Cited 2 times since 2018 (0.3 per year) source: EuropePMC Clinical chemistry and laboratory medicine, Volume 57, Issue 1, 1 1 2018, Pages 78-88 Toward harmonization of clinical molecular diagnostic reports: findings of an international survey. Payne DA, Baluchova K, Russomando G, Ahmad-Nejad P, Mamotte C, Rousseau F, van Schaik RHN, Marriott K, Maekawa M, Chan KCA, IFCC Committee on Molecular Diagnostics
Background
The International Organization for Standardization (ISO) 15189 standard provides recommendations for the postexamination reporting phase to enhance quality in clinical laboratories. The purpose of this study was to encourage a broad discussion on current reporting practices for molecular diagnostic tests by conducting a global survey of such practices.
Methods
The International Federation of Clinical Chemistry and Laboratory Medicine's Committee for Molecular Diagnostics (IFCC C-MD) surveyed laboratories on selected ISO 15189 recommendations and topics. The survey addressed the following aspects: (1) laboratory demographics, (2) report format, (3) result reporting/layout, (4) comments in report and (5) interpretation and clinical decision-making information. Additionally, participants indicated categories needing standardization.
Results
Sixteen responses from laboratories located in Asia, Europe, the Middle East, North America and South America were received. Several categories yielded 100% agreement between laboratories, whereas other categories had less than or equal to 50% concordance. Participants scored "nomenclature" and "description of methodologies" as the two most frequently cited aspects needing standardization.
Conclusions
The postexamination phase requires extensive and consistent communication between the laboratory, the healthcare provider and the end user. Surveyed laboratories were most likely to follow explicit ISO 15189 recommendations vs. recommendations when the term(s) "where appropriate or where applicable" was used. Interpretation and reporting of critical values varied among participants. Although the outcome of this study may not fully represent the practices of all molecular testing laboratories in countries around the world, the survey identified and specified several recommendations that are requirements for harmonized reporting in molecular diagnostics.
