service specification for the provision of long-acting

Transcription

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
Dorset County Council
Dorset Procurement, Level 3, North East Wing, County Hall, Colliton Park, Dorchester, Dorset, DT1 1XJ
DORSET COUNTY COUNCIL
Public Health
1.
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INTRODUCTION
1.1
With the transfer of Public Health 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 Public Health 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
Public Health 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
1
teenage pregnancies are unplanned (of which approximately 50% lead to abortions ).
c)
The repeat abortion rate for all ages remains high at approximately 47% for Dorset,
2
Bournemouth and Poole .
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
3
Pearl Index of 0.0 (95% CI 0.00-0.09) .
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
4
contraceptives .
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%
5
condoms (where user error often results in unintended pregnancies) .
1
2
3
4
5
NICE Clinical Guideline 30 (2005) Long-acting reversible contraception guidelines
NHS South West Sexual Health Quarterly Outcome Indicator Report Q3 2012/13
Croxatto HB, Mararainen L. The pharmacodynamics and efficacy of Implanon: An overview of data.
Contraception 1998; 58: 91s-97s
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g)
Increasing the uptake of LARC methods should reduce the numbers of unintended
h)
pregnancies.
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
6
device .
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.
3.1
AIMS AND OBJECTIVES OF THE SERVICE
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
3.1.2
3.1.3
3.1.4
4.
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;
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;
to ensure that a specified and clinically appropriate contraceptive procedure is
conducted safely in by the primary care Provider;
to submit quarterly on-going audit and evaluation of service provision.
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
Public Health
4.2
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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;
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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 Public Health service schedule and shall report
their activity for payment to Public Health 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.
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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 providingpractice 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 Public Health Dorset GP LARC
Accreditation sheet (see Appendix 3) for all trained GPs when signing the service
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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 recertifying 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
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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 Public Health Dorset, Dorset County Council 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.
5.1
QUALITY STANDARDS
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.
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5.4
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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 Dorset County Council’s organised audit of service
provision.
5.10 The Provider shall fully co-operate with any national or Dorset County Council 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.
6.1
CONTRACT MONITORING
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 Public Health 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:
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•
the number of insertions;
•
the number of removals;
•
the number of removals and reinsertions.
6.3
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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 Dorset County Council.
The report shall
include, as a minimum:
6.4
•
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
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 Public Health Dorset, Dorset County Council, 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.
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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, Public Health
England or Dorset County Council 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
Dorset County Council will make payments for claims submitted on a quarterly basis if
th
the claim is received by the Public Health Team by 20 of the month following the said
quarter.
8.3
Dorset County Council 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 Public Health 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.
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8.6
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In order to receive payment under this public health service, the Provider must:
• make available to any additional information/evidence that Public Health 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
Public Health Dorset, Dorset County Council 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, Dorset County Council 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.
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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
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Appendix B: IUD SDI LARC Audit
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Appendix C: Public Health Dorset GP LARC Accreditation
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Appendix D - Further Information/For Signposting
Dorset single phone line
0300 3031948
Keep Love Sweet
http://www.chlamydiascreendorset.co.uk/
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F-risky
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http://www.f-risky.co.uk/
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service specification for the provision of long-acting

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