Background
Multiple organizations produce guidance documents that provide opportunities to harmonize quality practices for diagnostic testing. The International Organization for Standardization ISO 15189 standard addresses requirements for quality in management and technical aspects of the clinical laboratory. One technical aspect addresses the complexities of the pre-examination phase prior to diagnostic testing.
Methods
The Committee for Molecular Diagnostics of the International Federation for Clinical Chemistry and Laboratory Medicine (also known as, IFCC C-MD) conducted a survey of international molecular laboratories and determined ISO 15189 to be the most referenced guidance document. In this review, the IFCC C-MD provides case-based examples illustrating the value of select pre-examination processes as these processes relate to molecular diagnostic testing. Case-based examples in infectious disease, oncology, inherited disease and pharmacogenomics address the utility of: 1) providing information to patients and users, 2) designing requisition forms, 3) obtaining informed consent and 4) maintaining sample integrity prior to testing.
Conclusions
The pre-examination phase requires extensive and consistent communication between the laboratory, the healthcare provider and the end user. The clinical vignettes presented in this paper illustrate the value of applying select ISO 15189 recommendations for general laboratory to the more specialized area of Molecular Diagnostics.

Additional Metadata
Keywords Good laboratory practice, Infectious diseases, Informed consent, Inherited diseases, ISO 15189, Molecular diagnostics, Molecular pathology, Molecular requisition, Oncology, Pharmacogenomics, Pre-analytic, Pre-examination, Specimen integrity, Standardization
Persistent URL dx.doi.org/10.1016/j.cca.2016.06.018, hdl.handle.net/1765/101667
Journal Clinica Chimica Acta
Citation
Payne, D.A. (Deborah A.), Baluchova, K. (Katarina), Peoc'H, K, van Schaik, R.H.N, Chan, K.C.A. (K.C. Allen), Maekawa, M. (Masato), … Ahmad-Nejad, P. (Parviz). (2017). Pre-examination factors affecting molecular diagnostic test results and interpretation. Clinica Chimica Acta, 467, 59–69. doi:10.1016/j.cca.2016.06.018