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BLOOD BANK AUTOMA TON - GALLEOTM Ricardo D Sumugod MS, MT(ASCP)SBB Technical Coordinator Blood Bank and Bone Marrow Transplant Northwestern Memorial Hospital Chicago, llinois Lab Southeastern Area Blood Bankers Annual Education Conference March 22-23, 2006 Doubletree Guest Suites, Atlanta, Georgia, USA Agenda Overview of Northwestern Memorial Hospital Why we decided to automate Understand the role of automation in the blood bank Familiarize the Galileo TMBlood Bank Automated Machine Describe the NMH workflow process of integrating the GalileoTM Automation Northwestern Memorial Hospital Who We Are Second Oldest Hospital in Chicago (1865) Primary Teaching Affiliate of Feinberg School of Medicine of Northwestern University One of 125 Academic Medical Center Hospitals Community Hospital Serving Near North Side GreatUrbanNeighborhood- Michigan Avenue Economically and Ethnically Diverse "Most Preferred' Hospital in Chicago Nationally recognized for Quality jfinancial Strength "Most Wired' AA+ Bond rating

-- ---'-'- VVlzydid we automate? + Manage volume growth of over 20% from 1999 to 2004 Handle additional duties + Organ banking & ABO compatibility confirmation Blood vessels storage ABO compatibility & tracking Tissue Services mplementation + Standardize testing techniques Achieve consistent TATs of less than one hour for STAT Type and Crossmatch Struggle to recruit Med Techs ncrease efficiency and productivity + mprove employee satisfaction + Lower operating costs Remove repetitive routine manual tasks from staff allowing complex & intensive work in the lab to be handled in a more timely and efficient manner We have an excellent model in our Core Lab Admissions and Overnight 0 P 51,000 4',000 47,000 45,000 43,000 41,000 3',000 37,000 35,000 FY97 FY FY99 FYOO FYO, FY02 FY03 FY04 ')

29,500 1 Blood Component Usage -RBC FFP 24,500 +- PLTDOSES -r=---~ -CRYO / 19,500j ~ 14,500 7,000 6,000 5,000 4,000 3,000 9,500 2,000 4,500 FY97 FY98 FY99 FYOO FY01 FY02 FY03 FY04 1,000 NMH Blood Bank Volume & Staffing 240,000 220,000 200,0001 2J 180,000 > t! 160,000 r 1 140,000~ j 120,000 1 100,000 t:: / / -- U'l /" -,15ft10 u 1-5 4"'' 4",'b4",'" 4~~ 4~" 4~'" 4~"J4~'" 4~" ~ ~ ~ ~ ~ ~ ~ ~ ~ J a HematologyjHemostasis Line J t-[h'5 i~ - ;>' :l~~:" -n ii' -'" -, 1'i 1: ~ J{ c --0 '-' ~, - "" ', ~) 3

Chemistry Line,--? ~ - ~~ What Blood Bankers want? Full Automation (roboticsand true walk-away capability) Broad Menu Ease of Use True Continuous Access High Throughput Process Controls Why GalileoTM +Process Benefits of Automated System Allowstestingto occuras it comesinto the lab Canaccommodate90%+of testing Reduceshands-ontechtimein routinetesting +lnstrumentation preferred by pathologists and techs +Cood Partner -s close to a "turn-key" implementation as possible One "endor '-f

GalileoTM- Full Automation Pipetting ncubation Washing Centrifugation Shaking Reading of Reactions nterpretation of results ASSAYS GalileoTM- Broad Menu TECHNOLOGES ABOjD Grouping Hemagglutination Donor Confirmation Hemaggl utination Antibody Screen Capture-R Ready Screen Antibody Capture-R Ready-lO, dentification Extend & Crossma tch Capture-R Select Weak 0 Testing Capture-R Select OAT Capture-R Select - ~-;) '1( ~,~~~ ' jll, GalileoTM- Broad Menu Future Assays ASSAYS TECHNOLOGES CMV Capture-CMV Syphilis Treponemal Based Assay Selective Cell Panel Capture-R Select RBC Phenotyping Capture-R Select Platelet Antibody Screen Capture-P Ready Screen Platelet Crossmatch Capture-P 5

GalileoTM- Characteristics Truly hands-oif walk away capability Computer controlled & totally robotic Complete bar-coding system Linear rack system PCAnywhere Dynamic Scheduler Bi-directional LS interface ndependent & simultaneous modules Touch screen monitor & user friendlv Large capacity for sampl,'s, rl',gents & microplates Capable of assay recoverv from mechanical failures by troubleshooting GalileoTM- Characteristics Password protected with different level of accessibility Consistent color coding system for consumables and resources Concise and comprehensive preventative maintenance schedules Multiple documented QC steps for each assa'< Generates actual instrument readings plus images and single result interpretation Extensive data availability, easy and quick retrieval r' NMH GalileoTMwork flow 'V roc n ss ;1/1 ~n gr n"'; ol /1 }-' c- LLLC- LLLL L EDTA samples received with barcodes- Floor Order Entry Samples received in LS 3 min spin time at 5600rpm Samples loaded onto the GalileoT~1using the linear rack Tests are selected via the touch screen monitor Load resources (f necessary) Testing process started 6

NMH GalileoTMworkflow process integration Continue sample loading as samples arrivewill batch all routines and/ or run STAT samples together with the routines to maximize effective resources usage Once testing is in progress, staff is available for various tasks within the lab Results are entered into LS manuallycurrently, interface not available with Misys LS GalileoTM general observation +ABO and 0 Typing - Nothing + The 0 Dilemma Magical +Two monoclonal anti-d's (04 and 05) are run on each patient sample +Same gg clones but different gm clones in blends GalileoTM general observation + Antibody Screen increased sensitivity will pick up weak reacting clinically significant antibodies but yet some clinically insignificant antibodies will also show up +Same issues as with any serologic testing +Antibodies do not read textbooks +Use the same rules for ruling out and confirming antibodies 7

GalileoTM general observation Sample with previously known + antibody screen -can simultaneously run the panel with the initial antibody screen More sensitive DA T compared to the standard tube technique for ABO incompatibilities Sample Failures QNS -250 ul packed RBCs/ 500 ul Plasma Exn'ssi"e hemolysis (3+), lipl'l1il,me! idl'rl'sil Clots Mechanical failures Automation in Blood Banking Benefitsof Automation ncreased productivity Enhanced QA",more controlled SOP and standardized process LSinterface reduces potential for transcription errors Reduces workload stress fewer errors more satisfied staff lower overtime expenses more flexibility with staff scheduling VVhat We've Learned from Automation Automation highlights process inconsistencies t is a key to staffing efficiency' t caused us to redesign our workflow and our physical space to maximize our through-put Creates positive culture accepting of more change because workflow is so dramatically improved, 8

~ GalileoTM in Operation at Northwestern Memorial Hospital since Oct 4, 2004 "ii1 i 1;1'''-1 ~~ tt ~, '' '" " " "'r~' ~, _-~-" Contact nformation RicardoSumugod,MS, MT(ASCP)SBB Technical Coordinator (312) 926-6495 rsumugod@nmhorg Susan R Masarik, MBS, MT(ASCP) Manager (312) 926-8446 smasarik@nmhorg Glenn Ramsey, MD Medical Director (312) 926-3082 g-ramsey@northwesternedu 9