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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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©2011 Dark Intelligence Group, Inc.

!"#$%&'(#)%"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.

www.darkdaily.com



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

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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



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



“ 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

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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

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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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