Background

In November 2021 NHS England identified £20 million funding over 3 years to implement emergency department (ED) opt out HIV testing in local authorities with high diagnosed HIV prevalence as part of the national HIV Action Plan. Partnering with the NHS England Hepatitis C Elimination Programme enabled the scope to expand to include testing for hepatitis B and C. This programme of routine blood-borne viruses (BBV) opt out testing in EDs launched April 2022. In participating EDs all adults who are having blood tests are tested for BBVs unless they opt-out. The First 100 Days Report and the 12-month interim report detail early outcomes and learning. In November 2023 £20 million of NIHR funding was announced to expand ED HIV testing to a further 47 sites in the form of research to evaluate the impact of expansion.

Purpose

This guidance is intended to support implementation of routine BBV opt out testing in EDs in a consistent manner that maximises uptake and linkage to care. These guidelines are informed by national guidance and models of good practice.

Context

England has made significant progress towards elimination goals for BBVs and reducing both preventable BBV deaths and the stigma associated with BBVs. However many people living with one or more of these BBVs remain undiagnosed or are diagnosed at a late stage. This is despite widely available, safe, effective and free treatments for BBVs. More needs to be done to expand testing to identify people living with BBVs earlier and EDs have a key role to play.

Opt out ED testing is an effective strategy to identify people living with undiagnosed BBVs and to support previously diagnosed people not in care to reengage. ED opt-out BBV testing supports the national HIV Action Plan’s commitment to end new HIV cases in England by 2030 (aligned to the World Health Organisation (WHO) and UNAIDS global HIV strategies), the WHO viral hepatitis elimination goals and a more inclusive and population-focused approach to elimination programmes.

Routine BBV testing in EDs builds on experience of HIV opt-out testing in EDs which has been successfully implemented in several EDs in the UK and Ireland and is supported by Fast Track Cities London, London HIV Community Advisory Group, London HIV Clinical Forum, Terrence Higgins Trust, National AIDS Trust , National Institute of Clinical Excellence (NICE), Royal College of Emergency Medicine (RCEM), the British HIV Association (BHIVA), British Association of Sexual Health and HIV (BASHH) and British Infection Association (BIA). Inclusion of routine hepatitis B and C testing in EDs is supported by UK Health Security Agency (UKSHA), Office for Health Improvement and Disparities (OHID), Hepatitis C Trust, the London Joint Working Group on Substance Use and Hepatitis C, the National Strategic Group on Viral Hepatitis and the NHS England Hepatitis C Elimination Programme.

1. Governance and oversight

1.1 The programme should be implemented by each integrated care system (ICS) with engagement of all relevant providers, specialty teams and voluntary sector and charitable organisations including those providing peer support. This would include at a minimum ED, local services for management of HIV and viral hepatitis (HIV, sexual health, hepatology, gastroenterology, infectious diseases, pathology, community organisations, IT, electronic patient record (EPR) and data/ business intelligence and public health).

1.2 A networked approach is recommended with ICSs taking overarching responsibility and governance for results management and delivery. At an ICS level there should be a named senior responsible officer (SRO), an operational lead, and named leads for data reporting and pathology.

1.3 There should be senior management and leadership oversight at each trust including a named SRO and named leads for each specialty area (HIV, hepatitis, emergency medicine, pathology).

1.4 Each site should develop their own standard operating procedure (SOP)s. SOPs should include end to end clinical pathways and data process flows with clear lines of responsibility and accountability for key elements including public facing communications, the testing process, staff training, pathology, IT, results management, linkage to care, data collection, reporting, monitoring, audit and evaluation.

2. Emergency department

2.1 Opt-out BBV testing should be normalised and considered part of routine care for people who are attending ED and having blood tests.

2.2 BBV opt-out testing should have minimal impact on ED staff efficiency and patient flow in the department and should ideally be delivered by existing ED staff.

2.3 All ED staff should be provided with training to carry out routine opt-out BBV testing, understand the rationale behind testing and how to signpost to further information.

2.4 Training should include clear and simple messaging such as “all adults are now routinely tested for HIV, hepatitis B and C unless they opt-out”.

2.5 EDs may wish to identify and train BBV testing champions to lead on updates and training, maintain momentum and support ED staff with opt-out testing.

2.6 Every effort should be made to secure accurate patient contact and GP details in ED to ensure that people with non-negative results can be contacted.

3. Opt-out testing

3.1 Routine BBV testing in EDs should be implemented using an opt-out approach.

For further information on the background and rationale for opt out HIV testing in EDs in areas of high diagnosed HIV prevalence, please see the BHIVA, BASHH, BIA and RCEM rapid guidance on opt-out blood-borne virus testing in high-prevalence and extremely high prevalence acute medical settings and emergency departments.

Key points in the implementation of the opt-out testing strategy include:

a. All adults attending ED who are having blood tests for any reason should routinely be tested for BBVs unless they opt out.

b. People should be informed using clearly visible, translated and accessible written information which is displayed throughout the ED (see section 4). 

c. Consent for opt out testing is based on pre-test information provided by posters, information leaflets or videos displayed in waiting rooms that BBV testing is included in routine blood testing or a medical investigation package. Consent is effectively given by allowing a healthcare worker to draw blood from the arm but without specific discussions about which conditions are being tested for and without the requirement of explicit, oral or written consent.

d. Pre-test counselling is not required for routine opt out HIV or BBV testing.

e. People attending ED should be informed about opt out BBV testing, including the option to opt-out and how to do so.

f. ED staff may wish to provide additional verbal information or reminders about BBV testing at the point of taking bloods. This would be appropriate if the patient is unable to see or understand visual publicity.

g. Use of simple or verbal prompts or reminders in staff training is recommended e.g.: “We now routinely test everyone for the common viruses: HIV, hepatitis B and hepatitis C along with the other blood tests you are having in A+E. If you would prefer not to have these tests done today, you can opt out.”

h. If patient requires or requests further information about BBV testing; testing should still be offered, and in addition there should be referral/ signposting to relevant specialist service.

3.2 Additional considerations for BBV testing: patients presenting with BBV indicator conditions and patients lacking capacity to consent.

Routine opt-out BBV testing is intended to be an opportunistic, population level testing programme. Additional considerations regarding BBV testing will apply in the following situations:

• Where the patient’s presentation to ED is thought to be BBV related and this will change management: In the event of a patient presenting to the ED with a suspected HIV, hepatitis B or C-related condition including HIV seroconversion, HIV indicator conditions and acute hepatitis expedited BBV diagnostic testing is advised with involvement of specialist teams as appropriate.
• If a patient is unconscious or otherwise lacks capacity to opt out of testing: BBV testing in someone who is unconscious or lacks capacity should be undertaken if it is considered to be in their best interests. HIV testing in the unconscious patient is further covered in the 2020 BHIVA HIV testing guidelines.

4. Public facing information

4.1 Key messages about BBV testing, and how to opt-out, should be displayed prominently in the ED, particularly in waiting areas and phlebotomy areas.

4.2 At the minimum public facing communications should include clear messaging on the following:

a. The opt-out nature of ED BBV testing and to speak to a member of staff if they wish to opt-out or discuss testing further.

b. BBV care and treatment is safe, effective and free.

c. BBV testing and results are confidential.

d. How results will be provided (“no news is good news”).

e. Public facing information should state that patients will only be contacted if they have a reactive or indeterminate result, or, if agreed locally, if there is a quality control issue (e.g. under filled sample).

4.3 Local SOPs should specify when the patient should expect to hear from the results team(s) in the event of a non-negative result: 14 days as a maximum is recommended.

4.4 How to seek further information.    

a. Trusts may wish to offer a “results phone line” or other point of contact where a patient can check their result or ask further questions about testing.
b. Sites should provide details of local services where patients can access BBV testing and information (for example local sexual health services and home testing or home sampling providers) – this may be useful for people who opt out of BBV testing in ED and for people who would like further information.

4.5. Local SOPs should develop appropriately cautious wording for local patient communications to reflect that while the intention is to test everyone and that every effort will be made to contact patients in the event of a non-negative result, the following caveats may apply:

a. In a small number of cases there may be BBV tests which are undertaken in ED but are not processed due to technical issues or human error.
b. If a patient’s details are incorrect or the patient is not able to respond to attempts to contact them, then there may be a delay in notifying them.

4.6 Ensuring accessibility of information:

Information should be available in a range of accessible formats including posters, banners and leaflets, digital and paper options, translations in at least the five most spoken languages and paper large print versions. There should be specific provision of accessible public facing information for people who are blind or partially sighted. A range of public facing communications materials will be made available by NHSE for sites to use, should they wish.

5. Pathology

5.1 For the purposes of this guideline BBV testing refers to testing to detect current infection with HIV, hepatitis B and Hepatitis C

5.2 The recommended tests are as follows:

• HIV: 4^th generation HIV antibody/antigen test
• Hepatitis B: Hepatitis B surface antigen
• Hepatitis C: Hepatitis C antibody with reflex RNA testing on the same sample if antibody positive. For sites that are unable to provide hepatitis C antibody with reflex RNA testing on the same sample, testing for hepatitis C with hepatitis C antigen is an acceptable alternative.

5.3 Failsafe automatic reporting of all non-negative results should be set up to report to all relevant parties as agreed in local SOPs (e.g. HIV/hepatology/infectious diseases) with clear protocols to ensure that all non-negative results are actioned.

6. Use of IT to increase ED BBV testing uptake: automated BBV test requesting and blocking duplicate testing

6.1 Trusts have achieved high and sustained uptake of BBV testing (>90%) in EDs through the use of automatic HIV/BBV test requesting when any blood test is ordered and automatic blocking to prevent duplicate testing in people who attend ED frequently.

Learning from Trusts who have achieved high and sustained uptake has informed the following recommendations:

a. BBV tests should be automatically added when any blood test is requested in ED. This removes the need for staff to manually add on  BBV testing. An automated system message such as “Added by system as part of ED BBV Testing” may be included.

b. Sites should consider implementing automatic “blocking” of BBV testing in people who attend ED frequently to minimise unnecessary testing.

c. In practice this means that the EPR system detects a recent BBV test in ED within a given period and flags an alert to the person requesting blood tests in the ED to check whether a repeat test is indicated. 

d. A blocking period of 12 months is recommended for all 3 BBVs, however sites should determine their local blocking period taking into consideration their local population, BBV epidemiology and resource constraints.

e. There must be an option for the clinician to override blocking if earlier repeat testing is indicated (e.g. new clinical or risk-based indication).

f. The opt-out triggered block on BBV testing should be automatically deleted after an appropriate time period (6 months is recommended). This means that BBV testing would automatically be blocked for 6 months following the person’s initial opt out, and if they attend the ED after 6 months, they will need to opt-out again.

6.2 Recording of opt out, blocking and initial reactive BBV results

a. Where feasible, opting out of BBV testing should be recorded on the person’s medical record, with the reason(s) for opting out.

b. Recording of opt-out on the system should automatically block ordering of BBV tests (including individual BBV tests) or generate a prompt for ED staff to deselect BBV tests from the order set.

c. Where feasible, recording of opt-out should generate a problem or condition on the person’s medical record including the date of decline: e.g. “BBV Testing Declined 11/2/22”.

d. Clinical and Pathology teams should work with EPR teams to develop appropriately cautious wording to accompany reporting of an initial non-negative BBV result on EPR. This should highlight that additional tests may be required to confirm a diagnosis and that positive and reactive results are managed by specialist teams who will contact and notify the patient. Other hospital specialists and GPs may be able to view initial BBV results before a patient has been informed, hence it is important that there is clear communication.

7. Results management

7.1 Delegation of results management for ED BBV testing to specialist services

a. ED Staff are not expected to manage non-negative results from BBV testing, nor are they expected to inform or counsel people about a reactive test result.

b. Results management of BBV opt out testing in EDs should be delegated to the appropriate specialist service for management of HIV, HBV and HCV in the Trust or Network who will notify the individual, organise confirmatory testing and facilitate linkage to care. This will typically be the HIV/GUM service for HIV results and the HCV Operational Delivery Network or local hepatology department for HBV and HCV results.

c. There should be automatic failsafe reporting of all non-negative BBV results to the relevant specialist services with clear protocols to ensure that all non-negative results are actioned.

d. Each site should develop a robust results management SOP which include end-to-end processes for recall, confirmatory testing, linkage to appropriate care and support services and management of quality control issues. It should be made clear in local SOPs the points at which clinical responsibility is transferred between different teams.              

e. Local SOPs should build on existing pathways for management of non-negative BBV results and should be suitable to manage the expected increased volumes of results generated by ED testing and additional considerations specific to ED testing.

f. ICSs should support ED, pathology and specialist clinical services to work jointly to agree on clear lines of responsibility and accountability for management of BBV results at each site. A networked approach is recommended with ICSs taking overarching responsibility and governance for results management and delivery.

7.2. Informing patients of a positive or reactive BBV result

a. All positive or reactive results should be automatically reported to and managed by the relevant specialist teams who will notify the individual, organise confirmatory testing and facilitate linkage to care and support.

b. ED staff are not expected to manage results from BBV testing as this should be delegated to specialist services.

c. In the event that an individual has a reactive or positive BBV test in ED and re-presents to ED before the specialist team have been able to inform them,  then the patient should be informed of their result by the ED team, with specialist input if available. There should be local pathways to ensure that someone who receives a positive or reactive result in ED will be seen by specialist services as soon as possible, ideally the next working day. ED should ensure correct patient contact and GP details are recorded.  

d. Inpatient teams should be informed if a patient has a reactive BBV test in ED and is subsequently admitted to hospital.

e. Specialist services should make all reasonable efforts to contact patients with a positive or reactive results. Local SOPs should define the process for attempting to contact patients with a result.

f. In the event that it has not been possible to contact a person who has had a positive or reactive HIV test in ED using all reasonable effort, we recommend the following steps:

i. In the event of a new HIV diagnosis (not known to local services) then the person’s GP should be contacted to notify them of the result and to seek their support in engaging the person in care
ii. If the person is known to be living with HIV but is not in care and has given consent to contact their GP then the GP should be contacted.
iii. If the person is known to be living with HIV but is not in care and has not given consent to contact their GP then a case by case approach should be taken including involvement of the MDT and taking relevant advice.

7.3. Management of negative results

A “no news is good news” approach for negative results is recommended. This means that the patient will only be contacted in the event of a positive or reactive result, and depending on local process, in the event of a quality control issue (e.g. under filled sample).

7.4. Quality control issues

a. Local protocols should be developed for quality control issues. This may include instances where a blood sample has been taken but BBV testing cannot be performed (e.g. under filled or unlabelled samples).

b. When there has been a quality control issue, it is recommended that the individual is notified and signposted to services where they can access a repeat test (e.g. the local sexual health clinic and/ or to home testing services).

7.5 Local audit and quality improvement activities

Trusts should undertake local audit and quality improvement to monitor ED BBV testing activities: recommended metrics include laboratory turnaround time, time to patient notification of reactive or positive results and proportion of failed samples (e.g. under filled or unlabelled). 

8. Resource allocation

8.1 Adequate resources should be allocated to the following key areas: staff training in EDs, ED testing, pathology, results management (including data entry, monitoring, reporting, audit and evaluation) and follow up (including peer support).

8.2 There should be adequate resource allocation to notify and engage people identified by ED BBV testing who have a previous BBV diagnosis but who are not in care, acknowledging that this group may require additional support.

9. Signposting to prevention/further support services

9.1 EDs should offer information on how to access local sexual health services, providers of home sexual health and HIV testing and sources of information and support around BBVs.

The following websites may be useful:

• the NHS.uk website signposts to local sexual health clinics, contraception and pregnancy services and help following a sexual assault
• information on where to get an HIV test can be found on the NHS.uk website
• free postal test for HIV and syphilis test kits are available from freetesting.hiv
• aAdvice and support about HIV can be found on the Terence Higgins Trust website and the National AIDS Trust website
• advice and support about hepatitis C can be found on the Hepatitis C Trust website
• free home testing kits for hepatitis C available from Hepatitis C Trust website
• advice and support about hepatitis B can be found on the British Liver Trust website
• peer support and information for people living with hepatitis B can be found on the Hep B Companion website

10. Peer support and community involvement

10.1 Peer support is an integral part of high quality BBV care. People differ in their emotional and psychological reaction to a positive BBV diagnosis and will require a range of community and peer support services. Information should be delivered in a culturally appropriate manner and language. Peer support can be vital to adjustment to their diagnosis, as well as supporting long-term condition management and adherence, and should therefore be integrated into their care and treatment. Particular attention should be given to vulnerable groups who may be at greatest risk of being lost to follow up or not engaged in services.

10.2 ICSs should ensure that services for newly diagnosed people are available and work with local community organisations and national groups to ensure that community and peer support is offered to all individuals who have a positive BBV diagnosis identified through ED testing. This offer should be co-produced with community organisations and integrated into the care and treatment pathway, in line with national standards for peer support, NICE guidance, BHIVA standards, and include the NHS England commissioned hepatitis C peer support. ICSs may wish to consider the use of peer and community support to help newly engaged people engage with services for initial evaluation.

11. Data collection, reporting, monitoring and evaluation

11.1 ICSs should work with sites to ensure robust processes and resources are in place to support data collection and reporting for the purposes of clinical care, programme assurance, audit, service evaluation and national surveillance.  

11.2 Data recorded by sites should include the following minimum set of core monitoring metrics. This is not intended to be an exhaustive list and will vary according to the BBV. 

Core monitoring metrics for sites undertaking ED BBV opt-out testing:

• BBV testing as a proportion of people attending ED who are having blood tests
• numbers of reactive tests
• proportion of reactive tests that are true positive results
• proportion of people with a positive test who are newly diagnosed and those who had previously been diagnosed
• proportion of those previously diagnosed who are in care vs. lost to follow up. 
• proportion of people with a reactive test who are contacted
• proportion of people with a reactive test who are offered peer/community support
• time to linkage to care
• time to starting treatment (acknowledging that not all people, particularly people living with HBV will start treatment)
• demographic data (age, ethnicity, gender and so on)

11.3 Data considerations for macro-level monitoring and surveillance.

a. Macro-level monitoring of the programme by UKHSA and NHSE will be mainly through the data submitted through the NHS Data Collection Framework and existing centralised data collection systems and data linkage to follow the person’s care pathway.

b. The systems include:  

• NHS Digital Hospital Episode Statistics (HES) Emergency Care Dataset (ECDS) for ED attendees and blood tests 
• UKHSA national BBV testing, diagnosis, care monitoring surveillance systems:
  • Sentinel Surveillance of BBV testing (SSBBV)
  • Second Generation Surveillance Systems (SGSS) for new diagnoses of notifiable organisms such as hepatitis B and hepatitis C  
  • HIV and AIDS Reporting System (HARS)
  • HIV and AIDS new diagnoses database (HANDD)
• National HCV Treatment Monitoring Registry  

Participation in the UKHSA Sentinel Surveillance of BBV testing (SSBBV) is of vital importance for the evaluation of this programme. SSBBV was initiated in England in 2002 and collects data on both positive and negative tests for hepatitis A-E, HIV, and HTLV, to estimate diagnosed prevalence in those tested, and enhance our knowledge and understanding of who is being tested, the types of services individuals are accessing for testing, and trends in numbers of positive diagnoses over time.

c. The recent 12-month interim evaluation report,  Emergency department bloodborne virus opt-out testing: 12-month interim report 2023 – GOV.UK (www.gov.uk), highlights the need to increase recruitment to SSBBV to improve representative coverage across sites participating in the programme.

d. SSBBV data is essential to the evaluation to be able to de-duplicate testing from different EDs, link between datasets and obtain patient demographic, clinical and risk information and assess outcomes, to understand the programme’s impact on healthcare access and outcomes.

e. For more information about whether your laboratory currently reports into SSBBV, and how to sign up, contact hepatitis@ukhsa.gov.uk

f. To support macro level monitoring and surveillance, data leads at sites should ensure: 

• accurate and consistent reporting to these systems, particularly NHS Digital HES/ECDS and UKHSA SSBBV
• laboratories are part of the SSBBV network
• agreed, standardised reporting metrics should be used. In addition to core metrics, measures for audit, monitoring equity, economic evaluation and quality assurance will be considered and introduced

g. Bespoke data collection may be necessary for some indicators that are not part of existing centralized systems – for example, proportion of people contacted with their result, and method of contact – unless these can be captured through site-specific / ICS systems and reported centrally.

h. Monitoring data also feeds into the evaluation of the programme, encompassing clinical/public health, economic and implementation optimisation, led by UKHSA in co-production with sites and stakeholders.

Contact for queries on this guidance

• Rachel Hill-Tout, Clinical Lead, ED BBV Opt out Testing, NHS England – London: R.Hill-Tout@nhs.net

Contact regarding support for: first wave ED opt out testing sites, research project sites in Midlands/South West/North West regions

• Stephen Hindle, Programme Manager NHS England Prevention and LTC team: stephen.hindle@nhs.net

Contact regarding support for: research project sites in South East/North East and Yorkshire/East of England regions

• Nicola Spencer, Programme Manager NHS England Prevention and LTC team: nicola.spencer7@nhs.net

Contact regarding support for hepatitis C funding and issues

• Georgia Threadgold, Senior Project Manager, NHS England Hepatitis C Elimination programme: georgia.threadgold@nhs.net
• Specioza Nabiteeko, Senior Project Manager, NHS England Hepatitis C Elimination programme: s.nabiteeko@nhs.net

For more information about whether your laboratory currently reports into SSBBV, and how to sign up to Sentinel Surveillance

• Sentinel Surveillance, UKHSA Sentinel Surveillance team: hepatitis@ukhsa.gov.uk

Publication reference: PRN01645