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SCOTTISH STATUTORY INSTRUMENTS


2006 No. 135

NATIONAL HEALTH SERVICE

The National Health Service (General Ophthalmic Services) (Scotland) Regulations 2006

  Made 10th March 2006 
  Laid before the Scottish Parliament 10th March 2006 
  Coming into force 1st April 2006 


ARRANGEMENT OF REGULATIONS


PART I

GENERAL
1. Citation and commencement
2. Interpretation

PART II

QUALIFICATIONS OF OPHTHALMIC MEDICAL PRACTITIONERS
3. Qualifications
4. Approval of qualifications
5. Appeals against determinations of Ophthalmic Qualifications Committee

PART III

OPHTHALMIC LIST
6. Ophthalmic List
7. Application for inclusion in Ophthalmic List and notification of changes
8. Grounds for refusal of application
9. Deferment of decision on application
10. Withdrawal from Ophthalmic List
11. Suspension
12. Removal from Ophthalmic List
13. Re inclusion in Ophthalmic List
14. Disclosure of information
15. Requirements with which an ophthalmic medical practitioner or optician included in an Ophthalmic List must comply
16. Effect to be given to corresponding decisions in England, Wales and Northern Ireland

PART IV

GENERAL ARRANGEMENTS
17. The Statement
18. Terms of service
19. Arrangements for particular districts
20. Payment
21. Payments to ophthalmic medical practitioners and opticians suspended

PART V

PROCEDURE FOR CHOOSING CONTRACTOR
22. Application for an eye examination
23. Application on behalf of children or incapable persons

PART VI

MISCELLANEOUS
24. Publication of particulars
25. Service of documents
26. Revocation, savings and transitional provisions

  SCHEDULE 1 — TERMS OF SERVICE

  SCHEDULE 2  
 PART A — INFORMATION, CERTIFICATES, CONSENTS, DECLARATIONS AND UNDERTAKINGS TO BE INCLUDED IN AN APPLICATION FOR INCLUSION IN THE FIRST PART OF THE OPHTHALMIC LIST
 PART B — INFORMATION, CONSENTS, DECLARATIONS, CERTIFICATES AND UNDERTAKINGS TO BE INCLUDED IN AN APPLICATION FOR INCLUSION IN THE SECOND PART OF THE OPHTHALMIC LIST
 PART C — DECLARATIONS TO BE PROVIDED IN TERMS OF REGULATION 26(6)

  SCHEDULE 3 — PRIMARY EYE EXAMINATION

  SCHEDULE 4 — SUPPLEMENTARY EYE EXAMINATION

  SCHEDULE 5 — RECORDS

  SCHEDULE 6 — REGULATIONS REVOKED

The Scottish Ministers, in exercise of the powers conferred by sections 26, 28A, 32A(7), 32D, 34, 105(7), 106(a) and 108(1) of the National Health Service (Scotland) Act 1978[
1] and of all other powers enabling them in that behalf, hereby make the following Regulations:



PART I

GENERAL

Citation and commencement
     1. These Regulations may be cited as the National Health Service (General Ophthalmic Services) (Scotland) Regulations 2006 and shall come into force on 1st April 2006.

Interpretation
    
2. —(1) In these Regulations–

or any successor body;

    (2) A reference to "the Agency" in these Regulations includes a reference to the Agency acting on behalf of a Board.

    (3) Unless the context otherwise requires, any reference in these regulations to a numbered regulation or Schedule is to the regulation in or Schedule to these regulations which bears that number, any reference in a regulation or Schedule to a numbered paragraph is to the paragraph bearing that number in that regulation or Schedule, and any reference in a paragraph of Schedule 1 to a numbered sub paragraph is to the sub paragraph bearing that number in that paragraph.



PART II

QUALIFICATIONS OF OPHTHALMIC MEDICAL PRACTITIONERS

Qualifications
     3. —(1) The prescribed qualifications which a doctor is to possess for the purposes of section 26 of the Act (general ophthalmic services) are that the doctor has (at the date of consideration of the doctor's application under regulation 4) recent experience and either–

    (2) “For the purposes of this regulation, "approved" means approved by the Ophthalmic Qualifications Committee.

Approval of qualifications
    
4. —(1) A doctor who wishes to establish his or her status as an ophthalmic medical practitioner shall apply to the Ophthalmic Qualifications Committee for approval of his or her qualifications and experience, and shall give to that Committee such particulars of his or her qualifications and experience as it shall require.

    (2) The Ophthalmic Qualifications Committee shall consider such application and within one month after the date thereof shall inform the applicant of its determination.

    (3) If the Ophthalmic Qualifications Committee is satisfied that the doctor possesses the qualifications prescribed by regulation 3, he or she shall be an ophthalmic medical practitioner.

    (4) Notwithstanding the provisions of regulation 3 and paragraph (1), a doctor who has the prescribed qualifications for the purposes of providing general ophthalmic services in England and Wales under the National Health Service Act 1977[
21] or in Northern Ireland under the Health and Personal Social Services (Northern Ireland) Order 1972[22], shall be an ophthalmic medical practitioner.

Appeals against determinations of Ophthalmic Qualifications Committee
     5. —(1) Any person aggrieved by a determination of the Ophthalmic Qualifications Committee that the person is not qualified to be an ophthalmic medical practitioner may, within one month from the date on which he or she received notice of that decision or such longer period as the Scottish Ministers may at any time allow, appeal against the determination by sending to the Scottish Ministers a notice of appeal stating the facts and contentions on which that person relies.

    (2) The Scottish Ministers shall appoint to determine the appeal an appeal committee of five persons of whom at least three shall be appointed after consultation with such bodies or organisations representing doctors as appear to them to be concerned and shall refer the appeal to that appeal committee.

    (3) The Scottish Ministers shall send a copy of the notice of appeal to the Ophthalmic Qualifications Committee and to such other persons as may appear to them to be interested in the appeal and shall inform the appellant, the Ophthalmic Qualifications Committee and any such other persons that the appeal has been referred and of the address to which communications to the appeal committee shall be sent.

    (4) The appeal committee may, and if requested so to do by the appellant or the Ophthalmic Qualifications Committee shall, hold a hearing in connection with an appeal at such time and place as it may direct, and notice of such hearing shall, not less than 28 days before the date of the hearing be sent by the recorded delivery service to the appellant, the Ophthalmic Qualifications Committee and any other person to whom the Scottish Ministers have under paragraph (3) sent notice of appeal.

    (5) Either the appellant or the Ophthalmic Qualifications Committee may within 28 days of being informed that the appeal has been referred to an appeal committee, or of being informed that a hearing of such appeal will be held, give notice that he, she or it desires to appear before the appeal committee.

    (6) The Ophthalmic Qualifications Committee shall be entitled to appear by a member or by their clerk or other officer duly appointed for the purpose; the appellant shall be entitled to appear in person, by any member of the appellant's family, by any friend, or by an officer or member of any organisation of which the appellant is a member; and any party to an appeal shall be entitled to appear and be heard by counsel or solicitor.

    (7) Subject to the foregoing provisions of this regulation the procedure of the appeal committee in determining the appeal shall be such as the appeal committee thinks proper.

    (8) An appeal committee shall have all the powers of the Ophthalmic Qualifications Committee including in particular the power of approval and, if satisfied that the appellant possesses the qualifications prescribed by regulation 3, it shall so determine and accordingly the appellant shall be an ophthalmic medical practitioner.

    (9) The appeal committee shall as soon as practicable notify its determination to the appellant, the Ophthalmic Qualifications Committee, the Scottish Ministers and any other person to whom the Scottish Ministers have under paragraph (3) sent notice of the appeal.



PART III

OPHTHALMIC LIST

Ophthalmic List
    
6. —(1) Each Board shall prepare and maintain in accordance with these Regulations a list called "the Ophthalmic List" of those persons–

    (2) The Ophthalmic List shall be divided into two parts–

    (3) The first part of the Ophthalmic List shall contain the following information:–

    (4) The second part of the Ophthalmic List shall contain the following information:–

    (5) Subject to regulation 26(8)–

    (6) The Board shall–

    (7) The Board shall, if necessary, prepare an updated Ophthalmic List each year and send a copy to the Scottish Ministers.

Application for inclusion in Ophthalmic List and notification of changes
     7. —(1) An ophthalmic medical practitioner or optician who wishes to be included in the Ophthalmic List of a Board shall submit to that Board a written application to that effect, which shall state whether the applicant is an ophthalmic medical practitioner, a person registered in the register of optometrists maintained under section 7 of the Opticians Act 1989, or a body corporate registered in the register of bodies corporate maintained under section 9 of that Act carrying on business as an optometrist, and whether the applicant wishes to be included in the first part of the Ophthalmic List, or in the second part of that list, and shall include–

    (2) An ophthalmic medical practitioner or optician whose name appears on the Ophthalmic List shall within 14 days of any change or addition affecting the entries which that list is required to contain in relation to that person, notify the Board accordingly.

    (3) Before determining an application submitted under paragraph (1), a Board shall–

    (4) If a Board considers that further information or documents, in addition to the documents, information and undertakings provided by the applicant in accordance with paragraph (1), are necessary to determine the applicant's application, the Board shall require the applicant to provide such further information or documents as are necessary before the Board shall determine an application in accordance with this regulation.

    (5) Where information about an applicant's previous conviction, including information disclosed by means of an enhanced criminal record certificate, or any other information or documents disclosed or provided to, or the investigations carried out by, the Board in terms of this regulation lead the Board to consider that there may be grounds for referral to the Tribunal then the Board may refer the matter to the Tribunal.

    (6) In the case of an application to a Board by a ophthalmic medical practitioner or optician who is included in either part of the Ophthalmic List for inclusion in the other part of that list, that person shall only be required to provide the information required by paragraphs (1), (2, (3) and (4) insofar as–

    (7) Any person who is not an optician, but expects to become so on successful completion of that person's training, may make an application to a Board to be included in either part of its Ophthalmic List not more than 4, and not less than 3, months before that person anticipates being registered in the register of optometrists maintained under section 7 of the Opticians Act 1989.

    (8) An application under paragraph (7) shall contain–

    (9) In the application of these Regulations to any application under paragraph (7), any reference to an optician shall be taken as being a reference to an applicant under paragraph (7).

    (10) An applicant under paragraph (7) shall provide the information required by paragraphs 1(b) and (c) and 3 of Part A, or 1(b) and (c) and 3 of Part B, of Schedule 2 as soon as the applicant has been notified by the General Optical Council that the applicant has been admitted to the register, and the Board shall then, provided–

decide the application within 7 days of receiving the information required under paragraphs 1(b)(c) and 3 of Part A, or 1(b)(c) and 3 of Part B, of Schedule 2.

Grounds for refusal of application
    
8. —(1) The grounds on which a Board must refuse to include an ophthalmic medical practitioner or optician in its Ophthalmic List are that–

    (2) Paragraph (1) is without prejudice to any duty on a Board not to add the applicant to an Ophthalmic List by virtue of regulation 26 (practitioners subject to inquiry) of the National Health Service (Tribunal) (Scotland) Regulations 2004[29].

    (3) When the Board has decided whether or not to include an applicant in its Ophthalmic List, it shall notify the applicant within 7 days of that decision of–

Deferment of decision on application
     9. —(1) Without prejudice to the Board's power under section 29 of the Act (the NHS Tribunal) to make representations to the Tribunal that an applicant meets a condition for disqualification, a Board may defer a decision on any application to be included in its Ophthalmic List, where–

    (2) A Board may only defer a decision under paragraph (1) until the outcome of the relevant event mentioned in any of sub paragraphs (a) to (i) of that paragraph is known.

    (3) The Board must notify the applicant that it has deferred a decision on the application and the grounds for the deferral.

    (4) Once the outcome of the relevant event mentioned in paragraph (1) is known, the Board shall notify the applicant in writing that the applicant must within 28 days of the date of the notification (or such longer period as the Board may agree)–

and the provisions of regulations 7, 8 and 9 shall apply to the application.

    (5) Provided any additional information required by paragraph (4) has been received by it within the period of 28 days specified in paragraph (4) or any longer period agreed, the Board shall notify the applicant as soon as possible–

    (6) In this regulation, "the outcome of the relevant event" means the final determination of any proceedings (including proceedings pending the determination of which the applicant is suspended) or investigation referred to in paragraph 9(1)(a) to (i).

Withdrawal from Ophthalmic List
    
10. —(1) Where a person whose name appears on a Board's Ophthalmic List gives notice in writing to the Board that that person desires to withdraw from the Board's Ophthalmic List, that person's name shall, with the agreement of the Board, be removed therefrom at the expiration of 90 days from the date of such notice or of such shorter period as the Board may agree, except that–

    (2) The Board shall, on receiving notice from any person pursuant to paragraph (1), as soon as practicable so amend the Board's Ophthalmic List–

whichever is the earlier.

    (3) Any notice given pursuant to paragraph (1) may not be withdrawn by the person giving that notice except with the consent of the Board.

    (4) A contractor shall give notice in writing to the Board that he or she intends to withdraw from the first part of its Ophthalmic List if the contractor is accepted on to the second part of its Ophthalmic List.

    (5) An ophthalmic medical practitioner or optician who assists in the provision of general ophthalmic services shall give notice in writing to the Board that he or she intends to withdraw from the second part of its Ophthalmic List if he or she is accepted on to the first part of its Ophthalmic List.

Suspension
     11. —(1) If a Board is satisfied that it is necessary to do so for the protection of members of the public or is otherwise in the public interest, it may suspend an ophthalmic medical practitioner or an optician from its Ophthalmic List in accordance with this regulation–

    (2) In a case falling within paragraph (1)(a) or (c), the Board must specify a period, not exceeding six months, as the period of suspension.

    (3) In a case falling within paragraph (1)(b), the Board may specify that the ophthalmic medical practitioner or optician (as the case may be) remains suspended after the decision referred to in that paragraph has been made for an additional period, not exceeding six months.

    (4) In a case falling within paragraph (1)(d), the term of suspension may exceed six months.

    (5) If the Board suspends an ophthalmic medical practitioner or an optician in a case falling within paragraph (1)(e) the suspension has effect from the date the Board informed that person of the suspension.

    (6) The Board may extend the period of suspension under paragraph (2) or impose a further period of suspension under paragraph (3), so long as the aggregate period of suspension does not exceed 6 months.

    (7) The effect of a suspension is that, while an ophthalmic medical practitioner or optician is suspended under these Regulations, that person is to be treated as not being included in the Ophthalmic List even though that person's name appears in it.

    (8) The Board may at any time revoke the suspension and notify the ophthalmic medical practitioner or optician (as the case may be) of its decision.

    (9) Where a Board is considering suspending an ophthalmic medical practitioner or an optician or varying the period of suspension under this regulation, it shall give the ophthalmic medical practitioner or optician (as the case may be)–

    (10) If the ophthalmic medical practitioner or optician (as the case may be) does not wish to have an oral hearing or does not attend the oral hearing, the Board may suspend that person with immediate effect.

    (11) If an oral hearing does take place, the Board shall take into account any representations made at the hearing before it reaches its decision.

    (12) The Board may suspend the ophthalmic medical practitioner or optician (as the case may be) with immediate effect following the hearing.

    (13) The Board shall notify the ophthalmic medical practitioner or optician (as the case may be) of its decision and the reasons for it (including any facts relied upon) within 7 days of making that decision.

    (14) During a period of suspension, payments shall be made to or in respect of the ophthalmic medical practitioner or optician (as the case may be) in accordance with regulation 21.

    (15) If an ophthalmic medical practitioner or optician (as the case may be) is dissatisfied with a decision of a Board ("the original decision")–

that person may ask the Board to review the original decision and, if that person does so, the Board shall reconsider the original decision, and once it has done so, it must notify that person in writing of the outcome of that reconsideration ("the reconsidered decision") and give that person notice of the reasons for the reconsidered decision.

Removal from Ophthalmic List
    
12. —(1) Where a Board has determined that a person whose name has been included in its Ophthalmic List–

it shall remove that person's name from the Ophthalmic List with effect from the date of its determination or, in the case of (d) above, the date on which the disqualification takes effect if that date is later than the date of the Board's determination, and shall notify that person as soon as practicable of the removal and the grounds for the removal.

    (2) Where a Board determines after consultation with any appropriate area medical committee in the case of an ophthalmic medical practitioner, or with any appropriate area optical committee in the case of an optician, that a person whose name has been included for the preceding 6 months in the first part of the Ophthalmic List of the Board has not during that period provided general ophthalmic services for persons in the Board's area, the Board shall remove the name of that person from its Ophthalmic List.

    (3) Where a Board determines after consultation with any appropriate area medical committee in the case of an ophthalmic medical practitioner, or with any appropriate area optical committee in the case of an optician that a person whose name has been included for the preceding 12 months in the second part of the Ophthalmic List of the Board has not during that period assisted with the provision of general ophthalmic services for persons in the Board's area, the Board may remove the name of that person from its Ophthalmic List.

    (4) In calculating the periods of 6 and 12 months referred to in paragraphs (2) and (3) the Board shall disregard any period during which the ophthalmic medical practitioner or optician (or the case may be)–

    (5) Before making any determination under paragraphs (2) or (3) the Health Board shall give the contractor or the ophthalmic medical practitioner or optician assisting with the provision of general ophthalmic services 28 days' notice of its intention so to do and shall afford that person an opportunity of making representations to the Board orally or in writing, if he or she so wishes.

    (6) No determination under this regulation shall be made in respect of any ophthalmic medical practitioner or optician who has completed a period of relevant service in the armed forces until 12 months after the date when that person completed that period of relevant service in the armed forces.

    (7) Nothing in this regulation shall prejudice the right of a person to have that person's name included again in a Board's Ophthalmic List.

    (8) Any document which is required or authorised to be given to any person under this regulation may be given by delivering it to that person or by sending it by recorded delivery service to that person's usual or last known place of business as recorded in the Ophthalmic List or in the case of an ophthalmic medical practitioner or optician who assists in the provision of general ophthalmic services to his or her home address.

    (9) Paragraph (1) is without prejudice to any duty on a Board to remove an ophthalmic medical practitioner or an optician from an Ophthalmic List by virtue of that person being suspended under section 32A or 32B of the Act.

    (10) Where information about the conviction(s) of any person on an Ophthalmic List or any other information relating to such a person is disclosed to a Board, including by means of an enhanced criminal record certificate, and the Board considers that the disclosure may be grounds for removal of that person from the Board's Ophthalmic List (other than under paragraph (1), (2) or (3)) then the Board may refer the matter to the Tribunal.

Re inclusion in Ophthalmic List
    
13. —(1) Where an ophthalmic medical practitioner or optician has been removed from a Board's Ophthalmic List under regulation 12, and the occurrence that led to that removal is overturned either on appeal, or for any other reason, the Board may include that person in its Ophthalmic List without an application being made in accordance with regulation 7 if the Board is satisfied that there is no further information which it should consider, and provided that the Board receives undertakings from that person to comply with these Regulations.

    (2) Where the Board considers that further information is required, a person who wishes to be re-included in the Ophthalmic List will be required to complete a full application in accordance with regulation 7.

Disclosure of information
    
14. —(1) Where a Board decides to–

the Board shall notify the persons or bodies specified in paragraph (2), and shall additionally notify those specified in paragraph (3), if requested to do so by those persons or bodies in writing, of the matters set out in paragraph (4).

    (2) Where paragraph (1) applies, a Board shall notify within 7 days of that decision–

    (3) The persons or bodies to be additionally notified in accordance with paragraph (1) are–

    (4) The matters referred to in paragraph (1) are–

    (5) The Board shall send to the person concerned a copy of any information about that person provided to the persons or bodies listed in paragraphs (2) or (3), and any correspondence with that person or body relating to that information.

    (6) Where the Board has notified any of the persons or bodies specified in paragraphs (2) or (3) of the matters set out in paragraph (4), it may, in addition, if requested by that person or body, notify that person or body of any information that was considered by the Board, including any representations from the ophthalmic medical practitioner or optician (as the case may be).

    (7) A Board may disclose information about an ophthalmic medical practitioner or optician supplied to it or acquired by the Board pursuant to these Regulations, or about references by the Board to the Tribunal, to any of the following–

Requirements with which an ophthalmic medical practitioner or optician included in an Ophthalmic List must comply
    
15. —(1) An ophthalmic medical practitioner or an optician included in an Ophthalmic List shall–

    (2) An ophthalmic medical practitioner or an optician included in an Ophthalmic List shall comply with the undertakings specified in Schedule 2 appropriate to the part of the Ophthalmic Lists on which his or her name appears whether or not those undertakings were included in an application by that person under regulation 7.

    (3) An ophthalmic medical practitioner or an optician shall not give, promise or offer, or cause to be given, promised or offered, to any person any incentive, gift or reward as an inducement to, or in consideration of, the provision of any general ophthalmic services.

Effect to be given to corresponding decisions in England, Wales and Northern Ireland
    
16. —(1) Where any corresponding decision is made in England, Wales or Northern Ireland by an equivalent body that–

a Health Board shall impose those conditions in relation to the provision, or the assistance in the provision, by that person of general ophthalmic services in the area of the Health Board.

    (2) The Health Board may make such modifications of the conditions referred to in paragraph (1) as it considers necessary for them to have the like effect in relation to Scotland as they do in relation to England, Wales or (as the case may be) Northern Ireland, but only if the Health Board has previously given the person concerned written notice of the proposed modifications and an opportunity to make representations about them.



PART IV

GENERAL ARRANGEMENTS

The Statement
    
17. —(1) The Scottish Ministers shall, after consultation with such organisations as appear to them to be representative of contractors providing general ophthalmic services, make provision in a determination (in these Regulations referred to as "the Statement") as to–

    (2) Any such determination–

    (3) A determination or an amendment to a determination shall be in respect of a period beginning on or after a date specified in the determination or the amendment to a determination, which may be the date of the determination or an amendment to the determination or an earlier or later date, but may be an earlier date only if it, taking the determination as a whole, it is not detrimental to the person to whose remuneration it relate.

Terms of service
    
18. The arrangements for the provision of general ophthalmic services made by a Board shall incorporate the terms of service and the Statement.

Arrangements for particular districts
    
19. Where it appears to a Board that provision is required to meet the needs of the residents of any particular district in the Board area, the Board may, after consultation with the area optical committee and with the approval of the Scottish Ministers, make arrangements with an optician or an ophthalmic medical practitioner whereby the optician or the ophthalmic medical practitioner undertakes to provide general ophthalmic services at suitable centres in that district on such terms as may be specified in the arrangements.

Payment
    
20. —(1) Each Board shall make or cause to be made by the Agency to contractors within its area payments in accordance with the Statement, and any payments which may become due to contractors by virtue of arrangements made under regulation 19.

    (2) Where the Agency considers that it has made a payment to a contractor owing to an error or in circumstances where it was not due, it shall, except to the extent that the Scottish Ministers on the application of the Board direct otherwise, draw the overpayment to the attention of the contractor and the amount overpaid shall be recoverable as a debt by any lawful means.

    (3) Recovery of an overpayment under the provisions of this regulation shall be without prejudice to the investigation of an alleged breach of the terms of service.

    (4) A contractor who is unable to complete for a patient the general ophthalmic services which he has undertaken to provide shall inform the Agency accordingly in writing, and if the Agency is satisfied that the inability is due to a reasonable cause it shall make payment in accordance with the Statement to the contractor for such part of those services as he shall have provided.

Payments to ophthalmic medical practitioners and opticians suspended
    
21. —(1) A Board shall authorise the Agency to make payments to any ophthalmic medical practitioner or optician who is suspended by direction of the Tribunal or by the Board in accordance with regulation 11 in accordance with the Scottish Ministers' determination for the time being in force in relation to such payments.

    (2) The Scottish Ministers shall make the determination in accordance with paragraphs (3) and (4) after consultation with the organisations referred to in regulation 17(1), and it shall be published with the Statement there referred to.

    (3) Any determination under paragraph (1)–

    (4) The Scottish Ministers' determination may include provision that payments in accordance with the determination are not to exceed a specified amount in any specified period.

    (5) Regulation 17(2) shall apply to determinations under this regulation as it applies to determinations under that regulation.

    (6) Regulation 20(2) shall apply to payments made under this regulation as it applies to payments made under that regulation.



PART V

PROCEDURE FOR CHOOSING CONTRACTOR

Application for an eye examination
    
22. —(1) A person who wishes to have an eye examination under general ophthalmic services may make an application to any ophthalmic medical practitioner or optician on the Ophthalmic List for an eye examination.

    (2) The application shall be made on an eye examination form provided for that purpose to contractors by the Board and shall contain a written declaration signed by the applicant.

    (3) An ophthalmic medical practitioner or optician to whom an application for an eye examination is made shall, before carrying out an eye examination–

    (4) Where the ophthalmic medical practitioner or optician has provided the eye examination at a place where the patient resides, the ophthalmic medical practitioner or optician shall record on the eye examination form the physical or mental illness or disability given by or on behalf of the patient as the reason for the patient not being able to leave home unaccompanied.

Application on behalf of children or incapable persons
23. —(1) Subject to paragraph (2), an application for an eye examination under general ophthalmic services in terms of these regulations shall be made and a signature required by these regulations shall be given–

    (2) A signature on an application may not be given by a contractor or any person employed by a contractor, or who assists a contractor in providing general ophthalmic services.



PART VI

MISCELLANEOUS

Publication of particulars
     24. Copies of the Ophthalmic List, these Regulations, the terms of service and the Statement shall be made available for inspection at the offices of the Board and at such other places in the Board's area as appear to be convenient for informing any person interested, and shall be kept revised and up to date

Service of documents
    
25. Subject to regulation 12(8), any document which is required or authorised under these regulations or under the terms of service to be given to an ophthalmic medical practitioner or optician may be given by delivering it to such a person or by sending it addressed to that person at any address notified by him or her to the Board for inclusion in the Ophthalmic List as a place at which the contractor has undertaken to provide general ophthalmic services, or in the case of a mobile practice, the address notified to the Board as the address to which correspondence may be sent or in the case of an ophthalmic medical practitioner or optician who assists in the provision of general ophthalmic services to his or her home address.

Revocation, savings and transitional provisions
    
26. —(1) Subject to paragraphs (2) and (3), the regulations specified in Schedule 6 ("the revoked Regulations") are hereby revoked.

    (2) In respect of any general ophthalmic services provided under the revoked Regulations for which arrangements were made before 1st April 2006, payments shall be made as though the revoked Regulations and determinations made under them and in force on 31st March 2006 continue to be in force.

    (3) The first part of a Board's Ophthalmic List on 1st April 2006 shall be deemed to include the name of any person whose name was included in the Ophthalmic List of that Board kept under regulation 6 (Ophthalmic List) of the National Health Service (General Ophthalmic Services) (Scotland) Regulations 1986[
32] ("the previous Ophthalmic List") on 31st March 2006, together with all the information relating to that person which is contained in the previous Ophthalmic List.

    (4) Any action taken by or on behalf of a Board prior to 1st April 2006 in relation to its previous Ophthalmic List, (or in relation to the persons or entries thereon), shall have effect on and after 1st April 2006 as if such action had been taken by that Board in relation to the first part of the Ophthalmic List maintained by that Board on 1st April 2006 or in relation to the persons or entries thereon.

    (5) Any action taken by or on behalf of any other person prior to 1st April 2006 in relation to the previous Ophthalmic List of a Board (or in relation to the persons or entries thereon) shall have effect on and after 1st April 2006 as if such action had been taken in relation to the first part of the Ophthalmic List maintained by that Board on 1st April 2006 or in relation to the persons or entries thereon.

    (6) Any person whose name is deemed to be included in the Ophthalmic List of a Board in terms of paragraph (3) shall no later than 30th June 2006–

    (7) The Health Board may extend the period prescribed in sub-paragraph (6) for such time as it considers appropriate in the circumstances of the case if it thinks it is not reasonably practicable for that ophthalmic medical practitioner or optician to provide it with such certificates, declarations and consent within the prescribed period.

    (8) Any person who wishes to be included in the second part of a Board's Ophthalmic List shall be entitled to assist in the provision of general ophthalmic services in the Board's area without that person's name being included in that list until 30th June 2006, provided that that person is an ophthalmic medical practitioner or optician.


RHONA BRANKIN
Authorised to sign by the Scottish Ministers

St Andrew's House, Edinburgh
10th March 2006



SCHEDULE 1
Regulations 2(1) and 18


TERMS OF SERVICE


Interpretation
     1. In this Schedule–

Incorporation of provisions
     2. Any provisions of the following affecting the rights and obligations of contractors and ophthalmic medical practitioners and opticians assisting in the provision of general ophthalmic services shall form part of the terms of service–

Certificate of training
     3. —(1) Except in the case of a body corporate, an ophthalmic medical practitioner or optician providing, or assisting in the provision of, general ophthalmic services shall undertake a course of training in the use of slit lamp biomicroscopy, condensing lens biomicroscopy, applanation tonometry and threshold visual fields from a training provider approved by NHS Education for Scotland and shall provide to the Board a certificate from the provider of that training that that person has completed the training satisfactorily

    (2) Except in the case of a body corporate, any application for inclusion in the Ophthalmic List must be accompanied by such a certificate.

    (3) Except in the case of a body corporate, in the case of any person to whom regulation 26(6) applies, that person shall provide such a certificate to the Board no later than 30 June 2006, or by such later date as the Board considers appropriate in the circumstances of the case if it thinks it is not reasonably practicable for that person to provide such certificate by 30 June 2006

Premises at which general ophthalmic services are to be provided
     4. —(1) Subject to sub paragraph (2), a contractor shall provide general ophthalmic services or cause such services to be provided by an ophthalmic medical practitioner or optician who assists in the provision of general ophthalmic services at any address which is included in relation to the contractor in the Ophthalmic List.

    (2) An ophthalmic medical practitioner or optician on the Ophthalmic List may, where requested to do so by or on behalf of a patient, who is–

Visits
     5. —(1) In the case of a mobile practice, a contractor shall give the Board notice in accordance with sub paragraph (2) of any visits which the contractor or an ophthalmic medical practitioner or optician who assists that contractor in the provision of general ophthalmic services intends to make to provide general ophthalmic services to at least three persons at day centres or in residential centres in the Board's area.

    (2) The contractor shall notify the Board at least one month in advance of the month in which the contractor or an ophthalmic medical practitioner or optician who assists that contractor in the provision of general ophthalmic services intends to visit any establishment in the Board's area and of the intervals at which the contractor intends that return visits shall be made.

Premises and equipment
     6. —(1) Subject to sub paragraph (2), a contractor shall provide, as may be requisite, proper and sufficient consulting and waiting room accommodation and suitable equipment, including required equipment, for general ophthalmic services.

    (2) In the case of a mobile practice, the contractor shall provide suitable equipment, including required equipment, for general ophthalmic services.

    (3) Subject to sub paragraph (4), a contractor, on receipt of a written request from the Board, shall admit at all reasonable times for the purposes of inspecting such accommodation or equipment and reviewing procedures an ophthalmic officer or any authorised officer of the Scottish Ministers or the Board or member of the Board.

    (4) In the case of a mobile practice, the contractor, on receipt of a written request from the Board to do so, shall arrange for an ophthalmic officer or any authorised officer of the Scottish Ministers or the Board or member of the Board to be allowed to inspect at a reasonable time the facilities and equipment that the contractor or an ophthalmic medical practitioner or opticians who assists the provider in the provision of general ophthalmic services uses.

Notices
     7. A contractor shall secure that at each place at which the contractor provides general ophthalmic services or an ophthalmic medical practitioner or optician assists the contractor in the provision of general ophthalmic services there is prominently displayed a notice and leaflet supplied or approved by the Board, indicating the services available under general ophthalmic services and indicating to which descriptions of the contractor's patients a payment may be made under the National Health Service (Optical Charges and Payments) (Scotland) Regulations 1998.

Records
     8. —(1) A contractor or ophthalmic medical practitioner or optician who assists the contractor in the provision of general ophthalmic services shall keep proper, complete, accurate and up-to-date records in respect of each patient to whom general ophthalmic services are provided, giving appropriate details of eye examinations carried out.

    (2) A contractor or ophthalmic medical practitioner or optician who assists the contractor in the provision of general ophthalmic services may keep the records referred to in sub paragraph (1) in computerised form.

    (3) A contractor shall retain all such records for a period of 7 years.

    (4) A contractor shall, when requested to do so by any authorised officer of the Scottish Ministers, the Agency or the Board during the period in which the contractor is required to retain such records–

Deputies
     9. —(1) An ophthalmic medical practitioner may arrange for eye examinations to be carried out on his behalf by another ophthalmic medical practitioner, and an optician may arrange for eye examinations to be carried out on his behalf by another optician, provided that such other ophthalmic medical practitioner or optician is included in the Ophthalmic List of the Board for the area in which such eye examinations are to be carried out.

    (2) Any contractor who makes an arrangement for the regular provision of services by a deputy in terms of paragraph (1) shall notify the Board of the arrangements.

Employees
     10. —(1) An ophthalmic medical practitioner who employs a person to carry out eye examinations shall employ only another ophthalmic medical practitioner on the Ophthalmic List of the Board for the area in which such eye examinations are to be carried out.

    (2) An optician who employs a person to carry out eye examinations shall employ only–

    (3) Any contractor who makes an arrangement for the regular provision of services by an employee in terms of paragraphs (1) or (2) shall notify the Board of the arrangement.

    (4) In this paragraph "employee" includes, in the case of a body corporate, a director and "employ" is to be interpreted accordingly.

Complaints
     11. —(1) Subject to sub paragraphs (2) and (3), a contractor shall establish and operate in accordance with this paragraph, a procedure (in this paragraph and in paragraph 12 referred to as a "complaints procedure") to deal with any complaints made by or on behalf of the patients and former patients of the contractor or an ophthalmic medical practitioner or optician who assists the contractor in the provision of general ophthalmic services.

    (2) The complaints procedure to be established by a contractor may be such that it also deals with complaints made in relation to one or more other contractors or ophthalmic medical practitioners or opticians who assist the contractor in the provision of general ophthalmic services.

    (3) The complaints procedure to be established by a contractor who provides general ophthalmic services or causes general ophthalmic services to be provided from more than one set of premises may be such that it relates to all those premises together.

    (4) A complaints procedure shall apply to complaints made in relation to any matter reasonably connected with the provision or assistance in provision of general ophthalmic services and within the responsibility or control of–

and in this paragraph and paragraph 12, references to complaints are to complaints falling within this sub paragraph.

    (5) A complaint may be made on behalf of a patient or former patient with his consent, or–

    (6) Where a patient has died, a complaint may be made by a relative or other adult person who had an interest in his welfare or, where the patient was as described in head (a)(ii) of sub paragraph (5), by the authority or voluntary organisation.

    (7) A complaints procedure shall comply with the following requirements–

    (8) At each of the premises at which the contractor provides general ophthalmic services or causes general ophthalmic services to be provided the contractor shall provide information about the complaints procedure which the contractor operates and give the name (or title) and address of the person specified in sub paragraph (7)(a).

Co-operation with investigations
     12. —(1) A contractor or an ophthalmic medical practitioner or optician who assists the contractor in the provision of general ophthalmic services shall cooperate with any investigation of a complaint by the Board in accordance with the procedures which it operates in accordance with directions given under section 2(5) of the Act, whether the investigation follows one under the contractor's complaints procedure or not.

    (2) The co operation required by sub paragraph (1) includes–

Payments
     13. —(1) Any claim by a contractor for fees in respect of the provision of general ophthalmic services shall be made by completing or securing the completion of an eye examination form and sending it to the Agency within 6 months after the date of completion of such provision of the services.

    (2) Any such claim shall be signed–

    (3) A signatory shall sign any such claim in ink with his or her initials or forename and with his or her surname in his own handwriting and not by means of a stamp.

    (4) Where an eye examination is undertaken by an ophthalmic medical practitioner or optician who assists the contractor in the provision of general ophthalmic services that ophthalmic medical practitioner or optician shall complete a claim for remuneration in respect of that eye examination which–

    (5) Except as provided in the regulations, in the Statement, or in the National Health Service (Charges for Overseas Visitors) (Scotland) Regulations 1989[36], or in sub paragraph (6), a contractor shall not demand or accept or cause to be demanded or accepted from any patient or from other persons the payment of any fee or other remuneration in respect of the provision of general ophthalmic services.

    (6) 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 a failure by that patient to keep an appointment.

    (7) A contractor shall not demand or accept or cause to be demanded or accepted from the Agency the payment of any fee or other remuneration in respect of any item of service–

Eye examinations
     14. —(1) An ophthalmic medical practitioner or optician who accepts in accordance with these regulations–

shall carry out an eye examination.

    (2) Where an ophthalmic medical practitioner or optician is of the opinion that it is clinically necessary to carry out a sight test on a patient whose eyes he or she has examined in accordance with sub paragraph (1), he or she shall carry out a sight test.

    (3) Where an ophthalmic medical practitioner or optician carries out a sight test, he or she shall fulfil any duty imposed on him or her by, or in regulations made under, the Opticians Act 1989.

    (4) Where an ophthalmic medical practitioner or optician is of the opinion that a patient whose eyes he or she has examined in accordance with sub paragraph (1)–

he or she shall, if appropriate, and with the consent of the patient–

    (5) Where an ophthalmic medical practitioner or optician undertakes an eye examination of a patient diagnosed as suffering from diabetes or glaucoma he or she shall inform the patient's doctor of the results of the test.

    (6) A prescription for glasses issued following an eye examination which includes a sight test shall be completed by the method recommended in Appendix A to British Standard 3521:1962 (Glossary of Terms relating to Ophthalmic Lenses and Spectacle Frames) published by the British Standards Institution, as effective on the date of its publication, and shall comply with any requirements as to its form specified in the Statement for the purposes of payment in respect of the eye examination.

    (7) An ophthalmic medical practitioner or optician shall carry out a maximum of 20 eye examinations in any working day.

    (8) Following a primary eye examination or a supplementary eye examination the ophthalmic medical practitioner or optician who carried out the examination shall give a statement of the outcome of the examination to the patient.

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, either alone or in combination with any other words or letters, of or used by, any person so long as that person is disqualified from inclusion in any Ophthalmic List.

    (2) Nothing in sub paragraph (1) shall prevent a contractor other than a body corporate from using his own name or being a body corporate, from using the name by which it is enrolled in the register maintained pursuant to the provisions of the Opticians Act 1989.



SCHEDULE 2
Regulation 7 and 26(1)



PART A

INFORMATION, CERTIFICATES, CONSENTS, DECLARATIONS AND UNDERTAKINGS TO BE INCLUDED IN AN APPLICATION FOR INCLUSION IN THE FIRST PART OF THE OPHTHALMIC LIST

     1. An application shall contain the following information:–

     2. An application shall contain the following declarations as to whether or not the applicant:–

     3. An applicant must include:

     4. An application shall include the following undertakings:–



PART B

INFORMATION, CONSENTS, DECLARATIONS, CERTIFICATES AND UNDERTAKINGS TO BE INCLUDED IN AN APPLICATION FOR INCLUSION IN THE SECOND PART OF THE OPHTHALMIC LIST

     1. An application shall contain the following information:–

     2. An application shall contain the following declarations as to whether or not the applicant:–

     3. An applicant must include with the application–

     4. An application shall include the following consent and undertakings:–



PART C

DECLARATIONS TO BE PROVIDED IN TERMS OF REGULATION 26(6)

     1. A declaration as to whether or not the person who is included in the Ophthalmic List in terms of regulation 26(3)–

     2. A declaration that–



SCHEDULE 3
Regulation 2(1)


PRIMARY EYE EXAMINATION



TABLE A
THE TESTS AND PROCEDURES SPECIFIED FOR THE PURPOSE OF THE DEFINITION OF PRIMARY EYE EXAMINATION IN REGULATION 2(1)

The taking of a detailed history and symptoms, including relevant medical, family, or ocular history
An assessment of current spectacle correction and their appropriateness to the patient's current needs by focimetry and identification of lens and frame type
A pupillary assessment including testing for Relative Afferent Pupillary Defects
The recording of unaided vision, visual acuity or pinhole vision as appropriate
An examination appropriate to the reason for referral from a medical practitioner or other carer
An eye health assessment appropriate to the patient's needs and presenting signs and symptoms
An internal eye examination, with mydriasis where appropriate, using direct ophthalmoscope and/or slit lamp biomicroscopy;
The external examination of the eyes using slit lamp biomicroscopy, and appropriate diagnostic agents
A relevant assessment of extra ocular motor function; oculo motor balance and ocular motility
The examination and checking for co-existing ocular disorders
The communication of the clinical findings, results and diagnosis to the patient, their carer (where appropriate), and other appropriate health professionals as agreed by the patient and their carer


TABLE B
THE TESTS AND PROCEDURES SPECIFIED FOR THE PURPOSE OF THE DEFINITION OF PRIMARY EYE EXAMINATION IN REGULATION 2(1)

Column 1 Column 2
Children aged under 16 years Tests appropriate to the age of a child to determine vision, refractive state, stereopsis, extra ocular motor function (muscle balance motility) and ocular health
Adults aged 40 years and over who have a family history of Glaucoma Intra ocular pressure measurement, visual field tests, and assessment of the optic nerve head by slit lamp biomicroscopy, should be performed on a screening basis. This will consist of Non contact tonometry, suprathreshold visual fields and slit lamp biomicroscopy
Adults aged 60 years and over (i) Supra-threshold fields on a screening basis

(ii) Amsler Test if the macula is suspect

(iii) The consideration of slit lamp biomicroscopy with mydriasis

Adults aged 70 and over The performance of slit lamp biomicroscopy with mydriasis
Patients referred from an ophthalmic hospital Postoperative cataract examination, refraction and report
Refractive Abnormality (i) Refraction, muscle balance, and other tests as required

(ii) Spectacle dispensing advice

Patient's presenting with sudden onset ‘flashes and floaters' or sudden vision loss Vitreous examination and fundus assessment by dilated slit lamp biomicroscopy
Patients with suspect glaucoma or ocular hypertensives Intra ocular pressure measurement , visual field tests, and assessment of the optic nerve head by slit lamp biomicroscopy, should be performed on a screening basis. This will consist of Non contact tonometry, suprathreshold visual fields and slit lamp biomicroscopy
Patients with macular disorders (i) Internal Eye examination must be with mydriasis, using slit lamp biomicroscopy

(ii) Amsler chart test

Patients with cataract Internal Eye examination must be with mydriasis when a clear view of the fundus cannot be obtained without mydriasis, using slit lamp biomicroscopy or head mounted indirect ophthalmoscopy
Patients with diabetes Internal Eye examination must be with mydriasis using slit lamp biomicroscopy or head mounted indirect ophthalmoscopy
Depending on the patient's presenting signs and symptoms (a) Standard tests such as binocular function and stereopsis, amplitude of accommodation, colour vision, confrontation fields and other appropriate tests

(b) Advice regarding the dispensing of the prescription, and discussion of an appropriate dispensing solution to the current needs of the patient

(c) Issue advice and instruction to patients prior to referral into a care pathway, shared care scheme or a level 2 optometric examination

(d) Direct referral to an ophthalmic hospital

(e) Completing a clinical report for another health care professional or referral letter if required.




SCHEDULE 4
Regulation 2(1)


SUPPLEMENTARY EYE EXAMINATION



TABLE
THE TESTS AND PROCEDURES SPECIFIED FOR THE PURPOSE OF THE DEFINITION OF SUPPLEMENTARY EYE EXAMINATION IN REGULATION 2(1)

Column 1 Column 2
Following routine refraction; Cycloplegic refraction
Paediatric follow up within six months of the previous examination include:     • A refraction;

    • Oculo motor balance; and

    • Stereopsis

Referral refinement To include, as required:

Repeat of visual field assessment by full threshold visual fields;

Repeat tonometry using applanation tonometry; and

Slit lamp biomicroscopy which may include mydriasis

Suspect glaucoma, unusual optic disc appearance and where abnormalities have been detected during the primary examination To include, as required:

Repeat of visual field assessment by full threshold visual fields;

Repeat tonometry using applanation tonometry; and

Slit lamp biomicroscopy which may include mydriasis

Diabetes, vitreo retinal disorders, tumour risk Dilated slit lamp biomicroscopy
Minor disorders such as, corneal abrasion, foreign body Minor disorders repeat external eye assessment using slit lamp and diagnostic agents
Children aged under 16 years on referral by an ophthalmic hospital Cycloplegic refraction



SCHEDULE 5
Regulation 2(1)


RECORDS


     1. An ophthalmic medical practitioner or optician shall keep the following data in records (this data is a record of patient details, symptoms, tests performed and results thereof):–

Personal Patient Data Name, title, address, telephone number, Date of Birth, General Practitioner's details, occupation, driver Yes/No, hobbies
Symptoms & History Presenting signs & symptoms, past ocular history, past medical history, family ocular and patient's own medical history, medication, reason for referral to or from the ophthalmic medical practitioner or optician, Smoker Yes/No
External Examination A record of all relevant findings
Internal Examination A record of whether this was with or without mydriasis, the apparatus and diagnostic agents used, and a description of the ocular media, fundus, blood vessels, optic disc and macula
Pupil Assessment Relative afferent pupillary defect, direct, consensual and near responses, pupil size and shape
Extra Ocular Motor Function Cover test, convergence, muscle balance, motility, stereopsis, amplitude of accommodation results
Visual Fields Record relative findings, apparatus, confrontation
Intra Ocular Pressure Intra ocular pressure measurement, contact or non-contact
Refraction Objective/subjective findings, unaided vision, pinhole acuity, visual acuity, back vertex distance, prescription issued, spectacle, dispensing details
Colour Vision Record findings and test procedure
Imaging Record reference to any electronic images taken
Supplementary Additional Procedures Note the reason for any supplementary or additional procedures
Diagnosis / Findings Make a record of all findings and any diagnosis
Communication Note any advice, statements, reports or referrals issued to the patient or made on behalf of the patient.



SCHEDULE 6
Regulation 26


REGULATIONS REVOKED


Orders and Regulations revoked References Extent of revocation
The National Health Service (General Ophthalmic Services) (Scotland) Regulations 1986 S.I. 1986/965 The whole Regulations
The National Health Service (General Ophthalmic Services) (Scotland) Amendment Regulations 1988 S.I. 1988/543 The whole Regulations
The National Health Service (General Ophthalmic Services) (Scotland) Amendment Regulations 1989 S.I. 1989/387 The whole Regulations
The National Health Service (General Ophthalmic Services) (Scotland) Amendment (No. 2) Regulations 1989 S.I. 1989/1177 The whole Regulations
The National Health Service (General Ophthalmic Services) (Scotland) Amendment Regulations 1990 S.I. 1990/1048 The whole Regulations
The National Health Service (Optical Charges and Payments) (Miscellaneous Amendments (Scotland) Regulations 1991 S.I. 1991/534 Regulation 19
The National Health Service (Optical Charges and Payments) (Miscellaneous Amendments (Scotland) Regulations 1992 S.I. 1992/531 Regulation 5
The National Health Service (General Ophthalmic Services) (Scotland) Amendment Regulations 1995 S.I. 1995/704 The whole regulations
The National Health Service (General Ophthalmic Services) (Scotland) Amendment Regulations 1996 S.I. 1995/843 The whole Regulations
The National Health Service (General Ophthalmic Services) (Scotland) Amendment (No) Regulations 1996 S.I. 1996/2353 The whole Regulations
The National Health Service (General Ophthalmic Services) (Scotland) Amendment Regulations 1999 S.I. 1999/725 The whole Regulations
The National Health Service (General Ophthalmic Services) (Scotland) Amendment (No. 2) Regulations 1999 S.S.I. 1999/55 The whole Regulations
The National Health Service (General Ophthalmic Services) (Scotland) Amendment Regulations 2001 S.S.I. 2001/62 The whole Regulations
The National Health Service (Optical Charges and Payments) and (General Ophthalmic Services (Scotland) Amendment Regulations 2002 S.S.I. 2002/86 Regulation 4
The National Health Service (General Ophthalmic Services) (Scotland) Amendment Regulations 2003 S.S.I. 2003/201 The whole Regulations
The National Health Service (General Ophthalmic Services) (Scotland) Amendment (No) Regulations 2003 S.S.I. 2003/432 The whole Regulations
The National Health Service (General Ophthalmic Services) (Scotland) Amendment Regulations 2004 S.S.I. 2004/36 The whole Regulations
The National Health Service (General Ophthalmic Services) (Scotland) Amendment (No) Regulations 2004 S.S.I. 2004/98 The whole Regulations
The National Health Service (General Ophthalmic Services) (Scotland) Amendment (No) Regulations 2004 S.S.I. 2004/169 The whole Regulations
The Primary Medical Services (Consequential and Ancillary Amendments) (Scotland) Order 2004 S.S.I. 2004/212 Schedule 1, paragraph 2
The National Health Service (General Ophthalmic Services) (Scotland) Amendment Regulations 2005 S.S.I. 2005/128 The whole Regulations
The National Health Service (General Ophthalmic Services) (Scotland) Amendment Regulations 2006 S.S.I. 2006/42 The whole Regulations



EXPLANATORY NOTE

(This note is not part of the Regulations)


These regulations provide for arrangements for the provision of general ophthalmic services under the National Health Service in Scotland, and for the preparation and maintenance by each Health Board in Scotland of an Ophthalmic List. The regulations define general ophthalmic services under the NHS in Scotland, and provide for a new eye examination. They supersede and revoke the National Health Service (General Ophthalmic Services) (Scotland) Regulations 1986 ("the 1986 Regulations").

These regulations are consequential on the coming into force of amendments made by the Smoking, Health and Social Care (Scotland) Act 2005 ("the 2005 Act") to the sections of the National Health Service (Scotland) Act 1978 ("the 1978 Act") dealing with general ophthalmic services and the disqualification of practitioners.

Those provisions of the 2005 Act were commenced on 1st April] 2006 by the Smoking, Health and Social Care (Scotland) Act 2005 (Commencement No. 4) Order 2006 (S.S.I. 2006/          ).

The changes to the 1978 Act made by the 2005 Act include changes to the structure and content of the Ophthalmic List, the introduction of free eye examinations and sight tests under the National Health Service in Scotland, powers and duties for the NHS Tribunal to enquire into representations that a practitioner meets a third condition for disqualification (which are referred to in Act as "unsuitability cases") and changes to the way in which effect is to be given in Scotland to disciplinary decisions in England, Wales or Northern Ireland which correspond to decisions which can be made by the NHS Tribunal in Scotland. These regulations make provision consequential upon these changes.

Part I of these regulations makes general provisions for the purpose of these regulations. Regulation 2 defines the terms used in the regulations.

Part II of the regulations consolidates the provisions of the 1986 regulations relating to qualifications which a doctor must possess for the purposes of general ophthalmic services.

Part III of the regulations makes provisions for the Ophthalmic List which is to be prepared and maintained by each Health Board.

Regulation 6 provides that each Health Board is to prepare and maintain an Ophthalmic List, which will be divided into 2 parts. The first part will contain the names and other details of ophthalmic medical practitioners and opticians who have undertaken to provide general ophthalmic services under arrangements with the Health Board in terms of the regulations. The second part will contain the names and other details of ophthalmic medical practitioners and opticians who are approved by the Health Board to assist in the provision of such services. In terms of regulation 2(1) an "ophthalmic medical practitioner" means a registered medical practitioner whose qualifications have been approved in accordance with Part II of the regulations as being prescribed qualifications. An "optician" means an ophthalmic optician, which is defined in section 108(1) of the 1978 Act as a person registered in the Register of Optometrists maintained under section 7 of the Opticians Act 1989, or a body corporate registered in the Register of bodies corporate maintained under section 9 of that Act to carry on business as an optometrist.

Regulation 6(5) provides that (subject to regulation 26(8) (transitional provisions)), an ophthalmic medical practitioner or optician may not provide general ophthalmic services in the area of the Health Board unless that person's name is included in the first part of the Ophthalmic List of that Health Board, and an ophthalmic medical practitioner or optician may not assist in the provision of general ophthalmic services in the area of a Health Board unless that person's name is included in the first or second part of that Health Board's Ophthalmic List.

Regulation 7 sets out the requirements and procedure for making an application for inclusion in an Ophthalmic List, and for the notification of any changes in the information provided. Paragraphs (7) to (10) contain provisions for applications by opticians in training. Regulation 7 also sets out the procedure to be followed by a Health Board in considering an application.

Regulation 7(5) provides that where information disclosed by, provided to, or the investigations carried out by the Health Board in terms of regulation 7 lead the Board to consider that there may be grounds for referral to the NHS Tribunal, then the Board may refer the matter to the Tribunal.

Regulation 8 sets out mandatory grounds for refusal to include an ophthalmic medical practitioner or optician in an Ophthalmic List.

Regulation 9 set out circumstances in which a Health Board may defer a decision on an application to include an ophthalmic medical practitioner or optician in the Ophthalmic List, and the procedure to be followed.

Regulation 10 sets out the circumstances in which a person whose name appears on a Health Board's Ophthalmic List may withdraw from the Ophthalmic List, and the procedure to be followed.

Regulation 11 sets out the grounds on which a Health Board may suspend an ophthalmic medical practitioner or optician from its Ophthalmic List, and the procedure to be followed.

Regulation 12 sets out the grounds of removal of a person's name from a Health Board's Ophthalmic List. Paragraph (1) sets out mandatory grounds of removal. Paragraph (2) provides that a person who has not provided general ophthalmic services within a Health Board's area for the preceding 6 months shall be removed from the Ophthalmic List. Paragraph (3) provides that a person whose name is included in the second part of the Ophthalmic List has not assisted with the provision of general ophthalmic services in the Health Board's area for a period of 12 months may be removed from the Ophthalmic List. Regulation 12 also provides for the procedure to be followed with regard to the removal of a person's name from a Health Board's Ophthalmic List.

Regulation 13 contains provisions regarding the re inclusion of an ophthalmic medical practitioner or optician in a Health Board's Ophthalmic List where the occurrence which led to the removal of that person's name is overturned on appeal or for any other reason.

Regulation 14 provides for certain information regarding the Health Board's decisions in relation to its Ophthalmic List to be disclosed to the parties specified in that regulation.

Regulation 15 sets out the requirements with which an ophthalmic medical practitioner or an optician included in an Ophthalmic List must comply.

Regulation 16 makes provision for effect to be given by a Health Board to a decision made in England, Wales or Northern Ireland which corresponds to a decision which may be made by the NHS Tribunal in Scotland under sections 29 to 32B of the 1978 Act. The definitions of "disqualification" and "suspended" in regulation 2(1) include decisions in England, Wales and Northern Ireland corresponding to disqualification and suspension by the NHS Tribunal in Scotland. Regulation 16 makes provision for decisions in England, Wales and Northern Ireland which correspond to conditional disqualification by the NHS Tribunal in Scotland.

Part IV of the Regulations sets out the general arrangements relating to the provision of general ophthalmic services, including payments to ophthalmic medical practitioners and opticians.

Part V of the Regulations (Regulations 22 and 23)sets out the procedure for applying for an eye examination.

Part VI of the Regulations contains miscellaneous provisions.

Regulation 24 provides for the publication of copies of the Ophthalmic List.

Regulation 25 provides for service of documents.

Regulation 26 and Schedule 6 repeals the 1986 regulations, and the regulations which subsequently amended those regulations, and makes transitional provisions.

Regulation 26 (3) provides that the names of those persons who are on a Board's previous ophthalmic list in terms of the 1986 Regulations on 31 March 2006 will be automatically transferred to the first part of the Board's Ophthalmic List on 1 April 2006. Such persons must provide the information specified in paragraph (6) by 30 June 2006, or such later date as the Board may permit. Paragraph (8) provides that an ophthalmic medical practitioner or optician who wishes to be included in the second part of a Board's Ophthalmic List can assist in the provision of ophthalmic services until 30 June 2006.

Schedule 1 sets out the terms of service for those providing or assisting in the provision of general ophthalmic services.

Paragraph 1 deals with interpretation of terms used in the Schedule.

Paragraph 2 incorporates the provisions of other documents into the terms of service.

Paragraph 3 provides that, except in the case of a body corporate, any ophthalmic medical practitioner or optician providing, or assisting in the provision of, general ophthalmic services, must undergo certain training, and provide a certificate to the Board to that effect.

Paragraphs 4, 5 and 6 contain provisions relating to the premises and locations at which general ophthalmic services are provided, and the equipment used.

Paragraph 7 provides for notices to be displayed at such places.

Paragraph 8 provides for the records to be kept by those providing, or assisting in the provision of, general ophthalmic services. The data to be kept in the records are specified in Schedule 5.

Paragraphs 9 and 10 set out the circumstances in which general ophthalmic services can be carried out by deputies and employees of persons on the Ophthalmic List.

Paragraphs 11 and 12 set out the procedure for dealing with complaints regarding the provision of general ophthalmic services.

Paragraph 13 sets out the procedure for claiming and making payment of charges for the provision of general ophthalmic services.

Paragraph 14 sets out the requirements for carrying out the eye examination.

Paragraph 14 prohibits the use of a name of a person who is disqualified from inclusion in an Ophthalmic List.

Schedule 2 contains the information and undertakings to be included in an application for inclusion in an Ophthalmic List. Regulation 7(1)(d) provides that an application to be included in the first part of the list shall include the information, undertakings, consents and declarations set out in Part A of Schedule 2 Regulation 7(1)(e) provides that an application to be included in the second part of the list shall include the information, undertakings, consents and declarations set out in Part B of Schedule 2.

Part C of Schedule 2 lists the information to be provided in terms of regulation 26(6) by persons who are deemed to be included in a Health Board's Ophthalmic List in terms of regulation 26(3), that is persons who were included in that Health Board's Ophthalmic List maintained under the 1986 Regulations.

Schedule 3 provides the definition of a primary eye examination. It specifies the tests and procedures in a primary eye examination. Table A sets out the mandatory requirements for a primary eye examination, and Table B sets out additional tests and procedures which must offered to specified categories of patients.

Schedule 4 provides the definition of a supplementary eye examination. It specifies the tests and procedures in a supplementary eye examination.

Schedule 5 provides the definition of records. Table A specifies the data to be included in records.

Schedule 6 specifies the regulations revoked by these regulations.

British Standard 3521:1962, referred to in paragraph 14(6) of Schedule 1 may be obtained from any of the sales outlets operated by the British Standards Institution or direct by post from the Institution at Linford Wood, Milton Keynes, MK14 6LE.


Notes:

[1] 1978 c.29. Section 26 was amended by the Health and Social Security Act 1984 (c.48), section 1(5) and Schedule 1, Part II, paragraphs 1 and 4 and Schedule 8, the Health and Medicines Act 1988 (c.49), section 13(4) and is amended by the Smoking, Health and Social Care (Scotland) Act 2005 ("the 2005 Act") (asp 13), sections 13(2) and 19 with effect from 1st April 2006 in terms of S.S.I. 2006/121; section 28A was inserted by the Health and Social Security Act 1984 (c.48), section 7(2) and 27(1); section 32A(7) is inserted by the 2005 Act, section 26(7)(d) with effect from 1st April 2006 in terms of S.S.I. 2006/121, section 32D is substituted by the 2005 Act, section 27 with effect from 1st April 2006 in terms of S.S.I. 2006/121, section 34 was amended by the National Health Service (Primary Care) Act 1997 (c.46), section 41(3) and (10) and Schedule 2, Part I, paragraph 46, section 105(7) was amended by the Health Services Act 1980 (c.53), Schedule 6, paragraph 5(1) and Schedule 7, the Health and Social Services and Social Security Adjudications Act 1983 (c.41), Schedule 9, Part 1, paragraph 24 and the Health Act 1999 (c.8) ("the 1999 Act"), Schedule 4, paragraph 60; section 108(1) contains definitions of "prescribed" and "regulations" relevant to the exercise of the statutory powers under which these Regulations are made. The functions of the Secretary of State were transferred to the Scottish Ministers by virtue of section 53 of the Scotland Act 1998 (c.46).back

[2] Section 10 was amended by the National Health Service and Community Care Act 1990 (c.19) ("the 1990 Act"), section 66(2) and Schedule 10; the 1999 Act section 65(1) and Schedule 4, paragraph 44(a); S.S.I. 1999/90, Art 2(a)(b) and Schedule 1, and is amended by the 2005 Act, Schedule 2, paragraph 2(a) with effect from 1st April 2006 in terms of S.S.I. 2006/121.back

[3] Section 9 was amended by the 1990 Act, section 29, the 1999 Act, section 65 and Schedule 4, paragraph 43, and the Primary Medical Services (Scotland) Act 2004 (asp 7), Schedule 2.back

[4] Section 2(1) was amended by the Health and Social Services and Social Security Adjudications Act 1983 (c.41), Schedule 7, paragraph 1, and the 1990 Act, section 28.back

[5] 1989 c.44; section 9 was amended by S.S.I. 2005/848, Art 9.back

[6] Section 29 was substituted by the 1999 Act, section 58, a relevant amendment is the 2005 Act, section 26 with effect from 1st April 2006 in terms of S.S.I. 2006/121.back

[7] Section 29C(1) was inserted by the Health Act 1999 (c.8), section 58, and amended by S.S.I. 2004/167 and the 2005 Act, section 26 with effect from 1st April 2006 in terms of S.S.I. 2006/121.back

[8] Section 32D is substituted by the 2005 Act, section 27, with effect from 1st April 2006, in terms of S.S.I. 2006/121.back

[9] O.J. No. L 1, 3.1.94, p.1.back

[10] O.J. No. L 1, 3.1.94, p.571.back

[11] 1997 c.50. Relevant amendments are the Criminal Justice and Police Act 2001 (c.16) Schedule 6, paragraph 7, Schedule 7, part 5, and the Criminal Justice (Scotland) Act 2003 (c.7), section 70(3)(c).back

[12] S.I. 1974/467. Relevant amending instruments are S.I. 1991/900, S.S.I. 2000/224 and 2003/306.back

[13] Section 29(8) was amended by the Community Care and Health (Scotland) Act 2002 (asp 5) ("the 2002 Act"), sections 25 and 27(2) and Schedule 2, paragraph 2(4)(b), and the 2005 Act, section 26(2)(e), with effect from 1st April 2006, in terms of S.S.I. 2006/121.back

[14] The definition of "ophthalmic optician" was substituted by the Opticians Act 1989 (Amendment) Order 2005/848, Schedule 1(2), paragraph 10.back

[15] (c.44); section 7 was amended by S.I. 2005/848, Art 7.back

[16] (c.54); section 2(2) was amended by S.I. 1996/1591 Regulation 7 and Schedule 2, paragraph 1 and by the Medical Act 1983 (Amendment) Order 2002/3135, article 9(1).back

[17] Section 9 was amended by S.I. 2005/848, Article 9.back

[18] Section 32A(2) was inserted by the National Health Service (Amendment) Act 1995 (c.31) ("the 1995 Act") section 1 amended by the 1999 Act, section 65 and Schedule 4, paragraph 51 and the 2005 Act, section 26(7)(b), with effect from 1st April 2006, in terms of S.S.I. 2006/121.back

[19] Section 32B(1) was substituted by the 1995 Act, section 8 and amended by the 1999 Act, section 65 and Schedule 4, paragraph 52, and by the 2005 Act, Schedule 3 with effect from 1st April 2006, in terms of S.S.I. 2006/121.back

[20] Schedule 8 was amended by the 1995 Act, section 12, S.I. 1995/3214; the National Health Service (Primary Care) Act 1997 (c.46), section 41(10), and Schedule 2, Part II, paragraph 58; S.I. 1998/631; the 1999 Act, sections 653 and Schedule 4, paragraph 64, and by the 2005 Act, Schedule 2, paragraph 2 with effect from 1st April 2006, in terms of S.S.I.back

[21] 1977 c.49.back

[22] S.I. 1972/1265.back

[23] Section 29B(2) was added by the 1999 Act, section 58, and amended by the 2002 Act, Schedule 2, paragraph 2, the 2004 Act, Schedule 1, paragraph 1, and the 2005 Act, section 26(4) and Schedule 3 with effect from 1st April 2006 in terms of S.S.I. 2006/121.back

[24] Section 30(2) was substituted by the 1999 Act, section 58 and amended by the 2005 Act, Schedule 3 with effect from 1st April 2006 in terms of S.S.I. 2006/121.back

[25] Section 30(5) was substituted by the 1999 Act, section 58 and amended by the 2005 Act, Schedule 3 with effect from 1st April 2006 in terms of S.S.I. 2006/121.back

[26] Section 32A(3) was inserted by the National Health Service (Amendment) Act 1995 (c.31), section 8, amended by the 1999 Act, section 65 and Schedule 4, paragraph 51 and the 2005 Act, Schedule 3 with effect from 1st April 2006 in terms of S.S.I. 2006/121.back

[27] Section 32B(1) was substituted by the 1999 Act, section 65 and Schedule 4, paragraph 52, and the 2005 Act, Schedule 3 with effect from 1st April 2006 in terms of S.S.I. 2006/121.back

[28] S.S.I. 2004/38; regulation 26 is amended with effect from 1st April 2006 by the National Health Service (Tribunal) (Scotland) Amendment Regulations 2006 (S.S.I. 2006/122).back

[29] S.S.I. 2004/38 as amended by S.S.I. 2004/122 and 271, 2005/335 and 2006/122.back

[30] Section 30 was substituted by the 1999 Act, section 58 and amended by the 2002 Act, Schedule 2, paragraph 2, and by the 2005 Act, Schedule 2, paragraph 2, and Schedule 3 with effect from 1st April 2006 in terms of S.S.I. 2006/121.back

[31] 1995 c.36.back

[32] S.I. 1986/965; regulation 6 was substituted by S.I. 1988/543, 1991/534, 1996/843, 1999/725, S.S.I. 1999/55, 2001/62, 2004/36, and 2004/169.back

[33] S.S.I. 2004/38 as amended by S.S.I. 2004/122 and 271, 2005/335 and 2006/122.back

[34] S.I. 1992/434 as amended by S.I. 1994/3038, 1995/3201, 1996/938, 1998/657, 1998/1424 and S.S.I. 1999/53, 2004/38, 2005/118 and 334 and 2006/139.back

[35] S.I. 1998/642. Regulation 9 was amended by S.I. 1999/748.back

[36] S.I. 1989/364, amended by S.I. 1992/411, 1994/1770, 1998/251, S.S.I. 2004/369, and S.S.I. 2006/141 with effect from 1st April 2006.back

[37] 1986 c.45.back

[38] 1986 c.46 as amended by the Insolvency Act 2000 (2000 c.39).back

[39] S.I. 1986/1032 (N.1.6).back

[40] 1986 c.45.back

[41] 1995 c.46.back

[42] 1992 c.5;. section 115A was inserted by section 15 of the Social Security Administration (Fraud) Act 1997 (c.47).back



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