The National Health Service (Personal Dental Services Agreements) (Wales) Regulations 2006

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

• (5) A Relevant Body will 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;

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

• (6) In this paragraph “health service body” includes a Strategic Health Authority and a Primary Care Trust.

Termination by the Relevant Body: patient safety and material financial loss

70

The Relevant Body 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 the Relevant Body considers that the Relevant Body is at risk of material financial loss.

Termination by the Relevant Body: remedial notices and breach notices

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, the Relevant Body will, 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 will specify—

• (a) details of the breach;

• (b) the steps the contractor must take to the satisfaction of the Relevant Body in order to remedy the breach; and

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

• (3) The notice period will, unless the Relevant Body 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 twenty eight days from the date that notice is given.

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

• (5) Where a contractor has breached the agreement other than as specified in paragraphs 68 to 70 and the breach is not capable of remedy, the Relevant Body 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,

the Relevant Body may serve notice on the contractor terminating the agreement with effect from such date as may be specified in that notice.

• (7) The Relevant Body will 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 the Relevant Body 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, the Relevant Body 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.

Termination by the Relevant Body: additional provisions specific to contracts with qualifying bodies

72

• (1) Where a party to the agreement is a qualifying body, if the Relevant Body becomes aware that the qualifying body is carrying on any business which the Relevant Body considers to be detrimental to the contractor’s performance of its obligations under the agreement—

• (a) the Relevant Body will be entitled to give notice to the contractor requiring that the qualifying body ceases carrying on that business before the end of a period of not less than twenty eight days beginning on the day on which the notice is given (“the notice period”); and

• (b) if the contractor has not satisfied the Relevant Body that the qualifying body has ceased carrying on that business by the end of the notice period, the Relevant Body 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 qualifying body 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 qualifying body cease to be either dental practitioners or dental care professionals;

• (b) the qualifying body has been convicted of an offence under section 43(1) of the Dentists Act⁷² (directors of bodies corporate); or

• (c) the qualifying body, or a director or former director of that qualifying body, has had a financial penalty imposed on it or him or her by the General Dental Council pursuant to section 43B (financial penalties in relation to bodies corporate) or 44⁷³ (further financial penalties on bodies corporate) of the Dentists Act,

the Relevant Body may, by written notice, terminate the agreement if it considers that as a consequence the qualifying body is no longer suitable to be a contractor.

Agreement sanctions

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 the Relevant Body 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 the Relevant Body is reasonably satisfied that the agreement sanction to be imposed is appropriate and proportionate to the circumstances which provide grounds for the Relevant Body to terminate the agreement.

• (3) If the Relevant Body decides to impose a 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, the Relevant Body will not impose the agreement sanction until at least twenty eight 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 the Relevant Body imposes an agreement sanction, it will be entitled to charge the contractor the reasonable costs of additional administration that the Relevant Body has incurred in order to impose, or as a result of imposing, the agreement sanction.

Agreement sanctions and the NHS dispute resolution procedure

74

• (1) If there is a dispute between the Relevant Body and the contractor in relation to an agreement sanction that the Relevant Body is proposing to impose, the Relevant Body will 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 twenty eight days beginning on the date on which the Relevant Body served notice on the contractor in accordance with paragraph 73(3) (or such longer period as may be agreed in writing with the Relevant Body), and notifies the Relevant Body in writing that it has done so, the Relevant Body will not impose the agreement sanction unless—

• (a) there has been a determination of the dispute pursuant to paragraph 56 and that determination permits the Relevant Body 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), the Relevant Body will be entitled to impose the agreement sanction forthwith.

• (4) If the Relevant Body 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,

the Relevant Body will be entitled to impose the agreement sanction forthwith, pending the outcome of that procedure.

Termination and the NHS dispute resolution procedure

75

• (1) Where the Relevant Body 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 will, in the notice served on the contractor pursuant to those provisions, specify a date on which the agreement terminates that is not less than twenty eight days after the date on which the Relevant Body has served that notice on the contractor unless sub-paragraph (2) applies.

• (2) This sub-paragraph applies if the Relevant Body is satisfied that a period less than twenty eight 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 the Relevant Body in writing that it has done so,

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

• (4) The agreement will only terminate if and when—

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

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

whichever is the sooner.

• (5) If the Relevant Body 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) will not apply and the Relevant Body will 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 10 — MISCELLANEOUS

Evidence of exemption under the Act

76

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

• (2) The contractor will 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 arrangements

77

• (1) Subject to paragraph (2), the contractor will co-operate with such clinical governance arrangements as the Relevant Body may establish in respect of contractors providing services under an agreement.

• (2) In the case where the contractor is the Local Health Board, that Board will have effective arrangements for clinical governance in place.

• (3) The contractor will 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.

Quality assurance system

78

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

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

• (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 performance

79

• (1) The contractor will at all times have in force in relation to it an indemnity arrangement which provides appropriate cover.

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

• (3) In this paragraph—

• (a) indemnity arrangement” means a contract of insurance or other arrangement made for the purpose of indemnifying the contractor;

• (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 will be regarded as having 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 insurance

80

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

• (2) In this paragraph, “ indemnity arrangement” has the same meaning as in paragraph 79.

Gifts

81

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

• (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 qualifying body, a director, chief executive or secretary of the corporation;

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

• (5) The register referred to in sub-paragraph (1) will 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 or her 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 will make the register available to the Relevant Body on request.

Compliance with legislation and guidance

82

The contractor will—

• (a) comply with all relevant legislation; and

• (b) have regard to all relevant guidance issued by—

• (i) the Relevant Body, or

• (ii) the Assembly.

Third party rights

83

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

Signing of documents

84

• (1) In addition to any other requirements relating to such documents whether in these Regulations or otherwise, the contractor will 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.

SCHEDULE 4 — PATIENT INFORMATION LEAFLET

A practice leaflet will include—

1

The name of the party or parties comprising the contractor.

2

In the case of an agreement with a qualifying body—

• (a) the names of the directors, chief executive and secretary of that body, in so far as those positions exist in relation to the qualifying body; and

• (b) the address of that body’s registered office.

3

The full name of each person performing services under the agreement.

4

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

5

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

6

The address of each of the practice premises.

7

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

8

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

9

How to request services as a patient.

10

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

11

The services available under the agreement.

12

The normal surgery days and hours of the practice.

13

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

14

If the services in paragraph 13 are not provided by the contractor, the fact that the Relevant Body referred to in paragraph 20 is responsible for commissioning the services.

15

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

16

How patients may—

• (1) in respect of complaints made prior to 1 April 2011 make a complaint in accordance with the provisions of Part 6 of Schedule 3;

• (2) in respect of concerns notified on or after 1 April 2011 notify a concern in accordance with the provisions of the National Health Service (Concerns, Complaints and Redress Arrangements) (Wales) Regulations 2011; or

• (3) comment on the provision of service.

17

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

18

The action that may be taken where a patient is violent or abusive to the contractor, its staff, persons present on the practice premises or in the place where treatment is provided under the agreement or other persons specified in paragraph 3(2) of Schedule 3.

19

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

20

The name, postal and website address and telephone number of the Relevant Body with which the contractor is a party to the agreement

21

The fact that details of primary dental services in the area may be obtained from the Relevant Body or, where the contractor is a Local Health Board, that Local Health Board.

SCHEDULE 5 — MODIFICATION OF PATIENT PROVISIONS WHERE THE CONTRACTOR IS A LOCAL HEALTH BOARD

1

Paragraphs 3 and 5 of Schedule 3 will apply as modified by paragraphs 2 and 3 respectively where the contractor is a Local Health Board.

2

As if for paragraph 3, there were substituted the following—

(3) (1) Where— (a) a patient of the contractor has committed an act of violence or behaved in such a way against any of the persons specified in sub-paragraph (2) as a consequence of which that person has feared for his or her safety; and (b) the contractor has reported the incident to the police, the Local Health Board may notify that patient that it will no longer provide services to him or her under the agreement. (2) The persons referred to in sub-paragraph (1) are— (a) any member of the Local Health Board’s staff; (b) a person engaged by the Local Health Board to perform or assist in the performance of services under the agreement; or (c) 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

As if for paragraph 5, there were substituted the following—

(5) (1) 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 no longer provide services to the patient under the agreement.

Signed

Signed on behalf of the National Assembly for Wales under section 66(1) of the Government of Wales Act 1998⁴²

D. Elis-Thomas — The Presiding Officer of the National Assembly — 28 February 2006

Explanatory note

(This note is not part of the Order)

These Regulations set out, for Wales, the framework for personal dental services agreements under section 28C of the National Health Service Act 1977 (“the Act”).

Part 2 of the Regulations prescribes the conditions which, in accordance with section 28D of the Act, must be met by a contractor before the Relevant Body may enter into a personal dental services agreement with it.

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

Part 4 of the Regulations provides for a contractor to be a health service body for the purposes of section 4 of the 1990 Act unless it objects by serving a notice on the Relevant Body before the agreement is made.

Part 5 of (and Schedules 1 to 3 to) the Regulations prescribe the terms which, in accordance with section 28E of the Act, must be included in a personal dental services agreement.

The prescribed terms include terms relating to—

• (a) whether the agreement is an NHS contract (regulation 10);

• (b) the services to be provided and the manner in which they are to be provided (regulations 11 to 14 and 16 and Schedules 1 and 2 and Parts 1 and 2 of Schedule 3);

• (c) finance, fees and charges (regulations 17 and 18);

• (d) prescribing of drugs and appliances (Schedule 3, Part 3);

• (e) the conditions to be met by those who perform services or are employed or engaged by the agreement or (Schedule 3, Part 4);

• (f) patient records, the provision of information and rights of entry and inspection (Schedule 3, Part 5);

• (g) complaints (Schedule 3, Part 6);

• (h) procedures for dispute resolution (Schedule 3, Part 7);

• (i) procedure for a mid-year review of activity under the agreement (Schedule 3, Part 8); and

• (j) procedures for variation and termination of agreements (Schedule 3, Part 9).

Part 6 of the Regulations provides for the contractor to terminate its agreement and enter into a general dental services contract.

Part 7 of the Regulations makes transitional provision.

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

Footnotes

Editorial notes