The MOH will develop and implement special policies, regulations, systems, structures and guidelines at the national level to ensure that your HIV & syphilis rapid test site can function effectively and efficiently. MOH will therefore undertake responsibility for establishing:
- A national HIV rapid testing policy
- Regulations for the operation of HIV rapid test sites
- National guidelines for conducting HIV rapid testing
- HIV rapid test training
- Monitoring of HIV rapid test site quality
- The MOH will put a national framework in place to support and regulate HIV and syphilis rapid testing. This will include policies and systems that will address the following:
- Certification of HIV & Syphilis Rapid Testing Sites
- Certification of HIV & syphilis rapid testers
- Establishment of a national HIV & syphilis Rapid Testing and Counselling Policy
- Establishment of a National HIV & Syphilis testing and counselling guideline
- Establishment of a validated national HIV & syphilis rapid testing algorithm
- Procurement and distribution of MOH-approved HIV & syphilis rapid testing kits
- Access to reliable HIV & syphilis rapid test training
- Provision of MOH-approved standard operating procedures (SOP) or job aids for use in HIV & syphilis rapid testing sites
- Monitoring of compliance with national guidelines for HIV & syphilis rapid testing at testing sites through periodic site assessments conducted by designated MOH-approved assessors (e.g National AIDS Programmes)
- Administration of a national proficiency testing (PT) or external quality assessment (EQA) programme to monitor HIV & syphilis test reliability at rapid testing sites
Rapid Testing Site Personnel must comply with the MOH’s regulations and guidelines and also implement the structures, systems and procedures that are needed within the HIV & syphilis rapid testing site to ensure that the site can function effectively and efficiently. Rapid Testing Site personnel will therefore be responsible for the following:
- Getting a copy of the Ministry of Health requirements
- Complying with ALL Ministry of Health regulations
- Implementing the national guideline for HIV & syphilis rapid testing
- Providing ALL required reports to the relevant persons
- Participating in quality monitoring activities
Sites should be aware of and comply with the MOH’s national policies, regulations and guidelines for the conduct of HIV & syphilis testing. These will include:
- Certification of your HIV & Syphilis Rapid Testing Site
- Certification of your HIV & Syphilis Rapid Testers
- Compliance with the MOH’s National Guidelines for HIV & Syphilis Testing.
- Compliance with the MOH’s National Algorithm for HIV & Syphilis Testing
- Participation in MOH HIV & Syphilis rapid test training and re-training programmes
- Use of ONLY MOH-approved HIV & Syphilis rapid testing kits and compliance with the manufacturer’s instructions for ALL testing supplies.
- Use of MOH-approved Standard Operating Procedures (SOPs) and/or Job Aids for HIV & Syphilis rapid testing site operations
- Participation in the MOH periodic monitoring site assessments
- Participation in MOH-facilitated Proficiency Testing (PT) or External Quality Assessment (EQA) programmes
- Timely compliance with corrective actions arising from site assessments and EQA participation
In order to function effectively, ALL personnel conducting testing at HIV & syphilis rapid testing sites will need training and periodic re-training to maintain competencies in all areas associated with the performance of HIV & syphilis community testing and the provision of quality results. Site personnel responsibilities include:
- Participation in Training on Pre and Post-test counselling of key populations.
- Participation in Training on the conduct of HIV & syphilis rapid testing according to the national algorithm and guidelines
- Participation in Proficiency Testing or External Quality Assessment programmes as one measure of competence.
- Participation in periodic external assessments (monitoring) conducted by the MOH or NAP as an additional competency check
In deciding to establish an HIV & syphilis rapid testing site you will need the following:
- A designated site for HIV & syphilis Testing with adequate lighting and ventilation
- An area for testing and counselling that allows for privacy and confidentiality (NB: Testing and counselling can be performed in separate areas if necessary and appropriate for site personnel and clients)
- A testing area that is clean and uncluttered
- Walls and floors that are made of materials that are easily cleaned and decontaminated in case of spills or splashes
- Tables and countertops used for testing with surfaces that are non-absorbent, non-porous and easy to clean and decontaminate.
- A continuous supply of electricity
- An accessible and continuous supply of running water
- Appropriate sewage facilities
- A designated area for storage of testing supplies, kits and consumables that is clean, cool, dry, protected and secure (e.g. a locked cupboard and/or refrigerator)
- A designated area for organised storage of documents, records and logs that is safe and secure (e.g.a locked filing cabinet)
When a decision is made to establish an HIV & syphilis testing site, an initial consideration must be where will the testing site be located? Resources may need to be mobilised to secure a site. If a location is not available free-of-cost, rental obligations will have to be met and sustained. Also important is early identification of the human resources needed to staff the rapid testing site and related cost implications. Additionally, the HIV & syphilis testing site has to be adequately resourced and equipped to provide the rapid testing service. A listing of all equipment, materials, supplies and test kit needs should be prepared and documented. A plan for ensuring the ongoing availability of reagents and supplies should be developed since supplies must be available to ensure that the HIV & syphilis rapid testing service is always accessible. Reagents and supplies should be procured and/or acquired only from approved suppliers, providers and/or donors. In many countries, the MOH may provide the approved HIV & syphilis rapid test kits. In order to ensure that all resource needs have been carefully considered, the following need to be addressed:
- Early determination of possible rental or other costs related to securing a site for establishing a testing service should be a priority consideration.
- Early identification of the persons who will assist with provision of the rapid testing service and any cost implications that may apply, needs to be made.
- A plan or realistic strategy for mobilizing resources should be developed to support the acquisition of equipment, materials, reagents and supplies so that the rapid testing site service will be sustainable and continuous. This should include identifying potential providers and/or donors as one of the first steps you take when you decide to set up an HIV & syphilis rapid testing site. Without a plan for sustaining resources you will not be able to provide a sustainable rapid testing service.
- A listing of ALL the equipment, materials, reagents and supplies for conducting HIV & syphilis rapid testing should be documented.
- All the reagents needed for testing that are not supplied in the approved HIV & syphilis rapid testing kits need to be identified and included in the full listing (e.g buffers, pipettes and controls).
- A designated refrigerator to be used ONLY for storage of quality control or proficiency testing material and/or testing supplies (where necessary) must be obtained. Note that many HIV & syphilis rapid test kits do not need refrigeration. This refrigerator must not be used to store food or drinking items.
- Developing a system for timely procurement or acquisition of all of the materials, supplies and reagents needed for HIV & syphilis rapid testing to ensure that the rapid testing service is continuous should be a priority focus.
Testing Site personnel should be aware of and adhere to Universal safety guidelines and practices. All rapid testers, Supervisors and testing site cleaning staff should participate in safety training provided by competent trainers. Safety training should include procedures for maintaining personal safety, managing waste disposal and dealing with testing site incidents and accidents among other key safety practices. Maintaining a safe and healthy working environment therefore requires compliance with safety procedures and techniques and a demonstrated competence in safety practices that include:
- Restricting access to the rapid testing area to ONLY authorized personnel
- Compliance with all instructions in the safety guidelines
- Demonstrating competence in laboratory safety techniques
- Observing Universal Safety Precautions
- Observing personal health and safety practices
- Using personal protective equipment (PPE) appropriately
- Practicing proper handwashing techniques
- Compliance with proper housekeeping practices including cleaning /disinfection of work areas
- Maintaining a clean and organized workspace
- Compliance with waste disposal practices
- Compliant handling and disposal of infectious and non-infectious material
- Compliant handling and disposal of sharps
- Effective management of splashes, spills and needle stick or other sharps injury
- Compliant incident and accident reporting and management
- Effective management of potential hazards & exposure
- Compliance with procedures for treatment, counselling and follow-up
- Appropriate maintenance and storage of safety records
HIV & syphilis rapid testing sites should have in place a system for effectively managing the stock of testing site materials, reagents and supplies needed for providing an HIV & syphilis testing service. Effective management of this inventory will ensure that you can provide an uninterrupted rapid testing service. Rapid testers should receive training in inventory management that includes procedures for effective management of inventory to allow for timely, efficient procurement while limiting stock outs and loss due to expiry of goods. An effective inventory management system should include the following:
- A listing of all consumables needed for testing (test kits, controls, lancets, gauze, bleach, cotton etc)
- A recording format for goods received that must include: date, time, expiry date, number/amount, receiver, condition of goods etc.
- A record for each stock item
- Forecasting (projecting needs) to allow adequate time for purchase and delivery
- An adequate stock of consumables at all times
- A system for inspecting all supplies delivered before acceptance to ensure acceptable quality
- A record of lot numbers and expiry dates for ALL reagents & supplies received
- Appropriate storage of test kits and supplies (according to the manufacturer’s instructions)
- Using a first-expiry-first-out concept when managing testing stock
- A system for appropriate maintenance and storage of all inventory records
Of major importance to a smooth and consistently high quality of HIV & syphilis rapid test site operations is the manner in which documents are developed and used to instruct and guide site operations. Instructions may be presented as a Standard Operating Procedure (SOP) or Job Aid. A Job Aids is generally a more concise, shorter version of an SOP that provides specific detailed stepwise guidance for conducting an activity. Also essential is the need to ensure that records of site operations are kept safely. Training for rapid testers should include introduction to and familiarity with all documents and records that relate to HIV & syphilis rapid test site operations. HIV & syphilis rapid test site documentation should include:
- A documented list of ALL documents and records essential to high quality operations of the HIV & syphilis rapid testing site
- Standard operating procedures (SOPs) or Job Aids that provide instructions and guidance for every action to be conducted at the testing site. These will include procedures for site preparation, environmental monitoring (e.g temperatures), safety, client management, counselling & confidentiality, blood collection, sampling, inventory management, pre-testing, testing, post-testing, quality control, proficiency testing (PT) or external quality assessment (EQA), quality monitoring and troubleshooting and any other issues that may be peculiar to a specific site
- An SOP or Job Aid for inventory management that provides instructions for receipt of stock, use of Stock, re-ordering of stock, kit labelling and storage, handling of expired kits, responsibilities etc.
- Recording and reporting logs for temperature checks, HIV & syphilis rapid testing, quality control, proficiency testing and inventory management
- An SOP or Job Aid for monitoring the quality of site operations, including specific responsibilities for HIV and syphilis rapid testers, site supervisors and the Ministry of Health
- An SOP or Job Aid for the preparation of internal and external audit reports (where necessary)
- An SOP or Job Aid for the preparation and submission of statistical, quality assurance and quality systems reports according to the Ministry of Health’s requirements and instructions
- An SOP or Job Aid for appropriate storage of testing site records
Pre-Testing*
As you begin to prepare to safely and reliably conduct HIV & syphilis rapid tests, there are several issues that must be addressed. You must have and be able to use as instructed:
- A standard operating procedure (SOP) or instruction for ensuring the confidentiality of client information
- An SOP or Job Aid for specimen collection
- An SOP or Job Aid for each kit used in the specific HIV & syphilis testing algorithm (compliant with the national algorithms)
- A mechanism (e.g a thermometer) and system for the daily monitoring of temperatures in the storage and testing areas and refrigerator
- A register or log for recording the relevant client information
- An SOP or Job Aid for inventory management including a listing of the reagents and supplies needed for testing, receipt of stock, labelling, storage and disposal of expired supplies
- An SOP or Job Aid for testing that includes the manufacturer’s Kit Storage Instructions (e.g storage temperature)
Testing*
HIV and syphilis rapid testing must ONLY be conducted by trained and certified rapid testers. The Ministry of Health will provide guidance and instructions for those wishing to become a certified HIV & syphilis rapid tester. Conducting HIV & syphilis rapid testing requires specific knowledge and skills (competencies) that include a ‘How To’ with respect to the use of materials, supplies, reagents and equipment, the conduct of the rapid testing process, the controls needed to ensure reliability of the results provided and the preparation of client and other required reports. All certified HIV & syphilis rapid testers must be able to:
- Use sample collection devices (capillary tubes, loops, disposable pipettes etc) accurately
- Label test devices accurately
- Use timers effectively
- Comply with the instructions for the use of standardized registers or logbooks
- Comply with the manufacturer’s and MOH instructions for conducting the HIV or syphilis rapid test
- Effectively perform, record and interpret Quality Control (QC) monitoring of routine rapid testing
- Follow instructions for participation in Proficiency Testing (PT) programmes and respond in a timely manner
Post-Testing*
When the HIV and syphilis rapid testing process has been completed, tests results must be clearly recorded and accurately reported. Rapid testers must be competent to interpret, record and report results to ensure a high quality of information provided to clients. Rapid testers must therefore competently undertake the following:
- Recording & reporting of results
- Interpretation of QC results
- Troubleshooting for problems arising e.g invalid results
- Conduct of periodic internal monitoring of the testing process e.g a review of testing records to determine ongoing compliance with instructions
- Maintaining the confidentiality of client information
- Summarizing results for reporting to clients, MOH and/or other key stakeholders as instructed (e.g testing and quality statistical reports)
- Safely archiving and storing testing registers and logs
Proficiency Testing (PT) or External Quality Assessment (EQA) is an essential tool used periodically to check the reliability of results produced at the HIV and syphilis rapid testing site. Proficiency testing programmes are generally coordinated by the Ministry of Health and are a component of the Ministry’s rapid test site monitoring responsibility. Every HIV & syphilis rapid test site must participate in the national PT programme as part of the site responsibility. Periodic onsite assessment of the overall rapid testing site operation will be conducted by the Ministry of Health to ensure compliance with national guidelines and requirements. All HIV & syphilis rapid testers must be trained to understand and comply with PT programme participation and onsite assessment programme instructions and must be able to:
- Follow instructions for participation in the national PT programme including compliance with deadlines for return of results
- Review PT results for clarity and compliance with instructions prior to submission to PT provider
- Follow instructions for systematic retesting of samples according to instructions e.g collection and preparation of dried blood spots (DBS) or dried tube samples (DTS) for every 10th client
- Follow instructions for storage of DBS/DTS samples (e.g out of sunlight, use of dessicants etc.)
- Follow instructions for the labelling of DBS/DTS samples for retesting
- Follow instructions for the recording of DBS/DTS results returned to the testing site
- Conduct timely corrective actions if indicated when PT/EQA results are returned
- Respond positively to advice for retraining if this is given
- Participate fully in onsite assessments conducted by the MOH and respond in a timely manner to recommended corrective actions
To ensure continued provision of high quality HIV and syphilis rapid test results at your testing site, the following must be observed at all times:
- HIV & syphilis rapid testing must be done in compliance with national policies and testing algorithms.
- All testers need appropriate training, certification and proof of competency
- Compliance with safety instructions or procedures is essential to both testers and client safety.
- Documents –SOPs, Job Aids and Records are critical to effective and reliable functioning of the HIV and syphilis rapid testing sites.
- Monitoring of environmental conditionse ensuring that thermometers in testing and storage areas and refrigerators are monitored daily protects reagents & supplies from deterioration and ensures that they perform optimally and support reliability of test results.
- Conduct of appropriate Quality Control (QC) (positive and negative controls) must be undertaken daily or as appropriate, to maintain the reliability of test results.
- Participation in rapid testing proficiency testing programmes is a requirement of the quality standard for point-of-care testing.
- If what you did is not documented you cannot prove that you did it. Using standardized registers and log books supports both consistency and reliability of testing as well as reliability of any other reports provided by testing site personnel.
- Competent ongoing supervisory oversight and review of site logs, records and general testing site operations is critical to maintaining the reliability of all rapid test information given to clients.
- Records are the only proof of compliance with the HIV & syphilis testing site regulations, guidance and standards and are essential for the successful conduct of the MOH’s onsite assessments.
The documents provided can be downloaded and used to develop your HIV and Syphilis rapid testing site operational manual. Every rapid test site must develop an instruction manual that all rapid testers and other relevant personnel use to guide their day-to-day operations. Documents provided include information and instructions for setting up a safe testing facility that complies with the national guidelines and regulations and for conducting HIV and syphilis tests safely and reliably.
- Roles & Responsibilities of MOH & Site Personnel
- Requirements for Compliance with MOH Policies, Regulations and Guidelines*
- Competency Requirements for HIV & Syphilis Rapid Testing Site Personnel *
- Space & Infrastructural Requirements for the HIV & Syphilis Rapid Testing Site *
- Resource Requirements: Equipment, Reagents & Supplies for the HIV & Syphilis Rapid Testing Site*
- Safety Requirements for the HIV & Syphilis Rapid Testing Site *
- Inventory or Stock Management Requirements for the Testing Site*
- Requirements for Documents & Records in the HIV & Syphilis Rapid Testing Site*
- Conducting HIV & Syphilis Rapid Testing
- Requirements for Participating in HIV & Syphilis Proficiency Testing
