Transferring Laboratory Data Into The Electronic Medical Record: Technological Options For Data Migration In The Laboratory Information System
By: Mark Terry
Editor: Robert L. Michel
DARK Daily Laboratory and Pathology News @ darkdaily.com
www.darkdaily.com ©2011 Dark Intelligence Group, Inc.
Transferring Laboratory Data Into The Electronic Medical Record: Technological Options For Data Migration In The Laboratory Information System 2
Table of Contents
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!"#$%&'(#)%"In an increasingly competitive economic environment for healthcare
services, clinical diagnostic laboratories are looking at tools that
can improve their efficiency and increase their profits. Of primary
interest are sophisticated laboratory information systems (LIS) that
can interact with the facility or institution’s electronic medical record
(EMR) system and/or electronic health record (EHR).
Although the LIS concept is not new, advances in technology have
made them more sophisticated than ever, offering clinical and
non-clinical applications, Web-based connectivity, customizable
configurations and rule-writing, scalability, and modular units
that can offer data handling for the most cutting-edge laboratory
techniques and testing.
Every clinical laboratory is unique, as are the needs of each
laboratory’s LIS. A number of different technological approaches have
been developed to meet the varied needs of the heterogeneous nature
of the clinical laboratory industry, including fully integrated LIS’s,
middleware solutions, and Software as a Service (SaaS) solutions.
This report will provide an overview of the clinical laboratory
industry, the impact that it has on LIS’s, and an understanding
of a variety of technological approaches to deciding which LIS
is appropriate for your facility. In addition, case studies will be
presented, suggestions made on how to decide which type of
technological approach is right for your laboratory, and ideas on
how to implement the LIS you choose.
Although the concept of an
LIS is not new, advances in
technology have made them more
sophisticated than ever,
offering clinical and non-clinical
applications, Web-based
connectivity, customizable
configurations and rule-writing,
scalability, and modular units that can offer data handling
for the most cutting-edge
laboratory techniques and
testing.
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Chapter 1:
=+./@,A%$,#%$B/@!C/,"&/!=/D"E)$%">."#Overview of the U.S. Clinical Laboratory System
In the United States, clinical diagnostic laboratories come under the
oversight of the U.S. Department of Health and Human Services
(HHS), specifically under a provision known as the Clinical
Laboratory Improvement Amendments of 1988. For the most part,
clinical diagnostic laboratories need to be certified under CLIA.
CLIA’s objective is to ensure quality laboratory testing. Certification
falls under two broad categories: waived and non-waived testing.
CLIA offers five types of CLIA certificates: Certificate of Waiver;
Certificate for Provider-Performed Microscopy Procedures
(PPMP); Certificate of Registration; Certificate of Compliance;
Certificate of Accreditation. Each level depends on the types of
laboratory tests performed.
Waived testing applies to fairly simple laboratory tests that provide
a positive or negative result, thus requiring little interpretation.
Examples of waived tests are Fecal occult blood (CPT 82962), which
tests for blood in the feces, and blood count (spun microhematocrit,
CPT 85013) to screen for anemia. Non-waived tests are more
complicated and typically require interpretation of results by a
healthcare professional.
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As of June 2011 there were 225,746 laboratories registered with CLIA.
The states of New York and Washington are CLIA exempt due to state
laws. New York state has 3,336 laboratories and Washington has 3,466.
CLIA also classifies laboratories by type, breaking them down into
29 different categories, including Ambulance, Blood Banks, Health
Fair, Hospice, Hospital, Independent, Pharmacy, Physician Office
Laboratory (POL), Prison, and Other. The largest category is POL,
accounting for 50.70% of CLIA-certified laboratories, with 114,461 in
the U.S. The next largest category is Other (8.62%; 19,467), followed
by Home Health Agency (6.08%; 13,716).
However, in terms of test volumes, the largest clinical diagnostic
laboratories are Independent (2.40%; 5,441); Hospital (3.86%; 8,772);
and Physician Office Labs. For the purposes of this report, these three
categories will discussed the most in terms of laboratory information
systems (LIS).
What Is An LIS?
A laboratory information system (LIS) is a software program
that provides the IT functionality needed for a clinical laboratory.
Components often included in an LIS handle patient check-in, order
entry, results entry, patient demographics, specimen processing, and
some level of reporting ability. In addition, an LIS should be able to
route test orders and results to various users and network locations.
In practical terms, the list of components above is too basic for most
modern laboratories. A modern LIS requires an ability to interface
with the institution’s electronic medical record (EMR), whether that
institution is a physician’s office, a clinic, larger laboratory, or hospital
or health center. The LIS needs to interface with the laboratory’s
instrumentation, preferably allowing test results to move directly into
A modern LIS requires an ability to
interface with the institution’s
electronic medical record
(EMR), whether that institution is a physician’s
office, a clinic, larger
laboratory, or hospital or health center.
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the database, then into the EMR. Modern LIS’s typically offer Web or
browser-based order entry/result inquiry.
Increasingly, LIS’s offer non-clinical functionality such as workflow
monitoring and billing services. Specialized laboratories, especially
labs that use molecular-based techniques or high-resolution image
capture, have highly specialized LIS requirements.
Although a physician office laboratory (POL) may have a single small
laboratory, the typical clinic, commercial laboratory, or hospital may
have many different laboratories utilizing a variety of components of
an LIS, often very specialized components.
What Is An Electronic Medical Record or EMR?
An electronic medical record (EMR) is a computerized medical
record. The distinguishing feature for an EMR versus an LIS is that
the EMR encompasses the health records of the specific organization
delivering care, whether that is a hospital, clinic, or physician’s office.
As part of the Health Information Technology for Economic and
Clinical Health (HITECH) Act, which was part of the American
Recovery and Reinvestment Act of 2009 (better known as “the
stimulus”), Congress provided incentives and penalties for physicians
to begin utilizing EMRs and electronic health records (EHR)*. The
incentives provided up to $44,000 per physician under Medicare, or
up to $65,000 over six years under Medicaid. There were penalties
as well, which decreased Medicare/Medicaid reimbursements to
physicians who failed to use EMRs by 2015.
Specialized laboratories,
especially labs that use
molecular-based techniques or
high-resolution image capture,
have highly specialized LIS
requirements.
* In many areas, Electronic Health Record (EHR) and Electronic Medical Record (EMR) are used interchangeably (as is Personal Health Record, or PHR, which is more easily differentiated from EHRs and EMRs). Some users define the EMR as the legal patient record, which utilizes data from the EHR. That’s a fairly fine difference, and with a significant percentage of individuals using them interchangeably, it’s very difficult to differentiate them. The simplest definition of an EHR is that it is an electronic health record utilized by a physician’s office that interfaces with an institution’s EMR. What makes this confusing is that physician’s offices, especially offices with multiple physicians and specialties, may have their own EMR. For the purposes of this paper, discussion will be held to EMRs, no matter what the institution.
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Studies have suggested
that the use of EMRs improve
healthcare efficiency by
6 percent a year...
Studies have suggested that the use of EMRs improve healthcare
efficiency by 6 percent a year, although there are critics of that
conclusion.
In the U.S., a number of technical standards have been developed to
ensure EMR interoperability, i.e., the ability for different brands of
EMRs to communicate with each other, as well as to communicate
with a variety of instrumentation, EHRs, and personal health records
(PHR). A short list of regulatory bodies and standards includes:
• HL7 (Health Level Seven International)
• CLIA (Clinical Laboratory Improvement Amendments)
• CCHIT (The Certification Commission for Health
Information Technology)
• ANSI (The American National Standards Institute)
• HITSP (The Healthcare Information Technology
Standards Panel)
• LOINC (Logical Observation Identifiers Names and Codes)
For the purposes of this paper, standards will focus on HL7, although
each certification (and others) is important in certification of LIS’s.
What Is A Personal Health Record?
A personal health record, or PHR, is a health record controlled and
maintained by the patient. Although a number of big players jumped
into the PHR market, including Google and Microsoft, the public
has been reluctant to embrace PHRs, possibly because they require
personal initiative to begin and maintain the records. In 2011 Google
Health announced that it would shut its PHR service down to new
consumers on January 1, 2012, and will be completely shut down a
year later.
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Although Microsoft Health Vault continues, as do other PHR services,
there are probably several reasons why the concept hasn’t been widely
deployed, including physicians are too busy, lack of interest on the
part of payers, and criticisms of numerous PHR interactions like
health alerts and reminders. Health information security is also a
significant issue. However, although PHRs are not universally in use,
most of the issues relevant to LIS’s and EMRs in terms of standards,
security and interoperability also apply to PHRs.
What Is A SLAM?
A supplemental lab application module, or SLAM, is one term for
additional software that adds on to an LIS for specialty laboratory
operations. SLAM is not an across-the-board term, although it has been
around since at least 2005, when an article in CAP Today written by
Drs. Raymond Aller, Michael Weilert and Hal Weiner, said:
“The classic LIS is slowly being phased out by a networked set of
discrete systems referred to as virtual LISs and supplemental lab
application modules, or SLAMs. The latter include all functions that
do not reside in the classic LIS and handle front-end, middle, and
back-end processing.”1
In current language, SLAMs are just as likely to be referred to
as “specialty modules” or simply modules. Despite the change in
vocabulary, what the article says is still true today:
“…SLAM products for the laboratory market, includ(e) such products
as Web portals, quality assurance and quality control systems,
enhanced analyzer work cell managers, total lab automation systems,
enhanced analyzer work cell managers, total lab automation systems,
business and financial systems, and blood bank, telepathology, and
“The classic LIS is slowly
being phased out by a networked
set of discrete systems referred
to as virtual LISs and
supplemental lab application
modules, or SLAMS.”
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imaging modules…. Products are being developed to meet the unique
needs of genomic and proteomic testing….”
What Is HL7?
As mentioned above, HL7, which stands for Health Level Seven
International, is the international group that determines standards
for the interoperability of health information technology. HL7 has
members in over 55 countries worldwide. HL7 is accredited by the
American National Standards Institute (ANSI) and is one of several
accredited Standards Developing Organizations (SDOs) involved
in healthcare. HL7’s specific standards domain is clinical and
administrative data.
HL7’s mission statement reads:
“HL7 provides standards for interoperability that improve care
delivery, optimize workflow, reduce ambiguity and enhance
knowledge transfer among all of our stakeholders, including
healthcare providers, government agencies, the vendor community,
fellow SDOs and patients. In all of our processes we exhibit
timeliness, scientific rigor and technical expertise without
compromising transparency, accountability, practicality, or our
willingness to put the needs of our stakeholders first.”
HL7 is not necessarily more important than various other standards
organizations involved in HIT and LISs. Because of its international
structure and membership, HL7 provides a framework for HIT
vendors worldwide to follow so that their information systems in the
healthcare field – whether laboratory information systems, radiology
information systems (RIS), hospital information systems (HIS) or
electronic medical records (EMR) – will have a basic alphabet in
which to communicate and interface with each other. It is estimated
HL7’s specific
standards domain is
clinical and administrative
data.
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Simply put, an instrument
interface allows a laboratory
instrument... to communicate
with the institution’s
medical record.
that more than 90 percent of information systems vendors serving
healthcare are members of HL7.
What Is An Instrument Interface?
Simply put, an instrument interface allows a laboratory instrument,
whether it is a hematology analyzer or a cytogenetics imaging and
karyotyping system, to communicate with the institution’s LIS. The
LIS, in turn, forwards the patient results directly into an EMR, rather
than requiring a technologist or clerical person to manually re-enter
data. It’s faster, more efficient, and less likely to introduce errors.
Interfaces are generally uni-directional, bi-directional, or host-query,
or often all of the above.
Uni-directional: Test results are transmitted from the instrument to
the LIS
Bi-directional: Orders are transmitted to the instrument from the LIS and
stored in the instrument until the appropriate specimen is loaded. Results
are then transmitted back to the LIS when the order is identified.
Host-Query: Upon scanning a specimen, the instruments sends
an order query to the LIS. The test is performed and the result is
transmitted back to the LIS when the order is identified.
Host interfaces: The instruments will be able to interface with a
wide selection of host products, such as EMRs and LIS’s. It can’t
be stressed enough the importance of LIS systems having nimble
Host interfacing capabilities. Agile Host interfacing allows for easy
manipulation of the interface content, especially in the current
marketplace where connectivity is a mandate of Meaningful
Use. Systems with this built-in technology don’t require external
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middleware to achieve easy connectivity to other, more complex
external systems.
Identifying The Challenges
The modern clinical diagnostic laboratory is a complicated entity,
interacting with patients, physicians both within and without the
institution, insurers, other laboratories, and other components of
hospitals or health institutions. It must also, in the U.S., meet CLIA
standards and in some cases, state licensing and inspections. In
addition, the field of clinical medicine is constantly changing with
new techniques and testing modalities brought on regularly. There are
numerous challenges for a laboratory information system,
which include:
• LIS cost
• IT staffing
• Legacy LIS integration
• Adapting workflow
• Downtime for installation or operational maintenance
• Complex and unique laboratory specialties
• Database interfaces
• Instrumentation interfaces
• Imaging and data storage
• Non-clinical applications
• Host interfaces
• Test Routing to remote sites and/or reference labs
These will be addressed in chapter 2.
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Chapter 2:
*+,88."F.9/)"/#+./*'$$."#/G,$H.#-8,(./;%$/G%E)"F/@,A/I,#,/;$%>/@!C/#%/DG:Most laboratories require some sort of LIS. There are, however, a
number of challenges for laboratories that immediately crop up, and
may vary by laboratory type and size.
LIS cost
A full-size laboratory information system that can be used in the
largest, most complex laboratory environments can cost hundreds of
thousands of dollars. Clearly such a system is beyond the economies
of a physician office laboratory or a small or even medium-sized
commercial or hospital laboratory.
Luckily, some vendors have developed LIS approaches or products
that provide fully functional applications for a reasonable price. Some
systems are smaller and have limited functionality; some systems
utilize middleware to expand existing (legacy) LIS’s. Some vendors are
offering software as a service (SaaS)-type services in which the LIS
resides primarily in the “cloud” and is connected via the Internet or a
local area network. In the SaaS model the laboratory or institution pays
a monthly service fee to connect to the SaaS LIS network.
IT staffing
A full-sized LIS often requires regular maintenance and interaction
by an IT staff. In large commercial laboratories and/or hospitals,
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there is typically a fairly good-sized IT department that oversees
the institution’s health information systems. This is not practical
for a physician office laboratory or small hospital or commercial
laboratory. Yet laboratories of all size have a need for a fairly
sophisticated LIS that can interact with institutional EMRs, regional
Health Information Exchanges (HIE), and other physicians, payers,
PHRs, and laboratories.
Legacy LIS integration
Many laboratories already have some form of a laboratory
information system in place. In many cases, these LIS’s were
developed as early as the 1970s or 1980s and may have been built on
hardware that is no longer being manufactured, or software languages
that are no longer being used. Legacy systems that utilize outmoded
programming languages present unique problems, in that there are
often no IT people employed in the system or laboratory that are
familiar with them.
Earlier programming languages and LIS’s suffer numerous problems,
but among them are an inability or difficulty in interfacing with
modern instrumentation, difficulty in interfacing with modern EMRs,
and inability or difficulty in interfacing with Web or browser-based
systems of any sort.
Adapting workflow
With 225,746 CLIA-certified laboratories in the U.S., it’s fair to say
that no two laboratories are identical. Each laboratory will vary by
test volume, personnel, and test menu. Each laboratory will have
unique workflows, which will affect the LIS needs of the laboratory.
Legacy systems that utilize outmoded
programming languages
present unique problems, in that
there are often no IT people employed in
the system or laboratory
that are familiar
with them.
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Larger laboratory facilities – both commercial (independent)
laboratories and hospital laboratories – have multiple laboratories that,
for the most part, run independently, have separate supervisors (and
in many case PhD and MD-level directors), and unique workflows.
A typical standard medium-to-large laboratory institution will
have laboratories performing microbiology, chemistry, blood bank,
hematology, anatomic pathology, serology, cytology, and histology
labs. They may also have molecular diagnostics, cytogenetics, DNA
diagnostics and molecular imaging laboratories. Each laboratory
type has its own unique workflow and that workflow, especially in
specialty areas like molecular diagnostics, place unique demands on
laboratory information systems.
In addition, these laboratories may be involved in reference laboratory
activities for outside institutions and/or customers, as well as in
sending out specialty testing to outside reference laboratories. These
complicate LIS functions and needs.
Some LIS’s are not flexible, and force a one-size-fits-all workflow
onto the laboratory. A desirable aspect of an LIS is a level of
customizability that allows the LIS to adapt to the workflow of
each laboratory.
Downtime for installation or operational maintenance
A large-scale LIS with an IT department often requires significant
downtime for operational maintenance. In a medium-sized
laboratory with lower-end weekend and evening volumes, this
may cause no particular problems. Each laboratory is unique and
their ability to handle maintenance issues is affected by number of
instruments, technologist schedules, and any system redundancies
they may have.
Some LIS’s are not
flexible, and force a
one-size-fits-all workflow
onto the laboratory.
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In the same way, installation of an LIS, depending on the size,
complexity and type of LIS and the laboratory, can involve significant
downtime on the part of the laboratory. Very few laboratories can
afford lengthy shutdown without incurring serious damage to their
business and/or inconvenience to their client/patients.
Complex and unique laboratory specialties
As mentioned earlier, a typical laboratory will offer tests in a variety
of areas – microbiology, chemistry, hematology, blood bank, and
anatomic pathology. Laboratories may additionally offer tests in
parasitology, toxicology, histology, serology, genetics, cytogenetics,
molecular medicine, and flow cytometry, as well as other specialty
areas. Increasingly radiology is expanding into molecular imaging
techniques that overlap with clinical diagnostics. Hospitals often have
a STAT laboratory to perform laboratory tests for the emergency
department.
Each laboratory has a unique workflow, in part due to variations in
incubation times, specimen samples and conditions, technological
platforms and varying levels of automation. Each laboratory typically
has its own LIS. Patients, however, rarely require just a single test that
can be performed by a single laboratory. Even in a small physician
office laboratory, a significant proportion of tests requests per patient
will have to be sent out to one or several reference laboratories, while
basic tests only are performed in-house.
The LIS’s at each of these laboratories performing tests for a single
patient need to be able to communicate with each other. The data
needs to be shared and integrated into a single report that can be
delivered to the ordering physician. Legacy LIS’s were often built
separately for individual laboratories and then interfaced with
each other with varying levels of success. Early legacy medical lab
The LIS’s at each of these laboratories performing
tests for a single patient need to be able to
communicate with each other.
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instrumentation did not typically have automated results distribution
(or order entry), requiring that results be manually entered into the
health record by a staffer.
Certain specialty areas bring increasingly complex problems to the
LIS arena. Molecular testing is definitely on an upswing, increasing
from 6% to 25% annually and is expected to continue to rise.
Molecular diagnostics and genetic testing are both broad categories,
but they can present unique problems for LIS’s, including: specialized
nomenclature; image importing and exporting; searchable karyotype
concepts; integration of images and workflow; advanced statistics;
sequencing and fragment analysis instrumentation interfaces. In
addition, molecular techniques change at a very fast pace, putting
pressure on LIS’s to be able to adapt to changing technology. This
applies to all of clinical diagnostics — it is a fast-changing area and
advances in diagnostics results in instrumentation advances, which
forces LIS’s to adapt along with them.
“Molecular, Genetic Data and the LIS,” published in the April 2008
issue of ADVANCE for Administrators of the Laboratory, stated:
“Molecular testing generates several types of results in various
modalities – quantitative, cytology, pathology or microbiology
interpretive text and, increasingly, related images. One common
molecular report is the combination of cytology and molecular tests
that have been routinely performed and reported separately.”
Database interfaces
An LIS, even in a smaller laboratory, will have numerous interfaces:
to instrumentation, to the institutional electronic medical record, to
reference laboratories’ electronic medical records and/or LIS, and
to one or several databases. Although instrumentation interfaces
will be discussed in the next section, databases present their own set
of problems.
Molecular techniques
change at a very fast pace,
putting pressure on LIS’s to be able to adapt
to changing technology.
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In a medium to large institution and/or laboratory, there are often a
number of LIS’s – one for the microbiology lab, one for the hematology
lab, one for the blood bank, etc. In an ideal world, these LIS’s are
all from the same manufacturer. In reality, they are often separate
manufacturers, sometimes legacy home-grown systems, and they each
will have an interface to the institution’s electronic medical record.
Further complicating this spider web of interconnectivity is that
each laboratory specialty may have its own database. For instance,
the LIS dumps data into a database. The database then connects to
the database from another specialty laboratory and so on. In larger
laboratories, especially regional and national laboratories (and in
some cases, international laboratories), there can be literally hundreds
of different databases with hundreds of interfaces. Although all
interfacing presents problems, synchronizing data across databases
is particularly complicated. The older the databases, the higher
the likelihood of problems arising; the more individual databases,
the more potential problems. In addition, shared databases require
particular adherence to HIPAA regulations that cover health
information security.
A potential solution is a single database. This can sometimes be
handled institutionally by a single database (and single vendor for
each individually laboratory). If the institution as a whole agrees on a
vendor, then that can work, no matter how unlikely that is to happen
in medium and larger institutions. Another solution is to have a single
database operating in a cloud into which all LIS’s interface.
Instrumentation interfaces
As mentioned earlier, increasingly laboratories utilize automated
instrumentation. These automated instruments are capable of
interacting with the LIS, responding to order entry, and feeding test
Further complicating this
spider web of interconnectivity
is that each laboratory
specialty may have its own
database.
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results directly to the database and/or LIS. In theory, these interfaces
are unlimited. More problematic is that each instrument may not
only require a unique interface, but a typical laboratory will have
instruments that range from a decade or older to fresh-off-the shelf.
Each of these systems present challenges to interfaces.
Imaging and data storage
Many types of molecular diagnostics, cytogenetics, anatomic
pathology (AP), and molecular radiology imaging techniques place
high demands on data storage. According to a Dark Daily report (June
2011) about Paul J. Chang, MD, FSIIM, Professor and Vice Chairman
of Radiology Informatics at the University of Chicago Hospitals, the
contents of a single pathology slide takes up about 15 gigabytes (GB)
of storage space. A complete AP study on a single patient converted
to digital images can exceed multiple terabytes (TB). For even a few
days of a typical lab’s anatomic pathology work, imaging and data
stores becomes huge.
In addition, molecular diagnostics, cytogenetics, and AP reports often
want to include imagery. Not all LIS’s allow this.
Non-clinical applications
In 2008, CAP Today noted that many LIS vendors were exiting the
financial aspect of the laboratory, including billing systems. Although
LIS vendors may be getting out of that end of the laboratories, few
laboratories are. Most laboratories, from POLs to regional and
national reference laboratories, require sophisticated billing systems.
The billing and regulatory environment for clinical laboratories is
changing constantly. Ideally non-clinical applications such as logistics
and supply inventory, billing, remote printing, insurance summaries,
client connectivity and sales representative monitoring are included in
a modern LIS.
A complete AP study on a single patient converted to
digital images can exceed
multiple terabytes.
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Chapter 3:
G)&&8.J,$.Middleware is a type of software that sits in the middle between software
components and applications. This allows several different processes that
run on several machines to communicate and interact across a network.
In the context of clinical diagnostics and clinical laboratories and
laboratory information systems, middleware is “used to connect
laboratory information systems (LIS) with the analyzers that do the
actual lab testing. It’s an interface between the two.”2
The problem with that definition is that it’s so broad it doesn’t quite
tell users what middleware does. That’s part of the problem with
middleware, in general. It essentially does whatever the existing
software fails to do. In that respect, middleware can be considered a
way of filling holes existing systems don’t fill.
Gary Tufel, in his 2009 CLPMag article, says, “A typical use is for
middleware to sit between a LIS and analyzers in labs to enhance
analyzers’ capabilities and take advantage of the features that a
LIS offers.”
Middleware, because of its flexible definition, can do a number of
different things for LIS’s, quite possibly an infinite number, giving the
broadness of most definitions. However, four areas in particular are
common functions for LIS middleware:
• Messaging
• Automation
• Inspection Preparedness/Compliance
• Quality Control
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Messaging
At its very core definition, middleware provides communication –
messaging, in a word – between different applications. For instance, it
can communicate between an instrument and the LIS, or from the LIS
to third-party software such as an HIE, EMR, or PHR. This requires
middleware to function a bit like a translator, working with various
programming languages and compliance guidelines.
Laboratories – hospital, independent, and POL – of differing
sizes will be able to utilize middleware to “message” in several
different contexts. Other facilities may use middleware to add
missing functionality to legacy LIS’s. “In the physician office
laboratory environment, middleware can be used to capture and
manage laboratory data from clinical analyzers and exchange
demographics, orders, and lab results to an EMR or a HIS. Other
users of middleware in the POL environment involve interfacing
billing information with the HIS, EMR, and PMS. In the smallest
environments where waived testing is allowed, middleware is used
to connect point-of-care testing (POCT) with various health care
management systems.”2
Automation
Middleware is also used to add layers of automation to the LIS
environment. This is often used by adding “rules” to the LIS, which
is to say, by specifying responses to test result ranges. For instance,
middleware can be programmed to look at a specific test result, and if
the result is in a specific range, the results are forwarded to the LIS. If
the result is above or below the test range, an order can be delivered to
the laboratory indicating the test needs to be repeated or checked for
technical and processing issues, or to reflex to another test.
Middleware is also used
to add layers of automation
to the LIS environment.
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“New software applications (separate from the LIS) give laboratory
professionals the tools not only to write their own rules, but also to
automate specimen handling and storage, instrument maintenance,
and outreach services. Experts refer to such applications as
middleware, expert software, extension software, surround-ware,
supplemental modules, and even mini-LISs.”3
It’s hard to understate the value of a laboratory being able to “write
their own rules.” They are often built into modern LIS’s, but not
necessarily into legacy LIS’s. In addition, laboratories may need unique
rules written to deal with the wider universe of the facility’s typical
patient set – a cancer facility versus an outpatient clinic, for instance.
“A rule can be set up for something as simple as alerting a
technologist that a certain physician always wants to be called for any
abnormal result. Another rule may call for a slide review if the total
WBC count is less than 4.0 or greater than 30.0 and if the test is being
conducted for the first time.”3
The result of this is to shift certain work in the laboratory from the
technologist to the computer, automating certain processes.
Inspection Preparedness/Compliance
Along with rules for test value results, middleware is used for
inspection preparedness. Middleware can be programmed to alert
for scheduled maintenance, to automate troubleshooting, and to
set up a schedule and track events leading up to inspections. If
middleware has a Web or browser-based component, it can be
programmed to automatically update software versions, user guides,
and package inserts.
Laboratories may need
unique rules written to deal with the wider universe of the
facility’s typical patient set.
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“Driving quick, electronic updates to a central location with prompt
removal of out-of-date information raises the quality of service
provided. It can also be used to help meet quality or patient safety
initiatives for accreditation purposed with features like start alerts or
required commenting, which ensures that appropriate documentation
features are followed.”2
Quality Control
Middleware can be utilized to streamline data management, track
operators and provide audit trails, and often “offer options that allow
labs to identify QC failure or instruments issues earlier.”2 Browser-
based systems can communicate across departments or sites, which
allows managers to compare and analyze QC data. Middleware can
also be utilized for Computerized Physician Order Entry (CPOE),
utilizing barcoding, which increases efficiency and decreases the
likelihood of order entry errors.
What is not completely clear is if middleware is merely a temporary
measure to improve legacy LIS’s by adding functionality. Newer,
high-end LIS’s tend to have all the functionality and more discussed
here, so middleware is not necessarily an end in and of itself. It may
end up becoming a point-in-time solution for many lab enterprises.
However, for a laboratory, especially POLs with limited budgets,
the advantages of a low-priced, flexible middleware solution that
enhances a smaller LIS and provides the functionality of higher-end
LIS’s can’t be underestimated.
It is not completely
clear... if middleware is merely a temporary measure to
improve legacy LIS’s
by adding functionality.
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Chapter 4:
C%;#J,$./,9/,/C.$E)(.//KC,,CLM<CNSoftware as a Service, or SaaS, is a software delivery method
associated with a thin-client application, i.e., the software and the
actual database and processing is performed on a remote server and
is accessed by users (the laboratory, in the case of an LIS) via a Web
browser. What distinguishes the SaaS approach for an LIS is simply
that the laboratory is investing in a service as opposed to investing in
hardware and software.
Typically the laboratory (client) invests in low-cost programs that
allow for access to the server via an Internet connection. The server/
host offers whatever functionality is desired by the laboratory. The
laboratory pays a low monthly fee to utilize the SaaS.
The advantage of a SaaS LIS is low cost, no need for onsite IT, no
hardware installation or investment beyond what is typically already
in place, and all updates, installation, upkeep, and maintenance is
handled by the host service.
SaaS is a type of application service provider (ASP). ASP is
basically a business that provides computer-based services over a
network. (What further complicated issues is that in IT terminology,
ASP also stands for Active Server Pages, which was, according
to Wikipedia, “Microsoft’s first server-side script-engine for
dynamically-generated web pages.” In that respect, it is further
complicated because ASP .NET is a type of IT architecture that is
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often involved in cloud computing and anything involved networks
and web-based cloud-type services.)
Although it’s useful to know what an ASP is, this report will not
discuss ASPs.
Advantages
The primary advantage of an SaaS LIS is low cost and no fuss. A
laboratory, especially a smaller physicians office laboratory, only
needs to load relatively inexpensive software on their POL computers
that allows them access to the SaaS provider’s servers via the Internet.
They then have whatever level of functionality the provider offers. In
other words, SaaS-based LIS systems offer full functionality to even
the smallest of laboratories.
In addition, any upgrades and configuration issues are handled by the
vendor/host.
SaaS-based LIS solutions also support multiple clients and users,
while requiring minimal resources. It is scalable, so if the laboratory
grows or merges with another facility, very little change in terms of
the laboratory is necessary.
An additional advantage is because the SaaS LIS is already
networked, it’s a fairly straightforward extension to connect
physicians offices and reference laboratory clients to the network.
SaaS-based LIS solutions simplify instrument connectivity through
reduced custom interface costs and manage data flow between
a large number of laboratory instruments and the corresponding
data. Most importantly, SaaS-based LIS solutions help integrate
otherwise standalone instruments directly to an EHR, EMR,
The primary advantage of an SaaS
LIS is low cost
and no fuss.
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practice management or other host system using industry-standard
interface protocols.
Concerns
There are not many fully functional, true SaaS laboratory information
system vendors operating at the moment, although there certainly
would seem to be a lot of interest in that direction, and cloud-based
computing in general is trending toward the SaaS model.
Within the healthcare industry, there are some concerns regarding
SaaS in general, and SaaS LIS specifically.
Downtime
All IT systems require maintenance and upgrades. LIS’s are no
different, no matter what type they are. Many in-house LIS’s
depend on in-house IT staff, or commonly in smaller laboratories,
a (hopefully) tech-savvy employee to handle the system for
maintenance and problem solving. According to technology research
firm Gartner, Inc., institutions running in-house systems have about
forty hours of unplanned outages annually – those are unplanned. The
planned outages are typically two hours per month.
However, most outages are technology failures, and www.Disaster-
Resource.com indicates that 29 percent of them last four to 24 hours.
In terms of downtime, many institutions worry that the downtime,
planned or unplanned, is largely out of their control when dealing
with an SaaS model. It could certainly be argued that a well-run SaaS
vendor with a good reputation is more likely to have disaster-recovery
plans in place and utilize backup systems than most independent or
SaaS-based LIS solutions
help integrate otherwise
standalone instruments
directly to an EHR, EMR,
practice management or other host system using
industry-standard interface
protocols.
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physician laboratories. It is, however, an issue that potential customers
for an SaaS LIS should inquire about.
Security
Because an SaaS-based LIS involves the transmission of enormous
amounts of private health information (PHI) over the Internet, digital
security is a major concern. Security roughly falls into two categories:
system vulnerabilities (hackers) and unauthorized physical access
(inappropriate users).
Any vendor offering SaaS-based LIS should have a clear security
policy and procedures in place for physical security, digital security,
and backup security. These can range from IT personnel whose job
it is to make sure software patches are installed, providing correct
passwords and HIPAA-related access protocols, to physical security
at the location of their host company’s servers. Again, potential
customers should inquire about all of these.
It is worth noting, of course, that laboratories and their IT
departments (if they have them) of all sizes need to deal with these
concerns as well, and unfortunately can be rather sloppy about it.
Functionality
There is an argument made that in-house LIS’s have more
functionality than SaaS-based LIS’s. Most evidence indicates this is
not the case, that institutions that create their own home-grown LIS
will find ongoing maintenance and support takes up most of their
time and that additions and innovation are delayed, often forever.
Because an SaaS-based
LIS involves the transmission of enormous
amounts of private health
information over the Internet,
digital security is a major
concern.
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Because an SaaS-based LIS focuses strictly on that system for a
multitude of clients, they will typically remain innovative in order to
keep customers and stay competitive.
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Chapter 5:
*,9./C#'&).9Granite Diagnostic Laboratories (GDL)
Granite Diagnostic Laboratories is a CLIA-certified and Florida-
licensed clinical diagnostic laboratory located in Palm Harbor, Florida
in Northern Pinellas County, and has eight branch facilities in the St.
Petersburg/Tampa area.
With increased test volumes and a growing number of remote patient
service center locations, GDL sought a laboratory information system
that would provide workflow improvements, but also handle remote
processing. GDL’s existing LIS was not able to efficiently handle
remote processing, and did not have communications features that
allowed physician order entry and results reporting. The existing LIS
also did not have Internet connectivity to connect the laboratory’s
nine locations.
After evaluating a number of available LIS systems, GDL chose
Merge Healthcare’s Merge LIS and had it implemented in the spring
of 2010. GDL in particular liked the Merge LIS’s scalability and
configurability that could accommodate nine separate facilities.
Rick Granite, President and co-founder of Granite Laboratories,
says, “With the increasing deployment of electronic medical records
(EMR), many of our physician clients were requesting direct order
entry and results reporting for their EMRs. Merge LIS’s HL7
compliant communications structure allows us to meet our clients’
demand for this capability. Also, the system’s SQL server platform
allows us to rapidly customize the system to meet our unique
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processing needs at each of our facilities, which ensures uniformity
and high quality of the results we report to our customers.”
Because the Merge LIS offered extensive choices and flexibility, GDL
described the system as being like having several individual LIS’s that
met the unique requirements of each client. Rick Granite also noted
the ease of use and intuitive learning aspect of the Merge LIS. “Our
concern with going with a different product was the learning curve
and the inefficiency of our staff.” However, implementation took
approximately four months, although Granite notes that some of that
time was just matching GDL’s timeline, which involved initiating the
system during their slower period in the late spring, early summer.
Granite says, “That was good. We knew that even with a familiar
product, there were going to be some inefficiencies getting everyone
up to speed. We wanted to do that when we had the flexibility in the
work schedule to allow for training.”
In addition, GDL utilized the Merge ePortal, which allows physicians
to access laboratory results around the clock from any authorized
workstation, PDA or laptop, even if they don’t have an EMR.
Physicians can also view results in real time. The Merge ePortal
provides Web-based laboratory outreach and is complementary to
other LIS systems, including Merge LIS. Basically, Merge ePortal is a
type of middleware that expands on an existing LIS.
Rick Granite notes that the Merge LIS and ePortal streamlined their
workflow and increased the laboratory’s efficiency, all while decreasing
costs. “The major thing was we had several remote locations, and the
new system allowed us to order-entry remotely, print off labels, and
then the main laboratory receives the manifest – so the work was being
pushed out, where in the past our remote locations filled out everything
on paper, the work came into the main lab, and was then entered in
The Merge ePortal
provides Web-based laboratory
outreach and is complementary
to other LIS systems,
including Merge LIS.
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the system and resulted out. Now it’s all pushed through the system.
It’s given us a lot more ability to customize with our clients, and it
also pushed the work upstream to where I don’t have to have a huge
processing department to bring in all the work and process it centrally.
It’s been a big efficiency gain for us.”
Florida Cancer Specialists & Research Institute
Florida Cancer Specialists & Research Institute is the largest
privately-owned Oncology and Hematology practice in the U.S.,
operating with almost 100 physicians, 60 nurse practitioners and 40
clinical sites. Associated with the Sarah Cannon Research Institute,
FCSRI has a significant involvement in clinical trials programs.
The FCSRI wanted an LIS that could connect their thirty clinics
and handle test volumes from their multi-facility practices. They
wanted the system to be scalable and changeable to accommodate
their rapid expansion.
FCSRI studied several LIS vendor products and selected Merge
Healthcare’s Merge LIS. In particular FCSRI liked the Merge LIS’s
unlimited flexibility and easy expansion via optional modules. The
Merge LIS’s interface is intuitive, and training and use are easily
accomplished.
The Merge LIS is easily configurable and scalable. Internet access is
built into the system.
FCSRI began deployment at 22 locations. The LIS included
bidirectional orders and results interface to their Onco EMR system.
In addition, they utilized barcode label generation and interfaces
to laboratory instrumentation at all locations, as well as container
routing of specimens to the FCSRI Central Laboratory.
In particular FCSRI liked
the Merge LIS’s unlimited flexibility and
easy expansion via optional
modules.
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Since implementing the system, FCSRI added several new facilities to
their network. Because of the Merge LIS’s ease-of-installation, FCSRI
deployed the software themself and provided their own training at the
new locations. This resulted in decreased implementation costs.
John Hodson, Laboratory Manager at Florida Cancer Specialists and
Research Institute, said, “The primary benefit of Merge LIS is the
connectivity it provides. We conduct 3.5 million tests per year from
30 diverse sites with just two people and all of our results are out
within 24 hours.”
Hodson in particular noted that the Merge LIS has a single database,
which minimizes database integration problems, and the Web-based
design allowed them to make configuration changes at a single
location, resulting in all locations being upgraded simultaneously.
The result was decreased costs, no redundant hardware, and
streamlined workflow. Hodson notes, “Another benefit of this central
database structure is that we can measure the performance of every
lab tech at each of our clinics. This gives us a process for quality
assurance of all our test procedures.”
“The primary benefit
of Merge LIS is the
connectivity it provides.”
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Chapter 6:
C.8.(#)"F/O%'$/@!C/<--$%,(+The nearly quarter million CLIA-certified laboratories operating
in the U.S. are unique in their test volumes, test menus and, as a
result, in their LIS needs. One system does not meet all. There are a
number of different technological approaches to solving laboratory
information communication and transfer that can be geared to each
individual laboratories needs. Considerations in choosing your
solution are:
• Do you need a complete LIS?/What are your LIS needs?
• What is your budget?
• Do you want to expand your existing LIS or replace it?
• Do you have multiple laboratory facilities that need to interface
with a central LIS, or expect to have one in the future?
• Do you wish physician clients to have real-time access to
test data?
• What is your implementation schedule like?
• Do you need integration with an electronic medical record
(EMR?)
• Do you need the LIS to be seamless with the EMR?
• What are the goals of your laboratory in terms of the LIS?
Dianna Powell, Pre-Sales Clinical Consultant, LIS, with Merge
Healthcare, says, “Often a laboratory’s LIS needs revolve around the
EMR, processing and dividing the workflow into the appropriate
areas of the laboratory, and disseminating results that came back from
instrument interfaces back to the EMR. Sometimes laboratories need
other things like an outreach portal.”
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Ultimately it comes down to what the laboratory wants the LIS to
do. Powell says, “Many LIS systems perform similar functions, but
how do they handle expansion and growth? How do they manage the
system? It depends upon the needs of the customers.”
Ultimately it comes down
to what the laboratory wants
the LIS to do.
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Chapter 7:
!>-8.>."#)"F/O%'$/@!C/*+%)(.Having made the choice to either replace or expand an existing
LIS, a systematic approach to implementation is required. A typical
approach requires five steps.
1. Analysis. Some of this will have been done during the decision
making process. It includes budget, existing infrastructure,
test volume, and backload parameter analysis which refers to
archival data that needs to be migrated into the new system. This
is “determined by peforming a retrospective LIS data review
specific for each physician client practice. Archival LIS data up
to 2 years back (are) transmitted to select EMRs. At this stage,
the identification of resources, roles, and responsibilities (are)
carried out, and a schedule determined.”5
2. Determining Business/Technology Rules. A legacy LIS may
not meet current regulatory, business, or technology rules. Before
legacy data can be transferred to a new system, it needs to be
determined what the old rules were and what the new system’s
rules and settings need to be. This can include billing cycle
workflow, reflex testing structure, and what data needs to be
saved and included in a final report. This is also referred to as
data mapping.6
3. Performing Data Transfer. After data mapping has occurred,
legacy data can be imported to the new system. This is automated
so clerical staff or technologists do not need to manually re-enter
data. Possible approaches include csv files, SQL dumps, and
database backups.
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4. Test and Validate. The new LIS must then be tested to ensure
that new data matches the legacy data. In addition, secure
connectivity must be validated.
5. Publish Legacy Data. Once the legacy data is transferred to the
new system, the old system is typically run in parallel so it can be
verified that the new LIS is working properly. Decisions can be
made about use of legacy data, i.e., which will be “read only” and
which will be utilized as “active data.”
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*%"(8'9)%"Technology has grown in a variety of ways to solve business and
technology problems. In the clinical diagnostic laboratory, changes
have come in the form of various legislation and certification,
new technologies, and complex reimbursement issues. Laboratory
information systems (LIS) have grown in a variety of ways to offer
solutions to multiple changes in the industry, as well as to many
different types of clinical diagnostic laboratories – physician office
laboratories, hospital laboratories, and commercial laboratories.
Although early LIS’s were often home-grown and are now built on
obsolescent hardware and software languages, newer LIS’s are designed
with future growth and flexibility in line. Modular design has allowed
add-ons to be designed for new and future diagnostic techniques like
specializing imaging, molecular diagnostics, and specialty areas.
In addition, new approaches to offering full LIS functionality to
any sized laboratory at a wide range of costs have been developed.
These include middleware, which can be used to expand functionality
to a legacy LIS, Software as a Service-style services in which the
laboratory connects to a remote server for a low monthly fee, or
moderately priced fully-integrated laboratory information systems
that reside on the institution’s own computers.
The reader now has the information they need to decide what their
institution’s needs are and what type of LIS approach is the most
practical and affordable. Case studies have been presented that
describe unique challenges and how they were solved using different
types of LIS technology solutions. Also, the reader now has the
information to develop an implementation plan for installation of a
new LIS, no matter which technological pathway they choose.
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:.;.$."(.91. Aller et al. From classic to virtual: the morphing of lab
information systems. CAP Today. May 2005.
2. Gary T. Middleware Update: Not Just a Facilitator Anymore.
CLP Magazine. March 2009.
3. Sullivan E. To the Middle and Beyond: Exploring the Expanding
Universe of Laboratory Software. Laboratory Medicine.
2006;37(7): 407-411.
4. How differences in technology affect LIMS functionality,
cost, & ROI: System Architecture Strengths and Limitations.
LABVANTAGE Solutions, Inc. 2011.
5. Pantowitz et al. Stepwise approach to establishing multiple
outreach laboratory information system-electronic medical record
interfaces. Journal of Pathology Informatics. 2010 May 26.
6. Stonecipher R. Time to Replace your LIMS? Laboratory
Informatics. Scientific Computing.
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Appendices
www.darkdaily.com
Transferring Laboratory Data Into The Electronic Medical Record: Technological Options For Data Migration In The Laboratory Information System 39
©2011 Dark Intelligence Group, Inc.
Mark Terry is a freelance writer and editor specializing in clinical
diagnostics, telemedicine and biotechnology. He worked for 18 years
in clinical genetics prior to turning to writing and has published over
600 magazine and trade journal articles, 13 books and more than a
dozen book-length market research reports and white papers related to
clinical diagnostics. He is a member of the Association of Health Care
Journalists and the Association of Genetic Technologists.
A-1About Mark Terry
www.darkdaily.com
Transferring Laboratory Data Into The Electronic Medical Record: Technological Options For Data Migration In The Laboratory Information System 40
©2011 Dark Intelligence Group, Inc.
Merge Healthcare Incorporated is the leading provider of enterprise imaging and interoperability solutions. Merge Healthcare solutions facilitate the sharing of images to create a more effective and efficient electronic healthcare experience for patients and physicians. Merge Healthcare provides enterprise imaging solutions for radiology, cardiology and orthopaedics and eye care; a suite of products for clinical trials; software for financial and pre-surgical management, and applications that fuel the largest modality vendors in the world. Merge Healthcare’s products have been used by healthcare providers, vendors and researchers worldwide to improve patient care for more than 20 years. Additional information can be found at www.merge.com.
A-2About Merge
www.darkdaily.com
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©2011 Dark Intelligence Group, Inc.
“ Dark Daily is a concise e-news/
management briefing on
timely topics in clinical
laboratory and anatomic
pathology group management. It is a solution to
the dilemma facing anyone in
the laboratory profession.
DARK Daily is a concise e-news/management briefing on timely topics in clinical laboratory and anatomic pathology group manage-ment. It is a solution to the dilemma facing anyone in the laboratory profession. New developments, new technology, and changing healthcare trends make it imperative to stay informed to be success-ful. At the same time, the Internet, cell phones, blackberries, laptop computers and wireless devices are overwhelming any one individu-al’s ability to absorb this crushing Tsunami of data.
DARK Daily is a quick-to-read, easy-to-understand alert on some key development in laboratory medicine and laboratory manage-ment. It has no counterpart in the lab world. Why? Because it is produced and written by the experts at THE DARK REPORT and The Dark Intelligence Group, who know your world, understand your needs and provide you with concise, processed intelligence on only those topics that are most important to you!
You will find DARK Daily to also be an exceptionally valuable resource in laboratory and pathology management. Some of the lab industry’s keenest minds and most effective experts will be offering their knowledge, their insights and their recommendations on win-ning strategies and management methods. Many of these experts are unknown to most lab directors. As has proven true with THE DARK REPORT for more than a decade, DARK Daily will be your invalu-able— and unmatched—resource, giving you access to the knowl-edge and experience of these accomplished lab industry professionals.
A-3About DARK Daily
www.darkdaily.com
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“ Membership is highly-
prized by the lab industry’s
leaders and early adopters.
It allows them to share
innovations and new knowledge
in a confidential, non-competitive
manner.
The Dark Intelligence Group, Inc., is a unique intelligence service, dedicated to providing high-level business, management and market trend analysis to laboratory CEOs, COOs, CFOs, pathologists and senior-level lab industry executives. Membership is highly-prized by the lab industry’s leaders and early adopters. It allows them to share innovations and new knowledge in a confidential, non-competitive manner. This gives them first access to new knowledge, along with the expertise they can tap to keep their laboratory or pathology organization at the razor’s edge of top performance.
It offers qualified lab executives, pathologists and industry vendors a rich store of knowledge, expertise and resources that are unavailable elsewhere. Since its founding in 1996, The Dark Intelligence Group and THE DARK REPORT have played in instrumental roles in support-ing the success of some of the nation’s best-performing, most profit-able laboratory organizations.
The Dark Intelligence Group (TDIG) is headquartered in Austin, Texas. This location makes it very accessible for any laboratory organization seeking input, insight and support in developing their business operations, creating effective business strategies and crafting effective sales and marketing programs that consistently generate new volumes of specimens and increasing new profits. The Dark Intelli-gence Group, Inc. owns and operates two Web sites in the TDIG Website network:
http://www.DarkReport.com
http://www.DarkDaily.com
A-4About The Dark Intelligence Group, Inc. and THE DARK REPORT
www.darkdaily.com
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A-5About the Executive War College on Laboratory and Pathology Management
Every spring since 1996, the lab industry’s best and brightest gather at the Executive War College on Laboratory and Pathology Management to learn, to share and to network. Many consider it to be the premier source of innovation and excellence in laboratory and pathology management.
Each year, a carefully selected line-up of laboratory leaders and inno-vators tell the story of how their laboratories are solving problems, tackling the toughest challenges in lab medicine and seizing oppor-tunities to improve clinical care and boost financial performance. The Executive War College is the place to get practical advice and solutions for the toughest lab management challenges. A unique case study format brings participants face-to-face with their most success-ful peers. They tell, first hand, how their laboratory solved intractable problems and successfully used new technology.
Many lab management secrets are shared, along with specific “what-not-to-do’s” gained from hard-won experience! It’s not pie-in-the-sky theory, but useful knowledge that can be put to use in any lab. The Executive War College offers superlative networking, with lab administrators and pathologists attending from countries as far away as the United Kingdom, Germany, Brazil and Australia. It makes the Executive War College a melting pot for all the best ideas, new lab technologies and management strategies now reshaping the laboratory industry. It’s also become a recruiting ground used by headhunters and major lab organizations.
In the United Kingdom, The Dark Intelligence Group and the Association of Clinical Biochemists (ACB) have co-produced a meeting every February since 2003. Known at Frontiers in Laboratory Medicine (FiLM), it attracts laboratory leaders and inno-vators in the United Kingdom. Also featuring a case study format, this meeting pioneered the international laboratory side-by-side case study, where a North American laboratory and a United Kingdom laboratory prepare a comparison of best practices and an operational assessment of their two organizations.
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In September 2005, a laboratory management meeting called Executive Edge was conducted in Toronto, Ontario, Canada, by The Dark Intelligence Group and QSE Consulting. It provided pathologists and lab directors in Canada with a customized meeting devoted to the strategic and operational issues of laboratory management in Canada.
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Robert L. Michel is a respected commentator, consultant, author, editor, speaker, and entrepreneur. He is a leading expert on the management of clinical laboratories and anatomic pathology group practices.
Lab Industry Leader and Consultant
Michel is Editor-In-Chief of The Dark Report <http://www.darkreport.com/index.htm> and President of The Dark Intelligence Group, Inc. Over the past three decades, he has provided strategic and tactical management services to a wide variety of companies, ranging from Fortune 100 firms like Procter & Gamble and Financial Corp. of America to leading laboratories ranging from Nichols Institute to hospital and health system laboratory organizations. He has a special talent for spotting new business opportunities in clinical diagnostics and identifying winning strategies to pursue them.
Some of his current and past clients include: Meridia Health System (Cleveland, OH), PACLAB Regional Laboratory Network (Seattle, WA), Consultants in Laboratory Medicine (Toledo, OH), PAML, Inc.(Spokane, WA), UMASS Healthcare Reference Laboratories (Worcester, MA), Ortho-Clinical Diagnostics (Raritan, NJ), Pathology Service Associates (Florence, SC), DIANON Systems, Inc, (Stratford, CT), Beaumont Health System (Detroit, MI), MedTox Laboratories, Inc. (St. Paul, MN), Joint Venture Hospital Laboratory Network (Detroit, MI), Bayer Diagnostics (Tarrytown, NY), Bio-Reference Laboratories, Inc. (Elmwood Park, NJ), Specialty Laboratories, Inc., (Santa Monica, CA), National Health Service-Pathology Services (London, England), Doctor’s Laboratory (Valdosta, GA), Sysmex Corporation (Mundelein, IL), Pathologist’s Medical Laboratory (La Jolla, CA), Abbott Laboratories (Abbott Park, IL), St. John Clinical Laboratory Pathology Laboratory (Detroit, MI), Esoterix, Inc.(Austin, TX), Beckman Coulter Corporation (Fullerton, CA), Health Care Systems, Johnson & Johnson (Atlanta, GA), ARUP Laboratories, Inc. (Salt Lake City, UT), Institute for Quality in Laboratory Medicine (Atlanta, GA), and American Society of Clinical Pathology (ASCP-Chicago, IL).
A-6About Robert L. Michel
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Michel was first to identify and describe many of the widely-used management strategies in the operation of clinical laboratories and pathology practices. He has one of the best track records of predictions in laboratory management over the past decade and a half.
Michel is a member of the Clinical Laboratory Management Association <http://www.clma.org/> (CLMA), the American Association of Clinical Chemistry <http://www.aacc.org/AACC/> (AACC), Specialized Information Publishers Association <http://www.newsletters.org/> (SIPA).
Popular Journalist, Author & Editor
Michel writes and edits The Dark Report <http://www.darkreport.com/>, a business intelligence service for pathologists and laboratory executives that, over its eleven years of publication, has garnered national and international respect of its ground-breaking coverage of events and industry trends within the laboratory profession.
International Meeting Innovator, Public Speaker
Michel is the Founder and Director of the Executive War College on Lab and Pathology Management <http://www.executivewarcollege.com/>. First conducted in 1996, this gathering has become the premier forum for laboratory management in the world. For pathologists, he developed the Pathologist’s Income Symposium a meeting series which is exclusively focused on helping pathologists increase their practice income, as well as their professional income. Every September he hosts a meeting by The Dark Report called Lab Quality Confab <http://www.labqualityconfab.com/>. It is an annual gathering dedicated to advancing the knowledge, skills, and effectiveness of quality management practitioners in diagnostic medicine. Programs, LEAN information, and training are designed for every level of management and all levels of knowledge and experience. Diagnostic medicine, particularly the services of clinical laboratory, pathology, imaging, and radiology, make up the primary emphasis of the Lab Quality Confab.
Since 2004, he has co-produced Frontiers in Laboratory Medicine <http://www.frontiersinlabmedicine.com/> (FiLM) in the United Kingdom with the Association of Clinical Biochemists <http://www.
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acb.org.uk/>. This meeting has quickly earned a reputation as the best source of laboratory best practices in Europe. In 2005, Michel co-produced Executive Edge <http://www.exec-edge.com/> in Canada with QSE Consulting. This meeting about strategic laboratory management innovations in Canada proved popular and is repeated in the fall since 2005.
Michel is regularly asked to address laboratory industry groups. In addition to regular speaking engagements throughout the United States, he has traveled to Brazil, England, Canada, Australia, Korea, Japan, Ireland, and South Africa to address laboratory audiences in those countries. Meeting participants regularly rate Michel’s presentations as one of the best at the event.
Experienced Educator, Strategist, and Business Facilitator
Over the past decade and a half, Michel has been invited to provide Grand Rounds and teach clinical laboratory and pathology management at the pathology departments of such medical schools as University of Minnesota, University of California at Los Angeles and University of Texas Southwest/Houston. He has provided strategic assessments to laboratory organizations, IVD manufacturers, pathology groups, information technology vendors, biotech companies, and diagnostic start-up companies. He is regularly asked to facilitate strategic management retreats and business planning meetings for such clients as PAML, OML, Sysmex Corporation.
Michel received his B.A. in Economics from the University of California at Los Angeles. He is a native of Santa Ana, California and currently lives and works in Austin, Texas.
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©2011 Dark Intelligence Group, Inc.
© 2011 by the Dark Intelligence Group, Inc.
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