The start of any
new year gives vendors the opportunity to take stock of their industry
and to “crystal ball” new trends and development goals. For
manufacturers of clinical laboratory analyzers, 2010 promises to be a
year when their instruments will be expected to meet the ever-growing
and changing demands of labs and lab professionals. According to Luis
Tapanes, global marketing manager for the Hematology Business Center at
Brea, CA-based Beckman Coulter, the trend is toward faster turnaround
times (TAT) and analyzers that are easy to use. Dave Kolesar, ELISA
marketing manager at Waltham, MA-based Inverness Medical, explains that
labs are looking for analyzers that can process more specimens faster
but are simple to operate.
What is fueling these trends appears to be an
increase in the number of tests being ordered by physicians, coupled with
the shortage of qualified laboratorians. Not only are many laboratory
technicians nearing retirement, but there are fewer entering the field, says
Ralph Taylor, vice president, marketing and medical affairs at Sysmex
America in Mundelein, IL.
“According to the Bureau of Labor and Statistics, the
U.S. graduates fewer than half the number of clinical laboratory personnel
needed to staff the country’s clinical laboratories. It is reasonable to
assume then that the nation’s medical staff technologists’ shortage is not
going to change in the near term. Therefore, one can predict that any
laboratory procedure requiring manual intervention is an appropriate
candidate for automation.”
Doing more with less
The buzz words today are “multiplexing” and
“automation.” Kolesar says multiplexing represents a quantum leap in
analyzer development. “With multiplexing, you can look at a hundred
different antibodies from a single well.” Pointing to his company’s
development of the DSX line of analyzers, he says that while a single run is
limited to four microplates, there are 70 autoimmune and infectious-disease
assays in the analyzer’s menu that can yield 384 patient results from a
single batch. Plus, he says, these analyzers feature an open system and use
universal reagents.
Another breakthrough for his company is the
development of both the AtheNA and AIMS (automated immunoassay multiplexing
system). “What we have done is to optimize a large number of assays in order
to process the results faster.” The company claims, for example, that its
AtheNA Multi-Lyte system represents a high-performance step-saving
alternative to indirect fluorescent, or IFA, and enzyme-linked immunosorbent
(ELISA) assays. It also claims that this multiplexed, fluorescent,
bead-based system is designed to perform simultaneous multiple assays from a
single sample in one well, thereby providing improved clinical sensitivity
and comparable clinical specificity in a labor-saving, automation-friendly
format.
Another vendor in the multiplexer market is Beckman
Coulter. Tapanes says the Unicel DxH 800 hematology analyzer can also run
other body fluids such as spinal-fluid samples. In addition, the DxH 800 is
scalable, allowing two or three to be connected. “In this case, you have
built-in automation, so you do not need to add tracks.” And with the
specimen-transport module, there is a handoff between analyzers, he adds.
Additionally, the integrated software and data-management system allows
results from connected analyzers to flow into a single, consolidated
database.
The buzz words today are “multiplexing” and “automation.”
This new analyzer also can run up to 100 CBC
differentials per hour and has a feature that automatically repeats any
specimen test necessary, Tapanes says. Part of Beckman Coulter’s innovation
process also has led to a standardization of software so that the operating
system, with its touch-screen capability and intuitive icons, is the same
for hematology or chemistry analyzers. Tapanes says slide making will soon
become easier. “We have automated the process of making slides. Doing cell
counts is still a manual process, but we have focused on the extended
differential.” Still in development, this product will use the DxH platform
to automatically count and classify cells.
Software development is becoming increasingly
important in the multiplexing and automation fields. “We are getting ready
to release a software package to go with our glucose and lactate analyzer,
the YSI 2300,” reports Jamie Lussier, product manager at Yellow Springs,
OH-based YSI. The new software will configure data from the analyzer into a
spreadsheet so test results can be analyzed at a workstation,” Lussier says.
Although he does not foresee many breakthroughs in
the glucose analyzer field, Lussier says the complexity of analyzers, in
general, needs to come down, including the methods used to calibrate and
recalibrate instruments. “You need to make sure the operation is as simple
as possible,” he says, adding that in many of today’s hospitals, nurses —
not certified lab techs — are being asked to run the equipment.
Key to simplifying and automating procedures was the
development of the Bioplex 2200, says Ginger Weeden, the analyzer’s senior
product manager at Hercules, CA-based Bio-Rad Laboratories. Launched in
2006, the Bioplex 2200 is a fully-automated multiplex platform that analyzes
multiple disease markers from a single patient sample. Weeden said her
company is currently adding more reagents for this analyzer and working
toward being able to use whole-blood specimens. Using the Bioplex 2200 as an
example, Weeden says using multiplexing and automation technology allows the
analyzer to run 12 different tests in one reaction vessel using only a
5-microliter sample. And since the laboratory information system (LIS) tells
the lab tech what the physician ordered, all the tests in the reagent pack
are performed, and the results of only those tests are released to the
physician. There is a caveat, she says. “As we automate traditional assays,
there are others being introduced. So, it is difficult to keep up with what
will come next.”
Looking ahead
Keeping up with technological
advances also means planning for the future, says Taylor. “We see
analyzers with greatly expanded reporting capabilities but without
additional costs and complexity. For example, the Sysmex RET-He (reticulocyte
hemoglobin equivalent) is an established parameter that is recognized by
the National Kidney Foundation’s Kidney Disease Outcomes Quality
Initiative guidelines. RET-He directly measures the mean hemoglobin
content of red blood cell precursors (reticulocytes) and assists with
early recognition of functional iron deficiency — critical when caring
for patients with end-stage renal disease, a common and costly
diagnosis,” he says.
Sysmex’ seven-part differential (a traditional
five-part differential plus nucleated red blood cells and immature
granulocytes), offers automated parameters that assist physicians with
disease management of anemias, leukemias, platelet anomalies, infections,
and bone-marrow transplants,” he continues.
“These newer parameters have been enabled by the use
of fluorescent flow technology — by quickly permeating, tagging, and
optically measuring light transmission and scatter in circulating cells to
more finely discriminating cell types.”
Advanced software also is crucial, he says. “Clinical
laboratories will look to middleware to fill important needs such as
autovalidation and improved TAT, enterprise-wide solutions and single-source
data management and storage.” Bio-Rad’s Weeden agrees that software upgrades
are needed.
While most manufacturers tend to guard their own
research and development efforts from others, Sysmex and Bio-Rad have
entered into a collaborative agreement, says Taylor. “In a recently released
article, the American Diabetes Association has recommended the use of HbA1c
in the diagnosis of diabetes. In aligning with the nation’s new
present-on-admission, or POA, healthcare initiatives for evidenced-based,
patient diagnosis on admission, and in keeping with healthcare reform’s
overall aim to cut cost while improving efficiency, Sysmex and Bio-Rad have
collaborated to introduce an ‘island’ that automates diabetes and hematology
testing.
This first-of-kind solution combines the Sysmex HST-N
hematology automation platform and the Bio-Rad Laboratories’ VARIANT II
TURBO Link, which enables automated, on-demand, diabetes testing in a
random-access setting. This integrated testing solution points to an
emerging trend toward clinical laboratory automation and testing/platform
integration or ‘islands of automation,'” he continues.
Traditionally, automation involved consolidation of
testing platforms from ‘like’ disciplines within the core laboratory (e.g.,
chemistry/immunochemistry). This trend is re-emerging with a new ‘twist’
that involves quality-testing areas across disciplines (e.g., HPLC HbA1c
testing [chemistry] with hematology [CBC differential, reticulocyte count],
and driving both data and sample management through ‘intelligent’ software.”
Sysmex has been developing its own line of products
independently. “The Sysmex XE-2100D automated hematology analyzer was
recently cleared by the Food and Drug Administration (FDA) for use in
blood-processing centers for quality-control release testing. The system
will be used to test post-processed red blood cell and platelet components
collected using a variety of anticoagulants,” Taylor says.
Another recent development was the release of what
the company calls lavender-top management, “which enables laboratories to
realize virtually hands-free analysis of the lavender-top tube, providing
>90% of tests compatible with EDTA samples (i.e., erythrocyte sedimentation
rate, or ESR, CBC differential, reticulocyte count, Hb A1c, and other
esoteric tests) through sample re-routing and archiving, with as little
human intervention as possible.”
According to Taylor, the benefit of this system
begins with reduction of draw volume and the avoidance of sample splitting
and aliquoting, where a single tube can be used to analyze >90% of
high-volume tests offered within the core laboratory, such as CBC
differential, reticulocyte count, ESR, sickle screen, and Hb A1c.
“With reduced draw volumes, laboratories and hospitals can improve quality
and provide higher levels of service and efficiency to their patients,” he
says.
Facing challenges
There are a number of
challenges facing analyzer developers, aside from the shortage of
qualified laboratorians. According to Rich Bohlmann, senior instrument
product manager for ELISA at Inverness, cost has become a major
challenge. “Labs cannot afford to acquire these new instruments because
of their prices,” but he points out that design and development costs
and those associated with quality control and regulatory compliance need
to be figured in when discussing the final cost to customers.
Murray Rosenthal, PhD, manager of reagent technology
at Alfa Wassermann in West Caldwell, NJ, says another challenge is the time
and effort it takes to get a new analyzer through the FDA’s regulatory
process. He also says the industry needs to work on standardizing analyzers
so that those from different manufacturers yield the same results. He would
like to see is the establishment of a central laboratory that sets
gold-standard certifications. “But,” he notes, “there has to be some kind of
coalition. Maybe the American Association for Clinical Chemistry could take
the lead and bring manufacturers together.”
Taylor at Sysmex sees yet another challenge: a shift
in diagnostics. “The role of the clinical laboratory in the care pathway has
become increasingly important, as hospitals nationwide brace for tougher
regulatory oversight aimed at quality and cost transparency,” he says. “The
restructuring of diagnosis-related groups (DRGs) to medical-severity DRGs
used in the inpatient prospective payment system and the new POA
requirements will impact how hospitals code patients and, consequently, the
way in which hospitals are reimbursed. This, coupled with an aging
population, increasingly complex cases, and diminished human and financial
resources, makes accurate patient diagnosis and instrument capability
critical elements to adequate reimbursement and hospital survival. “As we
shift from the use of traditional diagnostics to the use of additional,
personalized disease diagnostics and treatment, the value of laboratory
testing in healthcare will continue to grow.”
Richard R. Rogoski is a freelance journalist based in
Durham, NC. Contact him at
[email protected] .
Gearing up for the automated lab
By Richard R. Rogoski
The increasing number and complexity of tests
needing to be run in today’s clinical laboratory, coupled with a
shortage of qualified laboratorians, helps bring more automation to the
bench. Other factors also are having an impact, says Pete Manes, vice
president of sales at Troy, MI-based Integrated Laboratory Automation
Solutions. Manes points to concerns about patient safety, a push to
reduce errors, and financial constraints as contributing to the
automation trend. “In order to survive, labs need to automate,” he
states.
Pete Van Overwalle, group marketing manager for lab
automation at Roche Diagnostics in Indianapolis, IN, says, “The evolution in
lab automation over the past decade has been driven by the lab’s need to
reduce complexity and increase flexibility. Those factors will continue to
drive future innovation in lab-automation systems. For example, we will see
increased integration among instrument systems, middleware, and the LIS,
with enhanced functionality to cover gaps with information flow from
bar-coded primary samples to multiple aliquot tubes. As labs pursue more
aggressive outreach programs, their automation systems will likely have to
accommodate different types of sample tubes and caps. Finally, there is an
increasing trend for labs to link additional types of instruments, such as
coagulation or hematology analyzers, to automated platforms.
“A large part of the evolution in automation is due
to increasing economic pressures and the changing nature of the lab’s
business,” he says. “For example, until the recent economic downturn, many
hospital labs were experiencing an increase in testing volumes because they
are being viewed as a new source of revenue for the health network. Their
outreach programs provided a substantial and fairly quick return on
investment. Another factor driving the evolution in automation is the labor
shortage, which requires labs to make their processes ‘LEANer’ — which is an
effort to remove non-value-added tasks in order to focus more on what the
customer is actually willing to pay for.
“Automation can help labs address both issues by
enabling them to expand their capabilities without necessarily having to
hire more people,” he continues. “An effective automation system can
eliminate the need for highly skilled med techs to be performing the
repetitive, manual tasks that other staff can do — which frees them up to be
performing the high-level diagnostic analysis that other staff cannot do —
and, thus, the lab can handle a higher volume without increasing staff. By
matching the right kind of person to the right kind of job, the lab can
improve both the efficiency and the profitability of its operations. With
labor accounting for roughly 65% of the operating expenses in a typical lab,
those improvements can make a significant impact on the bottom line.”
From hardware to software
Manes says his company developed a track system
consisting of a process-control software that uses specimen-specific data
from the LIS, and the track hardware on which the specimen travels from
analyzer to analyzer. While not the only track system on the market, Manes
says the Lab Automation Efficiency Series is an open system, which allows it
to interface with instruments from different vendors as well as with a wide
variety of laboratory information systems. Because its track is 36 inches
wide, the system can accommodate wider containers, he adds. The system also
allows the lab tech to remove any specimen from the track and run it
manually on any analyzer, then return it to the track.
The ultimate in automation is the robot. While they
do not look like the type of robots most people envision, the AutoSorter II
and AutoSorter III from Motoman in Irvine, CA, do qualify as robots, says
Craig Rubenstein, the company’s life-science technology leader. Rubenstein,
however, is quick to assuage the fears of most lab techs. “We are not
heading toward replacing lab techs with robots. We are automating the
mundane, repetitive tasks so lab techs can do important work.”
AutoSorter II (designed for high-volume reference
labs) and AutoSorter III (for moderate-volume hospital labs) are flexible
specimen-processing platforms whose specimen grippers can handle tubes
within a 7-millimenter diameter range and a 40-millimenter height range. A
reader mounted on the gripper reads bar codes as the tubes are rotated
within the grippers. Specimen loading and unloading is managed by
continuous-flow conveyors.
Roche also is developing new products aimed at
specimen tubes, says Van Overwalle. “Roche is planning to launch the cobas p
501 and cobas p 701 post-analytic storage units,” he says. “These are
high-capacity systems with a relatively small footprint that automatically
store and retrieve bar-coded sample tubes to and from an environmentally
controlled, refrigerated storage space. They can be customized to
automatically dispose of samples after a pre-determined period of time, and
they are fully integrated into the LIS, which means they deliver a sample
automatically when a re-run or re-test is ordered.
“They are designed to connect directly to Roche
pre-analytics and analytics, giving the lab comprehensive automation for the
entire sample-management process, from receipt of the patient sample to
automated disposal,” he continues. “This helps eliminate manual labor tasks
and can reduce the time it takes for sample retrieval, which in the average
lab could be 20 minutes or more. It also helps prevent quality degradation
of the sample by sending tubes into storage within minutes of being
aliquoted.”
According to The Binding Site’s Faranak Atrzadeh,
marketing manager for serum proteins, “Laboratory testing continues to move
toward automation on larger analyzers for higher throughput, ability to run
more variety of assays, and better accuracy. This trend includes the
migration of nephelometric and turbidimetric testing to big chemistry
analyzers as well. However, the challenge in transitioning to large
analyzers is that not all the assays can be switched over to these
platforms. An example is Serum Free Light Chain (sFLC) assays which are used
for assessing monoclonal gammopathies such as Multiple Myeloma and AL
Amyloidosis. Currently, sFLC assays are run on many automated nephelometric
and turbidimetric instruments which are getting old and most likely will not
be supported going forward. This presents a great opportunity for the
SPAPLUS system in labs to run the sFLC assay. sFLC is a rapidly growing
test. We recently introduced Hevylite in Europe which includes assays
specific for IgA kappa/IgA lambda. The goal is to automate these assays on
the SPAPLUS. We foresee the use of sFLC and Hevylite tests to be important
and critical diagnostic tools to clinicians in assessing multiple myeloma
and AL amyloidosis and managing patients with B cell dyscrasias.”
Work yet to do
While Rubenstein applauds advances in automation, he
says work still needs to be done in the area of data management in order to
achieve true connectivity between systems. “We have written middleware to
allow our systems to connect to other systems and LIS,” he says.”
Another area that needs work, according to Van
Overwalle, is addressing misconceptions about automation and efficiency.
“There are two common mistakes that labs can make when they try to use
automation to boost their efficiency,” he says. “The first is the
unintentional attempt to automate a bad process. The right way to approach
it is to first look at the lab’s processes and see if there are wasted
efficiencies. For example, the lab might be able to streamline its workflow
by standardizing its tube types. This is where the lab can adopt LEAN
techniques to study its workflow and identify potential sources of wasted
efficiency, such as process delays, hand-off points, and other process gaps.
“The second common mistake is to assume that
implementing automation in the lab will make every result come out faster.
While the average TAT typically drops, it is due to the reduction of the
outliers on the upper end. What automation does do is to provide a
more consistent and predictable TAT. Like most other processes,
diagnostic-testing TAT falls into a bell curve. The outliers on the upper
end — in other words, the unusually long test times — are what skew the
curve up. Automation helps eliminate those outliers on the upper end and
bring the average test time down. That does not necessarily mean every test
will come out faster, but a reduction in the average TAT is a more
significant factor in terms of the impact on the lab’s overall profitability
and customer satisfaction. Labs that implement automation successfully enjoy
the benefits of a highly predictable workflow.”
So, what should labs do? “The single biggest piece of
advice I would give to someone looking to boost overall laboratory
efficiency is to look at boosting efficiency as a two-step process,” Van
Overwalle recommends. “The first step is to make sure your lab has a LEAN
workflow. Look at your processes, and evaluate to see if there are wasted
efficiencies. The second step is to look at automation solutions to
standardize your lab’s operations and eliminate wasted labor.
“Remember that not all automation solutions are
created equal. Make sure you carefully consider the product-quality aspect
of the proposed solution. For example, ask about ‘mean time to failure’
metrics so you can evaluate the potential for interruptions from unplanned
downtime. Overall, the best automation system for your lab is one that is
reliable and flexible enough to accommodate your changing needs. This will
allow you to reduce complexity, enhance your level of patient care, and
facilitate your financial growth.”
Richard R. Rogoski is a freelance journalist based in
Durham, NC. Contact him at [email protected].
Elevating patient care at University of Michigan Hospital
By Sue Stern, MS, MT(ASCP)
At a busy
tertiary-care academic center where the clinical lab churns out 8
million test results a year — 7 million just in chemistry and
immunodiagnostics — effective deployment of automation and information
technology to maximize productivity and cost efficiency is a given. Such
is the case at the University of Michigan Hospital (UMH). At the
chemical pathology department, productivity gains are only part of the
story. Indeed, the lab has been able almost to double its volume over a
period of almost four years, without adding staff or instrumentation.
Just as important are quality improvements that have made a positive
impact on patient care. From 2004 to 2009, the number of errors was
reduced by half while volume almost doubled. Turnaround time also kept
dropping. Today, 97.3% of in-patient STAT samples are delivered within
the targeted TAT of 45 minutes, while 99.8% of routine samples are on
time for the 120-minute goal. Last but not least, the lab was able to
reduce the number of SST tubes per patient, by as much as 60% in the
outpatient area — a welcome change that benefits patients and their
caregivers.
Powering productivity through workflow design
Chemical pathology at UMH provides chemistry,
special chemistry, immunology, and toxicology testing services for all
three hospitals on campus, with a total of 865 beds and 1,600
physicians, as well as 30 health centers and 120 outpatient clinics
within a 60-mile radius. To accommodate the consistent annual growth
rate of 3% to 5%, a mix of inpatient and outpatient, STAT, and routine
testing needs, the lab designed and implemented a new automation line in
2006, including three immunoassay systems, three chemistry systems, two
centrifuges, and two sample managers that handles 100 different
chemistry and immunoassays, all managed by networking solution. Six
instruments took over the workload of eight analyzers used prior to the
redesign and have supported the volume growth over the last four years.
Today, the automation line runs 24/7.
Automating previously manual tasks:
The networking solution can be programmed to execute tasks that are
often performed manually. At UMH’s chemical pathology lab, it handles
automatic repeat testing for some tests. The lab also takes advantage of
specialized algorithms for infectious-disease testing; for example, when
duplicates of hepatitis or HIV tests are required, the system will run
the duplicates automatically. This saves technologists time since, by
the time they review the results, the necessary dilutions and/or repeats
have been performed already. Similarly, when there is an add-on, the
system will locate the patient sample on the automation line with no
manual intervention, run the test, and report the result (or flag it for
technologist review as appropriate). Turnaround is faster since there is
no delay waiting for the technologist to locate the specimen.
For labs looking into lab-informatics solutions, the starting
point is a list of what the lab wants to accomplish.
Autoverification streamlines results
reporting: With autoverification, each result is classified
based on criteria programmed into the system, flagging only those
results that require technologist review. This means there are fewer
results to review — at UMH, 80% of test results are reported directly
without technologist review. It also means that the same rules are
applied, consistently, to review the results.
A backup for the LIS: When the LIS
is down, the networking solution provides a computerized backup,
alleviating delays.
Measurable gains in quality care
Even more important than the improvement in
productivity is the impact of automation and information technology on
patient care.
Improved TAT expedites clinical decisions:
Auto-verification and the automation of typically manual processes have
reduced manual steps and decreased TAT. Routine samples classified as
“on time” based on the 120-minute goal increased from 98.4% in August
2007 to 99.8% in August 2009. Using a 60-minute benchmark for all STAT
samples, on-time STAT-sample TAT increased in the same time period from
89.9% to 99.8%. Furthermore, inpatient STAT samples meeting a 45-minute
goal advanced from 66.7% to 97.3% in the same period, while 95.6% of
outpatient STAT samples were reported within the 45-minute goal,
compared to 77.6% two years ago. TATs such as these support timely
clinical decisions and specific clinical guidelines in some cases.
Delta checking by both absolute value and percentage is
important, as is quality control (QC) and the ability to stop results if
QC is out.
Reduced error rates enhance patient safety:
Error rate is an important benchmark of quality and safety. At UMH,
standardization of the results-review process, automation of error-prone
manual tasks (e.g., locating specimens for add-ons), and the reduction
of the number of results requiring staff review have contributed to a
reduction of the number of reported errors.
Fewer blood draws: The
consolidation of more than 100 different tests on the automation line
has significantly reduced the number of SST tubes required. In the past,
for example, a basic profile, lipids, and thyroids might require three
different blood tubes. Now, only one tube is needed. In the outpatient
group, this means a 60% reduction in number of SST tube draws.
Pointers for middleware evaluation
For labs looking into lab-informatics solutions, the starting point is a
list of what the lab wants to accomplish. In the case of UMH,
considerations such as reducing staff stress and handling the
ever-increasing volume were the primary concerns. And middleware needs
should be reviewed in the context of the current LIS, with the goal of
complementing LIS capabilities. With autoverification, one important
feature to look at is the ease of rules writing and the flexibility to
build rules, as needed, for special circumstances. Delta checking by
both absolute value and percentage is important, as is quality control
(QC) and the ability to stop results if QC is out. Technical support is
a factor, as is the vendor’s commitment to product enhancements on an
ongoing basis.
Sue Stern, MS, MT(ASCP), is administrative
healthcare manager in the Chemical Pathology Department at the
University of Michigan Hospital in Ann Arbor, MI. From Siemens’ ADVIA
line, Stern used its LabCell Automation Solution, three Centaur
Immunoassay Systems, three 2400 Chemistry Systems, and the CentraLink
Networking Solution.
