TB Laboratory Accreditation

The Score TB package has been developed to help laboratories assess the quality of test implementation in TB laboratories against international quality standards. Developed by the Foundation for Innovative New Diagnostics, in collaboration with the Global Laboratory Initiative, US Centers for Disease Control and Prevention and the African Society for Laboratory Medicine, the Score-TB Package consists of a User Guide, modular test-specific quality assessment scorecards and a quality management system assessment e-tool. All the tools are available in English, French and Portuguese. 

A key intervention to strengthen laboratory services is the implementation of a quality management system (QMS). A QMS is defined by the International Organization for Standardization (ISO) as the "management system to direct and control an organization with regard to quality". Standardization of testing through implementation of a QMS has been shown to improve the quality of testing by reducing testing errors, among other benefits.

Several tools and initiatives to assist clinical laboratories to implement quality improvement activities have been developed. The World Health Organization developed the Laboratory Quality Stepwise Implementation Tool (LQSI) to provide a stepwise plan to guide medical laboratories towards implementing a QMS in compliance with ISO 15189. This tool helps laboratories to fulfil the requirements of the standard to achieve accreditation. In addition, the Strengthening Laboratory Management toward Accreditation (SLMTA) program has been very successful in assisting laboratories across various diseases to achieve ISO standards. SLMTA is often used in conjunction with the Stepwise Laboratory Improvement Process Towards Accreditation (SLIPTA) checklist, which serves as a laboratory assessment tool to quantify laboratory progress toward quality standard achievement and simultaneously measure SLMTA program impact.

Based on SLMTA and SLIPTA, a TB laboratory-specific program (TB Strengthening Laboratory Management toward Accreditation (TB SLMTA)) and a TB laboratory assessment checklist (TB Laboratory Quality Management Systems Towards Accreditation Harmonized Checklist) were previously developed. These resources incorporate TB laboratory-specific biosafety and technical testing requirements into the TB laboratory accreditation process.

Most recently, the TB Laboratory Quality Management Systems Towards Accreditation Harmonized Checklist was revised to include new TB testing methods that were not included in previous versions and to provide an electronic format for checklist implementation. The new, ‘Score-TB Package’ includes this checklist as an e-tool, increasing the user friendly nature of the resource and reducing the risk of error by automating calculation of assessment scores. Automated results are reported via an incorporated worksheet so that TB laboratory QMS strengths and weaknesses can be visualized. The following components are included in the Score TB Package: