Section 16CA was inserted into the Act by section 170 of the 2003 Act.
S.I. 2004/905 (W.89) (as amended by 2005/603 (W.51)).
Sch. 3 para. 39 in force at 1.3.2006, see reg. 1(1)
Sch. 3 para. 34(1)(c) substituted (1.4.2011) by The National Health Service (Concerns, Complaints and Redress Arrangements) (Wales) Regulations 2011 (S.I. 2011/704), reg. 1(2), Sch. 2 para. 4(2)(a)
Sch. 3 para. 32 in force at 1.3.2006, see reg. 1(1)
Sch. 3 para. 35 in force at 1.3.2006, see reg. 1(1)
Sch. 3 para. 42 in force at 1.3.2006, see reg. 1(1)
Sch. 3 para. 34 in force at 1.3.2006, see reg. 1(1)
Sch. 3 para. 37 in force at 1.3.2006, see reg. 1(1)
Sch. 3 para. 44 in force at 1.3.2006, see reg. 1(1)
Sch. 3 para. 46 substituted (1.4.2009) by The Health and Social Care Act 2008 (Commencement No.9, Consequential Amendments and Transitory, Transitional and Saving Provisions) Order 2009 (S.I. 2009/462), art. 1(4), Sch. 5 para. 20(a)(ii)
Sch. 3 para. 38 in force at 1.3.2006, see reg. 1(1)
Sch. 3 para. 46 in force at 1.3.2006, see reg. 1(1)
Sch. 3 para. 43 in force at 1.3.2006, see reg. 1(1)
Sch. 3 para. 45 in force at 1.3.2006, see reg. 1(1)
Words in Sch. 3 para. 44(3)(a) substituted (1.4.2009) by The Health and Social Care Act 2008 (Commencement No.9, Consequential Amendments and Transitory, Transitional and Saving Provisions) Order 2009 (S.I. 2009/462), art. 1(4), Sch. 5 para. 20(a)(i)
Sch. 3 para. 41 in force at 1.3.2006, see reg. 1(1)
Sch. 3 para. 36 in force at 1.3.2006, see reg. 1(1)
Sch. 3 para. 40 in force at 1.3.2006, see reg. 1(1)
Sch. 3 para. 33 in force at 1.3.2006, see reg. 1(1)
The contractor will ensure that a full, accurate and contemporaneous record is kept in the patient record in respect of the care and treatment given to each patient under the contract, including treatment given to a patient who is referred to the contractor.
The patient record may be kept in electronic form.
The patient record will include details of any private services (to the extent that they are provided with services under the contract) and will be kept with—
a copy of any treatment plan or referral treatment plan given to the patient pursuant to paragraph 2 of Schedule 1 (referral services) or paragraph 7 of this Schedule;
all radiographs, photographs and study casts taken or obtained by it as part of the services provided to that patient;
where an orthodontic course of treatment has been provided to a patient, a copy of the orthodontic treatment plan;
where information is to be submitted to the Local Health Board in accordance with paragraph 38 and that information is submitted electronically—
the written declaration form in respect of exemption under paragraph 1(1) of Schedule 12ZA to the Act duly made and completed in accordance regulations made under section 79 of, and paragraph 7(a) of Schedule 12ZA to that Act; and
a note of the evidence in support of that declaration; and
the statement concerning any custom-made devices provided by any person as a consequence of regulation 15 of the Medical Devices Regulations 2002
The patient record and the items referred to in sub-paragraph (3) will be retained for a period of 2 years beginning with—
the date on which—
a course of treatment or orthodontic course of treatment is terminated, or
a course of treatment or an orthodontic course of treatment is completed; or
in respect of courses of treatment or orthodontic courses of treatment not falling within paragraph (a)(i) or (ii) the date by which no more services can be provided as part of that course of treatment or orthodontic course of treatment by virtue of paragraph 5(4)(b) of Schedule 1 (orthodontic course of treatment) or paragraph 6(4)(b) of this Schedule.
Nothing in this paragraph will affect any property right which the contractor may have in relation to the records, radiographs, photographs and study models referred to in this paragraph.
The contractor will nominate a person with responsibility for practices and procedures relating to the confidentiality of personal data held by it.
The contractor will ensure that there is displayed in a prominent position in its practice premises, in a part to which patients have access—
in respect of its practice based quality assurance system referred to in paragraph 80, a written statement relating to its commitment to the matters referred to in paragraph 80(4);
such information relating to NHS Charges as is supplied by the Local Health Board for the purposes of providing information to patients; and
information about the procedure for notifying concerns in accordance with Part 5A or, in respect of complaints made prior to 1 April 2011, the complaints procedure which it operates in accordance with Part 6 giving, in the case of a complaint under Part 6, the name and title of the person nominated in accordance with paragraph 50(2)(a) or, in the case of a notification of a concern, the name of the person designated as the senior investigations manager under regulation 8 of the National Health Service (Concerns, Complaints and Redress Arrangements) (Wales) Regulations 2011.
The contractor will—
compile a document (in this paragraph called a “patient information leaflet”) which will include the information specified in Schedule 4;
review its patient information leaflet at least once in every period of 12 months and make any amendments necessary to maintain its accuracy; and
make available a copy of the leaflet, and any subsequent updates, to its patients and prospective patients.
The requirements in sub-paragraph (2) do not apply to any contractor to the extent that it provides services to persons detained in prison.
The contractor will, at the request of the Local Health Board—
produce to the Local Health Board or to a person authorised in writing by the Local Health Board in such format, and at such intervals or within such period, as the Local Health Board specifies; or
allow the Local Health Board, or a person authorised in writing by it to access,
the information specified in paragraph (2).
The information specified for the purposes of sub-paragraph (1) is—
any information which is reasonably required by the Local Health Board for the purposes of or in connection with the contract; and
any other information which is reasonably required in connection with the Local Health Board’s functions,
and includes the contractor’s patient records.
Subject to sub-paragraph (2), where the contractor receives a written request from a Community Health Council to produce any information which appears to the Council to be necessary for the effective carrying out of its functions it will comply with that request promptly and in any event no later than the twentieth working day following the date the request was made.
The contractor will not be required to produce information under sub-paragraph (1) which—
is confidential and relates to a living individual, unless at least one of the conditions specified in sub-paragraph (3) applies; or
is prohibited from disclosure by or under any enactment or any ruling of a court of competent jurisdiction or is protected by the common law, unless sub-paragraph (4) applies.
The conditions referred to in sub-paragraph (2)(a) are—
the information can be disclosed in a form from which the identity of the individual cannot be ascertained; or
the individual consents to the information being disclosed.
This sub-paragraph applies where—
the prohibition of the disclosure of information arises because the information is capable of identifying an individual; and
the information can be disclosed in a form from which the identity of the individual cannot be ascertained.
In a case where the information falls within—
sub-paragraph (2)(a) and the condition in sub-paragraph (3)(a) applies; or
sub-paragraph (2)(b) and sub-paragraph (4) applies,
a Community Health Council may require the contractor to disclose the information in a form from which the identity of the individual concerned cannot be ascertained.
The contractor will, subject to sub-paragraphs (2) and (3), sufficiently answer any inquiries whether oral or in writing from the Local Health Board concerning—
any prescription form issued by a prescriber;
the considerations by reference to which prescribers issue such forms;
the referral by or on behalf of the contractor of any patient for any other services provided under the Act; or
the considerations by which the contractor makes such referrals or provides for them to be made on its behalf.
An inquiry referred to in sub-paragraph (1) may only be made for the purpose either of obtaining information to assist the Local Health Board to discharge its functions or of assisting the contractor in the discharge of its obligations under the contract.
The contractor will not be obliged to answer any inquiry referred to in sub-paragraph (1) unless it is made—
in the case of sub-paragraph (1)(a) or (1)(b), by an appropriately qualified health care professional; or
in the case of sub-paragraph (1)(c) or (1)(d), by an appropriately qualified dental practitioner,
appointed in either case by the Local Health Board to assist it in the exercise of its functions under this paragraph and that person produces, on request, written evidence that he or she is authorised by the Local Health Board to make such inquiry on its behalf.
The contractor will, within 2 months of the date upon which—
it completes a course of treatment in respect of mandatory or additional services;
it completes a case assessment in respect of an orthodontic course of treatment that does not lead to a course of treatment;
it provides an orthodontic appliance following a case assessment in respect of orthodontic treatment;
it completes a course of treatment in respect of orthodontic treatment;
a course of treatment in respect of mandatory services or additional services or orthodontic course of treatment being terminated; or
in respect of courses not falling within 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 6(4)(b) of this Schedule,
send to the Local Health Board, on a form supplied by that Board, the information specified in sub-paragraph (2).
The information referred to in sub-paragraph (1) comprises of—
details of the patient to whom it provides services;
details of the services provided (including any appliances provided) to that patient;
details of any NHS Charge payable (and paid) by that patient; and
in the case of a patient exempt from NHS Charges and where such information is not submitted electronically, the written declaration form and note of evidence in support of that declaration.
The Local Health Board will provide to the contractor an annual report relating to the contract which will contain the same categories of information for all persons who hold contracts with that Board.
Once the Local Health Board has provided the report referred to in sub-paragraph (1), the Local Health Board will arrange with the contractor an annual review of its performance in relation to the contract.
The Local Health Board will prepare a draft record of the review referred to in sub-paragraph (2) for comment by the contractor and, having regard to such comments, will produce a final written record of the review.
A copy of the final record referred to in sub-paragraph (3) will be sent to the contractor.
In addition to any requirements of notification elsewhere in the Regulations, the contractor will notify the Local Health Board in writing, as soon as reasonably practicable, of—
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 contract; or
any circumstances which give rise to the Local Health Board’s right to terminate the contract under paragraph 70 or 71(1).
The contractor will, unless it is impracticable for it to do so, notify the Local Health Board in writing within 28 days of any occurrence requiring a change in the information about it published by the Local Health Board in accordance with regulations made under section 16CA(3) of the Act
The Contractor will give notice in writing to the Local Health Board when a dental practitioner who is performing or will perform services under the contract (as the case may be)—
leaves the contractor, and the date upon which he or she left; or
is employed or engaged by the contractor,
which will include the name of the dental practitioner who has left, or who has been employed or engaged, together with his or her professional registration number.
A contractor which is a dental corporation will give notice in writing to the Local Health Board forthwith when—
it passes a resolution or a court of competent jurisdiction makes an order that the contractor be wound up;
circumstances arise which might entitle a creditor or a court to appoint a receiver, administrator or administrative receiver for the contractor;
circumstances arise which would enable the court to make a winding up order in respect of the contractor; or
the contractor is unable to pay its debts within the meaning of section 123 of the Insolvency Act 1986
A contractor which is a partnership will give notice in writing to the Local Health Board forthwith when—
a partner leaves or informs his or her partners that he or she intends to leave the partnership, and the date upon which he or she left or will leave the partnership; or
a new partner joins the partnership.
A notice under sub-paragraph (1)(b) will—
state the date that the new partner joined the partnership;
confirm that the new partner is a dental practitioner, or that he or she satisfies the conditions specified in section 28M(2)(b) of the Act;
confirm that the new partner meets the conditions imposed by regulation 4 (general conditions relating to all contracts); and
state whether the new partner is a general or a limited partner.
Where the contract is varied in accordance with Part 9 of this Schedule and, as a result of that variation there is to be a change in the range of services provided by the contractor, the contractor will ensure that there is displayed in a prominent position in its practice premises, in a part to which patients have access, written details of that change.
Subject to—
the conditions in sub-paragraph (2); and
sub-paragraph (3),
the contractor will allow persons authorised in writing by the Local Health Board to enter and inspect the practice premises at any reasonable time.
The conditions referred to in sub-paragraph (1) are that—
reasonable notice of the intended entry has been given;
written evidence of the authority of the person seeking entry is produced to the contractor on request; and
entry is not made to any premises or part of the premises used as residential accommodation without the consent of the resident.
Where the contractor is providing services under the contract in a prison, the contractor will not be obliged to comply with sub-paragraph (1), or paragraph 45 or 46, if—
the contractor has used its best endeavours to allow the Local Health Board, members of a Community Health Council or the
entry and inspection has been prevented by the prison authorities despite the contractor’s best endeavours.
In this paragraph “practice premises” includes a mobile surgery.
Subject to paragraph 44(3), the contractor will allow members of a Community Health Council authorised by or under regulation 20 of the Community Health Councils Regulations 2004
Subject to paragraph 44(3), the contractor will allow persons authorised by the Welsh Ministers to enter and inspect premises in accordance with section 72 of the Health and Social Care (Community Health and Standards) Act 2003 (right of entry).