11/5/2013

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Clinical Overview and DiscussionOf Laboratory Medicine inThe Oncology Practice

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Cancer & Hematology Centers of Western Michigan

● Eight Cancer Centers located in Western Michigan -privately owned but working collaboratively witharea hospitals

● Three Centers include on-site, physician ownedlaboratories

● Sixteen Oncologists/thirteen are also Hematologists● Treatment of all types of solid tumor cancers, blood

related cancers along with coagulation disorders andhematological disease

● Dedicated to bringing state of the art cancer caretreatment to the community

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Johnson Cancer Center

Laboratory Overview

• Main laboratory provides for the patients at Lemmen‐Holton CancerPavilion and also serves as a reference lab for the three clinic sites.

• Clinic labs have limited test menus which meet the immediate needsof the patients, nurses and physicians. Other specimens courieredback daily to main lab for testing.

• Staff at clinics consists of an ASCP certified Medical Technologist torun the tests and an experienced phlebotomist to draw blood andassist with various laboratory responsibilities.

• Staffing at main lab per day is three Medical Technologists andthree phlebotomists in order to handle high patient volumes andremote clinic testing.

• Other responsibilities include assisting physicians with bone marrowbiopsies, turnkey for blood bank products and all laboratory billing.

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Lab Staff of Today

Main Laboratory Instrumentation

Laboratory Equipment:– Sysmex XN 1000

– Roche Cobas 6000

– Siemens PFA 100

In‐house Test Menu:CBC, Sed Rate, Reticulocyte, Immature Platelet Fraction, Protime,

Urinalysis,Occult Blood, Monotest, PFA, Alpha Fetoprotein, Beta HCG, Beta 2

Microglobulin, CA125, CA15‐3, CA19‐9, CEA, PSA, IGA, IGG, IGM, CRP, TSH,

Free T4, Hgb A1C, ALT, AST, Albumin, Alk Phos,BUN, Direct and Total Bili,

Calcium, CL, Cholesterol, CO2, Creat, GGT, Glucose, LDH, Mag, Phos, Potassium,

T Protein, Sodium, Triglycerides, Uric Acid, Ferritin,Iron/Iron binding, B12,

Folate, Soluble Transferrin Receptor, Dilantin, UPC, Kappa/Lambda light chains,

FSH, LH, Estradiol, Testosterone, Vitamin D, Lipid Profile, Haptoglobin, Creat

Clearance.

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Sysmex XN 1000

Roche Cobas 6000

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Clinic Laboratory Instrumentation and Test Menu

Laboratory Equipment:

– Roche C111

– Sysmex KX‐21N

In‐house Test Menu:CBC, Sed Rate, Reticulocyte, Protime, Urinalysis, Occult Blood, Sodium,

Potassium, CL, CO2, BUN, Creat, Calcium, Glucose, Mag and Phosphorous

Sysmex KX 21N

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Roche C111

The Role of the Laboratory

• The testing menu was developed to supportboth cancer care needs and general lab testing

• Annual in‐house test volumes =150,000 panelswhich equates to over 1,000,000 tests per year

• Patients are drawn for all needed testswhether done on site or sent out to areference laboratory

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The Lab’s Role Continued….

• The lab plays a huge part in overall flow of thepatient through the center

• Lab results drive treatment options

• Speedy on‐site testing allows for real timedecision making by the provider

• Laboratory Information System interfaced topatient’s Electronic Medical Record for easyand fast access to laboratory results

Capital Acquisitions

• Many factors are considered when purchasing laboratory equipment– Space limitations

– Extensive test menu

– Reliability of equipment – relatively no down time

– Back‐up equipment is not an option – no room and increases overall costs

– Quick turn around time – stat option essential• Many chemotherapy treatments cannot be given until lab results areavailable and within range to proceed

• Several insurance companies require lab values to be submitted with thetreatment billing invoices or coverage will be denied

– High level training program for testing personnel in order to beknowledgeable and efficient in the use of the new equipment

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More Considerations

• Instrumentation down time halts care in acancer care environment– Need reliable and knowledgeable telephonesupport to get instrument up and running asquickly as possible

– Need field service engineers to respond to the sitein a timely fashion when issues are more severe

– A down instrument results in tests being sent outthus lost revenue and increase wait times forpatients – patient satisfaction greatly decreased

Revenue Benefit of the Lab

• Test menu developed not only for practicality butalso for revenue benefit.

• Tests to be brought in‐house are determined not onlyby the cost of the test, but also by the insuranceallowable reimbursement.

• Important to maximize equipment capabilities tolower cost of individual test.

• Decrease in turn around time of lab tests yieldsincreased number of patients that can be treated in agiven time. This equates to increased revenue fromchemotherapy treatment.

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The Business of Oncology Medicine

• Underlying all aspects of the Oncology practice in thecommunity setting is the need to be politically correct in thearena that we do business.

• Oncologist/Hematologists depend on referrals from primarycare physicians and surgeons.

• It is important to have laboratory testing that will optimize theOncologist’s ability to practice medicine without stepping onthe toes of health care partners.

• Physician Office Laboratory testing is often limited bymanaged care contracts between insurance companies andhospitals or large reference laboratories. Insurance companiesdictate which tests are allowed to be run in‐house versus sentout.

Why have a P.O.L.?

• It is important to provide the physicians with consistent, in‐house testing so they can compare apples to apples.

• Quick turn around times, with results populating the patient’sEMR, allow the physician to make changes in the patient’streatment regimen. The physicians get spoiled with this levelof service and it becomes their expectation.

• It is important to be proactive in introducing new tests thatwould play a beneficial role in their practice of medicine.

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Challenges in an Oncology Laboratory

• Space is often inadequate in a physician’s office lab. It limitsboth the size and the number of pieces of testing equipment.

• Laboratory support from the practice is not always prime.More focus is placed on the aspect of treating patients withchemotherapy and supporting the nursing requirementsrather than the needs of the lab.

• The laboratory is challenged to keep the cost of testing downand the revenue up in order to be a financial asset as well as aconvenient, easy to use, seamless entity for both the patientand the provider.

Why Sysmex Works at CHC• CHC has been a Sysmex customer for the past twenty years• As the physician practice grew from 4 doctors to 16 doctors our equipment

needs expanded.– K 1000→ K 4500→ XT 2000i→ XN 1000

• The XN 1000 is a perfect fit– It meets our space limitations– It has very little down time– It has additional parameters that provide useful information to the

physicians.– It has quick turn around times.– It allows us to be a reference lab for our off site clinics– It is interfaced with our LIS and EMR to provide real time results that

populate in the patient’s electronic chart• The account managers have been honest and knowledgeable. They have

developed strong, trusting, working relationships.• The customer service department is easy to work with and goes above and

beyond to exceed our expectations.• The field service engineers are friendly and quick to respond to problems.

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XN1000

• Cancer and Hematology Center Laboratory atLHCP is enjoying the benefit of the newSysmex XN‐1000.

• It provides five new reportable parameters.

– Immature Granulocytes

– Nucleated RBC’s

– Immature Platelet Fraction

– Immature Retic Fraction

– Reticulocyte Hemoglobin Equivalent.

Immature Granulocytes

‐ Automated IG counts (% and absolute) are reported withevery automated differential.

‐ It is measured by fluorescent flow cytometry on theXN1000.

‐ The IG count is FDA approved.

‐ IG count includes metamyelocytes, myelocytes andpromyelocytes.

‐ Comparison studies showed very good correlation with themanual differential.

‐ Parameter provides a more accurate and precise automatedimmature granulocyte count than a manual differentialbecause over 32,000 cells are counted by the instrumentversus 100 cells on the traditional manual differential.

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Benefits of IG Parameter @CHC

‐ We have a substantial number of patients withCML (Chronic Myelogenous Leukemia)

‐ Because the instrument differential has suchgood correlation, it has greatly reduced thenumber of manual differentials performed onthis patient population.

CML

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CML

CML

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Another important patient population the IG is particularly beneficial isthe patients receiving WBC production stimulation drugs such asNeupogen and Neulasta.

• While the purpose of chemotherapy drugs is to kill off the cancercells, one of the side effects is destroying many other cells,including WBC’s.

• When a patient’s WBC falls below 1000, they are very susceptible toinfection.

• Drugs such as Neupogen and Neulasta stimulate WBC production inthe bone marrow.

• Because the circulating white blood cell count is at such a low level,stimulated WBC’s are released from the marrow sooner – withoutthe chance to fully mature.

• These immature forms are mainly metas andmyelos with an occasional pro and even nowand then a blast.

• The IG parameter is useful in this situationwhere the increased WBC can be easilyexplained by the drug stimulation and theimmature grans expected.

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Receiving Neulasta

NRBC’S• Automated nucleated red blood cell (NRBC) counts (% and

absolute) are reported with every CBC.

• The NRBC count is also measure by fluorescent flowcytometry on the XN1000.

• Accurate detection of NRBC counts even at low numbers

• Eliminates the need to perform a time consuming manualdifferential and to do a corrected WBC due to NRBC’s.

• Provides quick and accurate WBC count so chemotherapyeligibility based on WBC can be determined and chemo ordersbe processed or held.

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• When the WBC count is @ 2000, it raises thequestion of whether chemo will be given:

‐depends on where the patient is in the theircycle

‐ possible dose reduction verses holding

• ANC (absolute neutrophil count) <1000 –physician dependent whether chemo will begiven.

• ANC <500 – chemo not given

Normal WBC

High NRBC

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Low WBC

High NRBC

Low WBC

High NRBC

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Hold ups and Holding Chemo

• Hold ups from the lab – such as performing a manual diff toget an accurate WBC‐ holds up the entire flow of the infusioncenter.

• Chairs are scheduled. Patients assigned to a particular chairfor a particular block of time based on their treatment for thatday.

• Lab result delays cause pharmacy orders to be delayed…causechair time to get off schedule, etc. etc to the point that nurses/ and support staff end up working over their scheduled hours(O.T. – very costly).

• Effects the overall bottom line and profitability of the practiceand increases cost of providing health care.

Effects of Holding Chemotherapy

• Holding chemo is necessary for the health of the patient butcauses problems of its own.

• Chemo drugs need to be authorized for payment.

• Included in the authorization day of treatment, dose and timeframe.

• Any changes require a need for reauthorization.

‐‐ example: Patient authorized to get chemo for 6 months.Chemo is held for a week due to low platelet count. Thischanges patient’s treatment out to 6 months and 1 week.Insurance stops paying at 6 months unless reauthorizationobtained.

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What is Held

• Chemo rarely held for anemia due to ease of correcting with PRBC transfusion.

• Chemo usually  dose reduced for low ANC’s and supported with Neulasta.

• Many times chemo is held because of low platelets.

• Transfused platelets are difficult to sustain in the presence of chemotherapy.  They are quickly killed off by the drugs.

• Best to wait for patient’s marrow to recover and begin platelet production on its own rather than to transfuse platelets for very little benefit.

Immature Platelet Fraction (IPF)

• IPF is a measure of immature platelets in thecirculating blood

• An increased IPF in the presence ofthrombocytopenia may indicate peripheraldestruction or consumption of platelets suchas in idiopathic thrombocytopenia (ITP)thrombotic thrombocytopenic purpura (TTP)or disseminated intravascular coagulation(DIC)

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• Another important use of the IPF, especially inour practice, is to monitor marrow recoverypost chemotherapy.

• Platelets are killed off by chemotherapy drugs–some drugs such as Gemzar are very hard onplatelets and can destroy most of thecirculating platelets and also suppressproduction in the bone marrow.

• When the bone marrows begin to recoverfrom the effects of the chemotherapy, itproduces platelets to resupply the peripheralblood.

• Just as immature WBC’s are pushed out of themarrow early when there is a need in thecirculating blood, immature platelets arereleased early from the marrow.

• A high IPF post chemotherapy is a goodindication that platelets are being produced.

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• Normally a platelet count of 20,000 or less would warrant a platelet transfusion, but with a platelet count less than 20 along with a high IPF a transfusion may not be needed.

• A high IPF means platelets are being produced.  Normal Range for IPF = 0.9 – 7.0 %.

• Eliminating a platelet transfusion saves time and money; increases profitability.

Normal IPF

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Increased IPF

Reticulocyte Profile

• Includes reticulocyte (% and absolute) immature reticulocyte fraction (IRF) and Reticulocyte Hemoglobin (RET‐He)

• Reticulocyte counts both percentages andabsolute have been around for some time asenumerations on hematology analyzers

• Two fairly new advances are the IRF and RET‐He.

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IRF

• The IRF is a direct cellular measurement oferythropoiesis. It is useful to the clinician inthe management of anemia and in the use oferythropoietic stimulating agents such asProcrit.

‐ A high IRF means the bone marrow isproducing RBC’s and sending them out of themarrow to quickly get into the peripheralblood stream in response to anemia.

IRF

• Although a reticulocyte is an immature red cell being pushed out of the marrow a little early, the immature retic fraction is even a younger stage.

• In a reticulocyte’s life, there are 3 stages of maturation reflected by low , medium and high fluorescence.  The Medium (MFR) and High (HFR) make up the immature reticulocyte fraction, the IRF. 

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Male with Anemia

‐High IRF

Bone marrow compensating

Male with Anemia

‐High IRF

Bone marrow compensating

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Female with Anemia

‐High IRF

Bone marrow compensating

Male with

Anemia

IRF = 0.0

Bone marrow not compensating

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RET‐HeReticulocyte Hemoglobin Equivalent

• RET‐He is the direct measurement of theincorporation of iron into the reticulocytehemoglobin.

• Lack of iron availability in the bone marrow is theprimary cause of decreased RET‐He.

• Retics only have a limited life span of 1‐2 days – ifthey are released from the marrow low in iron, theywill also have a decreased quantity of hemoglobin.

• RBC’s normally circulate for 120 days, and if they aredeficient in iron and hemoglobin they will remain sofor their entire lifetime.

• Low RET‐He results trigger the provider tobegin iron therapy much earlier.

• Patient’s experience with iron deficiency canbe better managed and time in this anemicperiod decreased.

• RET‐He Normal Range: = 28.2 – 36.6 pg

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Female 

Iron Deficiency Anemia 

Low Hgb

Low RET‐He

Male 

Iron Deficiency Anemia 

Low Hgb

Low RET‐He

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Female 

Iron Deficiency Anemia 

Low Hgb

Low RET‐He

Male 

Anemia –not due to iron deficiency 

Low Hgb

Nl RET‐He

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Female 

Anemia –not due to iron deficiency 

Low Hgb

Nl RET‐He

Summing It Up

• Easy to use

• Ready state ‐ no wait to start

• Fast processing of results

• Customized “rules” to fit our needs

• Reflex testing

• No routine maintenance

• Walk away shut down

• Simple step by step reagent replacement

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Overall Results• Accurate and rapid laboratory results greatly improve efficiency throughout the entire cancer center.

• Improves patient satisfaction by decreasing wait time and providing valuable information for treatment plan.

• New parameters on the Sysmex XN‐1000 expand the patient’s hematology picture.

• Allows physicians to make quick and important changes in the care and treatment of their patients to improve outcomes.

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Lab Staff of Tomorrow

11/1/2013

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Val Henry, MLS (ASCP)

Megan Krienert, MLS (ASCP)cm

XN 9000 Series at TNMC

U.S. News & World Report Ranks The Nebraska Medical Center as One of America’s Best Hospitals in Five Specialties Medical Center also named top hospital in Nebraska

U.S. News and World Report surveyed the nation’s roughly 5,000 hospitals to come up with this year’s list of Best Hospitals. Fewer than 150 of those hospitals are nationally ranked.

The Nebraska Medical Center is ranked in five different specialties:

Cancer (#40) Gastroenterology (#25)

Nephrology (#41) Neurology and Neurosurgery (#40)

Orthopaedics (#36)

In addition to these rankings, U.S. News and World Report ranked The Nebraska Medical Center as the top hospital in the state. Of the 16 specialties studied by U.S. News and World Report, The

Nebraska Medical Center was ranked in 12.

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• Overview of laboratory

• Statistics

• Patient testing/new parameters

• Quality Control

• Reagents

• Analyzers/HST/IPU

• Comments, Concerns & Questions

Overview

XN 9000 Series

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Previous HST NMC Lab Layout

Current HST NMC Lab Layout

SMALL FOOTPRINT/EASY WALK PATTERN

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HOOD

23'-1 1/16"

Nebraska Medical Center Phase 2 configuration Add Bio-Rad TurboLink

and TS 500 to XN 9000 line

SP 10TS 500Bio-RadTurboLink

3 XN LoadingHem/Coag

Bench

Coag

Chem line compressor

Future HST NMC Lab Layout

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Peak Hour Data

Nebraska Med Center Pre-Post XN Metrics

Feb‐11 Jul‐13

Cycles 1057 957

Pt tests 930 909

Repeat Rate 13% 5.3%

Slides Rev 160 128

Rev Rate 17.2% 14.1%

Manually Run 3.6% 5.8%

Stats 5.0% 6.8%

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• XN 3 had a couple service calls during the week

• CT-90-BT determines load balancing

Load Balancing

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Patient Testing• Increased speed - 100 tubes per hour

– Improved TATs (chart) 4-5 minutes

• Requires only 88μL of sample still with correct portions of anticoagulant to blood volume

• Every CBC includes NRBC

– Every WBC diff includes IG

– Every RETIC includes IRF and RET-He

– Every PLT-F includes IPF

• Suggested samples be submitted in 2mL, 3mL or 5mL EDTA tubes (lavender).

• 7mL or larger tubes will require transfer into an appropriate sized tube and may increase time to result.

• Auto-rerun / short walk pattern / better gripping

• Process specimens rapidly IE: Health Fairs

• STAT stop for testing with high volume

Patient Testing

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Core lab -- CBC data

Average TAT Standard Deviation Percentage within target goal Linear (Average TAT ) Linear (Percentage within target goal)

Goal = 80% within target goalTAT = 25 minutes or better

IT Issue

Body Fluids• BF Mode/Automatic backgrounds

– 2-part diff available

• TC-BF (blasts/tumors/meso/macro)

• RBC

• WBC (don’t report)

• Body fluid linear to 10,000/Ul

– Maximum dilution 1:10 with a reported value of >100,000 uL

• RBC <3,000

– Red cell counts on body fluids have a quantitative lower limit at 3000 cells/uL and red cell counts below that value will be reported as <3000 cells/uL.

– For CSF specimens, cell counts are performed on Tube #4 as is the current procedure. If red cell counts are above 3,000 uL/cells in Tube #4 a cell count will be performed on Tube #1 to differentiate traumatic tap from an intracranial bleed if indicated.

– Note: a CSF red cell count of 3,000 cells/uL represents <1.0 uL whole blood diluted in 1000 uL CSF.

– At first we reported <3,000 RBCs, now reflexes manual count. ED physicians wanted manual count.

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RETIC/RET-He

•Assessment of bone marrow function.

•Additional parameter for distinguishing iron deficiency anemia from other causes and provides an early indicator of response to iron supplementation in patients with iron deficiency anemia.

•Studies indicated a normal Reference Interval for RET-He: 30.0 – 38.0 pg•Iron deficiency anemia is associated with RET-He values <27.0 pg

•Added test to current Retic order

•IRF and RET-He are directly measured

•Ran on all babies initially due to small sample size

•Dilutions 1:3

•WAM does calculation

•User friendly

Immature Platelet Fraction (IPF)

An index of thrombopoiesis and can help determine the mechanism of thrombocytopenia. An increased IPF in the presence of thrombocytopenia is indicative of platelet destruction or consumption.

Normal studies indicate a reference interval: 1.0 – 7.9%

Provided in the PLT-F channel

Not being utilizing, requires more education.

Specific dye, dyes organelle in platelet.

“polymethine and oxazine flourescent dye is used topenetrate the cell membrane, staining the RNA and DNA in the cell. Forward scattered light (cell volume) and fluorescent intensity (RNA and DNA content) are measured. Immatureplatelets have increased volume and a higher fluorescent intensity compared to mature platelets. The immature platelet fraction is expressed as a proportional value of the total fluorescent plateletcount”-Sysmex

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WNR Channel• NRBC performed every time for more accurate WBC.

• Better TATs

• Differentials for NRBC is virtually eliminated.

– One experience with an abnormally high patient

• Discriminative against interferences such as lyse resistant RBCs and lipids

• The channels in general have better discrimination of cells.

• Packaging and barcode Radio Frequency Identification (RFID)

More info view article:https://www.sysmex.com/crc/Technology1/XN%20Series%20PLTF%20Channel%20Performance%20Specifications_1025-MKT_5-2013.pdf

Platelet - FXN PLT-F channel XE PLT-O channelFluorocell™ PLT RET-SEARCH®(II) dye solutionEmphasis on PLT fractions Emphasis on reticulocyte fractionsOxazine fluorescent dye Polymethine + oxazine fluorescent dyes

A more accurate platelet with PLT-F due to fragment discrimination.

PLT-O had a harder time discriminating

Bad draw vs. more accurate platelet

Amikacin PLT/Citrate PLT

RBCIPF

PLT-F

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AUTO ANC/CC

• Automated Neutrophil Counts will be released immediately to HIS in order to minimize turn-around-time in the management of neutropenic oncology patients.

• The neutrophil counts will be validated by manual count if indicated

• Do not use Low WBC or Pre-Dilution

– No manual differential performed on WBC <0.5K/uL.

• Cancer Center TAT

• AVE TAT FOR ANCC= 13.8 MIN

60

65

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100

Qtr 42011

Qtr 12012

Qtr 22012

Qtr 32012

Qtr 42012

Qtr 12013

Qtr 22013

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Percent

CBC TAT for Cowdery Patient Care Unit

CBCP Complete w/ in45 minutes

CBCP Complete w/in 60 minutes

CBCP 45 minute threshold

ANCC w/in 45minutes

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Maintenance

• Quality Control

– BF/XN is walk away• Bypass

– X BAR M• bottom of registering

• QC/Managing/Adjusting

– Upload automatically to Insight

– QC comparison (3 analyzers/previous lots)

– IPU access• Logging OFF and ON

Reagent UsageREAGENT USAGE/STORAGE

– Minimal storage due to concentrate

– Improved ergonomics!

– RFID(Radio Frequency Identification) scanning!

– Infrequent changing of reagents

– Have staff document reagent changes via IPU

– Run one level of QC after each change

– No reservoirs

– CELLCLEAN

• Pre-made

• One time use, cannot reuse if barcode scanned

• Walk away cleaning

– DCL/DST

• Changing several screens

• Run 3 levels after changing

• Documentation is on a clipboard due to no place to IPU

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WAM / IPU / CT90IPU

– Controls all analyzers

– Easy documentation of analyzer troubleshooting reagent changing and quality control documentation

– Filters

MODE SWITCHING

– admin / xn

– Settings only under admin/downtimes

– 4 for analyzer only use BF and WB

DILUTIONS -minimal

-RETIC / WBC / BFMake 1:10 dilutions automatically

AUTO RERUN -saves time

RACKS -never have to be cleared

STAINER

• Very comparable to previous stainer.

• Easy access to pipettes

• Slides load either direction in carrier

• Cassettes are reversed when loading

• Operator Alerts in WAM

• Do not use microtainers on slide maker

– Requires 300uL

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HST LINE/RU-20• Each unit shuts off independently

• Return line

• Lids flip back/forth

• Picture to indicate issue with the line

• CT-90

• BT-40

• Start up button

• RU-20

Staff Comments• “Wonderful, they do not pitch tubes!

• “Morning run is smoother”

• “Slide maker is great”

• “Minimal reagent changing”

• “Great that it does auto re-runs!”

• “WAM dilutions for retics are easier”

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Observations• Cannot hear the alarms “soft voice”

• 7mL tubes/microtainers

• Minimal tubes thrown since

go live May 15th, 2013

• If caught in grippers, not easy access.

• Would like stainer linked to IPU

• Analyzers should finish reading rack if it releases a tube manually.

• Seems to go straight to analyzer that was not put into bypass

• Add videos to IPU for maintenance/IE stainer

Sysmex -for a wonderful product “that lives up to the hype”

Barbara Connell – invitation for presentation

Jeff Gellar - pictures, slides and for his lab solutions, support and advice.

Steve Froscheiser - sales rep for encouraging us to wait for FDA approval of the XN line.

Nancy May-TIS

Steve Seidel -TAC

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