Managing cost, quality and profitability in a clinical laboratory Sambhu Chakraborty Accreditation of clinical laboratory has always been regarded as an expensive affair but effective implementation of accreditation system ensures quality, saves cost and increases profitability.Equipment history is one of the prime areas where cost can be managed and profitability can be increased. Equipment breakdown may affect laboratory sample testing turnover severely and lead to clinician and patient dissatisfaction.

Accreditation speaks about formal recognition of technical competency of laboratory testing. Quality system of laboratory is developed based on the 4 Msand A (Man, Machine, Materials, Method of testing & Accommodation condition). Accreditation system is now practiced in every countries. Quality system standard ISO/IEC 17025 is now mostly followed for developing quality system in a clinical laboratory and this will be revised to ISO/IEC 1589.

Accreditation of a laboratory means technical competency of the laboratory to carry out various tests. Accreditation process ensures technical infrastructure, competent manpower, and records systems, all of which together deliver quality output and quality test results. It is the responsibility of the accreditation body to deliver quality assessment by a knowledgeable expert.

ISO 15189 is the global quality management standard published by International Organization for Standardization (ISO). Document control is one of the Key requirements of ISO 15189. It is considered Document control is the major quality element to establish quality management system. The research study was carried out to understand the effectiveness of document control system followed in accredited medical laboratories. It was the key objective to identify the importance of document control system hypothesis vs practical implementation and Challenges of Document control system implementation

The infrastructure of industrial laboratory in India has improved with the advent of the concept of quality in testing. A look at the early ’90s shows that the most of the industrial testing laboratories were not aware about the role and importance of the quality in testing. Globalisation and impact of GATT agreement helped industrial laboratories to improve the infrastructure. Many government organisations and multinational companies followed these policies to hire the services of accredited laboratory.

ISO 15189 is the global quality management standard published by International Organization for Standardization (ISO). The current version of the standard is ISO 15189 2012. The objective of the quality management standard is to deliver uniform quality output, overcome the trade barrier such as acceptability of the test report globally. ISO 15189 2012 standard has been adopted by all the MRA partner of ILAC Member countries Accreditation body for medical laboratory accreditation.

Guideline for Good Clinical Laboratory Practices (GCLP)Issue dtd. September, 2008 Laboratory tests are used to support diagnosis in patient care as well as medical research. The test results therefore should be reliable, accurate and reproducible. Generation of such ‘quality’ results involves a step wise process of meticulous planning, perfect execution and thorough checking of results by the whole team involved. International guidelines lay down the principles of Good Clinical Laboratory Practices (GCLP) to be followed by medical researchers to generate ‘quality data’ but do not address the issues of reporting ‘quality’ test results for day-to-day patient care.