Assessment of knowledge and practices related to technical requirements recommended by ISO 15189:2012 standards among medical laboratory technology staff in tertiary care hospitals and institutions in Western Province, Sri Lanka

Abstract

Introduction: Accuracy and reliability of laboratory test results is a great expectation and ISO 15189:2012 is the globally recognized standard for medical testing laboratories. In Sri Lanka most of the government sector laboratories not accredited for ISO 15189. Objectives: The objective of this study was to describe the existing level of knowledge and practices related to ISO 15189:2012 standard and to find out the barriers to follow its technical recommendations among Medical Laboratory Technology (MLT) staff in government tertiary care hospital laboratories and institutions in Western province, Sri Lanka. Methods: A descriptive cross-sectional study was carried out among senior MLTs working in 23 tertiary care units in the Western province. A pre-validated self-administered questionnaire was used to assess knowledge, practice and barriers to implement ISO standard. Score value for knowledge was calculated using 6 predetermined questions giving score of I or 0 for “yes” and “no” responses respectively. Results: Of the participated laboratories, 8% (2 Institutions) were accredited. Among the participants 34% had good knowledge about the ISO standard and 96.6% indicated training requirement on accreditation. Acceptable internal quality control activities and documentation practices were observed among 93.2% and 60% of the laboratories respectively. Lack of knowledge on ISO (68.3%) and training on documentation (64.86%) identified as the major barriers to follow ISO requirements. Conclusions: Study findings indicate the need for training programmes for medical laboratory staff to overcome the barriers identified which will facilitate implementing reliable medical laboratory service based on the ISO 15189 standard in the future.