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

Regulation 20

SCHEDULE 3E+WOTHER CONTRACTUAL TERMS

PART 1E+WPATIENTS

Persons to whom mandatory services or additional services are to be providedE+W

1.—(1) Subject to sub-paragraphs (3) and (5), the contractor may agree to provide mandatory or additional services under the agreement 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)(b), 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 M1; 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—

[F1(a)a person’s age, sex (reassigned or otherwise), religion or belief, sexual orientation, race, cultural and linguistic background, any disability they may have, 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 practitionerE+W

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 patientsE+W

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 [F2NHS England] 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 [F2NHS England] shall be the time at which it makes the telephone call or sends or delivers the notification to [F2NHS England].

(5) [F2NHS England] 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, treatmentE+W

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 patientE+W

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 [F2NHS England] that it will no longer provide services to that patient under the agreement.

[F3Friends and Family TestE+W

5A.—(1) The contractor must give all patients who use the contractor's practice the opportunity to provide feedback about the service received from the practice through the Friends and Family Test.

(2) The contractor must—

(a)report the results of completed Friends and Family Tests to [F2NHS England]; and

(b)publish the results of such completed tests,

in the manner approved by [F2NHS England].

(3) In this paragraph, “Friends and Family Test” means the arrangements that the contractor is required by [F2NHS England] to implement to enable its patients to provide anonymous feedback about the patient experience at the contractor’s practice.]

PART 2E+WPROVISION OF SERVICES

Mandatory servicesE+W

6.  Where the agreement provides for a contractor to provide mandatory services, the contractor must provide—

(a)urgent treatment, at such times as are agreed with [F2NHS England] and specified in the agreement; and

(b)all other mandatory services during normal surgery hours.

Course of treatmentE+W

7.—(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, and that it is so completed within a reasonable time from the date on which—

(a)the treatment plan was written in accordance with paragraph 8(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 single 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 agreement 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 patient) occur and notice that it will no longer provide services has been given to [F2NHS England];

(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 [F2NHS England];

(b)the patient; or

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

(6) If a contractor is unable to complete the course of the treatment which has been commenced for reasons beyond its control, it shall give notice to [F2NHS England] of the extent of the treatment so provided and the reason for his inability to complete the remainder.

Treatment plansE+W

8.—(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 [F2NHS England] 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 agreement; and

(g)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 all or part of 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 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 7(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 11; 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).

[F4(7) The summary referred to in sub-paragraph (6) shall be supplied to the patient on a form supplied for that purpose by [F2NHS England] within 28 days of that request.]

[F5(8) Where, by virtue of this paragraph, a person is required to include anything in a treatment plan or a summary, or to ensure a patient signs a treatment plan, but as a consequence of a disease being, or in anticipation of a disease being imminently—

(a)pandemic; and

(b)a serious risk or potentially a serious risk to human health,

the Secretary of State has made an announcement to the effect that, in order to assist in the management of the serious risk or potentially serious risk to human health, for the period specified in the announcement, that requirement is to be waived or modified in the manner specified in the announcement, that requirement is waived or is as modified in the specified manner for the specified period.

(9) Modifications under sub-paragraph (8) may include modifications imposing requirements on a person other than the person who, but for the announcement, would be required to include anything in a treatment plan or a summary or to ensure a patient signs a treatment plan.

(10) An announcement under sub-paragraph (8) may be withdrawn or amended at any time.]

Completion of courses of treatmentE+W

9.—[F6(1) The contractor shall indicate on the form supplied by [F2NHS England] pursuant to paragraph 39 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 [F2NHS England]—

(a)determines that the number of 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 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 7(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 servicesE+W

10.—(1) Where a patient requires advanced mandatory services, domiciliary services or sedation services that are not provided under the agreement 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 provided 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 [F2NHS England] F7... 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 8;

(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 agreement with private servicesE+W

11.—(1) Subject to sub-paragraph (2) and the requirements in paragraphs 2 (referral services) and 6 (orthodontic treatment plans) of Schedule 1 and paragraph 8(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 agreement 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 agreement; and

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

(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 agreement; or

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

(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 restorationsE+W

12.—(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 agreement, including referral services, 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 the restoration specified in sub-paragraph (2) falls shall be determined in accordance with the NHS Charges Regulations [F8and if such restoration falls within a Band 2 course of treatment, the applicable sub-band for the purpose of calculating the appropriate number of units of dental activity shall be determined in accordance with Parts 1 and 1A of Schedule 2].

(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 indicated 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 equipmentE+W

13.—(1) The contractor shall ensure that the premises used for the provision of services under the agreement 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 agreement, such other facilities and equipment as are necessary to enable it to properly perform that service.

(4) In this paragraph, “premises” includes a mobile surgery.

Telephone servicesE+W

14.—(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 agreement; 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 guidanceE+W

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 M2, in particular the guidance entitled “Dental recall - Recall interval between routine dental examinations”M3.

Infection controlE+W

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

Treatment under general anaesthesia: prohibitionE+W

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 [F9[F2NHS England], an] 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”M4.

PART 3E+WSUPPLY OF DRUGS AND PRESCRIBING

GeneralE+W

18.  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 drugsE+W

19.—(1) A presciber may supply to a patient such 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 20.

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

Issue of prescription formsE+W

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

(2) The 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 agreement,

and a separate prescription form shall be issued for each patient.

[F10(3) For the purposes of this paragraph, “prescription form” means a form that is supplied for the purposes of paragraph (1) by [F2NHS England].]

Excessive prescribingE+W

21.  The contractor shall not prescribe drugs, medicines or appliances whose cost or quantity, in relation to any patient, is, by reason of the character of the drug, medicine or appliance in question, in excess of that which was reasonably necessary for the proper treatment of that patient.

PART 4E+WPERSONS WHO PERFORM SERVICES

[F11Dental PractitionersE+W

22.  A dental practitioner may perform dental services under the contract provided—

(a)that dental practitioner is included in the dental performers list held by [F2NHS England]; and

(b)that dental practitioner’s inclusion in that list is not subject to a suspension.]

Dental care professionalsE+W

23.—(1) Prior to the coming into force of the first regulations under section 36A(2) of the Dentists Act M5 (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 M6.

(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 M7 is not subject to a suspension.

Performers: further requirementsE+W

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 [F12in the dental performers list held by [F2NHS England]],

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 servicesE+W

25.—[F13(1) A contractor must not employ or engage a dental practitioner to perform dental services under the contract unless 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 practitionersE+W

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 servicesE+W

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 agreementE+W

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.

TrainingE+W

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 skillE+W

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

[F14Appraisal and assessmentE+W

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

(a)participates in the appraisal system (if any) provided by [F2NHS England]; and

(b)co-operates with [F2NHS England] in relation to patient safety.]

Sub-contracting of clinical mattersE+W

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 [F2NHS England] of the sub-contract as soon as is reasonable practicable; and

(b)provide [F2NHS England] 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.

PART 5E+WRECORDS, INFORMATION, NOTIFICATIONS AND RIGHTS OF ENTRY

Patient recordsE+W

33.—(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 agreement, 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 it is provided with services under the agreement) 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 8 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 [F2NHS England] F15... in accordance with paragraph 39 and that information is submitted or collated 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 with 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 M8 (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 two 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 (a)(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 or paragraph 7(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 dataE+W

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

Patient informationE+W

35.—(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 78, a written statement relating to its commitment to the matters referred to in paragraph 78(4);

[F16(b)such information relating to NHS Charges as is supplied by [F2NHS England] 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.

[F17Information about the contractor’s practiceE+W

35A.—(1) The contractor must ensure that a comprehensive and accurate profile in respect of its practice is provided to NHS England for the purpose of display on the NHS.uk website.

(2) The contractor must review the information contained in the profile referred to in paragraph (1) at least once in every period of 90 days from the date the profile is provided in accordance with paragraph (1).

(3) If, on such a review, it appears to the contractor that any of that information is inaccurate or incomplete, the contractor must provide NHS England with an updated profile in respect of its practice.]

Provision of and access to information: [F2NHS England]E+W

36.—(1) The contractor shall, at the request of [F2NHS England]—

(a)produce to [F2NHS England] or to a person authorised in writing by [F2NHS England] in such format, and at such intervals or within such time, as [F2NHS England] specifies; or

(b)allow [F2NHS England], or a person authorised in writing by it to access,

the information specified in sub-paragraph (2).

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

(a)any information which is reasonably required by [F2NHS England] for the purposes of or in connection with the agreement; and

(b)any other information which is reasonably required in connection with [F2NHS England’s] functions,

and includes the contractor's patient records.

Requests for information from Patients' ForumsE+W

F1837.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Inquiries about prescriptions and referralsE+W

38.—(1) A contractor shall, subject to sub-paragraphs (2) and (3), sufficiently answer any inquiries whether oral or in writing from [F2NHS England] concerning—

(a)any prescription form issued by a prescriber;

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

(c)the referral by or on behalf of the contractor of any patient for any other services provided under the Act; or

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

(2) An inquiry referred to in sub-paragraph (1) may only be made for the purpose either of obtaining information to assist [F2NHS England] to discharge its functions or of assisting the contractor in the discharge of its obligations under the agreement.

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

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

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

appointed in either case by [F2NHS England] to assist it in the exercise of its functions under this paragraph and the person produces, on request, written evidence that he is authorised by [F2NHS England] to make such inquiry on its behalf.

Notification of a course of treatment, orthodontic course of treatment etc.E+W

39.—(1) Subject to paragraph (2), the contractor shall, within two months of the date upon which—

(a)it completes a course of treatment in respect of mandatory or additional services;

(b)it completes a case assessment in respect of an orthodontic course of treatment that does not lead to a course of treatment;

(c)it provides an orthodontic appliance following a case assessment in respect of orthodontic treatment;

(d)it completes a course of treatment in respect of orthodontic treatment;

(e)it completes a course of treatment in respect of mandatory services or additional services or orthodontic course of treatment is terminated; or

(f)in respect of courses not falling with sub-paragraph (d) or (e), no more services can be provided by virtue of paragraph 5(4)(b) of Schedule 1 (orthodontic course of treatment) or paragraph 7(4)(b) of this Schedule,

[F19subject to sub-paragraph (5), send to [F2NHS England] by means of electronic submission], the information specified in paragraph (3).

F20(2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(3) The information referred to in sub-paragraphs (1) and (2) comprise of —

(a)details of the patient to whom it provides services;

(b)details of the services provided (including any appliances provided) to that patient;

(c)details of any NHS Charge payable and paid by that patient; and

[F21(d)in the case of a patient who is exempt from NHS Charges, the information required under sub-paragraph (4).]

[F22(4) In the case of a patient who is exempt from NHS Charges, the contractor must provide [F2NHS England] (or a person authorised on [F2NHS England's] behalf) with—

(a)such details of that exemption as [F2NHS England] may reasonably request; and

(b)the written declaration.

(5) [F2NHS England] may accept submission of the information mentioned in sub-paragraph (2) in paper form in such exceptional circumstances as [F2NHS England] may reasonably determine.

(6) In this regulation, ‘electronic submission’ means the submission of information electronically via a computer system approved by [F2NHS England].]

Annual report and reviewE+W

40.—(1) [F2NHS England] shall provide to the contractor an annual report relating to the agreement which shall contain the same categories of information for all persons who hold agreements with [F2NHS England].

(2) Once [F2NHS England] has provided the report referred to in sub-paragraph (1), [F2NHS England] shall arrange with the contractor an annual review of its performance in relation to the agreement.

(3) [F2NHS England] shall prepare a draft record of the review referred to in sub-paragraph (2) for comment by the contractor and, having regard to such comments, shall produce a final written record of the review.

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

Notifications to [F2NHS England]E+W

41.—(1) In addition to any requirements of notification elsewhere in these Regulations, the contractor shall notify [F2NHS England] in writing, as soon as reasonably practicable, of—

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

(b)any circumstances which give rise to [F2NHS England’s] right to terminate the agreement under paragraph 68 or 69(1).

(2) The contractor shall, unless it is impracticable for it to do so, notify [F2NHS England] in writing within 28 days of any occurrence requiring a change in the information about it published by [F2NHS England] in accordance with regulations made under section 16CA(3) of the Act M9 (primary dental services).

(3) The contractor shall give notice in writing to [F2NHS England] when a dental practitioner who is performing or will perform services under the agreement—

(a)leaves the contractor, and the date upon which he left; or

(b)is employed or engaged by the contractor,

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

[F23Notice provisions specific to an agreement with a dental corporationE+W

42.  Where a dental corporation is a party to the agreement, it shall give notice in writing to [F2NHS England] forthwith when—

(a)it passes a resolution or a court of competent jurisdiction makes an order that the contractor be wound up;

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

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

(d)the contractor is unable to pay its debts within the meaning of section 123 of the Insolvency Act 1986 (definition of inability to pay debts).]

[F24Notice provisions specific to an agreement with a company limited by sharesE+W

42A.—(1) Where a company limited by shares is a party to the agreement, it shall give notice in writing to [F2NHS England] forthwith when—

(a)it passes a resolution or a court of competent jurisdiction makes an order that the contractor be wound up;

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

(c)circumstances arise which would enable the court to make a winding up order in respect of the contractor;

(d)the contractor is unable to pay its debts within the meaning of section 123 of the Insolvency Act 1986 (definition of inability to pay debts); or

(e)changes take place in relation to the ownership of shares in the company.

(2) A notice under sub-paragraph (e) must—

(a)provide the name of any person ceasing to own a share in the company;

(b)provide the name of any new person acquiring a share in the company; and

(c)confirm that following any changes in share ownership, that the company continues to meet the conditions in section 108(1A) of the 2006 Act.

Notice provisions specific to an agreement with a limited liability partnershipE+W

42B.—(1) Where a limited liability partnership is a party to an agreement it shall give notice to [F2NHS England] forthwith when—

(a)it passes a resolution or a court of competent jurisdiction makes an order that the contractor be wound up;

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

(c)circumstances arise which would enable the court to make a winding up order in respect of the contractor;

(d)the contractor is unable to pay its debts within the meaning of section 123 of the Insolvency Act 1986 (definition of inability to pay debts); or

(e)any membership changes are notified in accordance with section 9 of the Limited Liability Partnership Act 2000 (registration of membership changes) to the registrar (within the meaning of that Act) in relation to a person who becomes or ceases to be a member or designated member (within the meaning of that Act) and the notice must specify the date on which that person becomes or ceases to be a member or designated member (as the case may be).

(2) A notice under sub-paragraph (e) must confirm—

(a)that any new member joining the partnership meets the conditions imposed by regulation 4 (general conditions relating to all agreements); and

(b)following the membership changes, that sub-sections 108(1B) or 108(1C) of the 2006 Act continue to apply to the partnership.]

Notifications to patients following a variation of the agreementE+W

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

[F25Notification provisions specific to prototype agreementsE+W

43A.  [F26Where the contractor has elected to enter into a prototype agreement, except for CDS prototype contractors, the contractor shall]—

(a)send to [F2NHS England] details of any private treatment provided to a capitated patient attending the practice, in electronic form, whether or not this treatment is associated with services that are provided under the prototype agreement; and

(b)provide to all patients attending for treatment at its practice a privacy notice in a form approved by [F2NHS England] notifying them about the obligation referred to in sub-paragraph (a).]

Entry and inspection by [F2NHS England]E+W

44.—(1) Subject to—

(a)the conditions in sub-paragraph (2); and

(b)sub-paragraph (3),

the contractor shall allow persons authorised in writing by [F2NHS England] to enter and inspect the practice premises at any reasonable time.

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

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

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

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

(3) Where the contractor is providing services under the agreement in a prison, the contractor shall not be obliged to comply with sub-paragraph (1), or paragraph F27... 46, if—

(a)the contractor has used its best endeavours to allow [F2NHS England] F28... or the [F29Care Quality Commission] to enter and inspect the practice premises; but

(b)entry and inspection has been prevented by the prison authorities despite the contractor's best endeavours.

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

Entry and inspection by members of Patients' ForumsE+W

F3045.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F31Entry and inspection by the Care Quality CommissionE+W

[F3246.  Subject to paragraph 44(3), the contractor shall allow persons authorised by the Care Quality Commission to enter and inspect the premises in accordance with section 62 of the Health and Social Care Act 2008 (entry and inspection).]]

[F33Entry and viewing by Local Healthwatch organisationsE+W

46A.  The contractor must comply with the requirement to allow an authorised representative to enter and view premises and observe the carrying-on of activities on those premises in accordance with regulations made under section 225 (duties of services-providers to allow entry by Local Healthwatch organisations or contractors) of the Local Government and Public Involvement Health Act 2007.]

[F34PART 5AE+W COMPLAINTS RECEIVED ON OR AFTER 1ST APRIL 2009

46B.  As regards complaints relating to any matter reasonably connected with the provision of services under the agreement which are received on or after 1st April 2009, the contractor must have in place a complaints procedure which meets the requirements of the Local Authority Social Services and National Health Service Complaints (England) Regulations 2009.]E+W

PART 6E+WCOMPLAINTS

Complaints procedureE+W

F3547.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Making of complaintsE+W

F3648.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Period for making complaintsE+W

F3749.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Further requirements for complaints proceduresE+W

F3850.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Co-operation with investigationsE+W

51.—(1) The contractor F39... shall co-operate with—

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

(i)[F2NHS England]; and

(ii)[F40the Health Service Commissioner]; and

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

(2) In sub-paragraph (1)—

“NHS body” means [F2NHS England], an NHS trust, an NHS foundation trust, F41... a Local Health Board, a Health Board, a Health and Social Services Board, a Health and Social Services Trust or, a Health Board or Special Health Board constituted under section 2 of the National Health Service (Scotland) Act 1978 M10;

“local authority” means—

[F45“Health Service Commissioner” means the person appointed Health Service Commissioner for England in accordance with section 1 of, and Schedule 1 to, the Health Service Commissioners Act 1993.]

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

(a)answering questions reasonably put to the contractor by [F2NHS England];

(b)providing any information relating to the complaint reasonably required by [F2NHS England]; and

(c)attending any meeting to consider the complaint (if held at a reasonably accessible place and at a reasonable hour, and due notice has been given) if the contractor's presence at the meeting is reasonably required by [F2NHS England].

Provision of informationE+W

52.  The contractor F46... shall inform [F2NHS England], at such intervals as [F2NHS England] requires, of the number of complaints it has received under the procedure established in accordance with this Part.

PART 7E+WDISPUTE RESOLUTION

Local resolution of agreement disputesE+W

53.  In the case of any dispute arising out of, or in connection with, the agreement, the contractor and [F2NHS England] must make every reasonable effort to communicate and co-operate with each other with a view to resolving the dispute, before referring the dispute for determination in accordance with the NHS dispute resolution procedure (or, where applicable, before commencing court proceedings).

Dispute resolution: non-NHS contractsE+W

54.—[F47(1) In the case of an agreement that is not an NHS contract, any dispute arising out of or in connection with the agreement, except matters dealt with under the complaints procedure pursuant to Part 6, may be referred for consideration and determination to the Secretary of State—

(a)if it relates to a period when the contractor was a health service body, by the contractor or by [F2NHS England]; or

(b)in any other case, by the contractor or, if the contractor agrees in writing, by [F2NHS England].]

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

(a)the procedure to be followed is the NHS dispute resolution procedure; and

(b)the parties agree to be bound by any determination made by the adjudicator.

NHS dispute resolution procedureE+W

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

(a)in accordance with section 4(3) of the 1990 Act (where the agreement is an NHS contract); or

(b)in accordance with paragraph 54(1) (where the agreement is not an NHS contract).

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

(a)the names and addresses of the parties to the dispute;

(b)a copy of the agreement; and

(c)a brief statement describing the nature and circumstances of the dispute.

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

(4) Where the dispute relates to an agreement which is not an NHS contract, the Secretary of State may determine the matter herself or, if she considers it appropriate, appoint a person or persons to consider and determine it M13.

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

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

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

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

(a)inform the parties in writing of the name of the person or persons whom she has appointed; and

(b)pass to the person or persons so appointed any documents received from the parties under or pursuant to paragraph (2), (5) or (7).

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

(a)invite representatives of the parties to appear before him to make oral representations either together or, with the agreement of the parties, separately, and may in advance provide the parties with a list of matters or questions to which he wishes them to give special consideration; or

(b)consult other persons whose expertise he considers will assist him in his consideration of the matter.

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

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

(a)any written representations made in response to a request under sub-paragraph (5), but only if they are made within the specified period;

(b)any written observations made in response to a request under sub-paragraph (7), but only if they are made within the specified period;

(c)any oral representations made in response to an invitation under sub-paragraph (9)(a);

(d)the results of any consultation under sub-paragraph (9)(b); and

(e)any observations made in accordance with an opportunity given under sub-paragraph (10).

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

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

Determination of disputeE+W

56.—(1) The adjudicator shall record his determination and the reasons for it in writing and shall give notice of the determination (including a record of the reasons) to the parties.

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

Interpretation of Part 7E+W

57.—(1) In this Part, “any dispute arising out of, or in connection with, the agreement” includes any dispute arising out of, or in connection with, the termination of the agreement.

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

PART 8E+WMID-YEAR REVIEW OF ACTIVITY UNDER AGREEMENTS

Mid-year reviewsE+W

58.—(1) This paragraph and paragraph 59 apply where services are to be provided under the agreement from 1st April in any financial year.

(2) In this paragraph and paragraph 59, references to requirements to provide units of dental activity or units of orthodontic activity are to such requirements under the terms of the agreement giving effect to regulation 13 (units of dental activity) or 14 (units of orthodontic activity).

(3) [F2NHS England] shall, by 31st October in each financial year, determine the number of—

(a)units of dental activity; or

(b)units of orthodontic activity,

that the contractor has provided between 1st April and 30th September of that financial year based on the data provided to it by virtue of paragraph 39.

(4) Where [F2NHS England] determines under sub-paragraph (3) that the contractor has, between 1st April and 30th September, provided less than 30 per cent of the total number of—

(a)units of dental activity; or

(b)units of orthodontic activity,

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

(5) Where this sub-paragraph applies, [F2NHS England] may—

(a)notify the contractor that it is concerned about the level of activity provided under the agreement in the first half of the financial year, setting out—

(i)the number of units of dental activity or units of orthodontic activity (as the case may be) that it has determined that the contractor has provided; and

(ii)the percentage of the total number of units of dental activity or units of orthodontic activity (as the case may be) required to be provided during the financial year that the number in sub-paragraph (i) represents; and

(b)require in that notification that the contractor participate in a mid-year review of its performance in relation to the agreement with [F2NHS England].

(6) Where a mid-year review is required by [F2NHS England] under sub-paragraph (5), [F2NHS England] and the contractor shall discuss at that review—

(a)any written evidence the contractor puts forward to demonstrate that it has performed a greater number of units of dental activity or units of orthodontic activity during the first half of the financial year than those notified to it pursuant to sub-paragraph (5)(a)(i); and

(b)any reasons that the contractor puts forward for the level of activity in the first half of the financial year.

(7) [F2NHS England] shall prepare a draft record of the mid-year review for comment by the contractor and, having regard to such comments, shall produce a final written record of the review.

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

Action [F2NHS England] can take following a mid-year reviewE+W

59.—(1) Where, following the mid-year review and the provision of the final record of that review to the contractor, [F2NHS England], having taken account of any evidence or reasons put forward by the contractor at that review, nevertheless has serious concerns that the contractor is unlikely to provide the number of—

(a)units of dental activity; or

(b)units of orthodontic activity,

that it is required to provide by the end of the financial year, [F2NHS England] shall be entitled to take either or both of the steps specified in paragraph (2).

(2) [F2NHS England] may—

(a)require the contractor to comply with a written plan drawn up by [F2NHS England] to ensure that the level of activity during the remainder of the financial year is such that the contractor will provide the number of units of dental activity or units of orthodontic activity it is required to provide; or

(b)withhold monies payable under the agreement.

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

(a)the amount that is payable under the agreement in respect of the number of units of dental activity or units of orthodontic activity required to be provided in a financial year, less

(b)the amount that would be payable under the agreement as a relevant proportion of that amount if the contractor provided in the whole of the financial year only twice the number of units of dental activity or orthodontic activity that it provided between 1st April and 30th September.

(4) Nothing in this paragraph shall prevent [F2NHS England] and the contractor agreeing to vary the contract in accordance with paragraph 61 to adjust—

(a)the level of activity to be provided under the agreement; or

(b)the monies to be paid by [F2NHS England] to the contractor under the agreement.

(5) Where [F2NHS England] withholds monies pursuant to paragraph (2), it shall ensure that it pays the withheld monies to the contractor as soon as possible following the end of the financial year where the contractor has—

(a)provided the number of units of dental activity or units of orthodontic activity required to be provided; or

(b)failed to provide that number of units of dental activity or units of orthodontic activity, but 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 during that financial year (and therefore regulation 15 applies).

PART 9E+WVARIATION AND TERMINATION OF AGREEMENTS

60.—(1) Subject to paragraph 32(3), no amendment or variation shall have effect unless it is in writing and signed by or on behalf of [F2NHS England] and the contractor.E+W

(2) In addition to the specific provision made [F48in paragraphs 61A and] 73, [F2NHS England] may vary the agreement without the contractor's consent where it—

(a)is reasonably satisfied that it is necessary to vary the agreement so as to comply with the Act, any regulations made pursuant to that Act, or any direction given by the Secretary of State pursuant to that Act; and

(b)notifies the contractor in writing of the wording of the proposed variation and the date upon which that variation is to take effect,

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

Variation of an agreement: activity under the agreementE+W

61.—(1) Where the contractor or [F2NHS England] is of the opinion that there needs to be a variation to the number of—

(a)units of dental activity; or

(b)units of orthodontic activity,

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

(2) The contractor or [F2NHS England] shall notify the other party to the agreement in writing of its opinion of the need for a variation, specifying in that notice the variation that it considers necessary, together with its reasons.

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

(a)units of dental activity; or

(b)units of orthodontic activity,

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

[F49Variation of an agreement: rebasing for persistent under performanceE+W

61A.—(1) In this paragraph—

“contracted activity” means the number of units of dental activity or units of orthodontic activity the contractor is required to provide under the agreement,

“Covid years” means the financial years ending on 31st March 2021 and 31st March 2022,

“rebasing” means a permanent variation of the agreement pursuant to sub-paragraph (2) and “rebase” is to be read accordingly,

“rebasing date” means the date, notified by NHS England under a rebasing notice, from which the rebasing takes effect,

“rebasing notice” means a notice in writing sent by NHS England to the contractor, notifying the contractor of the wording of a proposed rebasing and the rebasing date,

“relevant financial years” means any three consecutive financial years, save for the Covid years, which—

(2) If all the conditions in sub-paragraph (3) are met, NHS England may rebase the agreement to—

(a)reduce the contracted activity, and

(b)carry out any related variations of the agreement, including in relation to the monies to be paid to the contractor under the agreement,

but the rebasing must not result in the contracted activity being reduced to less than the highest number of units of dental or orthodontic activity provided by the contractor in any one of the relevant financial years.

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

(a)in respect of each relevant financial year—

(i)NHS England invited the contractor to participate in a mid-year review of its performance under the agreement, pursuant to paragraph 58(5)(b), whether the contractor has engaged with this procedure or not,

(ii)the contractor provided less than 96% of contracted activity,

(iii)there have not been force majeure circumstances under the agreement, which have caused the under delivery pursuant to sub-paragraph (ii),

(iv)NHS England issued a breach notice to the contractor by reason of under delivery pursuant to sub-paragraph (ii), which has not been set aside, and no formal dispute is pending in respect of the circumstances that have given rise to the breach notice, and

(b)NHS England has not been able to agree with the contractor a permanent variation of the agreement under paragraph 61(3).

(4) If NHS England decides to rebase a contract—

(a)it must serve a rebasing notice on the contractor and allow a minimum of 28 days, starting with the day the rebasing notice is served on the contractor, before taking any action pursuant to that notice, and

(b)it must specify in the rebasing notice a rebasing date it considers appropriate, which may be any date from 1st April in the financial year in which the rebasing notice is served on the contractor.]

Termination by agreementE+W

62.  [F2NHS England] and the contractor may agree in writing to terminate the agreement, and if the parties so agree, they shall agree the date upon which that termination should take effect and any further terms upon which the agreement should be terminated.

Termination on the death of an individualE+W

63.—(1) Where the agreement is with a single individual and that individual dies, the agreement shall terminate at the end of the period of [F5028 days] after the date of his death unless, before the end of that period—

(a)subject to sub-paragraph (2), [F2NHS England] has agreed in writing with that individual's personal representatives that the agreement should continue for a further period, [F51not exceeding 6 months] after the end of the period of [F5028 days]; and

(b)that individual's personal representatives have confirmed in writing to [F2NHS England] that they are employing or engaging one or more dental practitioners to assist in the provision of dental services under the agreement throughout the period for which it continues.

(2) Where [F2NHS England] is of the opinion that another individual may wish to enter into an agreement in respect the mandatory services which were provided by the deceased, the [F526 month period] referred to in sub-paragraph (1)(a) may be extended by a period not exceeding six months as may be agreed.

(3) Sub-paragraph (1) does not affect any other rights to terminate the agreement which [F2NHS England] may have under paragraphs 67 to 71.

Termination by the contractorE+W

64.—(1) A contractor may terminate the agreement by serving notice in writing on [F2NHS England] at any time.

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

(3) This paragraph and paragraph 65 are without prejudice to any other rights to terminate the agreement that the contractor may have.

Late payment noticesE+W

65.—(1) The contractor may give notice in writing (a “late payment notice”) to [F2NHS England] if [F2NHS England] has failed to make any payments due to the contractor in accordance with a term of the agreement that has the effect specified in regulation 17, and the contractor shall specify in the late payment notice the payments that [F2NHS England] has failed to make in accordance with that regulation.

(2) Subject to sub-paragraph (3), the contractor may, at least 28 days after having served a late payment notice, terminate the agreement by a further written notice if [F2NHS England] has still failed to make the payments that were due to the contractor and that were specified in the late payment notice served on [F2NHS England] pursuant to sub-paragraph (1).

(3) If, following receipt of a late payment notice, [F2NHS England] refers the matter to the NHS dispute resolution procedure within 28 days of the date upon which it is served with the late payment notice, and it notifies the contractor in writing that it has done so within that period of time, the contractor may not terminate the agreement pursuant to sub-paragraph (2) until—

(a)there has been a determination of the dispute pursuant to paragraph 56 and that determination permits the contractor to terminate the agreement; or

(b)[F2NHS England] ceases to pursue the NHS dispute resolution procedure,

(c)whichever is the sooner.

Termination by [F2NHS England]: general provisionsE+W

66.  [F2NHS England] may only terminate the agreement in accordance with the provisions in this Part.

Termination by [F2NHS England]: noticeE+W

67.—(1) [F2NHS England] may terminate the agreement by serving notice in writing on the contractor at any time.

(2) Where a notice is served pursuant to sub-paragraph (1), the agreement shall terminate on the date provided for in the agreement.

Termination by [F2NHS England] for the provision of untrue etc. informationE+W

68.  [F2NHS England] may serve notice in writing on the contractor terminating the agreement forthwith, or from such date as may be specified in the notice if, after the agreement has been entered into, it comes to the attention of [F2NHS England] that written information provided to it by the contractor before the agreement was entered into in relation to the conditions set out in regulation 4 or 5 (and compliance with those conditions) was, when given, untrue or inaccurate in a material respect.

Termination by [F2NHS England] on grounds of suitability etc.E+W

69.—(1) [F2NHS England] may serve notice in writing on the contractor terminating the agreement forthwith, or from such date as may be specified in the notice if—

(a)in the case of an agreement with an individual as a party, that individual;

[F53(b)in the case of an agreement with a dental corporation, any director, chief executive or secretary of that corporation;

(c)in the case of a company limited by shares, any director, chief executive or secretary of that company; or

(d)in the case of a limited liability partnership, any member of that partnership.]

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

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

(b)subject to sub-paragraph (3), he or it is disqualified or suspended (other than by an interim suspension order or direction pending an investigation or a suspension on the grounds of ill-health) from practising by any licensing body anywhere in the world;

(c)subject to sub-paragraph (4), he has been dismissed (otherwise than by reason of redundancy) from any employment by a health service body unless before [F2NHS England] has served a notice terminating the agreement pursuant to this paragraph, he is employed by the health service body that dismissed him or by another health service body;

(d)he or it is 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 M14 respectively) unless his name has subsequently been included in such a list;

(e)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;

(f)subject to sub-paragraph (5), 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;

(g)he has been convicted of an offence referred to in Schedule 1 to the Children and Young Persons Act 1933 M15 (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 M16 (offences against children under the age of 17 years to which special provisions apply);

(h)he or it has—

(i)been [F54made] bankrupt or had sequestration of his estate awarded [F55or is a person in relation to whom a moratorium period under a debt relief order (under Part 7A of the Insolvency Act 1986) applies] unless F56... he has been discharged [F57from the bankruptcy or the sequestration] 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[F58, or a debt relief restrictions order or interim debt relief restrictions order under Schedule 4ZB,] to the Insolvency Act 1986 M17, unless that order has ceased to have effect or has been annulled;

(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; or

(iv)been wound up under Part 4 of the Insolvency Act 1986;

(i)there is—

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

(ii)an administration order made in respect of it under Schedule B1 to the Insolvency Act 1986 M18;

(j)he has been—

(i)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)removed under section 7 of the Law Reform (Miscellaneous Provisions) (Scotland) Act 1990 M19 (powers of the Court of Session to deal with management of charities) [F59or under section 34 of the Charities and Trustee Investment (Scotland) Act 2005 (powers of Court of Session)], from being concerned in the management or control of any body;

(k)he is subject to a disqualification order under the Company Directors Disqualification Act 1986 M20, the Companies (Northern Ireland) Order 1986 M21 or to an order made under section 429(2)(b) of the Insolvency Act 1986 (failure to pay under county court administration order); or

(l)he has refused to comply with a request by [F2NHS England] for him to be medically examined on the ground that it is concerned that he is incapable of adequately providing services under the agreement.

(3) [F2NHS England] shall not terminate the agreement pursuant to sub-paragraph (2)(b) where it is satisfied that the disqualification or suspension imposed by a licensing body outside the United Kingdom does not make the person unsuitable to be—

(a)a contractor; F60...

[F61(b)in the case of an agreement with a dental corporation, any director, chief executive or secretary of that corporation;

(c)in the case of a company limited by shares, any director, chief executive or secretary of that company; or

(d)in the case of a limited liability partnership, any member of that partnership.]

(4) [F2NHS England] shall not terminate the agreement pursuant to sub-paragraph (2)(c)—

(a)until a period of at least three months has elapsed since the date of the dismissal of the person concerned; or

(b)if, during the period of time specified in paragraph (a), the person concerned brings proceedings in any competent tribunal or court in respect of his dismissal, until proceedings before that tribunal or court are concluded,

and [F2NHS England] may only terminate the agreement at the end of the period specified in paragraph (b) if there is no finding of unfair dismissal.

(5) [F2NHS England] shall not terminate the agreement pursuant to sub-paragraph (2)(f) where it is satisfied that the conviction does not make the person unsuitable to be—

(a)a contractor; F62...

[F63(b)in the case of an agreement with a dental corporation, any director, chief executive or secretary of that corporation;

(c)in the case of a company limited by shares, any director, chief executive or secretary of that company; or

(d)in the case of a limited liability partnership, any member of that partnership.]

Termination by [F2NHS England]: patient safety and material financial lossE+W

70.  [F2NHS England] may serve notice in writing on the contractor terminating the agreement forthwith or with effect from such date as may be specified in the notice if—

(a)the contractor has breached the agreement and as a result of that breach, the safety of the contractor's patients is at serious risk if the agreement is not terminated; or

(b)the contractor's financial situation is such that [F2NHS England] considers that [F2NHS England] is at risk of material financial loss.

Termination by [F2NHS England]: remedial notices and breach noticesE+W

71.—(1) Where a contractor has breached the agreement other than as specified in paragraphs 68 to 70 and the breach is capable of remedy, [F2NHS England] shall, before taking any action it is otherwise entitled to take by virtue of the agreement, serve a notice on the contractor requiring it to remedy the breach (“remedial notice”).

(2) A remedial notice shall specify—

(a)details of the breach;

(b)the steps the contractor must take to the satisfaction of [F2NHS England] in order to remedy the breach; and

(c)the period during which the steps must be taken (“the notice period”).

(3) The notice period shall, unless [F2NHS England] is satisfied that a shorter period is necessary to—

(a)protect the safety of the contractor's patients; or

(b)protect itself from material financial loss,

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

(4) Where [F2NHS England] is satisfied that the contractor has not taken the required steps to remedy the breach by the end of the notice period, [F2NHS England] may terminate the agreement with effect from such date as [F2NHS England] may specify in a further notice to the contractor.

(5) Where a contractor has breached the agreement otherwise than as specified in paragraphs 68 to 70 and the breach is not capable of remedy, [F2NHS England] may serve notice on the contractor requiring the contractor not to repeat the breach (“breach notice”).

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

(a)repeats the breach that was the subject of the breach notice or the remedial notice; or

(b)otherwise breaches the agreement resulting in either a remedial notice or a further breach notice,

[F2NHS England] may serve notice on the contractor terminating the agreement with effect from such date as may be specified in that notice.

(7) [F2NHS England] shall not exercise its right to terminate the agreement under sub-paragraph (6) unless it is satisfied that the cumulative effect of the breaches is such that [F2NHS England] considers that to allow the agreement to continue would be prejudicial to the efficiency of the services to be provided under the agreement.

(8) If the contractor is in breach of any obligation and a breach notice or a remedial notice in respect of that default has been given to the contractor, [F2NHS England] may withhold or deduct monies which would otherwise be payable under the agreement in respect of that obligation which is the subject of the default.

[F64Termination by [F2NHS England]: additional provisions specific to contracts with dental corporations, companies limited by shares and limited liability partnerships]E+W

72.—(1) Where a party to the agreement is a [F65dental corporation, company limited by shares, or limited liability partnership], if [F2NHS England] becomes aware that the [F65dental corporation, company limited by shares, or limited liability partnership] is carrying on any business which [F2NHS England] considers to be detrimental to the contractor's performance of its obligations under the agreement—

(a)[F2NHS England] shall be entitled to give notice to the contractor requiring that the [F65dental corporation, company limited by shares, or limited liability partnership] ceases carrying on that business before the end of a period of not less than 28 days beginning on the day on which the notice is given (“the notice period”); and

(b)if the contractor has not satisfied [F2NHS England] that the [F65dental corporation, company limited by shares, or limited liability partnership] has ceased carrying on that business by the end of the notice period, [F2NHS England] may, by a further written notice, terminate the agreement forthwith or from such date as may be specified in the notice.

(2) Where the contractor is a [F66dental corporation or company limited by shares] and on or after the coming into force for all purposes of article 39 of the Dentists Act Order during the existence of the agreement—

(a)the majority of the directors of the [F66dental corporation or company limited by shares] cease to be either dental practitioners or dental care professionals;

(b)the [F66dental corporation or company limited by shares] has been convicted of an offence under section 43(1) of the Dentists Act M22 (directors of bodies corporate); or

(c)the [F66dental corporation or company limited by shares], or a director or former director of that [F66dental corporation or company limited by shares], has had a financial penalty imposed on it or him by the General Dental Council pursuant to section 43B (financial penalties in relation to bodies corporate) or 44 M23 (further financial penalties on bodies corporate) of the Dentists Act,

[F2NHS England] may, by written notice, terminate the agreement if it considers that as a consequence the [F66dental corporation or company limited by shares] is no longer suitable to be a contractor.

[F67(3) Where the contractor is a company limited by shares and the company ceases—

(a)to be a company limited by shares; or

(b)to satisfy the conditions in section 108(1A) of the 2006 Act,

[F2NHS England] shall serve notice in writing on the contractor terminating the contract forthwith.

(4) Where the contractor is a limited liability partnership and—

(a)the partnership ceases to be a limited liability partnership; or

(b)section 108(1B) or (1C) of the 2006 Act ceases to apply in respect of that partnership,

[F2NHS England] shall serve notice in writing on the contractor terminating the contract forthwith.]

Agreement sanctionsE+W

73.—(1) In this paragraph and paragraph 74, “agreement sanction” means—

(a)termination of specified reciprocal obligations under the agreement;

(b)suspension of specified reciprocal obligations under the agreement for a period of up to six months; or

(c)withholding or deducting monies otherwise payable under the agreement.

(2) Where [F2NHS England] is entitled to terminate the agreement pursuant to paragraph 68, 69, 70, 71(4), 71(6) or 72, it may instead impose any of the agreement sanctions if [F2NHS England] is reasonably satisfied that the agreement sanction to be imposed is appropriate and proportionate to the circumstances which provide grounds for [F2NHS England] to terminate the agreement.

(3) If [F2NHS England] decides to impose an agreement sanction, it must notify the contractor of the agreement sanction that it proposes to impose, the date upon which that sanction will be imposed and provide in that notice an explanation of the effect of the imposition of that sanction.

(4) Subject to paragraph 74, [F2NHS England] shall not impose the agreement sanction until at least 28 days after it has served notice on the contractor pursuant to sub-paragraph (3) unless it is satisfied that it is necessary to do so in order to—

(a)protect the safety of the contractor's patients; or

(b)protect itself from material financial loss.

(5) Where [F2NHS England] imposes an agreement sanction, it shall be entitled to charge the contractor the reasonable costs of additional administration that [F2NHS England] has incurred in order to impose, or as a result of imposing, the agreement sanction.

Agreement sanctions and the NHS dispute resolution procedureE+W

74.—(1) If there is a dispute between [F2NHS England] and the contractor in relation to an agreement sanction that [F2NHS England] is proposing to impose, [F2NHS England] shall not, subject to sub-paragraph (4), impose the proposed agreement sanction except in the circumstances specified in sub-paragraph (2).

(2) If the contractor refers the dispute relating to the agreement sanction to the NHS dispute resolution procedure within 28 days beginning on the date on which [F2NHS England] served notice on the contractor in accordance with paragraph 73(3) (or such longer period as may be agreed in writing with [F2NHS England]), and notifies [F2NHS England] in writing that it has done so, [F2NHS England] shall not impose the agreement sanction unless—

(a)there has been a determination of the dispute pursuant to paragraph 56 and that determination permits [F2NHS England] to impose the agreement sanction; or

(b)the contractor ceases to pursue the NHS dispute resolution procedure,

whichever is the sooner.

(3) If the contractor does not invoke the NHS dispute resolution procedure within the time specified in sub-paragraph (2), [F2NHS England] shall be entitled to impose the agreement sanction forthwith.

(4) If [F2NHS England] is satisfied that it is necessary to impose the agreement sanction before the NHS dispute resolution procedure is concluded in order to—

(a)protect the safety of the contractor's patients; or

(b)protect itself from material financial loss,

[F2NHS England] shall be entitled to impose the agreement sanction forthwith, pending the outcome of that procedure.

Termination and the NHS dispute resolution procedureE+W

75.—(1) Where [F2NHS England] is entitled to serve written notice on the contractor terminating the agreement pursuant to paragraph 68, 69, 70, 71(4), 71(6) or 72, it shall, in the notice served on the contractor pursuant to those provisions, specify a date on which the agreement terminates that is not less than 28 days after the date on which [F2NHS England] has served that notice on the contractor unless sub-paragraph (2) applies.

(2) This sub-paragraph applies if [F2NHS England] is satisfied that a period less than 28 days is necessary in order to—

(a)protect the safety of the contractor's patients; or

(b)protect itself from material financial loss.

(3) In a case falling with sub-paragraph (1), where—

(a)the exceptions in sub-paragraph (2) do not apply;

(b)the contractor invokes the NHS dispute resolution procedure before the end of the period of notice referred to in sub-paragraph (1); and

(c)the contractor notifies [F2NHS England] in writing that it has done so,

the agreement shall not terminate at the end of the notice period but instead shall only terminate in the circumstances specified in sub-paragraph (4).

(4) The agreement shall only terminate if and when—

(a)there has been a determination of the dispute pursuant to paragraph 56 and that determination permits [F2NHS England] to terminate the agreement; or

(b)the contractor ceases to pursue the NHS dispute resolution procedure,

whichever is the sooner.

(5) If [F2NHS England] is satisfied that it is necessary to terminate the agreement before the NHS dispute resolution procedure is concluded in order to—

(a)protect the safety of the contractor's patients; or

(b)protect itself from material financial loss,

sub-paragraphs (3) and (4) shall not apply and [F2NHS England] shall be entitled to confirm, by written notice to be served on the contractor, that the agreement will nevertheless terminate at the end of the period of the notice it served pursuant to paragraph 68, 69, 70, 71(4), 71(6) or 72.

PART 10E+WMISCELLANEOUS

Evidence of exemption under the ActE+W

76.—(1) Subject to sub-paragraph (2), the contractor shall ensure that it requests, in respect of a person who makes a declaration relating to exemption under paragraph 1(1) of Schedule 12ZA to the Act, evidence in support of that declaration.

(2) The contractor shall ensure that—

(a)a note of the type of evidence submitted is made; or

(b)in the case where no evidence is submitted, a note of that fact is made.

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

Clinical governance arrangementsE+W

77.—(1) Subject to paragraph (2), the contractor shall comply with such clinical governance arrangements as [F2NHS England] may establish in respect of contractors providing services under an agreement.

F68(2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(3) The contractor shall nominate a person who manages services under the agreement to have responsibility for ensuring compliance with clinical governance arrangements.

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

[F69Duty as to education and trainingE+W

77A.  The contractor must co-operate with the Secretary of State in the discharge of the Secretary of State's duty under section 1F of the 2006 Act (duty as to education and training), or co-operate with [F70NHS England] where [F70NHS England] is discharging that duty by virtue of [F71section 97 of the Care Act 2014].]

Quality assurance systemE+W

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

(2) The specified persons are—

(a)any dental practitioner who performs services under the agreement; and

(b)any other person employed or engaged by the contractor to perform or assist in the performance of services under the agreement.

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

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

(a)effective measures of infection control are used;

(b)all legal requirements relating to health and safety in the workplace are satisfied;

(c)all legal requirements relating to radiological protection are satisfied; and

(d)any requirements of the General Dental Council in respect of the continuing professional development of dental practitioners are satisfied.

Insurance: negligent performanceE+W

79.—(1) The contractor shall at all times [F72have in force in relation to it an indemnity arrangement which provides appropriate cover].

(2) The contractor shall not sub-contract its obligations to provide clinical services under the agreement unless it has satisfied itself that the sub-contractor [F73has in force in relation to it an indemnity arrangement which provides appropriate cover].

(3) In this paragraph—

(a)[F74“indemnity arrangement” means] a contract of insurance or other arrangement made for the purpose of indemnifying the contractor;

[F75(aa)“appropriate cover” means cover against liabilities that may be incurred by the contractor in the performance of clinical services under the agreement, which is appropriate, having regard to the nature and extent of the risks in the performance of such services;] and

(b)a contractor or sub-contractor shall be regarded as [F76having in force in relation to it an indemnity arrangement if there is an indemnity arrangement in force in relation to] an employee of its in connection with clinical services which that employee provides under the agreement or, as the case may be, sub-contract.

Public liability insuranceE+W

80.—(1) The contractor shall at all times hold adequate public liability insurance in relation to liabilities to third parties arising under or in connection with the agreement which are not covered by [F77an indemnity arrangement] referred to in paragraph 79(1).

(2) In this paragraph, “[F78indemnity arrangement]” has the same meaning as in paragraph 79.

GiftsE+W

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

(a)a patient;

(b)a relative of a patient; or

(c)any person who provides or wishes to provide services to the contractor or its patients in connection with the agreement,

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

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

(a)the contractor;

(b)where the agreement is with a [F79dental corporation], a director, chief executive or secretary of the corporation;

[F80(ba)where the agreement is with a company limited by shares, a director, chief executive or secretary of the company;

(bb)where the agreement is with a limited liability partnership, a member of the partnership;]

(c)any person employed by the contractor for the purposes of the agreement;

(d)any dental practitioner engaged by the contractor for the purposes of the agreement;

(e)any spouse or civil partner of a contractor (where the contractor is an individual) or of a person specified in paragraphs (b) to (d); or

(f)any person whose relationship with the contractor (where the contractor is an individual) or with a person specified in paragraphs (b) to (d) has the characteristics of the relationship between husband and wife or civil partners.

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

(a)there are reasonable grounds for believing that the gift is unconnected with services provided or to be provided by the contractor;

(b)the contractor is not aware of the gift; or

(c)in a case falling within sub-paragraph (1)(c), the contractor is not aware that the donor wishes to provide services to the contractor.

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

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

(a)the name of the donor;

(b)in a case where the donor is a patient, the patient's National Health Service number or, if the number is not known, his address;

(c)in any other case, the address of the donor;

(d)the nature of the gift;

(e)the estimated value of the gift; and

(f)the name of the person or persons who received the gift.

(6) The contractor shall make the register available to [F2NHS England] on request.

Compliance with legislation and guidanceE+W

82.  The contractor shall—

(a)comply with all relevant legislation; and

[F81(b)have regard to all relevant guidance issued by [F2NHS England] and the Secretary of State.]

Third party rightsE+W

83.  The agreement shall not create any right enforceable by any person not a party to it.

Signing of documentsE+W

84.—(1) In addition to any other requirements relating to such documents whether in these Regulations or otherwise, the contractor shall ensure that the documents specified in paragraph (2) include—

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

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

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

(a)forms that are required to be completed pursuant to these Regulations, where such forms require a signature;

(b)prescription forms; and

(c)any other clinical documents.