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79.—(1) The contractor must have in place an effective system of clinical governance which includes appropriate standard operating procedures in relation to the management and use of controlled drugs.
(2) The contractor must nominate a person who is to have responsibility for ensuring the effective operation of the system of clinical governance.
(3) The person nominated under paragraph (2) must be a person who performs or manages the performance of services under the agreement.
(4) In this regulation—
(a)“controlled drugs” has the meaning given in section 2 of the Misuse of Drugs Act 1971 M1 (which relates to controlled drugs and their classification for the purposes of that Act); and
(b)“system of clinical governance” means a framework through which the contractor endeavours continuously to improve the quality of its services and safeguards high standards of care by creating an environment in which clinical excellence can flourish.
Marginal Citations
M11971 c.38. Section 2 was amended by section 151 of, and paragraphs 1 and 2 of Schedule 17 to, the Police Reform and Social Responsibility Act 2011 (c.13).
80.—(1) A contractor which provides essential services must give all patients who use the contractor's practice the opportunity to provide feedback about the service received from the contractor's practice through the Friends and Family Test M2.
(2) The contractor must—
(a)report the results of completed Friends and Family Tests to the Board; and
(b)publish the results of such completed Tests M3.
(3) In this regulation, “Friends and Family Test” means the arrangements that a contractor which provides essential services is required by the Board to implement to enable its patients to provide anonymous feedback about the patient experience at the contractor's practice.
Marginal Citations
M2See the guidance for GP practices on the Friends and Family Test, published in July 2014, which is available in full and summary form at:
http://www.england.nhs.uk/ourwork/pe/fft-guidance/. Hard copies of this guidance are available from Primary Care Contracting, NHS Employers, 50 Broadway, London SW1H 0DR.
M3See pages 7 and 8 of the full Guidance for GP Practices on the Friends and Family Test in respect of the requirement on GP practices to submit monthly reports to the Board and to publish the results of completed tests. This guidance is available at http://www.england.nhs.uk/ourwork/pe/fft-guidance/. Hard copies of this guidance are available from Primary Care Contracting, NHS Employers, 50 Broadway, London SW1H 0DB.
81. The contractor must co-operate with the Board in the discharge of any of the Board's obligations, or the obligations of the Board's accountable officers, under the Controlled Drugs (Supervision and Management of Use) Regulations 2013 M4.
Marginal Citations
82. The contractor must co-operate with—
(a)the Secretary of State in the discharge of the Secretary of State's duty under section 1F of the Act M5 (duty as to education and training); and
(b)Health Education England M6 where Health Education England is discharging the Secretary of State's duty under section 1F of the Act by virtue of its functions under section 97(1) of the Care Act 2014 M7 (planning education and training for health workers etc.).
Marginal Citations
M5Section 1F was inserted by section 7 of the Health and Social Care Act 2012 (c.7).
M6Health Education England is a body corporate established by section 96 of the Care Act 2014 (c.23).
83.—(1) The contractor must at all times have in force in relation to it an indemnity arrangement which provides appropriate cover.
(2) The contractor may not sub-contract its obligations to provide clinical services under the agreement unless it is satisfied that the sub-contractor has in force in relation to it an indemnity arrangement which provides appropriate cover.
(3) In this regulation—
(a)“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;
(b)“indemnity arrangement” means a contract of insurance or other arrangement made for the purpose of indemnifying the contractor; and
(c)a contractor is to be regarded as holding insurance if it is held by a person employed or engaged by the contractor in connection with clinical services which that person provides under the agreement or, as the case may be, sub-contract.
84. The contractor must 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 the indemnity agreement referred to in regulation 83.
85.—(1) The contractor must keep a register of gifts which—
(a)are given to any of the persons specified in paragraph (2) by or on behalf of—
(i)a patient,
(ii)a relative of a patient, or
(iii)any person who provided or would like to provide services to the contractor or its patients in connection with the agreement; and
(b)have, in the contractor's reasonable opinion, an individual value of more than £100.00.
(2) The persons specified in this paragraph are—
(a)the contractor;
(b)where the agreement is with a qualifying body—
(i)any person both legally and beneficially owning a share in the qualifying body, or
(ii)a director or secretary of the qualifying body;
(c)any person employed by the contractor for the purposes of the agreement;
(d)any general medical 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 medical practitioner) or of a person specified in sub-paragraphs (b) to (d); or
(f)any person whose relationship with a contractor (where the contractor is an individual medical practitioner) or with a person specified in sub-paragraphs (b) to (d) has the characteristics of the relationship between spouses.
(3) 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)the contractor is not aware that the donor would like to provide services to the contractor or its patients.
(4) The contractor must take reasonable steps to ensure that it is informed of any gifts which fall within paragraph (1) and which are given to the persons specified in paragraph (2)(b) to (f).
(5) The register referred to in paragraph (1) must 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, the patient's 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 must make the register available to the Board on request.
86. The contractor must—
(a)comply with all relevant legislation; and
(b)have regard to all relevant guidance issued by the Board, the Secretary of State or local authorities in respect of the exercise of their functions under the Act.
87. The agreement does not create any right enforceable by any person who is not a party to it.