Download Vasectomy Service Specification

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 Vasectomy
Service
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
Domain 2
Domain 3
Domain 4
Domain 5
Preventing people from dying prematurely
Enhancing quality of life for people with long-term
conditions
Helping people to recover from episodes of illhealth or following injury
Ensuring people have a positive experience of
care
Treating and caring for people in safe environment
and protecting them from avoidable harm
X
X
2.2. Local defined outcomes
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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/clinicalguidance/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 ongoing 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;
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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:
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3.3.3.
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.
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
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.
3.3.4.5.
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.
3.3.4.7.
The Provider shall forward seminal analysis results to the patient and their
GP.
3.3.4.8.
The Provider shall maintain a register of all consultations, including failed
vasectomies and any postoperative complications
3.4. Confidentiality
3.4.1.
The Service shall be, and be known to be strictly confidential. A written
Confidentiality Policy shall be made available to patients upon request. Staff
should be able to demonstrate full understanding of the policy and be able to
communicate this to patients using the service.
3.4.2.
Confidentiality shall be maintained throughout the patients’ visit including the
minimal use of names in public areas such as the reception or waiting areas.
3.4.3.
In order to maintain confidentiality no information should be sent to the patient’s
home address unless the patient expressly wishes this.
3.4.4.
The Provider must ensure that information is not shared with anyone else
including the patients GP without consent.
3.4.5.
The Provider shall be expected to demonstrate that the collection, storage and
transfer of information to other services including that in electronic format is
secure and complies with any data protection requirements.
3.5. Consent
3.5.1.
The Service Provider will be expected to operate a policy for obtaining consent
that complies in all respects with the requirements of National Minimum
Standards and the Private and Voluntary Healthcare (England) Regulations
2001 and any other relevant guidelines.
3.5.2.
Competent consent is understood in terms of the patient’s ability to understand
the choices and their consequences, including the nature, purpose and
possible risk of any treatment (or non-treatment). In assessing competence the
Provider needs to refer to the Department of Health (DOH) Reference Guide to
Consent for Examination or Treatment (2001).
3.6. Population covered
The service will be available to all male patients who are registered with a North Derbyshire
CCG General Practitioner and/or who reside within the North Derbyshire CCG geographical
area, so long as they are not registered with a GP practice belonging to another CCG.
3.7. Acceptance and Exclusion Criteria
3.7.1.
Referrals will be accepted from:
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GP’s
Genito Urinary Medicine (GUM) Clinics
Contraception and Sexual Health (CASH)
Any other relevant agencies/clinicians
3.7.2.
Surgery should be delayed if the following conditions are present:
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3.7.3.
Surgery should be undertaken with caution if the following are present:
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3.7.4.
Previous scrotal surgery
Hydrocele
BMI>35
Drug or alcohol misuse
Community Vasectomy Services Exclusion criteria:
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3.8.
Scrotal skin infection
Active sexually transmitted disease
Balanitis
Epididymitis
Orchitis
Anybody under the age of 18
Lack of consent
Lack of capacity to give informed consent
Varicocele
Inguinal hernia (unless the vas can be easily isolated)
Cryptorchidism
Anticoagulant therapy
Coagulation disorders
A history of an allergy to local anaesthetic
Those deemed unsuitable for local anaesthetic
Scrotal skin infection
Active sexually transmitted disease
Balanitis
Epididymitis
Orchitis
Discharge Procedure (Transfer of Care)
3.8.1.
The Provider should give information to the patient on discharge which
explains the likely course of recovery including pain and bleeding and with
sufficient information to allow other clinicians elsewhere to deal with any
complications.
3.8.2.
The Provider will give information on symptoms indicating deviations from
the normal course of recovery and will explain to the patient how and when
to seek medical help.
3.8.3.
Patients should have a list of those complications that require urgent
medical consultation and should be given a 24 hour telephone helpline
number to ring if they have concerns.
3.8.4.
Urgent clinical assessment and emergency admission must be available if
necessary. This should be supported by written information which must be
available in languages and formats appropriate to patients using the
service. In most cases the local Acute Trust will deal with emergency
admissions.
Staff should be secured to stay beyond their contractual hours where necessary,
and this must be incorporated into the overall unit cost.
3.9.
Promotion and support of self-care
The service will promote a culture of encouraging informed decisions regarding healthcare.
The aim will be to facilitate self-care and patient/carer empowerment. The Provider should
ensure that patients are equipped with appropriate information and resources to facilitate
this.
3.10. Information provided to patients and carers
3.10.1.
Patients and carers will receive information on what they can expect from
the Provider, details of appointments, chaperone facilities, confidentiality
issues and contact details for the clinicians.
3.10.2.
Patients and carers will be informed of the vasectomy procedure, the
implications, the possible benefits and risks involved.
3.10.3.
Patients will be informed of the rationale for all onward referrals ensuring
they maintain their right to make choices.
3.10.4.
All information will be available in a variety of communication formats to
ensure that all those with visual or hearing difficulties or whose first
language is not English will not be disadvantaged. Professional interpreters
will be used as appropriate.
3.11. Interdependencies with other services
3.11.1.
Key professions that the Provider will be expected to develop effective links
with include:
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3.11.2.
General Practitioners (GPs)
Secondary care vasectomy service Providers
Accredited andrology services
Sexual Health and Contraceptive Clinic (SHACC)
Genito-Urinary Medicine (GUM)
Walk in Centres (WiCs).Interpreters
Any other appropriate service
Acute training provision
As all local non anaesthetic vasectomy procedures are now carried out in
the community within NDCCG, the Provider will be expected to make
reasonable provision for registrars/clinicians from the acute trust to come
and observe/train with the operating clinician whilst they are carrying out
vasectomy procedures, in order that they can gain experience which is
unavailable to them within the acute trust
3.12. Patient Experience
The Provider will undertake additional patient satisfaction surveys annually. The
information gathered by the patient satisfaction survey should be taken into account
when reviewing standards as part of clinical audit. This information should be made
available to the CCG as required.
3.13. Complaints
The Provider shall comply with NHS Standard Contract 2013/14 Service Conditions;
point 7.6.2, with regards to complaints.
3.14. Serious Incidents
The Provider shall comply with the North Derbyshire Clinical Commissioning Group
for reporting and management of serious incidents.
3.15. Monitoring Staff Quality
3.15.1.
Clinical audit should be undertaken annually as part of the annual appraisal
of any operating clinician(s) performing the vasectomy procedure and the
Provider must be able to demonstrate as part of this that their service has
acceptably low complication rates and high patient satisfaction scores.
3.15.2.
Support staff should be audited annually.
3.15.3.
All operating clinicians must have been trained to the standard advocated
by the Faculty of Family Planning and reproductive Health Care (FFPRHC)
and evidence of this must be seen by the Commissioner.
3.15.4.
Providers will be expected to demonstrate the regularity of the personal
development proposed for all members of staff on an annual basis.
3.15.5.
Providers must ensure that they are aware of and compliant with any
relevant Care Quality Commission Guidance and must be able to evidence
this.
3.15.6.
Providers will undertake an annual staff survey and results and any action
plan will be sent to commissioners.
3.15.7.
The Provider must be able to supply proof of/demonstrate compliance with
all sub-headings under point 3.15 at the request of the CCG.
4. Applicable Service Standards
4.1. Applicable national standards e.g. NICE, Royal College
4.1.1.
The Provider shall be aware of and involved in the below networks and
programmes as appropriate:
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Andrology
Microbiology
Infection Control
Code of Practice for the Prevention and Control of Healthcare Associated
Infections
The Health and Social Care Act 2008
The environment for the procedure must include completion of the Infection
Prevention
Quality Improvement Tool (QIT) for treatment rooms
All Providers will have CQC registration for surgical procedures.
4.2. Applicable local standards
4.2.1.
All Independent GPs performing the procedure will be registered as a GP with
Special Interests (GPSI) with North Derbyshire CCG
4.2.2.
The Provider shall ensure all relevant staff have been trained to perform
Vasectomy procedures to the standard advocated by the Faculty of Family
Planning and reproductive Health Care (FFPRHC)
The Provider and any relevant staff shall have enhanced DBS clearance.
4.2.3.
The Provider shall ensure all clinician(s) carrying out the vasectomy procedure
undertake a minimum of 40 procedures annually
4.2.4.
The Provider shall have in place and operate effective management systems for
prevention and control of healthcare associated infections (HCAI’s) Standards
relevant to premises requirements including:
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4.2.5.
Appropriate CQC registrations must be in place
A procedure for cleaning of the environment must be in place and audited
Hand hygiene training of staff involved
Equipment cleaning protocol must be in place
The Provider must demonstrate a clear process for decontamination and
sterilization of re-useable instruments using an accredited sterile services
company/provider (if applicable).
4.3. Provider Premises
4.3.1.
The Provider’s premises should be suitable for carrying minor surgery in a
general practice/primary care/ community setting.
4.3.2.
The Provider must ensure that the premises are conducive to ensuring the
dignity, privacy and comfort of patients.
4.3.3.
The Provider should ensure that the clinic is accessible for patients with mobility
concerns.
4.3.4.
The Provider should ensure that their premises are sufficient to provide adequate
space for the number of patients and their partners to wait before, during and
after a consultation.
5. Applicable quality requirements and CQUIN goals
5.1
5.2
Applicable quality requirements (See Schedule 4)
Applicable CQUIN goals
6. Patient Pathway
Patient Referred by own
GP through Choose & Book
Unsuitable referrals
to be referred on to
secondary care
within 5 working
days & pts GP
informed
Pre-op assessment, men’s
health promotion, consent
and counselling
Min. 2 weeks
between
assessment
and procedure
Procedure
Referred back to
Provider:
-Alternative
contraception
-Repeat procedure
-Refer to secondary
care
Semenology Testing
at 29 weeks
NO
Special
Clearance
YES
Initial Semenology Testing
12-20 weeks
SUCCESSFUL
UNSUCCESSFUL
Second Semenology Test
NO
Sample completely
clear of sperm
YES
Patient
Discharged