Pakistan is a country with numerous clinical laboratories, of which more than 70% are part of the private sector. Although several provinces are planning to implement a licensing system, the quality of services provided by most laboratories is unknown.

To be able to ensure that laboratories in Pakistan provide quality controlled and assured services, both in the human and veterinary sector, the World Health Organization Eastern Meditteranean Regional Office (WHO-EMRO), and the WHO Country Office of Pakistan requested us to assist Pakistan with the development of National Laboratory Quality Standards (NLQS).

Stepwise approach
We are following an approach similar to the one used last year, when we started the development of NLQS with/for Afghanistan. Back in 2008, during joint WHO/CDC conference on laboratory strengthening, the recommendation was made that countries should develop national laboratory standards and that countries with limited resources should consider taking a staged approach. As such it was decided to make the NLQS of Pakistan a tiered one. Level 1 contains the core licensing requirements. This is made such that the added burden to laboratories is minimized while quality of their services can still be assured. As such the requirements of level 1 can be implemented also by very small laboratories. Level 2, 3 and 4 are gradually more advanced and one builds on the other, which means that laboratories can gradually improve. From tier 4 it is only a small step towards compliance with international standards.

Two birds with one stone
DATOS also decided to make the NLQS of Pakistan such that, through its implementation, also elements of the revised International Health Regulations (2005) and the National Laboratory Policy of Pakistan are implemented. The national standard is based on the ISO 15189 international standard for quality and competence of medical laboratories. In addition, the standard also contains requirements related to laboratory biorisk management based on CWA 15793, to make sure that not only laboratory quality, but also laboratory (bio)safety and (bio)security are addressed.

Consensus approach
This week a start was made with review of the first draft of the NLQS by the National Laboratory Working Group of Pakistan, containing representatives of public and private laboratories from different provinces of Pakistan. This review will be completed in a second workshop, during which an elaborate strategy for roll-out and implementation will be designed, such that all laboratories country-wide will be trained and supported to implement the requirements of the NLQS.

Other activities in Pakistan
In addition to the development of NLQS, DATOS is also present in Pakistan for other activities, such as finalization of the National Laboratory Strategic Plan, and we are conducting activities for the Fleming Fund. We will report about this next week!