The National Health Service (Personal Dental Services Agreements) Regulations 2005

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"bank holiday" means any day that is specified or proclaimed as a bank holiday in England pursuant to section 1 of the Banking and Financial Dealings Act 1971[4];

"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—

(a) the issue of a prescription;

(b) the repair of a dental appliance;

(c) the arrest of bleeding; or

(d) the removal of sutures,

which, by virtue of regulation 3(2)(d) or (e) 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—

(a) a course of treatment, means that—


(i) where no treatment plan has to be provided in respect of a course of treatment pursuant to paragraph 8(5) of Schedule 3 (treatment plans), all the treatment recommended to, and agreed with, the patient by the contractor at the initial examination and assessment of that patient has been provided to the patient; or

(ii) where a treatment plan has to be provided to the patient pursuant to paragraph 8(1) of Schedule 3, all the treatment specified on that plan by the contractor (or that plan as revised in accordance with paragraph 8(3) of that Schedule) has been provided to the patient; and



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



(i) where the contractor determines in accordance with paragraph 4 of Schedule 1 (patients to whom orthodontic treatment may be provided) that no orthodontic treatment should be provided following the case assessment, the completion of the case assessment; or

(ii) where the contractor has determined that orthodontic treatment should be provided following the case assessment, all of the orthodontic treatment specified on the orthodontic treatment plan by the contractor pursuant to paragraph 6 of Schedule 1 (orthodontic treatment plans) (or that plan as revised in accordance with paragraph 6(3) of that Schedule) has been provided to the patient,



and "completed" shall be construed accordingly;

"contractor" means, except where the context otherwise requires—

(a) where a Primary Care Trust is not providing services under the agreement, a person or persons other than a Primary Care Trust, who is a party, or are parties, to the agreement; or

(b) where a Primary Care Trust is providing services under the agreement, that Primary Care Trust and any other person or persons (other than a Strategic Health Authority) who is a party, or are parties, to the agreement;

"course of treatment" means—

(a) an examination of a patient, an assessment of his oral health, and the planning of any treatment to be provided to that patient as a result of that examination and assessment; and

(b) the provision of any planned treatment (including any treatment planned at a time other than the time of the initial examination) to that patient,

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;

"dental care professional" means a person whose name is included in the register of dental care professionals or on the appropriate roll for dental auxiliaries established in accordance with Part II of the Dental Auxiliaries Regulations 1986[5];

"dental performers list" means a list of dental practitioners prepared in accordance with regulations made under section 28X of the Act[6] (persons performing primary medical and dental services);

"dental public health services" means services provided by the contractor by virtue of section 16CB(4)(c) of the Act[7] (dental public health);

"Dentists Act" means the Dentists Act 1984[8];

"Dentists Act Order" means the Dentists Act 1984 (Amendment) Order 2005[9];

"Dentists Register" means the register maintained by the General Dental Council pursuant to section 14 of the Dentists Act[10] (the dentists register and the registrar);

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

(a) the practice premises of any provider of primary dental services;

(b) a mobile surgery of any provider of primary dental services; or

(c) a prison;

"exempt person" means a person who is, by virtue of either Schedule 12ZA to the Act[11] (dental charging: exemptions) or the NHS Charges Regulations, exempt from the need to pay an NHS Charge in respect of the services he has received under the agreement;

"family member" means—

(a) a spouse;

(b) a civil partner;

(c) a person whose relationship with the registered patient has the characteristics of the relationship between husband and wife, or civil partners;

(d) a parent or step-parent;

(e) a son;

(f) a daughter;

(g) a child of whom the person is—


(i) the guardian; or

(ii) the carer duly authorised by the local authority to whose care the child has been committed under the Children Act 1989[12]; or



(h) a grandparent;

"FHSAA" means the Family Health Services Appeal Authority constituted under section 49S of the Act[13] (the Family Health Services Appeal Authority);

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

"GDS Contracts Regulations" means the National Health Service (General Dental Services Contracts) Regulations 2005[14];

"health care professional" has the same meaning as in section 28M of the Act[15] (persons eligible to enter into GDS contracts) and "health care profession" shall be construed accordingly;

"health service body" has, unless the context otherwise requires, the meaning given to it in section 4(2) of the 1990 Act[16] (NHS contracts);

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

"listed", in relation to drugs, medicines or appliances, means such drugs, medicines or appliances as are included in a list for the time being approved by the Secretary of State for the purposes of section 41(1)(c) of the Act[17] (arrangements for pharmaceutical services);

"mandatory services" means the services described in regulation 14 of the GDS Contracts Regulations;

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

"national disqualification" means—

(a) a decision made by the FHSAA under section 49N or under regulations corresponding to that section made under section 28X(4) of the Act[18] (national disqualifications);

(b) a decision under provisions in force in Scotland or Northern Ireland corresponding to section 49N of the Act; or

(c) a decision by the NHS Tribunal which is treated as a national disqualification by the FHSAA by virtue of regulation 6(4)(b) of the Abolition of the National Health Service Tribunal (Consequential Provisions) Regulations 2001[19] or regulation 6(4)(b) of the Abolition of the National Health Service Tribunal (Consequential Provisions) Regulations 2002[20];

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

"NHS Charges Regulations" means the National Health Service (Dental Charges) Regulations 2005[21];

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

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

"NHS Tribunal" means the Tribunal constituted under section 46 of the Act[22] for England and Wales, and which, except for prescribed cases, had effect in relation to England only until 14th December 2001 and in relation to Wales only until 26th August 2002[23];

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

"NPSA" means the National Patient Safety Agency established as a Special Health Authority by the National Patient Safety Agency (Establishment and Constitution) Order 2001[24];

"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—

(a) a case assessment of a patient; and

(b) the provision of any orthodontic treatment that the contractor determines should be provided to the patient in accordance with Part 2 of Schedule 1 (orthodontic services);

"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 agreement;

"patient record" means a form supplied by a Relevant Body for the purpose of maintaining a record of treatment, and may include an electronic form;

"practice premises", except where expressly provided otherwise in these Regulations, means an address specified in the agreement as one at which services are to be provided under the agreement 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 agreement;

"primary care list" means—

(a) a list of persons performing primary medical or dental services under section 28X of the Act[25];

(b) a list of persons undertaking to provide general ophthalmic services or, as the case may be, pharmaceutical services prepared in accordance with regulations made under section 39, 42 or 43 of the Act[26];

(c) a list of persons approved for the purposes of assisting in the provision of any services mentioned in paragraph (b) or (d) prepared in accordance with regulations made under section 43D of the Act[27];

(d) a list of persons who undertook to provide general medical services or general dental services prepared in accordance with regulations made under sections 29 or 35 of the Act[28];

(e) a services list which fell within the meaning of section 8ZA of the National Health Service (Primary Care) Act 1997[29];

(f) a list corresponding to a services list prepared by virtue of regulations made under section 41 of the Health and Social Care Act 2001[30]; or

(g) a list corresponding to any of the above lists in Scotland or Northern Ireland;

"Primary Care Trust" means, except where the context otherwise requires, the Primary Care Trust which is a party, or prospective party, to an agreement;

"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—

(a) "secure training centre" means a place in which offenders subject to detention and training orders under section 100 of the Powers of Criminal Courts (Sentencing) Act 2000[31] (offenders under 18: detention and training orders) may be detained and given training and education and prepared for their release; and

(b) "young offender institution" means a place for the detention of offenders sentenced to detention in a young offender institution or to detention in a young offender institution as part of a longer custodial sentence, including custody for life;

"private", in the context of services or treatment, means otherwise than under the agreement or Part 1 of the Act, and "privately" shall 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 10(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—

(a) another contractor; or

(b) another provider of primary dental services under Part 1 of the Act,

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(2) of that Schedule;

"register of dental care professionals" means the register maintained by the General Dental Council under section 36B of the Dentists Act[32] (the dental care professionals register);

"Relevant Body" means—

(a) in a case where a contractor is a party to an agreement with a Primary Care Trust, that Primary Care Trust; and

(b) in a case where a contractor is a party to an agreement with a Strategic Health Authority, that Strategic Health Authority;

"relevant Strategic Health Authority" means the Strategic Health Authority established for an area which includes the area for which the Primary Care Trust is established;

"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—

(a) the drugs and techniques used to provide the sedation are deployed by the contractor in a manner that ensures loss of consciousness is rendered unlikely; and

(b) verbal contact with the patient is maintained in so far as is reasonably possible;

"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 agreement used to—

(a) express the amount of; and

(b) measure in accordance with Part 1 of Schedule 2 the provision of,

mandatory services and advanced mandatory services provided under the agreement;

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

(a) express the amount of; and

(b) measure in accordance with Part 2 of Schedule 2 the provision of,

orthodontic services provided under the agreement;

"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—

(a) a prompt course of treatment is provided because, in the opinion of the contractor, that person's oral health is likely to deteriorate significantly, or the person is in severe pain by reason of his oral condition; and

(b) treatment is provided only to the extent that is necessary to prevent that significant deterioration or address that severe pain; and

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

    (2) In these Regulations—

(a) the use of the term it in relation to the contractor shall be deemed to include a reference to a contractor that is an individual dental practitioner or two or more persons contracting together to provide services under an agreement and related expressions shall be construed accordingly; and

(b) references to forms supplied by the Primary Care Trust to contractors includes electronic forms and forms which are generated electronically, but does not include prescription forms.

(a) regulation 4; and

(b) in the case of an agreement to be entered into with a qualifying body[33], on or after the coming into force for all purposes of article 39 of the Dentists Act Order (substitution of sections 43 and 44), regulation 5,

are met.

General conditions relating to all agreements
     4. —(1) A Relevant Body may make an agreement with an individual falling within section 28D(1)(b) to (d) if that individual does not fall within paragraph (3).

    (2) A Relevant Body may make an agreement with a qualifying body only if—

(a) the qualifying body; or

(b) any director, chief executive or secretary of the qualifying body,

does not fall within paragraph (3).

    (3) A person falls within this paragraph if—

(a) he or it (in the case of a qualifying body) is the subject of a national disqualification;

(b) subject to paragraph (4), he 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 agreement is to be commenced or, if earlier, the date on which the agreement is to be signed—


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

(ii) he 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[34] respectively) unless his or its name has subsequently been included in such a list;



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



(i) murder; or

(ii) a criminal offence other than murder, committed on or after 14th December 2001, and has been sentenced to a term of imprisonment of over six months;



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



(i) which would, if committed in England and Wales, constitute murder; or

(ii) committed on or after 14th December 2001, which would if committed in England and Wales, constitute a criminal offence other than murder, and been sentenced to a term of imprisonment of over six months;



(f) he has been convicted of an offence referred to in Schedule 1 to the Children and Young Persons Act 1933[35] (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[36] (offences against children under the age of 17 years to which special provisions apply) committed on or after 1st April 2006;

(g) he or it has—



(i) been adjudged bankrupt or had sequestration of his estate awarded unless (in either case) he has been discharged or the bankruptcy order has been annulled;

(ii) been made the subject of a bankruptcy restrictions order or an interim bankruptcy restrictions order under Schedule 4A to the Insolvency Act 1986[37] unless that order has ceased to have effect or has been annulled; or

(iii) made a composition or arrangement with, or granted a trust deed for, his or its creditors unless he or it has been discharged in respect of it;



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

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



(i) been removed from the office of charity trustee or trustee for a charity by an order made by the Charity Commissioners or the High Court on the grounds of any misconduct or mismanagement in the administration of the charity for which he was responsible or to which he was privy, or which he by his conduct contributed to or facilitated;

(ii) been removed under section 7 of the Law Reform (Miscellaneous Provisions) (Scotland) Act 1990[38] (powers of the Court of Session to deal with management of charities), from being concerned in the management or control of any body; or

(iii) been subject to a disqualification order under the Company Directors Disqualification Act 1986[39], the Companies (Northern Ireland) Order 1986[40] or to an order made under section 429(2)(b) of the Insolvency Act 1986[41] (failure to pay under county court administration order).

    (4) A person shall not fall within paragraph (3)(b) where the Relevant Body 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—

(a) a party to an agreement; or

(b) in the case of an agreement with a qualifying body, a director, chief executive or secretary of the qualifying body,

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 shall not fall within paragraph (3)(e) where the Relevant Body is satisfied that the conviction does not make the person unsuitable to be—

(a) a party to an agreement; or

(b) in the case of an agreement with a qualifying body, a member, director, chief executive or secretary of the qualifying body.

Additional conditions relating to agreements with qualifying bodies
     5. —(1) Subject to paragraph (2), it is a condition in the case of an agreement to be entered into with a qualifying body on or after the date of the coming into force 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) shall not apply if the Relevant Body is satisfied that any offence under section 43 or penalty imposed under section 43B or 44 of the Dentists Act does not make the qualifying body 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 Relevant Body is of the view that the conditions in regulation 4 or 5 for entering into an agreement are not met it shall notify in writing the person or persons intending to enter into the agreement of its view and its reasons for that view and of his, its, or their right of appeal under regulation 7.

    (2) The Relevant Body shall also notify in writing of its view and its reasons for that view, any director, chief executive or secretary of a qualifying body that is notified under paragraph (1) where its reasons for the decision relate 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 Relevant Body 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 Relevant Body served its notice.

    (2) The premises referred to in paragraph (1)(d) do not include any place in which a patient is residing.

Units of dental activity
     13. —(1) Where an agreement includes the provision of mandatory or advanced mandatory services, the agreement must specify the number of units of dental activity to be provided by the contractor—

(a) where the agreement begins on 1st April, in each financial year or, by virtue of the duration of the agreement, part financial year; or

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

    (2) An agreement 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 has provided under the agreement.

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

(a) where the agreement begins on 1st April, in each financial year or, by virtue of the duration of the agreement, part financial year; or

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

    (2) Where paragraph (1) applies, the agreement must also contain terms which have the effect of those specified in Part 2 of Schedule 2 in relation to the calculation of how many units of orthodontic activity a contractor has provided under the agreement.

Under-provision of units of dental activity or units of orthodontic activity
     15. —(1) The agreement shall provide that the Relevant Body shall not, pursuant to Part 9 of Schedule 3 (variation and termination of agreements), be entitled to take any action for breach of a term of the agreement giving effect to regulation 13 or 14 (including termination of the agreement) 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 agreement giving effect to regulation 13 or 14 where—

(i) that failure amounts to 4 per cent or less of the total number of units of dental activity or units of orthodontic activity that ought to have been provided; and

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

    (3) Paragraphs (1) and (2) shall not prevent the Relevant Body from taking action under Part 9 of Schedule 3 for breach of contract (including terminating the agreement) on other grounds.

    (4) In the case of an agreement with a duration period of less than 12 months, the period of 60 days in paragraph (2)(ii) may not apply if the Relevant Body considers it not appropriate or considers that another period of less than 60 days should apply.

Domiciliary services and sedation services
     16. Where an agreement includes the provision of domiciliary services or sedation services, the agreement 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 1st April, in each financial year; or

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

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

(a) the Relevant Body to make payments to the contractor under the agreement promptly and in accordance with both the terms of the agreement and any other conditions relating to the payment contained in directions given by the Secretary of State under section 28E(3A) of the Act[42] (personal medical or dental services: regulations);

(b) the contractor to make payments promptly to the Relevant Body and in accordance with both the terms of the agreement and any other conditions relating to the payment contained in directions given by the Secretary of State under section 17 (Secretary of State's directions: exercise of functions) or 28E(3A) of the Act.

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

(a) is owed by the contractor to the Relevant Body under the agreement;

(b) has been paid to the contractor owing to an error or in circumstances when it was not due; or

(c) the Relevant Body may withhold from the contractor in accordance with the terms of the agreement or any other applicable provisions contained in directions given by the Secretary of State under section 28E(3A).

    (3) The agreement must contain a term to the effect that where, pursuant to directions under section 17 or 28E(3A) of the Act, a Relevant Body is required to make a payment to a contractor under an agreement but subject to conditions, those conditions are to be a term of the agreement.

Fees, charges and financial interests of the contractor
     18. —(1) The agreement 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 shall 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 agreement, except as otherwise provided in the NHS Charges Regulations; or

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

    (3) The agreement 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 agreement.

    (4) The agreement 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 agreement; 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) shall have the same meaning as in regulation 2(1) of the NHS Charges Regulations.

Arrangements on termination
     19. An agreement shall make suitable provision for arrangements on termination of an agreement including the consequences (whether financial or otherwise) of the agreement ending.

Other contractual terms
     20. —(1) An agreement 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 and Schedule 5.

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

    (3) Where an agreement does not commence on 1st April in any financial year or the duration of an agreement is less than 12 months, 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.

(a) state that the contractor wishes to terminate the agreement and the date on which the contractor wishes the agreement to terminate which must be at least three months after the date of service of the notice;

(b) subject to paragraph (3), give the name or names of the person or persons whom the contractor wishes the Relevant Body to enter into a general dental services contract with; and

(c) confirm that the person or persons so named meet the conditions set out in section 28M of the Act (persons eligible to enter into GDS contracts)[43] and regulations 4 and 5 (where applicable) of the GDS Contracts Regulations or, where the contractor is not able so to confirm, the reason why it is not able to do so and confirmation that the person or persons immediately prior to entering into the general dental services contract will meet those conditions.

    (3) A person's name may only be given in a notice referred to in paragraph (1) if that person is a party to the agreement.

    (4) The Relevant Body shall acknowledge receipt of the notice served under paragraph (1) within the period of seven days beginning on the day that it received the notice.

    (5) Provided that the conditions set out in section 28M of the Act and regulations 4 and 5 (where applicable) of the GDS Contracts Regulations are met, the Relevant Body shall enter into a general dental services contract with the person or persons named in the notice served under paragraph (1).

    (6) In addition to the terms required by the Act and the GDS Contracts Regulations, a general dental services contract entered into pursuant to this regulation shall provide for—

(a) the general dental services contract to commence immediately after the termination of the agreement;

(b) the same services to be provided under the general dental services contract as were provided under the agreement immediately before it was terminated unless the parties otherwise agree;

(c) the contractor to complete any course of treatment or orthodontic course of treatment that were not complete immediately before the agreement was terminated—


(i) in accordance with the terms of the general dental services contract in so far as those terms correspond with the terms of the agreement immediately before it was terminated, and

(ii) subject to such terms of the general dental services contract that permits the termination of a course of treatment or orthodontic course of treatment; and



(d) unless the parties otherwise agree—



(i) subject to paragraph (ii), the same number of units of dental activity or units of orthodontic activity (as the case may be) specified in the agreement in a term giving effect to regulation 13 or 14 to be provided under the general dental services contract;

(ii) where the general dental services contract is to begin on a day other than 1st April, the contractor to provide under that contract during the remainder of that financial year any units of dental activity or units of orthodontic activity that the contractor would have been obliged to provide in that financial year under the agreement but had not yet provided immediately before the general dental services contract begins;



(e) unless the parties otherwise agree—



(i) subject to paragraph (ii), the same number of courses of treatment involving the provision of sedation services or domiciliary services specified in the agreement in a term giving effect to regulation 16 to be provided under the general dental services contract;

(ii) where the general dental services contract is to begin on a day other than 1st April, the contractor under that contract to provide or contribute to during the remainder of that financial year any courses of treatment involving the provision of sedation services or domiciliary services that the contractor would have been obliged to provide or contribute to in that financial year under the agreement but had not yet provided or contributed to immediately before the general dental services contract begins;



(f) in respect of a course of treatment or orthodontic course of treatment falling within sub-paragraph (c), the contractor to ensure that a patient who is not an exempt person only pays one NHS Charge in respect of that course of treatment or orthodontic course of treatment; and

(g) the contractor to comply with the term of the general dental services contract giving effect to paragraph 12 of Schedule 3 to the GDS Contracts Regulations (repair or replacement of restorations) in respect of any patients to whom it provided treatment under its agreement, in addition to patients to whom it provides treatment under the general dental services contract.

    (7) An agreement shall terminate on the date stated in the notice given by the contractor under paragraph (1) unless a different date is agreed by the contractor and the Relevant Body or no general dental services contract is entered into by the Relevant Body pursuant to this regulation.

    (8) Where there is a dispute as to whether or not a person satisfies the conditions set out in section 28M of the Act or regulation 4 or 5 of the GDS Contracts Regulations, the contractor may appeal to the FHSAA and the Relevant Body shall be the respondent.

    (9) Any other dispute relating to this regulation shall be determined by the Secretary of State in accordance with regulation 8(3) and (4) of the GDS Contracts Regulations (pre-contract disputes).

    (10) The parties to a dispute referred to the Secretary of State in accordance with paragraph (9) shall be the contractor and the Relevant Body.

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

    (3) The contractor shall, subject to the termination of, or being unable to complete a course of treatment in accordance with paragraph 7(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 (2), pursuant to that revised treatment plan.

    (4) This paragraph shall 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 shall only 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"[44], in so far as those recommendations and guidelines are relevant to—

(a) the type of sedation being administered; and

(b) the patient to whom the sedation is being administered.

(a) grade 4 or 5 of the Dental Health Component of the Index of Orthodontic Treatment Need[45], or

(b) grade 3 of the Dental Health Component of that Index with an Aesthetic Component of 6 or above,

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 shall 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—

(a) it provides a repair to an orthodontic appliance of a person; and

(b) the orthodontic course of treatment in which that orthodontic appliance was provided is being provided by another contractor, hospital or relevant service provider under Part 1 of the Act.

    (3) The contractor shall 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—

(a) terminated before it has been completed; or

(b) otherwise not completed within a reasonable time,

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

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

(a) the contractor—


(i) when the circumstances referred to in paragraph 3(1) of Schedule 3 (violent patients) occur and notice that it will no longer provide services has been given to the Relevant Body;

(ii) where the patient has refused to pay a charge in the circumstances referred to in paragraph 4 of Schedule 3 (refusal to pay NHS Charges prior to the commencement of, or during, treatment); or

(iii) where, in the reasonable opinion of the contractor, there has been an irrevocable breakdown in the relationship between the patient and that contractor and notice of such a breakdown has been given to the patient and the Relevant Body;



(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 shall, 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 Relevant Body which shall specify—

(a) the name of the patient;

(b) the name of the contractor;

(c) particulars of the places where the patient will receive orthodontic treatment;

(d) the telephone number at which the contractor may be contacted during normal surgery hours;

(e) details of the orthodontic treatment which is, at the date of the examination, considered necessary to secure the oral health of the patient;

(f) the NHS Charge, if any, in respect of those services if provided pursuant to the agreement; and

(g) subject to paragraph 11 of Schedule 3 (mixing of services provided under the contract with private services), any proposals the contractor may have for private services as an alternative to the services proposed under the agreement, including particulars of the cost to the patient if he were to accept the provision of private services.

    (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 agreement, the contractor shall ensure that the patient signs the treatment plan in the appropriate place to indicate that he has understood the nature of private services to be provided and his 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 shall provide the patient with a revised orthodontic treatment plan in accordance with that sub-paragraph.

    (4) Subject to paragraphs 5(4) and (5), the contractor shall 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 agreement shall require the contractor to monitor, in accordance with this paragraph, the outcome of the orthodontic treatment it provides.

    (2) The contractor shall, 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 shall monitor the outcome of orthodontic treatment in accordance with "Methods to determine outcome of orthodontic treatment in terms of improvement and standards"[46] in respect of—

(a) where the total number of cases is 20 or fewer, all the cases of orthodontic courses of treatment it provides; or

(b) where the total number of orthodontic courses of treatment provided is greater than 20—


(i) 20 of the cases; and

(ii) in addition, 10 per cent of the number of cases over 20,



of orthodontic courses of treatment it provides.

    (4) The agreement shall 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 paragraph (2), the contractor shall, in respect of the patients whose courses of treatment are monitored calculate a peer assessment rating of the patient's study casts—

(a) taken at or after the case assessment but prior to the commencement of orthodontic treatment; and

(b) taken at the completion of the orthodontic course of treatment,

using either Clinical Outcome Monitoring Program software[47] or by applying the methodology set out in "An introduction to Occlusal Indices"[48].

    (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[49].

Completion of orthodontic courses of treatment
     8. —(1) The contractor shall indicate on the form supplied to the Relevant Body pursuant to paragraph 39 of Schedule 3 (notification of a course of treatment) whether or not the orthodontic course of treatment was completed.

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

    (3) If the Relevant Body—

(a) determines that the number of orthodontic courses of treatment provided by the contractor which have not been completed is excessive; and

(b) does not consider that the reasons given by the contractor for the failure to complete the orthodontic courses of treatment are satisfactory,

it shall be entitled to exercise its powers under paragraph 71 of Schedule 3 on the grounds that the contractor is not, pursuant to paragraph 5(3), using its best endeavours to ensure orthodontic courses of treatment are completed.

(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[50]; or

(iii) a person duly authorised by a voluntary organisation by which the child is being accommodated under the provisions of that Act; or



(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 shall only refuse to provide services under the agreement to a person if it has reasonable grounds for doing so which do not relate to—

(a) a person's race, gender, social class, age, religion, sexual orientation, appearance, disability or medical or dental condition; or

(b) a person's decision or intended decision to accept private services in respect of himself or a family member.

    (5) Sub-paragraph (1) does not apply—

(a) where the contractor is providing mandatory or additional services in a prison; or

(b) in any event to dental public health services.

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

(a) notify the patient (or, in the case of a child or incapable adult, the person who made the application on their behalf) of the patient's right to express a preference to receive services from a particular performer; and

(b) record in writing any such preference expressed by or on behalf of the patient.

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

(a) has reasonable grounds for refusing to provide services to the patient; or

(b) does not routinely perform the services required by the patient within the practice.

    (3) This paragraph does not apply—

(a) where the contractor is providing mandatory or additional services in a prison; or

(b) in any event to dental public health services.

Violent patients
     3. —(1) Where—

(a) a patient of the contractor has committed an act of violence or behaved in such a way against any persons specified in sub-paragraph (2) as a consequence of which that person has feared for his safety; and

(b) the contractor has reported the incident to the police,

the contractor may notify the Relevant Body that it will no longer provide services to that patient under the agreement.

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

(a) any party to the agreement who is an individual;

(b) any member of the contractor's staff;

(c) a person engaged by the contractor to perform or assist in the performance of services under the agreement; or

(d) any other person present—


(i) on the practice premises; or

(ii) in the place where services were provided to the patient under the agreement.

    (3) Notification under sub-paragraph (1) may be given by any means including telephone, fax or email but if not given in writing shall 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 Relevant Body shall be the time at which it makes the telephone call or sends or delivers the notification to the Relevant Body.

    (5) The Relevant Body shall—

(a) acknowledge in writing receipt of the notice from the contractor under sub-paragraph (1); and

(b) take all reasonable steps to inform the patient concerned as soon as is reasonably practicable.

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

(a) refuse to begin a course of treatment; or

(b) terminate a course of treatment prior to its completion,

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—

(a) in the reasonable opinion of the contractor, there has been an irrevocable breakdown in the relationship between the patient and that contractor; and

(b) notice of such a breakdown has been given to the patient by the contractor,

the contractor may notify the Relevant Body that it will no longer provide services to that patient under the agreement.

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
     15. The contractor shall provide services under the agreement in accordance with any relevant guidance that is issued by the National Institute for Clinical Excellence[51], in particular the guidance entitled "Dental recall - Recall interval between routine dental examinations"[52].

Infection control
     16. The contractor shall ensure that it has appropriate arrangements for infection control and decontamination.

Treatment under general anaesthesia: prohibition
     17. —(1) Subject to sub-paragraph (2), the contractor shall not provide any services under the agreement that involve the provision of general anaesthesia.

    (2) Where the contractor is a Primary Care Trust, NHS Foundation Trust or an NHS Trust, that contractor may provide general anaesthesia in accordance with guidance issued by the General Dental Council in "Standards for Dental Professions"[53].

(a) included in a dental performers list for a Primary Care Trust in England; and

(b) his inclusion in that list is not subject to a suspension.

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

(a) a dental hygienist; or

(b) a dental therapist,

may perform dental services under the agreement provided he 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—

(a) a dental hygienist;

(b) a dental therapist; or

(c) a professional or member of a class as specified in regulations made under section 36A(2) of the Dentists Act,

may perform dental services under the agreement provided he is—

(i) a dental care professional; and

(ii) his registration in the dental care professional register established under section 36B of the Dentists Act[57] is not subject to a suspension.

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

    (2) Where—

(a) the registration of a dental practitioner, dental care professional or other health care professional; or

(b) a dental practitioner's inclusion in a dental performers list,

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

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

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

(a) that practitioner has provided it with the name and address of the Primary Care Trust on whose dental performers list he appears; and

(b) the contractor has checked that the practitioner meets the requirements in paragraph 22.

    (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 22 in accordance with sub-paragraph (1)(b) before employing or engaging him, he may be employed or engaged on a temporary basis for a single period of up to seven days whilst such checks are undertaken.

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

(a) prior to the coming into force of the first regulations under section 36A(2) of the Dentists Act, the contractor has checked that his name is on the roll of the appropriate register established in accordance with the Dental Auxiliaries Regulations 1986; and

(b) from the coming into force of the first regulations under section 36A(2) of the Dentists Act, the contractor has checked that—


(i) his name is included in the register of dental care professionals; and

(ii) his registration in the dental care professional register is not subject to a suspension.

    (2) Where the employment or engagement of a person specified in sub-paragraph (1) is urgently needed and it is not possible to check the references referred to in sub-paragraph (1) (where it applies) before employing or engaging him, he may be employed or engaged on a temporary basis for a single period of up to seven days whilst such checks are undertaken.

    (3) When considering a person's experience and training for the purposes of sub-paragraph (1), the contractor shall have regard in particular to—

(a) any post-graduate or post-registration qualification held by that person; and

(b) any relevant training undertaken by him and any relevant clinical experience gained by him.

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

(a) that person has provided two clinical references that relate to two recent posts (which may include any current post) exercising the profession in which he seeks employment or engagement with the contractor which lasted for three months or more without a significant break, or where this is not possible, that person has provided a full explanation and alternative referees; and

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

    (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 check the references in accordance with sub-paragraph (1)(b) before employing or engaging him, he may be employed or engaged on a temporary basis for a single period of up to 14 days whilst his references are checked and considered, and for an additional period of a further seven 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 12 months old.

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

    (2) The duty imposed by sub-paragraph (1) is in addition to the duties imposed by paragraphs 25 to 27.

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

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

(b) his education and training; and

(c) his previous employment or work experience.

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

(a) performing dental services under the contract; or

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

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

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

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

Appraisal and assessment
     31. The contractor shall ensure that any dental practitioner performing services under the agreement—

(a) participates in the appraisal system (if any) provided by the Relevant Body or where the contractor is a Primary Care Trust, by it, unless he participates in the appraisal system provided by another health service body; and

(b) co-operates with an assessment by the NPSA when requested to do so by the Relevant Body, or where the contractor is a Primary Care Trust, by that Trust.

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

(a) it has taken reasonable steps to satisfy itself that—


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

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



(b) it is satisfied in accordance with paragraphs 79 and 80 that the sub-contractor holds adequate insurance.

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

(a) inform the Relevant Body of the sub-contract as soon as is reasonable practicable; and

(b) provide the Relevant Body with such information in relation to the sub-contract as it reasonably requests.

    (3) Where the contractor sub-contracts clinical services in accordance with sub-paragraph (1), the parties to the agreement shall 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 shall 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.