Reports from the Molecular Haemato-Oncology laboratory are fully integrated within APEX and are available electronically via APEX (Lothian users only) and TRAK. For samples sent from out with NHS Lothian, paper copies of reports will be returned to the requesting laboratory, with the exception of BCR-ABL1 quantification for which results are emailed to the referring laboratory automatically. The Department of Laboratory Medicine adheres to NHS Lothian’s Policy on Confidentiality of Personal Health Information, meaning that results can only be communicated to individuals authorised to receive them. Communication of abnormal results to the requesting clinician: will contact the requesting clinician via telephone or email to make them aware of clinically urgent results.Molecular Haemato-Oncology Team will contact the requesting clinician via telephone or email to make them aware of clinically urgent results. Expected turnaround times for each test, or panel of tests, are as follows: Test Expected turnaround time (calendar days). ALL fusion gene assessment (diagnostic) BCR::ABL1 ETV6::RUNX1 TCF3::PBX1 3 working days ALL MRD monitoring (follow up) BCR::ABL1 ETV6::RUNX1 TCF3::PBX1 14 AML fusion gene assessment (diagnostic) BCR::ABL1 CBFB::MYH11 RUNX1::RUNX1T1 PML::RARA 3 working days AML MRD monitoring (follow up) BCR::ABL1 CBFB::MYH11 RUNX1::RUNX1T1 PML::RARA 14 BCR::ABL1 fusion gene (diagnostic) 3 working days BCR::ABL1 quantification MRD monitoring (follow up) 14 BCR::ABL1 kinase domain mutation detection 21 FIP1L1::PDGFRA fusion gene detection 14 FLT3 ITD and TKD D835 mutation detection 3 working days IgHV mutation status 21 KIT D816V mutation detection 14 KMT2A fusion gene panel 3 working days MYD88 L265P mutation detection 14 NPM1 mutation detection 3 working days NPM1 mutation detection MRD monitoring 5 working days TP53 mutation mutation detection 21 B cell clonality studies (IG gene rearrangement) 14 T cell clonality studies (TCR gene rearrangement) 14 NGS for Myeloid disorders 42 For guidance on interpretation of reports or for any queries please contact a member of the Molecular Haemato-Oncology team. Quality Assurance The Molecular Haemato-Oncology laboratory carries accreditation to international standard ISO15189:2012. All investigations are subject to rigorous Internal Quality Control (IQC) measures and the laboratory participates in the following External Quality Assurance (EQA) schemes: UK NEQAS Leucocyte Immunophenotyping Schemes Acute Myeloid Leukaemia and Myelodysplastic Syndrome Gene Panels (Pilot - Not accredited) BCR::ABL1 and AML Translocation Identification (assessed for PML::RARA; CBFB::MYH11 and RUNX1::RUNX1T1 analysis) BCR::ABL1 Kinase Domain Mutation Status BCR::ABL1 Major Quantification [E13A2 & E14A2 fusion transcripts] BCR::ABL1 Minor Quantification [E1A2 fusion transcript] (Pilot) FLT3 Mutation Status IGH / TCR Clonality Status KIT p.Asp816Val (D816V) Mutation Status for Mast Cell Disease Lymphoplasmacytic Lymphoma / Waldenstrom Macroglobulinaemia [MYD88 p.L265P] (Pilot) NPM1 Mutation Status Paediatric Acute Leukaemia Translocations (sssessed for ETV6::RUNX1; KMT2A::AFF1; TCF3::PBX1 analysis). MRD-AML by Molecular Genetics (Pre-Pilot) NPM1 Minimal residual disease monitoring (Pre-Pilot) Other EQA Schemes European Research Initiative on CLL: TP53 mutation detection Molecular Pathology, Royal Bournemouth Hospital : IGHV mutation status European Research Initiative on CLL: IGHV mutation status Due to the rapid pace of developments in the field of molecular haemato-oncology, the laboratory may offer certain services before they have been accredited to ISO 15189:2012. In all instances, relevant assays will have undergone a period of internal validation/verification and have been deemed suitable for diagnostic use prior to being offered to users. The current accreditation status of individual tests can be found in relevant sections of our test directory and will always be clearly marked on any reports issued by the service. Measurement Uncertainty The impact and estimates of measurement uncertainty are determined for all relevant assays. These are available, on request to users.
