assessment.

(3) The contractor will only provide orthodontic treatment to a person who is assessed by the contractor following a case assessment as having a treatment need in—

46

unless the contractor is of the opinion, and has reasonable grounds for its opinion, that orthodontic treatment should be provided to a person who does not have such a treatment need by virtue of the exceptional circumstances of the dental and oral condition of the person concerned.

    (4) In a case where a person does not have a treatment need but the contractor has reasonable grounds for its opinion that orthodontic treatment should be provided to that person because of the exceptional circumstances of the dental and oral condition of that person, such treatment as is referred to in sub-paragraph (3) may be provided.

Orthodontic course of treatment
     5. —(1) Subject to sub-paragraph (2), the contractor will provide orthodontic services to a patient by providing to that patient an orthodontic course of treatment.

    (2) The contractor may provide orthodontic services that are not provided by virtue of an orthodontic course of treatment where—

(3) The contractor will use its best endeavours to ensure that an orthodontic course of treatment is completed within a reasonable time from the date on which the orthodontic treatment plan was written in accordance with paragraph 6(1).

(4) If an orthodontic course of treatment is—

any further orthodontic services to be provided to that patient under the contract must be provided as a new orthodontic course of treatment.

(5) An orthodontic course of treatment may only be terminated by—

(b) the patient; or

(c) a person specified in paragraph 1(2) of Schedule 3 acting on the patient's behalf.

Orthodontic treatment plans
6. —(1) Where the contractor has, following a case assessment, determined that orthodontic treatment should be provided to a patient, it will, at the time of that case assessment, ensure that the patient is provided with an orthodontic treatment plan on a form supplied for that purpose by the Local Health Board which will specify—

    (2) If the patient, having considered the treatment plan provided pursuant to sub-paragraph (1), decides to accept the provision of private services in place of orthodontic services under the contract, the contractor will ensure that the patient signs the treatment plan in the appropriate place to indicate that he or she has understood the nature of private services to be provided and his or her acceptance of those private services.

    (3) Where, for clinical reasons, the services included in the orthodontic treatment plan under sub-paragraph (1) need to be varied, the contractor will provide the patient with a revised orthodontic treatment plan in accordance with that sub-paragraph.

    (4) Subject to paragraph 5(4) and (5), the contractor will provide the orthodontic services which are detailed in the orthodontic treatment plan provided pursuant to sub-paragraph (1) or, where the orthodontic treatment plan is revised, pursuant to the revised orthodontic treatment plan.

Monitoring outcomes
     7. —(1) The contract will require the contractor to monitor, in accordance with this paragraph, the outcome of the orthodontic treatment it provides.

    (2) The contractor will, in respect of orthodontic courses of treatment it provides in which orthodontic treatment is provided following the case assessment, monitor the outcome of that orthodontic treatment in accordance with sub-paragraph (3).

    (3) The contractor will monitor the outcome of orthodontic treatment in accordance with "Methods to determine outcome of orthodontic treatment in terms of improvement and standards"[47] in respect of—

of orthodontic courses of treatment it provides.

(4) The contract will specify the period of time which is relevant for calculating the number of orthodontic courses of treatment that need to be monitored in accordance with this paragraph.

(5) As part of its monitoring of the outcome of orthodontic treatment under sub-paragraph (2), the contractor will, in respect of the patients whose courses of treatment are monitored calculate a peer assessment rating of the patient's study casts—

using either the Clinical Outcome Monitoring Program software[48] or by applying the methodology set out in "An introduction to Occlusal Indices"[49].

    (6) In sub-paragraph (5), "peer assessment rating" means an index of treatment standards in which individual scores for the components of alignment and occlusion are summed to calculate an overall score comparing pre- and post-treatment[50].

Completion of orthodontic courses of treatment
     8. —(1) The contractor will indicate on the form supplied to the Local Health Board pursuant to paragraph 38 of Schedule 3 (notification of a course of treatment) whether or not the orthodontic course of treatment was completed.

    (2) If the Local Health Board requests in writing that the contractor provides reasons for the failure to complete one or more orthodontic courses of treatment, the contractor will, within such period as the Local Health Board may specify, provide the reasons for that failure.

    (3) If the Local Health Board—

it will be entitled to exercise its powers under paragraph 73 of Schedule 3 on the grounds that the contractor is not, pursuant to paragraph 5(3) of this Schedule, using its best endeavours to ensure orthodontic courses of treatment are completed.

SCHEDULE 2Regulations 2, 17 and 18

PROVISION OF SERVICES: UNITS OF DENTAL ACTIVITY AND UNITS OF ORTHODONTIC ACTIVITY

PART 1
UNITS OF DENTAL ACTIVITY
1. —(1) Where the contractor provides a banded course of treatment, the contractor provides the number of units of dental activity specified in the appropriate row of Table A.

(2) Where a banded course of treatment is commenced but not completed for whatever reason, the appropriate number of units of dental activity provided will be calculated on the basis of the components of the course of the treatment which has been—

2. Where the contractor provides a charge exempt course of treatment, the contractor provides the number of units of dental activity specified in the appropriate row of Table B.

Table A Units of dental activity provided under the contract in respect of banded courses of treatment

Type of course of treatment Units of dental activity provided

Band 1 course of treatment (excluding urgent treatment) 1.0

Band 1 course of treatment (urgent treatment only) 1.2

Band 2 course of treatment 3.0

Band 3 course of treatment 12.0

Table B Units of dental activity provided under the contract in respect of charge exempt courses of treatment

Type of charge exempt course of treatment Units of dental activity provided

Issue of a prescription 0.75

Repair of a dental appliance (denture) 1.0

Repair of a dental appliance (bridge) 1.2

Removal of sutures 1.0

Arrest of bleeding 1.2

PART 2
UNITS OF ORTHODONTIC ACTIVITY
3. —(1) Where the contractor provides an orthodontic course of treatment to a patient that solely consist of a case assessment, the contractor provides 1.0 units of orthodontic activity.

(2) Where the contractor provides an orthodontic course of treatment to a patient aged under 10 years that consists of—

the contractor provides 4.0 units of orthodontic activity.

(3) Where the contractor provides an orthodontic course of treatment to a patient aged between 10 and 17 years of age that consists of—

the contractor provides 21.0 units of orthodontic activity.

(4) Where the contractor provides an orthodontic course of treatment to a patient who is aged 18 years or over that consists of—

the contractor provides 21.0 units of orthodontic activity.

(5) Where the contractor—

the contractor provides 0.8 units of orthodontic activity.

SCHEDULE 3Regulations 2 and 24 and paragraphs 5(5), 6 and 8 of Schedule 1

OTHER CONTRACTUAL TERMS

PART 1
PATIENTS
Persons to whom mandatory services or additional services are to be provided
1. —(1) Subject to sub-paragraphs (3) and (5), the contractor may agree to provide mandatory or additional services under the contract to any person if a request is made for such services by—

(2) For the purposes of sub-paragraph (1), a request for services may be made—

(a) on behalf of any child by—

(i) either parent;

(ii) a person duly authorised by a local authority to whose care the child has been committed under the Children Act 1989[

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(b) on behalf of any adult who is incapable of making such an application, or authorising such an application to be made on their behalf, by a relative or the primary carer of that person.

(3) The contractor may refuse to provide mandatory or additional services in relation to a person falling outside a specified group of persons only where the contract provides for the contractor to provide such services to a specified group.

(4) The contractor will only refuse to provide services under the contract to a person if it has reasonable grounds for doing so which do not relate to—

(5) Sub-paragraph (1) does not apply—

Patient preference of practitioner
2. —(1) Where the contractor has agreed to provide services to a patient it will—

(2) The contractor will endeavour to comply with any reasonable preference expressed under sub-paragraph (1) but need not do so if the preferred performer—

(3) This paragraph does not apply—

Violent patients
3. —(1) Where—

the contractor may notify the Local Health Board that it will no longer provide services to that patient under the contract.

(2) The reference to person in sub-paragraph (1) means—

    (3) Notification under sub-paragraph (1) may be given by any means including telephone, fax or email but if not given in writing will subsequently be confirmed in writing within seven days (and for this purpose a faxed or email notification is not a written one).

    (4) The time at which the contractor notifies the Local Health Board will be the time at which it makes the telephone call or sends or delivers the notification to the Local Health Board.

    (5) The Local Health Board will—

Patients who refuse to pay NHS charges prior to the commencement of, or during, treatment
4. —(1) The contractor may—

if the contractor has, in accordance with the NHS Charges Regulations, requested that the patient pay a charge in respect of that course of treatment or orthodontic course of treatment, and that patient has failed to pay that charge.

Irrevocable breakdown in relationship between contractor and patient
5. Where—

the contractor may notify the Local Health Board that it will no longer provide services to that patient under the contract.

PART 2
PROVISION OF SERVICES
Course of treatment
6. —(1) Except in the case of orthodontic services and dental public health services, the contractor will provide mandatory and additional services to a patient by providing to that patient a course of treatment.

(2) The contractor will use its best endeavours to ensure that a course of treatment is completed within a reasonable time from the date on which—

(3) Where a contractor provides urgent treatment to a patient, the urgent treatment provided will constitute a course of treatment and no other services will be provided during that course of treatment.

(4) If a course of treatment is—

any further services to be provided to that patient under the contract must be provided as a new course of treatment.

(5) A course of treatment may only be terminated by—

(b) the patient; or

(c) a person specified in paragraph 1(2) of this Schedule acting on the patient's behalf.

(6) If the contractor is unable to complete the course of the treatment which has been commenced for reasons beyond its control, it will give notice to the Local Health Board of the extent of the treatment so provided and the reason for its inability to complete the remainder.

Treatment plans
7. —(1) Subject to sub-paragraph (5), where the contractor agrees to provide a course of treatment to a patient, it will, at the time of the initial examination and assessment of that patient, ensure that the patient is provided with a treatment plan on a form supplied for that purpose by the Local Health Board which will specify—

    (2) If the patient, having considered the treatment plan provided pursuant to sub-paragraph (1), decides to accept the provision of private services in place of all or part of services under the contract, the contractor will ensure that the patient signs the treatment plan in the appropriate place to indicate that he or she has understood the nature of private services to be provided and his or her acceptance of those services.

    (3) Where the services included in the treatment plan under this paragraph need to be varied, the contractor will provide the patient with a revised treatment plan in accordance with sub-paragraph (1).

    (4) Subject to paragraph 6(5), the contractor will provide the services which are detailed in the treatment plan, or where the treatment plan is revised, the revised treatment plan.

    (5) The obligation to provide a treatment plan under this paragraph will not apply to a Band 1 course of treatment or a charge exempt course of treatment unless—

    (6) Where a patient requests the contractor to provide him or her with a summary of the care and treatment provided under the treatment plan because he or she intends to receive services from another contractor, the contractor will provide him or her with such a summary as he or she considers appropriate (including details of the care and treatment which could not easily be observed on visual examination).

    (7) The summary referred to in sub-paragraph (6) will be supplied to the patient on a form supplied for that purpose by the Local Health Board within 28 days of that request.

Completion of courses of treatment
     8. —(1) The contractor will indicate on the form supplied to the Local Health Board pursuant to paragraph 38 whether the course of treatment was completed, and if the course of treatment was not completed, provide the reason for the failure to complete the course of treatment.

    (2) If the Local Health Board—

it will be entitled to exercise its powers under paragraph 59(2) on the grounds that the contractor is not, pursuant to paragraph 6(2), using its best endeavours to ensure courses of treatment are completed.

Referral to another contractor, a hospital or other relevant service provider for advanced mandatory, domiciliary or sedation services
9. —(1) Where a patient requires advanced mandatory services, domiciliary services or sedation services that are not provided under the contract by the contractor, it will, if the patient agrees, refer that patient in accordance with sub-paragraph (2) for the provision of a referral service by an alternative contractor, a hospital or other relevant service provider under Part 1 of the Act.

(2) In referring a patient pursuant to sub-paragraph (1), the contractor will provide—

    (3) Where the patient notifies the contractor, whether verbally or in writing, that he or she does not wish to be referred to the alternative contractor, hospital or other relevant service provider selected by the contractor, the contractor will, if requested to do so by the patient, use its best endeavours to refer the patient to another suitable contractor, hospital or other relevant service provider under Part 1 of the Act for the provision of the referral service.

Mixing of services provided under the contract with private services
     10. —(1) Subject to sub-paragraph 2 and the requirements of paragraphs 2 (referral services) and 6 (orthodontic treatment plans) of Schedule 1 and paragraph 7(1)(g) of this Schedule, a contractor may, with the consent of the patient, provide privately any part of a course of treatment or orthodontic course of treatment for that patient, including in circumstances where that patient has been referred to the contractor for a referral service.

    (2) A contractor may—

(3) A contractor will not, with a view to obtaining the agreement of a patient to undergo services privately—

    (4) In sub-paragraph (2)(a), "provision of sedation" means the provision of one or more drugs to a patient in order to produce a state of depression of the central nervous system to enable treatment to be carried out.

Repair or replacement of restorations
     11. —(1) Subject to sub-paragraph (5), where a restoration specified in sub-paragraph (2) needs to be repaired or replaced the contractor will repair or replace the restoration at no charge to the patient.

    (2) The restorations referred to in sub-paragraph (1) are any filling, root filling, inlay, porcelain veneer or crown provided by the contractor to a patient in the course of providing services under the contract, which within the relevant period has to be repaired or replaced to secure oral health.

    (3) The repair or replacement of a restoration specified in sub-paragraph (2) is a banded course of treatment for the purposes of calculating the number of units of dental activity and paragraph 1 of Schedule 2 will apply notwithstanding that no charge is made or recovered in accordance with the NHS Charges Regulations.

    (4) The band in which a restoration specified in sub-paragraph (2) falls will be determined in accordance with the NHS Charges Regulations.

    (5) Sub-paragraph (1) will not apply where—

(c) in the opinion of the contractor, the condition of the tooth in respect of which the restoration was provided is such that the restoration cannot satisfactorily be repaired or replaced and different treatment is now required; or

(d) the repair or replacement is required as a result of trauma.

(6) In this paragraph, "the relevant period" means the 12 month period beginning on the date on which the restoration was provided, and ceasing twelve months after that date.

Premises, facilities and equipment
12. —(1) The contractor will ensure that the practice premises used for the provision of services under the contract are—

    (2) The obligation in sub-paragraph (1) includes providing proper and sufficient waiting-room accommodation for patients.

    (3) The contractor will provide, in relation to all of the services to be provided under the contract, such other facilities and equipment as are necessary to enable it to properly perform that service.

    (4) In this paragraph, "practice premises" includes a mobile surgery.

Telephone services
     13. —(1) The contractor will not be a party to any contract or other arrangement under which the number for telephone services to be used by—

starts with the digits 087, 090 or 091 or consists of a personal number, unless the service is provided free to the caller.

    (2) In this paragraph, "personal number" means a telephone number which starts with the number 070 followed by a further 8 digits.

National Institute for Clinical Excellence guidance
     14. The contractor will provide services under the contract in accordance with any relevant guidance that is issued by the National Institute for Clinical Excellence[52], in particular the guidance entitled "Dental recall— Recall interval between routine dental examinations"[53].

Infection control
     15. The contractor will ensure that it has appropriate arrangements for infection control and decontamination.

Treatment under general anaesthesia: prohibition
     16. The contractor will not provide any services under the contract that involve the provision of general anaesthesia.

PART 3
SUPPLY OF DRUGS AND PRESCRIBING
General
     17. The contractor will ensure that any prescription form for listed drugs, medicines or appliances issued by a prescriber complies as appropriate with the requirements in this Part.

Supply of drugs
     18. —(1) A presciber may supply to a patient listed drugs, medicines or appliances as are required for immediate use before the issue of a prescription for such drugs, medicines or appliances in accordance with paragraph 19.

    (2) A prescriber may personally administer to a patient any drug or medicine required for the treatment of that patient.

Issue of prescription forms
     19. —(1) A prescriber will order listed drugs, medicines or appliances (other than those supplied under paragraph 18) as are required for the treatment of any patient to whom it is providing services under the contract by issuing to the patient a prescription form.

    (2) Every prescription form will—

(3) For the purposes of this paragraph, "prescription form" means a form that is supplied for the purposes of this paragraph by the Local Health Board.

Excessive prescribing
20. A prescriber will not prescribe drugs, medicines or appliances whose cost or quantity, in relation to any patient, is, by reason of the character of that drug, medicine or appliance, in excess of that which was reasonably necessary for the proper treatment of that patient.

PART 4
PERSONS WHO PERFORM SERVICES
Dental practitioners
21. A dental practitioner[54] may perform dental services under the contract provided—

Dental care professionals
22. —(1) Prior to the coming into force of the first regulations under section 36A(2) of the Dentists Act[55] (professions complementary to dentistry)—

may perform dental services under the contract provided he or she is enrolled in the appropriate register established in accordance with the Dental Auxiliaries Regulations 1986[56].

(2) Upon the coming into force of the first regulations under section 36A(2) of the Dentists Act—

may perform dental services under the contract provided—

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Performers: further requirements
23. —(1) No health care professional or other person other than one to whom paragraph 22 applies will perform clinical services under the contract unless he or she is appropriately registered with his or her relevant professional body and his or her registration is not subject to a suspension.

(2) Where—

is subject to conditions, the contractor will ensure compliance with those conditions in so far as they are relevant to the contract.

(3) No health care professional or other person will perform any clinical services under the contract unless he or she has such clinical experience and training as are necessary to enable him or her properly to perform such services.

Conditions for employment and engagement: dental practitioners performing dental services
24. —(1) A contractor will not employ or engage a dental practitioner to perform dental services under the contract unless—

(2) Where the employment or engagement of a dental practitioner is urgently needed and it is not possible to check the matters referred to in paragraph 21 in accordance with sub-paragraph (1)(b) before employing or engaging him or her he or she may be employed or engaged on a temporary basis for a single period of up to 7 days whilst such checks are undertaken.

Conditions for employment and engagement: persons performing dental services other than dental practitioners
25. —(1) The contractor will not employ or engage a dental care professional to perform dental services unless it has taken reasonable steps to satisfy itself that he or she has the clinical experience and training necessary to enable him or her to properly perform dental services and—

(2) Where the employment or engagement of a person specified in sub-paragraph (1) is urgently needed and it is not possible to check his or her registration in accordance with sub-paragraph (1) (where it applies) before employing or engaging him or her, he or she 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 person's experience and training for the purposes of sub-paragraph (1), the contractor will have regard in particular to—

Conditions for employment and engagement: all persons performing dental services
26. —(1) The contractor will not employ or engage a person to perform dental services under the contract unless—

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

    (3) Where the contractor 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 or engagement: persons assisting in the provision of services under the contract
     27. —(1) Before employing or engaging any person to assist it in the provision of services under the contract, the contractor will take reasonable care to satisfy itself that the person in question is both suitably qualified and competent to discharge the duties for which he or she is to be employed or engaged.

    (2) The duty imposed by sub-paragraph (1) is in addition to the duties imposed by paragraphs 24 to 26.

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

Training
28. —(1) The contractor will ensure that for any dental practitioner or dental care professional who is—

arrangements are in place for the purpose of maintaining and updating his or her skills and knowledge in relation to the services which he or she is performing or assisting in performing.

    (2) The contractor will afford to each employee reasonable opportunities to undertake appropriate training with a view to maintaining that employee's competence.

Level of skill
     29. The contractor will carry out its obligations under the contract with reasonable care and skill.

Appraisal and assessment
     30. The contractor will ensure that any dental practitioner performing services under the contract—

Sub-contracting of clinical matters
31. —(1) The contractor will not sub-contract any of its rights or duties under the contract to any person in relation to clinical matters unless—

(b) it is satisfied in accordance with paragraphs 81 and 82 that the sub-contractor holds adequate insurance.

(2) Where the contractor sub-contracts any of its rights or duties under the contract in relation to clinical matters, it will—

(3) Where the contractor sub-contracts clinical services in accordance with sub-paragraph (1), the parties to the contract will be deemed to have agreed a variation to the agreement which has the effect of adding to the list of the contractor's premises any premises which are to be used by the sub-contractor for the purpose of the sub-contract and paragraph 60 will not apply.

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

PART 5
RECORDS, INFORMATION, NOTIFICATIONS AND RIGHTS OF ENTRY
Patient records
     32. —(1) The contractor will ensure that a full, accurate and contemporaneous record is kept in the patient record in respect of the care and treatment given to each patient under the contract, including treatment given to a patient who is referred to the contractor.

    (2) The patient record may be kept in electronic form.

    (3) The patient record will include details of any private services (to the extent that they are provided with services under the contract) and will be kept with—

(e) the statement concerning any custom-made devices provided by any person as a consequence of regulation 15 of the Medical Devices Regulations 2002[58] (procedures for custom-made devices) in respect of services being provided to that patient.

(4) The patient record and the items referred to in sub-paragraph (3) will be retained for a period of 2 years beginning with—

(b) in respect of courses of treatment or orthodontic courses of treatment not falling within paragraph (a)(i) or (ii) the date by which no more services can be provided as part of that course of treatment or orthodontic course of treatment by virtue of paragraph 5(4)(b) of Schedule 1 (orthodontic course of treatment) or paragraph 6(4)(b) of this Schedule.

    (5) Nothing in this paragraph will affect any property right which the contractor may have in relation to the records, radiographs, photographs and study models referred to in this paragraph.

Confidentiality of personal data
     33. The contractor will nominate a person with responsibility for practices and procedures relating to the confidentiality of personal data held by it.

Patient information
     34. —(1) The contractor will ensure that there is displayed in a prominent position in its practice premises, in a part to which patients have access—

(2) The contractor will—

(3) The requirements in sub-paragraph (2) do not apply to any contractor to the extent that it provides services to persons detained in prison.

Provision of and access to information: Local Health Board
35. —(1) The contractor will, at the request of the Local Health Board—

the information specified in paragraph (2).

(2) The information specified for the purposes of sub-paragraph (1) is—

and includes the contractor's patient records.

Requests for information from Community Health Councils
36. —(1) Subject to sub-paragraph (2), where the contractor receives a written request from a Community Health Council to produce any information which appears to the Council to be necessary for the effective carrying out of its functions it will comply with that request promptly and in any event no later than the twentieth working day following the date the request was made.

(2) The contractor will not be required to produce information under sub-paragraph (1) which—

(3) The conditions referred to in sub-paragraph (2)(a) are—

(4) This sub-paragraph applies where—

(5) In a case where the information falls within—

a Community Health Council may require the contractor to disclose the information in a form from which the identity of the individual concerned cannot be ascertained.

Inquiries about prescriptions and referrals
37. —(1) The contractor will, subject to sub-paragraphs (2) and (3), sufficiently answer any inquiries whether oral or in writing from the Local Health Board concerning—

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

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

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

Notification of a course of treatment, orthodontic course of treatment etc.
38. —(1) The contractor will, within 2 months of the date upon which—

send to the Local Health Board, on a form supplied by that Board, the information specified in sub-paragraph (2).

(2) The information referred to in sub-paragraph (1) comprises of—

Annual report and review
     39. —(1) The Local Health Board will provide to the contractor an annual report relating to the contract which will contain the same categories of information for all persons who hold contracts with that Board.

    (2) Once the Local Health Board has provided the report referred to in sub-paragraph (1), the Local Health Board will arrange with the contractor an annual review of its performance in relation to the contract.

    (3) The Local Health Board will prepare a draft record of the review referred to in sub-paragraph (2) for comment by the contractor and, having regard to such comments, will produce a final written record of the review.

    (4) A copy of the final record referred to in sub-paragraph (3) will be sent to the contractor.

Notifications to the Local Health Board
     40. —(1) In addition to any requirements of notification elsewhere in the Regulations, the contractor will notify the Local Health Board in writing, as soon as reasonably practicable, of—

(2) The contractor will, unless it is impracticable for it to do so, notify the Local Health Board in writing within 28 days of any occurrence requiring a change in the information about it published by the Local Health Board in accordance with regulations made under section 16CA(3) of the Act[59] (primary dental services).

(3) The Contractor will give notice in writing to the Local Health Board when a dental practitioner who is performing or will perform services under the contract (as the case may be)—

which will include the name of the dental practitioner who has left, or who has been employed or engaged, together with his or her professional registration number.

Notice provisions specific to a contract with a dental corporation
41. A contractor which is a dental corporation will give notice in writing to the Local Health Board forthwith when—

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Notice provisions specific to a contract with two or more individuals practising in partnership
42. —(1) A contractor which is a partnership will give notice in writing to the Local Health Board forthwith when—

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

Notifications to patients following a variation of the contract
43. Where the contract is varied in accordance with Part 9 of this Schedule and, as a result of that variation there is to be a change in the range of services provided by the contractor, the contractor will ensure that there is displayed in a prominent position in its practice premises, in a part to which patients have access, written details of that change.

Entry and inspection by the Local Health Board
44. —(1) Subject to—

the contractor will allow persons authorised in writing by the Local Health Board to enter and inspect the practice premises at any reasonable time.

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

(3) Where the contractor is providing services under the contract in a prison, the contractor will not be obliged to comply with sub-paragraph (1), or paragraph 45 or 46, if—

    (4) In this paragraph "practice premises" includes a mobile surgery.

Entry and inspection by members of Community Health Councils
     45. Subject to paragraph 44(3), the contractor will allow members of a Community Health Council authorised by or under regulation 20 of the Community Health Councils Regulations 2004[61] to enter and inspect the practice premises for the purpose of any of the Council's functions in accordance with that regulation.

Entry and inspection by the Commission for Healthcare Audit and Inspection
     46. Subject to paragraph 44(3), the contractor will allow persons authorised by the Commission for Healthcare Audit and Inspection and the Assembly to enter and inspect premises in accordance with sections 66 and 72 of the Health and Social Care (Community Health and Standards) Act 2003[62] (rights of entry).

PART 6
COMPLAINTS
Complaints procedure
47. —(1) The contractor will establish and operate a complaints procedure to deal with any complaints in relation to any matter reasonably connected with the provision of services under the contract which will comply with the requirements of paragraphs 48 to 50 and 52.

(2) The contractor will take reasonable steps to ensure that patients are aware of—

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(3) The contractor will take reasonable steps to ensure that the complaints procedure is accessible to all patients.

Making of complaints
48. —(1) A complaint may be made by or, with his or her consent, on behalf of a patient or former patient, who is receiving or has received services under the contract, or—

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(b) where the patient is incapable of making a complaint, by a relative or other adult person who has an interest in his or her welfare.

(2) Where a patient has died, a complaint may be made by a relative or other adult person who had an interest in his or her welfare or, where the patient falls within sub-paragraph (1)(a)(ii) or (iii) by the authority of a voluntary organisation.

Period for making complaints
49. —(1) Subject to sub-paragraph (2), the period for making a complaint is—

(2) Where a complaint is not made during the period specified in sub-paragraph (1), it will be referred to the person nominated under paragraph 50(2)(a) and if he or she is of the opinion that—

the complaint will be treated as if it had been received during the period specified in sub-paragraph (1).

Further requirements for complaints procedures
50. —(1) A complaints procedure will also comply with the requirements set out in sub-paragraphs (2) to (6).

(2) The contractor must nominate—

(3) All complaints must be—

    (4) Within the period of 10 working days beginning with the day on which the complaint was received by the person specified under sub-paragraph (2)(a) or, where that is not possible, as soon as reasonably practicable, the complainant must be given a written summary of the investigation and its conclusions.

    (5) Where the investigation of the complaint requires consideration of the patient's dental records, the person specified in sub-paragraph (2)(a) must inform the patient or person acting on his or her behalf if the investigation will involve disclosure of information contained in those records to a person other than the contractor or an employee of the contractor.

    (6) The contractor must keep a record of all complaints and copies of all correspondence relating to complaints for a period of at least two years from the date on which such complaints were made, but such records will be kept separate from the patients' dental records.

Co-operation with investigations
     51. —(1) The contractor will co-operate with—

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

(2) In sub-paragraph (1)—

"NHS body" means a Local Health Board, an NHS trust, an NHS foundation trust, a Strategic Health Authority, a Primary Care Trust or an equivalent body constituted in Scotland or Northern Ireland;

"local authority" means—

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(3) The co-operation required by sub-paragraph (1) includes—

Provision of information
52. The contractor will inform the Local Health Board, at such intervals as the Local Health Board requires, of the number of complaints it has received under the procedure established in accordance with this Part.

PART 7
DISPUTE RESOLUTION
Local resolution of contract disputes
53. In the case of any dispute arising out of or in connection with the contract, the contractor and the Local Health Board must make every reasonable effort to communicate and co-operate with each other with a view to resolving the dispute, before referring the dispute for determination in accordance with the NHS dispute resolution procedure (or, where applicable, before commencing court proceedings).

Dispute resolution: non-NHS contracts
54. —(1) In the case of a contract which is not an NHS contract, any dispute arising out of or in connection with the contract, except disputes about matters dealt with under the complaints procedure pursuant to Part 6 of this Schedule, may be referred for consideration and determination to the Assembly, if—

(2) In the case of a dispute referred to the Assembly under sub-paragraph (1)—

NHS dispute resolution procedure
55. —(1) The procedure specified in the following sub-paragraphs and paragraph 56 applies in the case of any dispute arising out of or in connection with the contract which is referred to the Assembly—

(2) Any party wishing to refer a dispute as mentioned in sub-paragraph (1) will send to the Assembly a written request for dispute resolution which will include or be accompanied by—

    (3) Any party wishing to refer a dispute as mentioned in sub-paragraph (1) must send the request under sub-paragraph (2) within a period of three years beginning with the date on which the matter giving rise to the dispute happened or should reasonably have come to the attention of the party wishing to refer the dispute.

    (4) Where the dispute relates to a contract which is not an NHS contract, the Assembly may determine the matter itself or, if it considers it appropriate, appoint a person or persons to consider and determine it[67].

    (5) Before reaching a decision as to who should determine the dispute, either under sub-paragraph (4) or under section 4(5) of the 1990 Act, the Assembly will, within the period of 7 days beginning with the date on which a matter was referred to it, send a written request to the parties to make in writing, within a specified period, any representations which they may wish to make about the matter.

    (6) The Assembly will give, with the notice given under sub-paragraph (5), to the party other than the one which referred the matter to dispute resolution a copy of any document by which the matter was referred for dispute resolution.

    (7) The Assembly will give a copy of any representations received from a party to the other party and will in each case request (in writing) a party to whom a copy of the representations is given to make within a specified period any written observations which it wishes to make on those representations.

    (8) Following receipt of any representations from the parties or, if earlier, at the end of the period for making such representations specified in the request sent under sub-paragraph (5) or (7), the Assembly will, if it decides to appoint a person or persons to hear the dispute—

(9) For the purpose of assisting the adjudicator in the consideration of the matter, the adjudicator may—

(10) Where the adjudicator consults another person under sub-paragraph (9)(b), the adjudicator will notify the parties accordingly in writing and, where the adjudicator considers that the interests of any party might be substantially affected by the result of the consultation, the adjudicator will give to the parties such opportunity as the adjudicator considers reasonable in the circumstances to make observations on those results.

(11) In considering the matter, the adjudicator will consider—

    (12) In this paragraph, "specified period" means such period as the Assembly will specify in the request, being not less than two, nor more than four, weeks beginning with the date on which the notice referred to is given, but the Assembly may, if it considers that there is good reason for doing so, extend any such period (even after it has expired) and, where it does so, a reference in this paragraph to the specified period is to the period as so extended.

    (13) Subject to the other provisions of this paragraph and paragraph 56, the adjudicator will have wide discretion in determining the procedure of the dispute resolution to ensure the just, expeditious, economical and final determination of the dispute.

Determination of dispute
     56. —(1) The adjudicator will record the determination and the reasons for it, in writing and will give notice of the determination (including the record of the reasons) to the parties.

    (2) In the case of a contract referred for determination in accordance with paragraph 54(1), subsection (8) of section 4 of the 1990 Act will apply as that subsection applies in the case of a contract referred for determination in accordance with subsection (3) of section 4 of that Act.

    (3) In the case of a contract referred for determination in accordance with paragraph 54(1), subsection (5) of section 28P of the Act[68] (GDS contracts: disputes and enforcement) will apply as that subsection applies in the case of a contract referred for determination in accordance with subsection (3) of section 4 of the 1990 Act.

Interpretation of Part 7
     57. —(1) In this Part, reference to any dispute arising out of or in connection with the contract include any dispute arising out of or in connection with the termination of the contract.

    (2) Any term of the contract that makes provision in respect of the requirements in this Part will survive even where the contract has terminated.

PART 8
MID-YEAR REVIEW OF ACTIVITY UNDER CONTRACTS
Mid-year reviews
     58. —(1) This paragraph and paragraph 59 only apply where services are to be provided under the contract from 1 April in any financial year.

    (2) In this paragraph and paragraph 59, references to requirements to provide units of dental activity or orthodontic activity are to such requirements under the terms of the contract giving effect to regulation 17 (units of dental activity) or 18 (units of orthodontic activity).

    (3) The Local Health Board will, by 31 October in each financial year, determine the number of—

that the contractor has provided between 1 April and 30 September of that financial year based on the data provided to it by virtue of paragraph 38.

(4) Where the Local Health Board determines under sub-paragraph (3) that the contractor has, between 1 April and 30 September, provided less than 30 per cent of the total number of—

that it is required to provide in that financial year, sub-paragraph (5) will apply.

(5) Where this sub-paragraph applies, the Local Health Board may—

(b) require in that notification that the contractor participate in a mid-year review of its performance in relation to the contract with the Local Health Board.

(6) Where a mid-year review is required by the Local Health Board pursuant to sub-paragraph (5), the Local Health Board and the contractor will discuss at that review—

    (7) The Local Health Board will prepare a draft record of the mid-year review for comment by the contractor and, having regard to such comments, will produce a final written record of the review.

    (8) A copy of the final record of the mid-year review will be sent to the contractor.

Action the Local Health Board can take following a mid-year review
     59. —(1) Where, following the mid-year review and the sending of the final record of that review to the contractor, the Local Health Board, having taken account of any evidence or reasons put forward by the contractor at that review, nevertheless has serious concerns that the contractor is unlikely to provide the number of—

that it is required to provide by the end of the financial year, the Local Health Board will be entitled to take either or both of the steps specified in sub-paragraph (2).

(2) The Local Health Board may—

(3) The maximum amount that may be withheld pursuant to sub-paragraph (2)(b) is—

(4) Nothing in this paragraph will prevent the Local Health Board and the contractor agreeing to vary the contract in accordance with paragraph 61 to adjust—

(5) Where the Local Health Board withholds monies under paragraph (2), it will ensure that it pays the withheld monies to the contractor as soon as possible following the end of the financial year where the contractor has—

PART 9
VARIATION AND TERMINATION OF CONTRACTS
Variation of a contract: general
60. —(1) Subject to paragraph 31(3), no amendment or variation will have effect unless it is in writing and signed by or on behalf of the Local Health Board and the contractor.

(2) In addition to the specific provision made in paragraphs 62(6), 63(6) and 75, the Local Health Board may vary the contract without the contractor's consent where it—

and, where it is reasonably practicable to do so, the date that the proposed variation is to take effect will be not less than 14 days after the date on which the notice under sub-paragraph (b) is served on the contractor.

Variation of a contract: activity under the contract
61. —(1) Where the contractor or the Local Health Board is of the opinion that there needs to be a variation to the number of—

to be provided under the contract, sub-paragraphs (2) and (3) will apply.

(2) The contractor or the Local Health Board (as the case may be) will notify the other party to the contract in writing of its opinion of the need for a variation, specifying in that notice the variation that it considers necessary, together with its reasons.

(3) Following service of the notice referred to in sub-paragraph (2), both parties will use their best endeavours to communicate and co-operate with each other with a view to determining what (if any) variation should be made to the—

and any related variations to the contract, including to the monies to be paid to the contractor under the contract, and will, where appropriate, effect the variation in accordance with paragraph 60.

Variation provisions specific to a contract with an individual dental practitioner
62. —(1) If a contractor which is an individual dental practitioner proposes to practise in partnership with one or more persons during the existence of the contract, the contractor will notify the Local Health Board in writing of—

(2) A notice under sub-paragraph (1) will in respect of the person or each of the persons with whom the contractor is proposing to practise in partnership, and also in respect of itself as regards the matters specified in sub-paragraph (c)—

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(b) confirm that he or she is a person who satisfies the conditions imposed by regulation 4; and

(c) state whether or not it is to be a limited partnership, and if so, who is to be a limited and who is to be a general partner,

and the notice will be signed by the individual dental practitioner and by the person, or each of the persons (as the case may be), with whom he or she is proposing to practise in partnership.

    (3) The contractor will ensure that any person who will practise in partnership with it is bound by the contract, whether by virtue of a partnership deed or otherwise.

    (4) If the Local Health Board is satisfied as to the accuracy of the matters specified in sub-paragraph (2) that are included in the notice, the Local Health Board will give notice in writing to the contractor confirming that the contract will continue with the partnership entered into by the contractor and its partners, from a date that the Local Health Board specifies in that notice.

    (5) Where it is reasonably practicable, the date specified by the Local Health Board pursuant to sub-paragraph (4) will be the date requested in the notice served by the contractor pursuant to sub-paragraph (1), or, where that date is not reasonably practicable, the date specified will be a date after the requested date that is as close to the requested date as is reasonably practicable.

    (6) Where a contractor has given notice to the Local Health Board pursuant to sub-paragraph (1), the Local Health Board—

Variation provisions specific to a contract with two or more individuals practising in partnership
63. —(1) Subject to sub-paragraph (4), where a contractor consists of two or more individuals practising in partnership in the event that the partnership is terminated or dissolved, the contract will only continue with one of the former partners if that partner is—

and provided that the requirements in sub-paragraphs (2) and (3) are met.

(2) A contractor will notify the Local Health Board in writing at least 28 days in advance of the date on which the contractor proposes to change its status from that of a partnership to that of an individual dental practitioner pursuant to sub-paragraph (1).

(3) A notice under sub-paragraph (2) will—

(4) If a partnership is terminated or dissolved because, in a partnership consisting of two individuals practising in partnership, one of the partners has died, sub-paragraphs (1) to (3) do not apply and—

    (5) When the Local Health Board receives a notice pursuant to sub-paragraph (2) or (4)(b), it will acknowledge in writing receipt of the notice, and in relation to a notice served pursuant to sub-paragraph (2), the Board will do so before the date specified pursuant to sub-paragraph (3)(a).

    (6) Where a contractor gives notice to the Local Health Board pursuant to sub-paragraph (2) or (4)(b), the Local Health Board may vary the contract but only to the extent that it is satisfied is necessary to reflect the change in status of the contractor from a partnership to an individual dental practitioner.

    (7) If the Local Health Board varies the contract pursuant to sub-paragraph (6), it will notify the contractor in writing of the wording of the proposed variation and the date upon which that variation is to take effect.

Termination by agreement
     64. The Local Health Board and the contractor may agree in writing to terminate the contract, and if the parties so agree, they will agree the date upon which that termination should take effect and any further terms upon which the contract should be terminated.

Termination on the death of an individual dental practitioner
     65. —(1) Where the contract is with an individual dental practitioner and that practitioner dies, the contract will terminate at the end of the period of seven days after the date of his or her death unless, before the end of that period—

    (2) Where the Local Health Board is of the opinion, that another contractor may wish to enter into a contract in respect of the mandatory services which were provided by the deceased dental practitioner, the three month period referred to in sub-paragraph (1)(a) may be extended by a period not exceeding six months as may be agreed.

    (3) Sub-paragraph (1) does not affect any other rights to terminate the agreement which the Local Health Board may have under paragraphs 69 to 74.

Termination by the contractor
     66. —(1) A contractor may terminate the contract by serving notice in writing on the Local Health Board at any time.

    (2) Where a contractor serves notice pursuant to sub-paragraph (1), the contract will terminate on a date three months after the date on which the notice is served ("the termination date"), save that if the termination date is not the last calendar day of a month, the contract will instead terminate on the last calendar day of the month in which the termination date falls.

    (3) This paragraph and paragraph 67 are without prejudice to any other rights to terminate the contract that the contractor may have.

Late payment notices
     67. —(1) The contractor may give notice in writing (a "late payment notice") to the Local Health Board if the Board has failed to make any payments due to the contractor in accordance with a term of the contract that has the effect specified in regulation 21 (finance), and the contractor will specify in the late payment notice the payments that the Board has failed to make in accordance with that regulation.

    (2) Subject to sub-paragraph (3), the contractor may, at least 28 days after having served a late payment notice, terminate the contract by a further written notice if the Local Health Board has still failed to make the payments that were due to the contractor and that were specified in the late payment notice served on the Local Health Board pursuant to sub-paragraph (1).

    (3) If, following receipt of a late payment notice, the Local Health Board refers the matter to the NHS dispute resolution procedure within 28 days of the date upon which it is served with the late payment notice, and it notifies the contractor in writing that it has done so within that period of time, the contractor may not terminate the contract pursuant to sub-paragraph (2) until—

whichever is the sooner.

Termination by the Local Health Board: general
68. The Local Health Board may only terminate the contract in accordance with the provisions in this Part.

Termination by the Local Health Board: no longer eligible to enter into and breach of conditions of the contract
69. —(1) Subject to sub-paragraph (2), the Local Health Board will serve notice in writing on the contractor terminating the contract forthwith if—

(2) Where a contractor ceases to be a dental practitioner by virtue of a suspension specified in sub-paragraph (6), sub-paragraph (1) will not apply unless—

(3) Except in a case to which paragraph 63(4) applies, where the contractor is two or more persons practising in partnership and the condition prescribed in section 28M(2)(a) of the Act is no longer satisfied, the Local Health Board will—

(4) The period specified by the Local Health Board under sub-paragraph (3)(b) will not exceed—

(5) Where the contract was entered into pursuant to section 28M(1)(b) of the Act, but the contractor ceases to be a dental corporation, the Local Health Board will serve notice in writing on the contractor terminating the contract forthwith.

(6) The suspensions referred to in sub-paragraphs (2) and (4)(b) are—

(b) from the coming into force of article 18 of the Dentists Act Order for all purposes—

(7) For the purposes of sub-paragraph (6)(b)(i), a "relevant determination" is a determination that a person's fitness to practise is impaired based solely on the ground mentioned in—

Termination by the Local Health Board for the provision of untrue etc. information
70. The Local Health Board may serve notice in writing on the contractor terminating the contract forthwith, or from such date as may be specified in the notice if, after the contract has been entered into, it comes to the attention of the Local Health Board that written information provided to the Local Health Board by the contractor—

in relation to the conditions set out in regulation 4 or 5 (and compliance with those conditions) was, when given, untrue or inaccurate in a material respect.

Termination by the Local Health Board on grounds of suitability etc.
71. —(1) The Local Health Board may serve notice in writing on the contractor terminating the contract forthwith, or from such date as may be specified in the notice if —

falls within sub-paragraph (2) during the existence of the contract or, if later, on or after the date on which a notice in respect of his or her compliance with the conditions in regulation 4 or 5 was given under paragraph 42(2).

(2) A person falls within this sub-paragraph if—

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(f) subject to sub-paragraph (5), he or she has been convicted outside the United Kingdom of an offence—

(g) he or she has been convicted of an offence referred to in Schedule 1 to the Children and Young Persons Act 1933[71] (offences against children and young persons with respect to which special provisions of this Act apply) or Schedule 1 to the Criminal Procedure (Scotland) Act 1995[72] (offences against children under the age of 17 years to which special provisions apply);

(h) he, she or it has—

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(i) there is—

74

(j) that person is a partnership and—

(k) he or she has been—

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(l) he or she is subject to a disqualification order under the Company Directors Disqualification Act 1986[76], the Companies (Northern Ireland) Order 1986[77] or to an order made under section 429(2)(b) of the Insolvency Act 1986 (failure to pay under county court administration order); or

(m) he or she has refused to comply with a request by the Local Health Board for him or her to be medically examined on the grounds that it is concerned that he or she is incapable of adequately providing services under the contract and, in a case where the contract is with two or more individuals practising in partnership or with a dental corporation, the Local Health Board is not satisfied that the contractor is taking adequate steps to deal with the matter.

(3) A Local Health Board will not terminate the contract pursuant to sub-paragraph (2)(b) where the Local Health Board is satisfied that the disqualification or suspension imposed by a licensing body outside the United Kingdom does not make the person unsuitable to be—

(4) A Local Health Board will not terminate the contract pursuant to sub-paragraph (2)—

and the Local Health Board may only terminate the contract at the end of the period specified in paragraph (b) if there is no finding of unfair dismissal at the end of those proceedings.

(5) A Local Health Board will not terminate the contract pursuant to sub-paragraph (2)(f) where the Local Health Board is satisfied that the conviction does not make the person unsuitable to be—

as the case may be.

Termination by the Local Health Board: patient safety and material financial loss
72. The Local Health Board may serve notice in writing on the contractor terminating the contract forthwith or with effect from such date as may be specified in the notice if—

Termination by the Local Health Board: remedial notices and breach notices
73. —(1) Where a contractor has breached the contract other than as specified in paragraphs 70 to 72 and the breach is capable of remedy, the Local Health Board will, before taking any action it is otherwise entitled to take by virtue of the contract, serve a notice on the contractor requiring it to remedy the breach ("remedial notice").

(2) A remedial notice will specify—

(3) The notice period will, unless the Local Health Board is satisfied that a shorter period is necessary to—

be no less than 28 days from the date that notice is given.

    (4) Where a Local Health Board is satisfied that the contractor has not taken the required steps to remedy the breach by the end of the notice period, the Local Health Board may terminate the contract with effect from such date as the Local Health Board may specify in a further notice to the contractor.

    (5) Where a contractor has breached the contract other than as specified in paragraphs 70 to 72 and the breach is not capable of remedy, the Local Health Board may serve notice on the contractor requiring the contractor not to repeat the breach ("breach notice").

    (6) If, following a breach notice or a remedial notice, the contractor—

the Local Health Board may serve notice on the contractor terminating the contract with effect from such date as may be specified in that notice.

    (7) The Local Health Board will not exercise its right to terminate the contract under sub-paragraph (6) unless it is satisfied that the cumulative effect of the breaches is such that the Local Health Board considers that to allow the contract to continue would be prejudicial to the efficiency of the services to be provided under the contract.

    (8) If the contractor is in breach of any obligation and a breach notice or a remedial notice in respect of that default has been given to the contractor, the Local Health Board may withhold or deduct monies which would otherwise be payable under the contract in respect of that obligation which is the subject of the breach.

Termination by the Local Health Board: additional provisions specific to contracts with two or more individuals practising in partnership and dental corporations
     74. —(1) Where the contractor is a dental corporation, if the Local Health Board becomes aware that the contractor is carrying on any business which the Local Health Board considers to be detrimental to the contractor's performance of its obligations under the contract—

(2) Where the contractor is a dental corporation and on or after the coming into force for all purposes of article 39 of the Dentists Act Order during the existence of the contract—

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the Local Health Board may, by written notice, terminate the contract if it considers that as a consequence the dental corporation is no longer suitable to be a contractor.

(3) Where the contractor is two or more persons practising in partnership, the Local Health Board will be entitled to terminate the contract by notice in writing on such date as may be specified in that notice where one or more partners have left the practice during the existence of the contract if, in its reasonable opinion, the Local Health Board considers that the change in membership of the partnership is likely to have a serious adverse impact on the ability of the contractor or the Local Health Board to perform its obligations under the contract.

(4) A notice given to the contractor pursuant to sub-paragraph (3) will specify—

Contract sanctions
75. —(1) In this paragraph and paragraph 76, "contract sanction" means—

    (2) Where the Local Health Board is entitled to terminate the contract pursuant to paragraph 70, 71, 72, 73(4), 73(6) or 74, it may instead impose any of the contract sanctions if the Local Health Board is reasonably satisfied that the contract sanction to be imposed is appropriate and proportionate to the circumstances giving rise to the Local Health Board's entitlement to terminate the contract.

    (3) The Local Health Board will not, under sub-paragraph (2), be entitled to impose any contract sanction that has the effect of terminating or suspending any obligation to provide, or any obligation that relates to, mandatory services.

    (4) If the Local Health Board decides to impose a contract sanction, it must notify the contractor of the contract sanction that it proposes to impose, the date upon which that sanction will be imposed and provide in that notice an explanation of the effect of the imposition of that sanction.

    (5) Subject to paragraph 76, the Local Health Board will not impose the contract sanction until at least 28 days after it has served notice on the contractor pursuant to sub-paragraph (4) unless the Local Health Board is satisfied that it is necessary to do so in order to—

    (6) Where the Local Health Board imposes a contract sanction, the Local Health Board will be entitled to charge the contractor the reasonable costs of additional administration that the Local Health Board has incurred in order to impose, or as a result of imposing, the contract sanction.

Contract sanctions and the NHS dispute resolution procedure
     76. —(1) If there is a dispute between the Local Health Board and the contractor in relation to a contract sanction that the Local Health Board is proposing to impose, the Local Health Board will not, subject to sub-paragraph (4), impose the proposed contract sanction except in the circumstances specified in sub-paragraph (2)(a).

    (2) If the contractor refers the dispute relating to the contract sanction to the NHS dispute resolution procedure within 28 days beginning on the date on which the Local Health Board served notice on the contractor in accordance with paragraph 75(4) (or such longer period as may be agreed in writing with the Local Health Board), and notifies the Local Health Board in writing that it has done so, the Local Health Board will not impose the contract sanction unless—

whichever is the sooner.

(3) If the contractor does not invoke the NHS dispute resolution procedure within the time specified in sub-paragraph (2), the Local Health Board will be entitled to impose the contract sanction forthwith.

(4) If the Local Health Board is satisfied that it is necessary to impose the contract sanction before the NHS dispute resolution procedure is concluded in order to—

the Local Health Board will be entitled to impose the contract sanction forthwith, pending the outcome of that procedure.

Termination and the NHS dispute resolution procedure
77. —(1) Where the Local Health Board is entitled to serve written notice on the contractor terminating the contract pursuant to paragraph 70, 71, 72, 73(4), 73(6) or 74, the Local Health Board will, in the notice served on the contractor pursuant to those provisions, specify a date on which the contract terminates that is not less than 28 days after the date on which the Local Health Board has served that notice on the contractor unless sub-paragraph (2) applies.

(2) This sub-paragraph applies if the Local Health Board is satisfied that a period less than 28 days is necessary in order to—

(3) In a case falling with sub-paragraph (1), where the exceptions in sub-paragraph (2) do not apply, where the contractor invokes the NHS dispute resolution procedure before the end of the period of notice referred to in sub-paragraph (1), and it notifies the Local Health Board in writing that it has done so, the contract will not terminate at the end of the notice period but instead will only terminate in the circumstances specified in sub-paragraph (4).

(4) The contract will only terminate if and when—

whichever is the sooner.

(5) If the Local Health Board is satisfied that it is necessary to terminate the contract before the NHS dispute resolution procedure is concluded in order to—

sub-paragraphs (3) and (4) will not apply and the Local Health Board will be entitled to confirm, by written notice to be served on the contractor, that the contract will nevertheless terminate at the end of the period of the notice it served pursuant to paragraph 70, 71, 72, 73(4), 73(6) or 74.

PART 10
MISCELLANEOUS
Evidence of exemption under the Act
78. —(1) Subject to sub-paragraph (2), the contractor will ensure that it requests, in respect of a person who makes a declaration relating to exemption under paragraph 1(1) of Schedule 12ZA[80] to the Act evidence in support of that declaration.

(2) The contractor will ensure that—

    (3) Sub-paragraphs (1) and (2) do not apply where the contractor is satisfied that the person in respect of whom the declaration is made is under the age of 18 years.

Clinical governance arrangements
     79. —(1) The contractor will comply with such clinical governance arrangements as the Local Health Board may establish in respect of contractors providing services under a contract.

    (2) The contractor will nominate a person who manages services under the contract to have responsibility for ensuring compliance with clinical governance arrangements.

    (3) In this paragraph, "clinical governance arrangements" means arrangements through which the contractor endeavours to continuously improve the quality of its services and safeguard high standards of care by creating an environment in which clinical excellence can flourish.

Quality assurance system
     80. —(1) The contractor will establish, and operate a practice based quality assurance system which is applicable to all the persons specified in sub-paragraph (2).

    (2) The specified persons are—

(3) A contractor will ensure that in respect of its practice based quality assurance system, it has nominated a person (who need not be connected with the contractor's practice) to be responsible for operating that system.

(4) In this paragraph, "a practice based quality assurance system" means one which comprises a system to ensure that—

Insurance: negligent performance
     81. —(1) The contractor will at all times hold adequate insurance against liability arising from negligent performance of clinical services under the contract.

    (2) The contractor will not sub-contract its obligations to provide clinical services under the contract unless it has satisfied itself that the sub-contractor holds adequate insurance against liability arising from negligent performance of such services.

    (3) In this paragraph—

Public liability insurance
     82. —(1) The contractor will at all times hold adequate public liability insurance in relation to liabilities to third parties arising under or in connection with the contract which are not covered by the insurance referred to in paragraph 81(1).

    (2) In this paragraph, "insurance" has the same meaning as in paragraph 81.

Gifts
     83. —(1) The contractor will keep a register of gifts which are given to any of the persons specified in sub-paragraph (2) by or on behalf of—

and have, in its reasonable opinion, an individual value of more than £100.00.

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

(3) Sub-paragraph (1) does not apply where—

(4) The contractor will take reasonable steps to ensure that it is informed of gifts which fall within sub-paragraph (1) and which are given to the persons specified in sub-paragraph (2)(b) to (2)(g).

(5) The register referred to in sub-paragraph (1) will include the following information—

(6) The contractor will make the register available to the Local Health Board on request.

Compliance with legislation and guidance
84. The contractor will—

Third party rights
85. The contract will not create any right enforceable by any person not a party to it.

Signing of documents
86. —(1) In addition to any other requirement that may relate to the documents specified in sub-paragraph (2), whether in these Regulations or otherwise, the contractor will ensure such documents include—

(2) The reference to documents in sub-paragraph (1) include—

SCHEDULE 4Regulation 2 and paragraph 34 of Schedule 3

PATIENT INFORMATION LEAFLET

A practice leaflet will include—

1. The name of the contractor.

2. In the case of a contract with a partnership—

3. In the case of a contract with a dental corporation—

     4. The full name of each person performing services under the contract.

     5. In the case of each person performing dental services under the contract, his or her professional qualifications.

     6. Whether the contractor undertakes the teaching or training of persons who provide dental services or who intend to do so.

     7. The address of each of the practice premises.

     8. The contractor's telephone and fax numbers and the address of its website (if any).

     9. Whether the practice premises have suitable access for disabled patients and, if not, the alternative arrangements for providing services to such patients.

     10. How to request services as a patient.

     11. The rights of a patient to express a preference of practitioner in accordance with paragraph 2 of Schedule 3 and the means of expressing such a preference.

     12. The services available under the contract.

     13. The normal surgery days and hours of the practice.

     14. The arrangements for dental services for the hours and days that fall outside normal surgery hours (whether or not provided by the contractor) and how the patient may contact such services.

15. If the services in paragraph 14 are not provided by the contractor, the fact that the Local Health Board referred to in paragraph 21 is responsible for commissioning the services.

     16. The telephone number of NHS Direct and details of NHS Direct online.

     17. How patients may make a complaint or comment on the provision of service.

     18. The rights and responsibilities of the patient, including keeping appointments.

     19. The action that may be taken where a patient is violent or abusive to the contractor, its staff, persons present on the practice premises or in the place where treatment is provided under the contract or other persons specified in paragraph 3 of Schedule 3.

     20. Details of who has access to patient information (including information from which the identity of the individual can be ascertained) and the patient's rights in relation to disclosure of such information.

     21. The name, postal and email address and telephone number of the Local Health Board which is a party to the contract and from whom details of primary dental services in the area may be obtained.

EXPLANATORY NOTE

(This note is not part of the Regulations)

These Regulations set out, for Wales, the framework for general dental services contracts under section 28K of the National Health Service Act 1977 ("the Act").

Part 2 of the Regulations prescribes the conditions which, in accordance with section 28M of the Act, must be met by a contractor before the Local Health Board may enter into a general dental services contract with it.

Part 3 of the Regulations prescribes the procedure for pre-contract dispute resolution, in accordance with section 28P(1) of the Act. Part 3 applies to cases where the contractor is not a health service body. In cases where the contractor is such a body, the procedure for dealing with pre-contract disputes is set out in section 4 of the National Health Service and Community Care Act 1990.

Part 4 of the Regulations sets out the procedures, in accordance with section 28P(3) of the Act, by which the contractor may obtain health service body status.

Part 5 of (and Schedules 1 to 3 to) the Regulations prescribe the terms which, in accordance with sections 28O and 28P of the Act, must be included in a general dental services contract (in addition to those contained in the Act). It includes, in regulation 14, a description of the services which must be provided to patients under a general dental services contract pursuant to section 28L of the Act.

The prescribed terms include terms relating to—

Part 6 of the Regulations makes transitional provision.

A Regulatory Appraisal has been prepared for these Regulations and a copy has been placed in the library of the National Assembly for Wales. Copies of the Regulatory Appraisal can be obtained from Community Primary Care and Health Services Policy Directorate, National Assembly for Wales, Cathays Park, Cardiff CF10 3NQ.

Notes:

[1] 1977 c.49; sections 28L, 28M, 28O and 28P were inserted into the Act by section 172(1) of the Health and Social Care (Community Health and Standards) Act 2003 (c.43) ("the 2003 Act"); and section 126(4) was amended by section 65(2) of the National Health Service and Community Care Act 1990 (c.19) ("the 1990 Act"), the Health Act 1999 (c.8) ("the 1999 Act"), Schedule 4, paragraph 37(6) and the Health and Social Care Act 2001 (c. 15) ("the 2001 Act"), Schedule 5, paragraph 5(13)(b). See section 128(1) of the Act as amended by the 1990 Act, section 26(2)(g) and (i), for the definitions of "prescribed" and "regulations". As regards Wales, the functions of the Secretary of State under sections 28L, 28M, 28O, 28P and 126(4) of the Act and section 4 of the 1990 Act were transferred to Wales under S.I. 1999/672, article 2 and Schedule 1, as amended by the 1999 Act, section 66(5) and as read with section 40(1) of the National Health Service Reform and Health Care Professions Act 2002 (c.17) ("the 2002 Act") and section 197(1) of the 2003 Act.back

[2] 1990 c.19.back

[3] 1971 c.80.back

[4] Section 28K was inserted into the Act by section 172(1) of the 2003 Act.back

[5] S.I. 1986/887; relevant amending instruments are S.I. 1999/3460, 2003/3105 and 2002/1671.back

[6] Section 28X was inserted into the Act by section 179(1) of the 2003 Act.back

[7] Section 16CB was inserted into the Act by section 171(1) of the 2003 Act.back

[8] 1984 c.24.back

[9] S.I. 2005/ 2011.back

[10] Section 14 of the Dentists Act is prospectively substituted by article 6 of the Dentists Act Order.back

[11] Schedule 12ZA was inserted into the Act by section 183(2) of the 2003 Act.back

[12] 1989 c.41.back