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Standard 4,570 4,480 4,390 4,240 4,110 3,950 3,820 3,680 3,630

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Benefits of diagramming tools to the clinical laboratoryIntegrating laboratory workflow with informa-

tion system operations to maximize productivity is a challenging task, but diagramming tools can simplify the process.

How diagramming tools work and which types of diagrams are most helpful to labs are the focus of “Diagramming Tools for Requirements Analy-sis and Workflow Redesign,” a section of the book Laboratory Administration for Pathologists, published by CAP Press last year. This section of the book, written by James H. Harrison Jr., MD, PhD, is excerpted and adapted for cap today here.

Dr. Harrison, one of the book’s several contrib-uting authors, is associate professor and director of the Division of Biomedical Informatics, Depart-ment of Public Health Sciences and Pathology, University of Virginia, Charlottesville.

———————————Requirements and workflow analyses are impor-

tant parts of planning the installation of a new sys-tem and improving existing systems. To effectively support a workflow with an information system, pathologists must understand the key tasks and actors in the work-flow, their association with each other, and the data elements that are captured or communicated as part of that workflow. Document-ing this information accurately is very chal-lenging because it re-quires collaboration between individuals who normally play different roles in differ-ent work domains and often have different vocabularies and assumptions. These communication problems were the impetus for the develop-

ment of the Unified Model-ing Language (UML [www.uml.org]), a standardized set of diagramming techniques de-signed for collaborative doc-umentation and cross-do-main communication of work processes and informa-tion system design concepts. Workflows and information models captured in UML diagrams clarify complex real-world environments and relate directly to infor-mation system requirements and design elements.

The most useful diagrams for clinical laboratory settings are use case models, activity diagrams, and class diagrams. Use case models (above) are very simple and are designed to clearly depict key tasks and actors (human and technological). They are easy to create during a discussion, and they may be supplemented with a brief paragraph providing details for each task. All requirements analysis and workflow redesign should be rooted in use cases.

Activity diagrams (below), also known as swim-lane diagrams, are flow charts in which each actor has a lane, and the sequence of events moves down the chart and across the lanes to indicate the flow of actions and information between the actors. Class diagrams (at right) display data models that map all the data elements used in a workflow and their relationships with each other. Unlike activity diagrams, class diagrams are static; they do not specify a particular sequence of use of the data ele-ments they depict.

The combination of these three diagram types supplemented with some textual description can capture most of the information needed for the discussion and analysis of infor-mation flow in laboratory work processes. Most technical dia-gramming software includes templates for UML diagrams, and dedicated UML diagram-ming software is available com-mercially and in open source.

———————————Laboratory Administration for

Pathologists is $85 for CAP mem-bers and $100 for nonmembers. To order, call 800-323-4040, option 1, and request Pub. No. 312, or down-load an order form at www.cap.org.

CompuGroup Medical introduces cloud-based lab outreach software

CompuGroup Medical US has released Lab-Nexus, a software solution to help hospitals and reference labs with their outreach programs. LabNexus allows laboratories to send orders and review results within a cloud-based system.

LabNexus works independently from Com-puGroup’s LabDaq family of products. The system connects easily to an institution’s labora-tory information system or anatomic pathology system. CompuGroup provides a secure hosting environment for the product.

The LabNexus portal offers order-entry capabil-ity for multiple lab facilities, batch printing, label printing, and customizable lab branding. It can generate preliminary and final reports

March 2012 CAP TODAY / 83 82 / CAP TODAY March 2012

March 2012 page 83 March 2012 page 82

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© 2012 College of American Pathologists. All rights reserved.

Clinician

Transporter /Tube

Phlebotomist

Patient

SpecimenProcessor

Technologist

Figure 6-8. Use CaseDiagram of Preanalytical,Analytical, and Postana-lytical Laboratory Work-flow. Key tasks arecaptured in bubbles, andactors (personnel andtechnical systems) areshown as stick figureslinked to the tasks theyperform. Use case tasksmay be broad, as shownhere, or specific, andanalysis typically pro-gresses from broad tospecific.Task bubbles areoften arranged in se-quence, and brief textualdescriptions may accom-pany diagrams.

Orderlaboratory

test

Viewresult

Accessionand processspecimen

Analyzeand report

result

Drawspecimen

Deliverspecimen

Clinician EHR Phlebotomist Transporter /Tube

LIS SpecimenProcessing

Technologist Figure 6-9. Activity Di-agram of LaboratoryWorkflow. The actorsand tasks from the usecase diagram in Figure 6-8 are mapped in se-quence to an extendedflow chart, with one lanefor each actor. Some ad-ditional actors that werenot shown in the usecases (EHR and LIS) areincluded here to com-plete the informationflow. Activity diagramsshow the flow of tasksand information both intime and across partici-pants and systems.

Order testin EHR

Add tophlebotomy

worklist

Pass orderto LIS

Deliver tolaboratory

Accessionand prep

Drawspecimenand send

Add toanalysisworklist

Analyze andreport

Pass reportto EHRStore

dataView

report

Figure 6-10. Simplified Class Dia-gram for Laboratory Workflow.This diagram shows data elementsand their relationships from thesimple workflow shown in figures6-8 and 6-9. The boxes representclasses (entities for which data willbe collected). Items within theboxes are simple data elements,sometimes called attributes.Classes can also contain otherclasses as complex data elements,and these associations are shownas lines. Multiplicity relationshipsare shown as numbers on the as-sociations; for example, a patientcan have any number of visits (thepermissible range is shown as 0..*,where the asterisk indicates “anynumber”), but a visit can have onlyone patient. The clinician class isused in several settings; it repre-sents the patient’s primary physi-cian, and it also represents thephysician of record for a visit andthe ordering physician for a test.These may be different physicians,but the clinician class provides adata model for all of them.Class di-agrams express data models onlyand do not depict data flow or ac-tion sequences. Definitions: ICD,ICD-9-CM code; MRN, medicalrecord number.

Patient

MRNDemographicsContact

Clinician

IDDemographicsContact

Phlebotomyworklist

Analysisworklist

1

1

1

0..*

Test order

Test nameICDDate / timeComment

Specimen

ContainerID (barcode)Date / timePatient namePhlebotomistAccession #

1

0..*

Visit

DateChief complaint

1

0..*

0..*1

0..*1

11

0..*1

0..*

1

Test result

Analysis dateResultReference rangeFlagComment

Use case diagram of preanalytical, analytical, and postanalytical laboratory workflowUse case tasks may be broad or specific, and analysis typically progresses from broad to specific. Task bubbles are often arranged in sequence, and brief textual descriptions may accompany the diagram.

Activity diagram of laboratory workflowThe actors and tasks from the use case diagram are mapped in sequence to an extended flow chart. Additional actors are included to complete the information flow. Activity diagrams show the flow of tasks and information in time and across participants and systems.

0312_82-85_Newsb-QandA.indd 82 3/7/12 2:07 PM

Essential monthly reporting on the clinical laboratory for lab managers and administrators, physicians, lab directors, and supervisory technologists.

Combined Frequency Discounts:Insertions in CAP TODAY and the Archives of Pathology & Laboratory Medicine combine to determine the earned rate in each publication. Call your representative for details.

Digital Advertising:Print advertisers receive value-added online ads. See our digital edition at http://www.captodayonline.com/mag. In addition, CAP TODAY advertisers have exclusive digital advertising opportunities available. Please see separate CAP TODAY 2013 Digital Rate Card.

Every month CAP TODAY brings essential news to all key decisionmakers responsible for clinical laboratory purchases. This news includes advances in tests and equipment, trends in management and clinical operation, regulatory changes, and finance, plus news about the laboratory improvement programs of the College of American Pathologists.

August 2012 page 42

42 / CAP TODAY

August 2012

New screening guidelines—order amid complexity

Barbara A. Crothers, DO

Ritu Nayar, MD

Cervical cancer screening guide-�

lines were updated recently in

an effort to bring order to the com-

plexity and multiplicity of screen-

ing practices, with special consid-

eration to age and type of testing

used.1 The recommendations also

address followup, primary screen-

ing with HPV testing only, and the

impact of HPV vaccination on

screening. The American Cancer

Society led the effort in collaboration

with the American Society for Col-

poscopy and Cervical Pathology and

American Society for Clinical Pa-

thology. The U.S. Preventive Ser-

vices Task Force has also updated its

cervical cancer screening recommen-

dations, which closely parallel those

from the ACS/ASCCP/ASCP.2

The consensus meeting took

place in November 2011 at the Na-

tional Institutes of Health. Represen-

tatives from 25 organizations with

an interest in women’s health at-

tended. Guidelines were evidence-

based and constructed using the

Grading Recommendations Assess-

ment, Development, and Evaluation

(GRADE) system3 as a framework

for the process. Benefits and harms

were evaluated and strongly influ-

RODOLFO LAUCIRICA, MD, EDITOR

continued on page 44

Ann T. Moriarty, MD

“What a great case!” my pathologist ex-�

claimed as she first reviewed all

10 of my parts under the microscope. I had

been growing slowly, in a warm, subcu-

taneous location, until my life changed

abruptly. I suddenly found myself flow-

ing through a small caliber stainless steel

tunnel as I was rapidly aspirated, smeared be-

tween two glass slides, and unceremoniously

dunked into ethanol. Part of me was left out to

dry. After being delivered to a well-lit, organized

laboratory, I was carefully stained with a Papani-

colaou stain that left me a riotous kaleidoscope of

green, purple, pink, and orange, and given a

matching modified Giemsa stain that gave me a

general purple hue. After that, I had been covered

in glass after being swathed in a permanent mount-

ing media. I was gorgeous (if I do say so myself)

and apparently worth a second look. I was passed

around the department so all the cytologists could

appreciate my features.

After my debut, I was carefully filed into a

study set where I languished in the darkness for

years. After 10 years, I was scheduled to be dis-

carded with all my neighbors, to make room for

a new generation. My pathologist was pained to

see me leave, as I had managed to increase the

expertise of the entire laboratory. But the time had

come for me to move to glass disposal.

At the last minute, I was carefully culled from

the discard stack, packaged lovingly along with

my history before I became glass, and sent by mail

to a wonderful world called the College of Ameri-

can Pathologists. It was at the CAP that I came into

my true purpose as glass. First, I was given a

number. Then I was reviewed by a CAP cytotech-

nologist who understood what a treasure I was

(and I had been stored so well that I had not faded

or aged at all over 10 years). The cytotechnologist

took all my information and me along with about

2,000 other interesting new neighbors to

something called a Cytopathology Committee

meeting. Over the course of four days, at least three

American-Board-of-Pathology–certified anatomic

pathologists scrutinized me and my compatriots.

They unanimously agreed that I was a truly great

case and was going to play a role in three different

programs for the CAP.

First, I was going to get some enhancements.

The special stains performed on my cell block were

going to be photographed and electronically stored

in the computer system at the CAP. Then all my

parts were going to be digitized so I could be vir-

tual glass and immortalized as a great case, in case

my parts became too faded or (heaven help me)

broken. Once I was sent to virtual heaven, I would

circulate as a pair to as many laboratories that

subscribed to an educational interlaboratory com-

parison program. Any cytotechnologist or patholo-

gist who received me could go online and see my

special stains. After successfully identifying me

and understanding the importance of my ancillary

stains, they could answer a short scored assess-

ment and receive educational credits to maintain

their certification or fulfill their educational re-

quirements for credentialing or licensure. I was

proudly teaching in my field, once again.

The most exciting turn of events happened with

my virtual reincarnation. I was released as an on-

line challenge that could be viewed by hundreds

of people simultaneously. In that life, the

viewers saw me on their computer screens

and got to make a general diagnosis and

then to choose the special stains accompa-

nying me. It was like being reborn with

each viewing. The cytologists got to “work

me up” just like my original brilliant patholo-

gist had when she first encountered me. Once they

had all the available ancillary information, the

participants would make the most specific diag-

nosis they could. Then they have the opportunity

to prove they learned from me by passing an as-

sessment. I was a great teacher.

Not only am I now electronically immortal, but

I have gone on to have an impact on the whole

field of pathology, as more and more people have

had a chance to view my parts. My original pa-

thologist was brilliant to have shared me with her

colleagues in the United States and internation-

ally. My glass has been to 18 different countries

and my virtual self has beamed all around the

world. Who would have thought that a mere

lump could have had such a great legacy? I am a

truly great case.

If you have great cases to share with the world,

be a brilliant pathologist and share them. Dona-

tions for the nongynecologic and fine-needle as-

piration glass slide and virtual programs are be-

ing accepted (gynecologic cases welcome too).

Donation forms and instructions can be obtained

from the CAP Web site or by calling Larry Flen-

noy at 847-832-7275 or 800-323-4040 ext. 7275.

Donors are reimbursed for their clerical expenses

when donating slides to any CAP program.

Dr. Moriarty, chair of the CAP Cytopathology Com-

mittee, is in the Department of Pathology, AmeriPath

Indiana, Indianapolis.

My life as glass‘I was great and gorgeous’

Gil Adams

0812_42-48_Cytopath.indd 42

8/8/12 2:54 PM

Distribution

Readers* All key decisionmakers, no excess

Pathologists and Laboratory Directors 19,000Laboratory Managers and Laboratory Administrators 6,000Chief Techs; Section Managers/Supervisors of Chemistry, Hematology, Microbiology, Immunology, Blood Bank, Cytology, or Histotechnology

20,000

Hospital Administrators 5,000

TOTAL 50,000* This listing is specially grouped for convenience. See the BPA Publisher’s Statement for detailed circulation data.

Independent research studies show that CAP TODAY is #1 in total ad exposures for the marketplace. PERQ/HCI and/or Analytical Research Service Inc.

have completed recent studies on pathologists (PERQ/HCI), clinical lab directors, lab managers and administrators, and purchasing influence. In 2012, CAP TODAY carried more advertising than any other book in the field.

April 2012 Pathology/Laboratory Medicine/Laboratory Management

Vol. 26 No. 4

For respiratory virus detection, a golden ageWilliam Check, PhDWhen it comes to molecular detection of res- piratory viruses, laboratorians today have an embarrassment of riches. “This talk would have been very different five years ago,” Christine C. Ginocchio, PhD, MT(ASCP), said at last year’s Association for Molecular Pathol-ogy meeting at the outset of her review of multianalyte platforms for detecting respiratory viruses. The advances in this area have been substantial, she told CAP TODAY recently, adding: “There has been an explosion of molecu-lar assays, both IVD cleared and not.” Dr. Ginocchio, who is senior medical director and chief, Division of Infec-tious Disease Diagnostics, Depart-ment of Pathology and Laboratory Medicine, North Shore-LIJ Health System Laboratories in New York, calls this “an excellent time to be working in infectious diseases.”“We now have several FDA-cleared assays for detection of mul-tiple respiratory viruses in the same sample, and they have a wide range of multiplexity,” she says.With so many platforms avail-able—Dr. Ginocchio discussed 13, seven cleared and six in trials—and with such a wide range in multiplexity, turnaround time, throughput, degree of automation, and cost, how is a lab to know which system best fits its

needs? Or, for that matter, whether it even needs a multiplex platform? Laboratorians might follow the real estate mantra: “Location, location, location.” “It would seem that use of the new viral panels would be a no-brainer, but that is not the case,” says Richard B. Thomson, PhD, medical director of the microbiology laboratories at Evanston (Ill.) Hospital of NorthShore Uni-

versity Health System and clinical professor of pathology, University of Chicago. Reagent expense is a major reason, Dr. Thomson told CAP TODAY, as is capital expense. That makes it crucial to think about where specimens are coming from. “Right now there are many different outpatient and inpa-tient settings where viral diagnostics are used,” Dr.

Contaminated blood cultures: taking bold steps to lower ratesAnne PaxtonA frequent failure that is costly for a hospital can rightly be called a serious problem, but when the failure stems from avoidable er-ror, it’s especially troub ling. Blood culture contamination, a cause of false-positive results, diagnostic er-rors, and frustration, is one such fail-ure, says Dennis Ernst, MT(ASCP), executive director of the Center for Phlebotomy Education, Corydon, Ind. While high rates of blood culture contamination are common, they don’t have to be permanent, he says. Institutions can slash their contamination rates to two percent or less by mustering the will to tackle the causes. Ernst compares blood culture contamination to

The many new and varied assays for molecular detection of respiratory viruses make today “an excellent time to be working in infectious diseases,” says Dr. Christine Ginocchio.

Jenn

ifer

Altm

an

Two for the road with companion diagnosticsKaren TitusForget about the emerging world of personalized medicine. It’s now a merging world, one in which pharmaceutical companies and diag-nostics firms are shaking hands on any number of deals to develop drugs

and companion tests for oncology. Consider these recent partnership announcements: • Abbott and Pfizer • Pfizer and Ventana • Ventana and Bayer • Life Technologies and GSK • Roche and, well, Roche

Such unions may not count as kumbaya moments for these medical behemoths, but they do point to bud-ding awareness of how to pull drugs and tests alongside each other and before the FDA.Along the way, both pharma and diagnostics firms have encountered a few jolts. So has the FDA. This may have slowed things down over the years, though many in the field mere-ly shrug when asked about the pace at which drug-test pairs have come to market. Scientific knowledge may grow quickly, but putting it into a drug and onto a test platform doesn’t happen overnight.

Mara Aspinall, president/CEO, Ventana Medical Systems, has watch-ed personalized medicine unfold in a

TM

continued on page 50

continued on page 12

continued on page 28

April 2012 page 1

LPL software companies plug the gaps, hold their own

Page 3

Laboratory-provider links software, pages 71–820412_1_MultPx-APcan-Phleb2.indd 1

4/9/12 12:42 PM

CAP TODAY is available via mobile device

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

Blood bank information systems

September 2010 Page 71

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

Blood bank information systems

70 / CAP TODAY

September 2012

October 2011 Page 70

September 2012

CAP TODAY / 71

Part 1 of 5

Blood Bank Computer SystemsCerner Corp.

Haemonetics Software Solutions

Brian Forbis bforbis@bbcsinc.comJennifer Walker jennifer.walker@cerner.com Scott Dustin scott.dustin@haemonetics.com

1002 15th St. SW, Suite 1202800 Rockcreek Parkway

4925 Robert J. Mathews Parkway, Suite 100

See accompanying article on page xxAuburn, WA 98001

Kansas City, MO 64117El Dorado Hills, CA 95762

See captodayonline.com/productguides for an interactive version of guide 888-738-2227 www.bbcsinc.com816-201-2854 www.cerner.com

916-404-8415 www.haemonetics.com

Name of blood bank systemBlood Bank Control System Primary Application (BBCSP) Cerner Millennium PathNet Blood Bank Transfusion ElDorado Donor

First ever/Most recent blood bank system installation* 1987/July 20121986/July 2012

1996/June 2012

Last major product release for version of product featured July 2012

January 2012June 2012

Total number of contracts for sites operating blood bank system 30

388†

26

•Contracts for U.S. hospitals with donor and transfusion services 1

25†

14

•Contracts for U.S. hospitals with transfusion services only 0

363†

0

•Contracts for U.S. regional blood centers with donor services only 21

0

4

• Contracts for U.S. regional blood centers with donor and transfusion services 5

0

2

•Contracts for foreign hospitals and regional blood centers 0

70† (Australia, Canada, England, Guam, Saudi Arabia, Singapore, Egypt, United Arab Emirates) 4 (Egypt, Puerto Rico, Guam, Dubai)

•Contracts for other sites

3 (2 medical research facilities; 1 hospital with donor service only) 0

2 (hospitals with donor service only)

Number of contracts signed between June 2011–June 2012 1

52† (for calendar-year 2011)4

Total number of sites operating blood bank system123

388

14

Number of sites that went live between June 2011–June 2012 1

48

3

Installations not yet live (hospitals/regional blood centers/others) 1 (0/1/0)

34 (34/0/0)

17 (10/4/3)

Percentage of installations that are standalone blood bank systems 100%

0

100%

No. of employees in entire company/Dedicated solely to blood bank systems development, installation, support 30/25

10,072 (as of January 2012)/4202,374/338

Number of different versions of this software installed12

2

4

•Versions of product in field covered by FDA 510(k) clearance BBCSP 5.2.2, 5.3, 5.3.1, 5.3.2, 5.3.3, 5.3.4, 5.3.5, 5.3.6, 5.3.7, 5.3.8, 5.4, 5.4.1 Cerner Classic PathNet, Cerner Millennium PathNet 2.0, 2.1, 2.2, 2.3

•Versions of product that did not require FDA 510(k) clearance 0

0

0

Range in number of user workstations in live sites (average) 10–200 (average, 40)—

6–40 (average, 15)

Server platforms

IBM iSeries

IBM, Hewlett-Packard—

PC or workstation platformsIBM-compatible workstation, PCs

Microsoft Windows locally or via Citrix thin client Windows

Software programming language(s)RPG 400, Java

Java, Visual Basic, C++, C#, Visual CC#

Operating system(s)

OS/400

HP-UX, AIX, VMSWindows

Databases and tools

IBM DB2

Oracle

Oracle, Crystal Reports

Features (listed as percentage of live installs or based on availability)•Biometric ID of donors and/or patients

installed

available but not tracked—

•Full support of ISBT 128 unit labelinginstalled

100%

100%

•Bar-code reading of donor and unit informationinstalled

100%

100%

•Unit inventory

installed

100%

100%

•Autologous and directed unit trackinginstalled

100%

100%

•Direct entry of test resultsinstalled

100%

100%

•Crossmatch results

installed

99%

available via Haemonetics’ SafeTrace Tx

•Electronic crossmatch decisionmakinginstalled

>50%

available via Haemonetics’ SafeTrace Tx

•Antigen typing

installed

99%

100%

•Integrated bedside check for transfusion using positive patient ID not available

1%

available via Haemonetics’ BloodTrack

•Track all steps in production of productinstalled

99%

100%

•Print donor unit labels—bar codedinstalled

99%

100%

•Interface with blood irradiator or centrifugesnot available

not available

—

•Centralized transfusion service capabilityinstalled

available

available via Haemonetics’ SafeTrace Tx

•Donor recruitment and managementinstalled

available through partnership with a third party available via Haemonetics’ eDonor

•Donor questionnaire

installed

available through partnership with a third party available via Haemonetics’ Donor Doc

•Mobile scheduling

installed

available through partnership with a third party available via Haemonetics’ Hemasphere/eDonor

•Laptop-based mobile donor registration moduleinstalled

available through partnership with a third party installed

•Source or recovered plasma managementinstalled

available through partnership with a third party installed

•Accounts receivable

installed

15%

installed

•Management reports

installed

100%

100%

•Ad hoc report writer

installed

100%

available via Haemonetics’ ElDorado Donor Report Server

•Quality control managementinstalled

25%

available via Haemonetics’ ElDorado Control

•Collection management

installed

100%

100%

Interfaces to automated donor infectious disease testing instruments yes

yes

yes

Interfaces to automated ABO/Rh/antibody screening instruments yes

yes

yes

Electronic interface to bedside patient ID system from other vendors no

no

no

Languages (other than English) offered on systemnone

German, French, Spanishnone

Recommended tools to help clients validate their systems validation protocols, flow charts, risk mitigation online portal, installation and verification instructions, others

certification guidelines, design and build instructions and online help files for end-users, blood bank validation services for organizations that want to outsource their validation activities

validation templates and validation test plan for safety critical control checks, validation services through Haemonetics’ PeopleMed subsidiary

System available via ASP or cloud-based data centeryes

yes

yes

System provides indexed field in each test definition for LOINC code no

yes

no

Provide LOINC dictionary for each new installationno

yes

no

Other vendors to which software has a lab system-related interface Haemonetics Software Solutions, Ortho Clinical Diagnostics Haemonetics Software Solutions—

User group

yes (meets via Webinar and in person)yes (meets via Webinar and in person)

yes (meets via Webinar and in person)

Source code

no

no

escrow

Methods by which users can tailor blood bank system in their own setting

ad hoc query tools, user-defined interfaces, dictionary settings, BBCS configuration options user programming, ad hoc query tools, user-defined interfaces, dictionary settings, others user programming, ad hoc query tools, user-defined interfaces, table settings

Cost for software modifications to comply with federal regs and laws standard (no charge)standard (no charge)

standard (no charge)

Total cost for smallest standalone blood bank system installation** —

—

—

Total cost for largest standalone blood bank system installation** —

—

—

Total incremental cost for smallest blood bank configuration installed** —

—

—

Total incremental cost for largest blood bank configuration installed** —

—

—

Distinguishing features (supplied by company)

*based on July 2012 survey deadline**total cost includes hardware, software, installation, and trainingNote: a dash in lieu of an answer means company did not answer question or question is not applicable

• over 25 years of consistent client-driven design• provides an entirely integrated, real-time, fully customizable electronic questionnaire module capable of utilizing touch-screen/tablet technology, supporting a fully paperless donor room• controls within BBCS applications allow managers to be more effective by minimizing distractions and controlling risk

• positive patient ID capabilities at the patient bedside, from specimen collection to transfusion administration• increased efficiencies through such capabilities as mother-baby linking, online secondary review of results, QC specific to blood bank workflows, etc.• support for blood bank within a single lab information system and electronic medical record architecture

†sites, not contracts

• extensive safety checks throughout system with a commitment to compliance• open workflow with extensive user-defined, table-based rules• Service 360 commitment to ensure quality customer implementation and support experience

Product guide editors: Raymond D. Aller, MD, and Hal Weiner

Part 2 of 5

Haemonetics Software SolutionsMcKesson

Medical Information Technology

Scott Dustin scott.dustin@haemonetics.com Joseph R. Stabile joseph.stabile@mckesson.com Paul Berthiaume pberthiaume@meditech.com

4925 Robert J. Mathews Parkway, Suite 100 5995 Windward ParkwayMeditech Circle

El Dorado Hills, CA 95762Alpharetta, GA 30005

Westwood, MA 02090

See captodayonline.com/productguides for an interactive version of guide 916-404-8415 www.haemonetics.com404-338-4363 www.mckesson.com/laboratory 781-821-3000 www.meditech.com

Name of blood bank systemSafeTrace Tx†

Horizon Blood Bank†

Blood Bank System–6.0

First ever/Most recent blood bank system installation* 1996/July 20122004/June 2012

1981/June 2012

Last major product release for version of product featured March 2012

March 2011

January 2011

Total number of contracts for sites operating blood bank system 353

113

81†

•Contracts for U.S. hospitals with donor and transfusion services 19

0

—

•Contracts for U.S. hospitals with transfusion services only 312

110

—

•Contracts for U.S. regional blood centers with donor services only 0

0

—

• Contracts for U.S. regional blood centers with donor and transfusion services 10

0

—

•Contracts for foreign hospitals and regional blood centers 9 (Botswana, Puerto Rico, Canada, Guam, Ethiopia) 3 (Canada)

5† (Canada)

•Contracts for other sites

3 (regional donor centers with transfusion only) 0

—(acute care, behavioral health, critical access, long-term care, rehabilitation, others)

Number of contracts signed between June 2011–June 2012 47

0

1†

Total number of sites operating blood bank system444

174

118

Number of sites that went live between June 2011–June 2012 46

17

53

Installations not yet live (hospitals/regional blood centers/others) 59 (59/0/0)

13 (13/0/0)

61 (60/0/1)

Percentage of installations that are standalone blood bank systems 100%

0

0

No. of employees in entire company/Dedicated solely to blood bank systems development, installation, support 2,374/338

44,000/328 (from Haemonetics Software Solutions) 3,830/202 (for all LIS-related applications)

Number of different versions of this software installed6

5

1

•Versions of product in field covered by FDA 510(k) clearance SafeTrace Tx 3.4, 3.4.1, 3.5. 3.5.1, 3.6, 3.7 SafeTrace Tx 3.2, 3.3, 3.4, 3.5, 3.6Meditech 6.0

•Versions of product that did not require FDA 510(k) clearance 0

0

0

Range in number of user workstations in live sites (average) 1–105 (average, 7)1–7 (average, 2)

—

Server platforms

Windows-based servers, Intel based (determined by Oracle) Windows-based serversminimal 64-bit 2 GHz+ dual core processors operating Microsoft Windows Server 2003/2008 Standard Edition

PC or workstation platformsWindows

Windows

Windows PCs with 2 GHz or higher Intel or equivalent processor and minimum 2 GB RAM

Software programming language(s)Delphi

Delphi

Meditech-developed programming language

Operating system(s)

Windows

Windows

servers: Windows 2003/2008 SE; clients: Windows 2000 Professional, XP, XP Tablet, Vista, 7

Databases and tools

Oracle, Crystal ReportsOracle

Meditech Database Management System

Features (listed as percentage of live installs or based on availability)•Biometric ID of donors and/or patients

not available

not available

installed

•Full support of ISBT 128 unit labeling100%

installed

100%

•Bar-code reading of donor and unit information100%

installed

100%

•Unit inventory

100%

installed

100%

•Autologous and directed unit tracking100%

installed

100%

•Direct entry of test results100%

installed

100%

•Crossmatch results

100%

installed

100%

•Electronic crossmatch decisionmaking70%

installed

installed

•Antigen typing

100%

installed

installed

•Integrated bedside check for transfusion using positive patient ID available via a third partynot available

installed

•Track all steps in production of product100%

installed

100%

•Print donor unit labels—bar codedinstalled

installed

installed

•Interface with blood irradiator or centrifugesinstalled

installed

installed

•Centralized transfusion service capability100%

installed

100%

•Donor recruitment and managementavailable via Haemonetics’ eDonor

available via a third partyinstalled

•Donor questionnaire

available via Haemonetics’ ElDorado Donor Doc available via a third partyinstalled

•Mobile scheduling

available via Haemonetics’ Hemasphereavailable via a third party

installed

•Laptop-based mobile donor registration moduleavailable via Haemonetics’ ElDorado Donor available via a third party

installed

•Source or recovered plasma managementavailable via Haemonetics’ ElDorado Donor available via a third party

installed

•Accounts receivable

available via a third partyavailable via a third party

installed

•Management reports

100%

installed

100%

•Ad hoc report writer

available via a third partyinstalled

100%

•Quality control managementinstalled

installed

—

•Collection management

available via Haemonetics’ ElDorado Donor available via company’s LISinstalled

Interfaces to automated donor infectious disease testing instruments no

no

yes

Interfaces to automated ABO/Rh/antibody screening instruments yes

yes

yes

Electronic interface to bedside patient ID system from other vendors yes

no

no

Languages (other than English) offered on systemnone

none

Spanish in development

Recommended tools to help clients validate their systems validation guidelines, templates and test plan for critical control checks, validation services through Haemonetics’ PeopleMed subsidiary

validation services and guidelines from recommended third party testing scripts available on company Web site through Meditech validation guides

System available via ASP or cloud-based data centeryes

yes

no

System provides indexed field in each test definition for LOINC code no

no

yes

Provide LOINC dictionary for each new installationno

no

no

Other vendors to which software has a lab system-related interface McKesson, Cerner, Siemens, GE, CPSI, Meditech, Keane, SCC Soft Computer, Sysmex, Allscripts, Orchard, Sunquest, Quality Software Systems

Siemens, Meditech, Epic, Cerner (all interface to McKesson Horizon Lab or Paragon and then to Horizon Blood Bank)

—User group

yes (meets via Webinar and in person)yes (in person only)

yes (meets via Webinar and in person)

Source code

escrow

escrow

escrow

Methods by which users can tailor blood bank system in their own setting

ad hoc query tools, user-defined interfaces, table settings ad hoc query tools, dictionary settingsad hoc query tools, user-defined interfaces, dictionary settings, customer-defined screens, desktop preferences, rules-based logic

Cost for software modifications to comply with federal regs and laws standard (no charge)—

standard (no charge)

Total cost for smallest standalone blood bank system installation** —

—

—

Total cost for largest standalone blood bank system installation** —

—

—

Total incremental cost for smallest blood bank configuration installed** —

—

—

Total incremental cost for largest blood bank configuration installed** —

—

—

Distinguishing features (supplied by company)

*based on July 2012 survey deadline**total cost includes hardware, software, installation, and trainingNote: a dash in lieu of an answer means company did not answer question or question is not applicable

• extensive safety checks throughout system with a commitment to compliance• patents for Patient-At-A-Glance bar, antigen-antibody identification, and central transfusion service functionality• Service 360 commitment to ensure quality customer implementation and support experience

†also marketed by McKesson as Horizon Blood Bank

• extensive safety checks throughout system with a commitment to compliance• patents for Patient-At-A-Glance bar, antigen-antibody identification, and central transfusion service functionality• Service 360 commitment to ensure quality customer implementation and support experience

†also marketed by Haemonetics as SafeTrace Tx

• integrated component of Meditech EHR, providing a seamless exchange of data across the continuum• features centralized access to common routines and reports via roles-based desktops• blood bank and patient care and patient safety solu-tions fully integrated, fostering the sharing of blood bank unit and patient data between the products†sites, not contracts

8

Arch

ives of Path

ology & L

aboratory Med

icine

Au

gust 2012

Volu

me 136, N

um

ber 8

Pages 841–972

August 2012Special Section—2011 New Frontiers in Pathology

“Starry-Sky” Pattern and High Proliferative Fraction in an Aggressive B-Cell Lymphoma

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