Evaluation of the WHO laboratory quality stepwise implementation tool

Abstract

The LQSI tool, currently being used worldwide and available in English, French, Russian, Spanish, Arabic and Turkish, positively impacts the quality of services provided by clinical and public health laboratories, leading to improved clinical care and disease surveillance capacity as required by the IHR (2005) and envisioned by the Global Health Security Agenda.

The Future of Laboratory-Developed Tests in Hemostasis Laboratories

“…In many LMICs, there are no regional regulatory bodies charged with oversight for the use of LDTs. Clinical laboratories that are committed to quality adhere to accreditation or certification processes, 4 or voluntarily commit to good laboratory practices (GLPs) and not necessarily because it is an established regulation. In the latter case, laboratories may follow recommendations of opinion leaders or guidelines established by recognized regulatory or accrediting agencies such as the FDA, International Organization for Standardization (ISO), and international organizations such as Clinical and Laboratory Standards Institutes (CLSI), International Federation of Clinical Chemistry and Laboratory Medicine (IFCC), International Society for Thrombosis and Hemostasis (ISTH), International Council for Standardization in Haematology (ICSH), World Federation of Hemophilia (WFH) and others, or accrediting agencies such as the College of American Pathologists (CAP).…”