1 2 National biovigilance system a (net)work in progress biovigilance system a (net)work in progress...

National biovigilance system a (net)work in progressKaren L. Wa g n e r

The United States has lagged behind other de-veloped countries in creating a nationwide

monitoring system that tracks and analyzes er-rors and accidents associated with blood trans-fusion. But, as the 1964 Bob Dylan song pro-claims, “The times they are a-changin’.”

The leadership of the AABB, working with theCenters for Disease Control and Pre v e n t i o n ,has spearheaded a broad-based movement toc reate a biovigilance network to track adverseevents and ultimately improve blood safety andpatient outcomes. The network initially willinclude a hemovigilance system to track blood

transfusions. It will eventually be expanded tocollect data on donor- related events. Efforts arealso underway to track tissue grafting and org a ntransplantation through a cooperative agre e-ment between a number of organizations, amongthem the AABB, CDC, and United Network forO rgan Sharing.

A pilot phase of the hemovigilance network,which will test the network at a small number oftransfusion services of varying sizes and locations,is scheduled to get underway late next spring.

Hospitals in the United States have had their ow ninternal hemovigilance systems in place

for decades, says James AuBuchon, MD, chair-

man of the Working Group for the Intero rg a n i-zational Task Force on the U.S. BiovigilanceNetwork and chair of the CAP Tr a n s f u s i o nMedicine Resource Committee. But, he adds,these data are reported to internal transfusioncommittees only and not transferred to a na-tional repository for compilation and analysis,as they are in other countries.

“All we have had is a re q u i rement from theF D A to report deaths associated with transfu-sion and, more re c e n t l y, a re q u i rement to re p o r tblood product deviations,” Dr. AuBuchon con-tinues. However, he says, hospitals generallya re reluctant to report such events because of

reported out on unacceptables p e c i m e n s .

I have been a medical technolo-gist for almost 40 years, the last 17in management but I still workthe bench. Though pre a n a l y t i c a lfactors are now buzzwords, theyhave been important to mostlaboratorians for years. Standardlaboratory practice includes notrunning tests on hemolyzedspecimens, unfilled coagulationtubes, specimens drawn above anI V, clotted CBCs, and so on. In myopinion, if you run tests on thesespecimens, it is comparable torunning tests on the wro n gp a t i e n t .

We spend a lot of time in thelaboratory ensuring the integrityof the patient samples. We thenrun quality control, look at Levey-Jennings charts, follow We s t g a rdrules, etc., to give clinicians themost accurate laboratory testresults possible so they can bestt reat their patients.

If you establish a reputation asa quality-driven, reliable labora-t o r y, clinicians will call you whenthey question a result, and this isthe best relationship you canestablish for the care of patients.On the other hand, if you re p o r tout inaccurate results, or physio-logically impossible results, evenwith a disclaimer, without tryingto obtain a new specimen, you arenot only doing a disservice to thelaboratory but also to the clinicianand, most important, to thep a t i e n t .

Most laboratorians I have comea c ross over the years considerthemselves professionals, and,much like the medical doctoroath, we strive to “do no harm.”

Marilyn C. Kenyon, MT(ASCP)Director of Laboratory Services

St. Joseph Hospital Bangor, Me.

1 2 / CAP T O D A Y October 2007

Circle No. 84 on reader service card

L e t t e r scontinued from page 1 1

October 2

Send letters to Editor, C A P T O D A Y, 325Waukegan Road, Northfield, IL 60093.Fax: 847-832-8873; s r i c e @ c a p . o r g.

National biovigilance system a (net)work in progress

continued on page 14

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the risk of negative consequences, such as law-s u i t s .

“And the FDA has never had the manpowerto focus on the analysis of these data and thenturn around and provide useful information tohelp the reporters improve their processes,” Dr.AuBuchon adds. “That’s what hemovigilanceis all about—not only gathering the data in aconfidential system immune from discovery, buthaving it analyzed so that it makes sense and itcan be used to improve things.”

Although the U.S. biovigilance network is a work in pro g ress, plans call for it to be vol-

untary and Web based. Hospital and blood bankemployees will manually input data into thesystem. The data will consist of information ontransfusion reactions and incidents or situationsin which standard pro c e d u res were not fol-lowed, explains Dr. AuBuchon, who is chair-man of pathology at Dartmouth-Hitchcock Med-ical Center, Lebanon, NH.

In return for taking time to input the data, Dr.AuBuchon says, hospitals and other participantswill gain access to a robust system that will offer in-ternal analysis and anon-ymized data comparisonamong facilities of similarsize or within the same region. “So, they will beable to track and trend incidents and reactions overtime,” he explains. “They can look for corre l a-tions in their own set of data and try to learnf rom their amalgamated experiences.”

“Ul t i m a t e ly, what we ’d like to be able to dois build a system that will facilitate data

e n t r y,” says AABB president D. Michael Stro n g ,PhD. An eventual goal might beto link individual laboratory in-formation systems with the net-work, but many more details ofthe system need to be definedfirst, adds Dr. Strong, who is alsoclinical laboratory director andchief operating officer at the PugetSound Blood Center, Seattle.

D r. Strong says that with theCenters for Medicare and Medicaid Services’ re c e n tannouncement that it will no longer re i m b u r s ewhen transfusion-related errors occur, the net-work potentially will offer hospitals cost savingsby identifying and reducing such errors. “Those areall things that, if corrected, can save an org a n i z a-tion a fair amount of money,” he says.

The developers of the biovigilance network hopethat it will be as successful as systems used in

other countries, such as the United Kingdom’sSHOT (Serious Hazards of Transfusion) system.SHOT was instrumental in detecting transfusion-related acute lung injury, or TRALI, as a primarycause of post-transfusion fatality. Users of the

SHOT network linkedTRALI to the plasma offemale donors who had

been immunized during pre g n a n c y. So, Dr. A u B u-chon explains, a decision was made to use onlyplasma from male donors for transfusion. Whilenot all plasma in the United Kingdom as yetcomes from male donors, the country has alre a d y

seen a dramatic reduction in cases of TRALI sinceworking toward that end, he adds.

Following the lead of the United Kingdom’sSHOT system, the CDC, which is funding the ini-tial development of the infrastru c t u re for the on-line system, has guaranteed that data that are in-put into the system will not be released. The infor-mation cannot be divulged under the Freedom ofInformation Act, by subpoena in a civil suit, or byC o n g ressional subpoena, says Dr. AuBuchon. “Fur-t h e r m o re,” he adds, “the information in that sys-tem is not releasable to any other federal agencies,including the FDA. So no regulatory action can takeplace as a result of anything that is submitted.

“These,” he continues, “are exactly the kinds ofp rotection that a biovigilance system needs in or-der to be successful in a very litigious society. ”■

Karen Wagner is a freelance writer in Forest Lake, Ill.



Visit us at AABB Booth No. 755 See the PHS System Review Series listing, page 24

OctoberPage 1 4

“What blood bank software can do for biovigilance monitoring,” page 16

Dr. Strong

“If anatomic pat h o l o gy were to go digital,we'd have to go way beyond what we'rea l r e a dy doing in radiology.”

—Michael Montalto, PhD, of GE,on image size for digitized AP slides and

how surprised GE was to learn it. (“Two peas in a pod: digital AP, radiology,” page 56)

“There's an awful lot about TRALI that wedon't know.”

—Morris Blajchman, MD,on the research that will be needed to better

understand the pathogenesis of TRALI. (“Catching, tracking, and tackling TRALI,” page 1)

B i ovigilance systemcontinued from page 1 2B i ovigilance system



OctoberPage 1 6

Karen L. Wa g n e r

As the AABB and federal gove r n -ment develop a nationwide

biovigilance network (story, page 12),blood bank vendors have an oppor-tunity to focus on how their softwarecan support biovigilance monitoring.

Noah Bentley, MS,SBB(ASCP), seniormarketing director forWyndgate Te c h n o l o-gies, El Dorado Hills,Calif., says becausedata storage is so im-portant for a hemo-vigilance program, a

component of biovigilance monitoring,a software system should provide on-line capability to track and managepost-transfusion cases in real time. Itshould also manage donors who areimplicated in post-transfusion events.

Adata warehouse is also importantbecause “it facilitates a uniform formatfor data across organizations,” he says.In a warehouse, data can be more eas-ily combined, manipulated, extracted,and analyzed. “In addition,” Bentleycontinues, “performing these tasks ina data warehouse removes concernabout manipulating data in pro d u c-tion databases since the manipula-tion occurs in an offline enviro n m e n t ,w h e re reporting can be more easily ac-c o m p l i s h e d . ”

“ P e rhaps the most important fea-t u re that blood bank and transfusions o f t w a re can contribute to hemovig-ilance is the ability to exchange datawith other systems,” he says. Bentleyexplains that in the United States,blood centers generally operate in-dependently from transfusion serv-ices, and transfusion services rare l ys h a re databases. To better pro v i d ethe connectivity that hemovigilancere q u i res, he adds, software should in-

corporate the use ofs t a n d a rdized inter-face transactions,such as those gov-erned by HL7.

Flexibility is key,says Beth Simon,p resident and CEOof Blood Bank Com-puter Systems, A u-

burn, Wash. “The data should bes t o red in a relational database thatallows for the ease of performing s t a-tistical analysis,” she says. “Addi-t i o n a l l y, the application should pro-vide multiple mechanisms for re-porting and analyzing desired infor-m a t i o n . ”

The ability to compile and analyzethe information gathered from biovig-ilance monitors is important in pre-venting future errors, stresses LaurieSapp, BS, MT, SoftBank product man-ager for SCC Soft Computer, Clear-w a t e r, Fla. “Tr a d i t i o n a l l y, transfusionmedicine software systems have pro-vided the means to track and monitorunexpected transfu-s i o n - related eventsfor blood and bloodp roducts,” she adds.

Systems shouldalso offer a compre-hensive alerting sys-tem, says Yves Char-ron, product man-ager for Montre a l -based MediSolution, which distributesMak-System’s blood bank software .“This includes, but is not limited to,alerts related to previous testing, in-compatibilities of proposed pro d u c t s ,and specific attributes for the patientinvolved,” he says. “A f u l l - f e a t u re dalert system provides technologistswith the ability to proactively identi-

fy issues before they develop into anevent or incident.”

B a r-coding functionality is impor-tant as well, says Charron. The trans-fusion service’s computer systemshould not accept manual entry ofany data that can be entered easily us-ing bar coding or similar technolo-g y. “Reduction ofclerical errors isparamount to prac-tice impro v e m e n t , ”he asserts.

Cost, however,can be a hurdle toadopting those tech-nologies that wouldsupport biovigi-lance, as Brian Keefe, MT(ASCP),points out. Because of financial bar-riers, “many blood banks, particu-larly in small, rural community hos-pitals, do not have technology in placeto support even the most basic needs,let alone any biovigilance initiative,”says Keefe, director of marketing forclinical products at Psyche SystemsCorp., Milford, Mass.

Smaller facilities shouldn’t be over-b u rdened with a manual system, re-sponds James AuBuchon, MD, of theWorking Group for the Intero rg a n i-zational Task Force in the U.S. Biovig-ilance Network. “You don’t need anLIS in order to upload data,” he says.“ We will keep it simple so that anyonecan input data.”

In larger urban facilities, however,lab software systems clearly will cap-t u re some biovigilance information,says AABB president D. MichaelS t rong, PhD. “[But] it’s not clear yetwhether it’s going to capture every-thing that’s necessary. . . . But again, fa-cilitation of data entry is important,whether there be an interface to beable to push data across or thingslike bar coding tohelp facilitate that.”

“For systems withm o re computer capabilities,” addsD r. AuBuchon, “someday we hopeto be able to support automatic up-loading of key data elements to the he-movigilance system.”

Taking data entry to the next level,Arthur Bracey, MD, chair of the U.S.Department of Health and Human

Services Advisory Committee onBlood Safety and Av a i l a b i l i t y, saysone of the problems with current in-formation systems is finding eff i c i e n tways to extract the most meaningfuldata. As biovigilance develops, Dr.Bracey says, there should be someway of linking the laboratory infor-mation system into other databases,such as those that provide such out-come measures as length of stay orlength of time in the intensive careunit. Such data would be helpful indetermining how transfusion aff e c t spatient outcomes, he says. For exam-ple, cardiac bypass surgery patientswho have undergone transfusionscan be compared with those card i a cpatients who haven’t had transfu-sions in terms of length of stay and in-cidence of infection.

It’s important as we move aheadwith biovigilance systems that welook at not only emerging infectiousd i s o rders and diseases but at “the re l-ative proportion of selected adversephysiologic complications that aff e c tpeople with and without transfu-sion,” says Dr. Bracey, who is trans-fusion service medical director at St.Luke’s Episcopal Hospital, Houston.This is necessary, he adds, to better un-derstand how transfusion influencespatient outcomes.

Having an automated system thatcan track blood in-ventories on a na-tional basis is alsoneeded to avert thechances for chro n i cshortages of blood,he says. “In an idealworld, the comput-er systems shouldbe searchable sothat we would have a real-time ideaof the inventories that we have,” hecontinues. Dr. Bracey adds that in-ventory functionality would also sup-

port another piece ofb i o v i g i l a n c e — t r a c k-ing adverse events

and extracting other kinds of outcomesdata with minimal delay. “Computersystems,” he says, “that are designedideally should be able to address all ofthose needs.” ■

Karen Wagner is a freelance writer inForest Lake, Ill.


K e e f e

S i m o n

Dr. Bracey

B e n t l e y

C h a r r o n

W h at blood bank software can do for biovigilance monitoringW h at blood bank software can do for biovigilance monitoring

Blood bank information systems survey, pages 18–36



Tabulation does not represent an endorsement by the College of American Pathologists.

Part 1 of 10

See accompanying articles on pages 12 and 38

Name of blood bank system

First ever blood bank system installationLast major product release (for product featured)Total number of contracts for operational sites•U.S. hospitals with donor and transfusion service•U.S. hospitals with transfusion service only•U.S. regional blood centers with donor service only•U.S. regional blood centers with donor and transfusion service•Centralized transfusion services in the U.S.•Foreign hospitals and regional blood centersNo. of contracts signed between July 2006–July 2007Total number of sites operationalInstalls not yet live (hospitals/regional blood centers/others)No. of sites that went live between July 2006–July 2007Percentage of installations that are stand-alone systems

Staff to develop/install and support/other* in entire companyStaff to develop/install and support/other* in blood bank systems

No. of different versions of software installed•Versions of product in field covered by FDA 510(k) clearance

•Versions of product that did not require FDA 510(k) clearance

Range in No. of interactive workstations in live sites (average)

Central hardware or computer platform or servicesW o r k s t a t i o n s

Software programming language(s)Operating system(s)Databases and tools

Features (listed as percentage of live installs or based on availability)•Full support of ISBT 128 unit labeling•Bar-code reading of donor and unit information•Unit inventory•Autologous and directed unit tracking•Direct entry of test results•Crossmatch results•Electronic crossmatch decision making•Antigen typing•Handheld devices for positive patient ID•Integrated bedside check for transfusion•Track all steps in production of product•Print donor unit labels—bar coded•Interface with automated instruments•Interface with blood irradiator or centrifuges•Centralized transfusion service capability•Donor recruitment/donor questionnaire•Mobile scheduling screen instruments•Laptop-based mobile donor registration module•Source or recovered plasma management•Accounts receivable•Management reports/ad hoc report writer•Quality control management

System provides standard ASTM/HL7 interface?Interfaces to automated donor infectious disease testing instruments

Interfaces to automated ABO/Rh/antibody screening instruments

FDA 510(k)-approved interface to bedside patient ID system?Tools to help clients validate their systems

Complete blood bank A S P s o l u t i o n ?Method of charging for ASP s e r v i c eClient software requiredA S P information conduitClient contracts supported from data center not operated by clientHow data center is operated

System provides indexed field in each test definition for LOINC c o d e ?Provide LOINC dictionary for each new installation?

HIS and LIS interfaces

User group?Source code?Can user modify screens?User-defined report writer/custom programming?

Cost for smallest & largest stand-alone HW/SW/install & training/mo. maint.Cost for smallest & largest integrated HW/SW/install & training/mo. maint.

Distinguishing features (supplied by vendor)

*other=sales, marketing, administration, other company functions

Blood Bank Computer SystemsBrian Forbis b f o r b i s @ b b c s i n c . c o m1002 15th St. SW, Suite 120Auburn, WA 98001-6502253-333-0046 w w w . b b c s i n c . c o m

Blood Bank Control System

1 9 8 72 0 0 53 4402 640051 1 95 (1/4/0)31 0 0 %

1 0 / 9 / 71 0 / 9 / 7

2Blood Bank Control System 5.0, 4.4

—

10–150 (average, 40)

IBM iSeriesIBM 5250-compatible workstations and PCs

RPG 400, JavaO S / 4 0 0IBM DB2

i n s t a l l e di n s t a l l e di n s t a l l e di n s t a l l e di n s t a l l e di n s t a l l e di n s t a l l e di n s t a l l e dnot availablenot availablei n s t a l l e di n s t a l l e di n s t a l l e di n s t a l l e di n s t a l l e di n s t a l l e d / i n s t a l l e di n s t a l l e di n s t a l l e di n s t a l l e di n s t a l l e di n s t a l l e d / i n s t a l l e di n s t a l l e d

yes, versions 2.1, 2.2, 2.3, 2.3.1, 2.4, or 2.5 (configurable)uni-directional to Ortho, Immucor, Abbott, Olympus, DiaMed, IDM viaS u r r o u n duni-directional to Ortho ProVue, Immucor Galileo, Olympus Tango, IBG

n odepartment dedicated to development of validation protocols, flowcharts, management guides, validation guide documents, risk mitigationonline portal, and 24/7 client support

y e stransaction basedbrowser based, requires software be installed on a client PCoperates over the Internet5by a third party (blood bank or IBM Business Partner)

n on o

Cerner, Mediware, IDM, Meditech

yes (meets in person annually)e s c r o wn oy e s / y e s

——

• ISBT 128-compatible version 5.0 was FDA 510(k) cleared in 2005• self registration and online questionnaire• system is highly configurable to fit client needs

Cerner Corp.Jared Blankenship j a r e d . b l a n k e n s h i p @ c e r n e r . c o m2800 Rockcreek ParkwayKansas City, MO 64117816-201-0696 w w w . c e r n e r . c o m

Cerner Millennium PathNet Blood Bank Transfusion

1 9 8 52 0 0 61 1 301 0 40009u n a v a i l a b l e2 6 7187 (151/36/0)1 70 . 5 %

1 , 5 9 0 / 2 , 2 8 7 / 3 , 5 4 21 5 + / 3 4 + / 1 5

1 1HNA Classic 306, 2001.01, 2002.01, 2003.01, 2004.01, 2004.M04.01.0,2004.M04.02.01, 2004.M04.03.01, 2005.01, 2005.02, 2007.01n o n e

not tracked

IBM RS/6000, HP (Compaq)Intel Pentium PCs

Visual C, C++, Visual BasicAIX, Open VMS, Windows NTOracle (Cerner Millennium)

i n s t a l l e d1 0 0 %1 0 0 %1 0 0 %1 0 0 %1 0 0 %1 0 0 %1 0 0 %i n s t a l l e dnot available1 0 0 %i n s t a l l e di n s t a l l e dnot available1 0 0 %not available/not availablenot availablenot availablenot availablei n s t a l l e d1 0 0 % / 1 0 0 %i n s t a l l e d

yes, version 2.3.1—

bi-directional to Immucor ABS2000, Immucor Rosys, Micro TypingSystems Reader M/SA, Ortho ProVuen oCerner Millennium support validation documents

y e sfixed feerequires software be installed on a client PCrequires use of a private, dedicated circuit 3 3by vendor

y e sy e s

n / a

yes (meets via Internet quarterly; in person annually)e s c r o wy e sy e s / y e s

——

• customized historical and current patient demographic displays• clinical validation• flexible specimen expiration parameters

Blood bank information systems

Survey editors: Raymond D. Aller, MD, Hal Weiner, and Suzanne Butch, MT(ASCP)SBB

1007_18-36_BloodBankSvy.qxd 10/9/07 1:25 PM Page 18



Part 2 of 10





No. of different versions of software installed•Versions of product in field covered by FDA 510(k) clearance•Versions of product that did not require FDA 510(k) clearance





System provides standard ASTM/HL7 interface?Interfaces to automated donor infectious disease testing instrumentsInterfaces to automated ABO/Rh/antibody screening instruments


Complete blood bank A S P s o l u t i o n ?Method of charging for ASP s e r v i c eClient software required

A S P information conduitClient contracts supported from data center not operated by clientHow data center is operated







GE HealthcareBarbara Mullarky b a r b a r a . m u l l a r k y @ g e . c o m3100 Steeles Ave. East, Suite 900Markham, Ontario, Canada L3R 8T3520-722-9734 w w w . g e h e a l t h c a r e . c o m

Centricity Ultra Laboratory

1 9 9 62 0 0 79010008091 (1/0/0)10

43,500 (total)—

43.3, 4.02.4, 3.2

2–10 (average, 6)

Unix-based platformsPCs with Windows 2000, XP

C, C++, 4GLU n i xUnify Dataserver

i n s t a l l e di n s t a l l e d1 0 0 %i n s t a l l e d1 0 0 %1 0 0 %installed installed installed (via third-party vendor)installed (via third-party vendor)not availablenot availablei n s t a l l e dnot availablei n s t a l l e dnot available/not availablenot availablenot availablenot availablenot available1 0 0 % / 1 0 0 %not available

yes, versions 2.2, 2.3—bi-directional to Ortho ProVue, Immucor Galileo, Olympus Tango,AutoVue, Wadiana, DiaMedn ov a l i d a t ion checklists that cover setup, testing, and verification; internaltest case manual used for FDA validation available on request

n o——

———

y e sn o

Cerner, Meditech, Siemens, GE, others

yes (meets via Internet at least quarterly; in person annually)e s c r o wy e sy e s / n o

n / a$40k–$60k/$150k/—/$2.5k to $125k/$400k/—/$6k

• fully integrated with other laboratory disciplines in single relational d a t a b a s e

• full security control over data access; extensive audit tracking• multi-site capabilities that allow numerous blood banks to maintain

inventory and information individually

Haemonetics Software Solutions†

Shannon Swiderski s m s @ i d m . c o m9701 W. Higgins Rd., Suite 500Rosemont, IL 60018847-825-2300 w w w . i d m . c o m

IDM Select Series

1 9 9 1—1 0009001282 (0/2/0)—1 0 0 %

2 8 / 1 4 / 2 02 8 / 1 4 / 2 0

1DMIS 2.1n o n e

4–80 (average, 30)

HP 9000 business serversUnix terminals, X-terminals, PCs

C, C++U n i xO r a c l e

5 0 %1 0 0 %1 0 0 %1 0 0 %1 0 0 %not availablenot available1 0 0 %not availablenot available1 0 0 %not availablenot availablenot availablenot available100%/not available1 0 0 %not available1 0 0 %not available1 0 0 % / 1 0 0 %not available

n o——

n ocomplete product users manuals, product validation guide, configuration worksheets, training classes and materials, post go-live consultation, automated testing tools

y e sfixed feeuses dumb terminals

requires use of a private, dedicated circuit0—

n on o

IDM

yes (meets in person annually)e s c r o wy e sy e s / y e s

——

• longevity; large customer base; financial stability; continual R&D ensuring customer investment protection

• proactive stance on regulatory affairs• commitment to superior 24/7 customer support services†formerly IDM, a Haemonetics company





Part 3 of 10






















IDM Surround

1 9 9 1—3 1002 7301—2 6—17 2 %

2 8 / 1 4 / 2 02 8 / 1 4 / 2 0

54.0. 4.1, 4.2, 4.3, 4.4n o n e

3–40 (average, 5)

Intel Pentium serverPC workstation

J a v aWindows NT, 2000, 2003O r a c l e

1 0 0 %not availablenot availablenot available1 0 0 %not availablenot availablenot availablenot availablenot availablenot availablenot available1 0 0 %not availablenot availablenot available/not availablenot availablenot availablenot availablenot available1 0 0 % / 1 0 0 %not available

n ouni-directional to Ortho, Immucor, Abbott, Olympus, Biotech, DOMSuni-directional to Ortho ProVue, Immucor Galileo, Olympus Tango

n ocomplete product users manuals, configuration worksheets, trainingclasses and materials, product validation guide, post go-livec o n s u l t a t i o n

y e sfixed feerequires software be installed on a client PC

requires use of a private, dedicated circuitn / a—

n on o

Cerner, Mak System, Mediware, Wyndgate, others

yes (meets in person annually)e s c r o wn oy e s / y e s

——

• longevity; large customer base; financial stability; continual R&D ensuring customer investment protection




IDM Symphony Suite-Prelude

1 9 9 1—8008000217 (0/7/0)10

2 8 / 1 4 / 2 02 8 / 1 4 / 2 0

2Prelude 1.1Prelude 1.2

average, 25

compatible with HP-Unix or Windows operating systemsany compatible with Windows

Java J2EEUnix, Windows 2000/2003 server, Windows 2000, XPOracle 10g

5 0 %1 0 0 %1 0 0 %1 0 0 %not availablenot availablenot availablenot availablenot availablenot available1 0 0 %not availablenot availablenot availablenot availablenot available/100%not availableavailable but not installednot availablenot availablenot available/not availablenot available

n o——

—complete product users manuals, configured worksheets, automatedtesting tools, training classes and materials, complete productvalidation guide, post go-live consultation


requires use of a private, dedicated circuit0—

n on o

n / a

yes (meets in person annually)e s c r o wn on o / y e s

——

• longevity; large customer base; financial stability; continued R&D ensuring customer investment protection






Part 4 of 10




















Mak-System Corp.Stephane Sajot s a l e s . u s @ m a k - s y s t e m . n e t2720 River Rd., Suite 225Des Plaines, IL 60018847-803-4863 w w w . m a k - s y s t e m . n e t

Patient Health Software (PHS)

1 9 8 52 0 0 74 3 3000114 3 13 84 2 315 (14/1/0)—1 0 0 %

1 4 5 / 1 1 6 / 7 21 4 5 / 1 1 6 / 7 2

11 . 0—

3–2,000 (average, 35)

Unix, Windows, LinuxPC, Windows XP, 2000

Delphi, JavaW i n d o w sO r a c l e

1 0 0 %1 0 0 %1 0 0 %1 0 0 %1 0 0 %1 0 0 %1 0 0 %1 0 0 %—1 0 0 %1 0 0 %1 0 0 %not available1 0 0 %not availablenot available/not availablenot availablenot availablenot available1 0 0 %1 0 0 % / 1 0 0 %1 0 0 %

yes, version 2.xuni- and bi-directional to Ortho, Immucor, Abbott, Olympus, DiaMeduni- and bi-directional to Ortho ProVue, Immucor Galileo, OlympusT a n g o—user guides, hazard analysis, training manuals, data conversion,validation scenario samples

n o——

———

y e s—

no restrictions

yes (meets in person biannually)e s c r o wn o—

——

• comprehensive communication capabilities with Progesa blood bank software

• abundant functionality, including hemovigilance features and transfusion documentation at bedside

• highly customizable through parameterssoftware for PHS supplied by MediSolution

Mak-System Corp.Stephane Sajot s a l e s . u s @ m a k - s y s t e m . n e t2720 River Rd., Suite 225Des Plaines, IL 60018847-803-4863 w w w . m a k - s y s t e m . n e t

P r o g e s a

1 9 8 5—6 2 5105——6 1 93 75 9 817 (8/9/0)—1 0 0 %

1 4 5 / 1 1 6 / 7 21 4 5 / 1 1 6 / 7 2

14 . 4—

10–1,400 (average, 100)

no restrictionsSun, IBM, Wyse, HP, DEC, PC

C, C++, Pro5, JavaUnix, Web technology, client/server, SolarisOracle, Caché, C-ISAM

i n s t a l l e d1 0 0 %1 0 0 %1 0 0 %1 0 0 %i n s t a l l e d1 0 0 %1 0 0 %1 0 0 %1 0 0 %1 0 0 %1 0 0 %1 0 0 %i n s t a l l e d1 0 0 %1 0 0 % / 1 0 0 %1 0 0 %1 0 0 %1 0 0 %1 0 0 %1 0 0 % / 1 0 0 %1 0 0 %

yes, version 2.xuni- and bi-directional to Ortho, Immucor, Abbott, Olympus, DiaMeduni- and bi-directional to Ortho ProVue, Immucor Galileo, OlympusT a n g o—user guides, hazard analysis, training manuals, data conversion,validation scenario samples

n o——

———

n o—

no restrictions

yes (meets in person biannually)e s c r o wn o—

——

• modules fully integrated from donor to patient• abundant functionality• highly customizable through parameters





Part 5 of 10












Complete blood bank A S P s o l u t i o n ?Method of charging for ASP s e r v i c eClient software requiredA S P information conduit

Client contracts supported from data center not operated by clientHow data center is operated







McKesson Corp. Joseph Stabile j o s e p h . s t a b i l e @ m c k e s s o n . c o m5995 Windward ParkwayAtlanta, GA 30005404-338-6000 w w w . m c k e s s o n . c o m

Horizon Blood Bank

2 0 0 42 0 0 63 503 300022 23 526 (26/0/0)90

3 2 , 0 0 0 +93 (total)†

3a l l—

1–6 (average, 2)

Intel-based and Unix-based serversP C s

Delphi, SQL, Crystal ReportsWindows XP Professional, 2003 (Unix optional)O r a c l e

i n s t a l l e di n s t a l l e di n s t a l l e di n s t a l l e di n s t a l l e di n s t a l l e di n s t a l l e di n s t a l l e dnot availableavailable in 2008i n s t a l l e di n s t a l l e di n s t a l l e di n s t a l l e dnot availablenot available/not availablenot availablenot availablenot availablenot availablei n s t a l l e d / i n s t a l l e di n s t a l l e d

yes, version 2.2 and higher—uni- and bi-directional to Ortho ProVue, Immucor Galileo, OlympusT a n g ounder developmentvalidation services and guidelines available for purchase

y e sfixed fee, transaction basedbrowser based, requires software be installed on a client PCoperates over the Internet, requires use of a private, dedicatedc i r c u i t——

n on o

M c K e s s o n

yes (meets in person annually)e s c r o wn oy e s / n o

——

• numerous safety features, including Patient-At-A-Glance Bar• patent-pending CTS and other transfusion service functionality• Wyndgate’s Service 360 commitment to ensure quality

implementation and support experience

software for Horizon Blood Bank supplied by Wyndgate Technologies†from Wyndgate Technologies

Medical Information TechnologyPaul Berthiaume p b e r t h i a u m e @ m e d i t e c h . c o mMeditech CircleWestwood, MA 02090781-821-3000 w w w . m e d i t e c h . c o m

Blood Bank System–Client/Server

1 9 8 12 0 0 62 4 4———————2 2 222 (22/0/0)—2 %

6 2 2 / 1 , 6 3 1 / 5 0 4—

2Magic, client/server—

—

Hewlett-Packard, Dell, EMC, IBMHewlett-Packard, Dell, EMC, IBM

M a g i cWindows 2000, XP (client); Windows 2000, 2003 (server)Magic, SQL server 2005

i n s t a l l e di n s t a l l e d1 0 0 %1 0 0 %1 0 0 %1 0 0 %not availablei n s t a l l e di n s t a l l e di n s t a l l e di n s t a l l e di n s t a l l e di n s t a l l e dnot availablei n s t a l l e di n s t a l l e d / i n s t a l l e di n s t a l l e di n s t a l l e di n s t a l l e di n s t a l l e d1 0 0 % / 1 0 0 %i n s t a l l e d

yes, version 2.4—uni-directional to Ortho ProVue, Ortho AutoVue, Immucor Galileo

Meditech supplies own patient ID systemcomprehensive user manual, which is reviewed during training

n o———

——

y e sn o

Cerner, Siemens, Misys, McKesson, others

yes (meets via Internet and in person)y e sy e sy e s / n o

——

• fully integrated applications• developed 100% in house by Meditech• 36 years of LIS experience





Part 6 of 10




















Medical Information TechnologyPaul Berthiaume p b e r t h i a u m e @ m e d i t e c h . c o mMeditech CircleWestwood, MA 02090781-821-3000 w w w . m e d i t e c h . c o m

Blood Bank System–Magic

1 9 8 12 0 0 67 7 6———————6 6 08 (8/0/0)—2 %

6 2 2 / 1 , 6 3 1 / 5 0 4—

2Magic, client/server—

—

Hewlett-Packard, Dell, EMC, IBMHewlett-Packard, Dell, EMC, IBM

M a g i cWindows 2000, XP (client); Magic (server)Magic, SQL server 2005

1 0 0 %i n s t a l l e di n s t a l l e d1 0 0 %1 0 0 %1 0 0 %available but not installedi n s t a l l e di n s t a l l e di n s t a l l e d1 0 0 %i n s t a l l e di n s t a l l e dnot available1 0 0 %i n s t a l l e d / i n s t a l l e di n s t a l l e di n s t a l l e di n s t a l l e di n s t a l l e d1 0 0 % / 1 0 0 %i n s t a l l e d

yes, version 2.4—uni-directional to Ortho ProVue, Ortho AutoVue, Immucor Galileo

Meditech supplies own patient ID systemcomprehensive user manual, which is reviewed during training

n o——

———

y e sn o

Cerner, Siemens, Misys, McKesson, others

yes (meets via Internet and in person)y e sy e sy e s / n o

——

• fully integrated applications• developed 100% in house by Meditech• 36 years of LIS experience

Mediware Information SystemsSteve Sedlock s t e v e . s e d l o c k @ m e d i w a r e . c o m1900 Spring Rd., Suite 450Oak Brook, IL 60523630-218-2700 w w w . m e d i w a r e . c o m

HCLL Transfusion and Donor†

1 9 8 02 0 0 71 6 43 0† †

1 2 5† †

1† †

4† †

8† †

54 75 4219 (219/0/0)3 48 5 %

5 9 / 8 3 / 5 92 1 / 5 4 / 1 4

6HCLL Donor 1.0HCLL Transfusion 2.7, HCLL Transfusion 2.8, HCLL Transfusion 2.9,HCLL Donor 1.1.0, HCLL Donor 1.1.1

2–50 (average, 8)

Microsoft compatibleMicrosoft compatible

Visual Basic, C++ Com, Microsoft .Net, C++Windows XP, 2000, 2003Microsoft SQL 2000, 2005

i n s t a l l e di n s t a l l e di n s t a l l e di n s t a l l e di n s t a l l e di n s t a l l e di n s t a l l e di n s t a l l e davailable but not installedavailable but not installedi n s t a l l e di n s t a l l e di n s t a l l e dnot availablei n s t a l l e dnot available/not availablenot availablenot availablenot availablenot availablei n s t a l l e d / i n s t a l l e di n s t a l l e d

yes, versions 2.1–2.5—uni-directional to Ortho ProVue, Immucor Galileo, ABS2000

yes (to Mediware’s BloodSafe)validation scripts provided with system and each new release

n o——

———

n on o

to HL7-compliant HIS and LIS vendors

yes (meets via Internet quarterly; in person annually)e s c r o wy e sy e s / n o

$13.15k/$51k/$49.1k/$.935k to $27.9k/$90k/$72.5k/$1.81k$16.06k/$68k/$58.67k/$1.25k to $31.78k/$118.5k/$100k/$2.33k

• offer FDA 510(k)-cleared bedside transfusion administration package to extend blood safety controls outside the blood bank

• over 27 years’ experience in blood banking software industry• over 12% of staff in blood management division are SBB certified†company did not indicate if answers apply to both products or just one product† †breakdown reflects contracts that fit more than one category





Part 7 of 10





No. of different versions of software installed•Versions of product in field covered by FDA 510(k) clearance

•Versions of product that did not require FDA 510(k) clearance



Software programming language(s)

Operating system(s)Databases and tools











Mediware Information SystemsSteve Sedlock s t e v e . s e d l o c k @ m e d i w a r e . c o m1900 Spring Rd., Suite 450, Oak Brook, IL 60523630-218-2700 w w w . m e d i w a r e . c o m

L i f e T r a k

1 9 8 02 0 0 71 26†

02†

4†

2†

026 64 (3/1/0)21 0 0 %

5 9 / 8 3 / 5 92 1 / 5 4 / 1 4

4LifeTrak 2.03, 3.02

LifeTrak 3.01, 3.1.1

10–300 (average, 100)

Intel-based server (Linux), HP 9000 (HP-UX 11)Microsoft compatible

Oracle forms and reports, Pro*C

HP-UX, Linux ASO r a c l e

available but not installedi n s t a l l e di n s t a l l e di n s t a l l e di n s t a l l e dnot availablenot availablei n s t a l l e dnot availablenot availablei n s t a l l e di n s t a l l e di n s t a l l e davailable in 2008not availablei n s t a l l e d / i n s t a l l e di n s t a l l e di n s t a l l e di n s t a l l e dnot availablei n s t a l l e d / i n s t a l l e di n s t a l l e d

yes, versions 2.1–2.5uni-directional to Ortho, Abbott, Olympus, BioMérieux, Chironuni-directional to Immucor Galileo, Olympus Tango, Olympus PK,MTS, Immucor Dias, Immucor Rosysyes (to Mediware’s BloodSafe)validation scripts provided with system and each new release

n o——————n on o

via HL7 to Cerner

yes (meets via Internet quarterly; in person annually)e s c r o wn on o / n o

$15k/$75k/—/$2.6k to $250k/$400k/—/$23k—

• complete donor center suite from recruitment through final distribution• ISBT 128 compliant; can manage ABC Codabar and ISBT simultaneously• over 27 years’ experience in the blood banking software industry; sole

focus is blood, biologics, and medication management

†breakdown reflects contracts that fit more than one category

Misys Healthcare SystemsSylvia Rothrock s y l v i a . r o t h r o c k @ m i s y s h e a l t h c a r e . c o m250 S. Williams Blvd., Tucson, AZ 85711w w w . m i s y s h e a l t h c a r e . c o m

Misys Laboratory Blood Bank and Blo od Donor modules†

1 9 8 52 0 0 73 5 63 73 0 50001 4—> 4 0 08 (8/0/0)1 20

4 1 0 / 2 7 0 / 8 0230/250/80 (blood bank and LIS combined)

2blood bank and blood dono r v6.0.1 distributed with laboratoryversions v6.1 and v6.2blood bank and blood dono r v6.0.2 distributed with laboratory v6.3

5+–100+ (average, 20)

IBM p5, p6, HP Alpha servers, HP IntegrityDell, HP Windows

ANSI Standard M, Caché Script, Standard C/C++, Visual Basic,Visual C++, Active XAIX, HP UX, OpenVMSIntersystems Caché

1 0 0 %1 0 0 %1 0 0 %1 0 0 %1 0 0 %1 0 0 %1 0 %1 0 0 %2 0 %available in 2008 (pending FDA 510[k] clearance)1 0 0 %1 0 %1 0 %not available1 0 0 %15%/not availablenot availablenot availablei n s t a l l e d100% (charge capture)1 0 0 % / 1 0 0 %1 0 0 %

yes, versions 2.3–3.0uni-directional to Ortho, Immucor, Abbott, Olympus, DiaMedu n i - d i r ectional to Ortho ProVue, Immucor Galileo, Olympus Tango, DiaMed

no (pending FDA 510[k] clearance)client testing guidelines, documentation, training and consulting services

n o—————

n on o

Epic, McKesson, Meditech, Siemens, Eclipsys, Cerner, GE, others

yes (meets quarterly via Internet and in person)e s c r o wn oy e s / y e s

$70k/$208k/$100k/$38k to $180k/$980k/$185k/$202k$0 with Misys Lab/$50k/$58k/$12k to $0 with Misys Lab/$790k/$77k/$168k

• full integration with LIS for reporting, inquiry, maintenance, quality a s s u r a n c e

• full multi-facility capability, including unit inventory tracking and m a n a g e m e n t

• service and interoperability excellence†company did not indicate whether answers apply to both modules combinedor just one module





Part 8 of 10



















Netlims LLCAvi Allerhand a v i @ n e t l i m s . c o m111 Town Square Place, Suite 700Jersey City, NJ 07310201-894-5300 w w w . n e t l i m s . c o m

A u t o F u s i o n

2 0 0 22 0 0 73———————1 24 (4/0/0)—0

5 5 / 3 7 / 1 26 / 5 / 3

2n / a—

3–20 (average, 10)

Wintel (HP, IBM, Dell)Wintel (HP, IBM, Dell)

C + +W i n d o w sSQL, Oracle

i n s t a l l e di n s t a l l e di n s t a l l e di n s t a l l e di n s t a l l e di n s t a l l e di n s t a l l e di n s t a l l e di n s t a l l e d—i n s t a l l e d—i n s t a l l e d—i n s t a l l e d— / i n s t a l l e d—i n s t a l l e dnot availablenot availablei n s t a l l e d / i n s t a l l e d—

yes, version 2.3bi-directional to Abbott, Olympusuni-directional to Wadiana; bi-directional to Olympus Tango

n osystem is being validated as a part of company’s automated QAtesting processes and formal system validation plan

n o—————

y e sn o

any HL7

n oe s c r o wy e sy e s / y e s

$40k/$75k/—/$2k to $140k/$300k/—/$4.5k—

• full integration with all other lab modules and free choice of database on same database

• highly customizable and open system on all levels• unique user interface to provide unparalleled ease of use and

s a f e t y

Psyche Systems Corp.Rachel Stratman s a l e s @ p s y c h e s y s t e m s . c o m321 Fortune Blvd.Milford, MA 01757800-345-1514 w w w . p s y c h e s y s t e m s . c o m

Systematic Blood Bank

1 9 8 72 0 0 11 301 30000294 (4/0/0)52 3 %

1 0 / 1 6 / 1 03 / 5 / 2

1Systematic Blood Bank (SBB) 3.0n o n e

1–6 (average, 3)

hosted/Web deployedP C s

Visual Basic, Fortrana n yp r o p r i e t a r y

1 0 0 %1 0 0 %1 0 0 %1 0 0 %1 0 0 %1 0 0 %1 0 0 %1 0 0 %available but not installedavailable but not installed1 0 0 %not available1 0 %not available1 0 0 %not available/not availablenot availablenot availablenot availablenot available1 0 0 % / 1 0 0 %1 0 0 %

yes, version 2.3.1—uni-directional to Immucor Galileo

n osoftware validation guidelines

y e sfixed feebrowser based, requires software be installed on a client PCoperates over the Internet8by vendor

n on o

CPSI, Psyche Systems, Meditech, Siemens, McKesson, Cerner,Misys, others

yes (meets via Internet periodically; in person biannually)e s c r o wy e sy e s / n o

$0/$10k/$5k/$.350k to $1k/$40k/$5k/$.8k$0/$30k/$10k/$.6k to $5k/$10k/$15k/$1.5k

• complete, affordable blood bank system for the small to mid-size blood bank

• flexible and easy to use• securely hosted Web-deployed system that requires no additional

hardware investment





Part 9 of 10




















SCC Soft ComputerEllie Vahman e l l i e @ s o f t c o m p u t e r . c o m5400 Tech Data DriveClearwater, FL 33760727-789-0100, ext. 4052

S o f t B a n k

1 9 9 2—1 4 881 3 300071 32 4 427 (27/0/0)1 93 %

7 2 0 / 2 9 7 / 2 1 83 4 / 2 3 / 1 5

619.1, 21, 22, 23, 23 with Softscape, 23.1 with Oraclen o n e

1–90+ (average, 8)

IBM pSeriesP C s

C, C++, .NetIBM AIX (Unix)RDM, Oracle

7 0 %—1 0 0 %1 0 0 %1 0 0 %1 0 0 %7 0 %1 0 0 %—available third quarter 20081 0 0 %30% (component labels only)2 %available fourth quarter 20071 0 0 %———5 0 %9 5 %1 0 0 % / 1 0 0 %9 0 %

yes, versions 2–2.7—uni-directional to ABS2000, Ortho MTS; bi-directional to OrthoProVue, Immucor Galileon oprovide critical control points and instructions on how to write testcases with electronic screen capture


operates over the Internet1by vendor

n on o

Cerner, Meditech, McKesson, Siemens, IDX, CPSI, QuadraMed, Epic,Eclipsys, other vendors that support HL7 protocol

yes (meets in person annually)e s c r o wy e sy e s / y e s

$25k/$30k/$50k/$.45k to $50k/$125k/$80k/$1.875k$40k/$215k/$150k/$4.59k to $400k/$2.5m/$1.1m/$35k

• .Net, Oracle thin-client technology• management tools, including audits and reporting• development, support, and implementation through blood bankers

SCC Soft ComputerEllie Vahman e l l i e @ s o f t c o m p u t e r . c o m5400 Tech Data DriveClearwater, FL 33760727-789-0100, ext. 4052

S o f t D o n o r

1 9 9 22 0 0 68800000187 (7/0/0)21 0 %

7 2 0 / 2 9 7 / 2 1 83 4 / 2 3 / 1 5

24.3, 4.4n o n e

3–8 (average, 8)

IBM pSeriesP C s

C, C++, .NetIBM AIX (Unix)RDM, Oracle

i n s t a l l e d1 0 0 %1 0 0 %1 0 0 %1 0 0 %——1 0 0 %——1 0 0 %available in December 20071 0 0 %——1 0 0 % / 1 0 0 %5 0 %9 0 %1 0 0 %1 0 0 %1 0 0 % / 1 0 0 %5 0 %

yes, versions 2–2.7bi-directional to Abbottbi-directional to Ortho ProVue, Immucor Galileo

n oprovide critical points and instructions on how to write test caseswith electronic screen capture


operates over the Internet0by vendor

n on o

Meditech, McKesson, Siemens, IDX, Cerner, CPSI, QuadraMed, Epic,Eclipsys, other vendors that support HL7 protocol

yes (meets in person annually)escrow n oy e s / y e s

$25k/$30k/$50k/$.45k to $50k/$125k/$80k/$1.875k$40k/$215k/$150k/$4.59k to $400k/$2.5m/$1.1m/$35k

• .Net, Oracle thin-client technology• nearly 30 years of leading clinical software solutions• development, support, and implementation by donor specialists





Part 10 of 10










System provides standard ASTM/HL7 interface?Interfaces to automated donor infectious disease testing instruments

Interfaces to automated ABO/Rh/antibody screening instrumentsFDA 510(k)-approved interface to bedside patient ID system?Tools to help clients validate their systems









Wyndgate TechnologiesScott Dustin d u s t i n s @ w y n d g a t e . c o m4925 Robert J. Mathews Parkway, Suite 100El Dorado Hills, CA 95762916-404-8400 w w w . w y n d g a t e . c o m

S a f e T r a c e

1 9 9 6—5 515 (+3 with donor service only)02 490492 2 415 (8/7/0)41 0 0 %

4 0 / 3 4 / 1 94 0 / 3 4 / 1 9

3a l ln o n e

3–200+ (average, 40)

Unix-based servers, Sun, HP, IBMP C s

Delphi, PL/SQL, .Net, C, 4GLU n i xO r a c l e

1 0 0 %1 0 0 %1 0 0 %1 0 0 %1 0 0 %——1 0 0 %not availablenot available1 0 0 %1 0 0 %1 0 0 %—not available1 0 0 % / —1 0 0 %i n s t a l l e d1 0 0 %not available1 0 0 % / 1 0 0 %not available

n ouni-directional to Ortho, Immucor, Abbott, Olympus, DiaMed,Hitachi; bi-directional to Gambrouni-directional to Ortho ProVue, Immucor Galileo, Olympus Tangon ovalidation guidelines, templates, and validation test plan for safetycritical control checks

y e sfixed fee, transaction basedbrowser based

operates over the Internet, requires use of private, dedicated circuit8by a third party (Hemo-Net)

n on o

—

yes (meets via Internet quarterly and ad hoc; in person annually)yes or escrown oy e s / y e s

——

• extensive safety checks throughout the system with an outstanding record of compliance

• open workflow and extensive user-defined table-based rules• Service 360 commitment to ensure quality implementation and

support experience

Wyndgate TechnologiesScott Dustin d u s t i n s @ w y n d g a t e . c o m4925 Robert J. Mathews Parkway, Suite 100El Dorado Hills, CA 95762916-404-8400 w w w . w y n d g a t e . c o m

SafeTrace Tx

1 9 9 62 0 0 62 2 82 2†

2 1 0†

01 2†

1 6†

77 82 0 2113 (111/2/0)3 21 0 0 %

4 0 / 3 4 / 1 94 0 / 3 4 / 1 9

3a l ln o n e

1–75 (average, 8.5)

Intel-based and Unix-based serversP C s

Delphi, SQL, Crystal ReportsWindows XP Professional, 2003 (Unix optional)O r a c l e

1 0 0 %1 0 0 %1 0 0 %1 0 0 %1 0 0 %1 0 0 %4 5 %1 0 0 %——1 0 0 %i n s t a l l e d2 0 %i n s t a l l e d1 0 0 %not available/not availablenot availablenot availablenot availablenot available1 0 0 % / i n s t a l l e di n s t a l l e d

yes, versions 2.1, 2.2, 2.3—

uni- and bi-directional to Ortho ProVue, Immucor Galileon ovalidation guidelines, templates, and validation test plan for safetycritical control checks

y e sfixed fee, transaction basedbrowser based

operates over the Internet, requires use of private, dedicated circuit3by a third party (Hemo-Net)

n on o

McKesson, Cerner, Siemens, Aspyra, Misys, GE Medical, CPSI,Meditech, Keane, IDX, SCC, Sysmex, others

yes (meets via Internet quarterly and ad hoc; in person annually)e s c r o wn oy e s / y e s

——

• extensive safety checks throughout the system• numerous safety features, including the trademarked

Patient-At-A-Glance Bar• Patented CTS and other transfusion service functionality†breakdown reflects contracts that fit more than one category



Suzanne Butch, MT(ASCP)SBBTheresa Downs, MT(ASCP)SBB

Now that we have automation inthe transfusion service and

blood bank instruments interfacedwith laboratory information systems,it’s time to consider adding these in-struments to the core lab automa-tion line and autoverification.

This might seem like a radical sug-gestion since no automated typingand screening instrument for thetransfusion service can yet be addedto an automation line and since au-

toverification is only now being ac-cepted as a standard operating pro-cedure in other areas of the lab. But itmakes sense. Except for al-logeneic stem celltransplant patients, aperson’s blood typedoesn’t change, and nega-tive antibody screens predominate.Furthermore, samples requiring tech-nologist intervention may hold upother normal results, delaying thetime that blood components are avail-able for the patient.

So why address this now? Because

in order for instruments and softwareto be interfaced in five to 10 years,blood bank and transfusion service

specialists need to start askingfor such capabilities to-day. Vendors want to

make sure a market ex-ists for a new product before

beginning the development process.Federal requirements for FDA

510(k) premarket approval of bloodestablishment software add to the de-lay in adopting new features. Takeelectronic crossmatch as an example.The FDAjust issued draft guidance on

electronic crossmatch, more than 10years after the first facilities were ap-proved to use the technique. And LISvendors only recently began offeringelectronic crossmatch features in theirsoftware.

So we pose the question, whatwould it take to satisfy you that in-struments are ready for autoverifica-tion of results? For us, the softwareshould compare current with previousresults. If the past two times the pa-tient has been O-positive and the pa-tient types as O-positive today, wefeel confident the specimen and pa-tient are O-positive. There is no needto send the results to a technologist.Likewise, if the patient has alwayshad a negative antibody screen andthe current specimen’s results are alsonegative, there is no need for tech-nologist intervention. Just as withhematology and biochemistry, the al-gorithms determine whether au-toverification is appropriate.

One caveat is that the strengthsof the reactions used by the instru-ment or software to determine a pa-tient’s blood type must be controlledby the user, not hard coded by thevendor. For example, a weakly pos-itive (1+) result may be used by an in-strument to conclude that a patient isRh positive, but the end user may de-cide that a 1+ reaction with anti-D isnot sufficient to automatically con-clude that a person is Rh positive.

Some blood bankers may be slowto embrace the concept of autoveri-fication because of the burden of val-idation. Since blood bankers, overall,are a conservative group, many mayfeel more comfortable monitoringfor problems themselves. These in-dividuals could review a daily re-port of patients with positive anti-body screens and typing discrepan-cies to allay their concerns.

One must keep in mind that au-toverification with a hematology in-strument will be different than with ablood bank instrument. Once a hema-tology result is autoverified, the lab-oratory is finished with it. The processis more complex for verifying a typeand screen. The blood bank may beusing the sample to prepare bloodcomponents or may file it away tobe used in the future. How will thetechnologist know that testing is com-plete and components can be pre-pared? For blood banks that use elec-tronic crossmatch, samples with oneblood type need to be identified for asecond blood type. The sample wouldhave to be located and re-tested.

To convey to instrument and LISvendors what you want their respec-tive software to do, you should startdocumenting process specifications.These include the goals of autoveri-fication, the type of results that donot need intervention, an explana-tion of what constitutes a problemsample, or details of how the instru-

38 / CAP TODAY October 2007

Richartz Fliss Clark & Pope

*Expanded menu under regulatory reviewBiotest • 66 Ford Road, Denville, NJ 07834 USA • Tel: 800.522.0090 • Fax: 973.625.5882 • www.BiotestUSA.com

Easy to UseWith on-board reagent storage ofup to 7 days, blood bank profession-als just load samples, press startand walk away. It’s that easy.

Lower Operating Cost• Run QC once a day with no

additional controls required.• Reduce biohazard waste by 92%

over manual methods.• Three antibody screen options:

2-cell, 3-cell or pooled cell.

Increased ProductivityThe new TANGO Optimo offers:• Expanded menu* including:

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OctoberPage 38


The next step: bringing autoverification into the blood bank

OOpinionpinion

1007_01-88_Trali-Multi-Histo.qxd 10/4/07 3:51 PM Page 38

“liquid bead array”—microspheres suspended ina buffer to which capture probes are attached andto which target molecules can bind. Reactions onthis type of microarray support have certain the-oretical advantages. According to Luminex Corp.,which markets the beads (called the xMAP system)and associated readers, the high ratio of surfacearea to volume of the microspheres and the three-dimensional exposure they provide yield superi-or kinetics relative to flat arrays.

Certainly, companies that have developed as-says based on liquid bead array technology (xMAPis an open-architecture system) find practical ad-vantages to the method. At Planet xMAP USA2007, a conference sponsored by Luminex last

spring, Harry Prince, PhD, scientific directorof immunology at Focus Diagnostics, whichhas devised an assay that distinguishes herpessimplex virus types 1 and 2, said obtainingmultiple results in the same well “saves labor,cost, and time and decreases turnaround time.”Tm Bioscience, now a division of Luminex, devel-oped a clinical assay, using the xMAP system, for apanel of respiratory viruses. “We are at least assensitive as real-time PCR and in some cases moresensitive,” Richard Janeczko, PhD, chief scientific of-ficer of Tm Bioscience, said of the assay.

Scientists at Quest Diagnostics Nichols Institutehave developed and validated two genetic assaysusing liquid bead array technology: an AshkenaziJewish panel and a thrombophilia panel. Of theproblem of doing assays for different genes on dif-ferent platforms, Weimin Sun, PhD, of Quest said,

“Multiplexing is the solution.” The advantages ofthe xMAP-based assays are fewer controls, betterturnaround time, a saving of labor owing to fewerDNA extractions, and being able to run a full mi-crotiter plate of samples much of the time, accord-ing to Dr. Sun, who is scientific director of the mo-lecular genetics department at Quest.

Perhaps the highest endorsement of xMAP’spotential was given by a group at the Broad Insti-tute of the Massachusetts Institute of Technologyand Harvard. They measured gene expression us-ing a combination of ligation-mediated amplifica-tion with “an optically addressed microsphere and

flow cytometric detection system”—xMAP. This combination, they wrote,has the potential to be a “transfor-mative technology” in the gene ex-pression field (Peck D, et al. GenomeBiol. 2006;7:R61).

A variety of applications of xMAPhave been devised or are under de-velopment, from the immediatelyclinical to the futuristic. They rangefrom assays for a few analytes, suchas a 10-autoantibody panel, to onethat stretches the potential of thetechnology—measuring hundredsof miRNAs. But they all depend onthe same fundamental reagents andprocedures, which, along with un-derlying principles, are presented andillustrated on Luminex’s Web site(www.luminexcorp.com/technology/index.html).

Basically, 5.6-micron polystyrenemicrospheres are impregnated

with differing ratios of red and in-frared fluorophores, giving rise to 100distinct beads. Capture reagents, typ-

40 / CAP TODAY October 2007

xMAP 3D Liquid Bead Array

Your world is three-dimensional. Shouldn’t your detection system be?xMAP® technology gives you all the advantages of a 3D liquid bead array.

While two dimensional planar arrays simply sit and wait for markers to find

the single exposed surface, our microspheres are suspended throughout the

sample and actively seek the analytes. By actively exposing multiple surfaces

to the whole sample, xMAP’s 3D liquid bead arrays give you faster, more

reproducible and more accurate results. Plus, xMAP’s open-architecture

platform makes it ideal for a wide range of applications – like molecular

infectious and genetic disease, immunoassays, protein and molecular

research just to name a few. To find out more about the advantages of

three-dimensional multiplexing, visit www.luminexcorp.com/3D

Be sure to visit Luminex at the AMP conference and view the

NEW FlexMAP 3D™ Instrument – The Next Dimension in Multiplexing

at booth # 17/18 and 43/44.

xMAP technology can easilydetect multiple different

analytes or viral pathogens in a single patient sample

(like the virus shown here in 3D).

xMAP technology is a 3D liquid beadarray – microspheres are color-codedallowing for multiplexing of up to 100unique assays within a single sample.

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Visit us at AMP Booth Nos. 17 & 43 Circle No. 62 on reader service card

Multiplex technologycontinued from page 1

OctoberPage 40

ment will identify a problem thatneeds technologist intervention. Aprocess flow chart could help definethe path of a normal versus a problemsample.

Instrument limitations will con-tinue to determine process flow. Forexample, a chylous sample will in-fluence a gel technology result butmight not be a problem with a mi-crotiter plate. Examples of questionsthat relate to process flow are, Will therepeat test be on the same instrumentor use another test method? If the in-strument on the line is in anotherbuilding, and the tube is needed foradditional work in the blood bank,how will it be transported? Will theblood bank be completely paperless?

Think about process specificationsnow and then ask for what you wantand need for the future. In otherwords, ask for today what you wanttomorrow. ■■

Suzanne Butch is administrative manager,and Theresa Downs is supervisor, BloodBank and Transfusion Service, Universityof Michigan Hospitals, Ann Arbor.


Autoverificationcontinued from page 38

Among 227 patients, the respiratoryvirus panel detected all 125 specimens

containing one of seven conventional viruses,while DFA detected 113 (90.4 percent).

1007_01-88_Trali-Multi-Histo.qxd 10/4/07 3:51 PM Page 40

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