Laboratory services at the district level
In countries with limited resources, even rural health facilities can manage the most common diseases and those with outbreak potential by carrying out simple laboratory tests. Unfortunately, adequate diagnostic laboratory services sometimes fails and leads to inappropriate or wrong treatment.
The underlying causes can be
- Shortage of skilled staff
- Substandard infrastructure
- Obsolete laboratory procedures
Modern equipment can therefore be ineffective unless staff are trained to use it, and it is properly maintained. Without a quality management programme, it is difficult to avoid bad laboratory results.
One project which is aiming to overcome these problems involves three countries in East Africa, namely Kenya, Uganda and United Republic of Tanzania.
In each country, a National Quality Assurance Advisory Body has been established, as well as legal framework to regulate both laboratory premises and laboratory staff. A standard list of essential laboratory procedures is supported by generic standard operating procedures for use in district health services in all three countries. The project has already had a great impact on the quality of laboratory services and has allowed the countries to achieve goals that would have been difficult to achieve individually.
The WHO Essential Medicines and Health Products assists countries to achieve a safe and reliable level of health services in a variety of health technologies through its Basic Operational Frameworks. With the scaling up of interventions against the major diseases of poverty - HIV/AIDS, TB and malaria - the need for in vitro diagnostic and laboratory services has never been greater.
- EBOLA IVDs
- WHO list of prequalified in vitro diagnostic products
- Status of active applications to the prequalification of in vitro diagnostics
- Complaints and Product Alerts
- Streamlining of the Prequalification of Diagnostics
- WHO Prequalification of Male Circumcision Devices
- Procurement of in vitro diagnostics
- HIV incidence assay working group
- Information resources
Invitation to manufacturers of in vitro diagnostics for Zika virus to submit an application for emergency use assessment and listing by WHO
ZIKA VIRUS: Emergency Use Assessment and Listing Procedure (EUAL) announcement
- Sample product dossier for an IVD intended for HIV self-testing (for public comments to be submitted to firstname.lastname@example.org no later than 29 February 2016)
- New Guidance for Manufacturers (TGS 1 & TGS 2) (for public comments to be submitted to email@example.com no later than 29 February 2016)
Newsletter Issue 12, Q4 2015
Guidance for post-market surveillance
Prioritization criteria expanded to HPV