Revised for: 1 April 2015 Updated: 16 April 2015 Appendix 2.2 SERVICE SPECIFICATION FOR THE PROVISION OF LONG-ACTING REVERSIBLE CONTRACEPTION SUB-DERMAL CONTRACEPTIVE IMPLANTS IN BOURNEMOUTH, DORSET AND POOLE
Page 2 of 21 1. INTRODUCTION 1.1 With the transfer of from the NHS to local authority in April 2013, Dorset County Council now has the responsibility for the commissioning of a range of local enhanced services, now known as Services and previously delivered by primary care in Dorset, Bournemouth and Poole. This new Service Specification for Long-acting Reversible Contraceptive (LARC), Sub-dermal Implant relates to the overall Contract for primary care. 1.2 This Service Specification for Long-acting Reversible Contraceptive (LARC), Sub-dermal Implant outlines the more specialised services to be provided above the essential and those additional services that Practices are contracted to provide to their Service Users. The General Practitioner shall incorporate national and local guidance in order to promote best practice in service development. 2. BACKGROUND 2.1 Evidence shows that: a) In the UK in 2003/4 over 80% women aged 16-49 who had sought contraception in the previous 5 years reported to have done so via their GP. All women seeking contraception should be offered an informed choice and advice on Long-acting Reversible Contraceptive (LARC) methods. b) It is estimated that around 30% of all pregnancies are unplanned, and the majority of teenage pregnancies are unplanned (of which approximately 50% lead to abortions 1 ). c) The repeat abortion rate for all ages remains high at approximately 47% for Dorset, Bournemouth and Poole 2. d) The effectiveness of the barrier method and oral contraceptive pills depends on their correct and consistent use. By contrast, the effectiveness of long-acting reversible contraceptive (LARC) methods does not depend on daily concordance. Contraceptive implants provide excellent contraceptive protection over a long period. Nexplanon which is the only contraceptive implant currently licensed in the UK is reported to have a Pearl Index of 0.0 (95% CI 0.00-0.09) 3. e) All currently available LARC methods are more cost effective than the contraceptive pill at one year of use with sub-dermal implants being more cost effective than injectable contraceptives 4. f) The use of contraceptive implants has increased significantly with a 36% increase on volume of scripts to 2009 in primary care. However, in Great Britain, LARC uptake generally remains low at 10% compared to 25% for the oral contraceptive pill and 23% condoms (where user error often results in unintended pregnancies) 5. 1 NICE Clinical Guideline 30 (2005) Long-acting reversible contraception guidelines 2 NHS South West Sexual Health Quarterly Outcome Indicator Report Q3 2012/13 3 Croxatto HB, Mararainen L. The pharmacodynamics and efficacy of Implanon: An overview of data. Contraception 1998; 58: 91s-97s 4 NICE Clinical Guideline 30 (2005) Long-acting reversible contraception guidelines 5 NICE Clinical Guideline 30 (2013) Long-acting reversible contraception guidelines
Page 3 of 21 g) Increasing the uptake of LARC methods should reduce the numbers of unintended pregnancies. h) The use of implants is one of two areas of contraceptive provision with relatively high levels of litigation. The most important factor influencing the incidence of problems relating to insertion and removal is the competence of the professional inserting the device 6. i) High quality information and advice influences client satisfaction and continuation rates 7, 8 with long acting methods of contraception. 2.2 Implant fitting and removal are not undertaken by all clinical practitioners in general practice. Maintaining expertise in fitting and removal can be difficult and requires commitment from the practitioner. 2.3 Contraceptive service providers who do not provide LARC within their own practice or service should have an agreed mechanism in place for referring women for LARC. 3. AIMS AND OBJECTIVES OF THE SERVICE 3.1 To reduce unintended pregnancies by offering more convenient access to contraceptive implants and, where clinically appropriate, providing this in a primary care setting. 3.1.1 to ensure that the full range of contraceptive options is offered by the Provider practice and increase the availability of LARC methods provided in a primary care setting; 3.1.2 raise awareness of the benefits of LARC by providing high quality advice, support and information on the full range of contraceptive methods, and particularly to women under the age of 25; 3.1.3 to ensure that a specified and clinically appropriate contraceptive procedure is conducted safely in by the primary care Provider; 3.1.4 to submit quarterly on-going audit and evaluation of service provision. 4. SCOPE OF SERVICE Service Description 4.1 The provision of contraception to sexually active women should be in the context of promoting good sexual health, including the prevention of sexually transmitted infections. In women under 25 years any review should include the routine offer of a Chlamydia screening test and for over 25s, where indicated following a risk assessment. 6 Harrison PF, Rosenfield A. research, introduction and use: Advancing from Norplant Contraception 1998: 58;323-34 7 Counselling key in Norplant satisfaction. Contraceptive technology Update 1999 Aug; 20(8): 90-1 8 Chikamata DM, Miller S. The health services at the clinic level and implantable contraception for women. Contraception 2002; 65: 97-106
Page 4 of 21 4.2 The Provider shall deliver a Contraceptive Implant Service as specified below: 4.2.1 undertake a review of sexual and reproductive history, to ensure that the contraceptive implant is the most appropriate method of contraception for the patient based on medical evidence, clinical guidelines, sexual history and practice, and risk assessment. Latest NICE guidance can be found at the following link http://nice.org.uk/cg30; 4.2.2 undertake a risk assessment to assess the need for STI and HIV testing before recommending the contraceptive implant and if clinically appropriate, signpost to asymptomatic screening through the single phone line or website. (See Appendix D) Where indicated, offer Chlamydia screening for completion in the Provider s practice to all under 25 years old and those over 25 years old at increased risk of Chlamydia (new partner; more than one partner in past year; regular partner has other partners); 4.2.3 provide information and pre-insertion counselling. Women who are considering using or who use LARC shall have the opportunity to make informed decisions about their care and treatment. Appropriate evidence-based verbal and written information about all contraceptive options should be provided to the Service User at the time of counselling, tailored to the needs of the individual woman, to ensure informed choice (Appendix D). Adequate consent is essential: the Service User should give informed consent for the procedure to be carried out in accordance with Department of Health guidelines. Understanding regarding implant use should be reinforced to the Service User at fitting with information on effectiveness, duration of use, side effects and those symptoms that require urgent assessment. NICE guidance for patients can be found via the following link: http://guidance.nice.org.uk/cg30/publicinfo/printfriendly/doc/english http://www.nice.org.uk/nicemedia/live/10974/44129/44129.pdf; 4.2.4 provide the fitting, monitoring, checking and removal of contraceptive implants, in line with current guidelines on best practice (eg NICE guidelines on LARC, Faculty of Sexual and Reproductive Healthcare (FSRH)). All implants used must be licensed for use in the UK and approved by the local formulae. The fitting and removal of contraceptive implants shall be in line with the most current Summary of Product Characteristics guidelines; 4.2.5 ensure follow up. Routine annual checks are not required: however, arrangements should be in place to review clients experiencing problems in a timely fashion. The practice shall also make arrangements to ensure timely access for women requesting removal of the implant for any reason including problems or at expiry of device. The implant should be removed or replaced within three years. The practice should have in place a call and recall arrangement for Service Users towards the end of life of the implant. In Service Users under the age of 25 years, any review should include the routine offer of a Chlamydia screening test; 4.2.6 maintain an up-to-date register of Service Users fitted with a contraceptive implant. This will include the type of device, number of fittings and removals, continuation rates, complications, reasons for removal, the name and designation of the person fitting/removing the device. This will be used for audit purposes;
Page 5 of 21 4.2.7 produce an annual review, which shall include an audit of the register of patients fitted with a contraceptive implant. Target Population 4.3 The Service shall be available to patients registered with the Provider signed up to this Service Specification and any patient referred by other practices which are not participating in the service provision. Inter-referral of Patients 4.4 Any arrangements to provide the Service to patients of other GP practices must be agreed with the Purchaser prior to commencement of any provision and acceptable contracting arrangements must be in place between the Provider and any other GP practices and approved by the Purchaser. Payment will not be paid for any Provision outside of these requirements. 4.5 The Provider practice providing the fitting and/or removal of the contraceptive implant shall be paid the same tariff as per the service schedule and shall report their activity for payment to Dorset. Accessibility 4.6 The Service shall be available during the Provider practice s contracted hours (i.e. 8.00am to 6.30pm) for 52 weeks of the year Premises and Equipment 4.7 The Provider shall have adequate mechanisms and facilities, including premises and equipment, as are necessary to enable the proper provision of this service. The premises should provide an acceptable level of privacy to respect a patient s right to confidentiality and safety. 4.8 Certain special equipment is required for the fitting of contraceptive implants. This includes provision of a suitable room, with couch and sufficient space and equipment for resuscitation. Suitable equipment for insertion and removal needs to be provided as well as facility for local anaesthesia to be administered. Infection Control 4.9 The Provider shall follow infection control policies that are compliant with national and local guidelines. Information Provision 4.10 The Provider shall provide appropriate verbal and written information to the Service User about the effectiveness, duration of use and side effects of all contraceptive options at the time of counselling and, reinforce after fitting, with further information on follow up and those symptoms that require urgent assessment.
Page 6 of 21 4.11 The Provider shall demonstrate a robust information service/source for Service Users and review regularly, based on patient feedback. Patient Data and Record Keeping 4.12 The Provider shall produce an appropriate GP record. A full recording shall be made regarding the Service User s clinical, reproductive and sexual history; the counselling process; the results of any STI screening; problems with insertion; the type, manufacturer, batch and number of the implant; expiry date of the device and follow-up arrangements; the type, manufacturer, batch number and expiry date of the local anaesthetic used; complications and date of removal. 4.13 The Provider shall ensure that the Service User s consent to a contraceptive implant is always recorded. 4.14 The Provider shall ensure an appropriate record of activity is developed and maintained for audit and payment purposes, which meets the requirements of this Service Specification. 4.15 The Provider shall record each episode in the lifelong patient record. 4.16 Where the Service User is not registered with the Provider s practice, the providing- practice shall ensure that the Service User s registered practice is given all appropriate clinical details for inclusion into the patient s notes. Patient Participation 4.17 The Provider shall ensure that Service Users are able to contribute to the planning of their own care and that opportunity for feedback is easily available. Staffing 4.18 The Provider shall ensure that all Employees providing the Service are suitably qualified and competent and that there are in place appropriate arrangements for maintaining and updating relevant skills and knowledge and for supervision. 4.19 The Provider shall ensure that lines of professional and clinical responsibility and accountability are clearly identified. 4.20 The fitting of contraceptive implants shall be undertaken by a qualified clinical practitioner. 4.21 The clinician carrying out the procedures listed in 4.2 above must demonstrate the relevant competencies to do so by completing the Dorset GP LARC Accreditation sheet (see Appendix 3) for all trained GPs when signing the service
Page 7 of 21 specification. Clinicians undertaking diagnostic tests, assessments and initiating and administering treatment must be adequately trained and supervised and have a responsibility for ensuring that their skills and knowledge are regularly updated. 4.22 Sub-Dermal Implant insertion requires a demonstration of skills involving counselling for implants; knowledge of issues relevant to implant use; problem management; observation of insertion and removal, followed by supervised insertion and removal of a minimum number of insertions and removals as specified by the FSRH/RCN (as appropriate); and assessment of competence by a Faculty/RCN approved assessor. 4.22.1 The practitioner shall provide evidence of maintaining skills, for example, by re- certifying according to FSRH/RCN regulations. 4.23 Recertification shall depend on meeting training requirements and continuing practical experience at a level adequate to maintain skills. This shall be shown by the production of a log of clinical experience. 4.23.1 All practitioners undertaking the full range of contraceptive fitting services shall either hold the Faculty accredited qualifications of the FSRH and LoCs or hold the locally agreed equivalent certificate of competence. If a practitioner holds a Local Certificate of Equivalent Competence they are required to achieve new Faculty of Family Planning standards. The Provider shall be contacted directly to advise of next steps and timescales for achieving these standards; 4.23.2 Existing fitters shall have a minimum of a current Local Dorset Certificate of Competence (CC) or LoC SDI through the FSRH route whilst they undertake the required refresh training under the new guidance; 4.23.3 New implant fitters shall obtain the DFSRH/ LoC SDI route and training can be accessed through the Contraceptive and Sexual Health Department (CASH), Lead Speciality Doctor (See Appendix A); 4.23.4 All Nurses shall follow the process recommended by the RCN for SDI accreditation (contact the Lead Speciality Doctor, CASH (See Appendix A)). 4.24 All clinicians undertaking procedures in relation to contraceptive implants shall be competent in resuscitation and, as for other areas of clinical practice; they have a responsibility for ensuring that their skills are regularly updated. Doctors/Nurses carrying out contraceptive implant fittings shall: 4.24.1 demonstrate a continuing sustained level of activity: each practitioner must fit or remove a minimum of 6 sub dermal implants per year, which includes at least one insertion and one removal; and
Page 8 of 21 activity shall be reported and monitored by the practitioner as specified in the GP Accreditation section of the audit (Appendix C); 4.24.2 take part in necessary supportive continuous professional development; 4.24.3 conduct quarterly audits (see Performance Monitoring and Audit Arrangements). 4.25 The Provider will ensure that health and safety, safeguarding, equality and diversity training is provided to staff involved in this Service. 4.26 The Service shall be provided in a user-friendly, non-judgemental, person-centred and confidential way. 4.27 The Provider shall provide evidence that appropriate plans have been prepared, where feasible dependent on patient list sizes and Employee numbers, for cover of leave (both anticipated and unanticipated) and succession planning for Employee turnover. 4.28 The Provider shall inform Dorset, promptly when there is a change in the Provider s Employees that will affect the delivery of the Service. 4.29 The Provider shall ensure that thorough recruitment and selection processes are in place which includes full tracking of previous employment history, two written references and the appropriate Disclosure and Barring Service (DBS) check. Clinical Incident Reporting 4.30 The Provider shall ensure that there is a robust system of reporting adverse incidents or serious untoward incidents, that all incidents are documented, investigated and followed up with appropriate action and that any lessons learnt from incidents are shared across the Provider s organisation. 4.31 Any adverse incidents that occur must be reported according to general policy/guidance for clinical incident reporting. 5. QUALITY STANDARDS 5.1 The Provider shall demonstrate that all practitioners and Employees involved in the provision of the Service have successful completion of CPD relevant to the provision of the Service. 5.2 The Provider shall demonstrate compliance with all relevant national standards for service quality and clinical governance including compliance with the Code of Practice for Infection Control and relevant NICE guidelines. 5.3 The Provider shall demonstrate that a system of clinical governance and quality assurance is in place ensuring registration with appropriate quality bodies i.e. Care Quality Commission.
Page 9 of 21 5.4 All infection control, decontamination measures and sterilisation of equipment must meet the standards within the Health and Social Care Act (2008) and it s associated Code of Practice for Health and Social Care on the Prevention and Control of Infections and related guidance. 5.5 The Provider shall fully comply with the Pan-Dorset s Multi agency Safeguarding Adults Policy and the Pan Dorset LSCB Inter-Agency Procedures for Children and Young People. 5.6 The Provider shall ensure that relevant safety alerts and Medical & Healthcare Products Regulatory Agency (MHRA) notices are circulated to staff and acted upon where necessary. 5.7 The Provider shall address complaints from patients in relation to this Service through the Practice s own complaints procedure in the first instance. If further help is required, contact the Purchaser as detailed in this Contract. 5.8 The Provider shall ensure that a process is in place for any member of the professional team to raise concerns in a confidential and structured way. 5.9 The Provider shall participate in s organised audit of service provision. 5.10 The Provider shall fully co-operate with any national or led assessment of service user experience. 5.11 The Provider shall demonstrate that clear and accurate records are kept. 5.12 The Provider shall ensure that the provision of treatment and care takes into account women s individual needs and preferences. 5.13 The Purchaser shall undertake visits to the Provider s practice as appropriate as part of quality monitoring, verification of claims and payments and to ensure that the Provider is meeting the Service Specification. 6. CONTRACT MONITORING 6.1 The Provider shall ensure an appropriate record of activity is developed and maintained for audit and payment purposes, which meets the requirements of this Service Specification. 6.2 The Provider shall provide quarterly activity data to Dorset, Dorset County Council in respect of the Service within 1 calendar month following the end of each quarter during the year using the electronic monitoring return provided (see Payment). Activity data shall include:
Page 10 of 21 the number of insertions; the number of removals; the number of removals and reinsertions. 6.3 The Provider shall carry out a quarterly audit of the Service using the IUD SDI LARC Audit (See Appendix B). The audit template details the following activity at Service User and Provider practice level: Insertions Removals Patients with a complication A practice action plan The results of this audit shall be reported to. include, as a minimum: The report shall Service User postcode Service User age Service User age at time of fitting or removal Venue of original fitting If an STI risk assessment has been completed Chlamydia test result, where completed Removals and reasons why Service User feedback on the Service 6.4 Where the Provider-Practice is providing the Service on behalf of another GP practice, the data shall be recorded in the quarterly audit. 6.5 The Provider is required to meet the monitoring and reporting requirements as laid out within this Service Specification. 6.6 The Provider shall ensure that the necessary documentation, as detailed in this Service Specification, is maintained and made available to the Purchaser to enable the Service to be monitored and for the purpose of post payment verification. 6.7 The Provider must inform Dorset,, at the earliest opportunity, if there is a significant disruption to the Service in order that continuity can be maintained through an alternative provider. 6.8 The Provider Practice shall need to have in place the IT infrastructure and functionality to ensure data capture and submission.
Page 11 of 21 7. SERVICE SPECIFICATION REVIEW 7.1 It is recognised within this Service Specification that the Service may be subject to change due to a range of national and local policy initiatives. For example, government guidance and legislation, industry professional standards, NICE Guidance, England or Policy. 7.2 This Service Specification shall be reviewed annually taking into consideration a financial review of the Service, any service developments and/or changes in legislation. Three months notice will be given to the Provider of any significant changes which may impact on the service provided and will ensure sufficient transition arrangements are secured to ensure service continuity. Less significant changes may be made following an appropriate period of consultation with the Provider. 8. FINANCIAL INFORMATION Payment and Reimbursement Structure 8.1 The following fees will be paid to the Provider for each procedure undertaken and are inclusive of all related costs and consumables: 8.1.1 a fee of 45.00 for the insertion of a sub-dermal implant; 8.1.2 a fee of 60.00 for the removal of a sub-dermal implant: 8.1.3 a fee of 70.00 for the removal and reinsertion of a sub-dermal implant; 8.1.4 a fee according to the current British National Formulary (BNF) rate for the subdermal implant (plus VAT at 5%) The current fee as stated in the BNF (April 2015) is as follows (excluding VAT): Nexplanon 83.43 Please note this fee is subject to change and any updates should be accessed via the British National Formulary (BNF) Claims for Payment 8.2 will make payments for claims submitted on a quarterly basis if the claim is received by the Team by 20 th of the month following the said quarter. 8.3 will make payment in line with the payment for other public health services provided by the practice. Providers must submit a quarterly claim using the electronic Local Authority Claims provided by Dorset, Dorset County Council. 8.4 No claims will be considered if they are submitted more than one quarter in arrears. 8.5 No claim should be submitted more than one month after the end of this agreement.
Page 12 of 21 8.6 In order to receive payment under this public health service, the Provider must: make available to any additional information/evidence that Dorset, Dorset County Council requires, in order to establish whether the Provider has fulfilled its obligation under the Contract arrangements; make the returns required of it promptly and fully. This includes using the electronic Local Authority Claims provided and provision of audit data to coincide with the submission of the relevant quarter s payment claim; and ensure that all information supplied is accurate. 8.7 Dorset, reserves the right to undertake post payment verification of any claim. 8.8 If the Provider breaches any of the conditions specified in this Service Specification, including the timescales for claiming and audit, may, in appropriate circumstances withhold payment of any or any part of, any payment that is otherwise payable. 8.9 It is the Provider s responsibility to ensure that payment claims are accurate. Dorset County Council will not normally make any backdated payments in relation to inaccurate claims except at its discretion where the provider can demonstrate exceptional circumstances.
Page 13 of 21 The documentation presented in the Appendices is for illustration purposes only and will be sent to practices electronically to enable their quarterly returns. Please note that the electronic templates issued to Providers will collect post code data separately to meet information governance requirements Appendix A: Qualification and Recertification Information and access to training: Dr Alison Vaughan, Lead Speciality Doctor, Contraceptive and Sexual Health Service (CASH), DHUFT. alison.vaughan@dhuft.nhs.uk 0300 3031948
Page 1414 of 21 Appendix B: IUD SDI LARC Audit
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Page 1717 of 21 Appendix C: Dorset GP LARC Accreditation
Page 1818 of 21 Appendix D - Further Information/For Signposting Dorset single phone line 0300 3031948 Keep Love Sweet http://www.chlamydiascreendorset.co.uk/
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Page 2020 of 21 F-risky http://www.f-risky.co.uk/
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