SCHEDULE 2 – THE SERVICES
A. Service Specifications
Mandatory headings 1 – 4. Mandatory but detail for local determination and agreement
Optional headings 5-7. Optional to use, detail for local determination and agreement.
All subheadings for local determination and agreement
Service Specification No. / NDCCG 20 VasectomyService / Non-Scalpel Community Vasectomy Service
Commissioner Lead / North Derbyshire CCG
Provider Lead
Period / 1st January 2016 – 31st December 2019
Date of Review / Annual
1. Population Needs
1.1. National/local context and evidence base
This service specification relates to the provision of a community vasectomy service.
Providers should have local strategies in place for providing information to both clients and professionals on the choices available within the service and on access to the service.
This Service Specification will be regularly reviewed and updated as necessary in order to maintain and improve the quality of the service. The Commissioners will review all available evidence regarding the service provision including the Healthcare Commission reports and reserve the right to revise the Service Specification in light of emerging new evidence.
Within North Derbyshire CCG there have historically been a range of differing contracts and service specifications. The aim of this service specification is to align the services across all of NDCCG to ensure consistent levels of care, performance and service accessibility for all our patients.
The primary approach to be undertaken in offering this service is to be No-Scalpel Vasectomy (NSV) This differs in the fact that it obviates the need for incisions: following infiltration of local anaesthetic, a clamp is employed to secure the vas without skin penetration. A sharp-tipped dissecting forceps punctures the skin and vas sheath, to stretch a small opening in the scrotum, enabling isolation and occlusion of the vas.
Globally, NSV has broadened the acceptability of vasectomy as a means for sterilisation, via allaying the fear of incisions. It has been suggested that this technique also benefits from fewer post-operative complications, without a reduction in efficacy.
Within the NHS, suitably trained general practitioners are able to offer NSV as a safe and reliable contraceptive procedure within the primary care setting as a minor surgery procedure. (A Bagade 2012 – from NHS Cambridgeshire paper No –Scalpel
Vasectomy Vs Conventional Vasectomy)
2. Outcomes
2.1. NHS Outcomes Framework Domains & Indicators
Domain 1 / Preventing people from dying prematurely
Domain 2 / Enhancing quality of life for people with long-term conditions
Domain 3 / Helping people to recover from episodes of ill-health or following injury
Domain 4 / Ensuring people have a positive experience of care / X
Domain 5 / Treating and caring for people in safe environment and protecting them from avoidable harm / X
2.2. Local defined outcomes
· Equity of care.
· Support delivery of care closer to home.
· To reduce the number of patients referred to secondary care.
· Improve patient experience.
3. Scope
3.1. Service Aims
The service will provide a quality and safe primarily no-scalpel technique vasectomy under local anaesthetic, in accordance with the Royal College of Obstetricians and Gynaecologist guidelines, (RCOG), in a primary care setting to all consenting adult males who request it, and are registered with a General Practitioner (GP) within NHS North Derbyshire Clinical Commissioning Group (CCG).
The RCOG guidelines can be found at: http://www.rcog.org.uk/womens-health/clinical-guidance/male-and-femalesterilisation
3.2. Objectives
3.2.1. To provide high quality, cost effective, local community vasectomy services for North Derbyshire CCG patients.
3.2.2. To provide services that comply with accepted best practice in line with national and local guidance, relevant accreditations processes, relevant guidelines in clinical practice and robust governance arrangements.
3.2.3. To provide a complete holistic patient focussed care package including pre and post-operative care, information, advice and counselling.
3.2.4. To provide an opportunity for men’s health promotion.
3.2.5. To ensure consistent and continuous care between health professionals, effective and efficient communication.
3.2.6. To improve access and convenience for patients.
3.2.7. To ensure patient choice of provider is maintained.
3.3. Service description/Care pathway
3.3.1. Access to the service
3.3.1.1. The Provider of the service will define their service on Choose and Book (and subsequently the forthcoming NHS E-referrals service), and will have an on-going responsibility to ensure that the information in the Directory of Service (which GPs and Practices will refer to) is accurate and kept up-to-date.
3.3.1.2. The Provider will ensure that referrals can be reviewed and, where appropriate, accepted through Choose and Book (and subsequently the forthcoming NHS E-referrals service). All clinically appropriate referrals must be accepted.
3.3.1.3. The Provider shall complete an initial triage assessment of the referral to ensure the patient appears suitable for a community vasectomy service within 3 working days of receipt of the referral.
3.3.1.4. The Provider shall offer an initial appointment for pre-op assessment and counselling within 10 working days of the referral. of referral being accepted as suitable.
3.3.1.5. The Provider shall offer an appointment for the procedure no earlier than 2 weeks and no later than six weeks after the pre-operative assessment to ensure a cooling off period is allowed.
3.3.1.6. The service Provider will not cancel appointments except in exceptional circumstances. Where exceptional circumstances do occur the Provider will inform the Commissioners in writing within 2 working days of the event.
3.3.1.7. The clinics will be provided to meet the needs of the patients; this can be outside of usual GP practice surgery hours.
3.3.2. Support, Advice and Assessment Appointment
3.3.2.1. The Provider will ensure that written information about the procedure and follow up care is given to the patient.
3.3.2.2. The Provider will offer a pre-operative appointment within four weeks of receipt of referral.
3.3.2.3. Vasectomy should be discussed in detail with all men requesting sterilisation (Recommendation 5**)
3.3.2.4. Pre-operative individualised assessment must include a process of counselling and consent. Counselling and advice on sterilisation will also include a full range of information about and access to other long term reversible methods of contraception. This should include information on the advantages, disadvantages and relative failure rates of each method.(Recommendation 4**)
3.3.2.5. The patient will be provided with individual care based on a holistic assessment.
3.3.2.6. All verbal counselling will be supported by accurate, impartial printed or recorded information (in translation, where appropriate), which the person requesting vasectomy may take away and read or listen to before the procedure. (Recommendation 3**)
3.3.2.7. The operating clinician will need to ensure that the counselling, information exchange, history and examination have been completed and be satisfied that the patient does not suffer from concurrent conditions which may require an additional or alternative procedure or precaution. (Recommendation 8**).
3.3.2.8. Men will be informed that vasectomy has an associated failure rate and that pregnancies can occur several years after vasectomy. Failure rate for vasectomy will be quoted as approximately 1 in every 2000 after clearance has been given. (Recommendation 45**)
3.3.2.9. Although men must understand that this procedure is intended to be permanent, they will be given information of the success associated with reversal should it be necessary. (Recommendation 46**)
3.3.2.10. Men should be informed that reversal operations or intracytoplasmic sperm injections are rarely available on the NHS as it is considered a low priority procedure and will only be considered in exceptional cases. (Recommendation 47**)
3.3.2.11. Men will also be reassured that there is no increase in testicular cancer or heart disease associated with vasectomy. The association of an increased risk of prostate cancer is at present likely to be considered to be non-causative. (Recommendation 48**)
3.3.2.12. Men will be informed of the risk of chronic testicular pain after vasectomy. (Recommendation 49**)
3.3.2.13. Counselling should take into account cultural, religious, psychosocial, psychosexual and other psychological issues, some of which may have implications beyond fertility. Healthcare Professionals will concentrate on factual information and avoid persuasion or any act that may be deemed coercive however clear the advantage of their recommended option appears to be. Additional care will be taken when counselling patients that;
· Are under the age of 30 years
· Have few or no children already (few usually relates to two or fewer)
· Are not in a relationship
· Are not in a mutually faithful relationship or that are in a crisis relationship
· May be making the decision as a reaction to a loss of a relationship
· May be at risk of coercion by their partner, family or health or social welfare professional (Timing relating to abortion or childbirth (Recommendation 2**)
** (Reference: Male and Female Sterilisation, Evidence-based clinical guideline number 4, Royal College of Obstetricians and Gynaecologists, 2004).
3.3.2.14. The assessment will include men’s health assessments such as body mass index (BMI), testicular self-examination (TSE), smoking cessation, alcohol, drugs, blood pressure check, urinalysis and sexual health screening.
3.3.2.15. If the patient is deemed unsuitable for the community vasectomy service after their assessment they will be referred on to secondary care by the Provider within 5 working days of their appointment via the Choose and Book system (and subsequently the forthcoming NHS E-referrals service).
3.3.2.16. The Provider will offer an appointment for the procedure no earlier than 2 weeks and usually no later than 6 weeks after the pre-operative assessment to ensure a cooling off period is allowed.
3.3.2.17. Due to the permanency of the procedure, if there are concerns about a person’s mental capacity to give informed consent, guidance from the Mental capacity Act (2005) and Making Decisions- guide for people who work in Health and Social Care (2005) must be adhered to.
3.3.2.18. Information will be available in other languages, if required.
3.3.2.19. Evidence of the understanding of the counselling should be obtained from both parties where possible. The patient documentation should cover:
· Details of the procedure to be undertaken and the arrangements that the patient should make on the day of the operation
· Details of the post-operative resting required and precautions that should be undertaken following the procedure until such time as the testing confirms the sterilisation is complete
· Details of any contra indications or complications that may occur as a result of this operation and how to access the Provider (not their registered GP) for advice or actions on any complications that may occur including those complications requiring urgent medical attention.
· The documentation should also include the agreed date of the operation (usually within 6 weeks of the counselling appointment). Where a patient wishes to delay surgery, details of how to access the service for an operation date when a decision to proceed is made, should be provided. (The open arrangement should not be offered more than 6 months after the initial counselling appointment.)
· Information should be accurately recorded regarding the history, counselling process, problems with the vasectomy and any follow up arrangements discussed.
3.3.3. Vasectomy Procedure
3.3.3.1. All vasectomies should be carried out under local anaesthetic.
3.3.3.2. A no-scalpel approach should be used to identify the vas deferens, as this results in a lower rate of early complications. The scalpel approach should only be used where factors in the individual case make the no-scalpel approach inappropriate.
3.3.3.3. In order to maintain continuity of service to patients, existing service Providers currently performing scalpel only procedures are allowed a maximum of 6 months from the date of service commencement under this Service Specification to retrain to perform the non-scalpel method. If the operating clinician is unable to find a suitable training within this timeframe he/she must inform the CCG as soon as possible.
3.3.3.4. It is expected that single use disposable equipment will be used wherever possible, or that the Provider uses an accredited sterile services provider.
3.3.3.5. The clinic environment should be suitable for delivery of an invasive procedure.
3.3.3.6. Division of the vas deferens on its own is not an acceptable technique because of its failure rate. It should be accompanied by fascial interposition or diathermy.
3.3.3.7. Clips will not be used for occluding the vas, as failure rates are unacceptably high.
3.3.3.8. Excised portions of the vas will only be sent to histological examination if there is any doubt about their identity.
3.3.3.9. New Providers/Operating Clinicians - If the Provider employs/has any other operating clinicians who are trained in performing Vasectomy procedures but have no prior experience then they will be supervised for 3 operating sessions or 15 procedures. GPs with relevant prior vasectomy experience will perform 5 supervised procedures.
3.3.3.10. The clinician who performs or supervises a trainee performing a vasectomy will take responsibility for the procedure even when discussion, examination and consent were undertaken by other Healthcare Professionals.
3.3.3.11. The Provider will ensure all relevant notes/records of the procedure are forwarded to the patients GP, ensuring that this complies with point 3.4.4, below.
3.3.4. Post Procedure Care
3.3.4.1. The Provider will ensure that post vasectomy care including emergency contact numbers (when and who to contact), pain relief, wound care, resuming normal activities including sexual intercourse, contraception prior to clearance and semenology testing is given to all patients.
3.3.4.2. The Provider is responsible for ensuring the provision of post vasectomy testing and ensuring that seminal analysis is carried out at a recognised laboratory.
3.3.4.3. Patients shall be advised to continue to use effective contraception until azoospermia has been confirmed by semen analysis done between 12 and 20 weeks in line with BAUS and the British Andrology Society guidance. Patients should also be advised to have had between 20-30 ejaculates prior to producing a specimen for testing.
3.3.4.4. Irrigation of the vas deferens during vasectomy does not reduce failure rates or time to clearance
3.3.4.5. The Provider shall advise patients on how to comply with seminal analysis and supply all necessary equipment to the patient in advance of the 16 and 20 week target.
3.3.4.6. The Provider will inform patients that they will require at least one clear seminal analysis result at 3 months post vasectomy before the vasectomy is considered successful in line with British Association No Scalpel Vasectomy recommendations. In a small minority of men, non-motile sperm persist after vasectomy. In such cases ‘special clearance’ to stop contraception may be given when fewer than 10,000/ml non motile sperm are found in a fresh specimen examined at least seven months after vasectomy, as no pregnancies have yet been reported under these circumstances.