Ensuring quality (original) (raw)
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Quality assurance for HIV point-of-care testing and treatment monitoring assays
African Journal of Laboratory Medicine, 2016
In 2015, UNAIDS launched the 90-90-90 targets aimed at increasing the number of peopleinfected with HIV to become aware of their status, access antiretroviral therapies and ultimatelybe virally suppressed. To achieve these goals, countries may need to scale up point-of-care (POC) testing in addition to strengthening central laboratory services. While decentralisingtesting increases patient access to diagnostics, it presents many challenges with regard totraining and assuring the quality of tests and testing. To ensure synergies, the London Schoolof Hygiene & Tropical Medicine held a series of consultations with countries with an interestin quality assurance and their implementing partners, and agreed on an external qualityassessment (EQA) programme to ensure reliable results so that the results lead to the bestpossible care for HIV patients. As a result of the consultations, EQA International wasestablished, bringing together EQA providers and implementers to develop a strategic pla...
Monitoring quality at scale: implementing quality assurance in a diverse, multicountry HIV program
AIDS (London, England), 2015
The centrality of quality as a strategy to achieve impact within the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) has been widely recognized. However, monitoring program quality remains a challenge for many HIV programs, particularly those in resource-limited settings, where human resource constraints and weaker health systems can pose formidable barriers to data collection and interpretation. We describe the practicalities of monitoring quality at scale within a very large multicountry PEPFAR-funded program, based largely at health facilities. The key elements include the following: supporting national programs and strategies; developing a conceptual framework and programmatic model to define quality and guide the provision of high-quality services; attending to program context, as well as program outcomes; leveraging existing and routinely collected data whenever possible; developing additional indicators for judicious use in targeted, in-depth assessments; providi...
PLOS ONE
This is the first large-scale assessment of the implementation of HIV Rapid Test Quality Improvement Initiative in South Africa. Methods We used a quasi-experimental one group post-test only design. The intervention implemented starting April 2014 comprised health-care worker training on quality assurance (QA) of HIV rapid testing and enrolment of the facilities in proficiency testing (PT), targeting 2,077 healthcare facilities in 32 high HIV burden districts. Following the intervention, two consecutive rounds of site assessments were undertaken. The first, conducted after a median of 7.5 months following the training, included 1,915 facilities that participated in the QA training, while the second, conducted after a median of one-year following the first-round assessment included 517 (27.0%) of the 1,915 facilities. In both assessments, the Stepwise-Process-for-Improving-the-quality-of-HIV-Rapid-Testing (SPI-RT) checklist was used to score facilities' performance in 7 domains: training, physical facility, safety, pre-testing, testing, post-testing and external quality assessment. Facilities' level of readiness for national certification was assessed.
Development of National and Multiagency HIV Care Quality Measures
Clinical Infectious Diseases, 2010
See the editorial commentary by Bozzette, on pages 739-740.) Background. Human immunodeficiency virus (HIV) is now a complex, chronic disease requiring high quality care. Demonstration of quality HIV care requires uniform, aligned HIV care quality measurement. Methods.
Access and Quality of HIV-Related Point of Care Diagnostic Testing in Global Health Programs
Clinical Infectious Diseases, 2015
Access to point-of-care testing (POCT) improves patient care, especially in resource-limited settings where laboratory infrastructure is poor and the bulk of the population lives in rural settings. However, because of challenges in rolling out the technology and weak quality assurance measures, the promise of human immunodeficiency virus (HIV)-related POCT in resource-limited settings has not been fully exploited to improve patient care and impact public health. Because of these challenges, the Joint United Nations Programme on HIV/AIDS (UNAIDS), in partnership with other organizations, recently launched the Diagnostics Access Initiative. Expanding HIV programs, including the "test and treat" strategies and the newly established UNAIDS 90-90-90 targets, will require increased access to reliable and accurate POCT results. In this review, we examine various components that could improve access and uptake of quality-assured POC tests to ensure coverage and public health impact. These components include evaluation, policy, regulation, and innovative approaches to strengthen the quality of POCT.
Assessment of quality assurance in HIV testing in health facilities in Lake Victoria zone, Tanzania
Tanzania Journal of Health Research, 2007
Tanzania is currently implementing the antiretroviral treatment programme, and has a target of putting about 400,000 eligible HIV infected individuals on treatment by 2008. This will involve screening a large number of people, which will require non-laboratory personnel to be involved in doing HIV testing. In order to guarantee reliable and quality HIV test results, there is a need to ensure that quality assurance (QA) procedures are followed from specimen collection, testing and reporting of results. In light of the above a survey was conducted to assess QA in HIV testing in health facilities in Lake Victoria zone, Tanzania. A total of 89 health facilities (29 hospitals, 34 health centres, 9 dispensaries and 17 voluntary and counselling testing centres) were surveyed. Only three (10.3%) health facilities reported performing Uniform II ELISA for HIV diagnosis. All other health facilities reported to be using HIV rapid tests Capillus and Determine. Five (5.6%) of health facility laboratories performed CD4 counts. Internal quality control (IQC) were performed in 21 (63.6%) of the hospitals. Kits for HIV testing were reported to be readily available by 54 (60.7%) of the facilities. Only 16 (18%) of the health facilities had standard operating procedures in place. Systems of equipment calibration were reported by 13 (14.6%) of the health facilities. Counselling services were available in all health facilities and all counsellors had received the 6-week mandatory training course. These findings show that most of health facilities in the Lake Victoria zone do not adhere to QA procedures in HIV testing. There is therefore, a need to establish a monitoring system to laboratories performing HIV testing for the purpose of ensuring QA procedures are done. Personnel doing HIV testing should be retrained at a regular basis to cope with new techniques and ensure QA procedures are followed.
American Journal of Clinical Pathology, 2009
The expansion of HIV/AIDS care and treatment in resource-constrained countries, especially in sub-Saharan Africa, has generally developed in a top-down manner. Further expansion will involve primary health centers where human and other resources are limited. This article describes the World Health Organization/President's Emergency Plan for AIDS Relief collaboration formed to help scale up HIV services in primary health centers in high-prevalence, resource-constrained settings. It reviews the contents of the Operations Manual developed, with emphasis on the Laboratory Services chapter, which discusses essential laboratory services, both at the center and the district hospital level, laboratory safety, laboratory testing, specimen transport, how to set up a laboratory, human resources, equipment maintenance, training materials, and references. The chapter provides specific information on essential tests and generic job aids for them. It also includes annexes containing a list of laboratory supplies for the health center and sample forms.
Assessment of Quality Assurance Program of HIV Testing in Ethiopia
American Journal of Internal Medicine, 2014
Background: HIV/AIDS is one of the most challenging health crises facing the world today. The availability of excellent HIV (Human immunodeficiency virus) tests does not automatically guarantee reliable result. Many steps are involved between specimen collections to the moment when reported to physician and at each step something may go wrong. Measures to control the quality of result in HIV diagnostic laboratories are extremely important, because of the consequence of either false positive or false negative results are huge. Methods: A cross sectional study conducted to assess quality assurance program of HIV testing in Addis Ababa Hospitals and Clinics, Ethiopia from May to October 2012. A well designed and structured questionnaire, Checklist and onsite observation were used to collect data. Data was processed and analyzed with SPSS version16.0. Results: Out of 20 assessed hospitals and clinics cases, 3(14%) laboratory personnel's who conduct HIV testing were found to have no training in HIV testing. Some laboratories 2 (10%) do not follow HIV testing algorithm and also 2 (10%) laboratory personnel's do not know what to do in case of indeterminate result. HIV testing methods used were Rapid/ simple 20(100%), ELISA 13 (65%), and Western blot 1(5%). All laboratories use controls that are supplied with kit but 2 (10%) laboratories use external control (pooled sera) additionally. Seventeen (85%) uses manual (guidelines) supplied with kits but none of them uses SOPs (Standard operating procedures). There was poor participation in EQA (External Quality Assessment) program (50%). Conclusion: This study showed that there is lack of qualified human resources, not following HIV testing algorithm and poor participation in External quality assessment program. Therefore having a good quality assurance program and participation in external quality assessment scheme is indispensable. In addition, provision of refreshment training for laboratory personnel's' who conduct HIV testing and involving them in planning and management will increase the quality of HIV testing.
2018
Background: The implementation of HIV point-of-care testing technologies reduced turnaround-time (TAT), pre-analytical errors and sample transporting errors. But, it increased the complexity of QA implementation because it involves non laboratorians and outspread the testing sites to be covered by Proficiency testing. Objectives: To assess quality assurance practice for HIV rapid testing services at point of care sites in public health facilities in Addis Ababa, Ethiopia Methods: A cross-sectional prospective study was conducted based on random sampling technique in 3 hospitals and 41 health centers which included 265 point of care HIV rapid testing sites. Conveniently 310 HIV Rapid Test providers were also included. Standardized Checklists were used for the assessment. Data were captured, cleaned and analyzed using SPSS version 20. Results: HIV rapid testing sites had 65.59% performance score. Of the 265 point of care HIV rapid testing sites that were evaluated On-site, 0.4% of them have Zero level performance which Needs improvement in all areas and immediate remediation. One level performance was noted in 27.2% of testing points which needs improvement in specific areas; and 64.2% of testing points have level two performance which means partly eligible for HIV rapid testing. Three level performances that is close to national site certification is seen in 7.9% of testing points. Among 310 HIV rapid testing providers, 302 (97.4%) could correctly detect negative and positive panel samples. Eight (2.6%) had discordant result during screening test (test one) among these 3(37.5%) had false positive reports that corrected through the algorithm on the final result; 4 (50%) had false negative reports and 1(10%) was report as invalid. In the onsite checklist, lack of SOP for safety, use of expired Kits, lack of clean water for hand washing at testing sites, data management of quality elements of Registrations book contents and lack of personnel training on internal quality control and External quality assurance, lack of timer, were mentioned as a major bottle neck for quality performance. Conclusion: HIV rapid testing sites had 65.59% performance score which is below 80 %. HIV rapid testing providers scored 99.40% for proficiency panel testing which is below acceptable score of 100%. False negative results need attention since positives are released to the community due to misdiagnosis. Immediate intervention is needed on the identified findings.
Evaluation of an External Quality Assessment Program for HIV Testing in Haiti, 2006-2011
American Journal of Clinical Pathology, 2013
Objectives: To evaluate an external quality assessment (EQA) program for human immunodeficiency virus (HIV) rapid diagnostics testing by the Haitian National Public Health Laboratory (French acronym: LNSP). Acceptable performance was defined as any proficiency testing (PT) score more than 80%. Methods: The PT database was reviewed and analyzed to assess the testing performance of the participating laboratories and the impact of the program over time. A total of 242 laboratories participated in the EQA program from 2006 through 2011; participation increased from 70 laboratories in 2006 to 159 in 2011. Results: In 2006, 49 (70%) laboratories had a PT score of 80% or above; by 2011, 145 (97.5%) laboratories were proficient (P < .05). Conclusions: The EQA program for HIV testing ensures quality of testing and allowed the LNSP to document improvements in the quality of HIV rapid testing over time.