The National Health Service (General Medical Services Contracts) (Wales) Regulations 2023
- (9) The assessment panel’s determination must include its comments on the matters referred to in sub-paragraph (5), and notice in writing of that determination must be given to those contractors referred to in sub-paragraph (2)(a).
Assignment to closed lists: NHS dispute resolution procedure relating to determinations of the assessment panel
46
- (1) Where an assessment panel makes a determination under paragraph 45(7) that the Local Health Board may assign new patients to contractors who have closed their lists of patients, any contractor specified in the determination may refer the matter to the Welsh Ministers to review that determination.
- (2) Where a matter is referred to the Welsh Ministers under sub-paragraph (1), it must be reviewed in accordance with the procedure specified in the following sub-paragraphs.
- (3) Where more than one contractor specified in the determination would like to refer the matter for dispute resolution, those contractors may, if they all agree, refer the matter jointly and, in that case, the Welsh Ministers must review the matter in relation to those contractors together.
- (4) The contractor (or contractors) must send to the Welsh Ministers, before the end of the period of 7 days beginning with the date of the determination of the assessment panel in accordance with paragraph 45(7), a written request for dispute resolution which must include or be accompanied by—
- (a) the names and addresses of the parties to the dispute,
- (b) a copy of the contract (or contracts), and
- (c) a brief statement describing the nature of and circumstances giving rise to the dispute.
- (5) The Welsh Ministers must, before the end of the period of 7 days beginning with the date on which the matter was referred to the Welsh Ministers—
- (a) give notice in writing to the parties that the Welsh Ministers are dealing with the matter, and
- (b) include with the notice a written request to the parties to make, in writing before the end of a specified period, any representations which those parties would like to make about the dispute.
- (6) The Welsh Ministers must give, with the notice under sub-paragraph (5), to the party other than the one which referred the matter to dispute resolution, a copy of any document by which the dispute was referred to dispute resolution.
- (7) The Welsh Ministers must, upon receiving any representations from a party—
- (a) give a copy of those representations to each other party, and
- (b) request, in writing, that each party to which a copy of those representations is given makes, before the end of a specified period, any written observations which the party would like to make about those representations.
- (8) The Welsh Ministers may—
- (a) invite representatives of the parties to appear before, and make oral representations to, the Welsh Ministers either together or, with the agreement of the parties, separately, and may, in advance, provide the parties with a list of matters or questions to which the Welsh Ministers would like them to give special consideration, or
- (b) consult other persons whose expertise the Welsh Ministers considers is likely to assist the Welsh Ministers consideration of the dispute.
- (9) Where the Welsh Ministers consult another person under sub-paragraph (8)(b), the Welsh Ministers must—
- (a) give notice in writing to that effect to the parties, and
- (b) where the Welsh Ministers consider that the interests of any party might be substantially affected by the results of the consultation, give to the parties such opportunity as the Welsh Ministers consider reasonable in the circumstances to make observations about those results.
- (10) In considering the dispute, the Welsh Ministers must take into account—
- (a) any written representations made in response to a request under sub-paragraph (5)(b), but only if those representations are made before the end of the specified period,
- (b) any written observations made in response to a request under sub-paragraph (7), but only if those written observations are made before the end of the specified period,
- (c) any oral representations made in response to an invitation under sub-paragraph (8)(a),
- (d) the results of any consultation under sub-paragraph (8)(b), and
- (e) any observations made in accordance with an opportunity given under sub-paragraph (9).
- (11) Subject to the other provisions of this paragraph and to any agreement between the parties, the Welsh Ministers may determine the procedure which is to apply to the dispute resolution in such manner as the Welsh Ministers consider appropriate in order to ensure the just, expeditious, economical and final determination of the dispute.
- (12) In this paragraph, “specified period” means—
- (a) such period as the Welsh Ministers specify in the request being a period of not less than 7 days and not more than 14 days beginning with the date on which the notice referred to is given, or
- (b) such longer period as the Welsh Ministers may allow for the determination of the dispute where the period for determination of the dispute has been extended in accordance with sub-paragraph (16), and where the Welsh Ministers do so allow, a reference in this paragraph to the specified period is to the period as so extended.
- (13) Subject to sub-paragraph (16), the Welsh Ministers must—
- (a) determine the dispute before the end of the period of 21 days beginning with the date on which the matter was referred to the Welsh Ministers,
- (b) determine whether the Local Health Board may assign new patients to contractors which have closed their lists of patients, and
- (c) if the Welsh Ministers determine that the Local Health Board may assign new patients to those contractors, determine the contractors to which the new patients may be assigned.
- (14) The Welsh Ministers must not determine that patients may be assigned to a contractor which was not specified in the determination of the assessment panel under paragraph 45(7)(b).
- (15) In the case of a matter referred jointly by contractors in accordance with sub-paragraph (3), the Welsh Ministers may determine that patients may be assigned to one, some or all of the contractors which referred the matter.
- (16) The period of 21 days referred to in sub-paragraph (13) may be extended (even after it has expired) by a further specified number of days if an agreement to that effect is reached by—
- (a) the Welsh Ministers,
- (b) the Local Health Board, and
- (c) the contractor (or contractors) which referred the matter to dispute resolution.
- (17) The Welsh Ministers must—
- (a) record the determination, and the reasons for it, in writing, and
- (b) give notice in writing of the determination (including the record of the reasons) to the parties.
Assignments to closed lists: assignments of patients by the Local Health Board
47
- (1) Before the Local Health Board assigns a new patient to a contractor, the Local Health Board must, subject to sub-paragraph (3)—
- (a) enter into discussions with the contractor regarding the additional support that the Local Health Board can offer the contractor, and
- (b) use its best endeavours to provide such appropriate support.
- (2) In the discussions referred to in sub-paragraph (1)(a), both parties must use reasonable endeavours to reach agreement.
- (3) The requirement in sub-paragraph (1)(a) to enter into discussions applies—
- (a) to the first assignment of a patient to a particular contractor, and
- (b) to any subsequent assignment to that contractor to the extent that it is reasonable and appropriate having regard to—
- (i) the numbers of patients who have been or may be assigned to it, and
- (ii) the period of time since the last discussions under sub-paragraph (1)(a) took place.
PART 5 — Prescribing and dispensing
Prescribing: general
48
- (1) The contractor must ensure that—
- (a) any prescription form or repeatable prescription for drugs, medicines or appliances issued by a prescriber, and
- (b) any home oxygen order form issued by a health care professional,
complies, as appropriate, with the requirements in this Part.
- (2) In this Part, a reference to “drugs” includes contraceptive substances and a reference to “appliances” includes contraceptive appliances.
Orders for drugs, medicines and appliances
49
- (1) Subject to sub-paragraphs (2) and (4) and to the restrictions on prescribing in paragraphs 55 and 56, a prescriber must order any drugs, medicines or appliances which are needed for the treatment of any patient who is receiving treatment under the contract by—
- (a) issuing to the patient a non-electronic prescription form or a non-electronic repeatable prescription completed in accordance with sub-paragraph (6), or
- (b) creating and transmitting an electronic prescription in circumstances to which paragraph 50(1) applies,
and a non-electronic prescription form, non-electronic repeatable prescription or electronic prescription that is for health service use must not be used in any other circumstances.
- (2) If, on a particular occasion when a drug, medicine or appliance is needed as mentioned in sub-paragraph (1)—
- (a) the prescriber is able, without delay, to order the drug, medicine or appliance by means of an electronic prescription,
- (b) the Electronic Prescription Service software that the prescriber would use for that purpose provides for the creation and transmission of electronic prescriptions without the need for a nominated dispenser, and
- (c) none of the reasons for issuing a non-electronic prescription form or a non-electronic repeatable prescription given in sub-paragraph (3) apply,
the prescriber must create and transmit an electronic prescription for that drug, medicine or appliance.
- (3) The reasons given in this sub-paragraph are—
- (a) although the prescriber is able to use the Electronic Prescription Service, the prescriber is not satisfied that—
- (i) the access that the prescriber has to the Electronic Prescription Service is reliable, or
- (ii) the Electronic Prescription Service is functioning reliably,
- (b) the patient, or where appropriate the patient’s authorised person, informs the prescriber that the patient wants the option of having the prescription dispensed elsewhere than in Wales, or
- (c) the patient, or where appropriate the patient’s authorised person, insists on the patient being issued with a non-electronic prescription form or, a non-electronic repeatable prescription for a particular prescription and in the professional judgement of the prescriber the welfare of the patient is likely to be in jeopardy unless a non-electronic prescription form or a non-electronic repeatable prescription is issued.
- (4) A health care professional must order any home oxygen services which are needed for the treatment of any patient who is receiving treatment under the contract by issuing a home oxygen order form.
- (5) A prescriber may order drugs, medicines or appliances on a repeatable prescription only where the drugs, medicines or appliances are to be provided more than once.
- (6) In issuing a non-electronic prescription form or a non-electronic repeatable prescription, the prescriber must—
- (a) sign the prescription form or repeatable prescription in ink in the prescriber’s own handwriting, and not by means of a stamp, with the prescriber’s initials, or forenames, and surname, and
- (b) only sign the prescription form or repeatable prescription after particulars of the order have been inserted in the prescription form or repeatable prescription.
- (7) A prescription form or repeatable prescription must not refer to any previous prescription form or repeatable prescription.
- (8) A separate prescription form or repeatable prescription must be used for each patient, except where a bulk prescription is issued for a school or institution under paragraph 57.
- (9) A home oxygen order form must be signed by a health care professional.
- (10) Where a prescriber orders the drug buprenorphine or diazepam or a drug specified in Part 1 of Schedule 2 to the Misuse of Drugs Regulations 2001 (controlled drugs to which regulations 14 to 16, 16A, 18 to 21, 23, 26 and 27 of those Regulations apply) for supply by instalments for treating addiction to any drug specified in that Schedule, the prescriber must—
- (a) use only the prescription form provided specially for the purposes of supply by instalments,
- (b) specify the number of instalments to be dispensed and the interval between each instalment, and
- (c) order only such quantity of the drug as provides treatment for a period not exceeding 14 days.
- (11) The prescription form provided specially for the purpose of supply by instalments must not be used for any purpose other than ordering drugs in accordance with sub-paragraph (10).
- (12) In an urgent case, a prescriber may request an NHS pharmacist to dispense a drug or medicine before a prescription form or repeatable prescription is issued or created, only if—
- (a) that drug or medicine is not a Scheduled drug,
- (b) the drug is not a controlled drug within the meaning of section 2 of the Misuse of Drugs Act 1971 (which relates to controlled drugs and their classification for the purposes of that Act), other than a drug which is for the time being specified in Part 1 of Schedule 4 (controlled drugs subject to the requirements of regulations 22, 23, 26 and 27) or Schedule 5 (controlled drugs excepted from the prohibition on importation, exportation and possession and subject to the requirements of regulations 24 and 26) to the Misuse of Drugs Regulations 2001, and
- (c) the prescriber undertakes to—
- (i) provide the NHS pharmacist, within 72 hours beginning with the time of the request, with a non-electronic prescription form or a non-electronic repeatable prescription completed in accordance with sub-paragraph (6), or
- (ii) transmit an electronic prescription by the Electronic Prescription Service within 72 hours, beginning with the time of the request.
- (13) In an urgent case, a prescriber may request an NHS pharmacist to dispense an appliance before a prescription form or repeatable prescription is issued or created, only if—
- (a) the appliance does not contain a Scheduled drug, or a controlled drug within the meaning of section 2 of the Misuse of Drugs Act 1971 (which relates to controlled drugs and their classification for the purposes of that Act), other than a drug which is for the time being specified in Schedule 5 to the Misuse of Drugs Regulations 2001 (controlled drugs excepted from the prohibition on importation, exportation and possession and subject to the requirements of regulations 24 and 26),
- (b) where the appliance is a restricted availability appliance, the patient is a person, or the appliance is for a purpose, specified in the Drug Tariff, and
- (c) the prescriber undertakes to—
- (i) provide the NHS pharmacist, within 72 hours beginning with the time of the request, with a non-electronic prescription form or non-electronic repeatable prescription completed in accordance with sub-paragraph (6), or
- (ii) transmit an electronic prescription by the Electronic Prescription Service within 72 hours, beginning with the time of the request.
Electronic prescriptions
50
- (1) A prescriber may only order drugs, medicines or appliances by means of an electronic prescription if the prescription is not—
- (a) for a controlled drug within the meaning of section 2 of the Misuse of Drugs Act 1971 (which relates to controlled drugs and their classification for the purposes of that Act), other than a drug which is for the time being specified in Schedules 2 to 5 to the Misuse of Drugs Regulations 2001, or
- (b) a bulk prescription issued for a school or institution under paragraph 57.
- (2) If a prescriber orders a drug, medicine or appliance by means of an electronic prescription, the prescriber must issue the patient with—
- (a) subject to sub-paragraph (4), an EPS token, and
- (b) if the patient, or where appropriate the patient’s authorised person, so requests, a written record of the prescription that has been created.
- (3) On and after the contractor’s EPS go live date, if the order is eligible for Electronic Prescription Service use, the prescriber must ascertain if the patient, or where appropriate the patient’s authorised person, wants to have the electronic prescription dispensed by a nominated dispenser.
- (4) The prescriber must not issue the patient with an EPS token if the patient, or where appropriate the patient’s authorised person, wants to have the electronic prescription dispensed by a nominated dispenser.
- (5) A health care professional may not order home oxygen services by means of an electronic prescription.
Nomination of dispensers for the purposes of electronic prescriptions
51
- (1) A contractor authorised to use the Electronic Prescription Service for its patients must, if a patient, or where appropriate the patient’s authorised person, so requests, enter into the particulars relating to the patient which are held in the Welsh Demographic Service managed by Digital Health and Care Wales or the Personal Demographic Service managed by NHS England—
- (a) where the patient does not have a nominated dispenser, the dispenser chosen by the patient, or where appropriate the patient’s authorised person, and
- (b) where the patient does have a nominated dispenser—
- (i) a replacement dispenser, or
- (ii) a further dispenser,
chosen by the patient, or where appropriate the patient’s authorised person.
- (2) Sub-paragraph (1)(b)(ii) does not apply if the number of the nominated dispensers would thereby exceed the maximum number permitted by the Electronic Prescription Service.
- (3) A contractor must—
- (a) not seek to persuade a patient or a patient’s authorised person to nominate a dispenser recommended by the prescriber or the contractor, and
- (b) if asked by a patient or a patient’s authorised person to recommend an NHS pharmacist whom the patient or the patient’s authorised person might nominate as the patient’s dispenser, provide the patient or, as the case may be, the patient’s authorised person with the list given to the contractor by the Local Health Board containing all NHS pharmacists in the area who provide an Electronic Prescription Service.
Repeatable prescribing services
52
- (1) A contractor may only provide repeatable prescribing services to a person on its list of patients if the contractor—
- (a) satisfies the conditions in sub-paragraph (2), and
- (b) has notified the relevant Local Health Board of its intention to provide repeatable prescribing services in accordance with sub-paragraphs (3) and (4).
- (1A) The contractor must enable the repeat prescribing functionality within the NHS Wales App, to allow patients to order repeatable prescriptions.
- (2) The conditions referred to in sub-paragraph (1)(a) are—
- (a) the contractor has access to computer systems and software which enable it to issue non-electronic repeatable prescriptions and batch issues, and
- (b) the practice premises at which the repeatable prescribing services are to be provided are located in an area of the Local Health Board in which there is also located the premises of at least one NHS pharmacist who has undertaken to provide, or has entered into an arrangement to provide, repeat dispensing services.
- (3) The notification referred to in sub-paragraph (1)(b) is a notification, in writing, by the contractor to the relevant Local Health Board that it—
- (a) wishes to provide repeatable prescribing services,
- (b) intends to begin to provide those services from a date specified in the notification, and
- (c) satisfies the conditions in sub-paragraph (2).
- (4) The date specified by the contractor under sub-paragraph (3)(b) must be at least 10 days after the date on which the notification specified in sub-paragraph (1) is given.
- (5) Nothing in this paragraph requires a contractor or prescriber to provide repeatable prescribing services to any person.
- (6) A prescriber may only provide repeatable prescribing services to a person on a particular occasion if—
- (a) that person has agreed to receive such services on that occasion, and
- (b) the prescriber considers that it is clinically appropriate to provide such services to that person on that occasion.
- (7) The contractor may not provide repeatable prescribing services to any person on its list of patients to whom any person specified in sub-paragraph (8) is authorised or required by the Local Health Board to provide pharmaceutical services in accordance with arrangements under section 80 (arrangements for pharmaceutical services) and section 86 (persons authorised to provide pharmaceutical services) of the Act.
- (8) The persons referred to in sub-paragraph (7) are—
- (a) in the case of a contract with an individual medical practitioner, that medical practitioner,
- (b) in the case of a contract with two or more individuals practising in partnership, any medical practitioner who is a partner,
- (c) in the case of a contract with a company limited by shares, any medical practitioner who is both a legal and beneficial shareholder in that company, or
- (d) any medical practitioner employed by the contractor.
Repeatable prescriptions
53
- (1) A prescriber who issues a non-electronic repeatable prescription must at the same time issue the appropriate number of batch issues.
- (2) Where a prescriber wants to make a change to the type, quantity, strength or dosage of drugs, medicines or appliances ordered on a person’s repeatable prescription, the prescriber must—
- (a) in the case of a non-electronic repeatable prescription—
- (i) give notice to the person, and
- (ii) make reasonable efforts to give notice to the NHS pharmacist providing repeat dispensing services to that person,
that the original repeatable prescription is no longer to be used to obtain or provide repeat dispensing services and make arrangements for a replacement repeatable prescription to be issued to the person, or
- (b) in the case of an electronic repeatable prescription—
- (i) arrange with the Electronic Prescription Service for the cancellation of the original repeatable prescription, and
- (ii) create a replacement repeatable prescription in respect of the person and give notice to the person that this has been done.
- (3) Where a prescriber has created an electronic repeatable prescription for a person, the prescriber must, as soon as practicable, arrange with the Electronic Prescription Service for its cancellation if, before the expiry of that prescription—
- (a) the prescriber considers that it is no longer safe or appropriate for the person to—
- (i) receive the drugs, medicines or appliances ordered on the person’s electronic repeatable prescription, or
- (ii) continue to receive repeatable prescribing services,
- (b) the prescriber has issued the person with a non-electronic repeatable prescription in place of the electronic repeatable prescription, or
- (c) it comes to the prescriber’s notice that the person on whose behalf the prescription was issued has been removed from the list of patients of the contractor.
- (4) Where a prescriber has cancelled an electronic repeatable prescription in respect of a person in accordance with sub-paragraph (3), the prescriber must give notice of the cancellation to the person as soon as possible.
- (5) A prescriber who has issued a non-electronic repeatable prescription in respect of a person must, as soon as possible, make reasonable efforts to give notice to the NHS pharmacist that that repeatable prescription must no longer be used to provide repeat dispensing services to that person, if, before the expiry of that repeatable prescription—
- (a) the prescriber considers that it is no longer safe or appropriate for the person to—
- (i) receive the drugs, medicines or appliances ordered on the person’s repeatable prescription, or
- (ii) to continue to receive repeatable prescribing services,
- (b) the prescriber issues or creates a further repeatable prescription in respect of the person to replace the original repeatable prescription other than in the circumstances referred to in sub-paragraph (2)(a) (for example, because the person wants to obtain the drugs, medicines or appliances from a different NHS pharmacist), or
- (c) it comes to the prescriber’s notice that the person on whose behalf the prescription was issued has been removed from the list of patients of the contractor.
- (6) Where the circumstances in sub-paragraph (5)(a) to (c) apply in respect of a person, the prescriber must, as soon as possible, give notice to that person that their repeatable prescription must no longer be used to obtain repeat dispensing services.
Prescribing for electronic repeat dispensing
54
- (1) Subject to paragraphs 49, 50, 52 and 53(2)(b) to (4), where a prescriber orders a drug, medicine or appliance by means of an electronic repeatable prescription, the prescriber must issue the prescription in a format appropriate for electronic repeat dispensing where it is clinically appropriate to do so for that patient on that occasion.
- (2) In this paragraph, “electronic repeat dispensing” means dispensing as part of pharmaceutical services or local pharmaceutical services which involves the provision of drugs, medicines or appliances in accordance with an electronic repeatable prescription.
Restrictions on prescribing by medical practitioners
55
- (1) A medical practitioner, in the course of treating a patient to whom the practitioner is providing treatment under the contract, must comply with the following sub-paragraphs.
- (2) The medical practitioner must not order on a listed medicines voucher, prescription form or a repeatable prescription, drugs, medicines or other substances specified in any directions given by the Welsh Ministers in regulations made under section 46 of the Act (GMS contracts: prescription of drugs etc) as being drugs, medicines or other substances which may not be ordered for patients in the provision of medical services under the contract.
- (3) The medical practitioner must not order on a listed medicines voucher, a prescription form or repeatable prescription drugs, medicines or other substances specified in any directions given by the Welsh Ministers under section 46 of the Act (GMS contracts: prescription of drugs etc) as being a drug, medicine or other substance which can only be ordered for specified patients and for specified purposes unless—
- (a) the patient is a person of the specified description,
- (b) the drug, medicine or other substance is prescribed for that patient only for the specified purpose, and
- (c) if the order is on a prescription form, the practitioner includes on the form the reference “SLS”.
- (4) The medical practitioner must not order on a prescription form or repeatable prescription a restricted availability appliance unless—
- (a) the patient is a person, or the restricted availability appliance is for a purpose, specified in the Drug Tariff, and
- (b) the practitioner includes on the prescription form the reference “SLS”.
- (5) The medical practitioner must not order on a repeatable prescription a controlled drug within the meaning of section 2 of the Misuse of Drugs Act 1971 (which relates to controlled drugs and their classification for the purposes of that Act), other than a drug which is for the time being specified in Schedule 4 (controlled drugs subject to the requirements of regulations 22, 23 26 and 27) or Schedule 5 (controlled drugs excepted from the prohibition on importation, exportation and possession and subject to the requirements of regulations 24 and 26) to the Misuse of Drugs Regulations 2001.
- (6) Subject to regulation 21(2)(b) and to sub-paragraph (7), nothing in the preceding sub-paragraphs prevents a medical practitioner, in the course of treating a patient to whom this sub-paragraph refers, from prescribing a drug, medicine or other substance or, as the case may be, a restricted availability appliance or a controlled drug within the meaning of section 2 of the Misuse of Drugs Act 1971 (which relates to controlled drugs and their classification for the purposes of that Act), for the treatment of that patient under a private arrangement.
- (7) Where, under sub-paragraph (6), a drug, medicine or other substance is prescribed under a private arrangement, if the order is to be transmitted as an electronic communication to an NHS pharmacist for the drug, medicine or appliance to be dispensed—
- (a) if the order is not for a drug for the time being specified in Schedule 2 (controlled drugs subject to the requirements of regulations 14, 15, 16, 16A, 18, 19, 20, 21, 23, 26 and 27) or 3 (controlled drugs subject to the requirements of regulations 14, 15, 16, 18, 22, 23, 24, 26 and 27) to the Misuse of Drugs Regulations 2001, it may be transmitted by the Electronic Prescription Service, but
- (b) if the order is for a drug for the time being specified in Schedule 2 (controlled drugs subject to the requirements of regulations 14, 15, 16, 16A, 18, 19, 20, 21, 23, 26 and 27) or 3 (controlled drugs subject to the requirements of regulations 14, 15, 16, 18, 22, 23, 24, 26 and 27) to the Misuse of Drugs Regulations 2001, it must be transmitted by the Electronic Prescription Service.
Restrictions on prescribing by supplementary prescribers
56
- (1) The contractor must have arrangements in place to secure that an individual who is a supplementary prescriber may—
- (a) issue or create a prescription for a prescription only medicine,
- (b) administer a prescription only medicine for parenteral administration, or
- (c) give directions for the administration of a prescription only medicine for parenteral administration,
as a supplementary prescriber only under the conditions set out in sub-paragraph (2).
- (2) The conditions referred to in sub-paragraph (1) are that—
- (a) the individual satisfies the applicable conditions set out in regulation 215 of the Human Medicines Regulations 2012[^f00060] (prescribing and administration by supplementary prescribers), unless those conditions do not apply by virtue of any of the exemptions set out in the subsequent provisions of those Regulations;
- (b) the drug, medicine or other substance is not specified in any directions given by the Welsh Ministers under section 46 of the Act as being a drug, medicine or other substance which may not be ordered for patients in the provision of medical services under the contract;
- (c) the drug, medicine or other substance is not specified in any directions given by the Welsh Ministers under section 46 of the Act as being a drug, medicine or other substance which can only be ordered for specified patients and specified purposes unless—
- (i) the patient is a person of the specified description,
- (ii) the medicine is prescribed for that patient only for the specified purposes, and
- (iii) if the supplementary prescriber is giving a prescription, he or she endorses the face of the form with the reference “SLS”.
- (3) Where the functions of a supplementary prescriber include prescribing, the contractor must have arrangements in place to secure that that person may only give a prescription for—
- (a) an appliance, or
- (b) a medicine which is not a prescription only medicine,
as a supplementary prescriber under the conditions set out in sub-paragraph (4).
- (4) The conditions set out in this paragraph are that—
- (a) the supplementary prescriber acts in accordance with a clinical management plan which is in effect at the time the supplementary prescriber acts and which contains the following particulars—
- (i) the name of the patient to whom the plan relates,
- (ii) the illness or conditions which may be treated by the supplementary prescriber,
- (iii) the date on which the plan is to take effect, and when it is to be reviewed by the medical practitioner or dentist who is a party to the plan,
- (iv) reference to the class or description of medicines or types of appliances which may be prescribed or administered under the plan,
- (v) any restrictions or limitations as to the strength or dose of any medicine which may be prescribed or administered under the plan, and any period of administration or use of any medicine or appliance which may be prescribed or administered under the plan,
- (vi) relevant warnings about known sensitivities of the patient to, or known difficulties of the patient with, particular medicines or appliances,
- (vii) the arrangements for notification of—
- (aa) suspected or known adverse reactions to any medicine which may be prescribed or administered under the plan, and suspected or known adverse reactions to any other medicine taken at the same time as any medicine prescribed or administered under the plan,
- (bb) incidents occurring with the appliance which might lead, might have led or has led to the death or serious deterioration of state of health of the patient, and
- (viii) the circumstances in which the supplementary prescriber should refer to, or seek the advice of, the medical practitioner or dentist who is a party to the plan,
- (b) the supplementary prescriber has access to the health records of the patient to whom the plan relates which are used by any medical practitioner or dentist who is a party to the plan,
- (c) if it is a prescription for a drug, medicine or other substance, that drug, medicine or other substance is not specified in any directions given by the Welsh Ministers under section 46 of the Act as being a drug, medicine or other substance which may not be ordered for patients in the provision of medical services under the contract,
- (d) if it is a prescription for a drug, medicine or other substance, that drug, medicine or other substance is not specified in any directions given by the Welsh Ministers under section 46 of the Act as being a drug, medicine or other substance which can only be ordered for specified patients and specified purposes unless—
- (i) the patient is a person of the specified description,
- (ii) the medicine is prescribed for that patient only for the specified purposes, and
- (iii) when giving the prescription, the supplementary prescriber endorses the face of the form with the reference “SLS”,
- (e) if it is a prescription for an appliance, the appliance is listed in Part 9 of the Drug Tariff, and
- (f) if it is a prescription for a restricted availability appliance—
- (i) the patient is a person of a description mentioned in the entry in Part 9 of the Drug Tariff in respect of that appliance,
- (ii) the appliance is prescribed only for the purposes specified in respect of that person in that entry, and
- (iii) when giving the prescription, the supplementary prescriber endorses the face of the form with the reference “SLS”.
- (5) In sub-paragraph (4)(a), “clinical management plan” means a written plan (which may be amended from time to time) relating to the treatment of an individual patient agreed by—
- (a) the patient to whom the plan relates,
- (b) the medical practitioner or dentist who is a party to the plan, and
- (c) any supplementary prescriber who is to prescribe, give directions for administration or administer under the plan.
Bulk prescribing
57
- (1) A prescriber may use a single non-electronic prescription form where—
- (a) a contractor is responsible under the contract for the treatment of 10 or more persons in a school or other institution in which at least 20 persons normally reside, and
- (b) the prescriber orders, for any 2 or more of those persons for whose treatment the contractor is responsible, drugs, medicines or appliances to which this paragraph applies.
- (2) Where a prescriber uses a single non-electronic prescription form for the purpose mentioned in sub-paragraph (1)(b), the prescriber must (instead of entering on the form the names of the persons for whom the drugs, medicines or appliances are ordered) enter on the form—
- (a) the name of the school or other institution in which those persons reside, and
- (b) the number of persons residing there for whose treatment the contractor is responsible.
- (3) This paragraph applies to any drug, medicine or appliance which can be supplied as part of pharmaceutical services or local pharmaceutical services and which in the case of—
- (a) a drug or medicine, is not a prescription only medicine, or
- (b) an appliance, does not contain such a product.
Excessive prescribing
58
- (1) The contractor must not prescribe drugs, medicines or appliances the cost or quantity of which, in relation to a patient, is, by reason of the character of the drug, medicine or appliance in question, in excess of that which was reasonably necessary for the proper treatment of the patient.
- (2) In considering whether a contractor has breached its obligations under sub-paragraph (1), the Local Health Board must seek the views of the Local Medical Committee (if any) for the area in which the contractor provides services under the contract.
Provision of drugs, medicines and appliances for immediate treatment or personal administration
59
- (1) Subject to sub-paragraphs (2) and (3), a contractor—
- (a) must provide to a patient a drug, medicine or appliance, which is not a Scheduled drug, where such provision is needed for the immediate treatment of the patient before provision can otherwise be obtained, and
- (b) may provide to a patient a drug, medicine or appliance, which is not a Scheduled drug, which the contractor personally administers or applies to the patient.
- (2) A contractor must only provide a restricted availability appliance under sub-paragraph (1)(a) or (b) if it is for a person or a purpose specified in the Drug Tariff.
- (3) Nothing in sub-paragraph (1) or (2) authorises a person to supply a prescription only medicine to a patient otherwise than in accordance with Part 12 of the Human Medicines Regulations 2012 (which relates to dealings with medicinal products).
Provision of dispensing services
60
- (1) The contractor may only provide, and must ensure that those employed or engaged by it only provide, pharmaceutical services or dispensing services in the circumstances provided for in the Pharmaceutical Regulations.
- (2) Where the contractor, or a person employed or engaged by the contractor, is included in the Local Health Board’s dispensing doctor list, the contractor must ensure that in the provision of any pharmaceutical services or dispensing services the contractor, and the dispensing doctor (and any person authorised to dispense on their behalf under the Pharmaceutical Regulations)—
- (a) complies with the terms of service applicable to the person providing those pharmaceutical services or dispensing services by virtue of regulation 12(2) of the Pharmaceutical Regulations, and
- (b) ensures that the patient to whom they are seeking to provide those services is aware that the relevant drugs or appliances are not only available from them (or by a person with whom the contractor is associated) and that the patient has the option to obtain those drugs or appliances from any NHS pharmacist.
PART 6 — Persons who perform services
Qualifications of performers: medical practitioners
61
- (1) Subject to sub-paragraph (2), no medical practitioner may perform medical services under the contract unless the medical practitioner is—
- (a) included in a medical performers’ list for a Local Health Board in Wales,
- (b) not suspended from that list or from the Medical Register, and
- (c) not subject to interim suspension under section 41A of the Medical Act 1983 (interim order).
- (2) Sub-paragraph (1) does not apply to any medical practitioner who is an exempt medical practitioner within the meaning of sub-paragraph (3) but only in so far as any medical services that the medical practitioner performs constitute part of a post-registration programme.
- (3) For the purposes of this paragraph, an “exempt medical practitioner” is—
- (a) a medical practitioner employed by an NHS trust[^f00061], an NHS foundation trust[^f00062], a Health Board, or a Health and Social Care Trust who is providing services other than primary medical services at the practice premises,
- (b) a person who is provisionally registered under section 15 (provisional registration), 15A (provisional registration for EEA nationals) or 21 (provisional registration) of the Medical Act 1983 and who is acting in the course of the person’s employment in a resident medical capacity,
- (c) a GP Specialty Registrar who has applied to a Local Health Board to have their name included in its medical performers list until the first of the following events arises—
- (i) the Local Health Board notifies the GP Specialty Registrar of its decision on that application, or
- (ii) the end of a period of 12 weeks, starting with the date on which that GP Specialty Registrar begins a postgraduate medical education and training scheme necessary for the award of a Certificate of Completion of Training,
- (d) a medical practitioner who is already included in a medical performers list or an equivalent performers list and who has submitted an application to a Local Health Board in accordance with regulation 5 of the National Health Service (Performers Lists) (Wales) Regulations 2026 until the first of the following events arises—
- (i) the Local Health Board notifies the medical practitioner of its decision on that application, or
- (ii) the end of a period of 12 weeks, starting with the date on which the application was submitted, or
- (e) a medical practitioner, who—
- (i) is not a GP Specialty Registrar,
- (ii) is undertaking a post-registration programme of clinical practice supervised by the General Medical Council,
- (iii) has notified the Local Health Board that they are to undertake part or all of a post-registration programme in its area at least 24 hours before commencing any part of that programme taking place in the Local Health Board’s area, and
- (iv) has, with that notification, provided the Local Health Board with evidence sufficient for it to satisfy itself that they are undertaking a post-registration programme,
but only in so far as any medical services that the medical practitioner performs constitute part of a post-registration programme.
- (4) In this paragraph “equivalent performers list” has the meaning given in regulation 2 of the National Health Service (Performers Lists) (Wales) Regulations 2026.
Qualifications of performers: health care professionals
62
A health care professional (other than one to whom paragraph 61 applies) may not perform clinical services under the contract unless—
- (a) that person is registered with the professional body relevant to that person’s profession, and
- (b) that registration is not subject to a period of suspension.
Conditional registration or inclusion in primary care list
63
Where the registration of a health care professional or, in the case of a medical practitioner, the medical practitioner’s inclusion in a primary care list is subject to conditions, the contractor must ensure compliance with those conditions insofar as they are relevant to the contract.
Clinical experience
64
No health care professional may perform any clinical services unless the health care professional has such clinical experience and training as are necessary to enable the health care professional properly to perform such services.
Conditions for employment and engagement: medical practitioner
65
- (1) Subject to sub-paragraphs (2) to (4), a contractor must not employ or engage a medical practitioner (other than an exempt medical practitioner within the meaning of sub-paragraph 61(3)) unless—
- (a) that practitioner has provided the contractor with the name and address of the Local Health Board on whose medical performers list the practitioner appears, and
- (b) the contractor has checked that the practitioner meets the requirements in paragraph 61.
- (2) Where—
- (a) the employment or engagement of a medical practitioner is urgently needed, and
- (b) it is not possible for the contractor to check that the medical practitioner meets the requirements referred to in paragraph 61 before employing or engaging the health care professional,
the contractor may employ or engage the medical practitioner on a temporary basis for a single period of up to 7 days while such checks are undertaken.
- (3) Where the prospective employee is a GP Specialty Registrar, the requirements set out in sub-paragraph (1) apply with the modifications that—
- (a) the name and address provided under sub-paragraph (1) may be the name and address of the Local Health Board on whose list the GP Specialty Registrar has applied for inclusion, and
- (b) confirmation that the GP Specialty Registrar’s name appears on that list is not to be required until the end of the first 12 weeks of the GP Specialty Registrar’s training period.
- (4) Where the prospective employee is a medical practitioner who is already included in a medical performers list or an equivalent performers list and who has submitted an application to the Local Health Board in accordance with regulation 5 of the National Health Service (Performers Lists) (Wales) Regulations 2026, the requirements set out in sub-paragraph (1) apply with the modifications that—
- (a) the name and address provided under sub-paragraph (1) may be the name and address of the Local Health Board on whose list the medical practitioner has applied for inclusion, provided that the name and address of the primary care organisation on whose list the medical practitioner is already included is provided in addition; and
- (b) confirmation that the medical practitioner’s name appears on that list means confirmation that the medical practitioner is provisionally included in the Local Health Board’s medical performers list in accordance with regulation 4A of the National Health Service (Performers Lists) (Wales) Regulations 2004.
- (5) In this paragraph “equivalent performers list” and “primary care organisation” have the meanings given in regulation 2 of the National Health Service (Performers Lists) (Wales) Regulations 2026.
Conditions for employment or engagement: health care professionals
66
- (1) Subject to sub-paragraph (2), a contractor may not employ or engage a health care professional to perform clinical services under the contract unless—
- (a) the contractor has checked that the health care professional meets the requirements of paragraph 62, and
- (b) the contractor has taken reasonable steps to satisfy itself that the health care professional meets the requirements of paragraph 64.
- (2) Where—
- (a) the employment or engagement of a health care professional is urgently needed, and
- (b) it is not possible for the contractor to check that the health care professional meets the requirements referred to in paragraph 62 before employing or engaging the health care professional,
the contractor may employ or engage the health care professional on a temporary basis for a single period of up to 7 days while such checks are undertaken.
- (3) When considering a health care professional’s experience and training for the purposes of sub-paragraph (1)(b), the contractor must, in particular, have regard to—
- (a) any post-graduate or post-registration qualification held by the health care professional, and
- (b) any relevant training undertaken, and any relevant clinical experience gained, by the health care professional.
Clinical references
67
- (1) The contractor may not employ or engage a health care professional to perform clinical services under the contract (other than an exempt medical practitioner to whom paragraph 61(3)(e) applies) unless—
- (a) that person has provided two clinical references, relating to two recent posts (which may include any current post) as a health care professional which lasted for at least 12 weeks without a significant break or, where this is not possible, a full explanation of why this is the case and details of alternative referees, and
- (b) the contractor has checked and is satisfied with the references.
- (2) Where—
- (a) the employment or engagement of a health care professional is urgently needed, and
- (b) it is not possible for the contractor to obtain and check the references in accordance with sub-paragraph (1)(b) before employing or engaging that health care professional,
the contractor may employ or engage the health care professional on a temporary basis for a single period of up to 14 days while the references are checked and considered, and for an additional period of a further 7 days if the contractor believes that the person supplying those references is ill, on holiday or otherwise temporarily unavailable.
- (3) Where the contractor employs or engages the same person on more than one occasion within a period of 12 weeks, the contractor may rely on the references provided on the first occasion, provided that those references are not more than a year old.
Verification of qualifications and competence
68
- (1) The contractor must, before employing or engaging any person—
- (a) comply with the Pre-employment Checks Standards in relation to that person, and
- (b) take reasonable steps to satisfy itself that the person in question is both suitably qualified and competent to discharge the duties for which that person is to be employed or engaged.
- (2) The duty imposed by sub-paragraph (1) is in addition to the duties imposed by paragraphs 61 to 67.
- (3) When considering the competence and suitability of any person for the purpose of sub-paragraph (1), the contractor must have regard, in particular, to—
- (a) that person’s academic and vocational qualifications,
- (b) that person’s education and training, and
- (c) that person’s previous employment or work experience.
Training
69
- (1) The contractor must ensure that for any health care professional who is—
- (a) performing clinical services under the contract, or
- (b) employed or engaged to assist in the performance of such services,
there are in place arrangements for the purpose of maintaining and updating the health care professional’s skills and knowledge in relation to the services which they are performing or assisting in performing.
- (2) The contractor must afford to each employee reasonable opportunities to undertake appropriate training with a view to maintaining that employee’s competence.
Terms and conditions
70
The contractor may only offer employment to a general medical practitioner on terms which are no less favourable than those contained in the document the “Model terms and conditions of service for a salaried general practitioner employed by a GMS practice” published by the British Medical Association and the NHS Confederation as item 1.2 of the supplementary documents to the GMS contract 2003.
Arrangements for GP Specialty Registrars
71
- (1) The contractor may only employ a GP Specialty Registrar subject to the conditions in sub-paragraph (2).
- (2) The conditions referred to in sub-paragraph (1) are that the contractor must not, by reason only of having employed or engaged a GP Specialty Registrar, reduce the total number of hours that other medical practitioners perform primary medical services under the contract or that other staff spend assisting them in the performance of those services.
- (3) A contractor employing a GP Registrar must—
- (a) offer the GP Registrar terms of employment in accordance with the rates and subject to the conditions contained in any directions given by Welsh Ministers to Local Health Boards under section 12 of the Act (Functions of Local Health Board) concerning the grants, fees, travelling and other allowances payable to GP Registrars, and
- (b) take into account the guidance contained in the document entitled “A Reference Guide For Postgraduate Foundation and Specialty Training in the UK”[^f00064].
Notice requirements in respect of relevant prescribers
72
- (1) For the purposes of this paragraph, “a relevant prescriber” is—
- (a) an independent nurse prescriber,
- (b) a nurse independent prescriber,
- (c) a paramedic independent prescriber,
- (d) a pharmacist independent prescriber,
- (e) a physiotherapist independent prescriber,
- (f) a podiatrist or chiropodist independent prescriber,
- (g) a supplementary prescriber, or
- (h) a therapeutic radiographer independent prescriber.
- (2) The contractor must give notice to the Local Health Board where—
- (a) a relevant prescriber is employed or engaged by a contractor to perform functions which include prescribing,
- (b) a relevant prescriber whose functions include prescribing is a party to the contract, or
- (c) the functions of a relevant prescriber whom the contractor already employs or has already engaged are extended to include prescribing.
- (3) The notice under sub-paragraph (2) must be given in writing to the Local Health Board before the expiry of the period of 7 days beginning with the date on which—
- (a) the relevant prescriber was employed or engaged by the contractor or, as the case may be, became a party to the contract (unless, immediately before becoming such a party, sub-paragraph (2)(a) applied to that relevant prescriber), or
- (b) the functions of the relevant prescriber were extended to include prescribing.
- (4) The contractor must give notice to the Local Health Board where—
- (a) the contractor ceases to employ or engage a relevant prescriber in the contractor’s practice whose functions include prescribing in the contractor’s practice,
- (b) a relevant prescriber ceases to be a party to the contract,
- (c) the functions of a relevant prescriber employed or engaged by the contractor in the contractor’s practice are changed so that they no longer include prescribing in the contractor’s practice, or
- (d) the contractor becomes aware that a relevant prescriber whom it employs or engages has been removed or suspended from the relevant register.
- (5) The notice under sub-paragraph (4) must be given in writing to the Local Health Board before the end of the second working day after the day on which an event described in sub-paragraphs (4)(a) to (d) occurred in relation to the relevant prescriber.
- (6) The contractor must provide the following information when it gives notice to the Local Health Board in accordance with sub-paragraph (2)—
- (a) the person’s full name,
- (b) the person’s professional qualifications,
- (c) the person’s identifying number which appears in the relevant register,
- (d) the date on which the person’s entry in the relevant register was annotated to the effect that the person was qualified to order drugs, medicines and appliances for patients,
- (e) the date on which—
- (i) the person was employed or engaged (if applicable),
- (ii) the person became a party to the contract (if applicable), or
- (iii) the functions of the person were extended to include prescribing in the contractor’s practice.
- (7) The contractor must provide the following information when it gives notice to the Local Health Board in accordance with sub-paragraph (4)—
- (a) the person’s full name,
- (b) the person’s professional qualifications,
- (c) the person’s identifying number which appears in the relevant register,
- (d) the date on which—
- (i) the person ceased to be employed or engaged in the contractor’s practice,
- (ii) the person ceased to be a party to the contract,
- (iii) the functions of the person were changed so as to no longer include prescribing in the contractor’s practice, or
- (iv) the person was removed or suspended from the relevant register.
Signing of documents
73
- (1) The contractor must ensure—
- (a) that the documents specified in sub-paragraph (2) include—
- (i) the clinical profession of the health care professional who signed the document, and
- (ii) the name of the contractor on whose behalf the document is signed, and
- (b) that the documents specified in sub-paragraph (3) include the clinical profession of the health care professional who signed the document.
- (2) The documents specified in this sub-paragraph are—
- (a) certificates issued in accordance with regulation 19, unless regulations relating to particular certificates provide otherwise, and
- (b) any other clinical documents apart from—
- (i) home oxygen order forms, and
- (ii) the documents specified in sub-paragraph (3).
- (3) The documents specified in this paragraph are batch issues, prescription forms and repeatable prescriptions.
- (4) This paragraph is in addition to any other requirements relating to the documents specified in sub-paragraphs (2) and (3) whether in these Regulations or elsewhere.
Level of skill and compliance with pathways
74
The contractor must, and the contractor must ensure that those it employs or engages must—
- (a) carry out the contractor’s obligations under the contract with reasonable care and skill, and
- (b) consider the application of national condition pathways relevant for each patient.
Appraisal and assessment
75
- (1) The contractor must ensure that any medical practitioner performing services under the contract—
- (a) participates in the appraisal system provided by the Local Health Board unless that medical practitioner participates in an appropriate appraisal system provided by another health service body or is an armed forces GP, and
- (b) co-operates with the Local Health Board in relation to the Local Health Board’s patient safety functions.
- (2) The Local Health Board must provide an appraisal system for the purposes of sub-paragraph (1)(a) after consultation with the Local Medical Committee (if any) for the area in which the practitioner provides services under the contract and such other persons as appear to it to be appropriate.
- (3) In sub-paragraph (1), “armed forces GP” means a medical practitioner who is employed on a contract of service by the Ministry of Defence, whether or not as a member of the armed forces of the Crown.
PART 7 — Sub-contracting
Sub-contracting
76
- (1) Subject to sub-paragraph (2), the contractor must not sub-contract any of its rights or duties under the contract in relation to clinical matters, or non-clinical matters directly affecting patients, unless—
- (a) in all cases it has taken reasonable steps to satisfy itself that—
- (i) it is reasonable in all the circumstances to do so, and
- (ii) that person to whom any of those rights or duties is sub-contracted is qualified and competent to provide the service, and
- (b) the contractor has given notice in writing to the Local Health Board of its intention to sub-contract as soon as reasonably practicable before the date on which the proposed sub-contract is intended to come into effect.
- (2) Sub-paragraph (1)(b) does not apply to—
- (a) a contract for services with a health care professional for the provision by that professional personally of clinical services, or
- (b) a contract between the contractor and another practice in the contractor’s GP Collaborative under which that other practice is to provide, as part of that GP Collaborative’s activities, primary medical services to the contractor’s patients.
- (3) A notice given under sub-paragraph (1)(b) must include—
- (a) the name and address of the proposed sub-contractor,
- (b) the duration of the proposed sub-contract,
- (c) the services to be covered by the proposed sub-contract, and
- (d) the address of any premises to be used for the provision of services under the proposed sub-contract.
- (4) On receipt of a notice given under sub-paragraph (1)(b), the Local Health Board may request further information relating to the proposed sub-contract as appears to it to be reasonable, and the contractor must supply that information to the Local Health Board promptly.
- (5) The contractor must not proceed with the sub-contract or, if the sub-contract has already taken effect, the contractor must take all reasonable steps to terminate it, where the Local Health Board gives notice in writing of its objection to the sub-contract on the grounds that—
- (a) the sub-contract would—
- (i) put the safety of the contractor’s patients at risk, or
- (ii) put the Local Health Board at risk of material financial loss,
- (b) the sub-contractor would be unable to meet the contractor’s obligations under the contract,
and such notice is given by the Local Health Board before the end of the period of 28 days beginning with the date on which the Local Health Board received a notice from the contractor under sub-paragraph (1)(b).
- (6) A notice given by the Local Health Board under sub-paragraph (5)(a) must include a statement of the reasons for the Local Health Board’s objection.
- (7) Sub-paragraphs (1) and (3) to (6) also apply in relation to any renewal or material variation of a sub-contract in relation to clinical matters and non-clinical matters directly related to a patient.
- (8) Where the notification by the contractor pursuant to sub-paragraph (3) relates to clinical matters and the Local Health Board does not give notice of an objection under sub-paragraph (5), the parties to the contract are deemed to have agreed a variation of the contract which, subject to any notice served under sub-paragraph (5), has the effect of adding to the list of practice premises any premises the address of which was notified to the Local Health Board under sub-paragraph (3)(d) and, in these circumstances, paragraph 109(1) does not apply.
- (9) Subject to sub-paragraph (10), a sub-contract entered into by a contractor must prohibit the sub-contractor from sub-contracting any of the clinical services that it has agreed with the contractor to provide under the sub-contract.
- (10) A sub-contract entered into by the contractor falling within sub-paragraph (2)(b) may allow the sub-contractor to sub-contract clinical services provided the contractor obtains the written approval of the Local Health Board prior to the sub-contractor sub-contracting those services.
- (11) The contractor must not sub-contract any of its rights or duties under the contract in relation to the provision of unified services to a company or firm—
- (a) owned wholly or partly by the contractor, or by any former or current employee of, or partner or shareholder in, the contractor,
- (b) formed by or on behalf of the contractor, or from which it derives or may derive a pecuniary benefit, or
- (c) formed by or on behalf of a former or current employee of, or partner or shareholder in, the contractor, or from which such a person derives or may derive a pecuniary benefit,
where sub-paragraph (12) applies to that company or firm.
- (12) This sub-paragraph applies to a company or firm which is or was formed wholly or partly for the purpose of avoiding the restrictions on the sale of goodwill of a medical practice in regulation 3 of the Primary Medical Services (Sale of Goodwill and Restrictions on Sub-contracting) (Wales) Regulations 2004[^f00065].
Withdrawal and variation of approval and right to subsequently object to a sub-contract under paragraph 76
77
- (1) Without prejudice to any other remedies which it may have under the contract, where a Local Health Board is deemed to have approved an application made under paragraph 76, it is entitled to serve notice on the contractor withdrawing or varying that approval with immediate effect if—
- (a) it is no longer satisfied that the proposed arrangement enables the contractor to satisfactorily meet its obligations under the contract, or
- (b) it is satisfied that immediate withdrawal of variation is necessary to protect—
- (i) the safety of the contractor’s patients, or
- (ii) the Local Health Board from material financial loss.
- (2) A notice served under this paragraph takes effect on the date on which it is received by the contractor.
PART 8 — Records, information, notifications and rights of entry
Patient records
78
- (1) The contractor must keep adequate records of its attendance on and treatment of its patients and must do so—
- (a) on forms supplied to it for the purpose by the Local Health Board, or
- (b) with the written consent of the Local Health Board, by way of computerised records,
or in a combination of those two ways.
- (2) The contractor must include in the records referred to in sub-paragraph (1) clinical reports sent in accordance with paragraph 10 or from any other health care professional who has provided clinical services to a person on its list of patients.
- (3) The consent of the Local Health Board required by sub-paragraph (1)(b) must not be withheld or withdrawn provided the Local Health Board is satisfied, and continues to be satisfied, that—
- (a) the GP digital services upon which the contractor proposes to keep the records meet the requirements set out in the National Framework Agreement for GP Clinical Systems and Services in Wales,
- (b) the security measures, audit and system management functions incorporated into the GP digital services are compliant with the National Framework Agreement for GP Clinical Systems and Services in Wales and have been enabled, and
- (c) the contractor is compliant with the “Welsh Information Governance Toolkit” and is aware of and has signed an undertaking that it must have regard to the guidelines contained in “The Good Practice Guidelines for GP electronic patient records (GPGv5)”, published on 20th September 2023.
- (4) Where the contractor’s patient records are computerised records, the contractor must, as soon as possible following a request from the Local Health Board, allow the Local Health Board to access the information recorded on the computer system on which those records are held by means of the audit function referred to in sub-paragraph (3)(b) to the extent necessary for the Local Health Board to confirm that the audit function is enabled and functioning correctly.
- (5) Where a patient on the contractor’s list of patients dies, the contractor must—
- (a) retain the complete medical records relating to that patient on their clinical computer system,
- (b) upon receiving an appropriate Health Record request, the contractor must send the complete records relating to that patient to the Local Health Board or the requestor, as the case may be, and
- (c) provide the complete medical records to the Local Health Board or requestor within seven days, where possible, beginning with the day the request was made, and in any event before the expiry of 40 days.
- (6) Where a patient on a contractor’s list of patients has registered with another provider of primary medical services and the contractor receives a request from that provider for the complete records relating to that patient, the contractor must, as soon as possible and in any event before the end of the period of 28 days beginning with the day on which it receives the request from the provider, send to that provider the complete records (other than any part held only in paper form), via the GP2GP facility in accordance with paragraph 80 and send to the Local Health Board—
- (a) the complete records, or any part of the records, sent via the GP2GP facility in accordance with paragraph 80 for which the contractor does not receive confirmation of safe and effective transfer via that facility, and
- (b) any part of the records held by the contractor only in paper form.
- (7) Where a patient on a contractor’s list of patients—
- (a) is removed from that list at that patient’s request under paragraph 28, or by reason of the application of any of paragraphs 29 to 36, and
- (b) the contractor has not received a request from another provider of medical services with which that patient has registered for the transfer of the complete records relating to that patient,
the contractor must send a copy of those records to the Local Health Board.
- (8) Where a contractor’s responsibility for a patient terminates in accordance with paragraph 37, the contractor must send any records relating to that patient that it holds to—
- (a) if known, the provider of primary medical services with which that patient is registered, or
- (b) in all other cases, the Local Health Board.
- (9) For the purposes of this regulation, “GP2GP facility” has the same meaning as in sub-paragraph (2) of paragraph 80.
- (10) To the extent that a patient’s records are computerised records, the contractor complies with sub-paragraphs ... (7) or (8) if it sends to the Local Health Board a copy of those records—
- (a) in written form, or
- (b) with the written consent of the Local Health Board in any other form.
- (11) The consent of the Local Health Board to the transmission of information other than in written form for the purposes of sub-paragraph (10)(b) must not be withheld or withdrawn provided it is satisfied, and continues to be satisfied, with the following matters—
- (a) the contractor’s proposals as to how the record is to be transmitted,
- (b) the contractor’s proposals as to the format of the transmitted record,
- (c) how the contractor is to ensure that the record received by the Local Health Board is identical to that transmitted, and
- (d) how a written copy of the record can be produced by the Local Health Board.
- (12) A contractor whose patient records are computerised records must not disable, or attempt to disable, either the security measures or the audit and system management functions referred to in sub-paragraph (3)(b).
- (13) In this paragraph, “computerised records” means records created by way of entries on a computer and “appropriate Health Record request” is a request made by the Local Health Board or one made under the Access to Health Records Act 1990.
Welsh GP record
79
- (1) Subject to sub-paragraph (2), a contractor must, in any case where there is a change to the information included in a patient’s medical record, enable the automated retrieval of summary information from the Welsh GP Record ... and the NHS Wales App, when the change occurs, using approved systems provided to it by the Local Health Board.
- (2) The enabling of automated retrieval of summary information from the Welsh GP Record must be for clinical use.
- (3) In this paragraph—
- “NHS Wales App” (“Ap GIG Cymru”) means the system managed by Digital Health and Care Wales for accessing and managing health appointments, prescriptions and personal details;
- “Welsh GP Record” (“Cofnod Meddyg Teulu Cymru”) means the system approved by the Local Health Board for the automated retrieval, storing and displaying of patient data relating to medications, allergies, adverse reactions and, where agreed with the contractor and subject to the patient’s consent, any other data taken from the patient’s electronic record;
- “summary information” (“gwybodaeth gryno”) means items of patient data that comprise the Welsh GP Record.
Electronic transfer of patient records between GP practices
80
- (1) A contractor must use the GP2GP facility for the safe and effective transfer of any patient records—
- (a) in a case where a new patient registers with the contractor’s practice, to the contractor’s practice from the practice of another provider of primary medical services (if any) with which the patient was previously registered, or
- (b) in a case where the contractor receives a request from another provider of primary medical services with which the patient has registered, in order to respond to that request.
- (2) In this paragraph, “GP2GP facility” means the facility provided by the Local Health Board to a contractor’s practice which enables the electronic health records of a registered patient which are held on the computerised clinical systems of a contractor’s practice to be electronically transferred securely and directly to another provider of primary medical services with which the patient has registered.
- (3) The requirements of this paragraph do not apply in the case of a temporary resident.
Clinical correspondence: requirement for NHS number
81
- (1) A contractor must include the NHS number of a registered patient as the primary identifier in all clinical correspondence issued by the contractor which relates to that patient.
- (2) The requirement in sub-paragraph (1) does not apply where, in exceptional circumstances outside of the contractor’s control, it is not possible for the contractor to ascertain the patient’s NHS number.
- (3) In this paragraph—
- “clinical correspondence” (“gohebiaeth glinigol”) means all correspondence in writing, whether in electronic form or otherwise, between the contractor and other health service providers concerning or arising out of patient attendance and treatment at practice premises including referrals made by letter or by any other means;
- “NHS number” (“rhif GIG”), in relation to a registered patient, means the number, consisting of ten numeric digits, which serves as the national unique identifier used for the purpose of safely, accurately and efficiently sharing information relating to that patient across the whole of the health service in Wales.
Use of fax machines
82
- (1) Where a contractor can transmit information securely and directly by electronic means other than facsimile transmission, the contractor must not—
- (a) transmit information to a relevant person by facsimile transmission, or
- (b) agree to receive any information from a relevant person by facsimile transmission.
- (2) Sub-paragraph (1) does not apply to information which relates solely to a patient under a private arrangement for the provision of clinical services or treatment.
- (3) In this paragraph “relevant person” means—
- (a) an NHS body,
- (b) another health service provider,
- (c) a patient, or
- (d) a person acting on behalf of a patient.
Confidentiality of personal data: nominated person
83
The contractor must nominate a person with responsibility for practices and procedures relating to the confidentiality of personal data held by it.
Provision of information to patients
84
- (1) The contractor must—
- (a) have an online resource,
- (b) provide the information specified in Schedule4 digitally on the practice’s online resource and ensure that a written practice leaflet containing the information specified in Schedule 4 is also available,
- (c) review the information provided in paragraphs (a) and (b) at least once every year, and
- (d) make its patients and prospective patients aware of the information contained on their practice’s online resource or how they can access this information in a written practice leaflet.
- (2) The contractor must make any amendments necessary to maintain the accuracy of the information on its online resource following—
- (a) a review under sub-paragraph (1)(c),
- (b) a change to—
- (i) the address of any of the contractor’s practice premises,
- (ii) the contractor’s telephone number,
- (iii) the contractor’s electronic-mail address (if made available on its online resource), or
- (iv) any other stated means by which a patient may contact the contractor to book or amend an appointment, or to order repeat prescriptions for drugs, medicines or appliances.
Provision of information (or access to information) at the request of the Local Health Board
85
- (1) Subject to sub-paragraph (2), the contractor must, at the request of the Local Health Board, produce to the Local Health Board or to a person authorised in writing by the Local Health Board, or allow the Local Health Board or a person authorised in writing by it, to access—
- (a) any information which is reasonably required by the Local Health Board for the purposes of or in connection with the contract, and
- (b) any other information which is reasonably required in connection with the Local Health Board functions.
- (2) The contractor is not required to comply with any request made in accordance with sub-paragraph (1) unless it has been made by the Local Health Board in accordance with directions relating to the provision of information by contractors given to it by the Welsh Ministers under section 12(3) of the Act.
- (3) The contractor must produce the information requested, or, as the case may be, allow the Local Health Board access to that information—
- (a) by a date agreed as reasonable between the contractor and the Local Health Board, or
- (b) in the absence of such agreement, within 28 days beginning with the date the request is made.
Clinical audits and the National Data Resource
86
- (1) A contractor must record and allow Digital Health and Care Wales to access any data required by the Local Health Board for the purposes of the National Clinical Audit and Outcome Review Programme for NHS Wales in accordance with sub-paragraph (2).
- (2) The data referred to in sub-paragraph (1) must be appropriately coded by the contractor using standardised coding and uploaded onto the contractor’s computerised clinical systems in line with the requirements of guidance published by Digital Health and Care Wales for these purposes.
- (3) The contractor must permit the extraction of patient level data by Digital Health and Care Wales for the purpose of undertaking clinical audits included in the National Clinical Audit and Outcome Review Programme (NCAORP) to support the management of the health and care system.
- (4) Contractors must consider practice level data from national clinical audits and take relevant and proportionate action to reduce any significant and unwarranted variation that is identified.
Information relating to indicators no longer in the Quality Assurance and Improvement Framework
87
- (1) A contractor must allow the extraction from the contractor’s computerised clinical systems by the Local Health Board of the information specified in the table below (Indicators relocated from the Quality Assurance and Improvement Framework) at such intervals during each financial year as are notified to the contractor by the Local Health Board.
- (2) A contractor must—
- (a) establish and maintain the registers specified in the clinical indicators listed in the column “Indicator Description” of the table below (Indicators relocated from the Quality Assurance and Improvement Framework),
- (b) where an indicator specifies a particular statistic, contemporaneously record the related data as part of chronic disease management, and
- (c) where the indicator specifies a particular requirement or activity, continually record details of the contractor’s compliance with any such requirements or activities.
| Indicator ID | Indicator Description |
|---|---|
| AF001 | The contractor establishes and maintains a register of patients with atrial fibrillation |
| CHD001 | The contractor establishes and maintains a register of patients with coronary heart disease |
| HF001 | The contractor establishes and maintains a register of patients with heart failure |
| HYP001 | The contractor establishes and maintains a register of patients with established hypertension |
| STIA001 | The contractor establishes and maintains a register of patients with stroke or TIA |
| DM001 | The contractor establishes and maintains a register of all patients aged 17 or over with diabetes mellitus, which specifies the type of diabetes where a diagnosis has been confirmed |
| AST001 | The contractor establishes and maintains a register of patients with asthma, excluding patients with asthma who have been prescribed no asthma-related drugs in the preceding 12 months |
| COPD001 | The contractor establishes and maintains a register of patients with COPD |
| DEM001 | The contractor establishes and maintains a register of patients diagnosed with dementia |
| MH001 | The contractor establishes and maintains a register of patients with schizophrenia, bipolar affective disorder and other psychoses and other patients on lithium therapy |
| CAN001 | The contractor establishes and maintains a register of all cancer patients defined as a ‘register of patients with a diagnosis of cancer excluding non-melanotic skin cancers diagnosed on or after 1 April 2003’ |
| EP001 | The contractor establishes and maintains a register of patients aged 18 or over receiving drug treatment for epilepsy |
| LD001 | The contractor establishes and maintains a register of patients with learning disabilities |
| OST001 | The contractor establishes and maintains a register of patients—1. Aged 50 or over and who have not attained the age of 75 with a record of a fragility fracture on or after 1 April 2012 and a diagnosis of osteoporosis confirmed on DXA scan, and2. Aged 75 or over with a record of a fragility fracture on or after 1 April 2012 |
| RA001 | The contractor establishes and maintains a register of patients aged 16 or over with rheumatoid arthritis |
| PC001 | The contractor establishes and maintains a register of all patients in need of palliative care/support irrespective of age |
| OB001 | The contractor establishes and maintains a register of patients aged 16 or over with a BMI of 30 in the preceding 15 months. |
| AF006 | The percentage of patient with atrial fibrillation in whom stroke risk has been assessed using CHA2DS2-VASx score risk stratification scoring system in the preceding 3 years (excluding those patients with a previous CHADS2 or CHA2DS2-VASc score of 2 or more) and a record of counselling regarding the risks and benefits of anticoagulation therapy has been made |
| AF007 | In those patients with atrial fibrillation with a record of a CHA2DS2-VASc score of 2 or more, the percentage of patients who are currently treated with anticoagulation drug therapy |
| DEM002 | The percentage of patients diagnosed with dementia whose care has been reviewed in person or, if clinically appropriate, via telephone or remote video consultation in a face-to-face review in the preceding 15 months. |
| DM002 | The percentage of patients with diabetes, on the register, in whom the last blood pressure reading (measured in the preceding 15 months) is 150/90 mmHg or less |
| DM003 | The percentage of patients with diabetes, on the register, in whom the last blood pressure reading (measured in the preceding 15 months) is 140/80 mmHg or less |
| DM007 | The percentage of patients with diabetes, on the register, in whom the last IFCC-HbA1c is 59 mmol/mol or less in the preceding 15 months |
| DM012 | The percentage of patients with diabetes, on the register, with a record of a foot examination and risk classification; 1) low risk (normal sensation, palpable pulse), 2) increased risk (neuropathy or absent pulses), 3) high risk (neuropathy or absent pulses plus deformity or skin changes in previous ulcer) or 4) ulcerated foot within the preceding 15 months |
| DM014 | The percentage of patients newly diagnosed with diabetes, on the register, in the preceding 1 April to 31 March who have a record of being referred to a structured education programme within 9 months after entry on to the diabetes register |
| COPD003 | The percentage of patients with COPD who have had a review, undertaken by a healthcare professional, including an assessment of breathlessness using the Medical Research Council dyspnoea scale in the preceding 15 months |
| MH011W | The percentage of patients with Schizophrenia, Bipolar affective disorder and other psychoses who have a record of blood pressure, BMI, smoking status and alcohol consumption in the preceding 15 months and in addition to those aged 40 or over, a record of blood glucose or HbA1c in the preceding 15 months |
| PC002W | The contractor has regular (at least 2 monthly) multi-disciplinary case review meetings where all patients on the palliative care register are discussed |
| FLU001W | The percentage of the registered population aged 65 years or more who have had influenza immunisation in the preceding 1 August to 31 March |
| FLU002W | The percentage of patients aged under 65 years included in (any of) the registers for CHD, COPD, Diabetes or Stroke who have had influenza immunisation in the preceding 1 August to 31 March |
The Wales National Workforce Reporting System
88
- (1) The contractor must update the workforce elements of the Primary Care Workforce Intelligence System to include—
- (a) head count and whole-time equivalents, and
- (b) a record of all new starters and leavers.
- (2) The contractor must access, review and update, where necessary, their Primary Care Workforce Intelligence System dashboard view at least once per month.
General Practice Escalation Tool
89
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