A Guide to Total Quality Management System (TQMS) in Molecular Diagnostics from Experiences in Seeking Accreditation and Implementation

• Published in: SN comprehensive clinical medicine Vol. 1; no. 2; pp. 123 - 133
• Main Authors: Dayakar, Seetha, Pillai, Heera R., Kalpathodi, Sanughosh, Jeya Chandran, Ganesan, Nair, Radhakrishnan R.
• Format: Journal Article
• Language: English
• Published: Cham Springer International Publishing 01.02.2019
• Subjects: Medicine; Medicine & Public Health; Topical Collection on Medicine; Total quality management system; Real-time PCR/PCR; Molecular diagnostics; Accreditation; Next-generation sequencing; ISO15189:2012
• ISSN: 2523-8973; 2523-8973
• DOI: 10.1007/s42399-018-0018-3

The molecular diagnostic laboratories in developing countries are progressively improving and attaining international accreditation. Hence, understanding and implementing the concept of quality are the needs of the hour. Total quality management system (TQMS) in a diagnostic laboratory is an integrated program involving all laboratory staff aiming for integration, consistency, and increase in efficiency. A comprehensive understanding of such a system is unfortunately only through practice. Our endeavors in establishment of TQMS for laboratory accreditation has helped us gain comprehensive understanding of the process and have compelled us to share the knowledge with the community engaged in such diagnostics. A number of accreditation bodies have put forth guidelines for laboratories seeking accreditation; however, such documents can be overwhelming at times leading to confusion and difficulty in implementation. We aim to present to the reader a lucid script of basic reasoning behind such accreditation guidelines in conjunction with thorough and practical generalized workflows for TQMS implementation. The goal of TQMS is to provide the best possible care for patients; and to achieve top-notch quality, there should be a continuous drive for improvement. The clinical vignettes presented in this paper illustrate the value of applying select ISO 15189:2012 recommendations in a molecular diagnostic laboratory to efficiently ensure quality through TQMS and a basic understanding of nuances for its practical implementation. Implementation of TQMS in a diagnostic setting enables seamless flow of laboratory results and instills confidence in clinicians regarding disease interpretation and treatment.