The General Ophthalmic Services Contracts Regulations 2008

STATUTORY INSTRUMENTS 2008 No. 1185 NATIONAL HEALTH SERVICE, ENGLAND The General Ophthalmic Services Contracts Regulations 2008 Made - - - - - 28th April 2008 Laid before Parliament 6th May 2008 Coming into force - - 1st August 2008 6.50

STATUTORY INSTRUMENTS 2008 No. 1185 NATIONAL HEALTH SERVICE, ENGLAND The General Ophthalmic Services Contracts Regulations 2008 Made - - - - 28th April 2008 Laid before Parliament 6th May 2008 Coming into force - - 1st August 2008 1. Citation, commencement and application 2. Interpretation CONTENTS PART 1 General PART 2 Contractors 3. Conditions: introductory 4. Persons eligible to enter into GOS contracts 5. Reasons 6. Appeals and contract disqualifications 7. Pre-contract disputes 8. Health service body status PART 3 Pre-contract Dispute Resolution PART 4 Health Service Body Status PART 5 Contracts: Required Terms 9. Parties to the contract 10. NHS contracts 11. Contracts with individuals practising in partnership 12. Duration

13. Testing of sight 14. Services: general 15. Finance 16. Fees, charges and financial interests of the contractor 17. Arrangements on termination 18. Other contractual terms: mandatory services 19. Other contractual terms: additional services 20. Commencement of contract PART 6 Transitional Provision SCHEDULE 1 OTHER CONTRACTUAL TERMS PART 1 Patients PART 2 Provision of Services PART 3 Persons Who Perform Services PART 4 Records, Information, Notifications, Name and Rights of Entry PART 5 Complaints PART 6 Dispute Resolution PART 7 Variation and Termination of Contracts PART 8 Miscellaneous SCHEDULE 2 ADDITIONAL SERVICES SCHEDULE 3 APPLICATIONS FOR A CONTRACT SCHEDULE 4 PATIENT INFORMATION LEAFLET The Secretary of State for Health makes the following Regulations in exercise of the powers conferred by sections 28WB, 28WC, 28WE, 28WF and 126(4) of the National Health Service Act 1977(a) and section 9(8) of the National Health Service Act 2006(b). Citation, commencement and application PART 1 General 1. (1) These Regulations may be cited as the General Ophthalmic Services Contracts Regulations 2008 and shall come into force on 1st August 2008. (2) These Regulations apply in relation to England. (a) 1977 c.49 ( the 1977 Act ); see section 128(1) as amended by the National Health Service and Community Care Act 1990 (c.19) ( the 1990 Act ), section 26(2)(g) and (i), for the definitions of prescribed and regulations. Sections 28WB, 28WC and 28WF were inserted by the Health Act 2006 (c.28) ( the 2006 Act ), section 38. Section 126(4) was amended by the 1990 Act, s. 65(2); by the Health Act 1999 (c.8), Schedule 4, paragraph 37(6), by the Health and Social Care Act 2001 (c.15) ( the 2001 Act ), Schedule 5, paragraph 5(13)(b) and by the 2006 Act, section 80 and Schedule 8, paragraph 23. As regards Wales, the functions of the Secretary of State under sections 29 and 126(4) of the 1977 Act are transferred to Welsh Ministers under section 58 of, and Schedule 1 to, the Government of Wales Act 2006 (c. 32); these Regulations therefore extend only to England. (b) 2006 c. 41. 2

Interpretation 2. (1) In these Regulations the 1977 Act means the National Health Service Act 1977; the Act means National Health Service Act 2006; additional services means the primary ophthalmic services prescribed under section 115(1)(b) (primary ophthalmic services), which are provided to an eligible person, other than a prisoner; adjudicator means the Secretary of State or a person appointed by the Secretary of State under section 9(8) (NHS contracts) or paragraph 30(4) of Schedule 1 (NHS dispute resolution procedure); Charges Regulations means the National Health Service (Optical Charges and Payments) Regulations 1997(a); charity trustee means one of the persons having the general control and management of the administration of a charity; child means a person who has not attained the age of 16 years; contract means, except where the context otherwise requires, a general ophthalmic services contract under section 117 (general ophthalmic services contracts: introductory); contract disqualification order means an order of the FHSAA, under regulation 6, that a person be disqualified from entering into a contract; day centre means an establishment in the locality of the PCT attended by eligible persons, who would have difficulty in obtaining sight testing services from practice premises because of physical or mental illness or disability or because of difficulties in communicating their health needs unaided; eligible person means a person, who is entitled, by virtue of the POS Regulations, to receive mandatory services or additional services; employment means any employment whether paid or unpaid and whether under a contract for services or a contract of service and employ and employed shall be construed accordingly; family member means (a) a spouse; (b) a civil partner; (c) a person whose relationship with the patient has the characteristics of the relationship between husband and wife or civil partners; (d) a parent or step-parent; (e) a son; (f) a daughter; (g) a child of whom the person is (i) the guardian; or (ii) the carer duly authorised by the local authority to whose care the child has been committed under the Children Act 1989(b); or (h) a grandparent; FHSAA means the Family Health Services Appeal Authority constituted under section 169 (the Family Health Services Appeal Authority); health service body has, unless the context otherwise requires, the meaning given to it in section 9(4) (NHS contracts); (a) S.I.1997/818. (b) 1989 c. 41. 3

licensing body means any body that licences or regulates any profession; MHRA means the Medicines and Healthcare products Regulatory Agency(a); mandatory services means the primary ophthalmic services mentioned in section 115(1)(a) (sight-testing services) provided to an eligible person, except when those services are provided other than at the contractor s practice premises; mobile services means the sight testing service provided by a contractor to patients (a) attending at a day centre; (b) residing at a residential centre; or (c) at their home, where the patient is unable to leave it unaccompanied because of physical or mental illness or disability; where the contractor has entered into a contract with a PCT to provide additional services in the PCT s locality; national disqualification means (a) a decision made by the FHSAA under section 159 or under regulations corresponding to that section made under sections 91(3), 106(3), 123(3) or 146(3) (national disqualifications); (b) a decision under provisions in force in Scotland or Northern Ireland corresponding to section 159; or (c) a decision by the Tribunal, constituted under section 46 of the 1977 Act for England and Wales (which, except for prescribed cases, had effect, in relation to England, only until 14th December 2001 and, in relation to Wales, only until 26th August 2002), which is treated as a national disqualification by the FHSAA by virtue of regulation 6(4)(b) of the Abolition of the National Health Service Tribunal (Consequential Provisions) Regulations 2001(b) or regulation 6(4)(b) of the Abolition of the National Health Service Tribunal (Consequential Provisions) Regulations 2002(c); NHS contract has the meaning assigned to it in section 9(1); NHS dispute resolution procedure means the procedure for disputes specified in paragraphs 30 and 31 of Schedule 1; notice means a notice in writing (including electronically) and notify and notification shall be construed accordingly; ophthalmic performers list means a list of ophthalmic practitioners prepared in accordance with regulation 3(1)(c) of the National Health Service (Performers Lists) Regulations 2004(d) ophthalmic practitioner means either (a) a registered optometrist, who is not a corporate body; or (b) a registered medical practitioner, who is included in an ophthalmic performers list; Opticians Act means the Opticians Act 1989(e); PCT means the Primary Care Trust which is a party, or prospective party, to the contract; parent, in relation to any child, means a parent or other person who has parental responsibility for that child; patient means an eligible person to whom the contractor is providing or proposes to provide services under the contract; the POS Regulations means the Primary Ophthalmic Services Regulations 2008(f); (a) The MHRA is an executive agency of the Deprtament of Health. (b) S.I. 2001/3744, amended by S.I. 2002/2469. (c) S.I. 2002/1920. (d) S.I. 2004/585; regulation 3(1) was substituted by S.I. 2008/1187. (e) 1989 c. 44. (f) S.I. 2008/1186. 4

practice means the business operated by the contractor for the purpose of delivering services under the contract; practice premises means an address specified in the contract as one at which mandatory services are to be provided under the contract; primary care list means (a) a list of persons performing primary medical, dental or ophthalmic services under sections 91 (persons performing primary medical services), 106 (persons performing primary dental services), or 123 (persons performing primary ophthalmic services); (b) a list of persons undertaking to provide pharmaceutical services prepared in accordance with regulations made under sections 126 to 131 (provision of pharmaceutical services); (c) a list of persons approved for the purposes of assisting in the provision of pharmaceutical services prepared in accordance with regulations made under section 149 (supplementary lists); (d) a list of persons who undertook to provide general medical services, general dental services or general ophthalmic services prepared in accordance with regulations made under sections 29A (medical lists), 36 (regulations for general dental services) or 39 (regulations for general ophthalmic services) of the 1977 Act(a); (e) a list of persons approved for the purposes of assisting in the provision of general medical services or general ophthalmic services prepared in accordance with regulations made under section 43D of the 1977 Act(b) (supplementary lists); (f) a services list which fell within the meaning of section 8ZA of the National Health Service (Primary Care) Act 1997(c) (lists of persons who may perform personal medical services or personal dental services); (g) a list corresponding to a services list prepared by virtue of regulations made under section 145 (application of enactments local pharmaceutical services); or (h) a list corresponding to any of the above lists in Scotland, Wales or Northern Ireland; private, in the context of services or treatment, means otherwise than under the contract or Part 1, and privately shall be construed accordingly; professional registration number means the number against an ophthalmic practitioner s name in the register, together with the prefix and suffix given to that number in the ophthalmic performers list in which the name is included; register means, except in paragraph 4 of Schedule 3 (a) in the case of an optometrist, the register maintained by the General Optical Council under section 7(a) of the Opticians Act(d); or (b) in the case of a registered medical practitioner, the register of medical practitioners maintained pursuant to section 2(2) of the Medical Act 1983(e); registered means included in the register; relevant Strategic Health Authority means the Strategic Health Authority established for an area which includes the area for which the PCT is established; residential centre means an establishment in the locality of the PCT for persons, including eligible persons, who normally reside in that establishment and who are unable to leave the establishment unaccompanied because of physical or mental illness or disability; sight test form means the form which, in accordance with these Regulations or the POS Regulations, is to be completed for the purposes of payments in respect of a sight test; and (a) Sections 29A and 36 were repealed by sections 175(2) and 196 of and Schedule 11 to the Health and Social Care (Community Health and Standards) Act 2003 and section 39 was repealed in its application to England by section 80 of and Schedule 9 to the 2006 Act. (b) Section 43D was inserted by section 24 of the 2001 Act. (c) 1997 c. 46; section 8ZA was inserted by section 26(2) of the 2001 Act. (d) Section 7 was amended by S.I. 2005/848. (e) 1983 c.54; section 2(2) was amended by S.I. 2002/1315, 2006/1914 and 2007/3101. 5

working day means any day apart from Saturday, Sunday, Christmas Day, Good Friday or a day that is specified or proclaimed as a bank holiday in England pursuant to section 1 of the Banking and Financial Dealings Act 1971(a). (2) In these Regulations (a) the use of the term it in relation to the contractor includes a reference to a contractor who is an individual or two or more individuals practising in partnership and related expressions shall be construed accordingly; (b) all references to sections or Parts are to sections or Parts of the Act, except where specified otherwise; and (c) references to forms supplied by the PCT to contractors includes electronic forms and forms which are generated electronically, but does not include prescription forms. Conditions: introductory PART 2 Contractors 3. Subject to the provisions of any regulations made under section 43 of the Health Act 2006 (general ophthalmic services: transitional), a PCT may only enter into a contract if (a) the conditions set out in regulation 4 are met, and (b) an application to enter into a contract, which complies with Schedule 3, has been made to that PCT. Persons eligible to enter into GOS contracts 4. (1) For the purposes of section 118 (persons eligible to enter into GOS contracts) it is a prescribed condition that a person must not fall within paragraph (3). (2) The reference to a person in paragraph (1) includes any director, chief executive or secretary of a corporate body. (3) A person falls within this paragraph if (a) it is the subject of a national disqualification or a contract disqualification order; (b) subject to paragraph (4), it is disqualified or suspended (other than by an interim suspension order or direction pending an investigation) from practising by any licensing body anywhere in the world; (c) within the period of 5 years prior to the date the contract is to be commenced or, if earlier, the date on which the contract is to be signed, he has been dismissed (otherwise than by reason of redundancy) from any employment by a health service body, unless he has subsequently been employed by that health service body or another health service body and paragraph (5) applies to him or that dismissal was the subject of a finding of unfair dismissal by any competent tribunal or court; (d) within the period of 5 years prior to the date the contract is to be commenced or, if earlier, the date on which the contract is to be signed, it has been removed from, or refused admission to, a primary care list by reason of inefficiency, fraud or unsuitability (within the meaning of section 151(2), (3) and (4)) (disqualification of practitioners) respectively, unless its name has subsequently been included in such a list; (e) he has been convicted in the United Kingdom of (i) murder; or (a) 1971 c. 80. 6

(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 6 months; (f) it has been convicted of a criminal offence, not falling within subparagraphs (d), (e) or (g), and, in the opinion of the PCT, is not a person with whom it ought to contract; (g) subject to paragraph (6), he has been convicted outside the United Kingdom of an offence which would, if committed in England and Wales constitute (i) murder; or (ii) a criminal offence other than murder, and been sentenced to a term of imprisonment of over 6 months; (h) he has been convicted of an offence committed on or after 1st April 2006, referred to in Schedule 1 to the Children and Young Persons Act 1933(a) (offences against children and young persons with respect to which special provisions apply) or Schedule 1 to the Criminal Procedure (Scotland) Act 1995(b) (offences against children under the age of 17 years to which special provisions apply); (i) it has (i) been adjudged bankrupt or had sequestration of his estate awarded unless (in either case) he has been discharged or the bankruptcy order has been annulled; (ii) been made the subject of a bankruptcy restrictions order or an interim bankruptcy restrictions order under Schedule 4A to the Insolvency Act 1986(c) unless that order has ceased to have effect or has been annulled; or (iii) made a composition or arrangement with, or granted a trust deed for, its creditors unless he or it has been discharged in respect of it; (j) an administrator, administrative receiver or receiver is appointed in respect of it; (k) the PCT is not satisfied that the person (i) has the premises, equipment and record keeping arrangements, or (ii) will employ or engage, by the date the contract is to commence, appropriate staff, to provide the services under the contract; (l) the PCT is not satisfied that it is a person suitable to provide general ophthalmic services; (m) he has within the period of 5 years prior to the date the contract is to commence or, if earlier, the date on which the contract is to be signed (i) been removed from the office of charity trustee or trustee for a charity by an order made by the Charity Commissioners or the High Court on the grounds of any misconduct or mismanagement in the administration of the charity for which he was responsible or to which he was privy, or which he by his conduct contributed to or facilitated; or (ii) been removed under section 7 of the Law Reform (Miscellaneous Provisions) (Scotland) Act 1990(d) (powers of the Court of Session to deal with management of charities), from being concerned in the management or control of any body; or (n) he is subject to a disqualification order under the Company Directors Disqualification Act 1986(e), the Companies (Northern Ireland) Order 1986(f) or to an order made under section 429(2)(b) of the Insolvency Act 1986 (failure to pay under county court administration order)(g). (a) 1933 c. 12; as amended by the Domestic Violence, Crime and Victims Act 2004 (c. 28), section 58(1), Sechduel 10, para. 2; the Sexual Offences Act 2003 (c. 42), section 139 and Schedule 6, para. 7; the Criminal Justice Act 1988 (c. 33), section 170 and Schedule 15,. Para. 8, and Schedule 16, para. 16; and the Sexual Offences Act 1956 (c. 69), sections 48 and 51 and Schedules 3 and 4 and modified by the Criminal Justice Act 1988, section 170(1) and Schedule 15, para. 9. (b) 1995 c. 46. (c) 1986 c. 45; Schedule 4A was inserted by s. 257 of and Schedule 20 to the Enterprise Act 2002 (c.40). (d) 1990 c. 40. (e) 1986 c. 46; as amended by the Insolvency Act 2000 (c. 39). (f) S.I. 1986/1032 (N.I. 6). (g) 1986 c. 45. 7

(4) A person does not fall within paragraph (3)(b) where the PCT is satisfied that the disqualification or suspension from practising is imposed by a licensing body outside the United Kingdom and that disqualification or suspension does not make the person unsuitable to be, as the case may be (a) a contractor; or (b) a director, chief executive or secretary of a corporation entering into a contract. (5) The condition referred to in paragraph (3)(c) is that, where a person has been employed as a member of a health care profession, any subsequent employment must also be as a member of that profession. (6) A person does not fall within paragraph (3)(g) where the PCT is satisfied that the conviction does not make the person unsuitable to be, as the case may be (a) a contractor; or (b) a director, chief executive or secretary of a corporate body entering into a contract. Reasons 5. (1) Where a PCT is of the view that the conditions in regulation 4 for entering into a contract are not met, it shall notify the person intending to enter into the contract of (a) that view and its reasons for that view; and (b) the person s right of appeal under regulation 6. (2) The PCT shall also notify of that view and its reasons for that view, a director, chief executive or secretary of a corporate body that is notified under paragraph (1), where its reason for the decision relates to that person or those persons. Appeals and contract disqualifications 6. (1) A person who has been served with a notice under regulation 5(1) may appeal to the FHSAA against the decision of the PCT that the conditions in regulation 4 are not met, by giving notice to the FHSAA within the period of 28 days, beginning on the day that the PCT served its notice. (2) A PCT, which has given notice under regulation 5(1) may, if it considers that that person should be disqualified from entering into a contract, apply to the FHSAA for a contract disqualification order in relation to that person. (3) The FHSAA, in a case where a person has appealed under paragraph (1) may, of its own motion, make application to itself for a contract disqualification order in relation to that appellant. (4) In a case to which paragraph (2) or (3) applies, the FHSAA may make a contract disqualification if it considers it right to do so in all the circumstances of the case. (5) Subject to paragraph (7), where the FHSAA has made a contract disqualification order, the person in respect of whom it has been made may, not less than 3 years after the making of the order, apply to the FHSAA for a review of that order and, on such an application, the FHSAA shall either confirm that order or specify a date on which that order shall cease to have effect. (6) Subject to paragraph (7), in any case where the FHSAA has confirmed an order under paragraph (5) or this paragraph, the person in respect of whom a contract disqualification order was confirmed may, not less than 3 years after the making of the order, apply to the FHSAA for a review of that order and, on such an application, the FHSAA shall either confirm that order or specify a date on which that order shall cease to have effect. (7) The FHSAA may, when making or confirming an order under paragraph (5) or (6), determine that instead of the period of 3 years specified in those paragraphs, the period for a review shall be such period, of not less than 1 year or more than 5, as the FHSAA may decide. 8

PART 3 Pre-contract Dispute Resolution Pre-contract disputes 7. (1) Subject to paragraphs (2) and (3), if, in the course of negotiations intending to lead to a contract, the prospective contracting parties are unable to agree on a particular term of the contract, either party may refer the dispute to the Secretary of State to consider and determine the matter in accordance with the procedure provided for in paragraph 30(2) and (3) of Schedule 1 (NHS dispute resolution procedure). (2) Paragraph (1) does not apply in the case where both parties to the prospective contract are health service bodies (in which case section 9(7) (NHS contracts) applies). (3) Before referring the dispute for consideration and determination under paragraph (1), both parties to the prospective contract must make every reasonable effort to communicate and cooperate with each other with a view to resolving it. (4) Disputes referred to the Secretary of State in accordance with paragraph (1) or section 9(7) shall be considered and determined in accordance with the provisions of paragraphs 30(4) to (13) and 31(1) (determination of dispute) of Schedule 1 and paragraph (5) (where it applies) of this regulation. (5) In the case of a dispute referred to the Secretary of State under paragraph (1), the determination (a) may specify terms to be included in the proposed contract; (b) may require the PCT to proceed with the proposed contract, but may not require the proposed contractor to proceed with the proposed contract; and (c) shall be binding upon the prospective parties to the contract. Health service body status PART 4 Health Service Body Status 8. (1) Where a proposed contractor elects, in a notice served on the PCT at any time prior to the contract being entered into, to be regarded as a health service body for the purposes of section 9, it shall be so regarded, but only so far as concerns the contract, from the date on which the contract is entered into. (2) If, in accordance with paragraph (1) or (5), a contractor is to be regarded as a health service body, that fact shall not affect the nature of, or any rights or liabilities arising under, any other contract with a health service body entered into by that contractor before the date on which the contractor is to be so regarded. (3) Where a contract is made with an individual or two or more persons practising in partnership, and that individual or that partnership is to be regarded as a health service body in accordance with paragraph (1) or (5), the contractor shall, subject to paragraph (4), continue to be regarded as a health service body for the purposes of section 9, but only so far as concerns the contract, for as long as that contract continues and irrespective of any change in (a) the partners comprising the partnership; (b) the status of the contractor from that of an individual to that of a partnership; or (c) the status of the contractor from that of a partnership to that of an individual. (4) A contractor may at any time request a variation of the contract to include or remove the provision from the contract that the contract is an NHS contract, and if it does so (a) the PCT shall agree to the variation; and 9

(b) the procedure in paragraph 33(1) of Schedule 1 shall apply (variation of a contract: general). (5) Where, pursuant to paragraph (4), the PCT agrees to a variation of the contract, the contractor shall (a) be regarded; or (b) subject to paragraph (7), cease to be regarded, as a health service body for the purposes of section 9, but only so far as concerns the contract, from the date that variation takes effect pursuant to paragraph 33(1) of Schedule 1. (6) Subject to paragraph (7), a contractor shall cease to be regarded as a health service body for the purposes of section 9 if the contract is terminated. (7) Where a contractor ceases to be a health service body pursuant to (a) paragraph (5) or (6), it shall continue to be regarded as a health service body for the purposes of being a party to any other general ophthalmic services contract entered into after it became a health service body, but before the date on which the contractor ceased to be a health service body (for which purposes it ceases to be such a body on the termination of that NHS contract); (b) paragraph (5), it shall, if it or the PCT has referred any matter to the NHS dispute resolution procedure before it ceases to be a health service body, be bound by the determination of the adjudicator as if the dispute had been referred pursuant to paragraph 29 of Schedule 1 (dispute resolution: non-nhs contracts); or (c) paragraph (6), it shall continue to be regarded as a health service body for the purposes of the NHS dispute resolution procedure where that procedure has been commenced (i) before the termination of the contract; or (ii) after the termination of the contract, whether in connection with or arising out of the termination of the contract or otherwise, for which purposes it ceases to be such a body on the conclusion of that procedure. Parties to the contract PART 5 Contracts: Required Terms 9. A contract must specify (a) the names of the parties; (b) whether the contract is for mandatory services or for additional services; (c) in the case of a partnership (i) whether or not it is a limited partnership, and (ii) the names of the partners and, in the case of a limited partnership, their status as a general or limited partner; and (d) in the case of each party, the postal address to which official correspondence and notices should be sent. NHS contracts 10. In the case of a contractor who is to be regarded as a health service body pursuant to regulation 8, the contract must state that it is an NHS contract. 10

Contracts with individuals practising in partnership 11. (1) Where the contract is with two or more individuals practising in partnership, the contract shall be treated as made with the partnership as it is from time to time constituted and the contract shall make specific provision to this effect. (2) Where the contract is with two or more individuals practising in partnership, the contractor must be required by the terms of the contract to ensure that any person who becomes a member of the partnership after the contract has come into force is bound automatically by the contract whether by virtue of a partnership deed or otherwise. Duration 12. (1) Except in the circumstances specified in paragraph (2), a contract must provide for it to subsist until it is terminated in accordance with the terms of the contract or the general law. (2) The circumstances referred to in paragraph (1) are that the PCT has terminated the contract of another provider of primary ophthalmic services, and as a result of that termination, it wishes to enter into a temporary contract for a period specified in the contract for the provision of services. (3) Where a temporary contract is entered into pursuant to paragraph (2) (a) paragraph 39 of Schedule 1 (termination by the contractor) shall not apply to that contract; and (b) the parties to that contract may include such terms as to termination by notice as they may agree. Testing of sight 13. (1) A contract must contain terms to the effect specified in this regulation. (2) A contractor shall, having accepted an application from or on behalf of a patient for the testing of sight (a) secure the testing of the patient s sight to determine whether the patient needs to wear or use an optical appliance; and (b) in so doing, shall secure the fulfilment of any duty imposed on a tester of sight by, or in regulations made under, section 26 of the Opticians Act (duties to be performed on sight testing)(a). (3) Where a contractor or an ophthalmic practitioner employed by it to perform the contract is of the opinion that a patient whose sight was tested pursuant to paragraph (2) (a) shows on examination signs of injury, disease or abnormality in the eye or elsewhere which may required medical treatment; or (b) is not likely to attain a satisfactory standard of vision notwithstanding the application of corrective lenses, the contractor shall, if appropriate, and with the consent of the patient (i) refer the patient to an ophthalmic hospital, which includes an ophthalmic department of a hospital, (ii) inform the patient s doctor or GP practice that it has done so, and (iii) give the patient a written statement that it has done so, with details of the referral. (4) Where a contractor or an ophthalmic practitioner employed by it to perform the contract tests the sight of a patient diagnosed as suffering from diabetes or glaucoma, it shall inform the patient s doctor or GP practice of the results of the test. (a) Section 26 was amended by S.I. 2005/848. 11

(5) Where a contractor or an ophthalmic practitioner employed by it to perform the contract issues to a patient a prescription for glasses, it shall, immediately thereafter, require the patient to acknowledge its receipt on a sight test form. (6) A prescription for glasses issued following a testing of sight under general ophthalmic services shall be completed by the method recommended in Appendix A to British Standard BS 2738 Part 3: 2004 (Glossary of Terms relating to Ophthalmic Lenses and Spectacle Frames) published by the British Standards Institution(a) and shall comply with any requirements as to its form specified in any direction made under section 120 for the purposes of payment in respect of the sight test. Services: general 14. A contract for mandatory services must specify (a) the address of each of the premises to be used by the contractor for the provision of such services; and (b) the hours during which services are normally to be provided at each of those premises. Finance 15. (1) The contract must contain a term which has the effect of requiring (a) the PCT to make payments to the contractor under the contract promptly and in accordance with both the terms of the contract and any other conditions relating to the payment contained in any directions given by the Secretary of State under section 120 (GOS contracts: payments) ( the relevant directions ); and (b) the contractor to make payments promptly to the PCT and in accordance with both the terms of the contract and any other conditions relating to payment contained in the relevant directions. (2) The obligation referred to in paragraph (1) is subject to any right the PCT has to set off against an amount payable to the contractor an amount that (a) is owed by the contractor to the PCT under the contract; (b) has been paid to the contractor owing to an error or in circumstances when it was not due; or (c) the PCT may withhold from the contractor in accordance with the terms of the contract or any other applicable provisions contained in the relevant directions. (3) The contract must contain a term to the effect that where, pursuant to directions under section 8 (Secretary of State s directions: exercise of functions) or 120, a PCT is required to make a payment to a contractor under a contract, but subject to conditions, those conditions are to be terms of the contract. (4) The contract must contain a term to the effect that, where the PCT has a right to set off under paragraph (2), the PCT may also recover that amount, or any part of it that has not been recovered by set off, as a civil debt, whether or not the contract has been terminated. Fees, charges and financial interests of the contractor 16. (1) The contract must contain terms relating to fees, claims, charges and financial interests which have the same effect as those set out in this regulation. (2) The contractor shall not, either itself or through any other person, demand or accept a fee or other remuneration for its own or another s benefit from (a) any patient of its; or (a) Copies can be obtained from the British Standards Institute, 389 Chiswick High Road, London, W4 4AL or online at www.bsi-global.com/en/standards-and-publications/. 12

(b) any person who has requested services under the contract for himself or a family member, for the provision of any treatment under the contract or as a prerequisite to providing services under the contract to that person or the family member. (3) Obligations imposed on the contractor by virtue of the Charges Regulations or any determination under section 180(11) must be terms of the contract. (4) The contractor in making a decision (a) as to what services to recommend or provide to a patient who has sought services under the contract; or (b) to refer a patient for other services within the National Health Service, must do so without regard to its own financial interests. (5) Any claim by a contractor for fees in respect of the provision of mandatory services or additional services shall be made by completing or securing the completion of a sight test form and sending it to the PCT within 6 months after the date of completion of the provision of the services. (6) Any such claim shall be (a) signed by the ophthalmic practitioner who performed the sight test in respect of which the claim is made, who shall also supply, with that signed claim, his professional registration number; and (b) in a case where the ophthalmic practitioner is not the contractor, counter-signed on behalf of the contractor by a person (who may be the ophthalmic practitioner), duly authorised by the contractor to counter-sign, whom the contractor has previously notified the PCT is so authorised. (7) A signatory or counter-signatory shall sign any such claim in ink with his initials or forename and with his surname in his own handwriting and not by means of a stamp. (8) A contractor shall be entitled to demand and recover from a patient or person having charge of a patient a sum in respect of loss of remunerative time resulting from that patient s failure to keep an appointment. (9) A contractor shall not demand or accept from the PCT the payment of any fee or other remuneration in respect of any item of service (a) which has not been provided under the contract; or (b) for which another claim has already been submitted to the PCT. Arrangements on termination 17. A contract shall make suitable provision for arrangements on the termination of the contract including the consequences (whether financial or otherwise) of the contract ending. Other contractual terms: mandatory services 18. Where a contract is for the provision of mandatory services, it must contain other terms which have the same effect as those specified in Schedule 1. Other contractual terms: additional services 19. Where a contract is for the provision of additional services, it must contain other terms that have the same effect as those specified in Schedule 2. 13

PART 6 Transitional Provision Commencement of contract 20. The contract shall provide for services to be provided under it from any date that falls after 31st July 2008. Signed by authority of the Secretary of State for Health. 28th April 2008 Ann Keen Parliamentary Under-Secretary of State, Department of Health SCHEDULE 1 Regulation 18 OTHER CONTRACTUAL TERMS PART 1 Patients Persons to whom mandatory services are to be provided 1. (1) Subject to sub-paragraphs (3) to (5), the contractor shall provide mandatory services under the contract to any eligible person if a request is made for such services by (a) an eligible person who requires the services; or (b) a person specified in sub-paragraph (2), on behalf of an eligible 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(a); or (iii) a person duly authorised by a voluntary organisation which is accommodating the child 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 shall (a) (i) satisfy itself that the person is an eligible person by asking for satisfactory evidence that person is eligible, unless the contractor, in cases other than where the patient is a person specified in regulation 3(1)(d) of the POS Regulations (person of limited resources), already has satisfactory evidence of that available to it, or (a) 1989 c.41. 14

(ii) where the patient has been asked for, but not produced, satisfactory evidence that he is an eligible person, record that fact on the patient s sight test form; (b) subject to sub-paragraph (4), ensure that particulars of the patient and the approximate date of the last testing, if any, of his sight are inserted in a sight test form by the patient or on his behalf; and (c) satisfy itself that the testing of sight is necessary. (4) If the requirements of sub-paragraph (3)(b) cannot be met, the contractor may, instead of satisfying itself that those requirements are met, satisfy itself that the person is an eligible person by referring to its own records or by measuring the power of the lenses of the person s existing optical appliance by means of a focimeter or other suitable means. (5) The contractor shall only refuse to provide services under the contract to an eligible person if it has reasonable grounds for doing so, and those grounds cannot relate to a person s (a) race, gender, social class, age, religion, sexual orientation, appearance, disability or medical or ophthalmic condition; or (b) decision or intended decision to accept or refuse private services in respect of himself or a family member. (6) If the contractor refuses to provide services under the contract on any ground other than that it is not satisfied that (a) under sub-paragraph (3)(a)(i), the person to whom it has refused to provide services is an eligible person; or (b) under sub-paragraph (3)(c), the testing of sight is necessary, it shall keep a record of that refusal, specifying in that record its grounds for doing so. PART 2 Provision of Services Mixing of services provided under the contract with private services 2. A contractor shall not, with a view to obtaining the agreement of a patient to undergo services privately (a) advise an eligible person that mandatory services are not available from the contractor under the contract; or (b) seek to mislead the patient about the availability, quality and extent of the services under the contract. Premises, equipment and facilities 3. (1) The contractor shall ensure that the practice premises and equipment used for the provision of mandatory services under the contract are (a) suitable for the delivery of those services; and (b) sufficient to meet the reasonable needs of the contractor s patients. (2) The obligation in sub-paragraph (1) includes providing proper and sufficient waiting-room accommodation for patients. (3) The contractor shall provide, in relation to all of the services to be provided under the contract, such other facilities as are necessary to enable it to properly perform that service. Telephone services 4. (1) The contractor shall not be a party to any contract or other arrangement under which the number for telephone services 15

(a) to be used by patients to contact the practice for any purpose related to the contract; or (b) to be used by 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. Safety of the Public 5. (1) The contractor shall ensure that it has (a) appropriate arrangements for infection control and decontamination; and (b) regard to any relevant requirements of the MHRA or the Health and Safety Executive. (2) The contractor shall establish and operate arrangements applicable to all the persons specified in sub-paragraph (3). (3) The specified persons are (a) any ophthalmic practitioner who performs services under the contract; and (b) any other person employed by the contractor to perform or assist in the performance of services under the contract. (4) In sub-paragraph (2), arrangements means arrangements 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; and (c) any requirements of or recommendations by the MHRA are adhered to. Ophthalmic practitioners PART 3 Persons Who Perform Services 6. An optometrist or a registered medical practitioner may perform ophthalmic services under the contract provided (a) he is included in an ophthalmic performers list; and (b) his inclusion in that list is not subject to a suspension. Performers: registration and further requirements 7. (1) No person shall perform sight tests under the contract unless he is registered and his registration is not subject to a suspension. (2) Where (a) the registration of an ophthalmic practitioner; or (b) an ophthalmic practitioner s inclusion in an ophthalmic performers list, is subject to conditions, the contractor shall ensure compliance with those conditions, in so far as they are relevant to the contract or the delivery of services under it. Conditions for employment: ophthalmic practitioners performing ophthalmic services 8. (1) A contractor shall not employ an ophthalmic practitioner to perform ophthalmic services under the contract unless 16

(a) that practitioner has provided it with his professional registration number and the name and address of the Primary Care Trust on whose ophthalmic performers list his name appears; (b) it has checked that he meets the requirements in paragraphs 6 and 7 and has obtained and is satisfied with his clinical references; and (c) it has taken reasonable steps to satisfy itself that he has the clinical experience and training necessary to enable him to properly perform primary ophthalmic services. (2) Where the employment of a person falling within sub-paragraph (1) is urgently needed and it is not possible for the contractor to obtain and satisfy itself as to the references in accordance with sub-paragraph (1)(b) before employing him, the ophthalmic practitioner may be employed on a temporary basis for a single period of up to 14 days whilst those references are obtained and considered, and for an additional period of a further 14 days if the contractor has good reason to believe the person supplying the references is ill, on holiday or otherwise temporarily unavailable. (3) Where the contractor employs the same person on more than one occasion within a period of 6 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: persons assisting in the provision of services under the contract 9. (1) Before employing any person to assist it in the provision of services under the contract, the contractor shall take reasonable care to satisfy itself that the person in question is both suitably qualified and competent to discharge the duties for which he is to be employed. (2) When considering the competence and suitability of any person for the purpose of subparagraph (1), the contractor shall have regard in particular to that person s (a) academic and vocational qualifications; (b) education and training; and (c) previous employment or work experience. Level of skill 10. The contractor shall carry out its obligations under the contract with reasonable care and skill. Patient records PART 4 Records, Information, Notifications, Name and Rights of Entry 11. (1) The contractor shall ensure that a full, accurate and contemporaneous record is kept in the patient record in respect of each patient to whom it provides services under the contract, giving appropriate details of sight testing. (2) The contractor shall retain all such records for a period of at least 7 years. (3) The patient record may be kept in electronic form. Confidentiality of personal data 12. The contractor shall nominate a person with responsibility for practices and procedures relating to the confidentiality of personal data held by it. 17

Patient information 13. 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) a notice supplied or approved by the PCT, indicating the services available under the contract; (b) in respect of its arrangements under paragraph 5, a written statement relating to its commitment to the matters referred to in paragraph 5(4); (c) a notice supplied or approved by the PCT, indicating to which descriptions of its patients a payment may be made under the Charges Regulations; and (d) information about the complaints procedure which it operates in accordance with Part 5 of this Schedule, giving the name and title of the person nominated by the contractor in accordance with paragraph 25(2)(a). Provision of and access to information: PCT 14. (1) The contractor shall, at the request of the PCT (a) produce to the PCT or to a person authorised in writing by the PCT in such format, and at such intervals or within such period, as the PCT specifies; or (b) allow the PCT, or a person authorised in writing by it to access, the information specified in paragraph (2). (2) The information specified for the purposes of sub-paragraph (1) is (a) any information which is reasonably required by the PCT for the purposes of, or in connection with, the contract; and (b) any other information which is reasonably required in connection with the PCT s functions, and includes the contractor s patient records. Use of disqualified name 15. (1) Subject to sub-paragraph (2), a contractor shall not use in any manner whatsoever the name or part of the name or trading name, either alone or in combination with any other words or letters of, or used by, any person subject to a national disqualification or a contract disqualification order. (2) Nothing in sub-paragraph (1) shall prevent a contractor other than a body corporate from using its own name or, being a body corporate, from using the name by which it is registered pursuant to the provisions of the Opticians Act. Notification to the PCT 16. (1) In addition to any requirements of notification elsewhere in the Regulations, the contractor shall notify the PCT, 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 contract; or (b) any circumstances which give rise to the PCT s right to terminate the contract under Part 7 of this Schedule. (2) The contractor shall, unless it is impracticable for it to do so, notify the PCT within 28 days of any occurrence requiring a change in the information about it published by the PCT in accordance with regulations made under section 115(5) (primary ophthalmic services). (3) The contractor shall notify the PCT when an ophthalmic practitioner who is performing or will perform services under the contract (as the case may be) (a) leaves the contractor, and the date upon which he left or is to leave; or 18

(b) is or is to be employed by the contractor, and the notification shall include the name of the ophthalmic practitioner who has left, or who has been or is to be employed, together with his professional registration number and the name and address of the Primary Care Trust in whose ophthalmic performers list he is included. Notice provisions specific to a contract with a corporate body 17. (1) A contractor which is a corporate body shall notify the PCT 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) it is unable to pay its debts within the meaning of section 123 of the Insolvency Act 1986 (definition of inability to pay debts)(a); or (e) it has a new director, chief executive or secretary. (2) Where sub-paragraph (1)(e) applies, the notice shall (a) confirm that the new director, chief executive or secretary meets the conditions imposed by regulation 4 (general conditions relating to all contracts); (b) contain an application form in accordance with Schedule 3 in relation to that person. (3) Where the PCT is not satisfied that that person meets the conditions of regulation 4, it shall so notify the contractor and (a) the contractor shall within 28 days remove that new secretary, director or chief executive, as the case maybe, and so notify the PCT; and (b) if the contractor does not do so, the PCT shall terminate the contract in accordance with the provisions of paragraph 45. Notice provisions specific to a contract with two or more individuals practising in partnership 18. (1) A contractor which is a partnership shall notify the PCT forthwith when (a) a partner leaves or informs his partners that he intends to leave the partnership, and the date upon which he left or will leave the partnership; or (b) a new partner joins or proposes to join the partnership. (2) A notice under sub-paragraph (1)(b) shall (a) state the date that the new partner joined or it is proposed he will join the partnership; (b) state whether the new partner is an ophthalmic practitioner; (c) confirm that the new partner meets the conditions imposed by regulation 4 (general conditions relating to all contracts); (d) contain an application form in accordance with Schedule 3 from that new partner; and (e) state whether the new partner is or is to be a general or a limited partner. (3) Where the PCT is not satisfied that a new partner meets the conditions of regulation 4, it shall so notify the contractor and (a) the contractor shall within 28 days remove the new partner; and (b) if the contractor does not do so, the PCT shall terminate the contract in accordance with the provisions of paragraph 45. (a) 1986 c. 45. 19