Gonorrhoea testing and management template service specification Gonorrhoea testing and management template service specification About Public Health England Public Health England exists to protect and improve the nation's health and wellbeing, and reduce health inequalities. It does this through advocacy, partnerships, world-class science, knowledge and intelligence, and the delivery of specialist public health services. PHE is an operationally autonomous executive agency of the Department of Health. Public Health England Wellington House 133-155 Waterloo Road London SE1 8UG Tel: 020 7654 8000 www.gov.uk/phe Twitter: @PHE_uk Facebook: www.facebook.com/PublicHealthEngland Authors: Iain Kennedy, Kate Folkard, Gwenda Hughes and Nigel Field. © Crown copyright 2014 You may re-use this information (excluding logos) free of charge in any format or medium, under the terms of the Open Government Licence v2.0. To view this licence, visit OGL or email psi@nationalarchives.gsi.gov.uk. Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned. Any enquiries regarding this publication should be sent to [insert email address]. Published August 2014 PHE publications gateway number: 2014 260 2 Gonorrhoea testing and management template service specification Contents _ Background 4 Service specifications 5 3 Gonorrhoea testing and management template service specification Background Gonorrhoea is a relatively uncommon sexually transmitted infection (STI) that is concentrated in core risk groups and is characterised by its potential to develop antibiotic resistance. These features provide challenges for effective testing, treatment and management of infection. Consequently, testing for gonorrhoea requires more detailed specification to address this complexity. This document provides information to be included in the specification for any service offering gonorrhoea testing, including using dual chlamydia and gonorrhoea nucleic acid amplification tests (NAATs). It is based on the national service specification for integrated sexual health services and should be included in the wider specification for the testing service. 4 Gonorrhoea testing and management template service specification Service specifications All subheadings for local determination and agreement. Service specification number Service Gonorrhoea testing and management Authority lead Provider lead Period Date of review 1. Population needs 1.1 National/local context and evidence base An overview of the epidemiology of gonorrhoea and the benefits and risks of testing, and including a tool to assist in making decisions about gonorrhoea testing, is available in guidance published by Public Health England (PHE).1 Further data on gonorrhoea diagnosis rates are available here. 2. Key service outcomes 2.1 Insert any locally agreed outcomes and quality requirements that are not quality outcome indicators that should be set out in Appendix ‘Gonorrhoea diagnosis and management quality outcome indicators’. 1 Guidance for the detection of gonorrhoea in England; including guidance on the use of dual NAATs for chlamydia and gonorrhoea. Public Health England. © Crown copyright 2014. 5 Gonorrhoea testing and management template service specification 3. Scope 3.1 Aims and objectives of service In addition to the aims and service objectives of the integrated sexual health service, the gonorrhoea service aims to improve sexual health by supporting: rapid and easy access to services for the prevention, detection and management (treatment and partner notification) of gonorrhoea to reduce prevalence and transmission the delivery of sexual health care across a locality as part of an integrated sexual health service through health promotion, information and advice, and comprehensive referral pathways the requirements of the National Chlamydia Screening Programme (NCSP), if the gonorrhoea service includes testing samples collected as part of the NCSP participation in service development activities such as service evaluation, audit and training and, if relevant, research 3.2 Service description/pathway The service will provide open access, cost effective, high quality provision for diagnosis and management of gonorrhoea, according to evidence based protocols and adapted to the needs of local populations. 3.2.1 Service Levels The service will provide gonorrhoea testing and access to gonorrhoea management via clinics and outreach provision based on an up-to-date sexual health needs assessment. Providers will ensure and demonstrate that pathways of care for service users diagnosed with gonorrhoea are formally agreed. The service will be delivered in broad accordance with the Level 1, 2 and 3 service model which is well established for sexual health service provision 2. In addition to elements provided as part of the generic integrated sexual health service, the gonorrhoea service will include the following elements: Access and arrangements for testing Gonorrhoea testing will be available from the following settings [insert list] Service users should be provided with necessary information and advice to make an informed decision about testing 2 Standards for the management of sexually transmitted infections (STIs).MEDFASH and BASHH. January 2014. http://www.medfash.org.uk/standards-forthe-management-of-stis 6 Gonorrhoea testing and management template service specification Consent must be obtained prior to testing. If more than one test is performed, including the testing of samples collected by the NCSP using dual NAATs, then service users must be able to consent or withhold consent, separately for each STI Laboratory arrangements2 3 4 Laboratories must be appropriately accredited with a nationally approved accreditation scheme, such as Clinical Pathology Accreditation (UK) Ltd (http://www.cpa-uk.co.uk/), now part of the United Kingdom Accreditation Service, and be seen to comply with the international standards for medical laboratory accreditation, ISO 15189 The laboratory should show active participation in an External Quality Assurance programme The laboratory should demonstrate compliance with national guidance for testing samples for gonorrhoea The testing algorithm should give a minimum positive predictive value (PPV) of 90%; this will usually require the use of a supplementary molecular test with a different nucleic acid target to confirm the result Laboratories should provide final reports on supplementary testing to the clinician within 10 working days of the specimen being received by the laboratory; aboratories should only issue positive test results which are confirmed to the testing service Laboratories should have capability to offer culture and antibiotic sensitivity testing for all patients with a confirmed gonorrhoea diagnosis Treatment5 Patients with a confirmed diagnosis of gonorrhoea should be treated according to latest guidelines developed by the British Association for Sexual Health and HIV (BASHH) and the Royal College of General Practitioners to ensure successful cure and to reduce risk of antimicrobial resistance5 6 Partner notification5 7 Partner notification should be carried out in patients with a confirmed diagnosis of gonorrhoea in accordance with national standards 3 Guidance for the detection of gonorrhoea in England; including guidance on the use of dual nucleic acid amplification tests (NAATs) for chlamydia and gonorrhoea. Public Health England. © Crown copyright 2014. 4 United Kingdom National Guideline for Gonorrhoea Testing 2012. Clinical Effectiveness Group, British Association of Sexual Health and HIV. (http://www.bashh.org/documents/4490.pdf) 5 Bignell, C., FitzGerald M.; UK national guideline for the management of gonorrhoea in adults, 2011; International Journal of STD & AIDS 2011; 22: 541–547 6 Sexually Transmitted Infections in Primary Care 2013 (RCGP/BASHH) by Lazaro N. ( www.rcgp.org and www.bashh.org/guidelines) 7 Standards for the management of sexually transmitted infections (STIs).MEDFASH and BASHH. January 2014. (http://www.medfash.org.uk/standards-forthe-management-of-stis) 7 Gonorrhoea testing and management template service specification Test of cure8 9 A test of cure (TOC) should be carried out for all cases of gonorrhoea to monitor treatment failure Treatment failure8 Suspected cases of treatment failure should be reported to PHE using this link: https://www.gov.uk/government/publications/reporting-gonorrhoeatreatment-failure STI screening8 Patients diagnosed with gonorrhoea are at high risk of other STIs and should be offered a full STI screen, including tests for syphilis and HIV (and chlamydia if not already performed) Referral The above steps can be performed by the service provider if they are competent to under the integrated sexual health services specification If the provider cannot meet the requirements for patients who test positive for gonorrhoea, then patients should be referred to a specialist service, usually a genitourinary medicine (GUM) clinic, for further management The provider should take steps to ensure there is a mechanism to minimise loss to follow-up for all patients, and in particular for those patients who are referred to a different service 3.3 Population Covered(Insert details of population area to be covered) 3.4 Any acceptance and exclusion criteria and thresholds A suitable testing algorithm should be in place to avoid high rates of false positive test results. The testing algorithm should give a minimum PPV of 90%. In almost all cases, because of low prevalence, this will require the use of a supplementary molecular test with a different nucleic acid target to confirm the result. 3.5 Interdependencies with other services Care pathways must be in place to ensure prompt and effective treatment of confirmed gonorrhoea, test of cure, partner notification and a full STI screen, according to national guidelines. If the service cannot meet these requirements, documented referral pathways to a specialist service for further management, usually a GUM clinic, should be in place. 8 United Kingdom National Guideline for Gonorrhoea Testing 2012. Clinical Effectiveness Group, British Association of Sexual Health and HIV. (http://www.bashh.org/documents/4490.pdf) 9 Guidance for the detection of gonorrhoea in England; including guidance on the use of dual nucleic acid amplification tests (NAATs) for chlamydia and gonorrhoea. Public Health England. © Crown copyright 2014. 8 Gonorrhoea testing and management template service specification 3.6 Any activity planning assumptions [Insert details of activity planning assumptions. These could be informed by PHE’s gonorrhoea testing guidance, section 2]10 4. Applicable service standards 4.1 Applicable national standards, eg NICE In addition to the standards laid out in the integrated sexual health service specification, the provider must ensure they operate in line with the following relevant standards: guidance for the detection of gonorrhoea in England, including guidance on the use of dual nucleic amplification tests (NAATs) for chlamydia and gonorrhoea (Public Health England, 2014)10 UK national guideline for gonorrhoea testing 2012 (BASHH Clinical Effectiveness Group, 2012)11 UK national guideline for the management of gonorrhoea in adults, 2011 (BASHH, 2011)12 Standards for the management of sexually transmitted infections (BASHH , 2014)13 If the service includes testing of samples collected by the NCSP tested with dual NAATs, then the standards contained in National Chlamydia Screening Programme Standards (7th Edition 2014)14 should also be met. 4.2 Applicable local standards [Insert local standards if applicable] 4.3 Data requirements All Level 2 and Level 3 testing services are required to generate a quarterly data extract of all STI tests and diagnoses, including those for gonorrhoea, performed.15 This reporting should meet the standards of the PHE Genitourinary Medicine Clinic Activity Dataset (GUMCADv2 16). 10 Guidance for the detection of gonorrhoea in England; including guidance on the use of dual nucleic acid amplification tests (NAATs) for chlamydia and gonorrhoea. Public Health England. © Crown copyright 2014. 11 United Kingdom National Guideline for Gonorrhoea Testing 2012. Clinical Effectiveness Group, British Association of Sexual Health and HIV. (http://www.bashh.org/documents/4490.pdf) 12 Bignell, C., FitzGerald M.; UK national guideline for the management of gonorrhoea in adults, 2011; International Journal of STD & AIDS 2011; 22: 541– 547. 13 Standards for the management of sexually transmitted infections (STIs).MEDFASH and BASHH. January 2014. (http://www.medfash.org.uk/standardsfor-the-management-of-stis) 14 National chlamydia screening programme standards (7th edition). Public Health England. © Crown copyright 2014. (http://www.chlamydiascreening.nhs.uk/ps/resources/core-requirements/NCSP%20Standards%207th%20edition%20FINAL.pdf) 15 Sexual health commissioning. Frequently asked questions. Local Government Association, February 2013. (http://www.local.gov.uk/c/document_library/get_file?uuid=de86daf2-19e3-42f4-95c8-29bb6cc80a65&groupId=10180) 9 Gonorrhoea testing and management template service specification The service is expected to discuss quarterly data reports, in addition to any further information provided by PHE, with commissioners to ensure services commissioned continue to meet the needs of the local population. Information about access to data reports using GUMCADv2 data is available here: https://www.gov.uk/genitourinarymedicine-clinic-activity-dataset-gumcadv2 5. Location of Provider Premises The Provider’s Premises are located at: [Insert service location] 6. Required Insurances 6.1 If required, insert types of insurances and levels of cover required 16 PHE Genitourinary Medicine Clinic Activity Dataset (GUMCADv2). Starter pack; Guidance to Clinic Staff; Technical guidance and specification for data extract.(https://www.gov.uk/genitourinary-medicine-clinic-activity-dataset-gumcadv2) 10