Ensuring quality

Abstract

Objective:The objective of the WHO/US President's Emergency Plan for AIDS Relief consultation was to discuss innovative strategies, offer guidance, and develop a comprehensive policy framework for implementing quality-assured HIV-related point-of-care testing (POCT).Methods:The consultation was attended by representatives from international agencies (WHO, UNICEF, UNITAID, Clinton Health Access Initiative), United States Agency for International Development, Centers for Disease Control and Prevention/President's Emergency Plan for AIDS Relief Cooperative Agreement Partners, and experts from more than 25 countries, including policy makers, clinicians, laboratory experts, and program implementers.Main outcomes:There was strong consensus among all participants that ensuring access to quality of POCT represents one of the key challenges for the success of HIV prevention, treatment, and care programs. The following four strategies were recommended: implement a newly proposed concept of a sustainable quality assurance cycle that includes careful planning; definition of goals and targets; timely implementation; continuous monitoring; improvements and adjustments, where necessary; and a detailed evaluation; the importance of supporting a cadre of workers [e.g. volunteer quality corps (Q-Corps)] with the role to ensure that the quality assurance cycle is followed and sustained; implementation of the new strategy should be seen as a step-wise process, supported by development of appropriate policies and tools; and joint partnership under the leadership of the ministries of health to ensure sustainability of implementing novel approaches.Conclusion:The outcomes of this consultation have been well received by program implementers in the field. The recommendations also laid the groundwork for developing key policy and quality documents for the implementation of HIV-related POCT.

Xpert HIV-1 point-of-care test for neonatal diagnosis of HIV in the birth testing programme of a maternity hospital: a field evaluation study

“…Another potential solution, is implementation of POCT by building a “network of testers” within an institution. 29 …”

“…Achieving 3% error rates or less will require ongoing training, supervision and monitoring and engaging the manufacturer’s support. 29,30 …”

REASSURED diagnostics to inform disease control strategies, strengthen health systems and improve patient outcomes

“…Although not every error will result in an incorrect diagnosis, the alarming reality is that with 150 million tests being performed annually worldwide, assuming a 99% accuracy rate, as many as 1.5 million incorrect results per year could potentially be generated. Ongoing quality assurance efforts include developing key policy and quality documents for the implementation of HIV-related POC testing 16 . For example, as POC technologies for HIV viral load and early infant diagnosis were being developed, there was tremendous emphasis on quality, given the complexity of the test and lessons learned from HIV RDTs.…”

Diagnosis of Human Immunodeficiency Virus Infection

“…These volunteers included care coordinators, peer health workers, field officers, health extension workers, HIV/AIDS lay counselors, adherence supporters, and home-based care workers. The WHO has recommended the involvement of community volunteers or quality corps (Q-Corps) volunteers to support the rollout of quality activities and to ensure that the QAC is completed (167,179). Several PEPFAR-supported countries have implemented this initiative, with improved HIV testing in remote areas.…”

“…In some settings, they may still require an efficient specimen referral system to transport specimens. As POC tests are introduced into existing laboratory networks, they should be accompanied by effective quality measures to monitor the quality of testing (179).…”