The National Health Service (General Dental Services Contracts) 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 7(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 7 of Schedule 3, all the treatment specified on that plan by the contractor (or that plan as revised in accordance with paragraph 7(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(3) 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;



"contract" means, except where the context otherwise requires, a general dental services contract under section 28K of the Act[5] (general dental services contracts: introductory);
"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[6];
"dental corporation" means a body corporate carrying on the business of dentistry in accordance with the Dentists Act;
"dental performers list" means a list of dental practitioners prepared in accordance with regulations made under section 28X of the Act[7] (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[8] (dental public health);
"Dentists Act" means the Dentists Act 1984[9];
"Dentists Act Order" means the Dentists Act 1984 (Amendment) Order 2005[10];
"Dentists Register" means the register maintained by the General Dental Council pursuant to section 14 of the Dentists Act[11] (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[12] (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 contract;
"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[13]; or



(h) a grandparent;



"FHSAA" means the Family Health Services Appeal Authority constituted under section 49S of the Act[14] (the Family Health Services Appeal Authority);
"financial year" means a period of 12 months ending with 31st March in any year;
"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;
"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—
(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(1) 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 Primary Care Trust (and specified in the contract) 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 contract;
"patient record" means a form supplied by a Primary Care Trust 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—
(a) a list of persons performing primary medical or dental services under section 28X of the Act;

(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[25];

(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[26];

(d) a list of persons who undertook to provide general medical services or general dental services prepared in accordance with regulations made under section 29 or 35 of the Act[27];

(e) a services list which fell within the meaning of section 8ZA of the National Health Service (Primary Care) Act 1997[28];

(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[29]; or

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


"Primary Care Trust" means, unless the context otherwise requires, the Primary Care Trust which is a party, or prospective party, to the contract;
"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[30] (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 contract 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 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—
(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(3) of that Schedule;
"register of dental care professionals" means the register maintained by the General Dental Council under section 36B of the Dentists Act[31] (the dental care professionals register);
"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 contract 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 contract;



"unit of orthodontic activity" means the unit of activity which is in the contract 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 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—
(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 individuals practising in partnership 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.







PART 2
CONTRACTORS
Conditions: introductory
     3. Subject to the provisions of any order made by the Secretary of State under section 173 of the Health and Social Care (Community Health and Standards) Act 2003[32] (general dental services: transitional), a Primary Care Trust may only enter into a contract if the conditions set out in—


(a) regulation 4; and

(b) in the case of a contract to be entered into with a dental corporation 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 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 a 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 or it 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 contract is to be commenced or, if earlier, the date on which the contract 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 respectively[33]) 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[34] (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[35] (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[36] 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 contract is to be commenced or, if earlier, the date on which the contract 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; or

(ii) been removed under section 7 of the Law Reform (Miscellaneous Provisions) (Scotland) Act 1990[37] (powers of the Court of Session to deal with management of charities), from being concerned in the management or control of any body; or



(j) he is subject to a disqualification order under the Company Directors Disqualification Act 1986[38], the Companies (Northern Ireland) Order 1986[39] or to an order made under section 429(2)(b) of the Insolvency Act 1986[40] (failure to pay under county court administration order).



    (4) A person shall not fall within paragraph (3)(b) where the Primary Care Trust 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 contractor[41]; or

(b) a director, chief executive or secretary of a corporation entering into a contract, in the case of a contract with a dental corporation,



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 Primary Care Trust is satisfied that the conviction does not make the person unsuitable to be—



(a) a contractor; or

(b) a director, chief executive or secretary of a corporation entering into a contract, in the case of a contract with a dental corporation,



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) shall not apply if the Primary Care Trust 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 Primary Care Trust is of the view that the conditions in regulation 4 or 5 for entering into a contract are not met it shall 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, its, or their right of appeal under regulation 7.

    (2) The Primary Care Trust shall 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 Primary Care Trust 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 Primary Care Trust 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 Secretary of State 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 Secretary of State in accordance with paragraph (1), or section 4(4) of the 1990 Act, shall 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 Secretary of State under paragraph (1), the determination—


(a) may specify terms to be included in the proposed contract;

(b) may require the Primary Care Trust to proceed with the proposed contract, but may not require the proposed contractor to proceed with the proposed contract; and

(c) shall be binding upon the prospective parties to the contract.







PART 4
HEALTH SERVICE BODY STATUS
Health service body status
     9. —(1) Where a proposed contractor elects in a written notice served on the Primary Care Trust 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 shall 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 shall 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 shall, 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—


(a) the partners comprising the partnership;

(b) the status of the contractor from that of an individual dental practitioner to that of a partnership; or

(c) the status of the contractor from that of a partnership to that of an individual dental practitioner.



    (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—



(a) the Primary Care Trust shall agree to the variation; and

(b) the procedure in paragraph 60(1) of Schedule 3 shall apply (variation of a contract: general).



    (5) Where, pursuant to paragraph (4), the Primary Care Trust agrees to a variation of the contract, the contractor shall—



(a) be regarded; or

(b) subject to paragraph (7), cease to be regarded,



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 shall 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—



(a) paragraph (5) or (6), it shall continue to be regarded as a health service body for the purposes of being a party to any other NHS contract entered into after it became a health service body but before the date on which the contractor ceased to be a health service body (for which purposes it ceases to be such a body on the termination of that NHS contract);

(b) paragraph (5), it shall, if it or the Primary Care Trust has referred any matter to the NHS dispute resolution procedure before it ceases to be a health service body, be bound by the determination of the adjudicator as if the dispute had been referred pursuant to paragraph 54 of Schedule 3 (dispute resolution: non-NHS contracts); or

(c) paragraph (6), it shall continue to be regarded as a health service body for the purposes of the NHS dispute resolution procedure where that procedure has been commenced—


(i) before the termination of the contract; or

(ii) after the termination of the contract, whether in connection with or arising out of the termination of the contract or otherwise,



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—


(a) the names of the parties;

(b) in the case of a partnership—


(i) whether or not it is a limited partnership; and

(ii) the names of the partners and, in the case of a limited partnership, their status as a general or limited partner; and



(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 shall be treated as made with the partnership as it is from time to time constituted, and the contract shall 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 Primary Care Trust 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 shall 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[42] (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—



(a) the care which a dental practitioner usually undertakes for a patient and which the patient is willing to undergo;

(b) treatment, including urgent treatment; and

(c) where appropriate, the referral of the patient for advanced mandatory services, domiciliary services, sedation services or other relevant services provided under Part 1 of the Act.



    (3) A contractor must provide—



(a) urgent treatment; and

(b) all other services described in paragraph (2),



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—



(a) examination;

(b) diagnosis;

(c) advice and planning of treatment;

(d) preventative care and treatment;

(e) periodontal treatment;

(f) conservative treatment;

(g) surgical treatment;

(h) supply and repair of dental appliances;

(i) the taking of radiographs;

(j) the supply of listed drugs and listed appliances; and

(k) the issue of prescriptions,



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 1st April, in each financial year; or

(b) 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.



    (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 1st April, in each financial year; or

(b) 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.



    (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 shall provide that the Primary Care Trust 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 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 4 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 period as the Primary Care Trust specifies in writing, such period to consist of not less than 60 days.



    (3) Paragraphs (1) and (2) shall not prevent the Primary Care Trust 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 Primary Care Trust 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 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.



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



(a) the Primary Care Trust 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 Secretary of State under section 28N of the Act[43] (GDS contracts: payments); and

(b) the contractor to make payments promptly to the Primary Care Trust and in accordance with both the terms of the contract and any other conditions relating to payment contained in directions given by the Secretary of State under section 28N of the Act.



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



(a) is owed by the contractor to the Primary Care Trust under the contract;

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

(c) the Primary Care Trust may withhold from the contractor in accordance with the terms of the contract or any other applicable provisions contained in directions given by the Secretary of State under section 28N of the Act.



    (3) The contract must contain a term to the effect that where, pursuant to directions under section 17[44] (Secretary of State's directions: exercise of functions) or 28N of the Act, a Primary Care Trust 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 fee, 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 contract, except as otherwise provided in the NHS Charges Regulations; or

(b) any person who has requested services under the contract for himself or a family member, as a prerequisite to providing services under the contract to that person or his 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) shall have the same meaning as in regulation 2(1) of the NHS Charges Regulations.

Arrangements on termination
     23. A contract shall 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) shall have effect in relation to the matters set out in those paragraphs.

    (3) Where a contract does not commence on 1st 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 shall provide for services to be provided under it from any date after 31^st March 2006.



Signed by authority of the Secretary of State for Health


Rosie Winterton
Minister of State, Department of Health

6th December 2005



SCHEDULE 1Regulation 15


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—


(a) to a person to whom it is providing an entire course of treatment, during that course of treatment; or

(b) as a referral service.



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

    (3) 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 shall, 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 Primary Care Trust which shall specify—



(a) the name of the patient;

(b) the name of the contractor;

(c) the particulars of the places where the patient will receive the referral service to be provided to him by the contractor;

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

(e) details of the services which are at the date of that examination considered to be necessary for the contractor to provide having regard to the reason for the referral; and

(f) any proposals the contractor may have for private services as an alternative to the services proposed under the contract, 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 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 shall ensure that the patient signs that 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 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).

    (4) The contractor shall, 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 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 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—



(a) the type of sedation being administered; and

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







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


(a) only persons who are under the age of 18 years at the time of the case assessment;

(b) only persons who have attained or are over the age of 18 years at the time of the case assessment; or

(c) persons falling within paragraph (a) or (b).



    (2) Where a contract specifies the matters referred to in sub-paragraph (1)(b) or (1)(c), it shall 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 shall only provide orthodontic treatment to a person who is assessed by the contractor following a case assessment as having a treatment need in—



(a) grade 4 or 5 of the Dental Health Component of the Index of Orthodontic Treatment Need[46]; 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 contract must be provided as a new orthodontic course of treatment.

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



(a) the contractor where—


(i) 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 Primary Care Trust;

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

(iii) in the reasonable opinion of the contractor, there has been an irrevocable breakdown in the relationship between the patient and the contractor and, notice of such a breakdown has been given to the patient and the Primary Care Trust;



(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 Primary Care Trust 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 contract; and

(g) subject to paragraph 10 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 contract, 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 contract, 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 contract 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"[47] 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 contract 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 sub-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 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 shall indicate on the form supplied to the Primary Care Trust 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 Primary Care Trust 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 Primary Care Trust may specify, provide the reasons for that failure.

    (3) If the Primary Care Trust—



(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 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 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 shall be calculated on the basis of the components of the course of the treatment which has been—


(a) completed; and

(b) commenced but not completed.



     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 consists of a case assessment, the contractor provides 1.0 unit of orthodontic activity.

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


(a) a case assessment; and

(b) the provision of orthodontic treatment following the case assessment,



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 that consists of—



(a) a case assessment; and

(b) the provision of orthodontic treatment following the case assessment,



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—



(a) a case assessment; and

(b) the provision of orthodontic treatment following the case assessment,



the contractor provides 21.0 units of orthodontic activity.

    (5) Where the contractor—



(a) provides a repair to an orthodontic appliance of a patient; 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,



the contractor provides 0.8 units of orthodontic activity.





SCHEDULE 3Regulation 24


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—


(a) the person who requires the services; or

(b) a person specified in sub-paragraph (2), on behalf of the person who requires those services.



    (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[51]; 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 contract 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 or refuse 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) inform 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 of the 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 Primary Care Trust that it will no longer provide services to that patient under the contract.

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



(a) the contractor where it is an individual dental practitioner;

(b) in the case of a contract with two or more individuals practising in partnership, a partner in that partnership;

(c) in the case of a contract with a dental corporation, a director, chief executive, secretary or member of, or a legal and beneficial owner of shares in, that corporation;

(d) a member of the contractor's staff;

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

(f) any other person present—


(i) on the practice premises; or

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



    (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 Primary Care Trust shall be the time at which it makes the telephone call or sends or delivers the notification to the Primary Care Trust.

    (5) The Primary Care Trust 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 an orthodontic course of treatment; or

(b) terminate a course of treatment or orthodontic 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 contactor; and

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



the contractor may notify the Primary Care Trust 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 shall provide mandatory and additional services to a patient by providing to that patient a course of treatment.

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


(a) the treatment plan was written in accordance with paragraph 7(1); or

(b) where a treatment plan is not required pursuant to that paragraph, the initial examination and assessment of the patient took place.



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

    (4) If a course of treatment is—



(a) terminated before it has been completed; or

(b) otherwise not completed within a reasonable time,



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—



(a) the contractor—


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

(ii) where the patient has refused to pay a charge in the circumstances referred to in paragraph 4 of this Schedule (refusal to pay NHS Charges 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 the contractor and notice of such a breakdown has been given to the patient and the Primary Care Trust;



(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 shall give notice to the Primary Care Trust 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 shall, 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 Primary Care Trust 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 services;

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

(e) details of the services (if any) which are, 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 contract; and

(g) any proposals the contractor may have for private services as an alternative to the services proposed under the contract, 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 all or part of services under the contract, 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 services.

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

    (4) Subject to paragraph 6(5), the contractor shall 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 shall not apply to a Band 1 course of treatment or a charge exempt course of treatment unless—



(a) the contractor is providing privately any part of that course of treatment pursuant to paragraph 10; or

(b) the patient has requested that he be provided with written details of the course of treatment to be provided or that has been provided to him, whether or not he specifically requests a treatment plan.



    (6) Where a patient requests the contractor to provide him with a summary of the care and treatment provided under the treatment plan because he intends to receive services from another contractor, the contractor shall provide him with such a summary as he 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) shall be supplied to the patient on a form supplied for that purpose by the Primary Care Trust within 28 days of that request.

Completion of courses of treatment
     8. —(1) The contractor shall indicate on the form supplied by the Primary Care Trust 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 Primary Care Trust—



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

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



it shall 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 shall, 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 shall provide—



(a) to the patient being referred, a referral notice on a form supplied for that purpose by the Primary Care Trust which shall specify the services detailed on the treatment plan which will be carried out by the alternative contractor, hospital or other relevant service provider; and

(b) to the alternative contractor, hospital or other relevant service provider, either at the time of referral or as soon as reasonably practicable thereafter—


(i) a copy of the treatment plan provided to the patient pursuant to paragraph 7;

(ii) a copy of the referral notice; and

(iii) a statement of the amount paid to it, or due to be paid to it, by the patient under the NHS Charges Regulations in respect of the course of treatment during which the referral is made.



    (3) Where the patient notifies the contractor, whether verbally or in writing, that he does not wish to be referred to the alternative contractor, hospital or other relevant service provider selected by the contractor, the contractor shall, 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 in 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—



(a) not provide privately or under the contract treatment that involves the administration of general anaesthesia or the provision of sedation; and

(b) in the case of an orthodontic course of treatment provide—


(i) the case assessment wholly privately or wholly under the contract; and

(ii) the orthodontic treatment wholly privately or wholly under the contract.



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



(a) advise a patient that the services which are necessary in his case are not available from the contractor under the contract; or

(b) seek to mislead the patient about the quality of the services available under the contract.



    (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 shall 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 shall 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 shall be determined in accordance with the NHS Charges Regulations.

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



(a) within the relevant period, a person other than the contractor has provided treatment on the tooth in respect of which the restoration was provided;

(b) the contractor advised the patient at the time of the restoration and it was recorded on the patient record that—


(i) the restoration was intended to be temporary in nature; or

(ii) in its opinion, a different form of restoration was more appropriate to secure oral health but, notwithstanding that advice, the patient nevertheless requested the restoration which was provided;



(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 shall ensure that the practice premises used for the provision of services under the contract are—



(a) suitable for the delivery of those services; and

(b) sufficient to meet the reasonable needs of the contractor's patients.



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

    (3) The contractor shall 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 shall not be a party to any contract or other arrangement under which the number for telephone services to be used by—



(a) patients to contact the practice for any purpose related to the contract; or

(b) any other person to contact the practice in relation to services provided as part of the health service,



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 shall 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 shall ensure that it has appropriate arrangements for infection control and decontamination.

Treatment under general anaesthesia: prohibition
     16. The contractor shall 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 shall 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 shall 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 shall—


(a) be signed by the prescriber; and

(b) be issued separately to each patient to whom the contractor is providing services under the contract.



    (3) For the purposes of this paragraph, "prescription form" means a form that is supplied for the purposes of this paragraph by the Primary Care Trust.

Excessive prescribing
     20. A prescriber shall 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—


(a) he is 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
     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)—



(a) a dental hygienist; or

(b) a dental therapist



may perform dental services under the contract 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 contract provided—



(i) he is a dental care professional; and

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



Performers: further requirements
     23. —(1) No health care professional or other person other than one to whom paragraph 22 applies shall perform clinical services under the contract 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 contract.

    (3) No health care professional or other person shall perform any clinical services under the contract 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
     24. —(1) A contractor shall not employ or engage a dental practitioner to perform dental services under the contract unless—



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

(b) the contractor has checked that the practitioner meets the requirements in paragraph 21.



    (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 he 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 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 his registration in accordance with 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 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 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
     26. —(1) The contractor shall not employ or engage a person to perform dental services under the contract 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 obtain and 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 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 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 24 to 26.

    (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
     28. 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
     29. The contractor shall carry out its obligations under the contract with reasonable care and skill.

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



(a) participates in the appraisal system (if any) provided by the Primary Care Trust 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 Primary Care Trust.



Sub-contracting of clinical matters
     31. —(1) The contractor shall not sub-contract any of its rights or duties under the contract 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 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 shall—



(a) inform the Primary Care Trust of the sub-contract as soon as is reasonably practicable; and

(b) provide the Primary Care Trust 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 contract 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.





PART 5
RECORDS, INFORMATION, NOTIFICATIONS AND RIGHTS OF ENTRY
Patient records
     32. —(1) The contractor shall 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 shall include details of any private services (to the extent that they are provided with services under the contract) and shall be kept with—


(a) a copy of any treatment plan or referral treatment plan given to the patient pursuant to paragraph 2 of Schedule 1 (referral services) or paragraph 7 of this Schedule;

(b) all radiographs, photographs and study casts taken or obtained by it as part of the services provided to that patient;

(c) where an orthodontic course of treatment has been provided to a patient, a copy of the orthodontic treatment plan;

(d) where information is to be submitted to the Primary Care Trust in accordance with paragraph 38 and that information is submitted electronically—


(i) the written declaration form in respect of exemption under paragraph 1(1) of Schedule 12ZA to the Act duly made and completed in accordance regulations made under section 79 of, and paragraph 7(a) to, Schedule 12ZA to that Act; and

(ii) a note of the evidence in support of that declaration; and



(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) shall be retained for a period of 2 years beginning with—



(a) the date on which—


(i) a course of treatment or orthodontic course of treatment is terminated; or

(ii) a course of treatment or an orthodontic course of treatment is completed; or



(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 shall 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 shall 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 shall ensure that there is displayed in a prominent position in its practice premises, in a part to which patients have access—



(a) in respect of its practice based quality assurance system referred to in paragraph 80, a written statement relating to its commitment to the matters referred to in paragraph 80(4);

(b) such information relating to NHS Charges as is supplied by the Primary Care Trust for the purposes of providing information to patients; and

(c) information about the complaints procedure which it operates in accordance with Part 6, giving the name and title of the person nominated by the contractor in accordance with paragraph 50(2)(a).



    (2) The contractor shall—



(a) compile a document (in this paragraph called a "patient information leaflet") which shall include the information specified in Schedule 4;

(b) review its patient information leaflet at least once in every period of 12 months and make any amendments necessary to maintain its accuracy; and

(c) make available a copy of the leaflet, and any subsequent updates, to its patients and prospective patients.



    (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: Primary Care Trust
     35. —(1) The contractor shall, at the request of the Primary Care Trust—



(a) produce to the Primary Care Trust or to a person authorised in writing by the Primary Care Trust in such format, and at such intervals or within such period, as the Primary Care Trust specifies; or