External quality assessment scheme for hemostasis in India.

Regular participation in an external quality assessment scheme (EQAS) is critical for ensuring acceptable laboratory performance. However, participation in such programs is uncommon for laboratories performing tests of hemostasis in developing countries. There are several reasons, including lack of awareness of its significance, absence of locally administered and easily accessible programs, and costs associated with some of the international schemes. To address this problem, we initiated an EQAS for hemostasis in India in the year 2000. This initially was limited to approximately 25 laboratories associated with the chapters of the Hemophilia Federation (India), with samples and analysis of results supported by United Kingdom National External Quality Assessment Scheme. This was converted to a national program in 2003, in association with the Indian Society of Haematology and Transfusion Medicine. Local manufacture of survey samples began in 2004, along with analysis of results. Currently, more than 100 laboratories are registered in the program. They receive samples three times a year for the following tests: prothrombin time, activated partial thromboplastin time, and factor assays. Some surveys also include samples for fibrinogen and von Willebrand factor assays. In recent surveys, 60 to 95% of laboratories had their clotting times and 57 to 77% of laboratories had their factor assays within consensus. The program has helped identify causes of unacceptable performance. The challenges ahead are to increase participation, improve reporting of results, and provide individualized support to laboratories to improve performance when necessary.