Operating a Checkpoint

Regulatory and Legal Frameworks

National laws and regulations as well as the standards and codes of conduct of regulated professions govern the operations of health and social services. CBVCTs may fall under one or several of these frameworks.

This checklist asks questions about the main legal aspects of operating a CBVCT. Because regulatory and legal frameworks differ from country to country, it is important to find out exactly what is required in your situation. It may be helpful to get legal advice if you are unsure.

Item Does your CBCVT have this in place? Is there a documented standard, guideline, plan, policy, procedure, contract or agreement? Is it adapted to local needs and conditions? Is it working as intended? Action
Authorisation for testing
Description

Description

National laws regulate the use of medical and diagnostic devices, including HIV tests. Formal authorisation to conduct a specific type of test may be required. CBVCTs aiming to offer testing technologies that maximise uptake by MSM are therefore often forced to operate in a legal ‘grey’ area.

 

Guidance

Guidance

A key advantage of CBVCT services targeting MSM is their ability to provide a more or less immediate result, even though it may require confirmatory testing if reactive. This means most CBVCTs offer a form of rapid HIV testing using oral fluid or a capillary blood sample.

Laws and regulations may prohibit anyone other than a medical professional to conduct such tests and interpret the results. National health authorities provide information on which tests are approved for use and under which conditions.

The COBATEST Guide to doing it better’ (Chapter 3.4)’ offers detailed guidance on test options and criteria for selecting them: reliability, availability, acceptability, the time it takes to obtain a result, price etc.

It is important to remember that testing technology is evolving and new options become available from time to time. The European Centre for Disease Prevention and Control (ECDC) and WHO websites provide current advice and recommendations. Any new test must also be approved on the national level before it can be used at a CBVCT.

 

Adaptation

Adaptation

When new testing technologies become available on the global market, national regulations and approvals are required before a medical test can be used legally. In addition, national regulations may impose restrictions on the settings and type of personnel authorised to administer each testing technology.

Some CBVCT initiatives began testing using non-medical staff and volunteers, in many cases MSM peers, with the support of partners such as hospitals and laboratories or in the form of pilot, demonstration or research projects. Creating a precedent first, they then used their successes in detecting HIV infection and linking patients to care to advocate for formal exemptions or permanent changes to the rules.

Informing clients and obtaining their consent can help obtain permission to conduct testing in a community setting, e.g. “I agree to be tested having been informed that the person performing the HIV (syphilis, hepatitis) test is not a medical professional, but is trained in performing the test and interpreting the result.”

In addition, it is important to know the preferences of the key population in order to select the testing technology that will maximise access and uptake of HIV testing. Studies have revealed different local preferences, e.g. regarding oral fluid or blood samples in different settings.

 

Quality improvement

Quality improvement

If you do not have data regarding the needs and preferences of your key population, it is important to investigate them in a structured way in order to base your selection of testing technology on reliable information and to assess and improve it further in the future.

Selecting testing technology directly influences how clients experience the CBVCT service; it determines, for example, how the sample is obtained, how long clients have to wait for results and in which settings, including outreach, the test can be offered.

To obtain needs assessment data for your initial selection of testing technology or to improve it later, the PQD (Participatory Quality Development) tool available on  www.qualityaction.eu offers a range of easy to use methodologies such as Rapid Assessment or Focus Group, including step-by-step instructions.

 

Action plan

Action plan

This Action Plan helps you to work directly on the items identified as priorities (yellow and/or red fields in the Checklist). Please list actions that are as specific as possible. You can download your finished Action Plans for each section as an xlsx.-document and print it afterwards. The Action Plans form the basis for your further planning, implementation and evaluation.

The Action Plan shows a sequence of steps to be taken, or activities to be performed for a strategy to succeed. The Action Plan has four major elements: (1) what will be done (specific tasks), (2) by whom (responsibility), (3) by when (timeframe), and (4) how the implementation of the task will be monitored.

 


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Compliance with labour laws
Description

Description

Depending on local regulations and conditions, CBVCTs may employ clinical staff as well as social workers, counsellors and office workers. National labour laws may prescribe the way you can contract staff, their working hours and their remuneration. There may also be national laws governing volunteer work.

 

Guidance

Guidance

In general, MSM checkpoints, as a type of CBVCT service, aim to operate with personnel that are MSM themselves or as close to the MSM community as possible (often called ‘peers’, see also the COBATEST ‘Guide to doing it better’, Chapter 3.3).

If health professionals are required to operate a CBVCT, offering attractive positions may be difficult, especially if operations begin on a smaller scale that does not provide the scope for full-time work.

 

Adaptation

Adaptation

For some professional groups, there may be options other than being employed directly by your organisation. For example, doctors and nurses employed by other institutions such as hospitals, sexual health clinics or public health authorities may provide services at the CBVCT by agreement with their host organisation.

Social workers, counsellors and psychologists may also be based at the CBVCT without being employees, on a contract basis or as volunteers.

Options for reducing costs:

  • Identifying roles that can be performed by volunteers
  • Sharing specialist staff with other organisations

 

Quality improvement

Quality improvement

Quality improvement tools that include sections on the skills required to achieve objectives can improve the match between the requirements of operating a CBVCT and the staffing structure and job descriptions used.

The Succeed, QIP (Quality in Prevention, both available at www.qualityaction.eu), EQUIHP (European Quality Instrument for Health Promotion,  www.ec.europa.eu) and Quint-Essenz ( http://www.quint-essenz.ch/en) instruments also contain sections on human resources that can be used to improve this aspect of CBVCT set-up and operations.

 


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Compliance with data protection laws
Description

Description

Data protection laws govern the collection, processing, storage, use and movement of the data of living people.

 

Guidance

Guidance

Personal data play a role in all health services, including CBVCT. It is important to check the applicable local laws and regulations to ensure the CBVCT complies with them in all its operations.

The European Commission has published a new regulation and a directive on data protection, which Member States must integrate into their national law by 6 May 2018. This EU law means that organisations can collect and manage personal information legally only under strict conditions and for a legitimate purpose, must protect it from misuse and respect the rights of the data owners ( http://ec.europa.eu/).

In addition, most CBVCTs promote ‘anonymous’ and/or ‘confidential’ services. Anonymous means that a client does not need to disclose any personal details to obtain testing (e.g. through the use of a random code). Confidential means that any personal details that clients do disclose are not passed on or accessible to third parties (e.g. by storing personal information separately from the code used for the testing process). Please see the section on counselling for additional details.

 

Adaptation

Adaptation

To comply with national data protection laws, CBVCTs may need to adapt their operations, specific processes or forms.

This may mean, among other tasks:

  • Checking what kinds of personal data the CBVCT collects from individuals (staff and volunteers as well as clients) as part of its normal operations
  • Modifying the way questions are asked and forms are worded
  • Ensuring that consent is given in compliance with the law
  • Checking how data are stored, processed and passed on (e.g. as part of making appointments, risk assessment, referral or research)
  • Ensuring that information technology systems are sufficiently protected from unauthorised access.

 

Quality Improvement

Quality Improvement

Checking for changes to data protection laws and regulations as part of regular quality improvement activities helps ensure that all processes involving personal data are changed to reflect them.

NGO umbrella organisations may offer legal updates as part of the services they provide to members. If not, it is important to investigate any new laws or regulations that may impact on the CBVCT, including those on data protection.

 


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Professional standards
Description

Description

Professional standards are work processes and codes of conduct that are described and agreed upon by professional associations. To become and remain a registered member, the worker is expected to adhere to the standards of her or his profession. This may include regular membership renewal and ongoing training.

 

Guidance

Guidance

Many of the professions that provide services at CBVCTs – such as medical doctors, nurses, psychologists, social workers and counsellors – are subject to professional standards. Depending on local regulations, they must be registered with their professional governing body or association to be permitted to exercise their profession.
Professional standards vary from country to country, but there are international professional organisations that provide general principles and examples of national codes of ethics (e.g. the International Federation of Social Workers:  www.ifsw.org)

 

Adaptation

Adaptation

It can be helpful for clients to have access to professional standards stating how they can expect to be treated, e.g. in regard to confidentiality.

CBVCTs can, for example, display a copy of the nurses’ or counsellors’ Code of Conduct in the waiting area or the counselling room, or develop a specific Code of Conduct for all their staff and volunteers and display it.

Example:
‘Agencies should establish an ethical code of conduct for their HIV testing services, which should be read and understood by all testing providers. This code of conduct should clarify that HIV testing providers should not use or be under the influence of alcohol or drugs while on duty; have sex with clients; exchange money with clients; or engage in other inappropriate behavior with clients. Agencies should establish and enforce these boundaries to protect their staff and their clients, and to ensure clients receive high-quality HIV testing services.’

Implementing HIV Testing in Nonclinical Settings

A Guide for HIV Testing Providers

US CDC, Centre for HIV, Viral Hepatitis, STD and TB Prevention

http://www.cdc.gov/hiv/testing/nonclinical/

 

Quality Improvement

Quality Improvement

Professional associations are likely to conduct their own reviews and improvement processes for official professional standards. However, if you have developed a Code of Conduct or similar document to set a standard specific to your CBVCT, it is important to review the document from time to time with the participation of key stakeholders, including the key population, staff and volunteers.

The PQD (Participatory Quality Development) tool available on  www.qualityaction.eu offers step-by-step guides for a range of methods to increase participation.

 


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Professional responsibilities and liability
Description

Description

The law may require clearly allocated overall responsibility for the CBVCT and for particular functions. Regulations may hold particular professions or positions within an organisation liable for any claims against the CBVCT.

 

Guidance

Guidance

Having the responsibility for tasks clearly allocated within the team as well as with any visiting professionals facilitates management and also helps clients understand whom they can approach with particular needs.

CBVCTs use organisational charts that allocate responsibilities. It helps if these are closely related to the flowchart of CBVCT operations. Individual duty statements and job descriptions that complement the flowchart then help with recruitment, training and supervision.

Example:
Athens Checkpoint organisational chart (HCDCP = Hellenic Centre for Disease Control and Prevention; Positive Voice = Seropositive Association of Greece, founded in 2009 to combat the spread of HIV and to reduce its social and economic impact in Greece)

 

Adaptation

Adaptation

Responsibilities and duties can be adapted to the mode(s) in which the CBVCT operates (e.g. as a permanent checkpoint, as a temporary checkpoint, with or without mobile units or outreach activities) and to legal requirements. The responsibilities of different professions and positions vary locally. The organisational chart will also vary according to the roles that volunteers take on within operations.

 

Quality Improvement

Quality Improvement

Reviewing operational charts and individual duty statements regularly is part of quality improvement. Participation of the team and individual staff members will increase creative ideas for improving efficiency and client service.

Some CBVCTs have many people contributing as paid staff and volunteers at different times, which means that it is difficult to have meetings with everyone present. A number of short Focus Groups or a Rapid Assessment survey can help identify ways to improve organisational structure. The Participatory Quality Development (PQD) tool (available at www.qualityaction.eu) has step-by-step guides for using these methods to increase stakeholder participation in quality improvement.

 


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Insurance
Description

Description

Operating a CBVCT carries risks, and local laws may require a minimum level of insurance. Apart from insurance covering buildings and infrastructure, this includes legal liability insurance for the organisation as a whole and also for individual professionals.

 

Guidance

Guidance

Insurance requirements and providers vary greatly from country to country. It is best to get advice from an insurance specialist or from an umbrella organisation, e.g. a federation of social and/or health service NGOs.

 

Adaptation

Adaptation

It is important to review and adapt insurance coverage regularly, especially when operations change, e.g. by adding outreach or mobile unit services, or by recruiting volunteers.

Options for reducing costs;

  • Investigating reduced insurance premiums for NGOs
  • Investigating the availability of coverage through government insurance schemes.

 

Quality Improvement

Quality Improvement

Insurance may not be a specific item included in structured quality improvement tools. To regularly review insurance requirements, you could add the topic to the items discussed at annual budgeting meetings or similar, recurring occasions.

 


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Action Plan

Operating a Checkpoint
Regulatory and Legal Frameworks
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