Administrative Office St. Joseph's Hospital Site, L301 50 Charlton Avenue East HAMILTON, Ontario, CANADA L8N 4A6 PHONE: (905) 521-6141 FAX: (905) 521-6142 Issue No. 92 QUARTERLY NEWSLETTER August 2007 Hematology Update: a Focus on Innovation Within the Discipline of Hematology within the Hamilton Regional Laboratory Medicine Program we have aggressively sought and evaluated technological change as a method to increase our throughput, introduce novel tests and increase our quality while maintaining our focus on budgetary constraints. This newsletter will focus on recent and proposed changes in the regional hematology laboratories. We examine the specific changes that have been proposed or implemented, their immediate impact and our capacity to use this technology to enhance our ability to provide laboratory services to the Hamilton region. Molecular hematology: The molecular hematology laboratory has evolved under the supervision of Mr. Andrew McFarlane ART and Drs Waye, Leber and Hayward to provide an increasing menu of both high-volume and esoteric tests, reflecting this laboratory’s role as both a service laboratory and Provincial Reference Laboratory. Over the coming years the molecular hematology laboratory will increase its test menu using advanced technologies which reduce the time currently required for testing, will streamline its sample processing and reporting system and will replace some of our current “home grown” tests with commercially available tests which have more appropriate quality control systems. Looking forward, the Molecular Hematology Laboratory will embrace novel technologies under the leadership of Drs Waye, Leber, Hayward and Trus. Implementation of the Rotor-Gene cycler for routine molecular testing The Factor V Leiden (FVL - F5 1691G-A,F5 R506Q) and the Prothrombin gene (F2,20210 G-A) mutations occur frequently in patients with venous thrombosis, and are associated with venous thromboembolism. Testing is currently performed by the Special Coagulation Laboratory in cooperation with Molecular Hematology using traditional PCR approach with restriction enzyme digest followed by electrophoresis detection. These are batched and run every 2 weeks. The recent purchase of the Rotor-Gene cyler will allow a switch to an alternate, FDA-approved, method. Implementation of this methodology will reduce the current 2 day procedure to only a few hours. Ultimately, this advanced technology will be applied throughout the test menu, reducing the potential for technical errors, generally reducing TAT’s and increasing research opportunities. Routine hemoglobinopathy screening by Capillary Electrophoresis The extensive evaluation of a new capillary electrophoresis (CE) system for separation and quantification of hemoglobin fractions concluded in October 2006. The implementation of the Sebia CapillaryS 2 for routine hemoglobinopathy screening replaced the use of both the isoelectric focusing electrophoresis (IEF) and cation high performance liquid chromatography (HPLC) systems that had been used for the evaluation of suspected hemoglobinopathies for many years. This new CE system has an advantage of reporting accurate Hb A2 quantity in the presence of variant hemoglobins like Hb E or Hb S and consistently identifies Hb Constant Spring, which is not easily detected on IEF or HPLC. The acquired tyrosine kinase JAK2 (V617F) Gene Mutation Test Recent publications have described the importance of an acquired mutation at position 617 ((Val617Phe) of the JAK2 gene for confirmation of the presence of the myeloproliferative disorders, including polycythemia vera (PV=95%), essential thrombocythemia (ET=50%) and myelofibrosis (MF=50%). Traditionally, these diseases were diagnosed based on clinical suspicion coupled with typical morphologic appearances on bone marrow examination and the exclusion of alternate causes of an abnormal complete blood cell count. The high prevalence of the JAK2 mutation in such patients has revolutionized diagnostic evaluations by providing clinicians with a easily understood test which, if positive, essentially “rules in” these diagnoses. Detection of the JAK2 gene mutation, using an allele specific polymerase chain reaction (PCR) has been offered by the Molecular Hematology laboratory since October 2005. Transfusion medicine: The Transfusion Medicine Program underwent a change in leadership on August 1st, 2007 when Dr Ted Warkentin assumed the Role of Regional Director, and Dr Kathyrn Webert assumed the role of Operational Director for the HRLMP Transfusion Medicine Services. Dr Morris Blajchman will step down from the HRLMP after many years of dedicated service; he will continue in his academic and research roles. Initiatives underway in the Transfusion service include: Just in Time (JIT) Delivery of Red Blood Cells In February 2006 the Transfusion Medicine Service of the Hamilton Regional Laboratory Medicine Program moved away from traditional immediate spin crossmatches to a computer facilitated Electronic Crossmatch (EXM). The move to EXM reduced the time between product request and product availability. The next phase of this project is the introduction of “JIT” delivery of red blood cells with a ‘go live’ date slated for the fall of 2007. JIT delivery of red blood cells will see an improvement in blood product inventory management, standardization of ordering practices across the HHS and SJHH, and a reduction in non-value added workload. Automation – The Introduction of the ORTHO Clinical Pro-Vue® In December 2006 the ORTHO Clinical Pro-Vue® automated analyzer was introduced into the routine testing of the Transfusion Medicine Services of the Hamilton Regional Laboratory Medicine Program. The Pro-Vue® automates blood group (ABO and Rh) and routine antibody screens. At present the Pro-Vue® is located in the Transfusion Medicine laboratory at the Hamilton General Hospital and is being used for pre-operative antibody screening. By the fall of 2007 testing from the Rh Prevention clinic will be moved to the Pro-Vue® and additionally all non-stat or routine blood grouping and antibody screens at the Hamilton General Hospital will be moved to the Pro-Vue®. Completion of these two initiatives will lay the groundwork for the movement and consolidation of the Henderson Transfusion Medicine Services to the Hamilton General Hospital. Remote Release of Red Blood Cell Products The ability to consolidate Transfusion Medicine Services across the Hamilton Regional Laboratory Medicine Program hinges on the ability to provide blood products remotely. This is known as “remote release” of blood products. The Transfusion Medicine Service is in the process of acquiring the Neoteric Software System® and the Hemosafe Refrigerator System® that will facilitate the remote release of red blood cells. Through the use of a bi-directional interface with the laboratory information system, electronic crossmatch, and barcodes, blood can be released from one location and issued at another without the presence of a fully functioning Transfusion Medicine Laboratory on site. The acquisition of these systems will take place this fiscal year and they will be first introduced at the Henderson site of the HHS. Coagulation laboratory: In addition to the advances in Molecular diagnostic techniques discussed previously the Coagulation Laboratory has recently completed a renewal of the coagulometers in the each of the regional core laboratories Implementation of New Coagulation Analzyers in Core Coagulation In April 2007 the HRLMP successfully completed the implementation of nine Diagnostica Stago STA Compact® coagulation analyzers across the five Core laboratories. The implementation was staggered over a 12-month period and included both theoretical coagulation and practical training for the Core laboratory staff. The transition to the new coagulation analyzers was transparent for both the professional and laboratory staff due to the collaboration, commitment and enthusiasm of the STA Compact Project Team. The implementation of the STA Compact will improve turn around time for Core coagulation tests for our clinical services across both HHS and SJHH. Cell diagnostics laboratory: Implementation of a Centralized Morphology Service with Cellavision The HRLMP has purchased six Cellavision instruments to automate morphology in the five Core Laboratories and the JCC. Cellavision utilizes an automated digital cell morphology technology by which cells are automatically located on a stained peripheral blood smear, scanned and analyzed, stored and transmitted for technologist review. Cellavision has been configured to meet CLSI (formerly NCCLS) guidelines in conjunction with a group of global experts to train its neural network to analyze over 250 specific characteristics for each cell during the classification process. When classifications need to be changed, cells can be dragged and dropped into the appropriate cell class. This instrument provides the technologist with the ability to perform a side-by-side comparison between different cell classes by viewing the cells together or comparing to an on-board reference cell library. Figure 1: Intracellular organisms captured by the Cellavision system from a patient with fungemia The remote access to the cell images through the hospital networks or VPN access for off-site viewing will allow the HRLMP to centralize the morphology service to one consistent group of technologists. We anticipate implementation by Q2 of 2008, with subsequent software applications for bone marrows and body fluids. Dr. M.A. Crowther Discipline of Hematology Hamilton Regional Laboratory Medicine Program St. Joseph’s Healthcare Hamilton