Clinical Laboratory Standards

PEPFAR Ethiopia, in collaboration with the Ethiopian Health and Nutrition Research Institute (EHNRI), has

established and enhanced the nation laboratory testing services. The RT program has expanded to district

hospitals and health centers.

In FY07, support has been provided for training and for improvement of quality laboratory services. Tiered

laboratory services and referral linkages and networking were implemented to meet the rapid scale up of

the ART program and decentralization of services to the health center levels.

There are still major gaps in clinical laboratory layout design and work flow, and in maintenance of bio-

safety levels. Most of the laboratories at the regional and hospital level do not have uniform, standard

operating procedures (SOP), and, as such, are not organized because laboratories are not properly

designed. Design and introduction of appropriate laboratory layout is critical for ensuring the efficiency of

each facility and proper management of it.

Clinical Laboratory Standards Institute (CLSI) writes, distributes, educates, and trains on standards and

guidelines for best practices in the field of medical laboratory testing. CLSI has an inventory of over 170

different standards, guidelines, job aides, and tool kits in a range of areas, including: specimen collection;

general laboratory practices; chemistry, hematology, infectious diseases and microbiology; and quality

systems essentials and the reduction of errors. CLSI is based in the US, but has organizational members

from over 35 countries on five continents. CLSI is the convener for the committee of the International

Standardization Organization (the acknowledged standards-setting organization). CLSI has expertise and

experience in implementing laboratory standards in different PEPFAR-supported countries and will also

implement the activities initiated in FY07 in Ethiopia.

As a continuation of FY07, CLSI will provide technical assistance to Ethiopia to further assist in developing

and harmonizing SOP and to ensure they are being used properly.

Laboratory layout will be assessed and standard layout and designs will be developed for regional, hospital,

and health center laboratories. These layouts and designs will also be used in construction/renovation of

clinical laboratories to fit into the tiered health services

Laboratory trainings are provided at different levels, but trainees have not been assessed on how they apply

the acquired skills and knowledge from the trainings. Competency assessments of laboratory personnel are

poorly done. To have quality laboratory testing services at each clinical laboratory, the standard of each

laboratory should meet basic requirements. Training modules on bio-safety and implementation will be

developed and training-of-trainers programs will be provided.

Competency assessment tools will be developed and used following the provision of training at different

levels. CLSI will provide training on the development and use of SOPs, referral linkages, and competency

assessments.