Total quality management, laboratory accreditation and external quality assessment schemes

Abstract

Two contradictory pressures, ?high quality? and ?cost reduction? require the clinical laboratories to adopt effective management techniques such as Total Quality Management (TQM). It is not merely a management process for quality improvement in all spheres of industrial functioning but also a management philosophy for overall organization development. TQM has been adopted by many health care organizations including clinical laboratories in the developed world. In the developing countries, however, majority are still using the traditional frame work of quality management. Through the concept of Quality Assurance (QA) and Quality Control (QC) in health care laboratories in India is more than two decades old, it developed in a highly unequal plane and still faces multi factorial problems. External QA/ Proficiency Testing (PT) is used to compare performance of laboratories. This is recently made mandatory for accreditation process in India. Unfortunately only <10% of laboratories participate in EQA programs possibly due to high cost. Professional bodies/Institutions (ACBI, IAPM, ISHTM-AIIMS EHPT) and Government of India are working hard to make EQA Programs available at reasonable cost. National Board of Testing and Calibration Laboratories (NABL) has been setup by Department of Science and Technology, Government of India which has started accreditation of clinical laboratories since 1999. So for 33 laboratories (0.17%) has been accredited and almost the same number of applications are in process. The program is voluntary at the beginning, may be made mandatory later. We see a Herculean task ahead for NABL but they are doing a good job at low cost similar to international organization like ACP. The formation of laboratory policy with quality control as its integral part is very imperative in achieving, total quality management of clinical laboratories in India.