1 ADVANCE for Administrators of the Laboratory

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ADVANCE for Administrators of the Laboratory
1
2
FEBRUARY 2014 ❘ VOL.23 ❘ NO.2
12
COVER STORY
LIS Integration
vs. Interfacing
20
Critical considerations
are identified
Lab as a Revenue Center
The laboratory’s role in increasing
profitability in the new age of
healthcare is explored
By Dondapati Chowdary, MBA, PhD
By Dennis Winsten
24
FEATURES
Analytical and biological considerations
are particularly critical in coagulation
By Kim Ledingham, MT(AMT), MLT(ASCP)
Is Your LIS
Inspection Ready?
ABOUT THE COVER
Understanding what’s expected
and utilizing key resources will
help your LIS be prepared
This is a complex analysis involving true overall
costs, impact on access to clinical data and more.
By Hal Weiner and Dennis Winsten
Illustration by Matthew Taraborrelli
Copyright 2014 by Merion Matters. All rights reserved.
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Errors in Coagulation Testing
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DEPARTMENTS
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On Record
Rapid Evolutions In Healthcare
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Perspectives in Pathology
Pathology Networks
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Laboratorians’ Guide to
Healthcare Reform
How Labs Drive ACO Success
PRODUCT SECTION
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Focus On: Microbiology
Evolution of Methodologies
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EDITORIAL ADVISORY BOARD
DAVID G. BECKWITH, PHD
President, CEO and Clinical Director
Health Network Laboratories LLC, Allentown, PA
DONNA D. CASTELLONE, MS
Clinical Science Manager
ROCHE Diagnostics
DENNIS J. ERNST, MT(ASCP)
Director
Center for Phlebotomy Education, Corydon, IN
ROBIN FELDER, PHD
Director
Clinical Robotic Research Group
University of Virginia Health Sciences Center, Charlottesville, VA
WM. DANIEL FOLLAS, MS
President
Follas Laboratories Inc., Indianapolis, IN
GERRI S. HALL, PHD
Staff Microbiologist
Department of Clinical Pathology
Cleveland Clinic Foundation, Cleveland, OH
AD INDEX
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Support the companies that support your profession.
The companies listed below support the labora
M. LAMAR JONES, BS, HT(ASCP)
Education Coordinator
Carolinas College of Health Sciences
Charlotte, NC
tory profession by placing advertisements in
GERALD J. KOST, MD, PHD
Professor, Medical Pathology and Biomedical Engineering Director,
Clinical Chemistry, University of California, Davis
Their support keeps our publication coming to
JOHN A. LOTT, PHD
Professor of Pathology, Director of Clinical Chemistry
The Ohio State University Medical Center, Columbus, OH
PEGGY LUEBBERT, MS, MT(ASCP), CIC
Risk Management Specialist
Alegent Health Bergan Mercy Medical Center, Omaha, NE
GREGORY T. STELZER, PHD
Senior Vice President and Chief Scientific Officer
Esoterix Inc., Brentwood, TN
JOHN G. THOMAS, PHD, MS, HCLD
Director, Microbiology and Virology
West Virginia University Hospitals, Professor, Departments of
Pathology and Periodontics, West Virginia University Schools of
Medicine and Dentistry, Robert C. Byrd Health Sciences CenterNorth, Morgantown, WV
GREGORY J. TSONGALIS, PHD
Director, Molecular Pathology, Department of Pathology, Dartmouth
Medical School, Co-director, Pharmacogenomics, Dartmouth
Hitchcock Medical Center, Lebanon, NH
DENNIS WINSTEN, MS, FHIMSS, FCLMA
President
Dennis Winsten & Associates, Inc., Tucson, AZ
Healthcare Systems Consultants
WILLIAM E. WINTER, MD
Professor, Department of Pathology, Laboratory Medicine
Pediatrics and Molecular Genetics & Microbiology
Medical Director and Section Chief, Clinical Chemistry
Director of Residents Training Program, University of Florida College
of Medicine, Gainesville, FL
VENDOR ADVISORY BOARD
AUTOMATION
RON BERMAN
Vice President,
Global Operations Chemistry Systems Business Center
Beckman Coulter, Fullerton, CA
COAGULATION
JOGIN R. WU, PHD
Associate Clinical Professor of Pathology,
Duke University Medical Center, Associate Director,
Duke University Health System, Durham, NC
PAUL RILEY, PHD
Manager, Research Use Products
Diagnostica Stago, Inc.
Parsippany, NJ
HEMOSTASIS
KEVIN MCGLINCHEY, MT (ASCP), CLS (CG)
Marketing Manager
Diagnostica Stago, Inc., Parsippany, NJ
INFORMATION SYSTEMS
KERRY FOSTER
Director of Marketing
Orchard Software Corp., Carmel, IN
POINT-OF-CARE TESTING
PAUL HAUSMAN
Marketing Manager, Institutional Business
Lifescan, Milpitas, CA
TRANSFUSION MEDICINE/BLOOD BANKING
CHRISTIE NEWMAN
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GUEST EDITORIAL
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Rapid Evolutions
In Healthcare
he bottom line business imperative for
healthcare provider organizations is clear:
providing affordable, high quality healthcare
to individuals and populations. To accomplish
this in the new healthcare marketplace in which
providers are increasingly compensated on the
value of the care they provide, healthcare leaders will need to
transform their organizations, achieving 20-40% performance
improvement. As they do so, healthcare leaders will need to deal
with a number of key trends and challenges, including:
1. Pacing the Shift to Value-Based Models: Most providers
still have significant fee-for-service revenue. As healthcare
leaders continue to put infrastructure and governance in
place to support value-based payment models, many are
concerned that they may be reaching an inflexion point
at which the cost of building and maintaining their valuebased-infrastructure is not currently supported by fee-forservice reimbursement models.
2. Responding Effectively to the Economic Dynamics of
Local Markets: As organizations continue to operationalize value-based care delivery models, they are grappling
with what can be achieved given the economic dynamics
of their local markets.
3. Securing and Growing Market Share: Regardless of the pace
of payment model change, securing market share remains a
primary concern.
4. D
eveloping Alternative Revenue Streams: Organizations
with cash reserves and strong margins are better-positioned
to make investments that are related to, but not directly in
support of, their core business of patient care.
5. Containing Core Operating Costs: Executives continue to
seek ways to contain the costs of core operations, tackle
fundamentals, and reduce utilization through standardization, care variation management, and other next-generation approaches.
Based on the mandate in the marketplace, leaders need to
take an all-inclusive look at their organizations and ask hard
questions about every key operational, clinical, and governance
function to position their organizations for success in the rapidly
evolving healthcare market. n
To order article reprints:
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Curt Whelan is managing
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PATHOLOGY
PERSPECTIVES IN PATHOLOGY
Pathology
Networks
By Bill Taylor
rofessional pathology networks are taking
pathology to new levels by facilitating web-based
access to digital slide images and pathology expertise, enabling the provision of pathology consultations and fulfilling the diagnostic pathology needs of
hospitals, physicians and reference labs worldwide by
linking them to expert pathologists.
With a unique blend of cloud computing technology
and global connectivity, pathology networks enable
pathologists around the world to view and share digital slides with others regardless of location, globalizing
their practices and bringing expertise to all corners
of the world to more effectively meet the demands of
diagnostic medicine.
Consult, Collaborate, Improve Patient Care
Pathology networks provide pathologists around
the globe an opportunity to practice and collaborate
beyond their physical microscopes and offices. Lab
professionals and pathologists can use pathology networks as a means to improve operating efficiency,
ensure patient safety, increase revenue through consultation and outreach services, and become highly
competitive in their local markets.
Physicians and pathologists seeking consultations
or access to sub-specialty pathology expertise can
upload case files and digital images for participating
pathologists to review and render critical consulting
diagnoses on both a global and domestic real-time
basis. For complex cases, a network allows several
pathologists to access and review a digital pathology
slide and confer on a case.
The best pathology networks incorporate workflow
functionality that facilitates consultation and collaboration, such as the ability to seamlessly integrate a
full pathology report into the pathology LIS or patient
medical record.
Participating pathologists can receive consultation
requests from anywhere in the world via a secure
website where they can view, accept or decline specific requests. Detailed case information is submitted
along with digital whole slide images, with the ability
to annotate slide regions of interest. Requestors are
notified via email when consults are completed.
Pathologists can also use pathology networks to view and access
digital slides for tumor board presentations, educational purposes,
research and decision support or to collaborate with other pathologists on mutual cases and slides of interest.
Increasing the Reach
The U.S. has both the highest number of pathologists per capita
as well as the best trained and most skilled pathologists in the
world. Yet countries like China and Russia are struggling to provide pathology services for their citizens, especially for patients
with highly complex cases. A digital pathology network provides
access to sub-specialty pathology expertise from leading institutions in the U.S. and around the world to provide timely, accurate
and often life-saving diagnoses.
Case in point: When the big earthquake struck Haiti, destroying
the country’s only pathology laboratory, pathologists in the U.S.
were able to access a leading cloud-based digital pathology network to immediately diagnose patient cases in Haiti, even from a
plane at 35,000 feet.
Empowering Science
with Color Integrity
g y
Datacolor CHROMACAL™
standardizes color reproducƟon
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CHROMACAL uses a proprietary
color calibraƟon slide with imagee
and monitor calibraƟon soŌware to deliver
a consistent, reliable basis for evaluaƟon,
communicaƟon, quanƟcaƟon, documentaƟon
and publicaƟon.
Learn more
at www.chromacal.com,
or visit us at USCAP 2014,
booth #308.
7
PATHOLOGY
Pathology networks also connect the world’s pathologists
using social media tools, making it an ideal forum for pathologists to create professional connections, post information,
share cases, ask questions, follow interesting cases and expand
working relationships.
With zero up-front capital expenOnline
diture, some pathology networks can
For related
be accessed for free and enable the
content, enter
transmission and sharing of digitized
“Perspectives in
slide images in the cloud. Fortunately,
Pathology” in the
the networks are designed to be scankeyword search
ner- and viewer-agnostic to support all
box at www.
pathology users regardless of location or
advanceweb.
consulting institution.
com/laboratory.
Improved Efficiency and Costs
One of the primary benefits of cloud-based pathology networks
is the ability to connect with the right pathologist quickly and
efficiently across campus or around the world, significantly
reducing the wait time for results, and ensuring a faster turnaround of a secondary consult to facilitate rapid and accurate
patient treatment.
Healthcare providers in remote locations can share slide images
and consult with pathologists in real-time, rather than wait days or
weeks for slides to be sent by mail. Small rural hospitals and other
geographically challenged healthcare providers without access to
pathology expertise benefit by having access to a virtual pathologist
when and where they need it, obtaining the same level of pathology
expertise found in any major city.
The costs typically associated with having to ship glass pathology slides for a consultation are completely eliminated, as are
the risks of slide breakage. Pathologists no longer have to incur
the expense of travel to remote sites to provide much needed
pathology expertise.
Pathology networks offer an efficient and cost-effective solution to interact meaningfully with pathology users worldwide to
obtain expertise, enhance patient care, and meet the challenges
of modern day pathology. n
Bill Taylor is chief marketing offer at XIFIN, Inc.
If you would like to write for us contact lnace@advanceweb.com .
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REGULATORY ISSUES
LABORATORIANS’ GUIDE TO HEALTHCARE REFORM
How Labs Drive
ACO Success
By Jonathon Northover, JD, BVC (ICSL);
and James Carson, PhD, MBA, MLS (ASCP)
ealthcare is evolving faster now than ever in
response to a number of powerful forces. These
include HITECH, meaningful use, big data, decreasing
costs and increasing availability of personalized medicine, and EMR adoption. However, most significant is
the creation of Accountable Care Organizations (ACOs)
under the Affordable Care Act, and the significant shift,
practically and culturally, from volume to value.
If the financial outcome under the fee-for-service
model keeps patients in the hospital, they will be kept out
under the ACO model. While ACOs do not remove fees for
services, they do create savings incentives to motivate volunteer organizations to meet specific quality benchmarks
that demonstrate that they have saved healthcare dollars,
and ultimately improved patient care.
One problem, however, is that while volume is easy
to measure (the more you do, the more you get paid),
proving value with quality metrics is more difficult. And
when trying to predict outcomes (e.g., keeping patients
out of the hospital) the difficulty only increases.
The key to the laboratory fulfilling its potential and
enabling the ACO to fulfill its potential, lies in understanding how to interpret and apply its data in a strategically meaningful way.
Test Ordering Guidance
The test ordering process is one initial area upon which
the laboratory can have a significant impact. Under
the ACO model, we must unite a disparate network of
physicians on the one hand, and the need for first-time
accuracy of testing and rapid turnaround time on the
other. With rapidly expanding test menus, particularly
in molecular diagnostics, it is unrealistic for physicians
to know all of the recommended ordering practices.
Inevitably, the ordering of old tests when new ones are
available, the ordering of new tests to a panel without
replacing one in that panel or the ordering of tests useful for research but not necessarily in diagnosis, are all
risks to ACO success.
Just as pharmacists influence physicians' drug ordering, the lab can make a difference in test ordering to
pre-empt such potential issues. One uncommon method
is to create a lab test formulary. When offered tests are presented
to the physician as formulary products, some may require pathology review, some infectious disease review and even for some chief
medical officer review, before being approved. Such an approach
also aligns well with broader industry efforts such as the American Board of Internal Medicine’s ‘Choose Wisely’ campaign that
focuses on encouraging stakeholders to address tests and procedures that may be unnecessary. Even without required review steps,
the formulary offers “thought” guidance and directed assistance
when needed.
Another method is to ensure that the lab is supported with business intelligence tools that alert the ACO, for example, to “outlier”
physician practices that are ordering large numbers of CBCs, of
which a high average proportion are normal. The ACO can then
carry out a root cause analysis to reduce the u
nnecessary ordering,
which is not only relevant to the lab and its health system, but payers also want this information, as do the physicians themselves.
Business intelligence (BI) tools also enable the calculation of cost
per diagnosis as opposed to the cost per test–inextricably linked to
value, not volume, in synchronization with ACO goals. Test ordering
variation reduction can also be pursued by reviewing ordering
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REGULATORY ISSUES
pattern costs compared to patient outcomes. Taking the BI
thought a step further, with the right data integration and creation of industry best practices for test ordering, the laboratory
can provide benchmarking to the ACO that can be extremely
valuable for its purpose.
Admissions and Discharges
As part of the Affordable Care Act, reimbursements are cut
under a cost containment rule if patients are re-admitted within
30 days of being discharged, when national averages for certain
conditions are considered. While cutting the readmission rate
can be beyond the control of the hospital when managing very
sick patients, there are circumstances in which the laboratory
can contribute to a readmission reduction.
On the admission side, protocols can be developed based
on the patient’s anticipated diagnosis that help distinguish
a more accurate determination of whether they need to be
admitted in the first place; and outpatient testing can provide data to support the decision as to whether ambulatory or
inpatient treatment is best. On the discharge side, a battery
of tests can be run following treatment to determine whether
they really should be discharged. The laboratory is in a strong
position to support the key strategy of lower readmission rates
for aspiring ACOs.
Pharmacy
In certain cases, that are only set to increase, laboratory data
from molecular and related testing can guide the appropriate
choice of medication to prescribe and administer to the patient.
Perhaps the biggest challenge, and opportunity, in an ACO environment is the ability of the health system to stitch together
disparate data sets, ensure standardization and share that data
with all interested parties. However, assuming this interoperability challenge can be overcome, the potential impact on bringing down the massive costs relating to wrongly prescribed medicine could be significant, and the laboratory extends its reach
on behalf of the ACO even further. n
Jonathon Northover is a product manager at Sunquest Information Systems, headquartered in Tucson, Arizona. Dr. Carson
is a consultant, founder and senior partner with Adept Clinical Consultants Team in Spokane, Washington, and chief business and strategic officer with GoPath Laboratories in Buffalo
Grove, Illinois.
Online
This is the conclusion of our 4-part series. To
review all the articles in this series, enter “Laboratorians’ Guide to Healthcare Reform” in the keyword
search box at www.advanceweb.com/laboratory.
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V I S I T U S AT H I M S S 2 0 1 4 , B O O T H # 4 4 4 7
11
COVER STORY
n recent years integrated
laboratory information systems (LIS) offered as part
of an integrated enterprisewide solution have gained traction in hospitals, often replacing
a more traditional “best-ofbreed” LIS. Enterprise-wide
systems (EWS) typically claim
to offer integrated solutions
while “best-of-breed” LIS must
be interfaced with other hospital
information systems.
Defining,
Understanding Terms
To contrast the alternatives,
these are some definitions for
integration and interface:
Integration (from the Latin
integer, meaning whole or
entire) generally means combining parts so that they work
together or form a whole. In
information technology, there
are several common usages:
1) Integration during product
development is a process in
which components or subsystems are combined and
problems in their interactions are addressed; 2) The
application modules were
all designed together at the
same time with a unifying
purpose and/or architecture;
3) The application modules
share a common operating
system, programming language and database.
Interface means: 1) software and hardware that logically interconnects two computers or different application
modules and allows them to
interoperate; 2) The device or
component that serves to physically and logically interconnect
other devices or systems and
enables their interoperation; 3)
The actual connection between
application modules or hardware devices that facilitates
12
the exchange of data so that
they can communicate or work
together effectively.
The key difference is that
with integration, the various
modules are homogeneous in
architecture, e.g., share common operating system, database and programming language; whereas, for interfaces
they are usually heterogeneous
and differ in software archi-
tecture. Either can, if properly
done, provide interoperability
within the LIS.
Enterprise-wide Systems
Today many hospitals are moving to enterprise-wide infor-
mation systems (EWS). In that
transition, laboratories are often
being asked to replace their
existing “best-of-breed” LIS
with the LIS offered by the EWS
vendor. Typically, the change is
being driven by the C-suite who
envision an EWS as a benefit
both operationally and financially to the hospital at-large.
In such cases, laboratory man-
agement must consider the
impact of such a change on lab-
oratory operations. What will be
the benefits to the hospital and
the laboratory and what are the
drawbacks in changing from a
best-of-breed LIS to an LIS that
is part of an EWS?
The figure “Polar Extremes of
System Integration” humorously
depicts the differing viewpoints.
The various individual hospital departments, including the
laboratory, see each specific
breed as ideally suited to their
needs. On the other hand, the
C-suite envisions a single breed
as being the best option to meet
the hospital’s goals.
LIS
Integration –
Enterprise-Wide LIS
MATTHEW TARABORRELLI
S
Table: Key Characteristics
INTEGRATION
VS.
INTERFACING
CRITICAL CONSIDERATIONS ARE IDENTIFIED
BY DENNIS WINSTEN
Interfacing “Best-of-Breed” LIS
• Strong C-Suite commitment
• Strong Laboratory commitment
• No interfaces required
between the laboratory module
and other integrated modules of
the EWS. All modules share
a common database.
• Interface connectivity required
to other system modules
including EMR, CPOE and
clinical and/or financial modules
used by the hospital.
• Some EWS may not support
connectivity to HIS, CPOE, EMR
other than their own, which may
impact future hospital system
consolidations and/or acquisitions as well as limiting aspects
of lab outreach business.
• Most “Best-of-Breed”
LIS can be interfaced to other
“foreign” HIS/CPOE/EMR if
necessary to support laboratory
outreach business.
• Some EWS may place more
emphasis on less complex
laboratory services and
on a more limited scope of
outreach services
• Typically, most place more
emphasis on complex laboratory
services, e.g., molecular diagnostics, cytogenetics, and newer
technologies as well as broader
scope of outreach services.
• High level of “true”
integration across all EWS
system components
• Proven interfaces to existing
or planned enterprise
information systems
• Single sign-on and common
“look and feel” across integrated
EWS module.
• May require multiple sign-ons
and “look and feel” may be different between LIS and other
system components.
• Common, composite
view of clinical data across
multiple departments possible
for caregivers
• Caregivers may only be able
to view separately each department’s data and not a composite
of related clinical data.
• “Expert rules” can be applied
across multiple modules.
• “Expert rules” can be applied
only for laboratory data.
• Changes to any system component, if applicable, are automatically reflected for LIS.
• Changes to other system components may not affect LIS as long
as interface remains unchanged.
• Monolithic integrated structure; the hospital cannot easily
replace any EWS module.
• Multi-entity, interfaced structure.
Independent, interfaced modules
can be replaced but with new
interfaces required for the new
modules.
• Data nomenclature is standard
throughout the EWS.
• Data nomenclature will vary
between the LIS and other
system components
• All required data files exist in
single, common database used
by all EWS module.
• Data files exist both in the LIS
and other systems and must be
synchronized to assure that all
are consistent and up-to-date.
• Hospital IT department
expertise required only for
a single operating system
and database.
• Hospital IT department
expertise may be required for
a multiple different operating
systems and databases.
• Probable lower cost if
“bundled” with EMR and other
enterprise applications
• Possible better ROI if
demonstrable benefits for
laboratory operations.
13
COVER STORY
Overall Benefits
The most significant potential benefit of enterprise-wide information systems is the ability to
provide true integration of all clinical components, including lab data. Billing and accounts
receivable and some financial services may
True integration will provide
a single, unified database
in which all clinical and
financial information resides.
also be integrated into a single system. Such
integration can offer caregivers more comprehensive views of patient data, incorporating
data from multiple clinical sources. Further,
since only one vendor is the overall system
provider, instances of “finger-pointing” when
problems occur are diminished or eliminated.
However, many claim that best-of-breed
LISs offer enhanced functions and features
that optimize laboratory operations, better
support outreach and reduce labor costs. The
optimal choice of enterprise-wide LIS solution
or best-of-breed LIS requires careful consideration of the overall positives and negatives,
as they affect both the enterprise and future
laboratory operations. Doing this requires an
impartial, unbiased, evidence-based analysis
of the pros and cons of each alternative from
the laboratory’s perspective and the impact
on service levels, quality, productivity, staffing, revenue, functional gaps, automation line
connectivity and patient safety.
Identifying Differences
How does integration differ from interfacing
and are the differences important? Traditionally, interfacing has been used to interconnect
the LIS to disparate information systems,
including HIS, EMRs, billing systems and
so forth. Interfacing does work but has some
intrinsic issues, including the ongoing need to
ensure that the interfaced systems maintain
consistent and synchronized files, e.g., doctor
files, test codes, etc. Changes in either system
must be reflected in both. Further, downtimes
in either system require re-synchronization
after recovery. Maintenance of the interface
can be a chore.
True integration will provide a single,
unified database in which all clinical and
financial information resides. Reports and
displays of information to authorized users
can combine elements from multiple modules and provide a more complete picture of
patient diagnostic and therapeutic status.
However, laboratories need to assess
whether a best-of-breed LIS provides superior functionality to justify its selection compared to the function and features offered by
the “bundled” enterprise-wide LIS.
Key characteristics of integrated enterprise-wide solutions compared to interfaced best-of-breed LIS are identified in
the Table.
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15
COVER STORY
Things to Consider
In line w ith the new Meaningful Use
requirements, the drive for interoperability,
and the standardization of communication
protocols between systems, the need for one
system to achieve interoperability becomes
less of an issue. As we all conform to interoperability standards and systems are able
to “talk” to each other, the focus becomes
on meeting the specific needs of a department, while simultaneously enhancing their
efforts to increase efficiency of the overall
organization. As we move forward, the convergence of data from each department into
useful analytics and business intelligence
for the administrators of a healthcare organization becomes paramount to reducing
cost. The LIS has to be able to analyze to
a discrete level all data possible to ensure
cost effectiveness. This can include testing
algorithms, ordering patterns, and assisting with patient treatment plans—designed
with the data from the laboratory.
A best-of-breed solution is probably better
suited to large academic research facilities,
independent reference and specialty labs,
facilities with large outreach programs, and
community hospitals that require functionality to improve the efficiency of their labs.
By the same token, many small community
hospitals may benefit from the functionality
offered by a best-of-breed solution, but may
lack the staff and/or expertise to implement
and maintain a best-of-breed solution.
In any case, the optimal choice of an integrated enterprise-wide LIS solution or an
interfaced best-of-breed LIS requires careful consideration of the overall positives and
negatives, as they affect both the enterprise
and future laboratory operations.
This is a complex analysis involving determining the true overall costs of system implementation and operations, impacts on access
to clinical information by caregivers, efficiency
Online
For other information systems
articles written by ADVANCE
editorial advisory board member
Dennis Winsten, enter his name in
the keyword search box at www.
advanceweb.com/laboratory.
of operations and impact on laboratory outreach revenue and business growth. n
Dennis Winsten is president of Dennis Winsten & Associates, Inc. (DWA), a healthcare
systems consulting firm specializing in laboratory information systems with headquarters in Tucson, Arizona (www.dwinsten.com,
dwinsten@msn.com). An ADVANCE editorial
advisory board member, he has more than
30 years’ computer experience, including
over 25 years in healthcare systems.
+(;/DERUDWRU\6\VWHPV
16
LIS
IS YOUR LIS
INSPECTION
READY?
Understanding what’s expected
and utilizing key resources will
help your LIS be prepared
By Hal Weiner and Dennis Winsten
JEFFERY LEESER
Table: Valuable Resources - The following links can provide more detailed information from each
agency or organization regarding their standards and/or criteria for laboratory information systems
Resource
URL
Meaningful Use Standards
http://www.cdc.gov/ehrmeaningfuluse/elr.html
FDA Guidance
http://www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatoryInformation/
ComplianceActivities/Enforcement/
CompliancePrograms
CAP Checklists and
Inspection Criteria
http://www.cap.org/apps/cap.portal?_
nfpb=true&_pageLabel=accreditation
An Overview of Current
HIPPA Requirements
http://www.hhs.gov/ocr/privacy/hipaa/
understanding/srsummary.html
CLMA Body of Knowledge
http://www.clma.org/store/
ViewProduct.aspx?id=1665981
The Joint Commission Laboratory
Accreditation Documentation
http://www.jointcommission.org/
accreditation/laboratory.aspx
Current CMS/CLIA Regulations
and Guidance, Including Electronic
Exchange of Laboratory Information
http://www.cms.gov/Regulations-andGuidance/Legislation/CLIA/index.html
AABB Members Can Download
Checklists and Audit Tools
http://www.aabb.org/searchcenter/pages/
results.aspx?k=audit%20checklist
Information About the ISO 15189
A2LA Accreditation Program
http://www.a2la.org/medical/medical.cfm
number of criteria have
been published to help
ensure that your LIS
and LIS operations meet modern
standards of performance, operability
and security.
Many agencies may be inspecting your
laboratory—federal, state and professional
organizations—each of which have their
own criteria. In addition, organizations such
as CLSI publish performance standards
that can be utilized to assist laboratories in
maintaining best practices.
Sources and documents are available
to assist the laboratory in creating its
own preparation processes, including The
College of American Pathologists (CAP)
Checklist, CLIA/CMS Guidelines, HIPAA
Technical Security rules and the CLMA
Body of Knowledge (BOK) Information
Management and Technology domain. This
article is not intended to be comprehensive;
rather, it provides some useful references
for laboratory directors and/or LIS managers who wish to assure that their LIS is in
compliance with existing rules, guidelines
and standards.
Critical Components
The most important components of being
ready for an inspection are:
1. Know all of the organizations that may be
inspecting your laboratory.
2. Know the current and pending criteria
17
LIS
and be constantly prepared.
3. Document all processes, procedures and
results of validations.
4. Create your own checklists that are easy
to use and are part of your daily operation.
5. Appoint individuals who are responsible
for specific checklist items and keep upto-date on current requirements.
6. Provide continuing education to your laboratory staff on inspection readiness.
7. Create internal inspection verification
protocols with cross-section interactions,
including mini-audits.
Meaningful Use Criteria
In addition to all of the other inspection
and accreditation requirements, the Office
for the National Coordinator for Health
Information Technology has published a
series of Meaningful Use Criteria for Health
Information Systems, including Laboratory
Information Systems. The specific sections
Numerous resources are available to help
you keep your laboratory at inspection readiness. Incorporating and maintaining these
“standards” and employee expectations into
your daily operations will require an effort
on the part of all participants, but will be a
valuable investment when you fly through
your next inspection. n
Online
Interested in even more LIS content? Be sure to review our archived
IT webinars or related information
systems content at www.advance
web.com/laboratory.
of the 2014 Criteria that may affect your
LIS include:
1. 170.314(b)(6) Inpatient setting only—transmission of electronic laboratory tests
2. 170.314(f)(4) Inpatient setting only—transmission of reportable laboratory tests
3. 170.314(b)(5) Incorporate laboratory tests
and values/results
4. 170.314(g)(1) Automated numerator
recording
5. 170.314(d)(7) End-user device encryption
6. 170.314(g)(4) Quality management system
ARE YOU
INSPECTION READY,
EVERYDAY ?
Hal Weiner is president of Weiner Consulting Services, LLC located in Eugene, Oregon. (www.weinerconsulting.com). Dennis
Winsten is president of Dennis Winsten
& Associates, Inc. (DWA) a healthcare
systems consulting firm specializing in
laboratory information systems with
headquarters in Tucson, Arizona (www.
dwinsten.com, dwinsten@msn.com). An
ADVANCE editorial advisory board member, he has more than 35 years’ computer experience, including over 30 years in
healthcare systems.
• CAP/TJC Readiness Dashboard
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18
10
WAYS
InformAtIon SoftWAre from
SCC Soft Computer WIll help You
SkAte through Your lAb’S WorkfloW.
2. Safety
Patient identification mistakes can be deadly. SCC’s
SoftID® can help you prevent dangerous medical errors
by providing effective, error-free patient and specimen
identification at the point of care.
3. Automation
SCC’s LIS solutions support streamlined operations
that focus medical technologists on only those
functions that require direct attention. Improve
workflow, increase productivity, maximize
revenue, and transform your lab from a cost
center to a profit center.
1. Flexibility
The flexibility of
SCC’s LIS will turbocharge your lab.
You’ll get faster,
more comprehensive
management reports,
easier data search
and retrieval, and
enhanced quality
assurance, regardless
of the size of your
caseload. Your
laboratory will skate
through mountains of
data in nothing flat.
4.
5.
Having all laboratory
departments operating in an integrated
environment, on
a single database,
and with a highly
automated LIS,
delivers a value far
beyond what
HIS/EMR vendors
can offer.
Built upon SCC’s
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Genetics Information
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platform, this
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Genetics provides
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8. Longevity and
Stability
For 35 years, we
have continuously
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our systems—without
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ensure that the SCC
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today will be a viable
solution for the future.
6.
7.
Blood
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SCC’s award winning
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provides a wide
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These laboratory
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when combined
with SCC’s core
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genetics modules,
will enable you to
maximize revenue
while improving
patient care.
10. Speed
9. Dedication to R&D
SCC’s focus is on developing
products that enable our
clients to compete in the highly
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SCC clients can realize a
significant ROI simply by
implementing the features in
SCC’s powerful software modules, which can improve
workflow, increase productivity, and maximize revenue,
transforming their operations from cost centers to profit
centers for their organizations.
Time is critical when it comes to clinical
diagnostics. SCC’s feature-rich laboratory
and genetics information management
systems provide intuitive, distinctive, and
comprehensive workflow and management
tools designed to improve turnaround time.
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19
LAB REVENUE
LAB AS A REVENUE CENTER
The laboratory’s role in increasing profitability in the
new age of healthcare is explored
By Dondapati Chowdary, MBA, PhD
Partnering for Profit
With such a dynamically changing landscape, the clinical laboratory doesn’t need to be a cost center. In fact, there are several
opportunities that can increase its profitability. With the right
configurable solutions and technologies, laboratories can become
extremely efficient — thereby reducing waste and resulting in
actual profit generation.
As pressures increase with the rollout of PPACA, smaller laboratories are exploring ways to find partnerships. By leveraging the opportunity and bridging the gap in the services they can provide, many
medical centers and some private laboratories are positioning outreach programs for test consolidation. According to a report from
Chi Solutions , about 80% of hospital clinical labs have an outreach
program. This segment of outreach clinical laboratory collaborations
is continuing to grow, helping smaller labs realize the gains from
20
SCOTT FRYMOYER
s it becomes increasingly more important
for clinical laboratories to position their
services for inclusion in accountable care
organizations (ACOs) or coordinated-care models,
laboratories are tasked with assessing every process in their workflow to eliminate waste, minimize
variation and reduce costs. Standardizing processes greatly improves the quality of laboratory
measurements and also ensures laboratories across
the healthcare network are producing credible and
comparable data – resulting in the reduction of inefficiencies, errors, duplications and delays that contribute to unnecessary expenditures.
With the rollout of the Patient Protection and
Affordable Care Act (PPACA), the changing requirements for Electronic Health Records (EHR), and
reduced reimbursements, healthcare systems are integrating at a faster pace, resulting in the formation of
integrated delivery networks (IDNs). To deliver better
health outcomes and enhance the patient experience,
the IDNs are further exploring ways to deliver services across the continuum of care by interconnecting
acute care and non-acute care systems. To accomplish
these goals, standardization becomes critical in delivering consistent clinical results across these networks,
since about 70% of the clinical decisions and treatment options rely on clinical laboratory tests.
economies of scale. Once operationally efficient, these laboratory services have shown
to provide high visibility within the hospital
as a function that brings in a lot of value —
revenue dollars, recruiting talented staff and
also becoming investment vehicles for venture capitalists. Several labs, including those
within IDNs, are reaching out to labs within
communities to provide services to enable
their efficiency while still m
aintaining
SPEED FORWARD
PERFORMANCE FORWARD
LAB FORWARD
Your lab is the foundation of patient care
and we’ll never stop partnering with you to
move it forward.
Beckman Coulter has always been uniquely committed to
advancing and optimizing your lab.
We share your commitment to providing uncompromising service
to physicians and patients.
That’s why we remain focused on innovative and reliable
solutions to improve your lab performance.
Move your lab forward with Beckman Coulter.
www.beckmancoulter.com
©Copyright 2013 Beckman Coulter, Inc. Beckman Coulter and the stylized logo are trademarks of Beckman Coulter, Inc. and are registered with the USPTO.
21
LAB REVENUE
By standardizing laboratory processes,
systems and practices across an IDN,
clinical laboratories can reduce errors as
well as the time and cost associated with
managing variability and, in the end, achieve
operational efficiency.
required quality of
results. A s reimbursement drops,
labs have to look at productivity and push for
more outreach, expanding to smaller hospital
markets, clinics and even expanding beyond
the lab’s typical markets.
Technology for Best Performance
As test volumes and demands increase in
the clinical lab setting, making the right
instrument decisions can make all the difference in the lab’s profitability. Automation continues to evolve and today’s labs
are increasingly turning to more advanced
instrumentation to drive efficiency, reduce
errors and absorb higher workloads with
better resource allocation — all ultimately
increasing profitability. Time-consuming
manual steps can be virtually eliminated for
the technician, leading to better turnaround
time, more capacity and higher productivity,
allowing them meet the rising test volumes.
Automation with flexible options and innovative technologies enable labs to integrate
analyzers that are the best fit for their current workflow requirements, while offering
the ability to expand their analytical capacity in the future. IDN systems benefit from
continuous investment in technologies that
automate, consolidate and accelerate the
delivery of results.
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22
Laboratories can benefit from automation solutions that can bring efficiencies to
the entire lab — from chemistry and immunochemistry to hematology and urinalysis.
Today’s automation solutions offer clinical
labs the ability to attain a true total automation system that has the speed and capacity
to handle all testing types in one platform
with a single point of entry, without compromising the turnaround time of any of the disciplines, ensuring consistent speed of movement throughout the testing process to get
test results to physicians faster.
Ultimately, automation can help decrease
turnaround time and process more samples using fewer resources, allowing labs to
deliver accurate results in a timely fashion
so that physicians can make the best clinical
decisions for patients.
Additionally, by incorporating Lean
processes to remove unnecessary steps in
workflow, laboratories can save time and help
IDNs achieve the lowest total cost of ownership. Through partnerships with the right laboratory vendor, labs can deliver value-based
care that enables them to partner across the
entire IDN and ultimately provide the best
possible patient health outcomes.
Standardization a Key Driver of Efficiency
By standardizing laboratory processes, systems and practices across an IDN, clinical
laboratories can reduce errors as well as the
time and cost associated with managing variability and, in the end, achieve operational
efficiency. The clinical lab can decrease the
margin of human error and increase the
quality of results by simply standardizing the
decision-making processes through implementation of clinical laboratory information
systems and by using systems that enable
standardization. Data management systems
can help clinical labs determine the cost of
errors caused by sub-optimal work practices and can help minimize opportunities
for loss of reimbursement. By tracking both
the workflow and the outcomes, the clinical
lab can begin to see a decrease in work duplication, inefficient use of resources that lead
to erroneous clinical decisions.
Seamless integration and f lexibility
of innovative IT solutions can help drive
LAB REVENUE
future demands and growth opportunities.
By standardizing decision rules across the
organization, the entire institution gains
peace of mind in results reporting and can
benefit from advances in technology — ultimately driving improvements to productivity and quality.
Economic challenges and staff shortages in the laboratory industry leave little
room for underutilization of talented staff.
By implementing automated instrumentation and information systems that can
take over ordering, accessioning and other
pre- and post-analytical testing tasks and
data entry, laboratory personnel are freed
to direct their focus on higher value tasks
— enabling the lab to do more with the
resources they have.
Test Utilization Processes
Many clinical laboratories are embracing test utilization to identify and reduce
r edundant testing to minimize unnecessary tests. In some IDNs, labs are implementing processes where highly specialized
and expensive testing requires approval by a
designated clinical pathologist. Implementing best practices around test utilization can
result in increased efficiency, better care
delivery and reduced costs. Standardizing
systems and processes in the IDN is crucial
in obtaining and delivering common diagnostic results from every lab in the network
so that physicians can interpret the results
the same way for clinical decisions. Standardization and test utilization can result
in overall operational lab efficiency (from
staff recruitment to resource allocation)
that can help reduce waste and contribute
to increased profit margins.
As health economics continue to change,
laboratories can feel confident that there
are a multitude of options they can employ
to assure they contribute to the growth and
profitability of their network. With thoughtful consideration to the right processes, technology and partner, today’s laboratories can
adapt to move from a cost-center to a profit
center — all the while feeling confident they
are delivering high-quality results to physicians and patients. n
Dr. Chowdary is senior manager, Market
Development, Beckman Coulter.
Online
Be sure to visit our ACO Resource Center often for the most up-to-date content at www.advanceweb.com/laboratoryaco.
ADVANCE MARKS THE SPOT!
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23
THE LEARNING SCOPE
CE OFFERING 0.1 CEU OR 1.0 CONTACT HOURS
ERRORS IN
COAGULATION
TESTING
Analytical and biological considerations
are particularly critical in coagulation
oagulation testing is a basic
staple in the laboratory. From
rapid prothrombin time (PT)
assays in the physician office to screening and monitoring of PT and activated
partial-thromboplastin time (APTT) and
D-dimer in a hospital laboratory to larger
hemostasis and reference laboratories performing more in depth testing, millions of
coagulation tests are done each day. Are we
The Learning Scope
getting reliable, useful results?
Quality assurance requires that assays are examined
ADVANCE and the ASCLS
to assess the pre-analytical, analytical and post-analytical
are pleased to share our Learnfactors that may or may not affect a test. Many assays also
ing Scope continuing education
have biological considerations regarding time of draw and
opportunity. To read the other
individual variability. While these factors are important
articles in this CE series, Errors
considerations for all testing, they are particularly imporGet the free mobile
app for your phone Testing, and complete the Q&A
in Coagulation
http:/ / gettag.mobi
tant for coagulation testing. Let’s examine why.
for ASCLS PACE credit, visit http://laboratory-
manager.advanceweb.com/ce/learning/
Pre-Analytical Variables
learningscope.aspx CEUs or snap the tag above.
In coagulation testing, pre-analytic variables range from
the simple to the complex. Each variable is important.
First is patient identification. Each facility has standard measures in risk for hemolyzing the specimen.
place for correctly identifying the person from whom blood is drawn.
The preferred anticoagulant is always
Typically, identification is accomplished with two identifiers, often the sodium citrate and the recommended conpatient name and birthdate or medical record number. The most impor- centration is 3.2% with a whole blood to antitant point in this variable is to have the patient speak their name and coagulant ratio of 9:1. This ratio prevents
birthday while the phlebotomist is checking the armband. If the patient partially filled tubes from being accepted
is unable to respond, someone needs to verify the identity of the patient. for testing. The volume of the tube should be
Often family members with the patient can assist in this measure.
at least 90% or results can be compromised
The order of the draw is a common topic and has changed over due to excess anticoagulant.
the years. Sodium citrate tubes should be drawn first and no waste
Whenever possible, blood should be from
tube is necessary. However, if the collector is using a butterfly nee- a stick that was non-traumatic. A t raumatic
dle, a waste tube should be collected. If the blood is collected in a stick, meaning the phlebotomist had to “probe
syringe and transferred to a sodium citrate tube, the blood should around” searching for the vein, will compronever be forced or “squirted” into the tube. This will cause plate- mise results, as will leaving the tourniquet
let and coagulation activation. Many hospitals and offices prefer on longer than one minute. Needle size is
coagulation studies not be drawn in a syringe due to the increased important and needles less than 25 gauge
24
ADVANCE / MATTHEW TATABORRELLI
By Kim Ledingham, MT(AMT), MLT(ASCP)
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THE LEARNING SCOPE
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26
should be used. Specimens that are hemolyzed, icteric or turbid will
produce invalid results in an optical measurement system. Samples
should be gently inverted 3-6 times to ensure proper mixing of the
blood and anticoagulant. “Gently” is the operative word since vigorous
mixing might lead to hemolysis or platelet activation.
In the hospital setting, specimens are often collected from central
venous lines. These specimens can lead to partially clotted, clotted,
hemolyzed or activated samples. Another great risk with central lines
is the likelihood of heparin contamination. Specimen collection from
central lines always includes a process for flushing the line and discarding enough blood to protect against said contamination.
Another important pre-analytic consideration is the time until testing is completed. Samples for coagulation tests should be returned to
the laboratory as quickly as possible. Some experts say as soon as 1
hour from time of collection, but it is important that the PT and APTT
be tested within 4 hours of collection. A PT is stable for analysis for
up to 24 hours at room temperature, but the APTT should not be run
after four hours of collection.
Sample Processing and Storage
Sample processing and storage are also important when performing
coagulation studies. Not all tests are run in all laboratories and care
should be taken to provide the reference laboratory with the best
sample possible. Most of the common studies, such as PT, APTT and
clotting factor assays, are performed on samples that have been centrifuged once. However, lupus anticoagulant assays are performed
on samples that have been centrifuged twice prior to freezing to provide the laboratory with platelet-poor plasma. Centrifuge coagulation
tubes at less than 1500g for 10-15 minutes to prevent platelet activation. Once separated, plasma should be frozen. Frozen samples at
-20°C are stable up to 4 weeks.
Issues that arise from testing usually stem from the pre-analytical
phase of the sample. While instruments are often equipped with clot
sensors, any prolonged clotting time should cause one to investigate the
sample itself. The sample should be inverted and examined visually for
obvious clots. If none are seen, insert two wooden applicator sticks to
check for clots. Clotted samples are rejected. Other common pre-analytic causes for prolonged clotting times are the presence of EDTA in
the sample or heparin contamination. As previously stated, hemolysis,
badly processed samples, and lipemia will affect coagulation results.
Additionally, specimens with hematocrits over 55% will give errant
results because of the improper ratio of anticoagulant to sample.
Time of day is an overlooked factor in coagulation testing. Some components follow circadian rhythm and results will vary at different times
of the day. It is important that coagulation studies are drawn the same
approximate time each day. Fibrinogen levels are higher in the morning.
Patients who have experienced a clotting event, such as a venous
thrombosis or pulmonary embolism, will lose (due to consumption)
some of the natural anticoagulants; therefore, care should be taken
in determining the presence of a deficiency too quickly. n
Kim Ledingham is a medical technologist and freelance writer.
MEANINGFUL USE
PATHOLOGY & MEANINGFUL USE
Completing the information circle is critical
TOM WHALEN
By Michael Jones
he implementation of Meaningful Use has already had a substantial impact on healthcare facilities,
an impact which only stands to grow as
facilities integrate Meaningful Use (MU)
Phase 2. For pathologists and pathology
practices, the effect of the switch has been
focused on clinical testing and diagnostics. The improved testing combined with
MU standards and the introduction of
electronic health records (EHRs) has led to
an improved way of looking at “the whole
patient” – seeing all the information rather
than the results of a single test.
In a recent interview with ADVANCE,
Lisa-Jean Clifford, CEO of Psyche Systems
Corporation, discussed the influence of MU
on pathologists in healthcare facilities across
the country. Her company provides LIS
solutions for clinical, molecular, microbiology and anatomic pathology facilities, also
offering connectivity extension modules for
LIS systems across the board. In the case of
healthcare systems incorporating EHR and
MU, Clifford pointed out that standardization is essential in terms of the communication of patient information, especially for
pathologists in those facilities.
“I think that it’s going to provide more standardization and has the potential, if implemented correctly and consistently across
organizations and full healthcare facilities, to
improve patients’ outcomes and patient care,”
she explained.
One area of standardization stressed by
Clifford was the portability of available patient
information within a system. The concept of
an electronic footprint of patient information
throughout their continuum of care, allowing
physicians the ability to access that information as necessary regardless of their location,
could re-shape the way health facilities operate both independently as well as with other
facilities within a system. This is especially
important in making sure all aspects of
Online
Want to learn more about how Meaningful Use impacts your laboratory? Enter
“Meaningful Use” in the keyword search box at www.advanceweb.com/laboratory.
27
MEANINGFUL USE
a patient’s health are being considered, rather than simply relying on
the results of a singular test.
While standardization is beneficial overall, some portions of
integration are more applicable to one area of a health system than
another. In laboratories, for example, standards require SNOMED
coding capabilities even though these are not typically utilized in
practice, making the obligation largely unnecessary. As facilities and
health systems integrate different systems and try to interface technology, on the other hand, standardization is key. The connectivity
provided by MU and EHR systems allows physicians and clinicians
to study the patient and population to determine the best possible
course of action.
“I think having a standard format and standard interfacing connectivity protocols will certainly enhance or ensure that all disparate
systems will be able to provide consistent information in a consistent
manor,” continued Clifford. “So that, regardless of the vendor or the
platform from an IT or an HIT perspective, the patient information
will be the same.”
Part of the reason for the unnecessary criteria in certain areas of
healthcare is what Clifford views as somewhat excessive government
regulation. As facilities and healthcare system are adjusting and preparing to go through the 2014 phase certification, the industry requires
standardization in the overall scheme, but not quite as much when
it comes down to specific areas such as certain testing options in the
laboratory. She also noted that, although information should be carried via a transmittable data source that ties back to a patient, some
of that information would not be relevant during the laboratory portion
of their testing or diagnostic process.
“I think the issue is more the government trying to over-standardize
and not really employing people who truly understand the nuances of
the different areas of healthcare, or not being able to separate out what
is truly applicable in specific areas of healthcare,” said Clifford, discussing some obstacles as healthcare organizations continue to implement
MU across the country.
Another interesting point discussed during the interview was
the idea of a universal system of standardization throughout MU.
Additional Reading
Meaningful Use has an impact across the
clinical laboratory, and we’ve been covering this
extensively to keep you on the cutting edge.
Go to www.advanceweb.com/laboratory and
enter “Meaningful Use” for articles on:
Big Data for Small
Communities
How Geo-personalized care for
infectious disease management is
catching on
A Dying Breed?
In recent years LIS offered as part of
an enterprise-wide solution have gained
traction in hospitals
Information Systems: Managing
‘Uncertainty’ in the AP Lab
The right laboratory information system can help
leverage staff time and alter business processes
EMR & Lab Compatibility
Does your lab have a technology gap?
Laboratorians’ Guide to
Regulatory Change
Lab-based MU objectives
28
MEANINGFUL USE
ccording to Clifford, making the system comA
patible regardless of the equipment will allow
physicians and clinicians to have access not
only to their individual patients, but across a
population of patients as well. This could lead
to the increased ability to compare similar
cases, circumstances and diagnoses to better
patient outcomes. Despite the potential possibilities of more easily interfaced equipment,
an overarching solution like this would require
tremendous cooperation in the industry.
Despite the apparent hurtles, an effort on
behalf of vendors to make sure patient information is available no matter where that
patient is hospitalized could make all the difference in efficiency. The key comes down to
a more collaborative nature between industry competitors. The more readily different
products and technologies are able to communicate important data, the easier it will be
for physicians and other medical professionals to make accurate diagnoses without having to waste time duplicating tests that may
have already been performed – eventually
leading back to the patient, who can receive
the appropriate care more quickly.
“Some vendors just don’t play well with
each other,” said Clifford. “And, what I’m
hoping that this does is lift that barrier, so
that vendors are most incented and more
likely to work together in a cooperative fashion to make sure that their products are
interfacing seamlessly.”
Clifford went on to discuss the importance
of putting the patient first. Although the business side of things certainly has an impact on
individual facilities, healthcare systems and
the industry as a whole, it’s really about providing the best possible care. She commented
on vendor politics, saying they shouldn’t have
an impact on the information obtained by
clinical laboratories and passed on to pathologists and treating physicians. The more
cooperation the industry sees from its equipment manufacturers in terms of interfacing
between digital tools and solutions, the better the communication of vital information to
those seeking answers.
A pathologist’s ability to access patient
information is directly related to their ability to diagnose based on “the whole patient,”
a concept that Clifford noted as being vital
to delivering a better understanding of an
individual patient and, subsequently, a more
accurate diagnosis.
A s clinical laborator y technologies
improve and MU is implemented in healthcare facilities around the country, that information has never been more readily available
for diagnostic pathologists. The integration
of EHRs continues to better c onnectivity
both within individual hospitals and whole
healthcare systems, but the need for greater
standardization in system interfacing
remains as medical professionals are looking
for better connectivity between the clinical
laboratory and pathology assays, equipment
and instruments. n
Michael Jones is on staff at ADVANCE.
Connecting laboratories
to physicians since 1999
Bringing all the pieces
together for a successful
outreach program
• EMR/EHR Interfaces
• Patient Results Portal
• Electronic Order Entry (CPOE)
• Structured Electronic Results
• Mobile Platforms
• ePrescribing
• Patient Service Centers
• Courier Tracking
• Nursing Homes
• LIS Interfaces
• Accessioning/Billing
• Digital Imaging & Radiology
• PMS Interfaces
Call us today at 888-322-5222 or visit
www.careevolve.com to request a demo
sales@careevolve.com
© 2013 • CareEvolve, Elmwood Park, NJ
• All rights reserved
29
FOCUS ON:
MICROBIOLOGY
Evolution of Methodologies
By Michael Jones
s the technology surrounding
laboratory testing continues to
improve, the impact of automated testing
assays is being seen more in more in
laboratories of all sizes. For microbiologists
in particular, the level of automation is
improving and allowing laboratory professionals to expand their role as laboratories
are able to perform higher quality assays
such as rapid molecular testing options with
faster turnaround times. In a recent
interview with ADVANCE, Theresa Castellone, MT(ASCP), MPH, program director at
Our Lady of Fatima Hospital in Providence,
discussed the evolving methodologies and
increasing role of microbiologists in the
healthcare industry.
The switch to automated systems has
been unprecedented so far and continues
to grow in the healthcare industry.
Laboratories outside of microbiology have
largely been ahead of the curve in regards
to up-to-date technology, but as the role of
molecular testing is growing, so is the need
for better automation in microbiology.
According to Castellone, one of the main
benefits of these systems is the ability to
move microbiologists into areas of the lab
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30
where they can better utilize their skills and
focus on resulting high value work.
“What automation in microbiology is
allowing managers to do — or directors as
well — is free up a technologist to utilize
their strengths outside of something, such
as planting,” said Castellone. “Planting
takes up a lot of time in the microbiology
lab, because that’s where everything
starts, and now what labs are able to do,
as this automation continues to advance,
is free up a technologist to move into an
area that is growing along with automation, which is rapid molecular testing.”
Having originally started her career in the
microbiology/virology laboratory at Rhode
Island Hospital, Castellone spoke to the
advances being made in larger, more
profitable laboratories in regards to
microbiology. She noted the area of planting
and specimen processing as particularly
increasing sources of emerging trends and
technologies. The financial stability afforded
to these larger laboratories has allowed for
more state-of-the-art equipment, such as
automated specimen processors, which
actually plate specimens and put them onto
media for the technologist.
While larger laboratories have the budget
for advanced equipment, Castellone
pointed out companies like Cepheid,
BioFire and Quidel each offer rapid
molecular testing options at affordable
costs that are readily available for smaller
clinical laboratories. As molecular testing
and genetic sequencing options become
more the standard for the industry,
automated equipment allows a laboratory
to improve turnaround times while
adjusting to changing technologies. This
leads to a broad array of testing options in
laboratories with limited budgets, allowing
them to remain competitive in the evolving
healthcare industry testing market.
“Labs are going to have the option to
move from doing strictly conventional
culture — meaning reading media plates
— to being able to perform more
molecular testing at an affordable cost,
allowing labs to offer more testing than
they do now,” continued Castellone.
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2/6/14 2:27 PM
FOCUS ON
sizes, the integration of automated systems
is a welcome introduction, especially in the
cases of both infectious disease testing
and rapid molecular testing, which opens
up the facility’s available testing menu
significantly. These rapid instruments make
training for technologists of all levels more
efficient and allow laboratories to bring in
staff quickly to adjust to changing needs.
The introduction of this new equipment not
only helps with turnaround times, but
benefits the patients affected by results by
allowing providers to more effectively treat
based on quicker data processing.
Just as microbiology laboratories are
changing in the way they operate to adapt
to new developments in equipment, the
role of the microbiologist is also changing.
As Castellone commented, the microbiology field is becoming less hands-on and
more automated as technology improves.
Online
Looking for staff for your busy laboratory? Be sure to check out our job
board for qualified candidates at www.advancehealthcarejobs.com.
Far from a negative consequence, however,
better automation is simply changing the
role of microbiologists to mirror the
evolving field. Rather than focusing a
substantial portion of their time on planting
and specimen processing, automated
technologies are allowing healthcare
professionals to be used in a different
capacity, utilizing the skills they learned in
school to analyze the specimens.
“As a microbiologist, the thing that you
love is the hands-on, the identification of the
bacteria,” explained Castellone. “And, I feel,
as technology continues to advance, it’s
going to allow microbiologists to really utilize
the knowledge and skill sets to a greater
capacity than we have been before in terms
of identification and susceptibility testing,
which is huge in the world of microbiology.”
According to Castellone, the field of
microbiology is experiencing its first major
technological boom toward automation in
roughly 25 years. As microbiology is
gravitating toward more complete automation trends like other fields, such as
chemistry and hematology, equipment is
becoming more readily available for medical
facilities across the spectrum. n
Michael Jones is on staff at ADVANCE.
IMPROVE CARE
AND REDUCE COSTS
EXPLORE THE ACO RESOURCE CENTER FOR THE
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ADVANCE for Laboratory and Beckman Coulter continue
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32
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2/4/14 12:55 PM
FOR THE TECH
Bugs on Scrubs
There’s more to
this article! Snap
this tag with your
smartphone or
Spread of Infection
go to our ‘For the
Healthcare has a dirty little secret. We all
Tech’
section
Get the free mobile
app for
your phoneat www.advance
know we must work diligently to preventhttp:/ / gettag.mobi
web.com/laboratory. While
infections from spreading from patient to
you’re there, be sure to browse
patient, but too often we stop thinking
our healthcare shop for wellabout infection control when our shift is
fitting scrubs at www.advance
over. That’s when a healthcare-acquired
healthcareshop.com.
By Lisa Steinam, PBT(ASCP)
onsider this scenario: It’s flu season
on the south wing. At the same time,
an epidemic of Clostridium difficile patients
has hit the ER. You’ve been drawing blood
from both units all week, but you don’t
mind. You’re in healthcare because you
enjoy helping the sick and injured get
healthy and stay healthy.
Today, the pant legs of your scrubs are
dragging on the floor as they have all
week. They never really fit you, but you’ve
never found the time to hem them. Given
the germs you’ve been working around
lately, and a few you’ve unknowingly
collected on the bottom of your scrubs,
you think this might be a good day to
replace them.
On your way home, you stop at the
grocery store, still in your scrubs and work
shoes. The elderly man directly behind you
in the checkout line drops his package of
ground beef on the floor where you were
standing moments ago. He’s going to take
it home and make dinner for his wife. You’ll
recognize him next week when he brings
his wife into the ER for dehydration
secondary to diarrhea.
infection (HAI) becomes a communityacquired infection, as illustrated above.
Are you taking work home with you?
C. diff is responsible for 250,000
infections per year requiring hospitalization
(or affecting already hospitalized patients)
and 14,000 deaths. Ninety percent of deaths
occur in people 65 and older. C. diff spores
can survive for months on environmental
surfaces. The CDC has categorized the
organism as an urgent threat.
C. diff is not the only pathogen healthcare
workers can carry into the community. Lab
trays, carts and other hospital equipment
contaminated with the hepatitis C virus
(HCV) can remain infective for 6 weeks at
room temperature, increasing the risk of
accidental contact and spread of the virus.
Staphylococci and enterococci are able
to survive on fabrics up to 56 days. Yet in
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Snap it
most facilities, healthcare staff is allowed to
leave work wearing their infected scrubs and
lab coats to shop, make dinner and play
with their children.
Startling Statistics
Our communities would be less threatened
if healthcare workers employed standard
precautions and personal protective
equipment strictly and without exception.
Unfortunately, that’s not the case. One
study showed that only 62% of healthcare
staff regularly used proper PPE. Another
study showed 65 percent of nurses who
performed patient-care activities on
patients with MRSA-infected wounds or
urine contaminated their uniforms or
gowns with the pathogen. The same study
showed environmental contamination
occurred in the rooms of 73% of infected
patients. In a third study, it was found that
hand-hygiene compliance was only 50
percent, and as low as 30 percent at the
time healthcare workers interact with
patients. Therefore, at any given time,
everything in any patient’s room can be
contaminated with the pathogen for which
they’re being treated. Enter the room
without PPE and the pathogen contaminates your scrubs and lab coats and
leaves with you, eventually spreading into
the community where you shop and visit.
Eventually it comes home with you. n
Lisa Steinam is the program coordinator for
the Center for Phlebotomy Education in
Corydon, Indiana.
live online
...anytime, anywhere
Ensure accurate patient test results through interlaboratory comparison using Acusera 24•7 Live Online.
With peer group data available from 20,000 laboratory participants, 24•7 Live Online is the most
comprehensive peer group reporting package in the world.
Randox Acusera Quality Controls cover over
350 parameters, enabling accurate and reliable
testing. With over 30 years’ experience in the
diagnostics industry, excellent choice, stability
and performance is guaranteed.
• Multi analyte
• Third par ty controls
• Highest quality
• Accurate target values
• Consolidation
QUALITY CONTROL
Randox Laboratories-US, Ltd.
T +1 304 728 2890 TOLL FREE 8664 RANDOX F +1 304 728 1890 TOLL FREE 866 RANDOX 1
E marketing@randox.com I www.randox.com
35
A lab system hub bringing locations and
diagnostic data together
Electronic integration to your clients’ EHRs
Web-based access for clients without an EHR
Training and tools to implement your own EHR interfaces
PICK THE BEST
Your Partner for the Future of Diagnostics
An all-inclusive CP/AP information system
Designed for clinical, molecular, and anatomic
pathology testing and reporting
Consolidated results on a single patient report
Structured data for synoptic reporting
Orchard® Web AP for remote user access
A Strategic Partnership: Your Diagnostic Information System Vendor
The future in healthcare requires more than just an LIS. To effectively perform their role, laboratories will need a
strategic, long-term informatics partner, focused on the laboratory and the structure of the diagnostic data it provides.
One Vendor for Integrated Diagnostics
The dividing lines between laboratory disciplines are blurring. Molecular and genetic testing are driving much of this
change. Orchard’s information systems are all-inclusive applications for clinical, microbiology, cytology, molecular,
and anatomic pathology.
Structured Data for Synoptic Reporting, EMR Integration, Data Mining, and Analytics
Structured diagnostic data, discrete and codified, is essential to the future of healthcare. Unlike legacy text-based systems,
Orchard’s systems use configurable worksheets with established templates, drop-down menus, protocols, diagnoses, and
coding for data standardization and structure, synoptic reporting, integration, and comprehensive business analytics.
Orchard’s new enterprise-class LIS built on Microsoft®
SQL® Server Enterprise Edition architecture
Single application with a segmental design
Multi-tier structure with web-services connectivity
for maximum scalability
High-availability and disaster recovery integration
Know You Picked the Very Best Diagnostic Informatics Partner
For more than twenty years, our commitment to and focus on the laboratory has not wavered. Since our first
installation in 1993, more than 1,300 laboratories across the country have turned to Orchard Software. Orchard’s
success comes from our commitment and focus on the laboratory, the changes in healthcare, and partnering with our
customers to develop, deliver, integrate, and support the very best laboratory information systems on the market.
Automatic reimbursement screening using integrated
ICD-9/ICD-10 support
Rules-based decision support and error-proofing
technology
User-configurable patient report formats
Tools for data mining and business analytics
Be assured you pick the best.
Consider Orchard for your strategic partner to support you and your organization in
providing the valuable new currency of diagnostic information.
Simple software for viewing POC orders and results before
releasing them to your EHR
Enables the printing of bar code labels at the testing
locations
Tools for managing your POC testing QC
(800) 856-1948
36
www.orchardsoft.com
© 2014 Orchard Software Corporation
Cost-effective and easy-to-use, install, maintain,
and upgrade

1 ADVANCE for Administrators of the Laboratory

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