Clinical and Laboratory Standards Institutes (CLSI) objective is to provide laboratory capacity building assistance to NHL-QATC and five zonal hospital laboratories in Tanzania and enhance laboratory quality improvement skills through a quality systems approach. Utilizing accepted clinical and laboratory standards and guidelines, CLSI will facilitate the development of quality management systems, quality improvement and management skills, and provide on-going advice to sustain and maintain the quality improvements. CLSI will implement these activities through conducting detailed assessments (gap analysis) of the laboratories, deliver customized training and educational workshops based on critical needs, provide on-going advisement, and deliver a mentor/twinning program designed to facilitate the implementation of best practices and improvement strategies. The measurable program outcomes will include the number of laboratories that attain or apply for accreditation, number of laboratories that have written quality manual and standard operating procedures, participation in EQA, and conducting corrective actions on failed EQA panels. As the laboratories move towards accreditation, CLSI mentors will support the laboratories throughout the accreditation process. This will be accomplished by mentors' presence at the laboratories two weeks prior to the accreditation inspection and two weeks after the inspection. This will help the laboratories in the final preparations as well as address any issues after the inspection. CLSI will also train local quality assessors and mentors who will be able to continue to carry out assessments and mentorship in the other laboratories countrywide. This will ensure the sustainability of the CLSI programs in the long term.

CLSI will work closely with the six laboratories (NHL-QATC and five zonal hospital laboratories) to assist in the implementation of selected improvement plans and 'best practices.' Implementation of the mentor/twinning program will last up to a six week period. Within this period, expert volunteers will stay in country to work side-by-side local laboratory staff and managers to facilitate improvement strategies to prepare the laboratories for maintaining accreditation. The goal of this program is to not only facilitate the improvements for maintaining accreditation but to empower and build long-term working relationships with the laboratory staff and expand their network of laboratory professionals. Technical assistance and support to 10 local mentors will be provided. This will be achieved through a five-day workshop to build the local mentoring capacity. Two CLSI staff and two CLSI volunteers will travel to Tanzania to conduct the mentor training workshop. These mentors will be trained and assessed for competency in mentoring practices and skills. They will be assigned to regional or district laboratories where their main responsibility will be to mentor the laboratories in implementing quality management systems. The goal of this program will be to equip the local staff with adequate resources and skills to be effective mentors to other laboratories countrywide. CLSI staff and volunteers will travel to Tanzania to partner with the local quality assessor to conduct gap assessments of the six laboratories. The gap analysis will be based on the ISO15189 standard and checklists from the accrediting bodies, e.g. SADCAS/SANAS. The results of the assessments will highlight opportunities for improvement and each laboratory will be assisted in developing project plans that address the gaps that exist. CLSI has developed a certificate program in Laboratory Quality Management Systems that provides a robust and challenging curriculum designed to meet the needs of people who are responsible for laboratory policy and strategies at any level. CLSI will introduce this course through partnerships with local universities in order to strengthen local laboratory leadership in managing the laboratories. This program is part of an integrated approach to the delivery of high-quality patient results, which will support the achievement of a higher level of laboratory operations. Work with MOHSW laboratory leadership will be prioritized to develop national policies and guidelines for accreditation. This activity will involve the assembling of a Laboratory Working Group that will spearhead and play a leading role in the development and dissemination of the document. The Laboratory Working Group will conduct sensitization workshops and gather information from all relevant laboratory stakeholders before writing the final draft of the laboratory policy document.