Laboratory preparedness

Background

In the context of a global response to MDR and XDR TB, the WHO Stop TB Department and Partners in Health asked FIND in November 2006 to assess the National TB Laboratory in Lesotho in order to evaluate the operational feasibility of establishing an automated liquid culture system as a rapid DST detection tool. Part of FIND’s assessment was to determine which laboratory upgrades needed to be undertaken before demonstration could begin.

In collaboration with the Head of the Central Laboratory, the National TB Program, WHO, Partners in Health and the Clinton Foundation, FIND wrote a proposal on how to rapidly reinforce the Central TB Laboratory and introduce a modern liquid culture system for TB drug susceptibility testing.

FIND’s interest in Lesotho was to monitor, within the framework of a demonstration project, the process of implementing a modern and rapid technology for TB drug-susceptibility testing in a laboratory that up until now suffered from major quality constraints. The project would consist of two phases:

Phase I: To monitor and accompany activities that will prepare the Central TB Laboratory for the introduction of an automated liquid culture system.

Phase II: To demonstrate the feasibility and public health impact of using automated liquid culture in the Reference Laboratory of Lesotho.

Establishing TB culture facility in the Kingdom of Lesotho

In a very short period of time during 2007, FIND supervised the upgrading of Lesotho's National Reference Laboratory (NRL) into a quality-assured TB culture facility with the aim to streamline culture and drug susceptibility testing (DST) facilities in the country. Under the leadership of Lesotho's Health Ministry and WHO guidance, FIND prepared detailed technical and resource requirements and PIH provided the necessary human and financial support. (see Press Release)

In mid-November, FIND participated in the inauguration of the renovated national TB reference laboratory. The first lady of Lesotho and the Minister of Health and Social Welfare presided over the well attended ceremony. Dr. Giorgio Roscigno, CEO of FIND, and Dr. Mario Raviglione, Director of WHO's Stop TB Department, were some of several participants to give an address during the inauguration.

One of the most urgent needs for countries in sub-Saharan Africa, where TB is compounded by the HIV-AIDS epidemic, is to establish quality-assured, aerosol-free, safe laboratory facilities for tuberculosis culture and DST. Among these countries, the Kingdom of Lesotho, with a population of 1.88 million, ranks among the worst affected.

In response to the emergence of MDR and XDR TB in the neighboring South African province of KwaZulu-Natal, and in answer to a request from the Ministry of Health of Lesotho and the World Health Organization, FIND conducted an assessment in November 2006 to evaluate the TB laboratory facility in Lesotho. This evaluation revealed that the designated NRL in Maseru had (a) a shortage of qualified personnel; (b) a lack of technical know-how and training; and (c) a shortage of equipment and financial resources. The country-wide, organized quality assurance programme (QAP) for sputum microscopy, as well as guidelines and standardized training for such activities, also necessitated some technical and financial support. As a result, FIND provided a detailed report describing the technical and resource requirements needed to create a functional NRL and PIH provided the necessary human and financial support. In addition, the FIND team in Geneva and a FIND technical consultant, who was posted at the NRL in May 2007, coordinated the renovation and provided the necessary expertise.

The NRL at Maseru was promptly renovated within the two month period from May to July 2007 to meet all the basic laboratory requirements for smear microscopy, media preparation, sterilization, and TB culture and DST using liquid culture, including a negative pressure containment facility as recommended by the WHO. Engineering controls, such as a continuous negative air pressure system with a HEPA filtered air source to supply more than 10 air exchanges per hour, and an on-site sterilization system, were established. All the necessary equipment previously procured under GFATM funds were made functional inside the renovated facility.

Simultaneously, on-site evaluation visits of peripheral laboratories were carried out for external quality assessment in smear microscopy. Guidelines for the national laboratory network for quality assurance (QA) of smear microscopy, and training manuals and a module for laboratory technicians were developed. A rechecking programme is underway. The NRL, which also functions, at present, as a routine microscopy centre, has initiated the rechecking programme as of August, 2007. QA orientation trainings to all the laboratory technicians (LTs) in the country will begin from September, 2007.

Standard Operating Procedures for culture and DST have been introduced, and a standard recording and reporting system has been established. Four additional LTs were recruited and trained in August 2007. With the existing but limited resources, the lab has demonstrated adequate capacity and proficiency in carrying out cultures on solid egg-based LJ media. In a 20-day period in August, 175 sputum specimens, including 100 smear positives, were processed. All smear positive specimens were also set up for direct susceptibility testing for rifampicin. Standard International Proficiency Testing for the culture and DST programme has been initiated. Twenty unknown cultures were obtained from MRC (Medical Research Council), Pretoria for this purpose. After demonstrating expected level of proficiency in LJ media, MGIT liquid culture and DST are now established.

In conclusion, the NRL at Lesotho has been renovated within a short period of time without compromising internationally acceptable standards. This very rapid and cohesive response to a need for improved laboratory preparedness was made possible by the proactive collaboration of all concerned agencies under the auspices of the Government of Lesotho.