Standardization of Clinical Laboratory Services

This is a continuing activity from COP05 and COP06. As of August 2006, ASCP received 95% of COP06 funds and is on track according to original workplans. We have increased funding based on the achievements from COP05 and COP06 thus far. The 200% budget increase reflects the activity's increasing support for clinical laboratory education including development/revision of training modules, SOPs, fostering linkages, twinning partnerships between US Medical Laboratory training programs and Ethiopian Schools of Medical Laboratory Technology. The ASCP began a collaborative relationship with the Ethiopian Association for Public Health Laboratories (APHL) and with the CDC in Atlanta to develop and implement laboratory-training programs. The project was in response to PEPFAR. Ultimately this program will serve to enhance laboratory-testing practices and services, in order to improve the effectiveness of HIV/AIDS prevention, care and treatment services, and interventions in Ethiopia.

Since 2004, the ASCP has conducted assessment on current clinical laboratory practices and the educational needs within the areas of hematology and chemistry. ASCP developed standard modules for clinical chemistry, hematology, and CD4 in-service trainings and supported training of more than 200 laboratory personnel in collaboration with PEPFAR Ethiopia and the Ethiopian Health Nutrition and Research Institute (EHNRI).

In FY07 ASCP will be involved in expanding the COP06 activities and supporting new activities as outlined below.

ASCP will collaborate with senior laboratory leadership in the development and updating of standard operating procedures (SOP) in the areas of clinical chemistry, hematology, CD4 count, laboratory operations, and quality assurance and control. ASCP will develop TOT curriculum for chemisty and hematology and conduct a "Training of Trainers" of senior laboratorians from across Ethiopia. The main objective of the TOT is to immerse the laboratorians in one of the three specialty areas, i.e., chemistry, hematology, or CD4, which will give the participant a level of expertise and ability to provide training to other laboratorians throughout Ethiopia. The first week of training would consist of extensive didactic lectures during morning sessions and hands-on instrument training during the afternoons. The second week of training would focus on providing participants with an opportunity to "Teach-Back." This methodology provides the participants with opportunity to exercise their knowledge and skills.

ASCP will develop Curriculum for Clinical Laboratory Management at hospital and health center levels: ASCP will collaborate with senior laboratory leadership (PEPFAR Ethiopia and EHNRI) in the development of curriculum for laboratory management. Two individuals from Ethiopia attended a six week laboratory management course at Howard University and will be instrumental in working with ASCP consultants on development of the curriculum. It is envisioned that a "Train the Trainer" format will be utilized, i.e., train senior laboratorians who will then have the knowledge and expertise to train laboratorians on best practices (Quality Systems) in the laboratory. ASCP will seek input from PEPFAR Ethiopia and EHNRI on recommendations for trainees.

ASCP will provide technical assisitance to standardize clinical laboratory services: ASCP will assign technical experts for one to two months who will work with laboratories identified by PEPFAR Ethiopia and EHNRI to support the transition to adaptation of best laboratory practices. Areas to be addressed may include: further development of SOP for services provided in various health care settings ( hospitals to health centers), mentoring in laboratory mangement, and development of specimen transfer and referral systems.

ASCP will assign technical experts for two to three months who will work with laboratories identified by PEPFAR Ethiopia and EHNRI to support the transition of adapting best clinical laboratory practices (Quality Systems). The expert will work with local institutions in improving specimen management, quality control, equipment management and document and records in clinical laboratories.

ASCP will establish "Twinning Partnerships" of US Medical Technology training programs with Ethiopian Schools of Medical Technology. This is a new activity for FY07. As a result

of ASCP assessments and training experiences in PEPFAR countries, staff and volunteer faculty have quickly realized that the sustainability of ASCP's training efforts could be strengthened if initiatives are taken to support ‘pre-service training.' Pre-service training refers to the educational experience received by laboratory medicine students prior to entering the work force. A process by which ASCP could contribute to the strengthening of pre-service training is through "Twinning Partnerships," a formal and sustainable partnership between two or more similar organizations established to collaborate in providing human and organizational capacity development in HIV prevention, care, and treatment through exchange visits, training, and ongoing communications and information support. Activities that twinning partners may engage in are professional exchanges, training and mentoring; development of curricula and other educational/training materials; and scaling up or replicating successful care, treatment and support programs. ASCP will collaborate with PEPFAR Ethiopia to identify schools in country and prepare a plan of action.

Accreditation of Laboratory Services : This is a new activity for COP07. The ASCP will partner with Joint Commission International (JCI) to work with local partners and PEPFAR Ethiopia to develop and pilot an accreditation program that supports a sustained quality improvement and assessment infrastructure for participating laboratories. The project uses JCI laboratory standards to improve laboratory services for HIV/AIDS patients. While ASCP and other Cooperative Agreement Partners have provided the basic tools by which laboratories can meet PEPFAR goals, standards-based strategies are needed to assure that initial investments result in sustained and increased performance rather than decay for lack of ongoing support. Having a set of standards that can be uniformly applied to PEPFAR laboratories will provide a "roadmap" to assuring high quality and then an infrastructure and program to sustain quality performance. The focus for the accreditation program would involve the recently built, PEPFAR funded EHNRI laboratory.

Activities to be implemented in the first year of the plan include: 1) Building Awareness and forming consensus with national stakeholders; 2) Meet with partners; review country mechanisms and processes relating to monitoring HIV/AIDS patients using clinical lab results; 3) Adapt Laboratory Standards based on assessment findings; 4) develop an evaluation and impact methodology; 5) Develop training materials; 6) Recruit and train ten individuals that will participate in the evaluation; and 7) Build Capacity and Support the Implementation in the Pilot Sites.

As part of sustainability and local capacity development, ASCP will support and closely work with Ethiopian Medical Laboratory Association.