Rationale - WHO | World Health Organization
Validation of EMTCT of HIV and/or syphilis3Laboratory evaluation and assessmentGuidance, checklists and toolsPART l. BACKGROUND 1. IntroductionThis document is intended to provide operational guidance on how to assess quality management systems used in testing services for the purposes of validation of EMTCT of HIV and syphilis. This document should be sent to all countries as they develop plans for EMTCT to allow the appropriate testing service to be set up and data on quality management to be collected for verification during the laboratory review. Further, this document outlines the methodology for the assessment of laboratory and point-of-care (POC) testing for EMTCT, such that all countries seeking validation are assessed using a common set of standards. The proposed methodology draws from existing WHO guidance for laboratory audits, laboratory quality improvement and accreditation of the Pan American Health Organization (PAHO), and the International Organization for Standardization (ISO) 15189 standards.2. Mechanism for global and regional validation of elimination targetsThe national validation committee (NVC) is responsible for coordinating an initial preparatory laboratory assessment that involves the collection and analysis of the national data and its assembly into a country report. This information is in turn evaluated by a regional validation committee (RVC), which is responsible for reviewing the country data, conducting validation visits to the country and assembling the regional validation report for submission to the global validation advisory committee (GVAC). The GVAC, a multidisciplinary team of independent experts is mandated to ensure that the regional validation reports are compliant with the global elimination strategy and criteria, develop and evaluate validation tools, develop and summarize recommendations concerning validation, and provide advice and guidance to countries on elimination activities and through the validation process. The main objectives of laboratory assessment are: to verify the existence of an adequate testing service network to provide the services needed to achieve and maintain a programme for EMTCT of HIV and syphilis; and to ensure that the results generated by the testing service network are accurate and reliable.The proposed assessment consists of four principal steps: (1) assessment of the overall performance of the national testing service system in supporting the diagnosis HIV and syphilis; (2) observation of specimen collection, HIV and syphilis testing procedures in testing facilities and reporting results; (3) team communication on the day’s observations of the laboratory and POC testing sites; and(4) synthesis of data (observations and interviews) and dissemination of findings.In addition, there are several technical complexities around the testing of HIV and syphilis in pregnant women and their infants that need to be considered in the assessment of national programmes. An HIV-positive status in the mother requires at least three consecutive reactive test results from three different serological assays according to nationally validated testing algorithm(s). By contrast, the testing strategy for HIV-exposed infants consists of testing using a virological assay with confirmatory testing of any HIV-detectable results. If undetectable for HIV at six weeks and nine months of age, serology testing is conducted to confirm the HIV status of the infant at 18 months or three months after cessation of breastfeeding, whichever is later. ? For syphilis, there are both treponemal (Tp) and non-treponemal (NTp) assays. The former is specific for syphilis infection but does not discriminate between current and past infection, whereas for the latter, the reaction is not specific to syphilis and the antibody titers vary with the stage of infection and may be falsely positive, especially when titers are low. The testing strategy is set and should be the same globally, but the testing algorithms used to test for HIV and syphilis status in mothers and infants vary widely from country to country because of different brands of test kits. As a result, a detailed and thorough assessment of testing strategies and algorithms as well as the quality management system is essential to determine whether national programmes are accurately measuring the rate of maternal and infant syphilis or HIV infection.In response to changes in the HIV epidemic, WHO encourages countries to move toward using three consecutive reactive test results to provide an HIV-positive diagnosis. Western blotting and line immunoassays should not be used within HIV testing strategies/algorithms. Dual HIV/syphilis rapid diagnostic tests can be the first test in HIV testing strategies and algorithms in antenatal care settings."Finally, this tool is not meant to replace the WHO Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) but to complement it. It is highly recommended that laboratories apply for SLIPTA as a quantitative measurement of the quality of their laboratories, and to provide data and a basis for continuous laboratory improvement. SLIPTA is a comprehensive process that extends beyond HIV and syphilis testing, and participation in SLIPTA will facilitate and help to prepare a country for EMTCT laboratory validation.PART II: IMPORTANCE OF HIV AND SYPHILIS DATA ASSESSMENT Rationale for the validation of laboratory dataHIV and syphilis are best managed by accurate and timely diagnosis using a standardized testing strategy and validated testing algorithm. It is critical that countries have a robust testing network and that pregnant women have access to antenatal screening at all levels of the health-care system. The quality of the tests and of testing must meet appropriate quality control (QC) and QA mechanisms. The quality of the laboratory data is determined by the quality of the laboratory services that governs them. A deficient laboratory service will lead to unreliable surveillance data and incorrect diagnosis, which in turn will prevent appropriate treatment, compromising control and elimination efforts.In countries with limited access to laboratories for testing, access can be provided by using of rapid diagnostic tests (RDTs) conducted in antenatal clinics. The use of RDTs for syphilis and HIV testing is widespread. These tests can be used in non-laboratory settings by trained staff in any setting. Appropriate quality management systems need to be in place to ensure the quality and accuracy of results generated by non-laboratory staff conducting RDTs and the proficiency of staff that performs them. The quality of a diagnostic testing system is dependent on three major steps in the Quality Continuum.Quality of product used for EMTCT testing (in vitro diagnostics)The quality of a diagnostic testing system is dependent on 3 major steps in the Quality Continuum (See Figure 1). It starts with control programmes selecting the right test with its quality and performance assured through either the WHO Pre-qualification programme or by stringent regulatory authorities such as the founding members of the Global Harmonization Task Force for medical devices. The quality of the tests must be maintained after procurement with appropriate transport and storage conditions. Finally, the quality of testing should be assured through periodic proficiency panel testing at all testing sites, use of the tests in the correct testing algorithms, the results recorded through a robust data management system and made available to the patients and health care providers for appropriate treatment and linkage to care.Figure 1Product selectionCountries should be able to show that the product(s) selected for use has acceptable performance and operational characteristics. Furthermore, the product must have regulatory approval in the country use, and preferably, WHO prequalification or approval by a founding member of the Global Harmonization Task Force (EU, USA, Canada, Australia and Japan) HIV and syphilis testing algorithm verificationThe testing strategy and testing algorithms used to test for HIV and syphilis status in mothers and infants vary widely from country to country and different brands of test kits are used. As a result, a detailed and thorough assessment of testing strategies and algorithms as well as the quality management system is essential to determine whether national programmes are accurately measuring the rate of maternal and infant syphilis or HIV infection.HIV testing for infantsThe testing strategy for HIV-exposed infants consists of testing using a virological assay with confirmatory testing of any HIV-detectable results. If undetectable for HIV at six weeks and nine months of age, serology testing is conducted to confirm the HIV status of the infant at 18 months or three months after cessation of breastfeeding, whichever is later. ?Source: WHO: Diagnosis of HIV infection in infants and children of the Rapid Dual HIV/Syphilis test in ANCAs of December2019, dual HIV/syphilis rapid diagnostic tests (RDTs) can be considered as the first test in HIV testing strategies and algorithms in ANC settings per the updated WHO HIV testing guidelines.Use of a dual HIV/syphilis RDT as the first test in ANC offers the opportunity to test for both infections with a single finger prick. (see figure 2) Results are available quickly, enabling many to start either or both HIV treatment and syphilis treatment with benzathine penicillin.The testing strategy needed for dual detection of HIV and syphilis (Figure 2) differs from the recommended strategies for separately testing for HIV or syphilis. Countries introducing the dual HIV/syphilis RDT as the first test in ANC will need to revise their HIV testing strategy for pregnant women. It is important not to use the rapid dual HIV/syphilis test for: 1. women with HIV taking antiretroviral therapy (ART); 2. women already diagnosed with and treated for syphilis during their current pregnancy; and 3. retesting for HIV.To verify HIV-positive diagnoses and prevent misdiagnosis of HIV, WHO recommends retesting all people with HIV prior to starting lifelong treatment. This form of retesting is only for HIV and not for syphilis. Therefore, for verification of an HIV-positive result, countries should only use the national HIV testing strategy and algorithm, which would not include dual HIV/syphilis RDTs.Source: 2. WHO-recommended testing strategy for dual detection of HIV and syphilis infection for ANC settingsSingle HIV testing algorithm“In response to changes in the HIV epidemic, WHO encourages countries to move toward using three consecutive reactive test results to provide an HIV-positive diagnosis. Western blotting and line immunoassays should not be used within HIV testing strategies/algorithms. Dual HIV/syphilis rapid diagnostic tests can be the first test in HIV testing strategies and algorithms in antenatal care settings." (Figure 3)Figure 3: WHO Testing strategies for the diagnosis of HIVFor syphilis, there are both treponemal (Tp) and non-treponemal (NTp) assays. The former is specific for syphilis infection but does not discriminate between current and past infection, whereas for the latter, the reaction is not specific to syphilis and the antibody titers vary with the stage of infection but may be falsely positive especially when titers are low. The following are examples of algorithms that might be used by laboratories or clinical settings conducting syphilis testing (Figures 4-8).Algorithms for the diagnosis of syphilis:Figure 4: Traditional laboratory-based syphilis serologic testing. (Non-treponemal screening test confirmed with treponemal test)238125231457500Figure 5: Reverse sequence laboratory-based syphilis serologic testing.(Treponemal screening test to allow automated screening, confirmed with non-treponemal test) Figure 6: Treponemal rapid point-of-care syphilis testing-without confirmatory non-treponemal test. (clinic-based testing opportunity best used in antenatal clinic setting)left137160000Figure 7: Treponemal rapid point-of-care syphilis testing-with confirmatory non-treponemal. (clinic-based testing opportunity. Consider in settings serving patients who may have been previously treated for syphilis.1162050503872400 400050125730000Figure 8: Dual non-treponemal/treponemal rapid point-of-care syphilis testing Some countries may be using a dual RDT which detects both non-treponemal and treponemal antibodies. Other tests being used include: EIA enzyme immunoassay, FTA-ABS fluorescent treponemal antibody-absorption (test), NTp/Nontrep non-treponemal, POC point of care (test), RPR rapid plasma regain, TP-PA Treponema pallidum particle agglutination, Tp/Trep treponemal, TPHA Treponema pallidum haemagglutination assay, VDRL Venereal Disease Research Laboratory (test). An in-country study should be conducted to determine what the combination of selected products works well together, and the rate of common false reactive results is minimized. Procurement and supply chain management Testing coverage and public confidence in testing programmes can be adversely affected by stock-outs. Evidence of good procurement practice and sound national supply chain management is essential to ensure the quality of tests across the country and to avoid stock-outs. End-user quality control using well characterized and properly stored quality control material is an important tool for monitoring quality of products used in testing services. Test storageInappropriate storage conditions can affect the performance of any invitro diagnostics. Regular monitoring of storage and in-use conditions are necessary and must comply with the manufacturers stated storage conditions. Locally, it is important to establish the frequency of testing with positive and negative controls to monitor ongoing test quality and record the results as quality indicators. Post-market surveillanceRecords of any adverse events and product problems must be kept and all complaints notified to the manufacturer of the product. For certain incidents that would have a serious impact on public health, the national regulatory authority and WHO should also be informed.3. Quality of testing a. Staff competencyTesting providers (lay providers, healthcare workers, laboratory technicians) should undergo training in prescribed national programmes Evidence of staff training and competency-based examination is an important quality indicator. Standard operating procedures (SOPs) must be up to date and available for all staff at the testing site.b. Staff proficiencyIn addition to general competence, staff at testing sites must demonstrate that they are proficient in obtaining correct and accurate testing results through external quality assessment (EQA) using proficiency testing and on-site supervisory visits. Records of EQA must be retained for 12 months or longer as a quality indicator.The same applies equally for testing performed in a laboratory as well as at or near clinics where point-of-care (POC) is being used.PART III: COUNTRY VALIDATION MISSIONIn-country validation (both pre-validation and validation) missions include a dedicated laboratory team made up of a team leader and one or more additional laboratory experts. The laboratory team will be asked to observe and assess the laboratory components critical for EMTCT of HIV and/or syphilis, assess how well the observed procedures represent the procedures outlined in the country report, and synthesis the information into a final report. Members of the team will visit the testing sites at national sub-national (district or province) laboratories (in some cases, private laboratories as well), and selected lower-level facilities in primary care settings, at health posts and ANC sites.Scope: The testing service assessment for EMTCT is not a full audit. Rather, is an assessment of the components critical for testing related to EMTCT of HIV and/or syphilis.The assessment focuses on the four following areas: Quality management systems. This is an assessment of the general organization and functioning of the national testing programme for HIV/syphilis laboratories. In line with existing WHO guidance, it is proposed to assess organization (management commitment), and personnel (roles and responsibilities). It also serves and QC for HIV and syphilis testing. Other aspects assessed are supply chain management, including availability of HIV and syphilis in vitro diagnostics during any stage of pregnancy, labour and delivery, and postpartum, especially if breastfeeding. Quality of tests. This is an assessment of products used (acceptable performance and operational characteristics), as evidenced by national regulatory authority approval, and international organizations such as WHO prequalification or listing by a founding member of the Global Harmonization Task Force. This assessment includes review of testing strategies used and national validated HIV and syphilis testing algorithms appropriate for ANC screening, and choice of sufficiently well-performing tests that are appropriate for the country’s clinical settings where ANC services take place. Quality of testing. This is an assessment of staff competency in general through professional licensure as laboratory technologies, and other forms of training for non-laboratory trained personnel, and staff proficiency in performing the tests selected.Laboratory data management. This is an assessment of the laboratory information management, specifically focused on a functional laboratory information system for EMTCT of HIV and syphilis.Procedures to be followed by laboratory assessment teamEach member of the team will be asked to carry out the following steps: Step 1. Detailed review of the country report, with special focus on HIV and syphilis testing in laboratory facilities in the network. This step is carried out prior to the mission. Specific components include:HIV testing conducted for mothers and infants (serology testing test for mothers and virological testing for infants); syphilis testing for women and infants, including stillborn infants;evidence of proficiency and other QMS measures for HIV and syphilis testing throughout different levels of testing services.Prior to the mission, each member of the laboratory assessment team will be provided copies of the country report, national laboratory policies and plans, standards, SOPs for HIV and syphilis testing, reports from recent laboratory audits, and relevant documents and information on the organization and functioning of the quality management system. The report should include detailed information on the testing strategies used in pregnant women and the testing algorithms that is the brands of HIV and syphilis IVDs used at various levels (e.g. national, provincial, district, primary and community ); the quality, safety and performance of the product used, including EQA programmes in which the country participates; national policies o QMS implementation, including staff training and proficiency testing programmes; and distribution of key testing commodities, including data on recent stock-outs. Countries will also be asked to complete self-assessments of various levels of service (national and subnational), and these should be reviewed with an eye to identifying specific challenges the country faces, which require further observation and assessment during the mission.ImportantOne or more conference calls should be held prior to the mission. Any critical laboratory problems or omissions identified in the country report by laboratory assessment team members that might challenge validation should be identified during these calls. These problems or omissions must be addressed prior to the in-country mission.Step 2. Observation and facility assessments of in-country testing services, with a special focus on HIV and syphilis testing This step is carried out in country. For each mission, the laboratory assessment team will be asked to conduct on-site observations and assessments at the following: the national reference laboratory; selected provincial and district laboratories, including private laboratories that conduct a substantial number of HIV and/or syphilis testing in pregnant women;selected lower-level (e.g. primary care, health post, community) testing service that conduct ANC testing, observing how testing practices are carried out. The choice and number of testing sites to be included in the assessment will be determined prior to the mission, based on the size of the country and its tiered testing network. This will be done by a sub-regional team working with the country prior to the assessment, and members of the laboratory assessment team may be asked to contribute their opinion on the site decision. The laboratories to be visited will be chosen to best evaluate the national testing system for HIV and syphilis overall, including the lowest-performing sites, to ensure confidence in EMTCT. At each level, the sites to be included in the assessment should be aligned with underlying districts and facilities to allow data verification for the entire testing system. Once in the country, the laboratory assessment team leader will determine the facilities to be visited by specific team members. The team is expected to communicate with each other daily about the findings. ImportantThe laboratory assessment team may identify additional laboratories or facilities that they want to add to the assessment to ensure the team’s confidence in EMTCT from a laboratory perspective.For each testing site (e.g. national laboratory, provincial or district laboratory, maternity hospital, antenatal clinic, private laboratory or other facility) visited, a separate facility-specific checklist should be completed. A separate checklist should be used for each facility observed, with name, date, products used, and observer information included. In facilities where testing is observed, additional checklists may be required. Each team member should fill out the appropriate checklist(s) for each site they visit. These checklists will be used for the synthesis of data and results and will also become part of the official documentation of the mission. The checklists are intended to guide the review process to ensure that critical areas are covered, and to help adopt a common approach for all countries. Interviews will also be conducted with laboratory supervisors or managers and, as needed, laboratory technicians or other testing staff. Interviews with and observations of health service providers may also be needed in countries performing rapid diagnostic tests (RDTs) or collecting dried blood spot (DBS) specimens. The main purpose of the interviews and site visits is to collect information on the checklist items, request clarification regarding information gathered from the document review, and verify information from different informants. Data are collected through direct observation, and additional information or clarification provided by the site staff. Checklists should be filled out, if possible, at the time of the interview/visit, or completed on the same day as the visit.Note: Interviews with laboratory managers/supervisors or technicians should be scheduled by country representatives prior to the visits. It should be made clear that HIV and syphilis testing procedures may be observed during the process. ImportantTeam members may be asking potentially sensitive questions about the performance or quality of work of national and local laboratory staff members. It is important that observations are made in a neutral manner that conveys clearly that the assessment will not result in any punitive action.Step 3. Team communication on the day’s observationsThis step is carried out in country each day by the full laboratory assessment team. As each team member will be visiting different facilities and interviewing different staff members, no single person observes the entire laboratory system from top to bottom. Frequent communication of findings is important to better understand the system to inform future visits, and to identify challenges that should be investigated at other levels. Daily communication should focus on overall findings with emphasis on:Quality management systems: sufficiently supportive leadership and governance, including policy framework, structure and coordination, management and supervision of the laboratory network for EMTCT of HIV and syphilis;Quality of tests: appropriate use of products and enough availability of basic supplies, including availability of HIV and syphilis testing materials;Quality of testing: enough numbers of human resources of good quality, with the qualifications, training and oversight for HIV and syphilis testing. Also, sufficiently high-quality service delivery, including organization of services, roles and responsibilities, and quality control for HIV and syphilis testing among pregnant women and infants;Laboratory data management: sufficiently robust information management, including the existence of a functional laboratory information system for EMTCT of HIV and syphilis;Any additional strengths/challenges to the laboratory system that should be mentioned.During the discussions, team members should consider specific goals for EMTCT of HIV and syphilis, such as the following:For HIVAre the IVDs being used sufficiently sensitive to identify HIV-infected mothers’ infants, (Sensitivity >99%?)Are the IVDs being used sufficiently specific to rule out any false HIV-reactive results to ensure that HIV-positive women are identified? (Specificity>98%) Are all women identified as HIV-positive, retested before ART initiation to confirm their HIV status?Are sufficiently sensitive IVDs in place to detect HIV infection in HIV-exposed infants? Are all infants with detectable HIV infection retested using the same or another virological assay and/or confirmed for serological status at 18 months of age?Are the QMS measures in place consistent enough to ensure that staff conducting the tests are performing them correctly?Were there stock-outs of reagents or consumable that may have led to >4% of women/infant attendees not being tested for syphilis during the past 12 months?Are the reporting systems for testing data able to support accurate counts of the numbers of women/infants tested, found to be seropositive? For syphilisCan the testing sites perform any non-treponemal testing with >95% accuracy? Are the IVDs used for testing sufficiently sensitive to identify syphilis-infected mothers/infants, including stillborn infants? Are patients with evidence of treponemal antibodies tested further to confirm active infection? What is the testing strategy to address discordant/inconclusive results and to confirm existing results as determined by comparison with another laboratory? (The accuracy of treponemal RDTs should be ≥90%.)Step 4. Synthesis, summary and presentation of resultsThis is done in country at the end of the mission, led by the laboratory assessment team leader. While synthesizing the results, some critical questions need to be answered.The team determines the adequacy of the laboratory network to provide the services needed to achieve and maintain a programme for EMTCT of HIV and syphilis in the following areas:Are testing services for diagnosing HIV and monitoring treatment universally available (i.e. for >95% of pregnant women/their infants) and accessible to all, including vulnerable and marginalized populations? (includes CD4 testing, quantitative (viral load) nucleic acid testing, nucleic acid testing for infants)Is the manner of provision of these services supportive of timely and effective diagnosis, treatment and care of pregnant women and exposed infants to allow EMTCT of HIV? Are testing services for syphilis universally available (i.e. for >95% of pregnant women/their live and stillborn infants) and accessible to all, including vulnerable and marginalized populations?Is the manner of provision of these services supportive of sufficiently timely and effective diagnosis, treatment and care of pregnant women and exposed infants to allow EMTCT of syphilis? (i.e. allow effective treatment prior to 24 weeks’ gestation in most circumstances)The team also determines whether the results generated by the tiered testing network are reliable. Are there internal mechanisms to guarantee consistent application of appropriate procedures, and on-site supervision of HIV and syphilis testing services?Are there external mechanisms for ongoing QC of testing services for HIV and syphilis testing for pregnant women, such as QC material run with each new lot of products used and temperature monitoring in storage and testing environment?At the end of the mission, the laboratory team is expected to share findings from the assessment transparently with the participating staff and health ministry in a presentation (a few key slides) and a final report. The report should respect the anonymity and confidentiality of participating staff.The team lead or his/her designee will be responsible for synthesizing and analyzing the data obtained through the laboratory assessments to address the findings of the overall laboratory system regarding HIV and syphilis testing for supporting EMTCT. The presentation will have a predominantly qualitative character but will use quantitative data based on the assessment and will address the themes assessed in Step 3. Based on the joint analysis, the validation team can arrive at any of the following conclusions:Unqualified endorsement of the testing system;Endorsement of the testing system with clear recommendations for strengthening components that might pose a current or future threat;Determination of insufficiencies that preclude EMTCT validationThe conclusions outlined in the presentation should also be summarized in a report that clearly outlines the key findings from the mission, the principal conclusions and the recommended next steps. A template for this report is provided in the Global guidance Criteria and Processes for Validation: Elimination of Mother-to-Child Transmission of HIV and Syphilis. IV CHECKLISTS AND TOOLS USED IN THE LABORATORY ASSESSMENT This section contains the checklists for laboratory self-assessment (sent prior to validation mission) for national and subnational references laboratories, and assessment checklists for the national validation team (NVT) and/or regional validation teams (RVT) when conducting validation missions. Checklist 4.1 For pre-mission laboratory self-assessment:Note: Checklist 4.1 should be sent to the laboratories being assessed prior to the validation mission. This will ensure that the laboratories are prepared and have the necessary SOPs and documents ready for review by the mission team.This checklist can be used by the National and Subnational reference laboratory for self-assessment. This checklist will focus on the following 3 areas:Quality management systems Quality of test kits used for HIV and syphilis testingQuality of testingChecklist 4.2 To be used during a validation mission This checklist will be used to confirm self-assessments conducted by National and Subnational (provincial and district) laboratories. It will also be used by the laboratorian from the mission team conducting the laboratory assessment. Mission teams may assess the national reference laboratory, provincial and district laboratories, including larger maternity hospitals, district hospitals, private laboratories, etc. The laboratorian who is conducting the assessment will simply check which level laboratory is being evaluated. This checklist will focus on direct observation of laboratories and the HIV and syphilis testing done, with a focus on the following areas:types of HIV and syphilis test kits usedproficiency of HIV and syphilis testing done documentation of HIV and syphilis testing strategies and algorithms used availability of specialized equipment and commodities required for HIV and syphilis testingNOTE: For each laboratory visited, the team member should fill out one or more checklist, taking care to complete the information at the top of the form.Checklist 4.3To be used to assess commodities and equipment needed for HIV and syphilis testingChecklist 4.4To be used to assess and clarify which HIV and syphilis testing algorithms are used in the laboratoryChecklist 4.5 To be used to observe and document laboratory processes and certificationsChecklist 4.1 Pre validation mission self-assessmentNote: This assessment should be sent to the laboratory being evaluated so that staff has time to prepare manuals, logbooks, etc. for review by the mission team and to identify any potential problems that may interfere with validation of elimination. National level siteName of site_______________________________Subnational level siteDate of visit________________________________Service delivery siteLaboratory point person: _____________________________ (best person to contact if there are questions with the review)Contact information: ____________________________________ Laboratory quality managementYes/No?Comments??Does a national laboratory policy exist in the country?????Is there national regulation of IVDs used for the testing of HIV and syphilis?Is a national quality management system implemented at all testing sites?Is quality management and accreditation embedded in the structure of the national testing system?????Does the national laboratory provide training on quality management to all public and private testing sites in the country at the central and local levels?????Is the national laboratory equipped with a laboratory information system?Does the national disease surveillance system incorporate the laboratory information system? 2. Quality of products used for testingYes/No?Comments??Is the tender process for procurement of reagents and supplies (including equipment/analyzers) for all laboratories and testing sites managed through the Ministry of Health?Is there a national plan for procurement and distribution of HIV reagents?Is there a national plan for procurement and distribution of syphilis reagents?Is national and/or site level forecasting in place? Is there careful selection of supplies, reagents and testing kits based on:Quality (and performance) – sensitivity/specificity, ISO 13485 certification or similar for quality Quantity – enough to last until next tenderStability (shelf-life, storage conditions Ease of useConditions of useCost tendering and availability of product information?Is there a distribution plan allowing reagents and supplies to reach all testing sites within the appropriate time frame and prior to expiration?Does the plan consider emergency or unexpected needs?Have testing sites reported stock-outs of one or more testing supplies during the previous year?What are the processes in place for procurement and distribution of testing materials? What is the policy for lot testing upon receiving IVDs?Is there a procedure for verification of HIV testing algorithms?TEST PERFORMANCEHow do HIV serology IVDs perform in EQA (>99% accuracy)?How do syphilis Tp/NTp tests perform in EQA (>95% accuracy)? What are the standards in place for storage and disposal of tests and other consumables used in the testing procedure?Is there a complaint system in place for adverse events (false negative, false positive) and product problems (defects and malfunctions)?3. Quality of testingYes/NoComments?Does the MoH/ national reference laboratory have a means of assessing the quality of kits, reagents and supplies as they are received by the central purchasing body to ensure that standards and specifications are met? Are proficiency testing panels provided to testing sites for HIV and syphilis?Does the national laboratory review the results of proficiency testing within a month?Does the national laboratory provide corrective action based on the results? Are standardized SOPs in place for HIV and syphilis testing at the central and local levels?Are there reliable and efficient testing strategies for: HIV diagnosis, CD4 count, viral load, and early infant diagnosis?Syphilis – central-level algorithms and SOPs for syphilis testing?Is quality management system implemented in all testing sites across the country?Comment on the country’s use of proficiency testing panels.What quality control methods/materials are used?What is the frequency of quality control at the health centres?What are the number of out of range scores of the health centres for quality control testing?Is there regular follow up or corrective action taken at health centres with low scores?Does staff attend regular refresher training? Is the examination competency-based? 4.2 Checklist for assessment of the laboratory being visited during the validation mission(Complete one checklist at each level of government assessment) National level siteName of Institution: ______________________Subnational level siteService delivery siteLaboratory assessed _______________________Date _____________________Laboratory manager ____________________________Contact information ________________________________________________________________Validation team laboratory representative ___________________________Laboratory assessment checklistVerify information provided in country assessmentVerifiedY/NComments1. Laboratory quality management ????Does a national laboratory policy exist in the country?Y?N?Has the national laboratory had a quality management assessment SLIPTA validation recently? ??Y?NDoes the national reference laboratory provide the following? 1. Supervision?Y?N 2. Reference testing?Y?N 3. National norms and standards?Y?N 4. National quality management programmes?Y?N 5. Licensing or accreditation???Y?N?Does the national laboratory provide training on quality management to the central and local levels, and private sector laboratories???Y?N?Is the national laboratory equipped with a laboratory information system? ?Y?NIs the national disease surveillance system incorporated within the laboratory information system? ?Y?N2. Quality of HIV and syphilis testsDoes the testing site participate in an external quality assessment programme for HIV and/or syphilis testing??Y?NAsk to see this year and last year’s proficiency testing results?Y?NIs the tender process for procurement of reagents and supplies for all laboratories and testing sites managed through the Ministry of Health?If No: please see Sections 2 and 3 of subnational laboratory checklist ?Y?NIs there a national plan for procurement and distribution of HIV tests??Y?NIs there a national plan for procurement and distribution of syphilis tests??Y?NIs forecasting in place? ?Y?NIs there careful selection of supplies, reagents/test kits based on:?Y?NQuality (performance) – sensitivity/specificity and ISO 13485 or similar for quality ?Y?NQuantity – enough to last until next tender?Y?NStability - shelf-life, storage conditions ?Y?NEase of use?Y?NConditions of use?Y?NCost tendering and availability of product information??Y?NIs there a distribution plan allowing reagents and supplies to reach all testing sites within the appropriate time frame and prior to expiration??Y?NDoes the plan consider emergency or unexpected needs??Y?NHave testing sites report stock-out of one or more testing supplies during previous year??Y?NWhat are the processes in place for procurement and distribution of testing materials? ?Y?NWhat is the policy for lot testing upon receipt of test kits??Y?NWhat are the recommendations in place for storage and disposal of testing supplies??Y?N3. Quality of testing????Does the MoH/NRL have a means of assessing the quality of kits, reagents and supplies as they are received by the central procurement body, to ensure that standards and specifications are met? ?Y?NAre proficiency testing panels provided to all testing sites for HIV??Y?NDoes the national laboratory provide proficiency panels to regional and peripheral laboratories for syphilis??Y?NDoes the national laboratory review the results of proficiency testing within a month??Y?NDoes the national laboratory provide corrective action based on the results? ?Y?NAre standardized SOPs in place for HIV and syphilis testing at central and local levels??Y?NAre standardized testing strategies in place for HIV and syphilis??Y?NHIV testing strategy for HIV diagnosis in adults and infant diagnosis??Y?NSyphilis – central-level algorithms for syphilis testing??Y?NIs quality assurance and control procedures implemented in all laboratories across the country??Y?NWhat quality control methods/materials are used??Y?NWhat is the frequency of quality control at the health centres??Y?NWhat are the number of out of range results of the health centres for quality control testing??Y?NIs there regular follow up of or corrective action taken at health centres with low scores??Y?NDoes staff attend regular refresher training workshops? Is the evaluation competency-based=?Y?NAre there SOPs on safety procedures and proper disposal of testing consumables??Y?NDoes the national reference laboratory participate in an external HIV quality assessment programme??Y?NDoes the national reference laboratory participate in an external syphilis quality assessment programme??Y?N4. Laboratory data management????Is there a functioning laboratory information system: any method used for documenting archived specimens if processes for using the system are in place???Y?N?Are there mechanisms to ensure confidentiality of the laboratory information; are collective identifiers used for patient information and unique identifiers assigned to each specimen collected from the same patient???Y?N?How are results communicated back to the clinical site??Y?NWhat is the average time to report results back to the clinical site for referred specimens??Y?NAre records archived and results easily retrievable in a timely manner???Y?N?Does the recording system allow for linking of HIV and syphilis test results of the mother with results of her infant??Y?N4.4 Checklist for documenting HIV and syphilis testing algorithms and test performanceNational level siteName of site_______________________________Subnational level siteDate of visit________________________________Service delivery siteLaboratory manager ___________________________________Contact information ____________________________________Validation team laboratory representative ___________________________Testing Algorithm (Adult)SyphilisHIVRetesting to confirm statusNotes/CommentsNTpTpRDT or EIAAssay 1Assay 2 Assay 3N/AN/AAlternative Assay 1Alternative Assay 2 and 3Procedures for discrepant test resultsTesting Algorithm (Infant)SyphilisHIVNotes/CommentsNTpTpVirological assay Assay 1Assay 2Alternative Assay 1Alternative Assay 2123825topSyphilis screeningSyphilis confirmationHIV EQANotes/CommentsYesNoYesNoYesNoAccept/reject criteria for specimen?Proficiency testing performed?Quality controls included with each run?Appropriate reagents (kits) used?Reagents periodically checked?Reagent lot numbers and expiry dates (and respective instructions for use recorded) ? Appropriate and functioning equipment used? * (evidence of calibration records) ?Equipment in proper working condition (evidence of maintenance records)?Lab equipment calibrated (evidence of calibration records)?Manufacturer’s instructions for use followed?00Syphilis screeningSyphilis confirmationHIV EQANotes/CommentsYesNoYesNoYesNoAccept/reject criteria for specimen?Proficiency testing performed?Quality controls included with each run?Appropriate reagents (kits) used?Reagents periodically checked?Reagent lot numbers and expiry dates (and respective instructions for use recorded) ? Appropriate and functioning equipment used? * (evidence of calibration records) ?Equipment in proper working condition (evidence of maintenance records)?Lab equipment calibrated (evidence of calibration records)?Manufacturer’s instructions for use followed?4.5 Checklist for observing and documenting laboratory processes and certificationsNational level siteName of Institution: ______________________Subnational level siteService delivery siteDate ______________Laboratory manager _______________________Contact information ________________________________________________________________Validation team laboratory representative ___________________________General laboratory observationsYesNoN/ACommentsDoes the laboratory have ISO 15189 certification or equivalent? Check most recent certification certificate. If ISO 15189 status is current, may check non-availability of basic laboratory supplies and procedures as these are guaranteed to be in place if ISO 15189 designatedParticipation in an external QC programme. Which?Review quarterly QC reports covering 3 years.Participation in either SLIPTA or SLMTA programmeReview statusSource of deionized (DI) waterAdequate electricity?Y?NBack-up for electrical system?Y?NCalibration/maintenance of essential equipment?Y?NEquipment functionality monitored?Y?NLogbooks for equipment records?Y?NLogbooks for specimen records?Y?NLogbooks for reagent records?Y?NRecords on computer?Y?NComputer back-up?Y?NProtocol logbook?Y?NProtocols for corrective actions?Y?NSpecimen collection and handling Proper storage of test kits and reagents?Y?NProper equipment for processing specimens?Y?NProper storage of patient specimens (including dried blood spots [DBS] specimens)?Y?NReport on stock-outs of testing supplies over the past 12 months (stock-out is defined as lack of at least one basic supply for >2weeks)?Y?NDoes the laboratory have a back-up plan for specimen storage during stock-outs? (i.e. freeze and test when supplies become available?)?Y?N ................
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