CAP Jul 2015

pathology
laboratory medicine
laboratory management
JULY 2015
IQCP worries? Help with what ends and begins

Anne Paxton
Technically, its true: The Centers for Medicare and
Medicaid Services new program, the Individualized Quality Control Plan, is a voluntary, alternative option that clinical laboratories can use to
customize their QC plans according to test method,
patient population, environment, and personnel
competency.
For much of the laboratory community, however, optional is the last word association they
would make with IQCP. What many see is an
entirely new quality control framework to grapple
with every day; a looming cutoff date when the old,
reliable system will become extinct; and potentially
a major drain on their workday time and energy to
cope with unfamiliar concepts of risk assessment.
Dale Dong
In genetics, stay open

to the unexpected
William Check, PhD
When Uta Francke, MD, received the
Association for Molecular Pathology
Award for Excellence in Molecular
Diagnostics at the 2014 AMP meeting, she titled her lecture Adventures in Disease Gene Identifcation
and Characterization of Mutations.
Her title was appropriate for a research clinician who, during her 35year career, while working on several
major human genetic disease challenges, contributed in significant
ways to our understanding of important genetic disease mechanisms and
whose laboratory identifed the gene
for Wiskott-Aldrich syndrome.
Iris Schrijver, MD, who is one of her
past trainees, speaks of Dr. Franckes
passion for research and her many
groundbreaking discoveries.
Her research has advanced our
understanding of molecular mechanisms of many inherited conditions,
among them Marfan, Rett, PraderWilli, and Williams-Beuren syndromes, says Dr. Schrijver, director of
the molecular pathology laboratory
at Stanford University Medical Center and a professor of pathology and
pediatrics, Stanford University School
of Medicine. She tells CAP TODAY:
Uta pioneered how research testing
could be translated to the clinical
arena. In that sense continued on 88
Its no wonder that, as CMS Jan. 1, 2016 implementation date nears, some laboratory directors are
considering an Ativan prescription. But as a service
to CAP-accredited labsand with the aim of keeping panic at baythe CAP has marshaled an array
of resources to ease laboratories transition to IQCP.
Already available are workbooks, algorithms, templates, lists of frequently asked questions, and other
guidance from the CMS, the CAP, the
Clinical and Laboratory Standards
Institute, and the American Society
for Microbiology. Now, the CAP
Laboratory Accreditation Program
has integrated IQCP requirements
into the 2015 edition of the All Common Checklist, which at CAP TODAY
press time was scheduled for release
at the end of July.
For those who are writing individualized plans using IQCP, the
Laboratory Accreditation Program
wants to provide support, and so
were offering nuts-and-bolts help,
says checklist commissioner Gerald
A. Hoeltge, MD. The All Common
Checklist will have a brand-new section on IQCP that will itemize all the
Every lab accredited by the CAP has the expertise to do
a risk assessment, Dr. Gerald Hoeltge says. But now that
risk assessment will have a structure and a table behind it.
pieces that must be in place, and you

can go to the Colleges Frequently
Asked Questions page for a really
clear preview of
continued on 68
Business analytics insight within easy reach

Anne Ford
It used to be that business analytic solutions came only
from LIS or enterprise-wide vendors, accessing these
solutions meant going through the IT department, and
laboratories requests to join the business analytics party
frequently fell to the bottom of the priority pile.
Forget used to be. Now, says Hal Weiner of Weiner
Consulting Services LLC, in Eugene, Ore., new tools
have been developed by third-party vendors to make

it much easier for labs themselves to create their own
dashboards, their own queries, and their own monitoring tools. And interest in business analytics is high
among health care executives. A survey last year by
Price Waterhouse Cooper of 1,344 health care CEOs
found that 68 percent had concrete plans to implement
business analytics or had undertaken
continued on 18
New lab, new

effciencies
page 80
Conrad Schuerch, MD
Myra Wilkerson, MD
Geisinger Medical
Laboratories
Vol. 29
No. 7
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JULY 2015 | CAP TODAY 5
For CKD, work is on to refne and fnd biomarkers

Karen Lusky
Getting the upper hand on chronic
kidney disease requires taking maximum advantage of existing CKD
biomarker capabilities. It also
means discovering new markers,
though the trick is fnding those
that can expand treatment options.
Some believe fbroblast growth factor-23 has the potential to ft that
bill, with one researcher calling it
among the most exciting new tar-
July 2015 Vol. 29 No. 7

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In a talk at last years AACC annual

meeting, Dr. Narva reported that he
frequently gets questions from clinicians such as, We did the microalbumin test. It came back 5,726. What
do I do now? Do I get a 24-hour
urine? I say, No, that patient is in big
trouble. That patient has about 6
grams of urinary albumin per day.
The other issue, Dr. Narva said,
is the multiple names that are given
to these tests, and many clinicians
think that if you have a little bit of
kidney disease, you have the little
albumins, the microalbumins, and
then if you have bad kidney disease,
the big albumins come out. They
dont understand that its all albumin
and thats a continuous risk factor.
Urine albumin isnt standardized,
which can affect diagnosis and follow-up, especially if clinicians arent
aware of it. Dr. Miller and Lorin
Bachmann, PhD,
DABCC, associate
professor of pathology, Virginia Commonwealth University Medical Center,
are leading a standardization initiative. The NKDEP Dr.Bachmann
and International
Federation of Clinical Chemistry and
Laboratory Medicine have formed a
joint Laboratory Working Group to
facilitate standardization efforts for
urine albumin, says Dr. Bachmann,
who chairs the IFCC Working Group
for Standardization of Albumin in
Urine. The aim is a robust reference
system so the manufacturers have a
trusted accuracy base on which to
calibrate their clinical assays, says
John H. Eckfeldt, MD, PhD, former
chair and current member of the
NKDEP Laboratory Working Group
and a professor of laboratory medicine and pathology, University of
Minnesota.
How far off the mark are manufacturers assays? A study that Dr. Miller,
Dr. Bachmann, and colleagues conducted found as much as a 45 percent
difference among the various commercial urine albumin procedures
(Bachmann LM, et al. Clin Chem.

2014;60[3]:471480).
Most of the difference, Dr. Bachmann says, could be accounted for
by concentration-dependent bias,
where the methods differed by a
range of -35 to +35 percent at 15
mg/L and -15 to +18 percent at 30
mg/L.
That means patients who are near
the ACR cutpoint of 30 mg/g could
be classifed as being above or below
that threshold based on the laboratory
method used rather than actual physiology, Dr. Miller says. Theres a lot of
evidence that suggests that the threshold should actually be lower. Theres
an increased hazard ratio for progressing CKD at lower albumin/
creatinine ratios, but the bias becomes
even larger at lower values. So until
the standardization is complete, he
says, its not really practical from a
clinical implementation point of view to
consider lowering
the thresholds.
Dr. Miller predicts standardization will be wrapped
up in about six
years. The best route
Dr.Miller
for now may be for
clinicians to use the same laboratory
for urine albumin testing when monitoring a patient who, for example, has
diabetes, hypertension, or increased
cardiovascular risk, he says. The advantage of using the same lab is then
you see changes that probably refect
the patient rather than the lab method.
If you are tracking a diabetic who
doesnt yet have albumin in their
urine, you could make a case that you
should try two or three labs to see if
one of them gives you a value above
30 mg/g as an early indicator, but its
not a practical recommendation.
Diurnal variation and many physiological parameters that affect urine
albumin levels also can cause albumin/creatinine ratio results to vary.
Dr. Narva points out that the Centers
for Disease Control and Preventions
evaluation of NHANES (National
Health and Nutrition continued on 6
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Abstracts
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The recommendations of the new guideline

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Approaches to validating NGS procedures
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PO Box 207, Parker Ford, PA 19457 or call 888-4891555, sales@kerhgroup.com. Deadline: 15th of month
preceding desired issue date.
gets in chronic kidney disease.

Urine albumin, creatinine, and
newcomer cystatin C have their
strong points. Each has its pitfalls,
too, which stem from the nature of
the biomarker itself, testing accuracy
issues, or sometimes knowledge
gaps about how to use or interpret a
test result.
Laboratory professionals should
be aware that both clinicians and
patients may look at these [test] results as absolute without understanding the variables that may affect measurements, says Andrew Narva,
MD, director of the National Kidney
Disease Education Program at the
National Institutes of Health, who is
often on the stump educating clinicians and sometimes laboratory professionals about laboratory assessment of chronic kidney disease.
About half of the people identifed as having CKD in the U.S. have
that diagnosis only on the basis of
increased urine albumin, Dr. Narva
says. You can have albuminuria or
decreased glomerular fltration rate,
or both.
Urine albumin is the best biomarker for the more common causes
of kidney damage: diabetes, hypertension, and cardiovascular risk factors, says W. Greg Miller, PhD, professor of pathology at Virginia Commonwealth University Medical Center, chair of the NKDEP Laboratory
Working Group, and member of the
CAPs Accuracy-Based Testing Committee and of the International Standards Organization Technical Committee 212 Working Group 2 on
Clinical Laboratory Reference Measurement Procedures and Materials.
A lot of different studies over time
have shown very clearly that the albumin/creatinine ratio in the frst
morning void is very nearly identical
to the 24-hour urine albumin excretion rate, Dr. Miller says. The albumin/creatinine ratio, or ACR, compensates pretty nicely for hydration,
he adds. The standard cutoff is 30 mg
per gram of creatinine.
Misunderstandings about the ACR
can sidetrack clinical care, however.
6 CAP TODAY | JULY 2015
CKD biomarkers
continued from 5
Examination Survey) data found that

only 43 percent of the participants with
a positive random
urine exceeding 30
mg/g of creatinine
had a positive frst
void specimen. That
information was
useful, he says, because the timing of
Dr.Narva
the two specimen
collections refects the usual clinical
scenario in which a screening test is
performed on a random basis and a
confrmatory one on a frst morning

void.
It would be nice to have a random followed up by two frst voids
in a study to confrm thats the way
to do it, Dr. Narva says. As part of
the urine albumin standardization
process, the Lab Working Group will
provide data on the best timing for
reproducibility. The CDC data will
be useful in that regard, he adds.
n the use of glomerular fltration

rate to diagnose CKD, Dr. Narva
fnds theres confusion about the
difference between measured and
estimated GFR. He notes that the
estimated GFR equations were developed in populations of people

who had their GFRs measured.
They do provide a very good refection of the population, but when
you are looking at an individual
across the desk or exam table from
you, the uncertainty associated
with the prediction equation result
for that individual can be a signifcant matter, he cautions. The
performance characteristic thats
used is P30, which is the likelihood
of being within [plus or minus]
30 percent of the measured GFR.
Thats a pretty wide range, and it
increases as eGFR increases. So you
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can be telling someone they have

CKD when actually they do not.
The most useful aspect of the estimated GFR, he says, is identifying
those with CKD who have a near
normal creatinine. People often
dont understand that the creatinine
doesnt have to be very high for the
GFR to be much decreased. If someone sees a creatinine of three, they
know that person has a problem. Its
greatest purpose is as a warning fag
that someone actually may have kidney disease.
The 2012 Kidney Disease: Improving Global Outcomes recommendations, released in January 2013, advise
using cystatin C for patients who
have an eGFR based on creatinine
that falls between 45 and 59 without
elevated urine albumin. Thats sort
of an ambiguous area, Dr. Miller
says, and basing the eGFR on a cystatin C-based equation or ideally on
a combined creatinine and cystatin C
equation gives a more reliable estimate of GFR.
Dr. Eckfeldt says the group in
Lund, Sweden, that discovered cystatin C recommends reporting estimated GFRs individually, with one
based on creatinine
and another on cystatin C to discover
discordance and investigate why they
are different. For
example, if people
Dr.Eckfeldt
are cachectic, they
produce less creatinine than normal
people, and their eGFRcreatinine will
be artifcially high, Dr. Eckfeldt says.
Body builders will have an artifcially
low eGFRcreatinine.
An inaccurate cystatin C result
could explain the difference between
the two eGFRs. A study reported in
Archives of Pathology & Laboratory
Medicine says: [D]espite the availability of an international reference
material for more than 3 years, the
variability in cystatin C measured
values with several widely used clinical measurement procedures appears
to be too large for the values to be
very useful for diagnosing and managing patients with kidney disease
(Eckfeldt JH, et al. Arch Pathol Lab
Med. 2015;139[7]:888893).
Dr. Eckfeldt explains: Very roughly, a given percentage error in cystatin
C concentration translates into a similar percentage error in eGFRcystatin
C in the opposite direction. Thus, if
your measured cystatin C concentration is 25 percent low, then your eGFRcystatin C will be 25 percent high.
This could put the patient in an entirely different category of chronic
kidney disease. While the inverse
relationship between serum creatinine and eGFRcreatinine is similar,
the accuracy of serum creatinine measurements has improved dramatically over the
continued on 8
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CKD biomarkers
continued from 6
past decade, says Dr. Eckfeldt, who is

also a member of the CAPs Chemistry Resource and Accuracy-Based
Testing committees and of the International Standards Organization
Technical Committee 212 Working
Group 2 on Clinical Laboratory Reference Measurement Procedures and
Materials.
hats needed more broadly,

Dr. Eckfeldt says, are better biomarkers to diagnose kidney
injury and predict development of
end-stage renal disease. Most of
the people classifed as at risk of developing end-stage renal disease or
adverse symptoms from the kidney
disease itself never really develop
end-stage renal disease. In fact, its a
relatively small percentage, he notes.
The National Institute of Diabetes
and Digestive and Kidney Diseases
has a CKD Biomarkers Consortium
of more than a dozen universities
looking for biomarkers that can predict and improve outcomes.
Nephrologist Paul L. Kimmel, MD,
senior advisor at the institute and
project scientist for the consortium for
phases one and two, says there has
been great interest at the NIDDK in

developing CKD biomarkers that
could be helpful in a number of ways.
One would be to identify which patients will have a rapid course to
end-stage renal disease, and another
to predict which patients will respond to a particular medication, or
which patients will have a complication seen in CKD.
Also, for designing clinical trials,
I think its imperative that we have
better markers, if they exist, to guide
getting the patients who would be
responsive to the therapy into the
trial, and excluding patients who
would not have a response to therapy
or perhaps have an adverse response, Dr. Kimmel says.
In Dr. Kimmels view, the most
promising marker appears to be fbroblast growth factor-23 (FGF23),
which he describes as an early marker of mineral metabolism dysfunction
in CKD.
The main finding of a recently
published study (Rebholz CM, et al.
J Am Soc Nephrol. 2015;26[1]:192
200) was that higher levels of intact
FGF23 were strongly associated with
development of end-stage renal disease. We adjusted for a number of
confounders, such as demographic
characteristics, and risk factors for
kidney disease as well as the baseline

kidney function, eGFR, and then
other mineral metabolism biomarkers, says Casey Rebholz, PhD, MS,
MPH, assistant professor, Department of Epidemiology, Johns Hopkins Bloomberg School of Public
Health.
The researchers, the abstract says,
assessed the relationship between
baseline (19901992) serum levels of
intact FGF23 and incident ESRD in
13,448 Atherosclerosis Risk in Communities (ARIC) study participants
(56.1 percent women, 74.7 percent
white) followed through 2010. At
baseline, the mean age of participants
was 56.9 years; the mean eGFR was
97 mL/min per 1.73m2. During a
median follow-up of 19 years, 267
participants, or two
percent, developed
ESRD.
Josef Coresh,
MD, PhD, also of the
Johns Hopkins Department of Epidemiology and a coinvestigator for the
Dr.Coresh
study, says they focused on FGF23 instead of comparing
it to other things. When you look at
CKD, the strongest risk factor is always estimated GFR by creatinine.
That alone can have a 10,000-fold risk

rate, but we know about that. The
goal, he says, is to get new biomarkers with information above and beyond that which is potentially actionable. The idea is the phosphate axis
[which is affected by FGF23 levels]
could be potentially actionable
through dietary intake or other
manipulation.
FGF23 researcher Myles Wolf, MD,
MMSc, says FGF23 is one of the main
regulators of serum phosphate. With
dietary phosphate a contributor to
FGF23 elevation, he too believes it
could be actionable in CKD.
However, a number of small pilot
studies have examined whether dietary phosphate restriction or dietary
phosphate binders that prevent gastrointestinal absorption can lower
FGF23, and the results have been
mixed, says Dr. Wolf, Margaret Gray
Morton professor of medicine and
director of the Center for Translational Metabolism and Health at
Northwestern University Feinberg
School of Medicine.
The COMBINE study (CKD Optimal Management With Binders and
Nicotinamide) is going to take a different tack, says Dr. Wolf, a member
of the studys steering committee.
Researchers will
continued on 10
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CKD biomarkers
continued from 8
use a phosphate binder, lanthanum

carbonate, along with nicotinamide
as a second method to reduce phosphate absorption, he says. The aim is
to lower FGF23 and serum phosphate levels. Participants are being
recruited now and the study is expected to be completed within 24 to
30 months.
The COMBINE study is a pilot
study, the primary goal of which is to
test whether these interventions can
lower biomarkers of phosphate homeostasis, including serum phosphate
and FGF23, explains Dr. Wolf. If the

study is successful, the next question
will be whether the interventions can
in turn improve clinical outcomes.
That would require
a subsequent randomized, controlled
trial that would
need to be much
larger and of substantially longer duration. So as far as
changing manageDr.Wolf
ment of chronic kidney disease, I believe that FGF23 testing and targeting is still a fair bit
away.
While the mechanisms of FGF23

elevation in kidney disease may be
somewhat related to phosphate intake, its likely other mechanisms are
involved too, Dr. Wolf says. So exclusively targeting phosphate might
be insuffcient in many patients.
He points out that several human
studies have shown an association
between higher FGF23 and left ventricular hypertrophy, and the latter is
a well-known underlying mechanism
that contributes to diastolic heart
failure. We published an [animal]
study in which we showed that elevated FGF23 might play a direct
causal role in the pathogenesis of
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LVH by stimulating hypertrophic

growth of cardiac myocytes. And we
showed that LVH was present in
several experimental states of elevated FGF23 (Faul C, et al. J Clin Invest.
2011;121[11]:43934408).
FGF23 is extremely strongly predictive of death and heart failure, he
adds.
Dr. Wolf says his groups theory is
that kidney disease results in increased FGF23 levels. This helps
patients maintain a normal serum
level of phosphate, but chronically
elevated FGF23 levels, especially in
the setting of chronic kidney disease,
promote LVH which puts patients at
risk for heart failure and perhaps
death.
Are there other ways to lower
FGF23 levels? To answer that question, Dr. Wolf notes a paper published
online last month in Circulation on a
secondary analysis of the EVOLVE
trial, which had 4,000 dialysis patients. The new analysis showed that
a medication called cinacalcet (Sensipar) decreased FGF23 and that participants with the largest reduction
had a signifcant survival beneft and
significantly fewer cardiac events,
particularly heart failure (Moe SM, et
al. Circulation. Epub ahead of print
June 9, 2015. doi:10.1161/circulation
aha.114.013876).
So it all fts with the hypothesis
that elevated FGF23 increases risk of
heart failure and death, and suggests
that cinacalcet is a non-dietary approach to lowering FGF23, Dr. Wolf
says. Theres a catch: Cinacalcet is not
FDA-approved for use by CKD patients who arent on dialysis. Part of
the reason is that the drug causes
excessive hypocalcemia, he says.
Our hope, Dr. Wolf says, is that
the cardiac receptor that mediates the
toxic effects of FGF23 is distinct from
the receptor that mediates the benefcial effects of FGF23 to regulate phosphate excretion in the kidney. If so,
that could create the opportunity to
block FGF23 effects on the heart
selectively.
I think FGF23 is a reasonably
good biomarker, but I think its promise may prove to be ultimately greater
as a target or mediator than as a biomarker, Dr. Wolf concludes. He says
it could lead to important clinical
advances in the future and considers
it among the most exciting new
targets in CKD.
Dr. Eckfeldt, a co-investigator with
Dr. Rebholz of the study reported in
the Journal of the American Society
of Nephrology linking FGF23 levels to
future ESRD risk, thinks that FGF23
could be clinically useful as a solo
biomarker or in conjunction with others but that the jury is still out. At this
point, more clarity about how to measure the marker is needed.
There are several different IVD
manufacturers assays for FGF23 that
give somewhat
continued on 15
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from the
Presidents Desk
Gene N. Herbek, MD
Our role in shared decision-making

Responsibilities as medical director for transfusion and coagulation services at Nebraska Methodist Hospital in Omaha occupy about 15 percent
of my time. We have an excellent staff, the work
is satisfying, and I enjoy the patient contact. In
2007, we became one of what are now three hospitals in Nebraska with recognized blood conservation programs and one of about 150 nationally
that accommodate patients who refuse or restrict
blood use for personal or religious
reasons. Many of these patients
travel a significant distance to
reach us.
We follow evidence-based guidelines to accommodate our no
blood patients, who account for
about 800 visits annually. Members
of our staff are asked to sign a form
attesting that they will abide by
patient wishes in this regard; while
we respect the right to decline, most
have signed on. I think many of
those who eventually agree to honor our patients values have done
some serious thinking in the interim. At heart, it is all about respect
for patient preferences and commitment to patient-centered care, our
topic for this month.
The recent consensus statement defning the
pathologists role in determining the eligibility of
patients with low-risk prostate cancer for management via active surveillance (Amin MB, et al.
Arch Pathol Lab Med. 2014;138:13871405) identifes criteria for evaluation of treatment options
that can then be discussed with patients as part
of shared decision-making. Pathologists collaborated with urologists, oncologists, surgeons, and
radiation oncologists to develop the consensus
statement, and the backstory, captured in a frontpage article in the April 2015 issue of CAP TODAY,
is great reading. The consensus statement and the
article should interest anyone with responsibility
for the precise communication skills and specimen management practices that active surveillance requires.
M. Elizabeth Hammond, MD, a consultant
pathologist at Intermountain Healthcare and a
CKD biomarkers
continued from 10
discordant answers. So the fndings

are somewhat assay-dependent,
which is partly due to different forms
of FGF23 being present in serum of
certain patient groups. The problem,
Dr. Eckfeldt says, is somewhat similar to early parathyroid hormone assays where C-terminal assays got very
different values from N-terminal or
intact assays, particularly in patients
with renal disease where non-biologically active PTH accumulates.
s for other potential biomarkers,

Dr. Kimmel says theres been a
fnding for about fve years that vari-
professor of pathology and adjunct professor of

internal medicine at the University of Utah School
of Medicine, will moderate at CAP 15 a scientifc
plenary on shared decision-making in prostate
cancer screening, diagnosis, and treatment. Now
that the consensus statement has been published,
she says, each of us has to fnd the best way to
enable the clinician and patient to engage in
thoughtful discussion of management options.
How do we talk about the specifc
risks and benefts of active surveillance, surgery, and radiation in each
individual case? How can we enable patients to appreciate all the
possible outcomes and understand
that we can never know everything
for certain?
Given the technical nature of our
work and the accessibility of the
electronic health record, pathologists need to start thinking about
the terminology employed to communicate with clinicians and patients both orally and in our reports,
says Dr. Hammond, who is a former
chair of the Department of Pathology for UCR Hospitals (Intermountain Healthcare). Everything in the
pathology report should be useful
to the doctor and understandable to the patient,
she says; we need to clarify and explain our diagnoses in a standardized way that refects what we
understand about what patientsand clinicianswant to know. The need to communicate
clearly in pathology reports will become even
more important as active surveillance is used
more widely, meaning that patients and clinicians
will be following progress as refected in more
reports. We can help them make the most of those
conversations by providing clear content and using the same nontechnical words to say the same
things each time.
The University of Washington in Seattle is the
coordinating center for the largest active surveillance study in North America. They have been
holding separate focus groups for physicians and
patients to identify how best to frame pathology
reports. John Gore, MD, MSHS, an associate pro-
ants in apolipoprotein L1 (APOL1)

alleles confer a very high risk of susceptibility to developing common renal diseases, such as focal glomerular
sclerosis, hypertensive nephrosclerosis, and HIV-associated nephropathy.
While everyone has the APOL1 gene,
says Johns Hopkins Dr. Coresh, its
only present as a susceptibility variant in populations of African origin.
In people who have the two variant
alleles, early on the risk [of CKD]
isnt that high, but later on in kidney
disease the risk probably accelerates, he says. So it will likely be an
important marker, but right now its
not ready for widespread screening
because we arent completely clear
about the risk or appropriate action.
fessor in the UW Department of Urology, who

will be on the panel at the CAP 15 scientifc plenary, was among the experts who drafted the
consensus document. Dr. Gores clinical and
surgical practice is primarily in kidney and bladder cancer while his research focuses on prostate
cancer. He knows frsthand about the increasing
pressure clinicians face to become evermore effcient while documenting the details of each
patient encounter.
The need to protect time for patient counseling
is one of the best reasons to adopt synoptic pathology reports, Dr. Gore says, and separate
streamlined reports for patients in addition to the
standard reports already in the EHR are well
worth considering. If the clinician knows exactly
where various types of information will appear
in the report, patients will not need to wait anxiously while they search for it. A standardized,
less technical vocabulary and stable format are
more accessible to clinicians and to the increasing
numbers of patients who access the EHR directly.
The outcome will be clarity that enables patients
to explore options with their clinicians more fully
in less time.
One person whos been studying these issues
for a long time is Albert G. Mulley Jr., MD, MPP,
director of the Dartmouth Center for Health Care
Delivery Science and a professor of medicine at
the Dartmouth Geisel School of Medicine. Dr.
Mulleys research has shown there are often wide
gaps between what patients want and what physicians think they want. These preference misdiagnoses can harm patients, divert funds from
needed health care services, and drive up overall
costs. These consequences can be avoided, Dr.
Mulley says, when there is clarity between physicians and patients about the outcomes that are
possible and those that would be most valued.
Perhaps most important, he says, recognizing the
need for this clarity enables physicians to adopt
a posture of humility about what they can know
and what they cannot know without engaging
their patients and learning what matters most to
them.
As Dr. Hammond has been known to say, we
may be the experts in what we do, but our patients are the experts in what they want.
Editors note: The CAP 15 scientifc plenary will
take place in Nashville, Tenn., on Oct. 4 at 8 am. The
speakers will be John Gore, MD, MSHS, and Jonathan
Epstein, MD.
Dr. Herbek welcomes communication from CAP
members. Write to him at president@cap.org.
Thats the issue for the CKD Biomarkers Consortium, Dr. Kimmel
says: Whether we can come up with
something meaningful that a doctor
can use during a patient visit that will
be better than proteinuria so the physician can say to a patient: You are 62
years old and have a long history of
hypertension. Now your kidney
function is slightly diminished, you
have a certain level of proteinuria,
and theres this great test that says,
We dont have to worry, because if
you take a certain drug, your renal
function isnt going to change for 30
years.
We prescribe ACE inhibitors or
ARBs to control blood pressure, carefully watch the medication list for
[nephrotoxic drugs], and make sure

no obstructive uropathy develops,
but we dont now have a test or a
therapy where we are going to radically change things in most cases of
hypertension-attributed or diabetic
kidney disease, Dr. Kimmel says.
We need that kind of information.
He holds in high regard the clinicians who back in the day developed
the tests still in useserum creatinine
and urinary protein. Its very, very
hard to do better than those in predicting outcomes, Dr. Kimmel says,
which is the challenge for the kidney
biomarker community.
Karen Lusky is a writer in Brentwood,
Tenn.
Letters
Breast biopsy study
The article Laying worries to rest
over breast biopsy discord (May
2015) misses the mark. It fails to
expose the essential faw in the
JAMA study (Elmore JG, et al.
2015;313:11221132): The study
design assumes the duct hyperplasia/atypical duct hyperplasia/
low-grade DCIS categories are
reproducible at a high level among
a wide range of experienced pathologists, including breast pathol-
ogy experts. Where is the evidence to support this? The last time
breast pathologists participated in a
study of reproducibility was in 1992
(Schnitt SJ, et al. Am J Surg Pathol.
1992;16:11331143). In that study,
the error rate for DCIS was 30
percent and for ADH 25 percent.
Where were these statistics in the
CAP TODAY and JAMA articles for
background and perspective?
Your story failed to ask crucial
questions: Why was the JAMA
study done? Why structure the
test so that it in no way resembled the routine daily practice of
surgical pathology? Why over-
weight ADH/DCIS? (The authors

said this was done for statistical
purposes, but the result is overwhelmingly negative spin for
pathology because virtually no one
reads the fne print.) The CAP
TODAY article bemoans the fact that
pathologists are targeted yet again
for negative media coverage of the
practice of breast pathology. When
the press hypes this on its own, it is
unfortunate. When pathologists
doing poorly designed studies
contribute to this frenzy, it is
irresponsible.
Karen Titus asks, Are there
deeper issues to explore? But then
fails to follow through. Dr. Bloom
suggests its a communication
issue. Dr. Simpson says, Its
possible to see the study as a compliment. Have these experts gone
down the rabbit hole to Wonderland? Reality check, please! The
takeaway message from the JAMA
article is clear to the medical community and to the public: Community pathologists cannot be trusted
to sign out your breast biopsies
because they cannot distinguish
ADH from low-grade DCISand
experts can. (Of note: Originally
this was to be a study of academic
and community pathologists.
Somewhere along the way, the
academic participation was largely
dropped.)
No, this CAP TODAY article does
not lay to rest worries over breast
biopsy discord. It is a weak critique
of an irresponsible and harmful
article and does not confront the
elephant in the room: Are the diagnostic categories of DH/ADH/
DCIS reproducible at a high level
by reasonably experienced pathologists, including the experts? What
rate of reproducibility is acceptable?
Defne breast pathology expert.
Comments I have read about the
JAMA article and heard in conversations with colleagues vary from
amusement at the studys absurdity
to anger to boredom for a subject
that has been around for 30 years
without resolution.
We need to tone down the rhetoric of error and experts versus
community pathologists, which
only serves to increase patient
anxiety. Organized pathology needs
to take a strong stand on this issue
and educate clinicians and the
public on the reality of diagnosing
precancerous breast lesions.
Diane J. Schecter, MD
Surgical Pathologist
White Plains Hospital Center
White Plains, NY
We appreciate your sharing your opinion
of the study and our story but wish to note
there was never an intent for the CAP
TODAY coverage to be a critique of the JAMA
study but simply reaction to it by a few
distinguished breast pathologists. Editor
Labs and public health

The editorial by Gene Herbek, MD,
Lab leadership in public health
(June 2015), is excellent. As a former
physician in the Argentine jungle
and pediatric pathologist for the
past 50 years, I can appreciate the
importance of our work and its
relation with public health (unfortunately not always duly recognized).
L. David Mirkin, MD
Professor of Pathology and Pediatrics
Wright State University
Boonshoft School of Medicine
Director, Pathology
and Clinical Laboratory
Dayton (Ohio) Childrens Hospital
Book on healing art

CAP Press is creating a new book
titled Healing Art of Pathology and
is looking for contributions. As the
editor of the book, I would like not
only the contributions of CAP TODAY readers but also their support
in spreading the word that we are
inviting submissions consisting of
images of art and/or inspiring
stories of how pathology and pathologists make a difference in
patient care.
My Sarcoma by Mofftt Cancer Center

patient and artist Ray Paul, who combined
paint, photographic images of his tumor cells,
printmaking, video, and music to create an
exhibit of his experiences. Paul says Dr. Bui
stepped out of the shadows of the lab and
made me realize pathologists are an integral
part of the team . . . . She helped me begin my
journey from cancer patient back to artist.
We welcome contributions from

you, pathologists and laboratory
professionals. What inspires your
work? How do you connect your art
and science of pathology to the
patient? We also welcome contributions from patients and families
(How do they feel about the value of
the pathologist, in partnership with
other physicians, in contributing to
their diagnoses and clinical care?
How does their seeing their slides/
specimens and/or interacting with
their pathologists infuence their
experience, or their art?) and clinicians (How do they value the role of
the pathologist and laboratory in
maintaining the health of their
patients?).
For more detail, please contact me
at marilyn.bui@mofftt.org.
Marilyn M. Bui, MD, PhD
Departments of Anatomic
Pathology and Sarcoma
Mofftt Cancer Center
Tampa, Fla.
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Fig. 1. Use Case: Client/Physician Management
Business analytics
Alerts and Predictive Analytics on Physician Behavior
continued from 1
or completed an implementation. An additional 22 percent

were developing a strategy to
implement, Weiner reported in
a presentation in May at the
Pathology Informatics Summit
(a presentation developed in
tandem with Dennis Winsten of
Dennis Winsten and Associates,
Tucson, Ariz.). In the talk and in
a CAP TODAY interview, Weiner
discussed what to consider in
evaluating and implementing
business analytics tools and re-
Courtesy of Viewics. Example does not contain real data.
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Try brilliant ideas. And we have plenty of them. Now, for 25 years,
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viewed acquisition and pricing options.

First, he provided several illustrations of
how laboratories can use dashboards and
reports from various analytics companies.
What this is doing, he says of Fig. 1, is
looking at clients whose volume has decreased by 30 percent, so I can fnd out whos
not giving me business (see Use Case:
Client/Physician Management).
I want to look at what tests, what revenue,
whats the differentiation in the account from
month to month, from client to client, because
decreasing volume is a leading predictor that
those clients might go somewhere else. A
business analytics tool can help a laboratory
see what tests its customers are ordering and
not ordering. It can alert you when your client has had a practice variation, it can tell you
what tests are being improperly utilized, and
it can prompt you to reach out to your clients
to determine whats going on and give you
suggestions to retain their business.
Business analytics tools can help laboratories not only preserve revenue but also increase customer satisfaction. If youre a
service organization, you want to provide
absolutely the best service to your clients,
Weiner says. You want to be able to turn
around calls quickly when clients complain
about issues. Referring to Fig. 2, Case Management, he says: This is a way to manage
issue resolution for both your internal and
external clients. The people who are leading
the client service organization can look at this
and ensure their group is providing service
by tracking issue resolution, the root cause,
the correct action, the length of time it took to
resolve the issues. And then by

proactively addressing those
issues, at-risk clients can be reduced and relationships can be
expanded.
Some business analytics systems, he says, include a customer relationship module and
can integrate to an existing laboratory information system.
What this lets you do is not
only look at the volume of work
but also at how well you are
servicing your top clients.
Then, too, business analytics
has much to offer in the reference testing arena. Fig. 3 (page
24), Use Case: Reference Testing, shows where volume is
going, how much work is going outside the laboratory, what kinds of tests they are, the top tests
by test and by client, which tests it makes sense
to perform internally rather than send out. This
also lets you look at what send-out tests physicians are ordering for which there is a good inhouse substitute, Weiner says. Maybe there are
tests that dont really need to be ordered. So one
could look at defning best practices for certain
sets of orders, especially in genomics testing, so
that you can set appropriate test-ordering processes within your organization and signifcantly
reduce the cost and the waste that may happen
in that area.
All well and good, but what concrete benefts
have laboratories realized from business analytics? Weiner proffers a bouquet of examples. An
850-bed hospital looked at its turnaround time
for the emergency department, which had signifcantly increased over time, he begins. Business analytics helped them monitor their turnaround time and determine where the bottlenecks were occurring. They used Lean to improve
the process while continually using this business
analytics tool to monitor their progress. Turnaround time improved so much that stats are no
longer ordered, he says. It also resulted in reducing their order entry errors by 22 percent, because
theyre able to classify them by type of error and
retrain the people who were making the highest
percentage of them.
Weiner credits business analytics, too, with
helping a teaching hospital frst determine which
of its physicians were ordering inappropriate
cardiac genetic panels based on diagnoses and
results and then recommend best-practice alternative protocols. That saved
continued on 23
Number of Cases
Average Time to Resolve (Hours)
Fig. 2. Case Management
Accessioning error
Billed party error
Client connectivity issue
Client error
Client invoice error
Date Created
Total Cases Created
Cases Remaining Open
Hearth Stone Extended Care

Alta Hospital
Courtesy of HC1.com. Example does not contain real data.

www.platinumcode.us | 888.446.9965
Date Created
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Appointment
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Alton, Jake
Arona, Tom
Arnett, Dan
Barnwell, Jennifer
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ARE YOU TESTING FOR RAS ?

Amgen is committed to the integration of RAS testing into routine clinical practice, which may help oncologists select an
appropriate rst-line treatment plan for their patients with mCRC.
KRAS and NRAS are part of the RAS family of oncogenes1
KRAS
EXON 2
NRAS
EXON 2
12
12
13
13
EXON 3
59
61
EXON 3
59
61
EXON 4
117 146
EXON 4
117 146
A mutation on the RAS gene can continuously activate intracellular signaling, leading to increased cell growth and proliferation.
The EGFR pathway is always turned on, and the cell keeps growing and dividing regardless of anti-EGFR therapy2
Patients with mutant-type RAS tumors should not be treated with Vectibix2
In addition, in an exploratory subgroup analysis of Study 3,* overall survival was shorter in patients with RAS-mutant mCRC
who received Vectibix and FOLFOX versus FOLFOX alone2
Indication
Vectibix is indicated for the treatment of patients with wild-type KRAS (exon 2 in codons 12 or 13) metastatic colorectal cancer
(mCRC) as determined by an FDA-approved test for this use:
As rst-line therapy in combination with FOLFOX
As monotherapy following disease progression after prior treatment with uoropyrimidine-, oxaliplatin-, and irinotecan-containing
chemotherapy
Limitation of Use
Vectibix is not indicated for the treatment of patients with RAS-mutant mCRC or for whom RAS mutation status is unknown.
Important Safety Information

WARNING: DERMATOLOGIC TOXICITY
Dermatologic Toxicity: Dermatologic toxicities occurred in 90% of patients and were severe (NCI-CTC grade 3 and higher) in 15% of patients
receiving Vectibix monotherapy [see Dosage and Administration (2.3), Warnings and Precautions (5.1), and Adverse Reactions (6.1)].
In
Study 1, dermatologic toxicities occurred in 90% of patients

and were severe (NCI-CTC grade 3 and higher) in 15% of patients
with mCRC receiving Vectibix. The clinical manifestations included,
but were not limited to, acneiform dermatitis, pruritus, erythema,
rash, skin exfoliation, paronychia, dry skin, and skin ssures.
Monitor patients who develop dermatologic or soft tissue toxicities
while receiving Vectibix for the development of inammatory
or infectious sequelae. Life-threatening and fatal infectious
complications including necrotizing fasciitis, abscesses, and
sepsis have been observed in patients treated with Vectibix.
Life-threatening and fatal bullous mucocutaneous disease with
blisters, erosions, and skin sloughing has also been observed in
patients treated with Vectibix. It could not be determined whether
these mucocutaneous adverse reactions were directly related
to EGFR inhibition or to idiosyncratic immune-related effects
(eg, Stevens-Johnson syndrome or toxic epidermal necrolysis).
Withhold or discontinue Vectibix for dermatologic or soft tissue
toxicity associated with severe or life-threatening inammatory or
infectious complications. Dose modications for Vectibix concerning
dermatologic toxicity are provided in the product labeling.
Vectibix is not indicated for the treatment of patients with colorectal
cancer that harbor somatic mutations in exon 2 (codons 12 and 13),

exon 3 (codons 59 and 61), and exon 4 (codons 117 and 146) of
either KRAS or NRAS and hereafter is referred to asRAS.
Retrospective subset analyses across several randomized clinical trials
were conducted to investigate the role of RAS mutations on the clinical

effects of anti-EGFR-directed monoclonal antibodies (panitumumab or
cetuximab). Anti-EGFR antibodies in patients with tumors containing
RAS mutations resulted in exposing those patients to anti-EGFRrelated adverse reactions without clinical benet from these agents.
Additionally, in Study 3, 272 patients with RAS-mutant mCRC tumors
received Vectibix in combination with FOLFOX and 276 patients

received FOLFOX alone. In an exploratory subgroup analysis, OS was
shorter (HR = 1.21, 95% CI: 1.011.45) in patients with RAS-mutant
mCRC who received Vectibix and FOLFOX versus FOLFOX alone.
Important Safety Information (continued)

Progressively decreasing serum magnesium levels leading to severe
(grade 34) hypomagnesemia occurred in up to 7% of patients in

Study 2. Monitor patients for hypomagnesemia and hypocalcemia
prior to initiating Vectibix treatment, periodically during Vectibix
treatment, and for up to 8 weeks after the completion of treatment.
Other electrolyte disturbances, including hypokalemia, have also
been observed. Replete magnesium and other electrolytes as
appropriate.
In
Study 1, 4% of patients experienced infusion reactions and 1%

of patients experienced severe infusion reactions (NCI-CTC grades
34). Infusion reactions, manifesting as fever, chills, dyspnea,
bronchospasm, and hypotension, can occur following Vectibix
administration. Fatal infusion reactions occurred in postmarketing
experience. Terminate the infusion for severe infusion reactions.
Severe diarrhea and dehydration, leading to acute renal failure and
other complications, have been observed in patients treated with

Vectibix in combination with chemotherapy.
Fatal
and non-fatal cases of interstitial lung disease (ILD) (1%) and

pulmonary brosis have been observed in patients treated with
Vectibix. Pulmonary brosis occurred in less than 1% (2/1467)
of patients enrolled in clinical studies of Vectibix. In the event of
acute onset or worsening of pulmonary symptoms, interrupt Vectibix
therapy. Discontinue Vectibix therapy if ILD is conrmed.
In
patients with a history of interstitial pneumonitis or pulmonary

brosis, or evidence of interstitial pneumonitis or pulmonary brosis,
the benets of therapy with Vectibix versus the risk of pulmonary
complications must be carefully considered.
Exposure
to sunlight can exacerbate dermatologic toxicity. Advise

patients to wear sunscreen and hats and limit sun exposure while
receiving Vectibix.
Keratitis
and ulcerative keratitis, known risk factors for corneal

perforation, have been reported with Vectibix use. Monitor for
evidence of keratitis or ulcerative keratitis. Interrupt or discontinue
Vectibix for acute or worsening keratitis.
In
an interim analysis of an open-label, multicenter, randomized

clinical trial in the rst-line setting in patients with mCRC, the addition
of Vectibix to the combination of bevacizumab and chemotherapy
resulted in decreased OS and increased incidence of NCI-CTC grade
35 (87% vs 72%) adverse reactions. NCI-CTC grade 34 adverse
reactions occurring at a higher rate in Vectibix-treated patients
included rash/acneiform dermatitis (26% vs 1%), diarrhea (23% vs
12%), dehydration (16% vs 5%; primarily occurring in patients
with diarrhea), hypokalemia (10% vs 4%), stomatitis/mucositis

(4% vs < 1%), and hypomagnesemia (4% vs 0).
NCI-CTC grade 35 pulmonary embolism occurred at a higher rate
in Vectibix-treated patients (7% vs 3%) and included fatal events

in three (< 1%) Vectibix-treated patients.
As
a result of the toxicities experienced, patients randomized to

Vectibix, bevacizumab, and chemotherapy received a lower
mean relative dose intensity of each chemotherapeutic agent
(oxaliplatin, irinotecan, bolus 5-FU, and/or infusional 5-FU) over
the rst 24 weeks on study, compared with those randomized to
bevacizumab and chemotherapy.
Advise patients of the need for adequate contraception in both males
and females while receiving Vectibix and for 6 months after the last
dose of Vectibix therapy. Vectibix may be transmitted from the
mother to the developing fetus, and has the potential to cause fetal
harm when administered to pregnant women.
Because
many drugs are excreted into human milk and because of

the potential for serious adverse reactions in nursing infants from
Vectibix, a decision should be made whether to discontinue nursing
or to discontinue the drug, taking into account the importance of
the drug to the mother. If nursing is interrupted, it should not be
resumed earlier than 2 months following the last dose of Vectibix.
who become pregnant during Vectibix treatment

are encouraged to enroll in Amgens Pregnancy Surveillance
Program. Women who are nursing during Vectibix treatment are
encouraged to enroll in Amgens Lactation Surveillance Program.
Patients or their physicians should call 1-800-77-AMGEN
(1-800-772-6436) to enroll.
Women
In
Study 1, the most common adverse reactions ( 20%) with

Vectibix were skin rash with variable presentations, paronychia,
fatigue, nausea, and diarrhea. The most common (> 5%) serious
adverse reactions in the Vectibix arm were general physical health
deterioration and intestinal obstruction.
In
Study 3, the most commonly reported adverse reactions

( 20%) in patients with wild-type KRAS mCRC receiving Vectibix
(6 mg/kg every 2 weeks) and FOLFOX therapy (N = 322) were
diarrhea, stomatitis, mucosal inammation, asthenia, paronychia,
anorexia, hypomagnesemia, hypokalemia, rash, acneiform dermatitis,
pruritus, and dry skin. Serious adverse reactions ( 2% difference
between treatment arms) in Vectibix -treated patients with
wild-type KRAS mCRC were diarrhea and dehydration.
Visit Vectibix.com to learn more
*A phase 3, open-label, randomized, multicenter study of 1,183 previously untreated patients with
mCRC who were treated with Vectibix Q2W + FOLFOX or FOLFOX Q2W alone.2
EGFR = epidermal growth factor receptor; mCRC = metastatic colorectal cancer;
Q2W = every two weeks.
References: 1. Douillard J-Y, Oliner KS, Siena S, et al. Panitumumab-FOLFOX4 treatment and RAS
mutations in colorectal cancer. N Engl J Med. 2013;369:10231034. 2. Vectibix (panitumumab)
prescribing information, Amgen.
Please see Brief Summary of full Prescribing Information on adjacent pages.
2015 Amgen Inc. All rights reserved. 05/15 USA-945-105509
Vectibix (panitumumab)
BRIEF SUMMARY OF FULL PRESCRIBING INFORMATION
WARNING: DERMATOLOGIC TOXICITY
Dermatologic Toxicity: Dermatologic toxicities occurred in 90% of patients and were severe
(NCI-CTC grade 3 and higher) in 15% of patients receiving Vectibix monotherapy [see Dosage
and Administration (2.3), Warnings and Precautions (5.1), and Adverse Reactions (6.1)].
INDICATIONS AND USAGE
Metastatic Colorectal Cancer
Vectibix is indicated for the treatment of patients with wild-type KRAS (exon 2 in codons 12 or 13) metastatic
colorectal cancer (mCRC) as determined by an FDA-approved test for this use:
As frst-line therapy in combination with FOLFOX [see Clinical Studies (14.2)].
As monotherapy following disease progression after prior treatment with fuoropyrimidine-, oxaliplatin-, and
irinotecan-containing chemotherapy [see Clinical Studies (14.1)].
Limitation of Use
Vectibix is not indicated for the treatment of patients with RAS-mutant mCRC or for whom RAS mutation status is
unknown [see Dosage and Administration (2.1), Warnings and Precautions (5.2), and Clinical Pharmacology (12.1)].
DOSAGE AND ADMINISTRATION
Patient Selection
Prior to initiation of treatment with Vectibix, assess RAS mutational status in colorectal tumors and confrm
the absence of a RAS mutation. Information on FDA-approved tests for the detection of KRAS mutations
in patients with metastatic colorectal cancer is available at: http://www.fda.gov/CompanionDiagnostics.
Recommended Dose
The recommended dose of Vectibix is 6 mg/kg, administered as an intravenous infusion over 60minutes,
every 14 days. If the frst infusion is tolerated, administer subsequent infusions over 30 to 60 minutes.
Administer doses higher than 1000 mg over 90 minutes [see Dosage and Administration (2.4)].
Appropriate medical resources for the treatment of severe infusion reactions should be available during
Vectibix infusions [see Warnings and Precautions (5.4)].
Dose Modifcations
Dose Modifcations for Infusion Reactions [see Warnings and Precautions (5.4) and Adverse Reactions (6.1, 6.3)]
Reduce infusion rate by 50% in patients experiencing a mild or moderate (grade 1 or 2) infusion reaction for
the duration of that infusion.
Terminate the infusion in patients experiencing severe infusion reactions. Depending on the severity and/or
persistence of the reaction, permanently discontinue Vectibix.
Dose Modifcations for Dermatologic Toxicity [see Boxed Warning, Warnings and Precautions (5.1), and
Adverse Reactions (6.1, 6.3)]
Upon frst occurrence of a grade 3 (NCI-CTC/CTCAE) dermatologic reaction, withhold 1 to 2 doses of Vectibix.
If the reaction improves to < grade 3, reinitiate Vectibix at the original dose.
Upon the second occurrence of a grade 3 (NCI-CTC/CTCAE) dermatologic reaction, withhold 1 to 2 doses of
Vectibix. If the reaction improves to < grade 3, reinitiate Vectibix at 80% of the original dose.
Upon the third occurrence of a grade 3 (NCI-CTC/CTCAE) dermatologic reaction, withhold 1 to 2 doses of
Vectibix. If the reaction improves to < grade 3, reinitiate Vectibix at 60% of the original dose.
Upon the fourth occurrence of a grade 3 (NCI-CTC/CTCAE) dermatologic reaction, permanently discontinue Vectibix.
Permanently discontinue Vectibix following the occurrence of a grade 4 dermatologic reaction or for a grade 3
(NCI-CTC/CTCAE) dermatologic reaction that does not recover after withholding 1 or 2 doses.
Preparation and Administration
Do not administer Vectibix as an intravenous push or bolus.
CONTRAINDICATIONS
None.
WARNINGS AND PRECAUTIONS
Dermatologic and Soft Tissue Toxicity
In Study 1, dermatologic toxicities occurred in 90% of patients and were severe (NCI-CTC grade 3 and higher)
in 15% of patients with mCRC receiving Vectibix. The clinical manifestations included, but were not limited to,
acneiform dermatitis, pruritus, erythema, rash, skin exfoliation, paronychia, dry skin, and skin fssures.
Monitor patients who develop dermatologic or soft tissue toxicities while receiving Vectibix for the development of
infammatory or infectious sequelae. Life-threatening and fatal infectious complications including necrotizing fasciitis,
abscesses, and sepsis have been observed in patients treated with Vectibix. Life-threatening and fatal bullous
mucocutaneous disease with blisters, erosions, and skin sloughing has also been observed in patients treated with
Vectibix. It could not be determined whether these mucocutaneous adverse reactions were directly related to EGFR
inhibition or to idiosyncratic immune-related effects (eg, Stevens-Johnson syndrome or toxic epidermal necrolysis).
Withhold or discontinue Vectibix for dermatologic or soft tissue toxicity associated with severe or life-threatening
infammatory or infectious complications [see Boxed Warning and Adverse Reactions (6.1, 6.3)]. Dose modifcations
for Vectibix concerning dermatologic toxicity are provided [see Dosage and Administration (2.3)].
Increased Tumor Progression, Increased Mortality, or Lack of Beneft in Patients with RAS
Vectibix is not indicated for the treatment of patients with colorectal cancer that harbor somatic mutations
in exon 2 (codons 12 and 13), exon 3 (codons 59 and 61), and exon 4 (codons 117 and 146) of either KRAS
or NRAS and hereafter is referred to as RAS [see Indications and Usage (1.1), Dosage and Administration
(2.1), Clinical Pharmacology (12.1) and Clinical Studies (14)].
Retrospective subset analyses across several randomized clinical trials were conducted to investigate the
role of RAS mutations on the clinical effects of anti-EGFR-directed monoclonal antibodies (panitumumab
or cetuximab). Anti-EGFR antibodies in patients with tumors containing RAS mutations resulted in exposing
those patients to anti-EGFR related adverse reactions without clinical beneft from these agents [see
Indications and Usage (1.1), and Clinical Pharmacology (12.1)].
Additionally, in Study 3, 272 patients with RAS-mutant mCRC tumors received Vectibix in combination
with FOLFOX and 276 patients received FOLFOX alone. In an exploratory subgroup analysis, OS was shorter
(HR=1.21, 95% CI: 1.01-1.45) in patients with RAS-mutant mCRC who received Vectibix and FOLFOX
versus FOLFOX alone [see Indications and Usage (1.1)].
Electrolyte Depletion/Monitoring
Progressively decreasing serum magnesium levels leading to severe (grade 3-4) hypomagnesemia occurred
in up to 7% (in Study 2) of patients across clinical trials. Monitor patients for hypomagnesemia and
hypocalcemia prior to initiating Vectibix treatment, periodically during Vectibix treatment, and for up to 8
weeks after the completion of treatment. Other electrolyte disturbances, including hypokalemia, have also
been observed. Replete magnesium and other electrolytes as appropriate.
Infusion Reactions
In Study 1, 4% of patients experienced infusion reactions and 1% of patients experienced severe infusion
reactions (NCI-CTC grade 3-4).
Infusion reactions, manifesting as fever, chills, dyspnea, bronchospasm, and hypotension, can occur following
Vectibix administration [see Adverse Reactions (6.1, 6.3)]. Fatal infusion reactions occurred in postmarketing
experience. Terminate the infusion for severe infusion reactions [see Dosage and Administration (2.3)].
Acute Renal Failure in Combination with Chemotherapy
Severe diarrhea and dehydration, leading to acute renal failure and other complications, have been observed
in patients treated with Vectibix in combination with chemotherapy.
Pulmonary Fibrosis/Interstitial Lung Disease (ILD)
Fatal and nonfatal cases of interstitial lung disease (ILD) (1%) and pulmonary fbrosis have been observed
in patients treated with Vectibix. Pulmonary fbrosis occurred in less than 1% (2/1467) of patients enrolled
in clinical studies of Vectibix. In the event of acute onset or worsening of pulmonary symptoms, interrupt
Vectibix therapy. Discontinue Vectibix therapy if ILD is confrmed.
In patients with a history of interstitial pneumonitis or pulmonary fbrosis, or evidence of interstitial
pneumonitis or pulmonary fbrosis, the benefts of therapy with Vectibix versus the risk of pulmonary
complications must be carefully considered.
Photosensitivity
Exposure to sunlight can exacerbate dermatologic toxicity. Advise patients to wear sunscreen and hats and
limit sun exposure while receiving Vectibix.
Ocular Toxicities
Keratitis and ulcerative keratitis, known risk factors for corneal perforation, have been reported with
Vectibix use. Monitor for evidence of keratitis or ulcerative keratitis. Interrupt or discontinue Vectibix
therapy for acute or worsening keratitis.
Increased Mortality and Toxicity with Vectibix in Combination with Bevacizumab and Chemotherapy
In an interim analysis of an open-label, multicenter, randomized clinical trial in the frst-line setting in patients
with mCRC, the addition of Vectibix to the combination of bevacizumab and chemotherapy resulted in
decreased OS and increased incidence of NCI-CTC grade 3-5 (87% vs 72%) adverse reactions. NCI-CTC grade
3-4 adverse reactions occurring at a higher rate in Vectibix-treated patients included rash/acneiform dermatitis
(26% vs 1%), diarrhea (23% vs 12%), dehydration (16% vs 5%), primarily occurring in patients with diarrhea,
hypokalemia (10% vs 4%), stomatitis/mucositis (4% vs < 1%), and hypomagnesemia (4% vs 0).
NCI-CTC grade 3-5 pulmonary embolism occurred at a higher rate in Vectibix-treated patients (7% vs 3%)
and included fatal events in three (< 1%) Vectibix-treated patients.
As a result of the toxicities experienced, patients randomized to Vectibix, bevacizumab, and chemotherapy received
a lower mean relative dose intensity of each chemotherapeutic agent (oxaliplatin, irinotecan, bolus 5-FU, and/or
infusional 5-FU) over the frst 24 weeks on study compared with those randomized to bevacizumab and chemotherapy.
ADVERSE REACTIONS
The following adverse reactions are discussed in greater detail in other sections of the label:
Dermatologic and Soft Tissue Toxicity [see Boxed Warning, Dosage and Administration (2.3), and
Warnings and Precautions (5.1)]
Increased Tumor Progression, Increased Mortality, or Lack of Beneft in RAS- and KRAS-Mutant mCRC
[see Indications and Usage (1.1) and Warnings and Precautions (5.2)]
Electrolyte Depletion/Monitoring [see Warnings and Precautions (5.3)]
Infusion Reactions [see Dosage and Administration (2.3), and Warnings and Precautions (5.4)]
Acute Renal Failure in Combination with Chemotherapy [see Warnings and Precautions (5.5)]
Pulmonary Fibrosis/Interstitial Lung Disease (ILD) [see Warnings and Precautions (5.6)]
Photosensitivity [see Warnings and Precautions (5.7)]

Ocular Toxicities [see Warnings and Precautions (5.8)]
Increased Mortality and Toxicity with Vectibix in combination with Bevacizumab and Chemotherapy
[see Warnings and Precautions (5.9)]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates in the clinical
trials of a drug cannot be directly compared to rates in clinical trials of another drug and may not refect the
rates observed in practice. The adverse reaction information from clinical studies does, however, provide a
basis for identifying the adverse events that appear to be related to drug use and for approximating rates.
Safety data are presented from two clinical trials in which patients received Vectibix: Study 1, an open-label,
multinational, randomized, controlled, monotherapy clinical trial (N = 463) evaluating Vectibix with best supportive
care (BSC) versus BSC alone in patients with EGFR-expressing mCRC and Study 3, a randomized, controlled trial
(N=1183) in patients with mCRC that evaluated Vectibix in combination with FOLFOX chemotherapy versus
FOLFOX chemotherapy alone. Safety data for Study 3 are limited to 656 patients with wild-type KRAS mCRC.
Vectibix Monotherapy
In Study 1, the most common adverse reactions ( 20%) with Vectibix were skin rash with variable
presentations, paronychia, fatigue, nausea, and diarrhea.
The most common (> 5%) serious adverse reactions in the Vectibix arm were general physical health
deterioration and intestinal obstruction. The most frequently reported adverse reactions for Vectibix
leading to withdrawal were general physical health deterioration (n = 2) and intestinal obstruction (n = 2).
For Study 1, the data described in Table 1 and in other sections below, except where noted, refect exposure to Vectibix
administered to patients with mCRC as a single agent at the recommended dose and schedule (6 mg/kg every 2 weeks).
Table 1: Adverse Reactions ( 5% Difference) Observed in Patients Treated with Vectibix Monotherapy
and Best Supportive Care Compared to Best Supportive Care Alone (Study 1)
Study 1
SYSTEM ORGAN CLASS

Preferred Term
Vectibix Plus
Best Supportive Care
(N = 229)
Best Supportive Care

(N = 234)
Any Grade
n (%)
Grade 3-4
n (%)
Any Grade
n (%)
Grade 3-4
n (%)
1 (< 1)
EYE DISORDERS
Growth of eyelashes
13 (6)
GASTROINTESTINAL DISORDERS
Nausea
52 (23)
2 (< 1)
37 (16)
Diarrhea
49 (21)
4 (2)
26 (11)
Vomiting
43 (19)
6 (3)
28 (12)
Stomatitis
15 (7)
2 (< 1)
2 (< 1)
GENERAL DISORDERS AND

ADMINISTRATION SITE CONDITIONS
Fatigue
60 (26)
10 (4)
34 (15)
Mucosal infammation
15 (7)
1 (< 1)
2 (< 1)
57 (25)
4 (2)
7 (3)
INFECTIONS AND INFESTATIONS

Paronychia
RESPIRATORY, THORACIC, AND
MEDIASTINAL DISORDERS
Dyspnea
41 (18)
12 (5)
30 (13)
Cough
34 (15)
1 (< 1)
17 (7)
Erythema
150 (66)
13 (6)
2 (< 1)
Pruritus
132 (58)
6 (3)
4 (2)
Acneiform dermatitis
131 (57)
17 (7)
2 (< 1)
Rash
51 (22)
3 (1)
2 (< 1)
Skin fssures
45 (20)
3 (1)
1 (< 1)
Exfoliative rash
41 (18)
4 (2)
Acne
31 (14)
3 (1)
Dry skin
23 (10)
Nail disorder
22 (10)
Skin exfoliation
21 (9)
2 (< 1)
Skin ulcer
13 (6)
1 (< 1)
8 (3)
SKIN AND SUBCUTANEOUS TISSUE

DISORDERS
Table 2: Adverse Reactions ( 5% Difference) Observed in Patients with Wild-type (WT) KRAS Tumors
Treated with Vectibix and FOLFOX Chemotherapy Compared to FOLFOX Chemotherapy Alone (Study 3)
SYSTEM ORGAN CLASS

Preferred Term
FOLFOX Alone
(n = 327)
Any Grade
n (%)
Grade 3-4
n (%)
Any Grade
n (%)
Grade 3-4
n (%)
58 (18)
5 (2)
10 (3)
Diarrhea
201 (62)
59 (18)
169 (52)
29 (9)
Stomatitis
87 (27)
15 (5)
42 (13)
1 (< 1)
EYE DISORDERS
Conjunctivitis
SYSTEM ORGAN CLASS

Preferred Term
GASTROINTESTINAL DISORDERS
GENERAL DISORDERS AND

ADMINISTRATION SITE CONDITIONS
Mucosal infammation
82 (25)
14 (4)
53 (16)
1 (< 1)
Asthenia
79 (25)
16 (5)
62 (19)
Any Grade
n (%)
Grade 3-4
n (%)
Any Grade
n (%)
Grade 3-4
n (%)
Rash
179 (56)
55 (17)
24 (7)
1 (< 1)
Acneiform dermatitis
104 (32)
33 (10)
Pruritus
75 (23)
3 (< 1)
Dry skin
68 (21)
5 (2)
13 (4)
Erythema
50 (16)
7 (2)
14 (4)
Skin fssures
50 (16)
1 (< 1)
1 (< 1)
Alopecia
47 (15)
Acne
44 (14)
10 (3)
1 (< 1)
Nail disorder
32 (10)
4 (1)
4 (1)
Palmar-plantar erythrodysesthesia syndrome
30 (9)
4 (1)
9 (3)
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
11 (3)
68 (21)
11 (3)
58 (18)
3 (< 1)
22 (7)
Anorexia
116 (36)
14 (4)
85 (26)
6 (2)
Hypomagnesemia
96 (30)
21 (7)
26 (8)
1 (< 1)
Hypokalemia
68 (21)
32 (10)
42 (13)
15 (5)
Dehydration
26 (8)
8 (2)
10 (3)
5 (2)
METABOLISM AND NUTRITION

DISORDERS
RESPIRATORY, THORACIC, AND

MEDIASTINAL DISORDERS
Epistaxis
46 (14)
30 (9)
30 (9)
2 (< 1)
USE IN SPECIFIC POPULATIONS

Pregnancy
Pregnancy Category C There are no studies of Vectibix in pregnant women. Reproduction studies in
cynomolgus monkeys treated with 1.25 to 5 times the recommended human dose of panitumumab resulted
in signifcant embryolethality and abortions; however, no other evidence of teratogenesis was noted in
offspring [see Nonclinical Toxicology (13.3)]. Vectibix should be used during pregnancy only if the potential
beneft justifes the potential risk to the fetus.
Based on animal models, EGFR is involved in prenatal development and may be essential for normal
organogenesis, proliferation, and differentiation in the developing embryo. Human IgG is known to cross the
placental barrier; therefore, panitumumab may be transmitted from the mother to the developing fetus, and
has the potential to cause fetal harm when administered to pregnant women.
Women who become pregnant during Vectibix treatment are encouraged to enroll in Amgens Pregnancy
Surveillance Program. Patients or their physicians should call 1-800-77-AMGEN (1-800-772-6436) to enroll.
Nursing Mothers
It is not known whether panitumumab is excreted into human milk; however, human IgG is excreted into human milk.
Published data suggest that breast milk antibodies do not enter the neonatal and infant circulation in substantial amounts.
Because many drugs are excreted into human milk and because of the potential for serious adverse reactions in nursing
infants from Vectibix, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into
account the importance of the drug to the mother. If nursing is interrupted, based on the mean half-life of panitumumab,
nursing should not be resumed earlier than 2 months following the last dose of Vectibix [see Clinical Pharmacology (12.3)].
Women who are nursing during Vectibix treatment are encouraged to enroll in Amgens Lactation Surveillance
Program. Patients or their physicians should call 1-800-77-AMGEN (1-800-772-6436) to enroll.
Pediatric Use
The safety and effectiveness of Vectibix have not been established in pediatric patients. The pharmacokinetic
profle of Vectibix has not been studied in pediatric patients.
Geriatric Use
Of the 737 patients who received Vectibix monotherapy in Study 1 and 2, 36% were 65 and over while 8% were
75 and over. No overall differences in safety or effcacy were observed in elderly patients ( 65 years of age) treated
with Vectibix monotherapy.
Of the 322 patients in Study 3 who received Vectibix plus FOLFOX, 128 (40%) were 65 and over while 8% were
75 and over. Patients older than 65 years of age experienced an increased incidence of serious adverse events
(52% vs 36%) and an increased incidence of serious diarrhea (15% vs 5%) as compared to younger patients.
OVERDOSAGE
Doses up to approximately twice the recommended therapeutic dose (12 mg/kg) resulted in adverse
reactions of skin toxicity, diarrhea, dehydration, and fatigue.
Patient Counseling Information
Advise patients to contact a healthcare professional for any of the following:
Skin and ocular/visual changes [see Boxed Warning, Dosage and Administration (2.3), Warnings and Precautions
(5.1, 5.8), and Adverse Reactions (6.1, 6.3)]
Signs and symptoms of infusion reactions, including fever, chills, or breathing problems [see Dosage and
Administration (2.3), Warnings and Precautions (5.4), and Adverse Reactions (6.1, 6.3)]
Diarrhea and dehydration [see Warnings and Precautions (5.5)]
Persistent or recurrent coughing, wheezing, dyspnea, or new-onset facial swelling [see Warnings and
Precautions (5.6) and Adverse Reactions (6.1)]
Pregnancy or nursing [see Use in Specifc Populations (8.1, 8.3)]
Advise patients of the need for:
Periodic monitoring of electrolytes [see Warnings and Precautions (5.3)]
Limitation of sun exposure (use of sunscreen, wear hats) while receiving Vectibix and for 2 months after the
last dose of Vectibix therapy [see Warnings and Precautions (5.7)]
Adequate contraception in both males and females while receiving Vectibix and for 6 months after the last
dose of Vectibix therapy [see Use in Specifc Populations (8.1, 8.3)]
INVESTIGATIONS
Weight decreased
14 (4)
Adverse reactions that did not meet the threshold criteria for inclusion in Table 2 were abdominal pain (28%
vs 23%), localized infection (3.7% vs < 1%), cellulitis (2.5% vs 0%), hypocalcemia (5.6% vs 2.1%), and deep
vein thrombosis (5.3% vs 3.1%).
Infusion Reactions
Infusional toxicity manifesting as fever, chills, dyspnea, bronchospasm or hypotension was assessed within 24 hours of an
infusion during the clinical study. Vital signs and temperature were measured within 30 minutes prior to initiation and upon
completion of the Vectibix infusion. The use of premedication was not standardized in the clinical trials. Thus, the utility of
premedication in preventing the frst or subsequent episodes of infusional toxicity is unknown. Across clinical trials of Vectibix
monotherapy, 3% (24/725) experienced infusion reactions of which < 1% (3/725) were severe (NCI-CTC grade 3-4). In one
patient, Vectibix was permanently discontinued for a serious infusion reaction [see Dosage and Administration (2.2, 2.3)].
Immunogenicity
As with all therapeutic proteins, there is potential for immunogenicity. The immunogenicity of Vectibix has been
evaluated using two different screening immunoassays for the detection of binding anti-panitumumab antibodies:
an acid dissociation bridging enzyme-linked immunosorbent assay (ELISA) detecting high-affnity antibodies and a
Biacore biosensor immunoassay detecting both high- and low-affnity antibodies. For patients whose sera tested
positive in screening immunoassays, an in vitro biological assay was performed to detect neutralizing antibodies.
Monotherapy: The incidence of binding anti-panitumumab antibodies (excluding preexisting and transient
positive patients) was 0.4% (5/1123) as detected by the acid dissociation ELISA and 3.2% (36/1123) as detected
by the Biacore assay. The incidence of neutralizing anti-panitumumab antibodies (excluding preexisting and
transient positive patients) was 0.8% (9/1123). There was no evidence of altered pharmacokinetic or safety
profles in patients who developed antibodies to Vectibix.
In combination with chemotherapy: The incidence of binding anti-panitumumab antibodies (excluding
preexisting positive patients) was 0.9% (12/1297) as detected by the acid dissociation ELISA and 0.7%
(9/1296) as detected by the Biacore assay. The incidence of neutralizing anti-panitumumab antibodies
(excluding preexisting positive patients) was 0.2% (2/1297). No evidence of an altered safety profle was
found in patients who developed antibodies to Vectibix.
The detection of antibody formation is highly dependent on the sensitivity and specifcity of the assay.
Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may
be infuenced by several factors, including assay methodology, sample handling, timing of sample collection,
concomitant medications, and underlying disease. For these reasons, comparison of the incidence of
antibodies to panitumumab with the incidence of antibodies to other products may be misleading.
Postmarketing Experience
The following adverse reactions have been identifed during post-approval use of Vectibix. Because these
reactions are reported in a population of uncertain size, it is not always possible to reliably estimate their
frequency or establish a causal relationship to drug exposure.
Skin and subcutaneous tissue disorders: Skin necrosis, angioedema, life-threatening and fatal bullous mucocutaneous
disease [see Boxed Warning, Dosage and Administration (2.3), and Warnings and Precautions (5.1)]
Immune system disorders: Infusion reaction [see Dosage and Administration (2.3) and Warnings and Precautions (5.4)]
Eye disorders: Keratitis/ulcerative keratitis [see Warnings and Precautions (5.8)]
INFECTIONS AND INFESTATIONS

Paronychia
FOLFOX Alone
(n = 327)
DRUG INTERACTIONS
No formal drug-drug interaction studies have been conducted between Vectibix and oxaliplatin or fuoropyrimidine.
Adverse reactions in Study 1 that did not meet the threshold criteria for inclusion in Table 1 were conjunctivitis
(4.8% vs < 1%), dry mouth (4.8% vs 0%), pyrexia (16.6% vs 13.2%), chills (3.1% vs < 1%), pustular
rash (4.4% vs 0%), papular rash (1.7% vs 0%), dehydration (2.6% vs 1.7%), epistaxis (3.9% vs 0%), and
pulmonary embolism (1.3% vs 0%).
In Study 1, dermatologic toxicities occurred in 90% of patients receiving Vectibix. Skin toxicity was severe
(NCI-CTC grade 3 and higher) in 15% of patients. Ocular toxicities occurred in 16% of patients and included, but
were not limited to, conjunctivitis (5%). One patient experienced an NCI-CTC grade 3 event of mucosal infammation.
The incidence of paronychia was 25% and was severe in 2% of patients [see Warnings and Precautions (5.1)].
In Study 1 (N = 229), median time to the development of dermatologic, nail, or ocular toxicity was 12 days after
the frst dose of Vectibix; the median time to most severe skin/ocular toxicity was 15 days after the frst dose
of Vectibix; and the median time to resolution after the last dose of Vectibix was 98 days. Severe toxicity
necessitated dose interruption in 11% of Vectibix-treated patients [see Dosage and Administration (2.3)].
Subsequent to the development of severe dermatologic toxicities, infectious complications, including sepsis,
septic death, necrotizing fasciitis, and abscesses requiring incisions and drainage were reported.
Vectibix in Combination with FOLFOX Chemotherapy
The most commonly reported adverse reactions ( 20%) in patients with wild-type KRAS mCRC receiving
Vectibix (6 mg/kg every 2 weeks) and FOLFOX therapy (N = 322) in Study 3 were diarrhea, stomatitis,
mucosal infammation, asthenia, paronychia, anorexia, hypomagnesemia, hypokalemia, rash, acneiform
dermatitis, pruritus, and dry skin (Table 2). Serious adverse reactions ( 2% difference between
treatment arms) in Vectibix-treated patients with wild-type KRAS mCRC were diarrhea and dehydration.
The commonly reported adverse reactions ( 1%) leading to discontinuation in patients with wild-type
KRAS mCRC receiving Vectibix were rash, paresthesia, fatigue, diarrhea, acneiform dermatitis, and
hypersensitivity. One grade 5 adverse reaction, hypokalemia, occurred in a patient who received Vectibix.
Vectibix Plus FOLFOX

(n = 322)
Vectibix Plus FOLFOX

(n = 322)
This brief summary is based on the Vectibix

Prescribing Information v23, 03/15.
Vectibix (panitumumab)
Manufactured by:
Amgen Inc.
One Amgen Center Drive
Thousand Oaks, CA 91320-1799 USA
Patent: http://pat.amgen.com/vectibix/
2006-2015 Amgen Inc. All rights reserved.
v23 03/15
Business analytics
continued from 18
them about $120,000 per year, he says.

The third example is one that really resonates
with many of his clients. In this one, an extremely large reference laboratory used a business analytics tool to determine which of its
clients were ordering supplies for tests such as
Pap testsbut never placing orders for those
tests. It happens all the time, Weiner says,
and in the past there were very few ways to
monitor it, because your inventory was typically
in a separate system from your test-ordering
patterns, and there were very few ways to link
them. Now, with business analytics, you dont
have to write a lot of code to do it; you can just
go in and create a query. As a result, this laboratory reduced its supply order usage by 18 percent. When
those clients ordered supplies, it
would have a sales rep call and say,
We noticed you havent ordered
any Pap tests in the last year. Well
be happy to send you the supplies
if you start ordering Pap tests from us.

Another very large facility is the star of example No. 4. This multisite facility monitors
physician ordering patterns by diagnosis and
payer, Weiner explains, and
they managed inappropriate or
non-reimbursed tests and improved both revenues and profitability by about nine percent
by going in and suggesting alternative tests and working with
physicians.
But for all this to work, he
Weiner
says, a full top-down commitment from the highest levels of the organization
is needed. Because if the lab just has this data
and tries to talk to doctors without some top-
down push that says, This is important. You

need to work with the lab. Were working together as a team to improve the whole process
within the institution, the probability that a lab
acting solely on its own will have an impact is
lower than if it had a top-down commitment
from top-level management.
Finally, Weiner points to the example of a private reference laboratory that improved customer
satisfaction by 61 percent, simply by monitoring
key indicators such as number of calls, complaints, turnaround time, and order errors. This
is nothing more than looking at data that every
lab currently has, he says. I think were just at
the very top of the pyramid in using this kind of
data, and as more and more people start using
these tools, the deeper well go. continued on 24
A frst in digital IFA.
People
News of CAP members
awards and appointments
Lucy Balian Rorke-Adams, MD,
was appointed in April to the board
of trustees of the Knowles Science
Teaching Foundation, which was established in 1999 to
improve the quality
of high school science and mathematics education in
the U.S. through
teaching fellow- Dr.Rorke-Adams
ships and research.
She retired at the end of June as senior neuropathologist, Division of
Neuropathology, Childrens Hospital of Philadelphia, and clinical professor of pathology and laboratory
medicine, Perelman School of Medicine, University of Pennsylvania. She
practiced pediatric neuropathology
for more than 50 years. In 2010,
CHOP established the Lucy Balian
Rorke-Adams chair in pediatric
neuropathology.
Federico A. Monzon, MD, medical
director, oncology
and Latin America,
for the reference laboratory Invitae in
San Francisco, was
elected presidentelect of the Association for Molecular
Pathology, for a term
Dr.Monzon
to begin Nov. 7.
NOVA View
NOVA View is the frst automated digital IFA microscope to receive
FDA clearance for detection of antinuclear antibodies.
NOVA View automatically acquires and presents digital images
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NOVA View recognizes and displays mitotic cells and identifes
fve common ANA patterns
Single well titer prediction can reduce IFA workload and lower material costs
NOVA Lite DAPI ANA Kit provides optimal clinical sensitivity
and specifcity, and excellent agreement with manual IFA
DAPI stain provides built-in control to visualize cells in a negative well
Calibration technique facilitates standardization
Step confdently into the future of digital IFA with NOVA View.
If you are a member of the CAP, send

news of appointments, awards, and other professional honors to the College of
American Pathologists, CAP TODAY
People column, 325 Waukegan Road,
Northfeld, IL 60093-2750; srice@cap.org.
For more information, please visit us

at www.inovadx.com/NOVAView
See our Product Guide listings, pages 42, 44
NOVA View and NOVA Lite are registered trademarks of Inova Diagnostics, Inc. 2015 Inova Diagnostics, Inc. All rights reserved.
690487 April 2015 Rev. 0
Fig. 3. Use Case: Reference Testing

Analyzing Performance and Use of Reference Partners
continued from 23
Anoxomat from Advanced Instruments is the precise,

automated solution for oxygen removal that helps everyone:
> Lab managers appreciate the lower cost of ownership
and smaller footprint.
Maternal Scrn
Integrated Sp..
Stone
Analysis w/o..
Meconium 5
Drug Screen
LIPOPROTEIN
MARKERS
Reference
Test to Misc..
Newborn Screening
(Washington)
VAP Cholesterol
Test
NMR LipoProfle
Test
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Create
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people to thrive.
40000
f course, before you can go

deeper, you have to dive
in. Weiner reviewed several considerations to bear in mind when
evaluating a business analytics
tool, such as how the database
is handled.
Is this a separate database
thats created and maintained, or
is your LIS database used? he
suggests asking. What data
sources can be accessed? Can it
look at your inventory, your customer relations management?
Whats the cycle time? How long Courtesy of Viewics. Example does not contain real data.
does it take to get the data? Is it
instantaneous? Does it have an impact on the
from a group of staff members, or to look at venperformance of your LIS? Because it doesnt make
dors of my supplies to see if someones charging
sense to use a dashboard if its going to slow down
me way more than another vendor. So I have all
your LIS by 15 percent.
these changing, evolving requirements.
Whats the scope? Is it only your LIS or do
The LIS project value is usually easily measuryou want to look at other sources of informaable, he adds. I can do an ROI on an LIS project
tion? Do you want to look at the actual clinical
because I know how much its going to cost and
results themselves, or do you just want to look
what my return is going to be. With a business
at statistics? And how easy is it to create access
analytics tool, I dont know what results Im going
to the business analytics tool itself? Do you need
to be getting until I start using it, so its very difan IT guru, or can someone in the lab be trained
fcult to do an ROI. This is important because if
to use it?
youre going to be looking at business analytics
Bear in mind, he says, the differences between
and I think every lab is going to, with the changes
traditional projects (such as implementing an LIS)
in reimbursement and the move from a patientand business analytics projects.
centric to a population-centric modelmost users
When youre looking for an LIS, your requirecant get that type of information out of the existments are known in advance. You know what
ing system.
your needs are. You can put out an RFP that says
When establishing the need for an investment
exactly what your LIS has to do. The requirements
in a business analytics tool, Weiner suggests conare pretty fxed and stable, he says. When I go
sidering that If youre using Excel spreadsheets
into business analytics, I have no idea what Im
to download data and then spending weeks magoing to be needing in terms of queries. As I fnd
nipulating it to get a report, people need to ask:
out more information, I may need to have access
How much time and effort is this taking me, and
to a different databasemaybe to payroll data to
am I having to do it more and more? If so, maybe
fnd out if Im getting appropriate productivity
theres a better solution. And is what youre get-
LIPIDS
ting data and not information?

The key difference, he says, is
that business analytics systems
today can organize data in a
fashion that lets a laboratory gain
insight into its operation to be
able to track key indicators and
do change management.
And then lets talk about
implementation strategies and
considerations, he continues.
Do I have appropriate top-level
leadership and support? Do I
have adequate IT support? And
do I have a working team made
up of caregivers, the IT department, and my laboratory organization? Youve got to have a cohesive team and buy-in.
Some hospitals choose to implement business
analytics systems in a phased approach, department by department, while others implement it
immediately and all at once. Some limit the analytics project to those at the C-level, while some add
it to current software such as an LIS or provide the
tools only to end users to perform self-service
reporting. In making their implementation decisions, users should consider how many data
sources are involved, and which types; the datas
size, complexity, and location; the number of
people who will be running queries at the same
time; the number of licenses needed; and the softwares ease of use.
The nice thing is, business analytics solutions
can now come from dedicated analytics vendors
or from your LIS vendor or your enterprise-wide
vendor, so theres lots of choices to look at,
Weiner says. Pricing can vary from very little to
a whole lot and is based on number of users,
number of system data sources (LIS, AP, A/R,
EMR), scope (operational, fnancial, clinical), complexity, and annual test volume. Some subscription-based tools offer minimal upfront costs, the
option to discontinue, and built-in support, maintenance, and upgrade costswhereas
other licensing-based tools may require a larger upfront cost, software
that operates on a hospitals servers
and under the hospitals control, and
annual support/upgrade fees (18 to
20 percent of initial purchase price).
Both solutions offer potential for integration with other applications for
additional fees.
Whichever pricing model an institution chooses, Weiner says, you
really want to evaluate the characteristics of what you want a business
analytics system to do for you. Create
the requirements before you just say,
OK, well take whatever the LIS vendor or my enterprise-wide vendor is
going to offer.
Reference
Test to ARUP
Business analytics
> Clinicians and researchers enjoy faster, more precise results.
Anne Ford is a writer in Evanston, Ill.
> Lab techs like the repeatability and the way it fts into their
workfow. Plus, they love our new ergonomic jars that are easier
to use, lighter to carry, and take up far less room.
Want to print a story?

Would you like a PDF of a CAP
TODAY article in this issue? Go
to www.captodayonline.com, and then
click on the article of interest.
The Adobe PDF button sits just
below the headline.
INFO@AICOMPANIES.COM
AICOMPANIES.COM/ T EAM A NOXOMAT_CAP
Come see the

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Orchard Sequoia Architecture Diagram

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Other 3rd Party

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Molecular
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Enterprise-class LIS utilizing

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Client
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Instrument Interface Tools Provide

Seamless Integration
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Apache Service Mix - Apache Karaf and Apache CXF - OSGi
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Data Access Layer (DAL)
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Tis new LIS is instinctively easy-to-use, and its three-tier segmental
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Sample Tracking & Supply

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automated immunoassay
analyzers
See captodayonline.com/productguides
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Abbott Diagnostics
Jonathan Burgart jonathan.burgart@abbott.com
100 Abbott Park Rd., CP1-4, Abbott Park, IL 60064
224-667-5678 www.abbottdiagnostics.com
Abbott Diagnostics
Abbott Diagnostics
Name of instrument/First year sold/Where designed
ARCHITECT i1000SR/2008/U.S.
ARCHITECT i2000SR/2002, i4000SR/2007/U.S.
ARCHITECT ci4100 (2009), ci8200 (2003), ci16200 (2007)/U.S.
Country where manufactured/Where reagents manufactured

Number of units in clinical use in U.S./Outside U.S.
Operational type/Model type/Sample handling system
Singapore/U.S., Europe
continuous random access/floor standing/robotic sample

handler allows batch, random access, continuous access, and
reagent loading and unloading
Singapore/U.S., Europe
batch, random access, continuous random access/

floor standing/track and LAS
Singapore (IA), Japan (chemistry)/U.S., Europe
batch, random access, continuous random access/floor

standing/robotic sample handler uses multidimensional
sample handling
Dimensions in inches (H W D)/Instrument footprint in sq. feet
49 59 30/12.3
48 61 49/20.7 (i2000SR)
48 127 49/43.2
Tests available on instrument in U.S.

Tests not available in U.S. but submitted for clearance
Tests not available in U.S. but available in other countries
Tests in development
Tests not available on other manufacturers analyzers
Fully automated microplate system
Number of each analyte performed in separate disposable unit

Number of wells in microplate
Methods supported/Separation methods
chemiluminescence/magnetic particle
Chemiflex (enhanced chemiluminescence) with 5 flexible

protocols/magnetic microparticle
photometric, potentiometric, and Chemiflex (enhanced

chemiluminescence)/
Number of different measured assays onboard simultaneously

Number of different assays programmed, calibrated at once
Number of user-definable (open) channels
Number of different analytes for which system accommodates reagent
containers onboard at once/Tests per container set
Shortest/Median onboard reagent stability/Refrigerated onboard
25
61
none
25/100
25
62
none
25/100 tests and 500 tests per kit
8093, based on analyzer

149 assays available
220 (on chemistry modules only)
93/611,700
14 days (vitamin D)/30 days tracked in hours/yes
14 days (vitamin D)/30 days tracked in hours/yes
Multiple reagent configurations supported

Reagent container placed directly on system for use
Reagents barcoded/Information in barcode
yes
yes
yes/assay number, reagent serial number, lot number, tests per
kit, expiration onboard stability time, others
yes
yes
yes/assay No., reagent serial No., lot No., tests per kit, exp.
date, onboard stability time, master calibration curve
CC: 5 days/28 days/yes; IA: 14 days (vitamin D)/30 days

tracked in hours/yes
yes
yes
yes/assay name, reagent number, lot number, tests per kit,
expiration date, others
Same capabilities when 3rd-party reagents used/Susceptibility to carryover

Walkaway capacity in minutes/Specimens/Tests, assays
no/<0.1 ppm
180/65/25
no/<0.1 ppm
300/135/12,500
yes (chemistry)/<0.1 ppm

300/367/>75,000
System is open (homebrew methods can be used)/Liquid or dry system

Uses disposable cuvettes/Maximum number stored
no/liquid
yes/360
no/liquid
yes/1,200
Uses washable cuvettes/Replacement frequency

Minimum specimen volume required
Minimum sample volume aspirated precisely at once/Minimum dead volume
Supplied with UPS (backup power)/Requires floor drain
Requires dedicated water system/Water consumption
no/
varies based on assay
10 L/50 L
yes/no
no/
no/
10 L/50 L
yes/no
no/
Noise generated
58 decibels during normal operation, 62 decibels maximum
4870 decibels
yes (chemistry)/liquid
disposable and semipermanent/see individual standalone
modules
yes/as needed, minimum 1-year guarantee
2 L (chemistry), 10 L (IA)/50 L
yes/yes
yes/25 L per hour (ci8200); 52 L per hour (ci16200);
15 L per hour (ci4100)
4870 decibels
Has dedicated pediatric sample cup/Dead volume

Primary tube sampling/Tube sizes/Pierces caps on primary tubes
Sample barcode reading capability/Autodiscrimination
no/
yes/5-, 7-,10-mL tubes and sample cups/no
yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes
no/
yes/5-, 7-,10-mL tubes and sample cups/no
no/
yes/5-, 7-, 10-mL tubes and sample cups/no
Barcode placement per CLSI standard Auto2A

Onboard test auto inventory (determines volume in container)
Measures number of tests remaining/Short sample detection
Automatic detection of adequate reagent or specimen
Clot detection/Reflex testing capability
Hemolysis detection-quantitation/Turbidity detection-quantitation
Dilution of patient samples onboard/Automatic rerun capability
Sample volume can be increased to rerun out-of-linear range high results/
Increased to rerun out-of-linear range low results
Time between initial result and reaspiration of sample for rerun
Autocalibration or autocalibration alert
Number of calibrators required for each analyte
Calibrants can be stored onboard/Average calibration frequency
Multipoint calib. supported/Multiple calibs. stored for same assay
How often QC required
Onboard real-time QC/Support multiple QC lot Nos. per analyte
Automatic shutdown/Startup is programmable/Startup time
yes
yes
yes/yes
yes
yes/yes
no/no
yes/yes
no/no
yes
yes
yes/yes
yes
yes/yes
no/no
yes/yes
no/no
yes
yes
yes/yes
yes
yes/yes
yes/yes
yes/yes
no/no
yes
26, assay dependent
no/calibration required with new lot
yes/yes (up to 4 curves per analyte)
every 24 hours or per lab-specific procedure
yes/yes
no/no/6.5 minutes
yes
26, assay dependent
no/calibration required with new lot
yes/yes
/no/10 minutes
yes
26, assay dependent
IA: no/calibration with new lot; CC: no/28 days
yes/yes
/no/10 minutes
Stat time to completion of hCG test
18 minutes
18 minutes
18 minutes
Time delay from ordering stat test to aspiration of sample

Throughput per hour for three analytes on each specimen, in number of
specimens/Number of tests (cycle time)
Can autotransfer QC results to LIS/Onboard capability to review QC
Data-management capability/Instrument vendor supplies LIS interface
LIS interfaces up and running in active user sites
LIS interface operates simultaneously with running assays
Bidirectional interface capability
Interface available (or will be) to auto specimen handling system
Modem servicing/Can diagnose own malfunctions/
Determine malfunctioning component
Can order (via modem) malfunctioning part(s) without operator
On-site response time of service engineer
Mean time between failures/To repair failures
Average time to complete maintenance by lab personnel
up to 33 samples/100 tests per hour
up to 67 samples/200 tests per hour
yes/yes
onboard/no
all major LIS vendors
yes
yes (broadcast download and host query)
yes
yes/yes/yes
yes/yes
onboard/no
yes
yes
yes/yes/yes
up to 267/800 (c4000), 400/1200 (c8000), 600/1800 (c16000),

33/100 (i1000sr), 67/200 (i2000sr)
yes/yes
onboard/no
yes
no
yes/yes/yes
yes
yes, AbbottLink
yes, AbbottLink
Onboard maintenance records/Maintenance training demo module
yes/yes
yes/yes
yes/yes
List price/Targeted bed size or daily volume
Annual service contract cost (24 hours/7 days)

Training provided with purchase/Advanced operator training
yes/yes
yes/yes
yes/yes
Distinguishing features (supplied by company)
streamlined workload management; continuous access to

reagents, samples, and supplies; 65-sample load capacity;
13 universal bays, 7 customizable priority bays; refrigerated
reagent carousel with 25 100 test-kit sizes; reagents stable
onboard up to 30 days; priority tests; 18-minute turnaround
time on stat assays
Chemiflex technology delivers excellent sensitivities and

extended linearities; RSH allows priority and routine samples
to be processed simultaneously without compromising
stats; refer to operations manual for operational precautions,
limitations, and hazards; class 1 laser product
integration of CC and IA without compromising stat turnaround

time, results, or throughput because of patented SmartWash
technology, which minimizes carryover to <0.1 ppm; reagent
capacity of 93 assays, with sample load up to 367; refer to
operations manual for operational precautions, limitations, and
hazards
Part 1 of 20
Note: a dash in lieu of an answer means company did not answer

question or question is not applicable
Tabulation does not represent an endorsement by the College of American Pathologists.
analyzers
Alere
Matthew Carrier matthew.carrier@alere.com
2 Research Way, Princeton, NJ 08540
207-210-0446 www.alere.com
Agility/2012/U.S.
Alere
DS2/2007/U.S.
Alere
DSX/2004/U.S.

U.S./U.S.
~20/35
batch/benchtop/rack
U.S./U.S.
~100/
batch/benchtop/rack
U.S./U.S.
~500/
batch/benchtop/rack
48 48 36/8.6
27 21 26/4
32 42 36/7
open system, tests provided by various manufacturers

ID: chlamydia, CMV, EBV-EA, EBNA, EBV-VCA, H. pylori, HSV,

legionella, lyme, measles, mumps, myco, rubella, syphilis,
toxo, VZV, Parvo B19; AI: ANCA, ANA, CCP, cardios, dsDNA, ENA,
gliadin, histone, Jo-1, mitochondria, MPO, PR-3, RF, Scl-70,
SM, SM/RNP, SS-A, SS-B, TPO, TG, TTG; osteo: NTx. bladder
cancer-NMP22; enterics: tox AB, GDH, crypto, giardia, E histo,
ASCA, IBD. leukocyte
ID: chlamydia, CMV, EBV-EA, EBNA, EBV-VCA, H. pylori, HSV,

legionella, lyme, measles, mumps, myco, rubella, syphilis,
toxo, VZV, Parvo B19; AI: ANCA, ANA, CCP, cardios, dsDNA, ENA,
gliadin, histone, Jo-1, mitochondria, MPO, PR-3, RF, Scl-70,
SM, SM/RNP, SS-A, SS-B, TPO, TG, TTG; osteo: NTx. bladder
cancer-NMP22; enterics: tox AB, GDH, crypto, giardia, E histo,
ASCA, IBD. leukocyte
yes
yes
yes

1 per well
96 (minimum: 1 strip; maximum: 12 full plates)
enzyme immunoassay/coated microplate wells
16
12
unlimited
16/96
1 analyte per well, multiple analytes per well

96 (minimum: 1; maximum: 96)
enzyme immunoassay/coated microwell
24
24
unlimited
18/24
1 analyte per well, multiple analytes per well

48
48
unlimited
24/48
8 hours/1 day/no
yes
yes
yes/lot information
8 hours/1 day/no
yes
yes
no/
8 hours/1 day/no
yes
yes
no/

yes/disposable tip
assay dependent/200+ continuous load/12+ continuous load
yes/liquid
no/
no/zero
120 minutes/98/24
yes/liquid
no/
no/zero
120 minutes/98/48
yes/liquid
no/

Noise generated
no/
10 L
10 L/150 L
yes/no
no/
no/
yes/1017 mm diameter, 45100 mm depth/no
yes
yes/yes
yes
yes/no
no/no
yes/no
no/no
no/
10 L
10 L/50 L
no/no
no/
no/
yes
yes
no/yes
yes
yes/no
no/no
yes/no
no/no
no/
10 L
5 L/50 L
yes/no
no/
no/
yes
yes
no/yes
yes
yes/no
no/no
yes/no
no/no
no
assay dependent
no/per plate
no/no
per plate
no/no
no/no/35 minutes
no
assay dependent
no/within each run
no/no
with every assay
no/yes
yes/yes/5 minutes
no
assay dependent
no/within each run
no/no
with every assay
no/yes
yes/yes/5 minutes

assay dependent/
assay dependent/
assay dependent/
yes/yes
onboard/yes
Cerner, Sunquest, Soft, Orchard, etc.
yes
no
yes/yes/yes
yes/yes
onboard/yes (additional cost)
yes
yes (host query)
no
no/yes/no
yes/yes
yes
yes (host query)
no
no/yes/no
no
24 hours
daily: <15 minutes; weekly: <30 minutes; monthly: <1 hour
no
24 hours
daily: 5 minutes; weekly: 20 minutes; monthly: 20 minutes
no/no
no/no
no
24 hours
4 months/2 hours
daily: 10 minutes; weekly: 20 minutes;
monthly: 20 minutes
no/no
$149,999 (includes one-year warranty)/various
$49,000/<350 beds
$65,000/>350 beds

$14,000
yes/yes
$7,400
3 days on site/yes
$9,000
3 days on site/no
SmartKit, direct-load reagents can be loaded at any time, in

any order, thus reducing preanalytic time by 75% of traditional
ELISA automation systems; the 2-D barcode on each SmartKit
is detected, loaded, and tracked in real time, continuously;
open platform capacity allows for a very flexible test menu
to automate Aleres ~100 ELISA assays along with any other
ELISA manufacturer and eliminates carryover possibility with
disposable tips
combined with the Alere ELISA product line and the ability to
automate enteric assays and front-end dilute Inverness Athena
assays, the DS2 provides an efficient, open, fully automated
solution for customers looking for laboratory automation
open DSX platform enables customers to run many ELISAbased assays; modular design allows users to customize
system to unique needs; work list load wizard for easy setup;
shows graphically where to place reagents, samples, and
plates at beginning of each run; complete daily maintenance
in less than 5 minutes, including removal of consumables and
rinsing washer
Part 2 of 20

analyzers
Awareness Technology
Jamie Raistano info@awaretech.com
1935 SW Martin Highway, Palm City, FL 34990
772-283-6540 www.awaretech.com
Awareness Technology
Jamie Raistano info@awaretech.com
1935 SW Martin Highway, Palm City, FL 34990
772-283-6540 www.awaretech.com
Beckman Coulter
Mark Smith mark.smith@beckman.com
250 S. Kraemer Blvd., Brea, CA 92821
714-961-3711 www.beckmancoulter.com

ChemWell Fusion/2014/U.S.
U.S./
0/10+
batch/benchtop/rack
16 34 20/4
unlimited (open system)
ChemWell/1998/U.S.
U.S./
80+/4,350+
batch/benchtop/rack
16 34 20/4
Access, Access 2 Immunoassay System/2001/U.S.

U.S./U.S., France, Ireland
>2,000/>2,500
continuous random access/benchtop/rack
18.5 39 24/6.5
cortisol, total IgE, EPO, ferritin, folate, intrinsic factor Ab, sTfR,
vitamin B12, intact PTH, ostase, CK-MB, digoxin, myoglobin,
ultrasensitive insulin, rubella IgG, toxo IgG, toxo IgM II, DHEA-S,
estradiol, hFSH, hLH, inhibin A, progesterone, prolactin, SHBG,
testosterone, total hCG, unconjugated estriol, fast hTSH, free
T3, total T4, thyroglobulin, TPOAb, PSA, free PSA, BR-GI-OV
monitors, troponin I, vitamin D, and many others

HAV Ab, HAV IgM, HBc Ab, HBc IgM, HBs Ab, HBsAg, HBsAg
confirmatory, CMV IgG, CMV IgM, rubella IgM
AMH

yes
up to 12
minimum strip: 8; maximum full plate: 96
enzyme immunoassay (ELISA) and CLIA/coated microwell
plate, strips
up to 12
unlimited
unlimited
27/assay dependent
yes
up to 12
no
up to 12
unlimited
unlimited
27/assay dependent
24
24
0
24/100 tests per kit; 50 tests per cartridge
assay dependent/assay dependent/yes (10C below ambient)
assay dependent/assay dependent/yes (10C below ambient)
14 days/28 days/yes (310C)

yes
yes
no/
yes
yes
no/

no/zero
assay dependent/96/12
no/zero

Noise generated
yes/liquid
yes/96
yes/assay dependent
2 L
2 L/
no/no
no/
no/
yes/12 100 mm/no
no/
yes
no/no
yes
no/yes
no/no
yes/no
yes/yes
yes/liquid
yes/96
yes/assay dependent
2 L
2 L/
no/no
no/
no/
yes/12 100 mm/no
no/
yes
no/no
yes
no/yes
no/no
yes/no
yes/yes
yes
yes
yes/specific cartridge ID, expiration date, lot number, unique
reagent pack ID number
no/<10 ppm
up to 180 based on consumable capacity/60/
assay dependent
no/liquid
yes/294
no/
specimen container dependent
5 L/100 L
no/no
no/
<70 decibels
yes/100 L
yes/12 75, 13 75 and 100, 16 75 and 100/no
yes
no
yes/yes
yes
yes/yes (Access 2 only)
no/no
no/no
no/no
assay dependent
no
assay dependent
yes/assay dependent
yes/yes
shortest interval: each run; longest: daily
yes/yes
yes/yes/2 minutes
assay dependent
no
assay dependent
yes/assay dependent
yes/yes
shortest interval: each run; longest: daily
yes/yes
yes/yes/2 minutes
36 seconds
no
assay dependent
no/28 days
yes/yes
24 hours
yes/yes
no/no/remains in ready mode
assay dependent
assay dependent
15 minutes

30 seconds
assay dependent/
30 seconds
assay dependent/
36 seconds
33/100 (36 seconds)
yes/yes
onboard/yes (included)
no
no
yes/yes/yes
yes/yes
no
no
yes/yes/yes
yes/yes
onboard/yes
yes
no
no/no/no
no
within 48 hours
daily: <10 minutes; weekly: <10 minutes;

monthly: <10 minutes
no/no
no
daily: 15 minutes; weekly: 30 minutes
no
within 48 hours

monthly: <10 minutes
no/no

$29,000/up to 500 tests per day

$4,500
3 days on site/no
$25,000/up to 500 tests per day

$4,000
3 days on site/no
$149,800/all volumes and hospital sizes
yes/yes (Access 2 only)
dual use as random-access ELISA and CLIA analyzer, capable

of performing ELISA and CLIA on the same microwell plate
using 8-well microwell strips
dual use as random-access biochemistry analyzer when not

in EIA mode; optional reagent cooling module
ability to network up to four Access 2 systems using one

LIS interface with remote diagnostics; fully automated userdefined reflex testing; continuous random-access benchtop
analyzer
Part 3 of 20


yes (Access 2 only)/online help with maintenance instructions
QUALITY CONTROL
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Your strategy to elevate your entire teams quality performance.
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Increase confdence in reporting patient results.
Download infographic to discover how
qcnet.com/unity
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For more information, contact your local Bio-Rad offce | US: 1-800-224-6723 | qcnet.com/unity
analyzers
Beckman Coulter
Beckman Coulter
Beckman Coulter
UniCel DxI 600 Access Immunoassay System/2007/U.S.
UniCel DxI 800 Access Immunoassay System/2003/U.S.
UniCel DxC 600i Synchron Access Clinical System/2006/U.S.


>200/>150
continuous random access/floor standing/rack, direct track
sampling
67 61.5 37.5/16.02

>500/>1,000
continuous random access/floor standing/rack, direct track
sampling
67 67.5 37.5/17.6

>449/>150
continuous random access/floor standing/rack-closed tube

AMH
AMH
AMH

no
50
50
50/100 and 300 tests per kit; 50 tests per cartridge
no
50
50
0
50/100 and 300 tests per kit; 50 tests per cartridge

yes
yes
yes/specific cartridge ID, number of available tests, expiration
date, lot number, calibration expiration, within lot calibration

yes
yes
no
chemiluminescence, enzyme immunoassay/magnetic particle

89
89
100
89/100 tests per kit (immunoassay); 300 tests per container
(general chemistry)
yes
yes

yes/<10 ppm
180240 based on consumable capacity/60/assay dependent
yes/<10 ppm
60/76/assay dependent

Noise generated
no/liquid
yes/1,000
no/
5 L/80 L
no/no
no/
<65 decibels
yes/100 L
yes/12 75, 13 75 and 100, 16 75, 85 and
100 mm/no
yes
no
yes/yes
yes
yes/yes
no/no
yes/yes
no/no
yes/<10 ppm
180240 based on consumable capacity/120/
assay dependent
no/liquid
yes/>1,000
no/
5 L/160 L
no/no
no/
<60 decibels
yes/100 L
yes/12 75, 13 75 and 100, 16 75, 85, and 100 mm/no
yes
no
yes/yes
yes
yes/yes
no/no
yes/yes
no/no

yes
yes
yes/yes
yes
yes/yes
yes/yes (general chemistry)
yes/yes
yes/yes
36 seconds
yes
assay dependent
no/28 days
yes/yes
24 hours
yes/yes
36 seconds
yes
assay dependent
no/28 days
yes/yes
24 hours
yes/yes
chemistry dependent
assay dependent
no/28 days
yes/yes
24 hours
yes/yes
15 minutes
15 minutes
15 minutes

18 seconds
/200 (18 seconds)
18 seconds
133/400 (918 seconds)
1 minute (general chemistry)

90/720 (40 seconds) (general chemistry)
yes/yes
onboard/yes
yes
yes, Beckman Coulter automation systems
yes/yes/yes
yes/yes
onboard/yes
yes
yes/yes/yes
yes/yes
optional add-on/yes (additional cost)
yes
yes/yes/validate for the DxC 600i
no
daily: <10 minutes
no
daily: <10 minutes
no
yes/online help with maintenance instructions
$199,500/200300 beds or 100300 tests per day
$325,000/300+ beds or >400 tests per day
$325,000/moderate volume, <300 samples per day

yes/yes
yes/yes
per negotiated contract

yes/yes
integrates with UniCel DxC chemistry systems; uses

chemiluminescent technology; allows operators to load
consumables on the fly, without interacting with the system;
offers ProService remote diagnostic service capability
high-throughput immunoassay analyzer; integrates with

UniCel DxC chemistry systems; uses chemiluminescent
technology; allows operators to load consumables on the fly,
without interacting with the system; offers ProService remote
diagnostic service capability
performs parallel processing of immunoassay and chemistry

tests on one system; ClozCap technology (closed-tube
aliquot and closed-tube sampling) eliminates manual
processes; chemistry reagent packs are identical across
the UniCel family of systems; offers ProService remote
diagnostic service capability
Part 4 of 20


62 128 48/42.7
no/liquid
yes/125
yes/
container dependent
3 L/20 L (general chemistry)
yes/yes
yes/16 L per hour
yes/
yes/13 75 and 100, 15 75 and 92, 16 100 mm/yes
MOVING HEALTHCARE FORWARD beckmancoulter.com
Moving healthcare forward

We are devoted to helping labs deliver better patient care
by giving clinical professionals the accurate diagnostic
information they need, when they need it.
The combination of our scalable diagnostic systems and tests, along with our clinical business
intelligence tools can help laboratories achieve standardization, physician and patient satisfaction
and meet critical key performance metrics throughout an entire laboratory network.
Supporting a clinical lab's goal to deliver excellent patient care effectively is at the heart of all we do.
Learn how at Clinical Lab Expo Booth #2409
Copyright 2015 Beckman Coulter, Inc. Beckman Coulter, the stylized logo and AU are registered trademarks of Beckman Coulter, Inc. and are registered with the USPTO.
analyzers
Beckman Coulter
Beckman Coulter
Beckman Coulter


>40/>20
continuous random access/floor standing/
rack-closed tube
68 147 48/49

5/13
rack-closed tube
68 153 48/51

>10/>25
rack-closed tube
68 155 48/51.7

AMH
AMH
AMH

no

115
115
100
(general chemistry)
no

115
115
100
(general chemistry)
no

120
120
100
(general chemistry)

yes
yes
yes
yes

yes/<10 ppm
yes
yes
yes/specific cartridge ID, number of available tests,
expiration date, lot number, calibration expiration, within
lot calibration
yes/<10 ppm

Noise generated
no/liquid
yes/125
yes/
container dependent
yes/yes
yes/up to 16 L per hour
yes/
yes/13 75 and 100, 15 92 and 75, 16 100 mm/yes
no/liquid
yes/125
yes/
container dependent
yes/yes
yes/
yes/13 75 and 100, 15 75 and 92, 16 100 mm/yes
no/liquid
yes/125
yes/
container dependent
yes/yes
yes/
yes/13 75 and 100, 15 75 and 92, 16 100 mm/yes


yes
yes
yes/yes
yes
yes/yes
yes/yes
yes/yes

yes
yes
yes/yes
yes
yes/yes
yes/yes
yes/yes

yes
yes
yes/yes
yes
yes/yes
yes/yes
yes/yes
yes/yes
chemistry dependent
assay dependent
no/28 days
yes/yes
24 hours
yes/yes
chemistry dependent
assay dependent
no/28 days
yes/yes
24 hours
yes/yes
chemistry dependent
assay dependent
no/28 days
yes/yes
24 hours
yes/yes
15 minutes
15 minutes
15 minutes




yes/yes
yes
yes/yes/yes
yes/yes
yes
yes/yes/validate for the DxC 680i
yes/yes
yes
yes/yes/yes
no
no
no
$575,000/high volume, 300750 samples per day
$610,000/high volume, 300750 samples per day
$615,000/high to very high volume, 5001,500 samples per

day


yes/yes

yes/yes

yes/yes

tests; ClozCap technology (closed-tube aliquot and closedtube sampling) eliminates manual processes; chemistry
reagent packs are identical across the UniCel family of
systems; offers ProService remote diagnostic service
capability

tests; ClozCap technology (closed-tube aliquot and closedtube sampling) eliminates manual processes; chemistry
reagent packs are identical across the UniCel family of
systems; offers ProService remote diagnostic service
capability
parallel processing of immunoassay and chemistry tests;

ClozCap technology (closed-tube aliquot and sampling)
eliminates manual processes; chemistry reagent packs
are identical across the UniCel family of systems; offers
ProService remote diagnostic service capability
Part 5 of 20

yes/<10 ppm
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Beckman Coulter and the stylized logo are trademarks of Beckman Coulter, Inc. and are registered in the USPTO.
MOVING HEALTHCARE FORWARD beckmancoulter.com
analyzers
Beckman Coulter
250 S. Kraemer Bvld., Brea, CA 92821
VIDAS Immunoassay Analyzer/1991/U.S.
PR4100 Microplate Reader/2012/Austria


>40/>150
rack-closed tube
68 161 48/53.7
Italy/France
2,200/25,000
batch, random access/benchtop/
Austria/U.S.
85/10
batch/benchtop/
VIDAS 30 system: 16 32 2/4.5;

MiniVIDAS system: 21 21 17/4
procalcitonin, TSH, FT4, T4, T3, total PSA, HCG, LH, FSH, estradiol 2, prolactin, progesterone, testosterone, ferritin, C. difficile
GDH, D-dimer, troponin I, NT pro BNP, CKMB, C. difficile toxin
A&B, mumps IgG, rubella IgG, varicella zoster virus IgG, lyme
IgG & IgM, Helicobacter pylori, toxo competition, toxo IgG, toxo
IgM, toxo IgG avidity, CMVM, CMVG, measles IgG, others
HIV, HBsAg, HBs, HAV, HAV IgM, HBc, HBc IgM, HCV, syphilis,
measles, mumps, VZV, lyme, toxoplasma, ANA, SSA, SSB

HBs Ag, anti-HBs total, anti-HBc total, anti-HBc IgM, anti-HBe,

HAV IgG, anti-HAV total, HIV duo, myoglobin, others
AMH
vitamin D

no
no
1 test per strip
fluorescence, enzyme immunoassay/enzyme immunoassay

coated, solid phase receptacle pipetting device
no

120
120
100
(general chemistry)
yes
yes
yes/<10 ppm
no/liquid
no/125
yes/
container dependent
yes/
yes/
yes/13 75 and 100, 15 75 and 92, 16 100 mm/yes
yes
yes
yes/yes
yes
yes/yes
yes/
yes/yes
MiniVIDAS: 12; VIDAS: 30

total menu
unit-dose format 30 or 60/
//no
no
yes
yes/assay name, lot number, calibration, expiration
//no
no
no/zero
no/dry
no/
no/
100200 L, dependent on assay
100 L, dependent on assay/
yes/no
no/
no/
no//no
yes (2 of 5 interleaved, Codabar, codes 39 and 128)/no
no
no
no/no
no
no/no
no/no
no/no
no/no
yes/dry
no/
no/
70 L
no/no
no/
no/
no//
chemistry dependent
assay dependent
no/28 days
yes/yes
24 hours
yes/yes
yes
no/14 or 28 days, assay dependent

no/yes
shortest interval: 8 hours; longest: 24 hours
yes/yes
no/no/always remains ready

15 minutes
30 minutes
no delay
/VIDAS: 20; MiniVIDAS: 8; VIDAS: 60; MiniVIDAS: 24
yes/yes

yes
yes/yes/yes
yes/yes
Misys, Medtech, McKesson, Advanced Lab Systems, Citation,
Cerner, Dawning, Geneysis, Compulab, others
yes
yes (broadcast download)
no
no/yes/yes
no
no
within 24 hours
VIDAS: 860 days; MiniVIDAS: 1,200 days/

weekly: 1015 minutes

yes (includes audit trail)/
$650,000/high to very high volume, 7502,250 samples per

day

tests; ClozCap technology eliminates manual processes; chemistry reagent packs are identical across the UniCel family of
systems; offers ProService remote diagnostic service capability
routine batch testing as well as emergency stat testing; ELISA

methodology; dual-function combination solid phase and
pipetting device results in no fluid contact with instrument or
sample carryover; single-dose assay format readily adaptable
to batch or single test runs
Part 6 of 20

Noise generated


bioMrieux Inc.
Alicia Rico-Lazarowski Alicia.rico-lazarowski@biomerieux.com
100 Rodolphe St., Durham, NC 27712
919-479-3629 www.biomerieux-usa.com
Bio-Rad Laboratories Clinical Diagnostics Group

Greg Stewart greg_stewart@bio-rad.com
4000 Alfred Nobel Drive, Hercules, CA 94547
800-224-6723 (800-2BIO-RAD) www.bio-rad.com
Together, we move
forward to achieve
better patient care.
Patients are counting on you. Only the College of
American Pathologists can connect you to the
broadest global network of laboratory experts,
peers, and support to help you achieve your goals
and make a positive impact.
Connect with us at the 2015 AACC Annual Meeting
and see whats new. Attend one or more of our
Learn, Discuss, Advance in-booth sessions with
CAP experts and discover ways to make your
laboratory even better. Topics include:
Implementing individual quality control plans
Ensuring instrument quality assurance
Managing and complying with the six
elements of personnel competency
Managing a quality management system
(QMS)
Learn more and register for sessions
online now at http://capatholo.gy/AACC.
July 2630
Atlanta
Booth #1925
2015 College of American Pathologists. All rights reserved.

23665.0515
cap.org
analyzers

Greg Stewart greg_stewart@bio-rad.com

Paulina Leung-Lee paulina_leung-lee@bio-rad.com

Greg Stewart greg.stewart@bio-rad.com

PhD Ix System/2012/France
France/U.S.
62/
batch/benchtop/reagent rack
30 36 27/16
open system, method file consists of autoimmune and
infectious disease assays, both EIA and IFA methodologies
EVOLIS/2001/Germany
Germany/U.S.
300/1,350
batch/benchtop/rack
37 44 30/10
HIV Ab, HIV Ab/Ag, HBsAg, HBs, HBc, HBc M, HAV, HAV M

BioPlex 2200/2006/Australia
Australia/U.S.
continuous random access/floor standing/rack

58 72 34/12
ANA screen, anti-dsDNA (quantitative), anti-SS-A, anti-SS-B, antiSm/RNP, anti-Sm, anti-RNP, anti-Scl-70, anti-Jo-1, anti-centromere
B, anti-chromatin, anti-ribosomal P, anti-CCP, anti-GBM IgG, antiMPO IgG, anti-PR3 IgG, EBV-nuclear antigen IgG, EBV-viral capsid
antigen IgG, EBV-early antigen diffuse IgG, EBV-viral capside
antigen IgM, heterophile IgM, syphilis IgG, toxoplasma gondii IgG,
cytomegalovirus IgG, rubella IgG (quantitative), cytomegalovirus
IgM, rubella IgM, measles IgG, mumps IgG, rubella IgG (qualitative),
varicella-zoster virus IgG, HSV-1 IgG, HSV-2 IgG, anti-deamidated
gliadin (DGP) IgA, anti-tissue transglutaminase (tTG) IgA, anti-DGP
IgG, anti-tTG IgG, anti-cardiolipin IgA, anti-beta2 glycoprotein
(2GPI) IgA, anti-cardiolipin IgG, anti-2GPI IgG, anti-cardiolipin
IgM, anti-2GPI IgM
HIV Ag-Ab, 25-OH vitamin D
syphilis IgM, toxoplasma gondii IgM
no

fluorescence, enzyme immunoassay/coated microwell
syphilis total, lyme borreliosis

heterophile antibodies
no
bead flow cytometric (multiplex)/magnetic particle
yes


Noise generated
8 enzyme immunoassay or 4 IFA

8 enzyme immunoassay or 4 IFA
no limit
up to 8 different assays/96
44
44
44/100
48
48
4/96
4 hours//no
yes
yes
no/
yes/
/192/8 EIA or 4 IFA
yes/liquid
no/
150 L
1 L/150 L
yes/no
no/
no/
yes/1213 mm diameter, 75100 mm height/no
yes
no
no/no
yes
no/no
no/no
yes/no
no/no

no
yes
yes/kit type, lot number, kit serial number
no/2 ppm
480 minutes/800/9,600
no/liquid
yes/800
no/
5 L
5 L/220 L
yes/no
no/0.5 L per hour
<67 decibels
no/
yes
yes
yes/yes
yes
yes/yes
no/no
yes/no
30 minutes/assay dependent/
yes
yes
yes/
no/no (disposable tips)
varies by assay/180/4
no/liquid
microplates/
microplates/
0.2 L
10 L/200 L
yes/no
no/
60 decibels
no/
yes/up to 16 mm diameter, up to 100 mm height/no
no
yes
no/no
no
yes/no
no/no
yes/no
no/no
no
assay dependent
no/each run
yes/no
each run
no/no
no/no/<5 minutes
yes
assay dependent
no/30 days
yes/yes
24 hours
yes/yes
no/yes/10 minutes
no
assay dependent
no/with each run
yes/no
user determined
yes/yes
no/no/5 minutes

assay dependent/
100/100 (36 seconds)
assay dependent/
no/no
onboard/
yes/yes
onboard/yes
yes

yes
no
no/no/no
yes/yes
onboard/no
Antrim, CCA, Cerner Classic/Millennium, CHCS/SAIC, Data
Innovations, Labsoft, Meditech, Orchard, Rubicon, SCC,
Schuyler, SOFT, Sunquest/Misys
yes
yes
no
yes/yes/yes
no
24 hours
daily: <5 minutes; weekly: 15 minutes; monthly: 30 minutes
no
<24 hours
no
24 hours
daily: 5 minutes; monthly: 60 minutes
no/no
yes/no
yes/no

$68,000/all bed sizes

$6,700
2 days on site/no
open platform with assay programming wizard; bidirectional
LIS with broadcast download, capable of running IFA and
EIA; accurate down to 1 L, IFA hyperwash for cleaner
backgrounds, precise well-to-well timing; networking
capabilities for multiple workstations
/200800 samples
5 days at Bio-Rad/no
full random access automation; three internal quality control
beads run simultaneously with each sample; innovative
multiplex chemistry
$85,000/30500 tests per day
5 days in Redmond, WA/no

fully automated microplate system that meets a high level of
safety (positive identification of samples, reagents, microplates,
clot detection, no contamination), flexibility (reagents and
microplates) and productivity (46 plates, up to 180 specimens,
48 different assays can be processed simultaneously)
Part 7 of 20

HCV Ab, toxo IgG, toxo IgM, rubella IgG, EBV VCA IgG, EBV VCA
IgM, EBV EAD, EBV EBNA, infectious disease serology and
autoimmune, others
yes
no
yes/no/no
analyzers
DiaSorin
Brian Lauber brian.lauber@diasorin.com
1951 Northwestern Ave., Stillwater, MN 55082
800-328-1482/651-439-9710 www.diasorin.com
DiaSorin
Alice Farago alice.farago@diasorin.com
800-328-1482/651-439-9710 www.diasorin.com
DiaSorin
Brian Lauber brian.lauber@diasorin.com
800-328-1482/651-439-9710 www.diasorin.com
LIAISON XL/2010/Italy
Germany/Italy, Germany, U.S.
>300/>1,600
batch, random access, continuous random access/floor
standing/rack
59 59 36/14.6
ETI-MAX 3000/2002/Germany
Germany/U.S., Italy
batch, random access/benchtop/rack
LIAISON/1997/Germany
Germany/U.S., Italy
>300/>4,100
batch, continuous random access/benchtop/rack
40 45 30/10
45 96 34/10
measles IgG, varicella zoster IgG, mumps IgG, H. pylori IgG,

Trep-Sure syphilis, ANA screen, ENA 6 screen, anti-dsDNA,
anti-Sm, anti-Sm/RNP, anti-SS-A, anti-SS-B, anti-Jo-1, antiScl-70, anti-MPO, anti PR3 (cANCA), anti-TPO, anti-cardiolipin,
IgG, IgM, others
25 hydroxyvitamin D total, intact PTH, EBV IgM, EBNA IgG,

VCA IgG, EA IgG, toxo IgG, toxo IgM, CMV IgG, CMV IgM,
treponema IgG/IgM, VZV IgG, hGH, Borrelia burgdorferi, HAV
IgM, HAV total antibodies, rubella IgG, HSV-1 type specific IgG,
HSV-2 type specific IgG, insulin, measles IgG, mumps IgG,
rubella IgM, IGF-1, testosterone, estradiol, FT4, direct renin,
aldosterone, LH, FSH, C-peptide, FT3, prolactin, progesterone
25 hydroxyvitamin D total, treponema IgG/IgM, anti-HAV

total, measles IgG, mumps IgG, Borrelia burgdorferi, EBV IgM,
VCA IgG, EA IgG, EBNA IgG, VZV IgG, rubella IgG, rubella IgM
testosterone, estradiol, TSH, HSV-1 type specific IgG, HSV-2
type specific IgG, CMV IgG, direct renin, aldosterone, LH, FSH,
intact PTH, toxo IgG, toxo IgM, CMV IgM, insulin, C-peptide,
hGH, IGF-1, prolactin, progesterone, hCG, FT3, FT4, 1,25
dihydroxyvitamin D
PTH 1-84, Ca 125, Ca 15-3, Ca 19-9, TPA-M, AFP, CEA, PSA,

fPSA, S100, NSE, calprotectin, Brahms procalcitonin II, many
others
sclerostin, H. pylori IgG, FGF-23
avidity, HSV I/II IgM, HSV I/II IgG, -2-microglobulin, S-100, AFP,
ferritin, T3, T4, anti-TG, TG, PTH 1-84, calprotectin, Brahms
procalcitonin II
sclerostin, H. pylori IgG, FGF-23

no
yes
minimum strip: 1, 8 wells; maximum full plate: 96 wells, can

accommodate up to 7 plates at a time
no

25
25
0
25/100
enzyme immunoassay/coated microplate

open
open
0
volume dependent/
15
15
0
15/100

no
yes
yes/quantity, stability, lot number, and more
no/no
7 days/120/3,000
no/no/no
yes
yes
yes/
yes/no
assay dependent/180/variable

no
yes
yes/all lot information
no/no
360/144/1,500

Noise generated
no/liquid
yes/1,000
no/
assay dependent
5 L/150 L
yes/
no/
yes/50 L
yes/1016 mm diameter/no
yes
yes
yes/yes
yes
yes/yes
no/no
yes/yes
no/no
no/liquid
no/
no/
10 L
10 L/200 L
yes/no
no/no
no/
yes/multiple/no
yes/yes
yes
yes
yes/yes
yes
yes/no
no/no
yes/no
no/no
no/liquid
yes/720
no/
assay dependent
5 L/150 L
yes/no
no/
no/75 L
yes//no
yes
yes
yes/yes
yes
yes/yes
no/no
yes/yes
no/no
2 minutes
no
2
yes/14 weeks
yes/yes
24 hours
yes/yes
yes/no/8 minutes
no
varies per kit
no/each run
yes/no
per run
yes/yes
no/yes/5 minutes
2 minutes
no
2
yes/28 days
yes/no
24 hours
no/yes
no/no/15 minutes

2 minutes
57/171 (21 seconds)
assay dependent/
2 minutes
yes/yes
onboard/no
yes
yes (Inpeco)
yes/yes/yes
yes/yes
yes/yes
yes
yes
yes
no
no/no/no
yes/yes
yes/yes (additional cost)
Cerner, Soft, others
yes
yes (host query)
no
no/no/no
no
24 hours
weekly: 10 minutes; monthly: 10 minutes
no
24 hours
yes/no
yes/no
no
24 hours

monthly: 30 minutes
no/no
$275,625 (includes first year of service)/>400 beds
$100,879 (includes first year of service)/all bed sizes, all test

volumes
$194,040 (includes first year of service)/all bed sizes, all

volumes
yes/yes
3 days/yes
3 days on site/yes
secure traceability of all processes, status of reagents, and

consumables; disposable pipette tips prevent sample carryover;
clot detection, aspiration, and dispensation verification; singlecavity reaction cuvettes; no daily maintenance; instrument
monitors maintenance needs; flash chemiluminescence
technology with paramagnetic microparticle solid phase
multiple assays on a plate; Windows 2000 software;

continuous loading of samples, reagents, and microplates;
primary tube sampling; bidirectional interface
fully automated benchtop analyzer with high throughput;

unique menu; up to 15 assays onboard with ready-to-use,
reagent-integral, random-access, batch and stat operation
Part 8 of 20


analyzers
Dynex Technologies
Rich Bahlmann rbahlmann@dynextechnologies.com
14340 Sullyfield Circle, Chantilly, VA 20151
703-631-7800 www.dynextechnologies.com
Dynex Technologies
Dynex Technologies
Agility/2012/U.S., U.K.
DS2/2005/U.S.
DSX/2001/U.S.

U.S./various
>25/>25
batch/benchtop/rack
49 50 36/8.6
U.S./worldwide
1,000/600
batch/benchtop/rack
26 21 27/3.79
U.S./worldwide
1,200/1,600
batch/benchtop/rack
32 42 36/7

none
none
none

yes
1 per well
yes
1 per well
yes
1 per well
enzyme immunoassay/coated microplate wells

12
12
unlimited
12/96
assay dependent (24 control positions)

unlimited
assay dependent (18 reagent positions)/96

unlimited
assay dependent (24 reagent positions)/96
//no
yes
yes
yes/lot information
yes/none (uses disposable tips)
assay dependent/200+ continuous load/12+ continuous load
//no
yes
yes, 2 mL control vials (other reagents are pour off)
no/
assay dependent/100/assay dependent
//no
yes
yes (when using custom racks)
yes/lot information when used with custom racks
assay dependent/assay dependent/4+

Noise generated
yes/liquid
no/
no/
10 L
10 L/150 L
yes/no
no/
no/
yes
yes/yes
yes
yes/no
no/no
yes/no
no/no
yes/liquid
no/
no/
10 L/
no/no
no/
no/
yes (2 of 5 interleaved, Codabar, codes 39 and 128)/
yes
yes/yes
yes
yes/no
yes/no
no/no
yes/liquid
no/
no/
10 L/
no/no
no/
no/
yes
yes/yes
yes
yes/
yes/no
no/no
no
assay dependent
no/per plate
no/no
per plate
no/no
no/no/35 minutes
no
assay dependent
no/
no/no/
no
assay dependent
no/no
no/no/

yes/yes
onboard/yes
yes
yes
yes (host query and broadcast download)
no
yes/yes/yes
yes/yes
yes
yes
no/yes/yes
yes/yes
yes
yes
no/yes/yes
no
24 hours

monthly: <1 hour
no
24 hours

monthly: 15 minutes
no
24 hours

monthly: 15 minutes
yes/no
no/no
no/no

/yes
reduces hands-on time by more than 60 percent for ELISA
testing; tracks all assays, test kits, consumables, reagents, and
waste so analyzer can run without interruption
/yes
washer synchronization, eliminates plate drift; disposable tips;
small footprint
/yes
washer synchronization, eliminates plate drift; modular design;
disposable tips
Part 9 of 20

BD Flow Cytometry Solutions

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Because ever est is the most

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so man linical labs rel n BD fow c tometr
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as well as workfow-enhancing tools such as
BD L otubes** and the BD FACS L se Wash
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eam
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2350 Qume Drive
San Jose, CA 95131
bdbiosciences.com
analyzers
Grifols USA
Timothy Wigginton tim.wigginton@grifols.com
2410 Lillyvale Ave., Los Angeles, CA 90032
323-227-7037 www.grifolsusa.com
Hycor Biomedical
Richard Hockins rhockins@hycorbiomedical.com
7272 Chapman Ave., Garden Grove, CA 92841
800-382-2527 www.hycorbiomedical.com
Immunodiagnostic Systems (IDS)

info.us@idsplc.com
948 Clopper Rd., Gaithersburg, MD 20878
877-852-6210 www.idsplc.com
HYTEC 288 PLUS/outside U.S.: 1998; U.S.: 1999/Netherlands

Netherlands/U.S.
>85/>200
random batches/benchtop/rack robotics
IDS-iSYS/2009/France
France/Belgium
>90/>500
continuous random access/benchtop/rack sample loading

Triturus/1999/Spain
Spain/Spain, U.S., Italy
>200/>1,700
batch, random access and continuous random access/
benchtop/universal carousel
28.3 41.3 34.3/10
system is completely open; any U.S. clinically cleared and
research-use-only EIA procedure can be programmed;
infectious diseases, autoimmune diseases, bone markers,
endocrinology, hemostasis, oncology markers, hepatitis, and
HIV profiles
29.5 42.5 27.5/8

total/specific IgE, ANA scr, TG, TPO, dsDNA, RF IgG, RF IgM, RF
IgA, PR-3 (c-ANCA), MPO (p-ANCA), anti-mitochondrial, ENA-6
scr., SS-A, SS-B, Sm, Sm/RNP, Scl-70, Jo-1, gliadin IgA & IgG,
GBM, GPC, anti-cardiolipin IgG & IgM, anti-cardiolipin scr., 2
BPI IgG, IgA & IgM, user-defined channels
specific IgG, ssDNA, total RF, anti-tissue transglutaminase IgA

and IgG, circulating immune complex -C1q and -C3d, CCP
ANCA profile, centromere, ECP, tryptase

yes
8
96 (minimum strip: 1; maximum: 4 full plates)
enzyme immunoassay, EIA-coated microwell plates, onboard

shaker, 4 individually temperature-controlled microplate
positions/coated microwell
18 tests on 14 plates
8
8/48
yes
8 (1 analyte, multiple analytes/screens per well, up to 8
analytes)
96 (minimum strip: 1 strip/8 wells; maximum full plate: 12
strips/96 wells)
enzyme immunoassay, tube-based and microplate-based
assays/activated cellulose and coated well
28 42 30/~6
IDS-iSYS 1,25-dihydroxy vitamin D, IDS-iSYS 25 hydroxy vitamin
D, IDS-iSYS insulin-like growth factor-I (IGF-I), IDS-iSYS human
growth hormone (hGH), IDS-iSYS insulin-like growth factor binding protein-3 (IGFBP-3), IDS-iSYS CTX-I (CrossLaps), IDS-iSYS
intact PTH, IDS-iSYS PTH (1-34) (for research use only), IDS-iSYS
direct renin, IDS-iSYS aldosterone, 25 hydroxy vitamin DS
IDS-iSYS intact PINP, IDS-iSYS ostase BAP, IDS-iSYS N-MID
osteocalcin
IDS-iSYS 1,25 VitDXp, IDS-iSYS intact PINP, IDS-iSYS N-MID
osteocalcin, IDS-iSYS ostase BAP, IDS-iSYS TRAcP5b
IDS-iSYS ACTH, IDS-iSYS salivary cortisol, IDS-iSYS cortisol,
IDS-iSYS inaKtif MGP, IDS-iSYS total testosterone, IDS-iSYS
17-beta estradiol, IDS-iSYS free testosterone, IDS-iSYS 17-OH
progesterone
IDS-iSYS TRAcP5b, future also IDS-iSYS free testosterone, IDSiSYS inaKtif MGP, IDS-iSYS 17-OH progesterone
no
Part 10 of 20

Noise generated
chemiluminescent and spectrophotometric/

magnetic particle
varies by assay, up to 288 allergens or 8 autoimmune

multiple
3
varies by assay/up to 288 allergens or 8 autoimmune
15
15
0
15/100
//no
yes
minimal operator preparation, handling
no/
yes/no
180/92/8
yes/liquid
no/
no/
300 L
2 L/200 L
yes/no
no/
no/
yes/12, 13, 16 mm/no
yes
yes
yes/yes
yes
yes/yes
no/no
yes/no
no/no
8 hours/12 hours/no
yes
yes
no/
yes/<1 part in 10,000
yes/liquid
no/
no/
10 L, 110 L with dead volume
10 L50 L, assay dependent/100 L
yes/no
no/
no/
yes//no
no
yes
yes/yes
yes
no/no
no/no
yes/no
no/no

yes
yes
yes/lot, key information
no/no
no/liquid
yes/up to 1,120
no/
6 L (assay dependent)
4 L/80 L
yes/no
no/
yes/80 L
yes/all up to 16 100 mm/no
yes
yes
yes/yes
yes
yes/no
no/no
yes/yes
no/no
yes
114
no/check every month
yes/yes
each run
yes/no
yes/yes/12 minutes
system is open, depends on reagent methodology
dependent on reagent methodology/
yes
16
no/monthly
yes/yes
every assay
yes/yes
yes/no/23 minutes
dependent on run cycle or immediately after first result

yes
2
no/321 days
yes/yes
daily
yes/yes
yes/yes/<10 minutes
>26/>80 (every 45 seconds)
yes/yes
onboard/no
CHCS, Softmax, Sunquest
yes
no
yes/yes/yes
yes/yes
onboard/optional
yes
no
yes
no
yes/yes/no
yes/yes
onboard/no (additional cost)
yes
yes
no
yes/yes/yes
no
within 24 hours
daily: 520 minutes
no
within 48 hours
7 months/4 hours
monthly: 2025 minutes
yes (includes audit trail of who replaced parts)/yes
$55,000/all sites, variable test volumes
3 days on site/yes
fully automated allergy and autoimmune testing; user-defined
software channels for microtiter plate and tube-based assays
no
2448 hours
>200 days/<24 hours
monthly: 10 minutes
yes (includes audit trail)/no
/all bed sizes, all volumes
3 days on site/yes
full walkaway automation; compact benchtop design;
continuous loading with batch, random, and stat flexibility; auto
startup and shut down; onboard refrigeration of ready-to-use
reagent cartridges; total traceability and full data transmitted
to the LIS (results, QC, lot reagents and consumables,
messages, operator ID, washer used, and more); intelligent clot
management (iCM) prevents measurement interruption and
enhances productivity via maximized up time
yes (includes audit trail)/yes

$79,000/300+
/yes
multibatch or continuous throughput EIA analyzer; user-defined
menu, completely open system; easy color-coded worksheet
and setup for operator; 2 probes for high-speed processing;
unique cross-well washing; can use fixed probes or disposable
tips

Sharpen your view of multiple myeloma

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Introducing Hevylite, a highly sensitive and specific test for monitoring myeloma patients
Hevylite is the first test to distinguish and quantify intact heavy/light chain combinations (eg, IgA vs IgA).
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info@thebindingsite.com
800-633-4484
www.thebindingsite.com
The Specialist Protein Company
Visit us at AACC
Booth No. 3505
analyzers
Inova Diagnostics
Kaz Nakanishi knakanishi@inovadx.com
9900 Old Grove Rd., San Diego, CA 92131
800-545-9495 www.inovadx.com
Inova Diagnostics
Inova Diagnostics

BIO-FLASH/2011/U.S.
U.S./U.S.
continuous random access/benchtop/racks

21 34 24/5
tTG IgA, tTG IgG, DGP screen, DGP IgA, DGP IgG, aCL IgG, aCL
IgM, aCL IgA, B2GP1 IgG, B2GP1 IgM, B2GP1 IgA, MPO, PR3,
GBM, ENA 7, RNP, Sm, centromere, SS-B, Jo-1, Ro52, Ro60,
B2GP1 domain 1
DS2/2006/U.S.
U.S./U.S., U.K.
batch, with continuous load/benchtop/rack

30 17 26/3.07
autoimmune, infectious disease
DSX/2000/Guernsey, U.K.
U.S./U.K.
300/>500
batch/benchtop/rack
32 42 36/7
autoimmune, infectious disease
CTD screen, Jo-1, Scl-70, DFS70, dsDNA, CCP3
ELISA
any ELISA
CTD screen plus, SS-B, Jo-1, Scl-70, Ro52, Ro60, DFS70,

dsDNA, domain 1, CCP3

no
yes
yes
minimum strip 1 8; maximum full plate: 96 wells plates
minimum strip: 1 8; maximum full plate: 96 4 plates
chemiluminescence/magnetic particle, bead

20
50
0
20/50 and 100 test kits
12 assays per plate

unlimited
unlimited
8/96
12 assays per plate

unlimited
unlimited
25/96 per 4 plates

yes
yes
yes/type, number of tests, lot number, expiration date, master
calibration curve
no/
/30/20
no/liquid
yes/280
no/
10 L
10 L/50 L
yes/no
no/
yes/50 L
yes/1216 mm/no
yes (2 of 5 interleaved, codes 39 and 128)/yes
yes
yes
yes/yes
yes
yes/yes
no/no
yes/yes
no/yes
24 hours//no
yes
yes
yes/yes
24 hours//no
yes
requires operator prehandling, preparation
yes/yes
/zero with disposable tips

yes/liquid
no/
no/
200 L
5 L/200 L (50 L with microtubes)
yes/
no/
yes/50 L
yes//no
yes
no
no/yes
yes
yes/no
no/no
yes/no
no/no
yes/zero
yes/liquid
no/
no/
200 L
5 L/200 L (50 L with microtubes)
yes/no
no/
yes/50 L
yes/various/no
yes
no
no/yes
yes
yes/no
no/no
yes/no
no/no
30 minutes
yes
2
no/lot change or failure of controls
yes/yes
daily
yes/yes
yes/yes/<10 minutes
less than 5 minutes

20/60 (30 minutes)
no
varies
yes/each assay
yes/no
each assay
yes/no
no/yes/12 minutes
assay dependent/
no
assay specific
yes/once per analyte per plate
yes/yes
per plate
yes/no
yes//12 minutes
assay dependent/
yes/yes
/yes

yes
yes
yes/yes/no
yes
yes (host query)
no
no/no/no
yes/yes
Cerner Classic and Millennium, Misys, SoftComp,
Live Link, Triple G, FCC, ACA, LCW, LabLink
yes
yes (host query)
no
no/yes/yes
no
24 hours
no
/<24 hours
daily: 5 minutes
no
within 24 hours
/<24 hours
daily: 5 minutes

yes/no
/100500
yes/yes
random access, continuous load, chemiluminescent; benchtop
footprint completing up to 450 results per shift; onboard
reagents with stable calibration curves to eliminate batching
and improve turnaround time
yes/no
8 days on site/yes
graphic interface with drag-and-drop icons; large sample
throughput, with 98 samples and continuous load feature;
consumable status window shows location and volume
requirements during loading
no/no
/200+ beds
8 days on site, 2 days at vendor offices/yes

fully open, true four-plate system; modular design of reader,
washer, incubators; barcode reader and ambient drawer
enables easy upgrades and express shipping of replacement
modules, reducing downtime; software can be configured for
learned error recovery
Part 11 of 20

Noise generated

DONT GUESS.
KNOW.
Syndromic infectious disease testing in about an hour.
Patient symptoms help you identify a syndrome, but not necessarily a pathogen. Many pathogens produce
identical or significantly overlapping symptoms. Yet many diagnostics in use today ignore the syndrome and
target single pathogens. This may leave physicians guessing which bug to test for.
BioFires syndromic approach to infectious disease diagnostics is changing all that.
With three industry leading comprehensive panels (Respiratory, Blood Culture Identifcation, and Gastrointestinal),
the FilmArray eliminates the guesswork and helps pinpoint bugs faster than ever.
Get faster results at FilmArray.com
analyzers
Inova Diagnostics
Ed Bass ebass@inovadx.com
Inova Diagnostics
Ed Bass ebass@inovadx.com
Orgentec-Corgenix
Ken Dier info@corgenix.com
11575 Main St., Suite 400
Broomfield, CO 80020 www.corgenixonline.com

Quanta Lyser 240/2008/Switzerland, Italy

Switzerland/U.S.
135/171
batch/benchtop/racks
36 47 32/10.5
Quanta Lyser 2/2008/

Switzerland/U.S.
5/72
batch/benchtop/racks
29.5 25.6 27.6/
SkyLAB752/2012/Italy
Italy/U.S.
10/30
batch/benchtop/rack
39 37 51/13.1
open system: autoimmune, infectious disease
open system: autoimmune, infectious disease
ELISA open channel

yes
96
enzyme immunoassay/coated microwell, IFA slides
yes
96
enzyme immunoassay, IFA slides/coated microwell
yes
12
ELISA/coated microwell

1222
open system
enzyme immunoassay/IFA
open system
enzyme immunoassay/IFA
unlimited
assay dependent/96
//no
yes
requires prehandling
//no
yes
requires prehandling
yes/
//no
yes
yes
no/yes

Noise generated
/<10
assay dependent/up to 240/9 quantitative, 21 qualitative
yes/liquid
no/
no/
200 L
5 L/200 L
yes/no
no/
no/
yes/1016 mm/no
no
no/yes
no
yes/no
yes/no
no/<10-6
//64 IFA, 96 enzyme immunoassay
yes/liquid
no/
no/
100 L
5 L/150 L
yes/no
no/
no/
yes/1016 mm/no
no
no/yes
yes/no
no/no
yes/no
yes/disposable tip
assay dependent/assay dependent/384 samples for one assay
yes/liquid
yes/480 per rack
no/
100 L
1 L/100 L
yes/no
no/
no/
yes/up to 16 mm diameter 100 mm height/no
yes
yes
yes/yes
yes
yes/no
no/no
yes/no
yes/yes
no
assay dependent
no/per run
yes/no
per run
no/yes
no/no/2 minutes
no
varies
/per run
yes/no
per run
no/
no/no/2 minutes
no
assay dependent
no/once per run
yes/no
once per run
no/yes
yes/yes/10 minutes

100/300 (2.5 hours, assay dependent)
yes/yes
Cerner Classic and Millennium, Misys, SoftComp
yes/yes
yes/yes
onboard/yes
proprietary systems, Cerner

yes
yes (host query)
no
no/no/no
yes
yes (broadcast download, host query)
no
no//
yes
yes (host query)
no
yes/yes/yes
24 hours
68 months/
monthly: 10 minutes
no/
no
24 hours after phone troubleshooting
3 months/one day
no
24 hours
89 months/less than 2 hours
monthly: 10 minutes
no/
/500 tests per day

yes (2 days on site)/yes

fast processing time; low operating costs due to elimination
of disposable tips; completely open high-throughput batch
analyzer; reads IFA barcodes
yes (2 days on site)/

processes IFA slides and ELISA assays simultaneously, LIS
interface, large menu, and open-assay capability; reads IFA
barcodes
$99,500 with full-service, first-year warranty/>300 beds and

reference labs
$14,925
3 days on site/yes
dual pipetting system; multitasking via 3 independent arms;
runs independent of PC platform
Part 12 of 20

no/no
analyzers
Ortho Clinical Diagnostics

Mark Steelman msteelma@its.jnj.com
100 Indigo Creek Drive, Rochester, NY 14626
585-453-3420 www.orthoclinical.com
Ortho Clinical Diagnostics

Mark Steelman msteelma@its.jnj.com
100 Indigo Creek Drive, Rochester, NY 14626
585-453-3420 www.orthoclinical.com
Randox Toxicology
David McConville info@randoxtoxicology.com
55 Diamond Rd., Crumlin, County Antrim, BT29 4QY
0044 28 9442 2413 www.randoxtoxicology.com
VITROS ECi Immunodiagnostic System/1997/U.S.

U.S./U.K.
>3,100 worldwide
continuous random access/floor standing/universal sample
trays (circular) accommodate primary and secondary
containers without need for adapters
51 44 29/8.9
3rd-gen. TSH, TT3, TT4, FT3, FT4, T3-uptake, total hCG,
estradiol, progesterone, LH, FSH, prolactin, NTx, CEA, AFP, CA
125 II, CA 15-3, ferritin, cortisol (serum and urine), CK-MB,
troponin I, aHBs, B12, folate, RBC folate, equimolar PSA,
HBsAg, aHCV, HBsAg (conf.), myoglobin, aHBc, aHBc IgM,
aHBs, testosterone, NT-proBNP, CA 19-9, aHAV total, aHAV
IgM, rubella IgG, aHIV 1+2, iPTH, HBeAg, aHBe, vitamin D
VITROS 3600 Immunodiagnostic System/2009/U.S.

U.S./U.K.
>400 worldwide
continuous random access/floor standing/universal sample
trays (circular) accommodate primary and secondary
containers without need for adapters
68 83.5 34.9/20.2
3rd-gen. TSH, TT3, TT4, FT3, FT4, T3-uptake, total hCG,
estradiol, progesterone, LH, FSH, prolactin, NTx, CEA, AFP, CA
125 II, CA 15-3, ferritin, cortisol (serum and urine), CK-MB,
troponin I, aHBs, B12, folate, RBC folate, equimolar PSA,
HBsAg, aHCV, HBsAg (conf.), myoglobin, aHBc, aHBc IgM,
aHBs, testosterone, NT-proBNP, CA 19-9, aHAV total, aHAV
IgM, rubella IgG, aHIV 1+2, iPTH, vitamin D
Evidence/2002/Northern Ireland
Northern Ireland/Northern Ireland
8/27
batch/floor standing/carousel
toxo IgG, rubella IgM, toxo IgM, CMV IgG, CMV IgM, syphilis,
free PSA, total PSA II
NTx
aHBe, HBeAg, rubella IgM, toxo IgG, toxo IgM, CMV IgG, CMV
IgM, syphilis, free PSA, total PSA II
C-peptide, HIV combo, insulin, NephroCheck, syphilis, high
sensitivity troponin
NTx

Reagents bar-coded/Information in barcode
Noise generated
no
chemiluminescence (enhanced)/individually coated microwell

20
20, up to 25 lots calibrated per assay
0
20/100
no
chemiluminescence (enhanced)/indiv. coated microwell

31
31, up to 25 lots calibrated per assay
31/100

yes
yes
yes/test ID, expiration, lot number, pack ID
/zero
720/60/800 (with enhanced productivity module)
no/liquid
no/
no/
10 L
10 L/80 L
no, but it is available/no
no/
60 decibels
no/
yes/multiple pediatric, microtainers, and cups, 5 mL,
7 mL, 10 mL on same universal sample tray/no
yes (2 of 5 interl., Codabar, codes 39 & 128 & ISBT 128)/yes
yes
yes
yes/yes
yes
yes/yes
no/no
yes/yes
no/no

yes
yes
yes/test ID, expiration date, lot number, pack ID
no/zero
varies/90/3,100
no/liquid
no/
no/
10 L
10 L/35 L
no, but it is available/no
no/
no/
yes/1.5 mL micro-collection containers; 0.5, 2.0 mL cups; 5,
7, 10 mL on same universal sample tray, no adapters/no
yes (2 of 5 interl., Codabar, codes 39 & 128 & ISBT 128)/yes
yes
yes
yes/yes
yes
yes/yes
yes/yes
yes/yes
no/no

yes
yes
yes/yes
yes
no/yes
no/no
no/no
no/no
assay dependent
yes
13
no/28 days
yes/yes
once per 24 hours
yes/yes
24 minutes
immediate upon completion of last sample metering
assay dependent/assay dependent (40 seconds)
assay dependent
yes
13 depending on assay
no/28 days
yes/yes
once per 24 hours
yes/yes
//0
24 minutes
immediate upon completion of last sample metering
assay dependent/assay dependent (19 seconds)
assay dependent
no
9 (multianalyte calibrators)
no/dependent on panel
yes/yes
each worklist
yes/yes
yes/yes/13 minutes
assay dependent/assay dependent (5 minutes)
yes/yes
onboard and optional add-on/no
Cerner, Misys, Meditech, CHCS, Antrim, PathLab 2, RPNS VA,
Citation, DHCP, Unisys, McKesson, PathLab 3, Soft, others
yes
no
yes/yes/yes
yes/yes
onboard and optional add-on/yes (additional cost)
Cerner, Misys, Meditech, CHCS, Antrim, PathLab 2, RPNS VA,
Citation, DHCP, Unisys, McKesson, PathLab 3, others
yes
yes, enGen
yes/yes/yes
yes/yes
onboard/yes (included in price)
yes
no
<4 hours (contract dependent)
dependent on corrective action
daily: <5 minutes; weekly: <30 minutes; monthly: <10 minutes
no/yes
$109,000/various
yes/yes, as needed
uses Intellicheck technology to perform, monitor, document, and
verify diagnostic checks throughout sample and assay processing
to reduce potential of misreported results; IntelliReport provides
real-time status and traceability on quality of reported results;
uses enhanced chemiluminescence, MicroWell technology
no

yes (includes audit trail)/yes
$220,000/various
yes/yes, as needed
diagnostic checks throughout sample and assay processing reduces
misreported results; real-time status and traceability on quality of
reported results; fully automated, true random access stat testing
for routine and specialty immunodiagnostic testing; single-use tips
for sample and reagent metering; measures and flags results
no

no/
contract dependent/various
yes/yes
biochip enables simultaneous analysis of multiple analytes
in single sample; maximum throughput of 1,188 tests per
hour; unreported tests retrieved retrospectively; arrays contain
multiple tests applicable to forensic toxicology and workplace
drug testing
Part 13 of 20



68 78 39/22.75
acetaminophen, amphetamine, barbiturates, bath salts (alpha
PVP, MDPV, methcathinone, mephedrone), benzodiazepine,
benzlpiperazines, buprenorphine, cannabinoids, carbamazepine,
chloral hydrate metabolite, cocaine metabolite, dextromethorphan,
digoxin, dox series, EDDP, escitalopram, ethanol, ethyl glucuronide,
fentanyl, flunitrazepam, fluoxetine, generic opiods, gentamicin,
haloperidol, ibuprofen, ketamine, lithium, LSD, MDMA, meperidine,
meprobamate, mescaline, methadone, methamphetamine,
methaqualone, methylphenidate, mitragynine (kratom), NBOMe,
nor buprenorphine, nor fentanyl, opiates, oxycodone, phencyclidine,
phenobarbital, phenylpiperazines, phenytoin, propoxyphene, ritalinic
acid, salicylate, salvinorin, sertraline, synthetic cannabinoids, more
bath salts (alpha PVP, MDPV, methcathinone, mephedrone),

dox series, mitragynine (kratom), NBOMe, synthetic
cannabinoids (JWH-018/AM-2201, JWH-250/RCS-8, UR144 /
XLR11, AKB48, AB PINACA)
chemiluminescence/
22
22
0
44/360
assay dependent/up to expiration/yes (28C)
yes
yes
yes/product component, size, lot number, expiration date
100/180/5401,080
no/liquid
no/
no/
7 L
7 L/350 L (varies with cup type)
optional/yes
no/
<60 decibels
no/
yes/12 mm, 16 mm/no
yes
yes (host query)
no
yes/yes/yes
Complete QC solutions for results you can trust
Visit us at
AACC
booth
#1335
As a laboratory professional, you

know that commutable quality control
material is essential in order to safeguard
your laboratorys reporting accuracy,
as a shift in QC results is not always
refected in patient sample results.
In order to effectively verify new reagent
lots and identify system errors, it is vital QC
samples react to the examining system in
the same manner as a patient sample and is
therefore, commutable.
At Randox, our unique manufacturing
process ensures highly consistent controls,
guaranteeing commutability and instilling
confdence in patient testing. Our complete
range of multi-analyte, third party controls
will cover clinical decision levels, delivering
test menu consolidation, ultimately reducing
costs and preparation time whilst ensuring
an unbiased performance assessment.
Save precious laboratory

time and money;
partner with Randox
for commutable Quality
Controls.
QUALITY CONTROL
Randox Laboratories-US, Ltd.

marketing@randox.com
randoxqc.com
analyzers
Part 14 of 20
Roche Diagnostics
Ryan Dempsey ryan.dempsey@roche.com
9115 Hague Rd., Indianapolis, IN 46250
800-428-5074 us.diagnostics.roche.com
Roche Diagnostics
Brittany Greiner brittany.greiner@roche.com
Roche Diagnostics
Ryan Dempsey ryan.dempsey@roche.com
cobas 8000 modular analyzer series/2010/Japan, Switzerland

Japan/Germany
random access, continuous random access/floor standing/

rack-based
52.8 58.8 45.6/
ACTH, AFP, anti-CCP, anti-HAV IgM, anti-HAV total, anti-HBs,
Anti-HCV, anti-Tg, anti-TPO, anti-TSHR, beta-crosslaps,
C-peptide, CA 125, CA 15-3, CA 19-9, CEA, CK-MB, CK-MB
stat, cortisol, DHEA-S, digoxin, estradiol, ferritin, folate, folate
RBC, free PSA, FSH, FT3, FT4, HBsAg, HBsAg confirmatory,
HCG II stat, HCG+ beta, HE4, hGH, HSV-1 IgG, HSV-2 IgG, IgE,
insulin, LH, myoglobin, myoglobin stat, N-MID osteocalcin,
proBNP, proBNP stat, progesterone, prolactin, PTH, PTH stat,
rubella IgG, rubella IgM, SHBG, T3, T4, testosterone, anti-HBc,
anti-HBc IgM, CMV IgM, others
free hCG, PAPP-A, PTH (1-84), HBeAg, anti-HBe, HIV Ag, HIV
Ag confirmatory test, HIV combi, others
tacrolimus, sirolimus, cyclosporine, toxo IgM, CMV IgG, troponin T
fifth generation, HBsAg (quant); PCT, Interleukin 6, syphilis, others
cobas e411 analyzer/2008/Japan

Japan/Germany
continuous random access/benchtop/rack, disk
cobas 6000 analyzer series/2006/Japan, Switzerland

Japan/Germany

46.1 71.8 40/19.73
ACTH, AFP, anti-CCP, anti-HAV IgM, anti-HAV total, anti-HBc
IgM, anti-HBs, anti-HCV, anti-Tg, anti-TPO, anti-TSHR, betacrosslaps, C-peptide, CA 125, CA 15-3, CA 19-9, CEA, CK-MB,
CK-MB stat, cortisol, DHEA-S, digoxin, estradiol, ferritin,
folate, folate RBC, free PSA, FSH, FT3, FT4, HBsAg, HBsAg
confirmatory, HCG II stat, HCG+ beta, HE4, hGH, HSV-1 IgG,
HSV-2 IgG, IgE, insulin, LH, myoglobin, myoglobin stat, N-MID
osteocalcin, proBNP, proBNP stat, progesterone, prolactin, PTH,
PTH stat, rubella IgG, anti-HBc, CMV IgM, others
9-min. TnT, 9-min. PTH, HSV-1, HSV-2, beta-crosslaps, more
disk: 31.4 47.2 28.7/94; rack: 31.4 67 37.4/17.4

ACTH, AFP, anti-CCP, anti-HAV IgM, anti-HAV total, anti-HBc IgM,
anti-HBs, Anti-HCV, anti-Tg, anti-TPO, anti-TSHR, beta-crosslaps,
C-peptide, CA 125, CA 15-3, CA 19-9, CEA, CK-MB, CK-MB stat,
cortisol, DHEA-S, digoxin, estradiol, ferritin, folate, folate RBC,
free PSA, FSH, FT3, FT4, HBsAg, HBsAg confirmatory, HCG II stat,
HCG+ beta, HE4, hGH, HSV-1 IgG, HSV-2 IgG, IgE, insulin, LH,
myoglobin, myoglobin stat, N-MID osteocalcin, proBNP, proBNP
stat, progesterone, prolactin, PTH, PTH stat, rubella IgG, rubella
IgM, SHBG, T3, T4, testosterone, total PSA, toxo IgG, troponin I,
troponin T, anti-HBc, CMV IgM, others
Ag confirmatory test, HIV combi, toxo IgM, CMV IgG, others
tacrolimus, sirolimus, cyclosporine, toxo IgM, CMV IgG, troponin
T fifth generation, HBsAg (quant); PCT, Interleukin 6, syphilis,
others

no
electrochemiluminescence/magnetic particle
25 per module, maximum of 60
25 per module
25/100200 tests per kit
no
18
18
0
no
25 per module, maximum of 60
25 per module
2 weeks/6 weeks/yes (20C)

yes
yes
yes/calibration curve, application parameters,
lot number, expiration, reagent name
/zero (uses disposable sample tips)
360/300/5,000
no/liquid
yes/1,006 per module
no/
10 L
10 L/100 L
yes/yes
yes/average 12 L per hour in full operation
<65 decibels
yes/100 L
yes/13 75, 16 100, false bottom/no
14 days/56 days/yes
yes
yes
no/zero (uses disposable sample tips)
disk: 120/30/180; rack: 120/100/180
no/liquid
yes/360 assay tips; 180 assay cups
no/
10 L
10 L/100 L
yes/no
no/3 L for 250 tests
<70 decibels
no/
yes/1316 mm diameter/no
2 weeks/6 weeks/yes (20C)

yes
yes
/zero (uses disposable sample tips)
360/150/5,000
no/liquid
yes/1,006 per module
no/
10 L
10 L/100 L
yes/yes
yes/average 12 L per hour in full operation
<65 decibels
yes/100 L
yes/13 75, 16 100, false bottom/no

How often QC required/

yes
yes
yes/yes
yes
yes/yes (data manager)
yes/yes, semiquantitative with integrated system
yes/yes
no/no

yes
yes
yes/yes
yes
yes/yes (with middleware)
no/no
yes/no
yes/yes

yes
yes
yes/yes
yes
yes/yes (with Roche Middleware Solutions)
yes/yes, semiquantitative with integrated system
yes/yes
no/no
yes
2
no/28 days
yes/yes
24 hours
yes/yes
yes/yes/11 minutes
9 min. incubation for hCG and 18 min. incubation for hCG
<1 minute
56/176 (21 seconds)
yes
2
no/monthly for lot, weekly for rack
yes/yes
once per day
yes/yes
yes/no/4 minutes
9 minutes
42 seconds
30/86 (42 seconds)
yes
2
no/every 28 days
yes/yes
24 hours
yes/yes
yes/yes/11 minutes
9 min. incubation for hCG and 18 min. incubation for hCG
<1 minute
56/176 (21 seconds)
yes/yes
onboard/
all major LISs
yes/yes
yes/yes

yes
yes (Roche MPA systems, task-targeted automation)
yes/yes/yes
yes
yes
yes/yes/yes
yes
yes (Roche MPA systems, task-targeted automation)
yes/yes/no
no
<24 hours
45 minutes hands-on daily maintenance

yes (includes audit trail)/yes (online help)
/large to very large
no
<24 hours
215 days/varies
daily: 5 minutes; weekly: 6 minutes; monthly: 1015 min.
no/no
/varies, primary immunoassay system or
backup unit
no
24 hours
35 minutes of hands-on daily maintenance

yes (includes audit trail)/yes (online help)

5 days at company offices/yes

ECL technology-based assays provide wide measuring ranges
and excellent low-end sensitivity (for example, troponin T);
ready-to-use and barcoded reagents compatible with other
Elecsys systems; range of stat assays with 9-minute assay
time, integral part of c8000 platform, connects with Modular
Pre-Analytics for total lab automation
4 days on site/yes
ready-to-use and barcoded reagents fully compatible with
other Elecsys systems; range of stat assays with 9-minute
assay time

ready-to-use and barcoded reagents compatible with other
Elecsys systems; range of stat assays with 9-minute assay
time, integral part of c8000 platform, connects with Modular
Pre-Analytics for total lab automation


Noise generated

Ag confirmatory test, HIV combi, others
tacrolimus, sirolimus, cyclosporine, toxo IgM, CMV IgG,
troponin T fifth generation, HBsAg (quant); PCT, Interleukin
6, syphilis, others
analyzers
Siemens Healthcare Diagnostics

Matthew Fitzgerald matthew.t.fitzgerald@siemens.com
511 Benedict Ave., Tarrytown, NY 10591
847-236-7404 www.usa.siemens.com/diagnostics


Meghan Berdelle

Dimension EXL 200/2011/U.S.

U.S./U.S.
>1,500 global
batch, random access/floor standing/segmented sample wheel
ADVIA Centaur CP Immunoassay System/2005/U.S.

Switzerland/U.S.
>557/>2801
continuous random access/benchtop/7 12 position racks
61 56 41/16
Dimension Vista 500 Intelligent Lab System/2009/U.S.

U.S./U.S., Germany
>1,000 global
continuous random access/floor standing/rack and aliquot
plate system, batch
56 85 44/26
tacrolimus, MPA, LOCI troponin, LOCI NT-proBNP, LOCI TSH,

LOCI free T4, LOCI free T3, sirolimus, total PSA, free PSA,
CardioPhase hsCRP, ferritin, HCG, LV HCG, mass CK-MB, LV
mass CK-MB, myoglobin, ammonia, urine/CSF protein, lactic
acid, microalbumin, prealbumin, carbamazepine, cyclosporine,
cyclosporine extended range, digoxin, digitoxin, gentamicin,
lidocaine, lithium, N-acetylprocainamide, LOCI folate, VB12,
many others
>130 (includes vendor-supported applications), 35 general

chemistry, 14 TDMs, 17 DATs, 3 anemia, 40 plasma proteins,
20 immunoassays, including cyclosporine, LH, FSH, prolactin,
and CA 19-9, progesterone
total IgE, ferritin, folate, RBC folate, vitamin B12, vitamin D

total, BNP, CKMB, myoglobin, Tnl-ultraTM, C-peptide, insulin,
eHIV 1/O/2, HAV IgM, HAV total, HBc IgM, HBc total, HBsAg,
HBsAg confirmatory, HCV, cyclosporine, cortisol, homocysteine,
AFP, BR, CA 15-3, CA 19-9, CA 125II, CEA, complexed PSA,
PSA, serum HER2/neu, DHEAS, enhanced estradiol, FSH, total
hCG, LH, progesterone, prolactin, SHBG, testosterone, rubella
IgG, rubella IgM, syphilis, others

LOCI B12, LOCI folate

>35
vitamin D
>20
testosterone
LOCI immunoassay, nephelometric assays, gen. chemistry
anti-HBs2
procalcitonin, HA, TIMP, PIIINP (ELF markers)
vitamin D, D-dimer, galectin-3, anti-HBe, HBeAg, HIV combo
(CHIV), tacrolimus, free PSA, PIGF, sFLT-1, CMV IgG, CMV IgM
complexed PSA, serum HER2/neu

no
photometry, potentiometry (ISE), turbidimetric and EMIT/

advanced LOCI chemiluminescence technology, PETINIA and
ACMIA
no
photometry, potentiometry (ISE), turbidimetric, nephelometry and

EMIT/advanced LOCI chemiluminescence technology, PETINIA
and ACMIA
no

Noise generated
47
47
10
47/15360
144
144
10
144/201,200
15
>84 assays and multiple calibration lots
15/50200
24 hours/30 days/yes (28C)

yes
yes
yes/lot number, unique flex ID, stability, expiration date
yes/none (due to probe washing)
can be hours/60/>2,000
yes/liquid (reconstitutes onboard, no reagent prep required)
yes/12,000
no/
2 L
2 L/
yes/no
yes/5 L
<75 decibels
yes/30 L
yes/5-, 7-, 10-, 1.5-, and 1.0-mL sample cups/no

yes
yes
yes/reagent ID, lot number, expiration date
no/zero
210/72/480
no/liquid
yes/400
no/
10 L, assay dependent
10 L/50 L
yes/no
no/none
<60 decibels
no (uses microtainers)/50 L
yes/5-, 7-, 10-, 1-mL cups, microtainer tubes/no
yes, on sample transport, shortly before sample is aspirated (2

of 5 interleaved, Codabar, codes 39 and 128)/yes
yes
yes
yes/yes
yes
yes/yes
yes/yes
yes/yes
yes/no

no
yes
yes/test method, lot number, expiration date, number of tests
yes/<1 ppm
>45/150/178,800
yes/liquid
yes/>1,600
yes/automatic as needed
50 L
50 L/10 L
yes/yes
no/20 L per hour
<64 decibels
no/10 L, if using small sample cup
yes/10 50, 10 65, 13 65, 13 75, 13 100, 15 92,
16 100, 13 90/no
yes
yes
yes/yes
yes
yes/yes
yes/yes
yes/yes
can decrease/no
<20 seconds
yes
varies (3 levels for most assays)
yes (NA, K, Cl)/most 90 days
yes/yes
24 hours or with lot change
yes/yes
no/no/8 minutes
<2 minutes
yes
26 (varies)
yes/3090 days
yes/yes
once per 24 hours
yes/yes
no/no/always ready
varies
yes
2
no/28 days (assay dependent)
yes/yes
user defined
yes/yes
no/always ready/<5 minutes
16 minutes
10 minutes
15 minutes

<24 seconds
up to 146/437 (7.2 seconds)
<2 minutes
>150/450 for immunoassay methods
20 seconds
60/180 (20 seconds)
yes/yes
onboard, optional add-on/yes (additional cost)
yes
yes, Siemens VersaCell, Streamlab, Aptio Automation
yes/yes
yes/yes
yes
no

yes/yes/yes
yes/yes
onboard/no
yes
yes, Siemens, Streamlab, Advia LabCell, Advia WorkCell, Aptio
Automation
yes/yes/yes
no
28 hours
daily: <5 minutes; weekly: 10 minutes;

monthly: 15 minutes
no/no
no
28 hours

monthly: 10 minutes
yes/yes
no
28 hours
daily: 15 minutes; weekly: 20 minutes; monthly:

30 minutes
yes/yes

integrates general chemistry with homogeneous LOCI and
heterogeneous immunoassays onboard; allows a single
platform for more than 95 percent of most requested tests;
eliminates sample splitting between general chemistry tests
and immunoassays; fully automated onboard ISD assays, QCC
PowerPak onboard; reagent management system standard

ultra-integrated chemistry platform with LOCI advanced
chemiluminescence and nephelometry onboard; enhanced
workflow efficiency with automated features, such as
autocalibration, auto QC, and system twinning; proactive
service and support through RealTime Solution Siemens
Remote Service
/200+ beds or 250 tests per day

automates routine operations, including ability to access/
change solutions, waste, disposables, and reagents without
pausing sampling or processing; onboard automatic dilutions, repeats, stats, and cascade reflex testing; disposable
tips; uses same reagents/consumables as Advia Centaur/
Advia Centaur XP with concordant results; throughput 180
tests per hour; average time to first result ~15 minutes
Part 15 of 20



32 43 29/8.7

yes
yes
yes/yes
yes
yes/yes
no/no
yes/yes
no (does have autodilution)/no (does have autodilution)
yes/yes/yes
analyzers
Part 16 of 20

Meghan Berdelle


ADVIA Centaur XP/2006/U.S.

Ireland/U.S.
>1,420/>4,550
continuous random access/floor standing/5-position multiple
size rack or puck via Advia LabCell and WorkCell, StreamLab,
VersaCell
51.5 76.5 41/20.6
Dimension Vista 1500 Intelligent Lab System/2006/U.S.

U.S./U.S., Germany
>1,000 global
floor standing/sample rack and aliquot plate system
Dimension EXL with LM Integrated Chemistry System/2009/U.S.

U.S./U.S.
>1,700 global
floor standing/racks
56 85 44/26
49 82 41 (without monitor)/25.1 (with printer shelf down)
total IgE, ferritin, folate, RBC folate, vitamin B12, vitamin D

>130 (includes vendor-supported applications)
total, BNP, CKMB, myoglobin, Tnl-ultraTM, C-peptide, insulin,
anti-HBs2, eHIV 1/O/2, HAV IgM, HAV total, HBc IgM, HBc total,
HBeAg, HBsAg, HBsAg confirmatory, HCV, cyclosporine, cortisol,
homocysteine, AFP, BR, CA 15-3, CA 19-9, CA 125II, CEA,
complexed PSA, PSA, serum HER2/neu, DHEAS, enhanced
estradiol, FSH, total hCG, LH, progesterone, others
>100 (includes vendor-supported applications)

progesterone, LOCI BNP

>20
testosterone, additional hormones, LOCI vitamin D, cortisol,
BNP, and intact PTH
LOCI technology, nephelometry, general chemistry
>35
LOCI BNP, LOCI IPTH
procalcitonin, HA, TIMP, PIIINP (ELF markers)

D-dimer, galectin-3, anti-HBe, HIV combo (CHIV), tacrolimus,
free PSA, PIGF, sFLT-1, CMV IgG, CMV IgM
complexed PSA, serum HER2/neu

no
acridinium ester, chemiluminescence/magnetic particle

Noise generated
30 primary reagents
300
30/50, 100, 200 tests per pack
no
photometry, potentiometry (ISE), turbidimetric, nephelometry and

EMIT/advanced LOCI chemiluminescence technology, PETINIA
and ACMIA
166
166
10
166/201,200
no
photometry, potentiometry (ISE), turbidimetric and EMIT/

advanced LOCI chemiluminescence technology, PETINIA and
ACMIA
91
91
10
91/15360
yes
yes
yes/lot number, unique flex ID, stability, expiration date
yes/none (due to probe washing)
can be hours/60/>2,000
yes/liquid (reconstitutes on board, no reagent prep required)
yes/12,000
no/
2 L
2 L/primary tube capable
yes/no
yes/up to 5 L
<75 decibels
yes/30 L
yes/5-, 7-, 10-, 1.5-, and 1.0-mL sample cups/no

yes
yes
yes/yes
yes
yes/yes
no/no
yes/yes
no (has autodilution)/no (has autodilution)

no
yes
yes/test ID, lot No., individual sequence number, exp. date
yes/<1 ppm
>45/150/205,200
yes/liquid
yes/>2,000
yes/as needed
2 L analytical, 50 L aliquot
2 L (GLU=1.2)/20 L
yes/no
no/20 L per hour
64 decibels
yes/10 mL
yes/10 50, 10 65, 13 65, 13 75, 13 100, 15 92,
16 100, 13 90/no
yes
yes
yes/yes
yes
yes/yes
yes/yes
yes/yes
no/no (has autodilution)
15 seconds
yes
2
no/28 days (assay dependent)
yes/yes
user defined
no/yes
no/no/always ready
<2 minutes
yes
26 (varies)
yes/3090 days
yes/yes
shortest interval: 24 hours
yes/yes
no/no/always ready
<20 seconds
yes
varies (3 levels for most assays)
yes (NA, K, Cl)/most 90 days
yes/yes
24 hours or with lot change
no/yes
no/no/not required
18 minutes
10 minutes
16 minutes

15 seconds
80/240 (15 seconds)
<2 minutes
150/450 for immunoassay methods
<24 seconds
up to 146/437 (7.2 seconds)
no/yes
yes/yes
yes
yes, Advia WorkCell, Advia LabCell, VersaCell, StreamLab
yes/yes
onboard, optional add-on/yes (additional cost)
yes
yes, Siemens VersaCell, Streamlab, Aptio Automation

yes/yes/yes
yes/yes
onboard/no
yes
yes, Siemens VersaCell, Streamlab, Advia LabCell, Advia
WorkCell, Aptio Automation
yes/yes/yes
no
28 hours

monthly: 30 minutes
yes/yes
no
28 hours

monthly: 10 minutes
yes/yes
no
28 hours
daily: <5 minutes; weekly: 10 minutes;

monthly: 10 minutes
no/yes
/300+ beds or 500 tests per day

multiple options
4.5 days on site/yes
automates operations: ability to access/change solutions,
waste, disposables, and reagents without pausing sampling or
processing, no-pause loading of disease menu, reagents, highthroughput consumables; onboard automatic dilutions, repeats,
stats, and cascade reflex testing; disposable tips; uses same
reagents/consumables as Centaur CP with concordant results;
processes 240 tests per hour

intelligent lab system with customer-driven design,
ultra-integration of technologies; LOCI advanced
chemiluminescence and automation onboard for efficiency,
simplicity, sensitivity, and convenience to provide an efficient
workflow for the laboratory; autocalibration and auto QC
onboard; proactive services and support through RealTime
Solution Siemens Remote Service
multiple types
4 days at company offices/no
integrates homogeneous LOCI and heterogeneous immunoassays onboard with other chemistries; allows single platform
for >95 percent of most tests; eliminates sample splitting
between general chemistry tests and immunoassays; fully automated onboard ISD assays; QCC PowerPak onboard; reagent
management standard



yes
yes
yes/assay name, lot No., expir. date, pack ID, No. of tests
/none
280/180/840
no/liquid
yes/1,000
no/
10 L, assay dependent
10 L/50 L
yes/no
no/2.5 L per hour
<62 decibels
no (uses microtainers)/50 L
yes/1-, 2-, 3-, 5-, 7-, 10-mL, microtainer tubes/no

yes
yes
yes/yes
yes
yes/yes
yes/yes
yes/yes
yes/no
yes/yes/yes
A91DX-9426-UA1-4A00. 2015 Siemens Healthcare Diagnostics Inc. All rights reserved.
Good News: Youre automating your lab.

Best News: Weve done it 1295 times.
Siemens has the most experience turning complexity into effciency.
usa.siemens.com/automation-leader
The challenges of automating a laboratory, whether for

the frst time or the third, can be formidable. So having
a partner with extensive experience can be the key to
achieving your goals. Perhaps thats why more laboratories
around the world rely on Siemens for total laboratory
automation than any other company.
How does Siemens do something so complex so well?
We bring expertise to every phase of your project.
For example, our Lean Healthcare-accredited workfow
consultants can apply best practices and leverage
Siemens proprietary database of rules to streamline
operations. Our teams are equipped with time-tested
analytical tools to set achievable benchmarks for
throughput, TAT, staffng, and resource utilization.
And by performing periodic, data-driven evaluations,

we can help you continually improve productivity
throughout years of partnership.
Siemens is the only single-source provider able to
connect all four key laboratory disciplines chemistry,
immunoassay, hematology, and hemostasis to the
automation track. Working with one vendor can help
reduce interoperability issues to ensure a more integrated
and effcient overall solution.
Laboratory automation can be complex, but having
completed more than 1295 track-based automation
projects, we can put your mind at ease and help you
achieve your goals. And that is very good news indeed.
Get more good news at usa.siemens.com/automation-leader.
Answers for life.
analyzers

Ryan Gresavage

Ryan Gresavage
ThermoFisher Scientific
Lisa Davis lisa.r.davis@thermofisher.com
4169 Commercial Ave., Portage, MI 49002

IMMULITE 1000/2002/U.S.
U.S./U.S., U.K.
>557/>2,386
continuous random access/benchtop/loading platform
19 46 26/7.98
total IgE, ferritin, folic acid, RBC folate, vitamin B12, calcitonin,
PYRILINKS-D, high-sensitivity CRP, myoglobin, troponin I, CMV
IgG, CMV IgM, herpes I & II IgG, toxo. quantitative IgG, toxo.
IgM, rubella quantitative IgG, rubella IgM, C-peptide (serum,
urine), insulin, microalbumin (urine) (ALB), growth hormone
(hGH), IGF-I, IGFBP-3, anti-HBc IgM, anti-HBc total, anti-HBs,
HBs Ag, HBs Ag confirmatory, H. pylori IgG, ACTH, cortisol,
homocysteine, AFP, others
IMMULITE 2000 XPi Immunoassay System/2009/U.S.

U.S./Wales, U.K.
>103/>1,283
random access/floor standing/rack
47 60 30/12.5
3gAllergy specific, total IgE, ferritin, folic acid, RBC folate,
vitamin B12, calcitonin, PYRILINKS-D, high-sensitivity CRP,
myoglobin, troponin I, CMV IgG, CMV IgM, herpes I & II IgG,
toxo. quantitative IgG, toxo. IgM, rubella quantitative IgG,
rubella IgM, C-peptide (serum, urine), insulin, microalbumin
(urine) (ALB), growth hormone (hGH), IGF-I, IGFBP-3, anti-HBc
IgM, anti-HBc total, anti-HBs, HBs Ag, HBs Ag confirmatory, H.
pylori IgG, syphilis, ACTH, cortisol, anti-CCP, others
Phadia Laboratory System 100/1995/Sweden

Sweden/Sweden
batch/benchtop/carousel
18 28 24 plus computer/
hundreds of ImmunoCAP-specific IgE allergens,
ImmunoCAP-total IgE, tryptase and ImmunoCAP TG and TPO,
EliA autoimmune products include CCP, dsDNA, symphony ANA
screen, 7 individual ENAs, Celikey (tissue transglutaminase)
IgA/IgG, gliadin (deamidated and native) IgA/IgG, RF IgM/IgA,
cardiolipin IgM/IgG/IgA, 2-glycoprotein I IgM/IgG/IgA, EliA
PR3s, GBM, MPOs

AlaTOP allergy screen, ECP, osteocalcin, CK-MB, D-dimer,

NT-proBNP, IL-10, IL-1B, IL-2R, IL-6, IL8, LBP, TNF-a, TPS, free
beta HCG, PAPP-A, nicotine metabolites
EliA anti-TPO, EliA anti-TG

EliA CTD screen (15 ENAs), Pm/Scl, EliA Anti IgA, EliA calprotectin, EliA ASCA IgG/IgA, EliA Rib-P and six other "rare" ENAs,
RF IgG, and CCP IgA
D-dimer, turbo D-dimer, CMV IgM

IGF-I, IGFBP-3, androstenedione, 2 microglobulin, gastrin,
canine TLI, canine total T4, canine TSH
AlaTOP allergy screen, allergen-specific IgG, allergen-specific

IgG4, ECP, osteocalcin, CK-MB, D-dimer, NT-proBNP, IL-2R,
IL-6, IL8, LBP, free beta HCG, PAPP-A, EBV-EBNA IgG, EBV-VCA
IgG, EBV-VCA IgM, nicotine metabolites
immunoglobulin (TSI)
IGF-I, IGFBP-3, androstenedione, 2 microglobulin, gastrin,
canine TLI, canine total T4, canine TSH, 3gAllergy-specific IgE

no
chemiluminescence/bead, centrifugation
no
chemiluminescence/bead, centrifugation
no
fluoroenzyme immunoassay/ImmunoCAP cellulose

polymer matrix reaction wells

Noise generated
12
unlimited
0
12, 5 for Turbo/100, 50 for Turbo i-PTH
24
unlimited
24/200
4
7
0 (closed system)
4896, depending on the conjugate type/48
//no (30 days refrigerator stability)

yes
yes
yes/test, lot number, expiration date
no/<10 ppm
100//70
no/liquid
yes/
no/
5 L
5 L/100 L
yes/no
no/0.5 L per hour
5568 decibels
no/
no//
yes/yes
yes
yes
yes/yes
yes
no/no
no/no
yes/no
no/no

yes
yes
yes/test, lot number, expiration date
no/<3 ppm
300/90/1,300
no/liquid
yes/1,300
no/
5100 L
5 L/50 L
yes/no
no/
52 decibels
yes/50 L
yes/75100 mm/no
yes (2 or 5 interleaved, Codabar, codes 39 and 128)/yes
yes
yes
yes/yes
yes
yes/yes
yes/yes
yes/yes
no (has autodilution)/no (has autodilution)
yes
yes (wash solution requires preparation)
yes/product name, lot number, expiration date
no/
180/varies with analyte/48
no/liquid
no/
40 L for ImmunoCAP tests and 20 L for EliA tests

ImmunoCAP: 40 L/40200 L; EliA: 50 L/20200 L
yes/no
no/1 L per run
no/
yes/1016 mm 50105 mm/no
no
no
no/yes
yes
yes/yes
no/no
yes/yes
no/no
yes
2-level adjusters, supplied in kit
minimum 18 seconds
yes
2-level adjusters, supplied in kit
2.5 hours (batch run)

yes
6 per analyte for calibration run, 2 when using stored curve

no/14 weeks (assay dependent), 2 weeks for Turbo

no/yes
customer determined
no/yes
no/no/5 minutes
no/14 weeks (assay dependent)

yes/yes
customer determined
yes/yes
yes/yes/4 minutes
yes/28 days or sooner if conjugate lots change

yes/yes
once per work shift (user defined)
yes/yes
yes/yes/20 min. including request entry or downloading
42 minutes; 15 minutes for Turbo (total hCG)
35 minutes

2.5 minutes
90/120
18 seconds
67/200 (18 seconds)
yes/yes
yes/yes
yes
yes/yes
yes/yes
yes

yes
no
yes/yes/no
yes
yes, Advia WorkCell, Advia LabCell, VersaCell, StreamLab
yes/yes/yes
batch analyzer/48 (180 minutes processing time for batch to

finish)
yes/yes
onboard/yes, instrument side only (included)
Misys, Cerner, SCC, Orchard, Antek, Triple-G, Tandem, American Health Net, Antrim, others
yes
yes
yes/yes/yes
no
28 hours
daily: 5 minutes; weekly: 10 minutes; monthly:

20 minutes
/yes
no
28 hours
daily: 510 minutes; weekly: 20 minutes; monthly: 2030

minutes
no/yes
no

monthly: 15 minutes
yes/no
/>200+ beds or 60 tests per day

multiple options
yes/yes
compact benchtop analyzer with extensive immunoassay
menu (77 assays) provides opportunity to reduce sendouts
and boost laboratory revenue; ideal for small lab environment
because of proven system uptime (reliability)
/>200+ beds or 250 tests per day

multiple options
yes/yes
extensive routine and specialty immunoassay menu (81
assays); includes menu of 300+ specific allergens and panels;
provides opportunity to reduce sendouts and boost laboratory
revenue; features extended reagent onboard stability (90 days)
for efficient operation and cost control
/>7,00020,000 tests per year
3.5 days at company offices/yes

provides accepted technology for serologic, specific IgE testing, and autoimmune markers; comprehensive clinical and
technical research; extensive medical information and education; measures and reports specific IgE quantitative results
across clinical range
Part 17 of 20


ImmunoCAP-specific IgE blood tests and EliA

autoimmune tests
analyzers
Lisa R. Davis lisa.r.davis@thermofisher.com
800-346-4364 www.thermoscientific.com/phadia

Phadia Laboratory System 250/2004/Japan, Sweden

Japan, Sweden/Sweden
203/2,019
continuous random access/floor standing/racks
73 50 30 plus 26-in. wide computer stand/
more than 650 ImmunoCAP-specific IgE allergens, ImmunoCAP total IgE, Tryptase and ImmunoCAP TG and TPO, EliA
autoimmune products include: CCP, dsDNA, Symphony ANA
Screen, 7 individual ENAs, celikey (tissue transglutaminase)
cardiolipin IgM/IgG/IgA, 2-glycoprotein I IgM/IgG/IgA, M2, EliA
PR3s, GBM, MPOs
Phadia Laboratory System 1000/2003/Japan, Sweden

Japan, Sweden/Sweden
127/308
83 71 40 plus 26-in. wide computer stand/
hundreds of ImmunoCAP-specific IgE tests, ImmunoCAP total
IgE, ImmunoCAP ECP, and ImmunoCAP tryptase

Japan/Sweden
5/28
71 158 47 plus 26-in. wide computer stand/51
more than 650 ImmunoCAP-specific IgE allergens,
ImmunoCAP total IgE, ImmunoCAP TG and TPO tests, CCP
EliA anti-TPO, EliA anti-TG
EliA CTD screen (15 ENAs), Pm/Scl, EliA anti IgA, EliA
calprotectin, EliA ASCA IgG/IgA, EliA Rib-P and six other
rare ENAs, RF IgG, and CCP IgA
ImmunoCAP-specific IgE blood tests and EliA

autoimmune tests
EliA PR3s, GBM, MPOs, tryptase, CCP, dsDNA, Symphony ANA

screen, 7 individual ENAs, celikey (tissue transglutaminase)
cardiolipin IgM/IgG/IgA, 2-glycoprotein I IgM/IgG/IgA, EliA
anti-TPO, EliA anti-TG
EliA CTD screen (15 ENAs), Pm/Scl, EliA anti IgA, EliA
calprotectin, EliA ASCA IgG/IgA, EliA Rib-P and six other
rare ENAs, RF IgG, and CCP IgA
ImmunoCAP-specific IgE blood tests and EliA autoimmune

assays

no
fluoroenzyme immunoassay/ImmunoCAP cellulose polymer

matrix reaction wells
no
fluoroenzyme immunoassay/ImmunoCAP cellulose polymer

matrix reaction wells
no
fluorescence/coated microwell, fluoroenzyme immunoassay,

ImmunoCAP cellulose polymer matrix reaction wells

6
not limited, though inventory manager software will instruct
operator of reagent insufficiencies in the onboard inventory
0 (closed system)
3/400 or 100, depending on the conjugate type
3
0 (closed system)
3/400 or 100, depending on the conjugate type
up to 8
0 (closed system)
8/400, 100, or 50, depending on the conjugate type
5 days/1 year/yes (28C)

yes
no/
470/50 simultaneously/370 tests
no/liquid
no/

40200 L for ImmunoCAP tests and 50 L/
50200 L for EliA tests (varies with tube type)
yes/no
no/10 L
65 decibels
no/
yes/1017 mm 50105 mm/no
no
yes
yes/yes
yes
yes/yes
no/no
yes/yes
no/no

yes
no/zero (disposable sample tips)
460/200 simultaneously/2,400 tests
no/liquid
no/
40 L per test
40 L/40200 L (varies with tube type)
yes/no
no/10 L
68 decibels
no/
yes/1017 mm 50105 mm/no
no
yes
yes/yes
yes
yes/yes
no/no
no/yes
no/no

yes
yes
470/800 simultaneously (370 tests)/6,400 tests
no/liquid
no/

40200 L for ImmunoCAP tests and 50 L/
50200 L for EliA tests (varies with tube type)
yes/yes
yes/121 L
64 decibels
no/
yes/1017 mm 50105 mm/no
no
yes
yes/yes
yes
yes/yes
no/no
yes/yes
no/no
100 minutes
yes
6 per analyte for calibration run, 2 per analyte when using
stored curve
yes/yes
yes/yes
yes/yes/30 minutes unattended
100 minutes
yes
6 per analyte for calibration run, 2 per analyte when using
stored curve
yes/yes
yes/yes
100 minutes
yes
5 or 6 per analyte for calibration run (assay dependent), 2 per
analyte when using stored curve
yes/yes
yes/yes
6 minutes
20 specimens/60 (100 minutes to first result, then 1 result per
60 seconds )
yes/yes
onboard/yes (instrument side only)
yes
yes
yes/yes/yes
6 minutes
80 specimens/240 (100 minutes to first result, then 1 result
per 15 seconds )
yes/yes
onboard/yes (instrument side only)
yes
yes
yes/yes/yes
160 specimens/480 (100 minutes to first result, then 8 results

per 15 seconds )
yes/yes
onboard/
Misys, Cerner, SCC, Orchard, Antek, Triple-G, Tandem, American Health Net, Antrim, HL7, others
yes
yes
yes/yes/yes
no
<24 hours
daily: 1 minute; weekly: 10 minutes; monthly: 15 min.

yes/
no
<24 hours

yes/
no
<24 hours

yes/
/>20,00095,000 tests per year
3.5 days at company offices/yes

provides accepted technology for serologic, specific IgE testing
with the ImmunoCAP family of products and autoimmune
markers with the EliA family of products; comprehensive clinical and technical research and extensive medical information
and education
/>95,000 tests per year
4.5 days at laboratory/yes

provides accepted technology for serologic, specific IgE testing
with the ImmunoCAP family of products; comprehensive clinical and technical research and extensive medical information
and education; measures and reports specific IgE quantitative
results across the clinical range
4 days on site/yes
continuous random access analyzer provides more than 6,000
tests in one run; high-throughput instrument optimized for
cost-conscious laboratories; efficient and flexible to meet
allergy and autoimmune assay testing needs
Part 18 of 20

Noise generated

ImmunoCAP-specific IgE blood tests
analyzers
4169 Commercial Ave.
Portage, MI 49002
TOSOH Bioscience
Susan Kolarik susan.kolarik@tosoh.com
6000 Shoreline Court, Suite 101
South San Francisco, CA 94080
800-248-6764 www.tosoh.com
TOSOH Bioscience


Japan/Sweden
1/16
71 236 47 plus 26-inch wide computer stand/77
more than 650 ImmunoCAP-specific IgE allergens,
ImmunoCAP total IgE, ImmunoCAP TG and TPO
EliA PR3s, GBM, MPOs, tryptase, EliA autoimmune products

currently include CCP, dsDNA, symphony ANA screen, 7
individual ENAs, celikey (tissue transglutaminase) IgA/IgG, gliadin
(deamidated and native) IgA/IgG, RF IgM/IgA, cardiolipin IgM/IgG/
IgA, 2-glycoprotein I IgM/IgG/IgA, EliA anti-TPO, EliA anti-TG
EliA CTD screen (15 ENAs), Pm/Scl, EliA Anti IgA, EliA
calprotectin, EliA ASCA IgG/IgA, EliA Rib-P and six other rare
ENAs, RF IgG, and CCP IgA
ImmunoCAP-specific IgE blood tests and EliA autoimmune

assays
no
fluorescence/coated microwell, fluoroenzyme immunoassay,

ImmunoCAP cellulose polymer matrix reaction wells
up to 8
0 (closed system)
8/400, 100, or 50, depending on the conjugate type
AIA-2000/2008/Japan
Japan/Japan
90/650
continuous random access/floor standing/rack, sorter drawer
49.6 59.1 35.7/14.66
TSH 3rd gen., TSH, FT4, FT3, T4, T3, T-uptake, TPOAb, TgAb,
bHCG, estradiol, FSH, LH, progesterone, prolactin, AFP, CEA,
PSA, CA 125, 27.29, beta 2 microglobulin, C-peptide, cortisol,
hGH, IgEII, insulin, PAP, CK-MB, myoglobin, troponin I 2nd gen.,
ferritin, folate, B12, testosterone, CA 19-9, intact PTH, RBC
folate, cystatin C, ACTH, DHEA-S, homocysteine, vitamin D
Tg, SHBG
AIA-360/2004/Japan
Japan/Japan
2,000/6,100
continuous random access/benchtop/carousel
21 19 16/2.1
10 minutes short-time assays: TSH, FT4, T3, T4,
T-uptake, FT3, hCG, estradiol, FSH, LH, progesterone,
prolactin, AFP, CEA, PSA, CA 125, 27.29, -2-microglobulin,
C-peptide, cortisol, hGH, IgE II, insulin, PAP, CK-MB, myoglobin,
troponin I second generation, ferritin, testosterone, CA 19-9,
intact PTH, cystatin C, HbA1c, ACTH, DHEA-S, homocysteine
Tg, SHBG
BNP, HBsAg, HBsAb, HBcAg, HBcAb, HBeAg, cTnI third

generation, PSA II, TrAb, HCVAb, HCG, free PSA
BNP, HBsAg, HBsAb, HBcAg, HBcAb, HBeAg, cTnI third

generation, PSA II, TrAb, HCVAb, HCG, free PSA
D-dimer, SHBG, and osteocalcin
no
fluorescence/bead
flourescence, enzyme immunoassay/bead
48
48
25
entire menu
0
48/unitized test cup
0
/unitized test cup

yes
yes
470/800 simultaneously (370 tests)/9,200 tests
no/liquid
no/

40200 L for ImmunoCAP tests and 50 L/50200 L for EliA
tests (varies with tube type)
yes/yes
yes/215 L
64 decibels
no/
yes/1017 mm 50105 mm/no
no
yes
yes/yes
yes
yes/yes
no/no
yes/yes
no/no
72 hours/72 hours/no
yes
yes
yes/lot number, test code
no/zero
172/200/960
no/dry
no/
no/
500 L tube, 100 L cup
10 L/500 L tube, 100 L cup
72 hours/72 hours/
yes
yes
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Part 19 of 20
Noise generated

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Evidence drives guideline on reducing interpretive error

Anne Paxton
Secondary review of surgical pathology cases is a common, if not universal, practice in U.S. anatomic
pathology departments. The evidence has shown that case reviews
detect errors. But until now, one
important thing has been missing:
consensus on the actual standard of
practice for such reviews. Anatomic
pathology departments have lacked
evidence-based guidelines on how
and when to conduct reviews.
A new guideline, Interpretive
Diagnostic Error Reduction in Surgi-
cal Pathology and Cytology, jointly

sponsored by the CAP and the Association of Directors of Anatomic
and Surgical Pathology, aims to fll
the gap.
Developed by a 10-member expert panel after an extensive literature review, the guidelines main
recommendations clarify that a systematic process of secondary review
should be adopted and that such
reviews should be timely, while
other consensus statements in the
guideline address monitoring and
documentation, relevant proce-
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dures, and responding to poor

agreement, if present. The guideline
was published online in May (Nakhleh RE, et al. Arch Pathol Lab
Med. Epub ahead of print May 12,
2015. doi:10.5858/arpa.2014-0511SA), following an open comment
period that indicated strong agreement87 percent to 93 percent
from those who weighed in.
An informed second review of
cases is an important step to decrease errors. Theres no question
about it, says study coauthor Vania
Nos, MD, who, as co-chair of the
guideline committee, represented

ADASP. We have a lot of information on different practices in error
reduction throughout the country,
and the majority of U.S. hospitals,
the majority of pathology departments, do have a way of reviewing
cases. But its not standardized.
There are few rules or recommendations to help directors of surgical
pathology develop a system of case
reviews.
In 2012, the CAP and ADASP
jointly developed and published
criteria for critical diagnoses in
anatomic and surgical pathology,
says Dr. Nos, professor of pathology at Harvard Medical School and
director of anatomic pathology and
molecular pathology at Massachusetts General Hospital. Later, the
CAP and ADASP agreed that recommendations for the review of pathology cases to detect or prevent interpretive diagnostic errors were needed, and the organizations decided to
jointly develop the interpretive diagnostic error reduction guideline.
The idea for this guideline was
approved in 2010 by the CAP and
ADASP, says Raouf Nakhleh, MD,
guideline co-chair representing the
CAP and a professor of pathology
at Mayo Clinic in Jacksonville, Fla.
It took a couple of years to get everything in place and get the expert
panel together. Then we worked to
evaluate the literature, which took a
little over two years. The expert
panel reviewed 823 published
articles.
Helping to push the guideline
forward are the more conservative
surgical approaches that are changing surgical pathology, Dr. Nakhleh
notes. Because the trend is to conduct less-invasive procedures, there
are more endoscopic biopsies, more
fne-needle aspiration, resulting in
less tissue. So as we get smaller and
smaller tissues, were challenged to
be as precise as possible. Within
this context, the need for secondary
review has become even greater, he
believes.
Dr. Nakhleh says a correct diagnosis boils down to fve factors: the
pathologists knowledge and experience, clinical correlation, use of standardized terminology, use of confrmatory ancillary studies when available, and some type of review process to make sure diagnoses are
correct.
The last component, case review,
has been discussed often. But there
hasnt been any systematic, methodical examination of this topic.
That was our intent in this project,
Dr. Nakhleh says.
Pathologists have traditionally
had an informal process of case review, he adds. Instinctively, most
pathologistswhen continued on 62
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Guideline
continued from 60
they have a case with an unfamiliar

lesionwill share that case with
someone who is more familiar with
that lesion. But its done in a haphazard way; the process is not defned. So we wanted to examine the
literature to fnd out if this is effective and, second, whether there is a
method of review that is superior in
identifying discrepancies.
fter a comprehensive literature

review, the expert panel crafted fve high-level recommendations
and expert consensus statements to

formalize the recommended process for review of surgical pathology and cytology cases.
The panels recommendations
are that anatomic pathologists
should: develop procedures for the
review of selected pathology cases
to detect disagreements and potential interpretive errors; perform case
reviews in a timely manner to avoid
having a negative impact on patient
care; have documented case review
procedures that are relevant to their
practice setting; and continually
monitor and document the results
of case reviews. The ffth of the rec-
ommendations is that if pathology

case reviews show poor agreement
within a defined case type, anatomic pathologists should take
steps to improve agreement.
To develop these recommendations, the panel asked two key questions during its systematic literature
search: Does targeted review at either the analytic or postanalytic
phase of surgical pathology or cytology cases (slides and/or reports)
reduce the error rate or increase the
rate of interpretive error detection
compared with no review, random
review, or usual review procedures?
And: What methods of selecting
cases for review have
been shown to increase or decrease the
rate of interpretive error detection compared with no review,
random review, or
usual procedures?
The panel evaluated more than 800
studies and extracted
data from 137 articles,
suggesting a broad
review, but Dr. Nakhleh insists that the
focus was actually
very limited. We really focused on pa- Dr. Nakhleh
pers that discussed a review of
cases that compared original diagnoses with subsequent diagnoses.
We didnt try to look at other factors. And it was pretty clear that if
you reviewed cases, diagnostic disagreements were found, and some
of those were real errors.
The quality of the literature was
graded as to rigorousness, though
most of it was not up to the gold
standard of a double-blind prospective randomized trial. In pathology, we dont really have very many
studies at that level, Dr. Nakhleh
says. Its a bit of a problem, because if you fnd an error in a diagnosis, youre always going to correct it, just as youre not going to
test whether parachutes save lives
by randomizing and having some
people jump out of planes without
parachutes. So it may not be possible to get to a high-level quality of
evidence.
Of the more than 800 studies,
we actually found only fve studies
that compared different types of
review. Prospective review was
compared with retrospective review
of surgical pathology and cytology
cases, Dr. Nakhleh says.
The analytic phase of surgical
pathology and cytology, unlike that
of clinical pathology, involves the
inherent judgment of the pathologist at the time of slide interpretation, the expert panel notes, saying,
It is therefore more subjective than
clinical laboratory tests. But this
label does not mean the judgments
in surgical pathology and cytology

are less scientifc.
A key fnding of the study, in addition to the recommendations, is
that the pathologists experience
and knowledge are paramount in
any review process. Obviously, the
more experienced a pathologist is
in a certain type of lesion, the easier
it is to make that diagnosis, Dr.
Nakhleh says. A pathologists expertise comes not only in the form
of being able to make a diagnosis
but also in sharing information
about addressing clinical correlation, or the type of ancillary testing
needed to confrm a diagnosis. The
interaction with a
more knowledgeable
pathologist helps
complete the balance
involved in managing
the fve factors leading to an accurate
diagnosis.
Some lesions require a high level of
judgment because
they lack objective criteria, Dr. Nakhleh
notes. It depends on
what type of diagnosis youre looking at.
For some lesions
where we have objective criteriafor example, the presence of an organism, seen morphologically or by special staina second opinion may not be necessary.
But there are many lesions, particularly those in a gray zone between
benign and malignant, where subjective criteria are used. Are the
nuclei big enough to be dysplastic?
Or too big to be benign? This requires some judgment. With experience, a pathologist becomes better
and develops a level of comfort at
making the diagnosis.
The pathologists knowledge and
experience remain the most important factors in interpretive diagnosis, Dr. Nos says. But pathology is
not one of the most subjective areas
in medicine. I would say that pathology is a science you learn by
putting things together. But the research shows that pathology is not
like a mathematical science, she
says. In my experience, training is
very important for error reduction.
With knowledge and experience, a
pathologist becomes expert at recognizing different lesions, but no
one knows all the lesions. Thats
why we share cases and have case
reviews.
Dr. Nos acknowledges that people dont like guidelines in general.
But the case review process has
proven value, and some standardization in how the process is applied will, in her view, signifcantly
improve its role in reducing error.
She hopes, as a result of this guideline, more
continued on 64
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Guideline
continued from 62
institutions will develop procedures

for review of cases.
The fve studies brought out the
critical importance of timeliness. If
a case is reviewed before it is signed
out and a discrepancy is detected,
thats the best-case scenario, Dr.
Nakhleh says. But we want to
make sure people understand a review after sign-out can also be timely, so long as the patient has not
been treated. Sometimes cases are
reviewed for a clinical-pathologic
correlation conference thats in-
tended as a working conference, but

the review is after the report is
signed out. Thats still timely because the patient is not going to be
treated until after that conference.
Speaking generally, he says, As
long as the review occurs in a timely
fashionbefore the patient is treatedif errors are detected, a lot of
headaches can be avoided.
Despite the extensive professional training and experience pathologists may have, Dr. Nos believes
discretion should give way to standardized and systematic practices
when it comes to case review. Im
a scientist, but when you talk about
surgical pathology sign-out cases,

we feel there should be standard
procedures for review and reviews
should be timely. That means they
should not be reviewed in a year; it
doesnt help patients if you take
that long and review it later. We
should review as soon as we have
the case.
ome components of the fvepart guideline did not rise to

the level of a recommendation but
are presented as expert consensus
opinion. The College has designated that there needs to be a certain amount of evidence for some-
thing to be a recommendation, Dr.

Nakhleh says.
The expert panel arrived at the
consensus that anatomic pathologists should have documented
case review procedures that are
relevant to their practice setting.
Possible choices include a review of
the following: selected types of diagnoses or a selected percentage of
cases, selected organ system or
specimen type, random cases, cases
for multidisciplinary conferences,
in-house cases sent outside for review, cases during cytology-histology correlation, and cases in a consensus conference. The laboratory
As long as the review

occurs in a timely
fashionbefore the
patient is treatedif errors
are detected, a lot of
headaches can be avoided.
Raouf Nakhleh, MD
medical director, the guideline says,

is responsible for choosing which
methods are best suited to the particular practice setting. One study
did demonstrate that review focused on an organ system was more
effcient at detecting discrepancies
than a random review of cases.
An important measure to ensure
error reduction is to include negative cases in the secondary reviews.
This is definitely valuable, Dr.
Nos says.
A common recommendation
that is made is to review all cancersin other words, all positive
cases, says Dr. Nakhleh. But the
literature shows us that up to 70
percent of interpretive errors are
diagnoses in which a lesion was
missed on initial review. So in a
secondary review procedure, negative cases should be included that
are high risk for being missed, or
else youre never going to catch
them. If you review only the positive cases, youre never going to
catch a false-negative case.
In his own department at Mayo
Clinic Florida, We like to review all
initial breast biopsies by two pathologists, because we view that as
a high-risk area, regardless of
whether they are positive or
negative.
Mayo Clinic Florida implemented this policy about 10 years ago,
Dr. Nakhleh says. An additional
personal preference that is not a
department policy: Sometimes I
have multiple prostate biopsies totaling several trays of slides. And if
theyre all negative, I personally like
for someone else to double-check
that work, because its very easy to
miss a small lesion.
Collaborative
continued on 66
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Guideline
continued from 64
discussions with clinicians help improve the diagnostic process in general, Dr. Nakhleh notes. Depending
on the size of the institution, at a
certain point, each pathologist tends
to serve as a point person to their
clinical counterparts. In the case of
breast cancer, at his hospital, a pathologist regularly goes to the radiographic correlation conference and
other meetings with oncologists and
surgeons. Those discussions help
clinicians understand what were
doing in pathology and vice versa.
So clinical correlation is very important, says Dr. Nakhleh, who meets

regularly with his hepatology colleagues and surgeons. This is part
of the overall spectrum of what we
do. Case reviews are only a tiny part
of it.
Which lesions are tricky or diffcult to diagnose can change over
time and with experience, he notes.
Thats why, in this guideline, were
not specifying the type of cases that
a department should review. What
could be difficult today may be
easier in the future, while something else will come up later. Thats
why we feel we have to continu-
clarient.com
ously re-assess a review policy

within the context of a quality assurance plan, and continuously focus on what is difficult at the
moment.
Many institutions already have
review processes in place that are
similar to what is recommended in
the guideline. They may not be
doing it in a very systematic way,
but a lot of institutions do have
prescribed lists of lesions they like
to show to other pathologists.
The expert consensus statement
on how to address poor agreement
on diagnoses within anatomic pathology groups notes that the causes
of poor agreement are variable.
Studies do show that some diagnoses have inherently higher interobserver variation than others; assessment of thyroid lesions by fineneedle aspiration cytology and assessment of esophageal dysplasia in
the setting of Barrett esophagus are
examples where low diagnostic
agreement is found. But the expert
panel notes that such methods as
intradepartmental consensus conferences, acceptance and use of uniform diagnostic criteria, and use of
calibration slide sets can reduce interobserver disagreement.
Smaller institutions often have to
take a different approach to handling pathology reviews. They
have to be a little more creative, and
many pathologists understand this
very well, Dr. Nakhleh says. For
example, many small institutions
dont try to tackle bone marrow
biopsies or fow cytometry, or renal

biopsies. They will send those complex specimens out to a laboratory
that has a higher volume. Down the
road, there may be a role for digital
pathology where a pathologist
could be practicing anywhere and
can share images of a particular lesion with willing partners anywhere
else in real time and be able to discuss the case.
Were so much better when we
are able to talk to a colleague about
a case, and think about it and go
through the workup to arrive at a
confdent diagnosis, he says. Its
much more diffcult for pathologists
practicing on their own. In many
cases a diagnosis made at a small
hospital will get referred to another
larger institution where the patient
will receive definitive treatment,
and those cases usually get reviewed at that second hospital. So
there are mechanisms in place to
deal with such cases.
To Dr. Nakhleh, the bottom line
is that making a diagnosis is a multifactorial process, and review of
cases is one important part of that.
Case review is actually a very nice
mechanism when done in an effective way. With prospective reviews
a pathologist can discuss the case
with a knowledgeable colleague,
plan out what needs to be done with
the case, and arrive at an accurate
diagnosis. It helps build a team and
its also better for patients.
Anne Paxton is a writer in Seattle.
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Individualized QC Plan
program as developed by CLSI, says Adrienne

Malta, MT(ASCP), MBA, senior manager of inspection services for the College.
The risk assessment component of the IQCP is
new and will require additional work to identify,
evaluate, and validate the laboratorys proposed
QC plan and frequency of internal and external
controls. Laboratories may have suffcient historical data to use as part of the risk assessment,
Malta says, but there may be some risks that are
identifed for which the lab has insuffcient data,
and it will need to gather this data to complete the
risk assessment.
Even if a laboratory already has all the necessary
data, the process of preparing a detailed risk
assessment will be time-consuming. Potentially
complicating the picture: instruments that use
several different test cartridges. It is possible
that a separate risk assessment and IQCP will
be needed for each cartridge type, even if many
of the risks are the same for all cartridge types,
Malta says.
But there is an upside to IQCP too, she notes.
It could save labs money. Depending on the
test and volume of requests, having to revert to
traditional QC requirements can signifcantly
increase the amount of external QC materials
that must be purchased, particularly if an internal control was used daily and the external
control was run only once or twice per month
under the EQC guidelines. If the test is a unit
device test kit, the laboratory will need to purchase additional test kits over the course of the
year to account for having to run daily external
QC, further running up costs, Malta adds.
Flexibility is another plus. The fexibility of
an IQCP does allow laboratories the ability to
personalize their QC processes and tailor them
to the test systems in use, she says. Laboratories may thus fnd QC options that better ft
their risk management objectives.
IQCPs breadth. The QC processes to date have

been focused on the analytical component only
continued from 1
asking Does the testing piece work? says Debowhat youll need to do.
rah A. Perry, MD, chair of the CAP Point-of-Care
Theres really nothing mandatory about IQCP,
Testing Committee. IQCP covers the whole proDr. Hoeltge emphasizes. Labs can continue to do
cessthe preanalytical and postanalytical as well
the traditional two controls each day of testing. But
as the testing process. In the past, from a regulatory
were getting toward the end of the transition pestandpoint, CMS did not look at the other pieces
riod, and more labs are going to be thinking about
to the degree they will now.
IQCP and working toward it.
Dr. Perry, too, stresses that IQCP is voluntary.
IQCPs downside is undeniable. Establishing an
The CLIA guidelines say to do two levels of QC
IQCP in a laboratory involves a signifcant amount
every day of testing. So if your lab
of work compared with what was required to imwants to do that instead of an
plement the Equivalent Quality Control (EQC)
IQCP, that is fully acceptable.
Those are your two options as of
January 2016.
However, IQCP is likely to
draw far more participants than
other forms of compliance with
QC requirements. Most will folDr.Perry
low IQCP for at least some of
their testing, says Dr. Perry, director of pathology
at Childrens Hospital and Medical Center in
Omaha, Neb. Two levels of QC per day is a lot of
To err is human.
quality control with point-of-care type testing. So
To blame someone else, politics.
I think in that world and in microbiology, for mi Hubert Humphrey
crobe identification and susceptibility testing,
To ascertain root cause
people will be highly likely to develop an IQCP.
in a just culture, progress.
Some tests are eligible for IQCP and some are
QA Expert Randy German
not. The frst thing labs have to do is make sure
the tests theyre considering for IQCP are eligible,
See how Quality Manager Randy German easily
Dr. Perry says. As helpful resources, she points to
analyzes nonconforming events at his top-ranked
hospital, then uses these metrics to inform quality
the eligibility criteria published by the CMS and
assurance and process improvement initiatives,
the CAP as well as a one-page algorithm workand drive compliance.
sheet the CAP has drawn up (see page 78 for list
of resources).
See his QA Webinar at otisnow.com/german-otis
From the point of view of the CAP accreditation
Use OTIS by Nouvation in a just culture and
program,
IQCP has special signifcance because
see how simple it is to track & trend deviations
CMS regulations on IQCP actually have two parts,
and transform laboratory, blood bank or
Dr. Hoeltge says. The option to customize ones
transfusion variances into golden nuggets of
own QC system is one, but the other is the eliminainformation that drive efciency
and protability.
tion of the EQC alternative. The CAP never emne of the key differences between the
braced CLSIs EQC as it was developed, but a
IQCP and past approaches to QC is
number of checklist requirements were based on
the EQC model, he explains. For example, some checklists have a requirement for non-waived testing that allows an accredited laboratory to use
electronic, procedural, or built-in controls to meet the daily QC requireVisit us at
ment. That kind of formulaic checklist language is going to disappear Jan.
AACC
1 because EQC disappears Jan. 1.
booth #3254
After that date, the CAP will limit
the eligibility for use of an IQCP to
testing that meets both of the following criteria: 1) nonwaived tests that
employ an internal (electronic/proceSimplicity & Control
Do
you
need
What
is
your
annual
dural/built-in) QC system (except
For Any Lab
What is your
no
immediate,
The LeadCare platform has
test volume?
that microbiology laboratories may
CLIA status?
near-patient results?
been used in clinical labs
implement an IQCP for media and
for nearly twenty years.
reagents used for microbial identifcaWe are proud to provide
<
2,000
2,000+
waived
yes
moderate / high
tion and susceptibility testing as dea family of FDA-cleared
fned in the checklist); and 2) tests
systems offering the
simplest way to perform
performed in specialties other than
clinical blood lead testing,
anatomic pathology and cytopatholregardless of volume.
ogy (unless such a test can be assigned
NEW!
to a different CMS subspecialtyfor
example, FISH testing, which may be
classifed as either histopathology or
cytogenetics).
LeadCareII II
LeadCarePlus
Plus*
LeadCare
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LeadCare
LeadCare
LeadCare Ultra
Labs can continue to make use of
the built-in controls if they want, Dr.
Typical setting
Physician ofce
Small / mid-size lab
Large lab
Hoeltge adds, but theyll need to craft
CLIA complexity
Waived
Moderate
Moderate
their own IQCP to do it and be ac800-305-0197 | www.Magellandx.com
LeadCare@magellandx.com
* Pending FDA 510(k) clearance.
credited. Thats a continued on 70
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continued from 68
really key aspect of what the College is doing to

prepare, he says. Its not just that the Laboratory
Accreditation Program is there to help labs write
an IQCP. Labs have to know that some of the familiar things in the checklist that weve been using
and counting on are going to disappear Jan. 1.
Beginning this summer, the 2015 edition of the
checklist does put restrictions on what labs can do
with regard to the IQCP. No. 1, it only applies to
nonwaived testing. And No. 2, it can only be done
in those states that permit it, Dr. Hoeltge says.
(The state of California recently approved the use
of IQCP. Kentucky and New Jersey are not allowing it, according to CAP checklist editor Lyn Wielgos, MT(ASCP).) This means that those laboratories must follow the default CLIA regulations for
quality control at a minimum [two levels of external controls per day of patient testing, or more
frequently for some types of testing, such as coagulation and blood gas testing] or more stringent
regulations if defned by the state, Dr. Hoeltge
adds.
The third restriction on the IQCP is that anatomic pathology and cytology are excluded, Dr.
Hoeltge says. No. 4 is that the IQCP must be used
on devices with an internal control process, or in
microbiology testing. For this frst foray into IQCP
and accreditation requirements, the Laboratory
Accreditation Program supported the two areas of
microbiology and point-of-care testing. Thats what
most labs are interested in right now. In the future,
Dr. Hoeltge says, we may have checklist requirements that will apply to a broader range of tests.
No specifc IQCP format will be required to
meet CAP checklist requirements. Laboratories will
be allowed to develop their own model or use
other resources, such as CLSI guideline EP23-A,
the CMS guidance, manufacturer protocols, or
other commercially available products. Laboratories will, however, need to complete CAP forms
that list and summarize their IQCP plans for inspector use during an on-site inspection. The CAP
is also working collaboratively with the ASM and
the CLSI to produce templates for developing an
IQCP for microbiology.
One other important feature of the checklist
requirements is that the accreditation program will
not require laboratories to validate their IQCPs.
The reason is that youre basing your QC on a
personal assessment of risk thats altogether different from compliance with external requirements. So youre not going to have to validate your
IQCP plan. The accreditation program will simply
expect labs that chose to write an IQCP to do it
well, Dr. Hoeltge says. Thats also why the College has been diligently offering guidance and
alerts so that laboratories will have access to expert
tools when preparing their IQCPs.
Its true that the kind of risk assessment the
IQCP will require is a lot of work. However, Dr.
Hoeltge doesnt view risk assessment as something
new or overly challenging. Risk assessment isnt
diffcult. Theres a method to it, and one works
through it step by step and comes up with a picture
of those variables that are most important and
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determines how to manage those variables. Its not

something labs havent been doing for a long time.
Every lab accredited by the College has the expertise to do a risk assessment if they choose to. But
now that risk assessment will have a structure and
a table behind it.
The better question is: Is it worth it? he says.
And it surely can be, especially when one has
multiple devices that are doing the same tests. So
the investment in the time and effort at this point
can pay long-term dividends for labs.
Dr. Hoeltge thinks labs are well advanced down
the path to IQCP. Some are going to put it off
awhile, but I do believe that most medium and
large labs will fnd that IQCP will help them. Small
labs that are doing a lot of point of care on identical
devices or having identical test methods going on
in multiple parts of the hospital will also fnd IQCP
useful, he says. This would be especially true in
microbiology. Its a lot of extra work to do QC on
each batch of media or each time youre doing a
test for antimicrobial susceptibility testing. And
there are good ways to do that through an IQCP.
So most every microbiology lab will want to look
into IQCP for media QC and for AST QC.
he IQCP arose from a sense that the old EQC

program was inadequate, says Christopher
Lehman, MD, a member of the CAP Standards
and Checklists committees. The EQC rules were
published in 2003 in response to manufacturers
who felt the QC requirements under CLIA were
too stringent for their instruments that had some
level of internal QC. But the
continued on 72
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for CAP members. The reason why I and other

members of the Checklists Committee supported
the concept of beginning with internal QC is because thats where EQC originated, Dr. Lehman
says. So the checklist standards are restricted to
assays or instruments that have internal QC.
From my perspective, we have three points of
view for approaching this, he says. One, we want
to make sure were protecting patients. Second,
were protecting laboratory directors under CLIA
rules. And third, we have to have a way of inspecting this. Since nobody has experience with evaluating IQCP plans, we felt we have to have a basis,
and starting with assays that had some kind of
internal QC running was a good place to start.
Since IQCP does not apply to waived testing,
if theyre running moderate-complexity testing
with internal controls, then any laboratory could

do this, Dr. Lehman says. And, he argues, there
continued from 70
are not only patient care benefts to adopting IQCP
EQC rules were pretty roundly criticized, because
but also economic incentives.
the algorithm they had created really had no staQC materials tend to be expensive, and it takes
tistical basis to support it. The
time and effort and personnel to monitor QC. The
EP23 standard for assessing risk
more you run, the more you have to monitor. So
from a patient point of view was
certainly money is one incentive. Labs are trying
a partial way of addressing that
to fnd ways to be cost-effective, and you cannot
critique, and the CMS gave its apdip below the manufacturers requirements for
proval to the EP23 document, but
QC, but in some circumstances the CLIA requireit set a date on which EQC would
ment will be greater than what the manufacturer
sunset: Jan. 1, 2016.
recommends, so with IQCP you can save money
Dr.
Lehman,
medical
director
and still provide quality care.
Dr.Lehman
of clinical laboratories at the UniThere has been a lot of progress in clarifying and
versity of Utah, was part of the workgroup that
feshing out the how-to of IQCP in the past sevdeveloped the plan for how to implement IQCP
eral months, Dr. Lehman says. When we were
designing the checklist requirements
and forms and guidebooks, the only
thing out at that time was the basic
brochure that CMS had published. It
had no real details about how to do

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dent the plan is appropriate.
So even small laboratories should
not be intimidated by IQCP, he believes. Any labs that are already
Serum Proteins
practicing Lean principles will recoga-1 Acid Glycoprotein
nize this and see that it is not really
a-1 Anti-Trypsin
anything new. Doing a risk assessa-1 Microglobulin
Nutrition
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Haptoglobin
Ferritin
labs that have implemented Lean or
IgA
Prealbumin
Toyota processes will be familiar with
IgG
Allergy
Transferrin
this. With so many proposed plans
IgM
Total IgE
coming out, I suspect that labs will
take a look and will say I can do
that.
Diabetes
There may be some confusion
Cystatin C
about what the CAP is going to reFructosamine
quire, he notes. But a glance at the
Hemoglobin A1c
CAP Frequently Asked Questions
Insulin
document should set labs minds at
Microalbumin
rest that the CAP is restricting the
checklist changes to only those tests
that have internal controls and certain
microbiology tests.
Inflammation / Cardiac
Accreditation program inspectors
Anti-Streptolysin O
Coagulation
may or may not be implementing
Complement C3
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D-Dimer
IQCP in their own labs, and there
Complement C4
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I think everyone can go through
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continued from 72
they may be able to do less than what CLIA recommends or CLIA requires currently.
Lab directors will need to determine the appropriate amount of QC based on their history of
running QC and evaluating what their rates of
failures are for each individual instrument or test,
Dr. Lehman says.
The volume of testing and the tests impact on
clinical care are critical questions. Are you doing
100 tests a day or two a week, and how quickly
will physicians act on the results? Those questions
may determine whether you want to go with a
more frequent QC or youre comfortable with less.
The reality is thats something that should oc-
cur anyway. When youre creating a QC plan, you

should be looking at your tests and saying in some
cases, This is a critical test; physicians will be acting on it immediately and we run a lot of these. So
we want to run QC more frequently. Or, youll
want to decide which tests seem to be more stable,
which are less stable. If you have concerns about
a test or the instrument or assay has the chance of
not functioning correctly, Dr. Lehman says, ideally
you would also be running QC more frequently,
because it will be one way to assess whether the
assay is running properly.
To his knowledge, there are no good statistical
models that tell laboratories exactly how often they
should run QC. But I think the principles that are
in the EQC document still apply, in terms of helping laboratory directors assess risk. All laboratory
directors do risk management in their heads, he

says. They just havent formalized it into a set
process. I think IQCP is just formalizing it, and
when you formalize things, youre having to use
tools you may not have used before. But it really
shouldnt scare people.
He agrees that the IQCP represents a signifcant
change. But if you look through the workbook
that CMS just put out, the concepts and the questions it runs you through are ones we should have
been thinking about anyway, and many institutions have incorporated them into their standard
procedures. A lot has been done. People have
thought about risk and have incorporated it into
how they collect specimens and manage training.
So I think the change is taking all that information
weve probably already been doing and putting it
into a more structured format. Then
we can kind of justify it.
T
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he IQCPs impact on microbiology

will be substantial, says CAP
committee members who have been
involved in the IQCP. The microbiology changes came late last year and
they are huge because they relate to
microbiology labs media and susceptibility testing, Dr. Perry says. To
now have to do two levels of QC every
day for that piece of the microbiology
world is a huge amount of work and
expense. I think people in labs are
willing to do additional work if it has
an impact on patient care, but nobody
really sees that in the microbiology
section it would positively change
anything.
Returning to two levels of QC daily
will be hard, agrees Denise K. Driscoll,
MS, MT(ASCP), CAP director for laboratory accreditation and regulatory
affairs. Microbiology labs just havent
done that in decades, so to them, IQCP
doesnt feel very voluntary. The reason this is happening, she explains, is
that the CMS removed mention of
CLSI documents from its interpretive
guidelines for quality control, because
government agencies cannot make
private guidelines regulatory in effect
unless those guidelines are available
for free. But those documents were
ones that microbiologists had been
going by for years to adequately defne their QC. So now microbiologists
feel blindsided, and they feel like
theyre being forced to do IQCP in
order to get back where they were,
Driscoll says.
Thats why the College, including
our Microbiology Resource Committee and the CAP checklist group,
worked with ASM and CLSI to produce sample guidelines the labs could
use in lieu of the purchasable CLSI
documents, she adds.
The IQCP has been a long time
coming, says Susan Sharp, PhD, director of regional microbiology and molecular infectious disease laboratories
for Kaiser Permanente in Portland,
Ore., and a member of the CAP Microbiology Resource Committee. Weve
been using EQC for many years,
which has worked well for the clinical
microbiology
continued on 76
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continued from 74
laboratory. CMS worked together with the CLSI

to come up with the EP23 document, and from
that document, CMS came up with IQCP. IQCP
is not exactly like EP23, but it has some of the
same principles in it, and it is based upon risk
assessment.
Dr. Sharp worked with another member of the
CAP Microbiology Resource Committee, Janet
Hindler, MT(ASCP), a senior specialist in clinical
microbiology at UCLA Medical Center, and other
colleagues to develop materials to guide microbiology laboratories in IQCP. But Dr. Sharp herself says
she did not become aware of IQCP until about a
year ago. CMS gave us two years notice, but I
dont think all the information made its way down

to the clinical microbiology directors. As a matter
of fact, it frst came to me through my compliance
people here at Kaiser last year.
The IQCP is going to affect microbiology much
more than some other parts of the
laboratory. In some areas like
hematology and chemistry, they
run controls every day on many
tests, which is what you must do
for CMS default QC. In microbiology, weve been using EQC for
the last decade or more, where
you dont have to do QC every
Dr.Sharp
day you perform the test.
That will end Jan. 1, leaving microbiology laboratories with the choice between IQCP and the daily
QC option. Thats not much of a choice as we cant

possibly do daily QC on our susceptibility testing
or some of our molecular testing. So its a pretty
drastic change. Dr. Sharp points out that point-ofcare testing has some of the same issues that microbiology has because oftentimes in the POC area QC
is also not performed daily.
The CAPs approachcoming out with preliminary general checklist items in the All Common
section on IQCPis helpful, Dr. Sharp says, as is
the joint effort involving the CLSI, ASM, and CAP
in production of guidelines, templates, and examples for susceptibility testing. Just reading the CMS
information, she says, Its diffcult to understand
the requirements. It took me several weeks of reading the materials to get my head around what we
were supposed to be doing. CMS is being very
nonprescriptive in how they ask people to go about developing an IQCP.
You can really approach it in any way,
shape, or formas long as you cover
all the required areas.
On the other hand, a nonprescriptive approach has disadvantages, she
adds. It leaves a lot to the discretion
of individual laboratories, and thats
why we felt it was important for the
three microbiology organizations to
work together and speak with one
voice to come up with some guidance to help clinical microbiology
laboratories.
There are tricky parts to risk assessment, Dr. Sharp notes. We can all
look back at our own data to determine the frequency of occurrence of
error in our laboratories. But to try to
determine what impact errors might
have had on a patient is diffcult. Depending on the results that might be
in error, there could be no effect at all
on the patient or it could be very signifcant; its diffcult for the laboratory
to determine, she says.
In the laboratory world outside
microbiology, Dr. Perry is not sure
most people will understand much
about IQCP until they start developing
their own plans. Nurses, in particular,
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continued from 76
developing an IQCP because they are testing

personnel.
The most signifcant work of transitioning to
IQCP will be at the front end, Dr. Perry says. We
have the materials and were already doing most
of the procedures. The processes for nurses and
other non-laboratory personnel at the testing sites
probably wont change signifcantly. But to document the procedures, to write up the plan, to get
people involved and understandingthats going
to be the big part. Its all so new.
The general understanding of risk assessment is
fairly basic, Dr. Perry says. I think a lot of people
are pretty green on it. They havent really thought
about lab testing and risk assessment in this way,

even though we all know theres always risk. The
EP23 and CLSI documents on risk are good resources, she adds. But theyre not something most
people have read yet.
The CMS, vendors, and professional groups
have already produced numerous guidebooks and
webinars. AACC has one of the really good documents, and CMS, along with the Centers for Disease
Control, issued a step-by-step guide that is really
helpful. So there are quite a few resources, Dr.
Perry says. She herself will lead a complimentary
CAP webinar in August that will walk Laboratory
Accreditation Program participants through development of an IQCP plan.
Dr. Perry advises a strong upfront effort in implementing IQCP. Use all the resources available
and develop a good team to get your frst one developed. Because after youve done it once, hopefully the ones that follow wont be quite as big a
challenge.
Its understandable that labs feel trepidation in
contemplating the shift to IQCP, Dr. Hoeltge says.
Up to this point, labs were told how to do their
QC, what frequency it was, and where they had to
go to get the materials. And although those are still
valid resources and practices, to have the option to
shape QC in your own laboratory environment is
a big deal. Thats a gift. But its not one that comes
without strings. IQCP requires a lab to conduct QC
thoughtfully and with a level of appreciation for
proper risk assessment.
Anne Paxton is a writer in Seattle.
Nuts, bolts, tips,

and templates for
developing an IQCP
n Individualized Quality
Control Plan Frequently Asked
Questions. Answers from the
CAP on IQCP general requirements, eligibility, risk assessment,
ongoing assessment, record retention, CAP inspections, and other
resources (http://j.mp/IQCP_FAQs).
n Eligibility Determination
for IQCP Option. A one-page
algorithm developed by the CAP
for determining which tests are
eligible for an IQCP (http://j.mp/IQCP_
What are you

missing in your
practice?
Now you can better understand
your practice to identify which
opportunities to pursue.
eligibility).
n Developing an IQCP: A
Step-by-Step Guide. An IQCP
workbook using an example scenario, published by the Centers
for Disease Control and Prevention (http://j.mp/IQCP_CDCguide).
n CMS IQCP brochures, presentations, and workbooks (http://
Improve your practice with the CAPs

Value Based Business Center tools:
Billing Assessment
Cost Assessment
Market Toolkits
Practice Planning Toolkits
CAP members can download the
complimentary tools at cap.org
j.mp/IQCP_CMS).
n CAP checklist requirements
for IQCP (http://j.mp/IQCP_checklistreqs).
n What You Really Need to
Know About the Individualized
Quality Control Plan and Ensuring Your Laboratorys Compliance. A complimentary CAP
Focus on Compliance webinar, to
be presented by Deborah A. Perry, MD, and CAP staff on Aug.
19. Register at https://learn.cap.org/
compliance.aspx.
n AST IQCP Introduction,
Q&A, Template, and Example
Materials developed by the CAP,
ASM, and CLSI to help guide
microbiology laboratories in developing an IQCP ( http://j.mp/
IQCP_AST).
AST IQCP Introduction http://
Get the support you need
j.mp/IQCP_ASTintro
The CAP is piloting a program to assist

members in implementing any of the
tools. Take advantage of this
complimentary one-on-one facilitation.
AST IQCP Q&A http://j.mp/

IQCP_ASTqa
AST IQCP Template http://j.mp/

IQCP_ASTppt
To learn more email

practicemanagement@cap.org
2015
2015College
Collegeof
ofAmerican
AmericanPathologists.
Pathologists.All
Allrights
rightsreserved.
reserved.
23705.0515
23705.0615
AST IQCP Example http://j.mp/

IQCP_ASTsample
cap.org
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New lab, new effciencies: doors open at Geisinger
Photos by Gordon Wenzel
Anne Ford
terms of effciency, says Conrad Schuerch, MD,
The last time Geisinger Medical Laboratories had
chair of laboratory medicine. This is something
a new facility, American women were still fve years
thats been needed for a very long time.
from getting the vote. Typhoid Mary had only reThe laboratories previous facilities, in the health
cently ceased merrily showering her employers
systems original hospital and in a few rented modufood with Salmonella enterica serovar Typhi. And
lar buildings, were far from ideal. Its 100 years old,
the celebrity name on
and the walls are a
everyones lips was
foot thick and solid,
Charlie Chaplin.
says Myra WilkerA century later,
son, MD, vice chair
the Danville, Pa.for laboratory medibased laboratories,
cine. So any time
which serve the Geisyou need to add a
inger Health System
new piece of laboraand other clients
tory equipment, it
throughout the state,
turns into a major
were (at CAP TODAY
construction project.
press time) poised to
And everything is
move into a sparcompartmentalized
kling-new $63.4 milinto little rooms
lion buildingone
spread over multiple
whose top-of-the-line
floors and multiple
features make Star
buildings. Weve
Trek look like Sesgrown so large that
ame Street.
we have to fnd closThis is truly a A view of the new laboratory building. I think we have actually achieved ets to put some of our
once-in-a-lifetime op- the ideal in terms of effciency, says Dr. Schuerch (left), with Dr. Wilkerson. instrumentation and
portunity, and its goour testing into. Plus
ing to be a phenomenal showcase for the world to
its very hard to maintain the humidity and temsee what lab medicine can do, says Tammy Gerperature control that you need for laboratory instrumini, operations director for clinical pathology.
ments to operate well.
Thirty years in the planning, the new building
At the section manager level, the situation has
will have a single automated line for chemistry,
been no better. Everything is in little comparthematology, immunology, and coagulation; an endments far away from each other, says system sulessly reconfgurable foor that also serves as a
pervisor for transfusion medicine Michael J. Lopatbiohazard and chemical containment system; a tube
ka, MS, MT(ASCP)SBB. Lets say you have to put
delivery method that always takes the shortest,
somebody in a small room to do one test with a
fastest route; and a materials management solution
30-minute incubation, but if they leave the room to
thatprevious analogy asidecalls to mind nothgo do something else while its incubating, they
ing so much as Captain Jean-Luc Picard saying
might not be able to get back in time for the changeTea, Earl Grey, hot to the replicator on Star Trek:
over. Or they might have to gown up to go into that
The Next Generation.
room, then de-gown and come out, just to gown
I think we have actually achieved the ideal in
back up again 30 minutes later.
Such a poor layout is not only a hassle for
staff but also a safety issue, Lopatka says. He
offers this example: We currently have one
spot where all our samples come in and all of
our blood product deliveries come in, and its
the same spot where products are picked up to
go to patients. So the person working in that
area is prone to more errors, because theyre
trying to deal with incoming specimens, incoming blood products, and issuing blood products
to patients.
Whereas previously the laboratories took up
69,622 fragmented, compartmentalized square
feet, the new laboratories will occupy 115,000
square feet over three foors of a four-story
building (with the lower level devoted to food
service). And the placement of sections within
the new building is highly strategic.
The frst foor butts right into our main
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We dont have an off-site core laboratory, and

we dont have people split up in different places,
he continues. In addition, we have anatomic pathology and clinical services together, so a pathologist can do all those functions and also not have to
walk far for clinical consultations, multidisciplinary
tumor conferences, and the like. I cant imagine
designing a laboratory with a better interface with
the health system.
r. Wilkerson helped design some of that interface, but her main role in this project has been
leading an interdepartmental team charged with
selecting an automation line for the new building.
Of course the team wanted the most effcient
best-of-breed system possible, but it had another
aim too: fexibility. Once you install one of these
large automation lines, you tend to have them in
place for at least 10 years, Dr. Wilkerson notes. So
it was also about durability and whether we would
have the option in the future to add other pieces to
it. A huge piece of it was also the software that
comes with it: Can we get real-time actionable reports out of it? How does it interact with our current LIS?
In the end, the team chose the Roche 8100 preanalytical line andin what they believe to be a
unique move for a laboratory within the United
Statescombined it with a Stago coagulation system and a Sysmex hematology system.
Roche has the chemistry analyzer that we
want, Dr. Wilkerson explains. But they are also
going to hook it up to the coagulation and hematology vendors that we chose. Some of the other
vendors were not willing to do that. Also, we liked
Roches times for immunoassays, in particular their
troponins. Its hugely important for emergency
departments to see if a patient is having a myocardial infarction and needs to get to cardiac catheterization. Their turnaround time is only nine minutes,
and thats a really big deal with a stopping heart.
Germini explains how the 8100 will work: As
samples come in, well load them onto the 8100. It
will sort them, spin down appropriate specimens
in centrifuges, and aliquot when necessaryall
within the instrument. It will then take them to the
end of the line and put them on a track, and that
track will flter them to the different instruments,
based on what the LIS says. It will then perform the
testing, and at the end of the testing, it will bring
the samples back over to the track and take them
to a storage unit, which will be attached to the line
also, and it will store those samples for a number
of days we defne.
Should an add-on order for a sample be received, we wont need a human to go into the
refrigerator, fnd the specimens, pull them out,
uncap them, put them back on the instrument,
Germini adds. The system itself will say, OK, I
have that, pull it out automatically, stick it back on
the track, and take it to the instrument that it needs
to perform the test. So our effciency gain from that
instrumentation alone is tremendous.
So tremendous, in fact, that Dr. Schuerch says:
We want to be running everything basically at a
stat speed if we canwithin an hour or less.
And if it becomes necessary to reconfgure instruments in the laboratory to achieve that stat
speed, they can, thanks to an innovative foor. The
foor is raised 18 inches, Dr. Schuerch says, and
so we can bring all of the different lines over to our
instruments, wherever we want to set them. Plumbing, deionized water, electrical, continued on 82
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The foor is raised 18 inches to allow plumbing and electrical and other lines to
run beneath it, Dr. Schuerch demonstrates, making architectural modifcation
unnecessary even as the laboratorys needs change.
Tammy Germini in the pneumatic tube room that houses the Pevco Smart
Path system (lower right) and next to the upgraded pneumatic tube system
(above). They expect the travel time for specimen delivery to be cut in half.
Geisinger
continued from 80
whatever you want, all can be taken to an instrument at any place. And you can move the instrument without having to change vertical conduits
or move walls or anything. We were in our frst
space for 100 years, and now this is a place where
we can be for 100 years without pain, because we
can evolve without the expense of architectural
modifcation.
The fooring system has another advantage, as
Dr. Wilkerson points out. When youre in a testing
area with patient specimens or caustic chemicals
and things are spilled on the foor, theres a seam
in the foor, and the fuid wont move more than 1
millimeter beyond that seam. So it becomes a biohazard and chemical containment system as well.
The new building will also feature an upgraded
pneumatic tube system, one that allows for sixrather than four-inch-diameter tubes and thus is for
blood products as well as patient specimens. The
new system will rely on a solution from Pevco
called Smart Path that, the company says, improves
performance by shortening wait times and increasing effciency and delivery speed.
Once somebody at a nursing station hits send,
itll be a maximum of three minutes at the frst point
to get that specimen to the lab, Dr. Wilkerson says.
Theres a turret where all the pneumatic tubes

come together, and it can receive the specimen and
then turn it and send it back out a different tube to
try to maximize the effciency of transport.
Says Germini: The tube system itself will be
able to know the shortest path or the quickest path
to get samples to the lab. We expect that the travel
timethe time a specimen leaves the foor to the
time we receive it in the labwill be literally cut in
half.
The system also features a secure send function,
so that we can not only send blood products to the
foor, but we can make sure its received by someone whos qualifed to receive it and in turn give it
to the patient, Germini says. So well be able to
do a lot of tracking. An accompanying software
package will make it possible to see in real time
where samples are and where tubes are going.
Maybe the doc says we should have received a
specimen, but we say we havent gotten it yet. Well
be able to do that troubleshooting right on the
spot, she says.
inventory about once a week. So theyll walk

around to their various cubbies or refrigerators.
They might have to go down the hall to a closet.
Wherever they can ft their supplies, Germini
says. Theyll do their inventory, theyll manually
put it into a computer system, and then supplies
management will process the order. Supplies are
brought to the lab in big boxes and our staff then
have to open the boxes, receive the supplies, put
them on the shelvesthe whole process.
In contrast, the new building contains two Remstar unitsone refrigerated, one room temperaturethat span all three foors and hold every
supply the laboratory might need: gloves, reagents,
pipettes, pipette tips, specimen bags, QC material,
you name it. Supply chain staff will put supplies
away in the Remstar units and restock the workbenches when appropriate.
An effciency gained will come from not walking around to all the cubbies, closets, and refrigerators looking for supplies, Germini says. When
supply chain or lab staff go to retrieve supplies,
they will walk up to the Remstar unit and enter into
ne of the new buildings most innovative
the computer the supply number of the item they
features is an electronic materials management
want. Inside the Remstar unit are carriers mounted
system called Kardex Remstar. Previously, the
to an oval track that rotates vertically, similar to a
laboratory relied on technical specialists to perform
Ferris wheel. The supplies are stored on these carDr. Wilkerson in front of the Roche 8000, which is connected by the new rier shelves, and the Remstar unit will rotate
Roche 8100 automation line to the Sysmex hematology and Stago coagulation to the appropriate foor and deliver the supanalyzers.
ply to the operator.
continued on 86
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Geisinger
men storage and tracking. It will

make finding a specimen very
easy, Lopatka says, since you can
look up the specimen in our computer and then tell the Remstar and
it will bring the rack to you in a bin.
Hes also looking forward to simply having a bigger space for blood
servicesone thats well laid out
from the start: Were able to place
everything in a way that allows it to
fow in one direction, from one end
to the other. That also allows people
to multitask. They might be the per-
continued from 82
It will also place an electronic order based on

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The system will recognize there are fve of a particular item left on the shelf and will know to
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popular at the bench level. The techs are going to
be able to get out of the supply unpacking business, he smiles. Theyll just have all the supplies
they need at their fngertips, so they can do Michael Lopatka in front of one of the Remstar units to be used
what they do for a living.
for specimen storage and tracking. In front of him is the bin in
which the Remstar transports the rack.
Remstar units will be used, too, for speci-
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son in charge of the frst step, but they

can also help engage in the second step
to some degree if the person doing the
second step is very busy. And then the
person from the second step can help
with part of the frst step. It allows
more fexibility. And everybody can
see everybody across the whole room,
so if somebody needs help, its easy to
move over and help out.
Of course, moving the laboratories
into the new building wont be quite
as easy as throwing things into boxes
and renting a U-Haul. First of all,
theres all the sorting and discarding
to be done. When youve been in a
space for 100 years, you collect a lot of
stuff, says Germini darkly.
Magazines. Magazines on top of
magazines, she cites as one example.
But the biggest piece is, how do
you keep 24/7 operations going as
you move from one building to the
next? she says. We are fortunate
enough to have a lot of redundancy in
our technology. In cases in which we
have two instruments, we will take
one instrument over, validate it, and
bring it back up; then we will bring the
second instrument over.
Considerable as the challenges of
moving may be, for Dr. Schuerch the
primary obstacle has already been
surmounted. The biggest challenge
in getting a new facility is to get your
organization behind you, he says.
Its taken us 30 years to get there.
Weve had various fts and starts. We
were offered a new lab down the road
at one point, and we dug in our heels
and said, No, the lab needs to be on
the main campus.
Then later we designed a new lab
on campus, he concludes, and we
went through a couple of iterations
there, partly because we had a change
in hospital leadership. Then we
moved it and re-drew it, and we had
Lean consultants in a couple times
during all this, and fnally, with leadership in agreement, we said, Lets
just get this laboratory building done,
and moved forward. We had our own
staff deeply involved in the planning
of this lab. And theyre happy with the
outcome.
Anne Ford is a writer in Evanston, Ill.
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Genetics
continued from 1
she helped shape molecular

diagnostics.
In a CAP TODAY interview, Dr.
Francke, now professor emerita of
genetics and pediatrics at Stanford
University School of Medicine, explained the discoveries she had chosen for her lecture, focusing on two
major genetic mechanisms: mosaicism and synonymous variants. She
also discussed the need for better
communication of genetic information to the public and her view of the
future of the molecular laboratory.
In genetics, mosaicism results

from mutation during mitosis after
fertilization, Dr. Francke explains. Dr.
Francke was working in the early
1970s at the University of California,
San Diego, on LeschNyhan syndrome in
the group of William
Nyhan, MD, co-discoverer of the gene
responsible for that
rare X-linked recesDr.Francke
sive disorder, caused
by defciency of hypoxanthine-guanine phosphoribosyltransferase 1
(HPRT1), an enzyme critical in purine
metabolism. Lesch-Nyhan syndrome

has a pleiomorphic phenotype that
includes self-mutilation. In particular,
affected boys have a strong urge to bite
themselves.
At the time, Dr. Francke says, they
were confrming the diagnosis by
measuring enzyme activity in blood
cells, not analyzing DNA directly.
With this method it was not possible
to detect the carrier state in the
mother because the blood enzyme
level is normal in female carriers,
due to non-random X-inactivation in
blood cells.
Dr. Francke realized that because
of the way hair follicles arise in the
Interferences, not imprecision, are the leading cause

of glucose meter adverse events
The CLSI guideline for hospital glucose meter accuracy is
12 mg/dL or 12.5%. Glucose meter accuracy within this range
avoids large glucose meter errors and adverse medical events.
Glucose meter errors due to interfering substances can greatly
exceed the CLSI guideline. Errors from known interferences such
as ascorbic acid, galactose, xylose, hematocrit, sodium,
n-acetylcysteine, oxygen, l-glutathione can be larger than
200 mg/dL, leading to adverse medical events.1,2,3,4,5
We report a 2-month-old child with galactosemia and falsely high
glucose readings with a glucometer using mutant variant of quinoprotein
glucose dehydrogenase chemistry. Potentially fatal hypoglycemia could
have been induced in the child if insulin infusion had been initiated.
In the three [galactose interference] cases, neonates were

judged to have hyperglycaemia and based on this fnding were
treated with insulin with disastrous consequences. Pillay 2013
We describe herein a case of life-threatening hypoglycemia
due to spurious elevation of glucose concentration during the
administration of ascorbic acid in a type 2 diabetic patient.
Kim 2013
In our study, hematocrit effect was the overriding cause for

glucometer error, and the false results masked hypoglycemia.
Mathew 2013
Pidcoke 2010
The only glucose meter with

no known interferences
After six years of clinical use and over 100 independent
publications, there have been no clinical interferences found
for the Nova StatStrip glucose meter. The reason is StatStrip
is the only meter and strip that measures and corrects for
interferences such as hematocrit, ascorbic acid, uric acid and
other electrochemical interferences. StatStrip has no interference
from oxygen, pH, sodium or non-glucose sugars including maltose
and galactose.
Roche Inform II has known interferences

including ascorbic acid and galactose6
Abbott Freestyle Pro has known interferences
including ascorbic acid and xylose7
1. Pillay TS et al. Continuing danger of glucose point-of-care test devices in the neonatal setting. SAMJ 103 (6) 2013.
2. Mathew V et al. Erroneous glucose recordings while using mutant variant of quinoprotein glucose dehydrogenase glucometer in a child with galactosemia.
J Endocrinol Metab 17 (Suppl1) 2013.
3. Newman JD et al. Monitoring Neonatal Hypoglycemia with the Accu-chek Advantage II Glucose Meter: The Cautionary Tale of Galactosemia.
Clinical Chemistry 48 (11), 2002.
4. Pidcoke H et al. Anemia causes hypoglycemia in intensive care unit patients due to error in single-channel glucometers: Methods of reducing patient risk.
Crit Care Med 38 (2)) 2010.
5. Kim SK et al. Spurious Elevation of Glucose Concentration during Administration of High Dose of Ascorbic Acid in a Patient with Type 2 diabetes on
Hemodialysis. EYMJ 54 (5) 2013.
6. Accu-Chek Inform II package insert. www.accu-chekinformii.com. Accessed 11 Feb 2014.
7. Abbott Freestyle Precision Pro 510k decision summary. www.accessdata.fda.gov. Accessed 11 Feb 2014.
embryo, hair root cells are clones. So

each hair follicle will have mostly
one or the other phenotype, while
some are mixed. Dr. Francke performed HPRT1 enzyme analysis on
hair follicles picked from different
sites. As expected, carrier women
had a significant number of hair
roots that were completely negative
for HPRT1 (Francke U, et al. J Pediatr.
1973;82:472478).
This test for carrier detection of
Lesch-Nyhan syndrome is relevant to
todays mosaicism problem because
it used independent biopsies to
study mosaic composition in the
body, Dr. Francke says. It is just
another noninvasive way to get samples from human beings. Newer analytical methods are sensitive for lowlevel mosaicism, she continues, citing whole-exome and whole-genome
sequencing. So it is important to
have access to other tissues to assess
whether the mosaicism is limited to
blood or not.
Her second example of mosaicism
occurred when Dr. Francke was at
Yale in the 1980s and working on Xlinked muscular dystrophy (DMD).
After Louis Kunkel, PhD, of Harvard,
had discovered the dystrophin gene,
Dr. Franckes lab used still-novel
cDNA probes to detect intragenic
deletions and analyze the mechanism
of transmission in multi-generation
pedigrees. In one family, two affected
cousins were born to mothers who
were sisters, and both were DMD
deletion carriers. However, another
three sisters were not carriers. Mosaicism in the grandmother would have
explained this fnding, but she did
not contribute the Xp haplotype that
included the dystrophin gene deletion. The mutant X chromosome was
derived from the grandfather who
was postulated to have germline, or
postzygotic, mosaicism for the condition while remaining unaffected
(Darras BT, Francke U. Nature .
1987;329:556558).
novabiomedical.com
he second important mechanistic

discovery that pertains to todays
molecular laboratory world concerns
synonymous mutations. Next-generation sequencing generates millions
of variants, some of which are de
novo, Dr. Francke notes. When there
is no affected parent for comparative
genetic analysis, it is more diffcult
to determine which variant causes a
specifc disease phenotype. To help
with this task, filters are applied.
Dr. Francke illustrates this process
as a funnela huge amount of information is poured in the top and
successive flters reduce the amount
of information to a small trickle at
the bottom. This process aims to
retain deleterious mutations, those
that cause a change in amino acid
sequence such as nonsense, missense,
frameshift, or changes in a splice
junction. Whats continued on 90
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Genetics
continued from 88
typically removed, Dr. Francke says,

are intronic variants, genes known
to cause a different disease, and synonymous substitutions, those that do
not cause an amino acid change. The
common assumption is that a synonymous mutation cannot be disease
causing, she says. The current success rate for fnding disease-causing
mutations in people with unknown
diseases by use of whole-exome or
whole-genome sequencing is only
about 25 percent.
In her lecture, Dr. Francke focused
on the missing mutations. She described two examples from the work
of her laboratory in the 1990s in
which disease-causing mutations
were disguised as synonymous
substitutions.
One situation concerned Laron
syndrome, a type of dwarfsm due to
growth hormone insensitivity. Dr.
Francke and her collaborators analyzed the growth hormone receptor
gene (GHR) in a cohort of individuals with growth hormone insensitivity syndrome in an inbred population from Ecuador. The only GHR
mutation they found, however,
didnt cause a change in the receptor
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amino acid sequence. Rather, it created a new donor splice site and
produced abnormal pre-mRNA
splicing leading to an in-frame deletion of eight amino acids (Berg MA,
et al. Am J Hum Genet. 1993;52:998
1005). Not every synonymous mutation is to be thrown away, Dr.
Francke concluded.
The second example of the importance of synonymous variants was
identifed in a patient with Marfan
syndrome, which results from an
abnormality in the very large gene for
fbrillin-1. By using cDNA from skin
fbroblasts in a long-range RT-PCR
approach, Dr. Franckes lab, then at
Stanford, found an exon-skipping
mutation that caused the disease (Liu
W, et al. Nat Genet. 1997;16:328329).
The splice junctions were intact and
a single nucleotide substitution was
present in the middle of the exon,
Dr. Francke says. It did not cause a
change in the amino acid sequence.
Now people know that splicing enhancers and splicing silencers can be
present within coding exons. This
mutation may have eliminated a
splicing enhancer necessary for the
exon to be included and translated
into protein.
Dr. Francke also pointed out that
filtering out mutations already
known to cause another disease may
result in missing a responsible gene.
Different mutations in the same gene
can cause different phenotypes depending on the location and type of
mutation, perhaps increasing or decreasing the activity of a protein.
Dr. Franckes example of this phenomenon starts with Wiskott-Aldrich
syndrome (WAS), an X-linked immunodeficiency characterized by
eczema, thrombocytopenia, small
platelets, and recurrent infections, for
which Dr. Franckes laboratory discovered the responsible gene by positional cloning (Derry JM, et al. Cell.
1994;78:635644). The WAS gene encodes a critical molecule in the actin
cytoskeleton, called WAS protein
(WASp), which is necessary for
phagocytes to migrate.
Besides the classic WAS phenotype, there is a group of patients with
congenital X-linked thrombocytopenia (XLT) who have small platelets
but only transient eczema, if any, and
minimal immune defciency. Patients
with the XLT phenotype also have
mutations in the WAS gene. However, Dr. Francke and her colleagues
found patients with classic WAS have
more complex mutations, resulting in
termination codons, frameshifts, and
early termination (Zhu Q, et al. Blood.
1995;86:37973804).
On the opposite side are variants
that have no pathogenic signifcance.
Current human databases contain
known mutations for which some
people have both copies knocked out,
Dr. Francke says. Yet these people
are walking around apparently nor-
mal. So these genes are not necessary

or other genes compensate. One
example Dr. Francke cites is a gene
acting in fast-twitch muscle fbers. If
you dont have it, you have no fasttwitch muscles, she says. You therefore are better at marathons than at
sprinting. People are increasingly
identifying these innocuous knockouts and including them in publicly
available databases. In the future, the
interpretation of sequencing results
will be a lot easier, Dr. Francke predicts. A lot more will be known
about variations in human genes and
more innocent variants will be found
that can be ignored.
Which brings us to the topic of
results reporting for variants of unknown signifcance. Some say we
should not even tell patients about
them, Dr. Francke says. People who
have been trying to get informed
consent for exome sequencing for
patients with inherited conditions tell
the family they might fnd abnormalities that arent directly pertinent to
the patient but that might relate to
conditions that could show up later
in life. The key question for patients
is: How much do they want to know?
Only what causes this childs phenotype? Not knowing enough, most
people say, I want to know everything. I think people should have a
right to access that information if they
want, but they should be forewarned
that they might learn something unexpected. Its their genome, but they
share it with family members. There
should be discussion in families.
In addition, Dr. Francke notes the
limits to genetic infuence. For instance, she says, the effects of gene
variant are probabilistic, not deterministic. The environment, too, has
an infuence. Brain development is
responsive to stimulation and sensory input. And we are learning more
about the role of epigenetics.
esides her laboratory work in

human genetics, Dr. Francke is
proud of her vision. I predicted that
genetic services would be provided
on the Internet, she says. Her 1999
presidential address to the American
Society of Human Genetics was titled
Human Genetics in the Information
Age. In it she said: I have no doubt
that interactive Web-based systems
will be developed that can provide
accurate, timely, and individualized
genetic information. People are still
arguing about whether this is good or
bad and how it should best be done,
but no one denies it has happened.
Dr. Francke was a consultant to
the Internet-based genetic services
company 23andMe from 2007 to
2010. (Jill Hagenkord, MD, chief
medical offcer of 23andMe, says Dr.
Francke predicted the company
before it existed.) They had bright,
educated PhD science writers who
would write clear continued on 92
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Genetics
continued from 90
reports that told customers in simple

language what their fndings meant,
Dr. Francke says of the company. In
2010 she became emeritus professor
at Stanford and took a part-time position (until October 2013) as senior
medical director at 23andMe. In that
capacity, Dr. Francke worked with its
professionals on several genetic
analyses of their consumer database
(for example: Tung JY, et al. PLoS
One. 2011;6: e23473. doi:10.1371/
journal.pone.0023473).
She directed an interview-based
study of the experience of clients who

received a positive result for one of
three BRCA mutations that are present in about two percent of the Ashkenazi Jewish population (Francke U,
et al. PeerJ. 2013;1:e8. doi:10.7717/
peerj.8. Print 2013). The bottom line
was that no one was extremely upset
when they found out, Dr. Francke
says. A lot of people went for confrmation at Myriad Genetics. All results
were confrmed. The survey also
found that people informed their
families of the fndings.
Controls in the survey were people
who had a negative result. Those
people understood they still had a
risk, Dr. Francke says.

As for the future, Dr. Francke told
the AMP audience, Everyone will
have their genome sequenced and
interact with it on mobile devices.
She added in the interview: Perhaps
everyone will have a next-generation
sequencing screen at birth. It could
replace all current newborn screening
tests and be cheap, and interpretation
will be assisted by sophisticated information technology systems.
One who was in the audience for
Dr. Franckes talk last year was Federico Monzon, MD, medical director,
oncology and Latin America, Invitae.
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Dr. Francke and her colleagues, he

tells CAP TODAY, was to show that
the mechanisms for genetic diseases
were more complex than expected.
Mosaicism had not been associated
with disease, and synonymous variants were thought to be clinically irrelevant. Her work led to an understanding that silent variants could
lead to disease via alterations in RNA
splicing.
What Dr. Francke and colleagues
showed us is that you should not take
for granted that current knowledge
explains everything. You can always
learn something new by studying
patients who do not conform to established paradigms and by being
open to genetics manifesting in unexpected ways. Keeping an open mind
often leads to the discovery of new
mechanisms of disease.
Without the understanding that
Dr. Francke and her generation provided in terms of causes and mechanisms of human hereditary disorders,
Dr. Monzon says, I dont think we
would have such a rich armamentarium of genetic testing as we do
now.
William Check is a writer in Ft. Lauderdale, Fla.
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In the June issue is a case report

(page 62), Coexisting germline
mutations in APC and BRCA2 in
a patient with colon cancer, provided by members of the Association for Molecular Pathology. Here
are answers (in bold) to the three
test yourself questions that followed the case report.
1. Mutations in KRAS are

associated with:
a) resistance to EGFR tyrosine kinase
inhibitors and monoclonal antibodies
b) enhanced response to EGFR tyrosine
kinase inhibitors and monoclonal
antibodies
c) no impact on response to EGFR tyrosine
kinase inhibitors and monoclonal antibodies
2. Mutations in the APC

(adenomatous polyposis coli)
gene result in:
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a) familial adenomatous polyposis (FAP)

b) attenuated familial adenomatous
polyposis (AFAP)
c) Lynch syndrome
d) a & b
3. Patients with AFAP

phenotype have:
a) alternatively spliced sequence in exon 9

b) mutations in 5' to codon 168
c) mutations in 3' to codon 1580
d) all of the above
THE CPOE LAB TEST

UTILIZATION OPPORTUNITY
A
s healthcare reform continues to progress,
CPOE (Computerized Physician Order Entry) has
Matthew D. Krasowski, M.D., Ph.D.

Director, Clinical Laboratories
University of Iowa Carver College of Medicine
Where to Start
Taking on electronic order sets for laboratory tests
can feel like a HUGE undertaking. However, once
you start, you wont have to look hard to fnd areas
where people are ordering excessive or unnecessary
tests. Start with the inpatient setting and take it
one order set at a time. Because inpatient care
is reimbursed according to DRG-based bundled
payments, every single improvement you make will
be felt on the bottom line.
Get the Data

As you undertake this process, it is essential that you
fgure out how to get the data out of the system. You
need to know what is being ordered, and by whom
especially in the case where there are excessive orders
being made. Colleagues in the hospital may push back
on your efforts to restrict and change their lab test
ordering procedures. You need to be armed with the
data that shows exactly how many unnecessary tests
are being ordered.
Collaboration is Key
Approach each order set as an opportunity to get
outside of the lab and collaborate with your peers in
their environment. It should start by having a team of
experts from your laboratory carefully review order
sets and fag any issues they see.
With this in hand, approach the owner of the order set
in the spirit of mutual education. They will likely want
to hear about new tests and areas for improvement.
Additionally, you will get educated on areas of
medicine that you were not aware of, which only
increases your value.
The combination of your expertise and the clinical
expertise of the order set owner will result in testing
procedures that are both more effcient and effective.
become ubiquitous. Not that long ago, physicians

were scribbling orders on a notepad. Now, they
are entering them into a computer. Hospital
networks all over the country are learning to
work within this new reality, opening up many
exciting opportunities for the lab to demonstrate
its value and leadership. When lab leaders get
engaged in an EMR-based strategy to optimize
laboratory test utilization, they can impact
the bottom line by helping to accelerate the
healing process.
Why Immediate Action by the

Lab is Essential
The rise of the EMR and electronic order sets is also
giving rise to some additional issues and opportunities.
CPOE order sets may be designed and implemented
under severe time constraints. Instead of taking the
time to evaluate all existing paper-based order sets
for clinical utility, some hospitals simply upload them
into the EMR instead. This means that many of the lab
tests contained in these order sets may be outdated
and not adhere to the most recent clinical evidence.
Outdated or incorrect CPOE order sets can result
in numerous lab tests being ordered, for which the
hospital will not be reimbursed. More importantly, this
has the potential to impact patient care as diagnosis
and treatment gets delayed. The laboratory has the
knowledge and expertise to address this issue.
CPOE and the laboratory test ordering process it
automates are just such an opportunity. Engaging in the
order set improvement process allows laboratorians to
bring value to their institution, directly impact patient
care, and be recognized by their physician colleagues
as being an integral component of the care process.
Use Pop-ups Selectively

CPOE pop-upsalso known as alertsare an
essential tool to help you improve lab test selection
at the time of ordering. This unique and powerful
capability also contributes to its biggest detraction:
overuse. First, start by monitoring how effective your
pop-ups are. If youve placed a pop-up warning for
every other test, physicians will quickly experience
prompt fatigue and stop paying attention to these
essential alerts.
A better strategy is to be as targeted as possible
with your pop-ups. Lay out the potential clinical
consequences and call out best practices. In certain
cases, pop-ups that require a user to enter a reason
why they are overriding the warning can be highly
effectivebut only if used sparingly.
Finally, touch base with the pharmacy about
pop-up best practices. The pharmacy has years
of experience designing and implementing
pop-ups to avoid drug/drug, drug/food and drug/
allergy adverse events. Their advice can make a
huge difference.
Be Ready for Pushback

Putting yourself at the center of order sets
can be a daunting task. Your colleagues may
already be feeling frustrated with the transition
to electronic order entry. If they think you are
restricting their ability to order the tests they
need, you may receive some unpleasant calls from
unhappy customers.
You will need patience, thick skin, and a sense
of confdence that you are doing the right thing.
As a laboratory leader in your institution, you
are the correct person to do this important task.
Dont shy away because you are encountering some
resistance. See it as an opportunity to engage and
provide added value for the physician.
4 Key CPOE Trouble Spots

1. Serum albumin
Many order sets have the testing
frequency for this test to automatically
repeat daily, but it takes days/weeks
for value to change
Make test a one-time order.
To order, HCPs must manually select
each time
2. Look-alike laboratory tests

Magnesium and manganese look
very similar and may be next to each
other alphabetically. Build a pop-up
asking if magnesium was intended
when they are in fact ordering
manganese
Beta-2-glycoprotein and
beta-2-microglobulin are also
often confused
3. HIV tests
HCPs may order specialized (and
expensive) tests when they really
only intend for basic screening
4. Sexually transmitted diseases

This is an area where you may fnd
STD order sets containing outdated
tests. Work with your infectious
disease colleagues to replace
them with better alternatives
Experience LabLeaders.com live by visiting the

LabLeaders.com Theatre at AACC (Roche Booth #1907)
See presentations from these industry experts and more:
> Zack Varughese, Senior Vice President of Oncology Services, Cancer Treatment Centers of America
Five Steps to Higher Patient Satisfaction
> Sean Agger, MS, PhD, DABCC, FACB, Co-Director Clinical Laboratory, Gundersen Health System
Lab Standardization: The Key to Unlocking the Integrated Healthcare System
For full list of speakers brought to you by LabLeaders.com,

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opportunities.
Visit LabLeaders.com for exclusive insights from key
laboratory leaders.
2015 Roche 461-61198-0715
Paths to validating next-gen sequencing assays

Kim Scott
As more clinical laboratories tread the unfamiliar
ground of next-generation sequencing, they are
faced with the age-old challenges of establishing
validation and quality control processes. Two
experts tackled the topic of molecular QC during
a recent CAP TODAY webinar presented in cooperation with Horizon Diagnostics and available
for viewing on demand at www.captodayonline.com/
cap-today-hosted-webinars/#horizon.
Because the Food and Drug Administration
classifes most sequencers as research instruments,
the majority of clinical NGS tests require full validation, not just verifcation. When validating a
test, laboratories must compare a number of parameters, including accuracy, trueness, precision,
reproducibility, and robustness, according to the
CAPs recommended principles and practices for
validating clinical molecular pathology tests (Jennings L, et al. Arch Pathol Lab Med . 2009;
133[5]:743755). Of these, accuracy is perhaps the
most important, said Josh Deignan, PhD, associate
director of the UCLA molecular diagnostics
laboratories.
How a lab approaches accuracy for a nextgeneration sequencing test really sets the stage for
how to address all of the other relevant parameters, Dr. Deignan said.
One approach to validating the accuracy of an
NGS test is to compare test results with those of
another clinical laboratory performing the same
test and whose results are presumed to represent
the gold standard.
When performing validations for single gene
and small variant panels, a lab typically would
require multiple (at least 20) positive and negative
samples, with each positive sample containing at
least one clinically relevant variant. While it is
possible to compare many variants from a single
sample, multiple samples are still recommended
due to the inherent matrix variability in different
extractions and the complexity of other genomic

alterations that may exist in specifc examples, Dr.
Deignan said.
The problem with comparing variants from a
single sample, he explained, is other laboratories
may not be performing the exact same test that
your lab is, which makes it diffcult to compare
NGS data from the same type of test between two
clinical laboratories.
A second approach to validating the accuracy
of an NGS test is to compare NGS results with the
results obtained from a gold standard method.
While Sanger sequencing once was considered the
gold standard, Dr. Deignan noted there are cases
where a Sanger test is negative while clinical
exome sequencing is positive for a particular
variant.
Sanger sequencing is no longer the gold standard, he said, because there is potential for allele
dropout due to polymorphic positions under
primers or unknown heterozygous deletions.
When this happens, the sequencing may either
miss variants or may erroneously assign homozygosity to a heterozygous/hemizygous variant.
Whats more, Sanger sequencing can only detect
a minimum allele frequency of 15 percent to 20
percent.
The conclusion is there may not be a different
gold standard method to compare next-generation
sequencing to anymore, Dr. Deignan said. I
would argue that next-generation sequencing is
the new gold standard.
A third approach to validating the accuracy of
a next-gen test is to compare the NGS results with
the results from well-characterized reference material. A new consortium called Genome in a Bottle
is developing the technical infrastructure, including reference standards, methods, and data, to
enable translation of whole human genome sequencing to clinical practices. The National Institute of Standards and Technology, in April, made
available for purchase its frst reference material8398, human DNA for whole-genome variant
assessment. Additional reference materials for
sequencing are under development.
ne of the QC challenges of NGS is whether

to run positive control and no-template
control samples with every exome run. This
is expensive; it also can be diffcult to defne a
positive exome or genome since there are so
many variants. Dr. Deignan noted that Sanger
sequencing tests dont require separate positive
controls if all of the peaks in the sequence match
the sequence of the gene.
If you think about treating
genomic DNA as its own nextgen sample type, which is something that a lot of clinical laboratories are now subscribing to, to
me it makes a lot more sense,
he said.
Dr. Deignan does recommend
Dr.Deignan
that laboratories validate an
NGS assay using their own routine extraction
method. However, there may be instances in
which other institutions wish to send your laboratory existing extracted DNA for testing instead of
fresh blood or cells. Because its not possible to
validate all DNA extraction methods, one approach is for the laboratory to develop defned
QC criteria that confrm sequencing was acceptable. Another approach is to use Sanger sequencing for confrmation, but Dr. Deignan believes this
is not the best approach.
What we did [at UCLA] for the frst year and
a half of offering clinical exome sequencing was
to confrm all reported variants, he explained.
After that time, we essentially validated our
ability to do away with Sanger confrmation for
high-quality single nucleotide variants.
The UCLA molecular diagnostics laboratories
still use Sanger confrmation for all
low-quality single nucleotide variants and all insertions and deletions.
Reads for any variants not confrmed
are manually evaluated. The quality
score cutoff that UCLA uses is specifc to its laboratory; each laboratory
will need to develop its own cutoff.
The UCLA laboratory does not
confrm somatic NGS panels, mainly
because of the challenges in fnding
a confrmatory method with comparable sensitivity. The CAP leaves it up
to individual laboratory directors to
decide whether or not to confirm
testing.
I encourage everyone to decide
for themselves, using a well-thoughtout, data-driven process, how they
want to approach this, he advised.
Next-generation sequencing is the
new gold standard for clinical molecular diagnostic testing, and while
NGS validation and quality control
is challenging and may require slightly different approaches, the principles
are the same.
night Diagnostic Laboratories

in Oregon is a good example
of a laboratory that has successfully
developed an NGS continued on 96
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Validating NGS
continued from 94
testing program and is performing comprehensive validations. Knight frst got involved with
next-generation sequencing in
2012, primarily to better target
therapeutics, said Christopher
Corless, MD, PhD, Knights director and chief medical offcer and a
professor of pathology at Oregon
Health and Science University.
Knight has developed a number
of custom amplicon-based
Dr.Corless
panels validated for DNA or
RNA from FFPE tissue (see GeneTrails next-gen
sequencing tests).
These are relatively small panels ranging from

20 to 76 genes because we have chosen to focus on
those genes that we think are truly actionable with
drugs today, Dr. Corless said.
To validate the panels, Knight Diagnostic Laboratories follows a four-step process:
n Run 1020 samples of DNA (or cDNA) from
normal FFPE tissue. This establishes false-positives
due to sequencing errors, pseudogene interference,
or other issues.
n Run 4050 samples with known SNVs, including insertions/deletions and/or copy number
alterations. The laboratory either uses control cell
line samples or FFPE tumor samples with known
mutations based on Sanger, MassArray, or other
assay. Increasingly, the laboratory is cross-validating from one panel to another using tumor samples
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GeneTrails next-gen sequencing tests

Panel
Non-small cell lung cancer
Number
of genes
DNA/RNA
23
DNA
GI stromal tumor
23
DNA
AML/MDS
42
DNA
General solid tumor
37
DNA
AML/lymphoma
76
DNA
Gene fusion
20
RNA
Custom amplicon-based panels validated for DNA (or RNA) from FFPE tissue.
with mutations at low mutant allele frequency.

n Run dilutions for limit of detection.
n Perform reproducibility runs.
When assessing a new panel, Dr. Corless recommends considering the following: Are
there areas with low coverage, and are
known mutation hotspots within
these regions? What is the lower limit
of detection and how does DNA deamination affect this? What is the size
range of insertions and deletions that
can be detected?
Another critical factor in NGS testing on tumor samples is assessing the
material that is being tested. At
Knight, the lower limit of an acceptable sample is 20 percent tumor content. As a general rule, pathologists
tend to overestimate how much tumor
they have in the starting material, and
this is something we need to keep in
mind, Dr. Corless said.
The amount of tumor content in a
sample is especially important when
detecting copy number alterations,
which are important in precision
medicine. Knight has developed an
algorithm to detect CNAs in amplicon-based sequencing data. The
laboratory used samples with a
known FISH status and microarray
results to validate the results of the
algorithm.
Ultimately, analytical validation of
cancer panels should include normal
samples, samples with a wide range
of mutations, and samples with low
mutant allele frequency, Dr. Corless
advised. It is important to correlate
sequencing results with tumor input,
he said. Copy number alteration can
be detected, but there are limitations.
RNA sequencing also can be useful in
detecting gene fusions.
Knight Diagnostic Laboratories has
invested a lot to develop its own genomic database, but also relies on
public resources such as My Cancer
Genome (www.mycancergenome.org), along
with the databases from MD Anderson Cancer Center (https://pct.mdanderson.
org) and Washington University in St.
Louis (https://civic.genome.wustl.edu).
Any laboratory venturing into NGS
testing will need to have a robust genomic database, Dr. Corless noted. A
laboratory might start with one that is
commercially available and then
adapt it to its own setting, or may invest in developing one of its own as
Knight has done.
Kim Scott is a writer in Lewes, Del.
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IN THE FIGHT
Clinical Pathology
Selected Abstracts
Editor: Deborah Sesok-Pizzini, MD, MBA, professor, Department of Clinical Pathology and Laboratory Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, and chief, Division of Transfusion Medicine, Childrens Hospital
of Philadelphia.
A study of biologic augmentation of rotator cuff repair

with mesenchymal stem cells during arthroscopy
Bone marrow-derived mesenchymal
stem cells from the iliac crest have
the potential to become a variety of
adult tissue cells, including teno-
cytes, chondrocytes, and osteoblasts,

as well as provide growth factors for
soft and hard tissue regeneration.
The authors conducted a study that
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used bone marrow-derived mesenchymal stem cells (MSCs) as an adjunct to rotator cuff repair for improved outcomes, including faster
healing and higher quality tendon
integrity. More specifcally, the prevalence of healing and prevention of
re-tears were correlated with the
number of MSCs injected at the repair site. Investigators studied 45
patients who received concentrated
MSCs as an adjunct to rotator cuff
repair at the time of arthroscopy. The
patients received an average of
51,000 25,000 MSCs. A matched
control group of patients who did not
receive MSCs was used for comparison. The results showed the MSC
injection as an adjunctive therapy
enhanced the rate of healing and
improved the quality of the repair, as
evidenced by ultrasound and MRI.
The data showed that 100 percent of
the MSC-augmented repairs healed
by six months compared with 67
percent of the repairs without MSC
treatment. The study also reported a
signifcant improvement in tendon

integrity with the MSC-treated group
compared with the control group
after a 10-year follow-up. The authors
concluded that this study supports
MSC augmentation in rotator cuff
repair for an enhanced rate of healing
and reduced number of re-tears.
Hernigou P, Lachaniette CHF, Delambre J,
et al. Biologic augmentation of rotator cuff
repair with mesenchymal stem cells during
arthroscopy improves healing and prevents
further tears: a case-controlled study. Int
Orthop. 2014;38:18111818.
Correspondence: P. Hernigou at philippe.
hernigou@wanadoo.fr
Effectiveness of multiple
initiatives to reduce blood
component wastage
Wastage of blood components is an
important utilization and cost issue
for hospitals. A robust patient bloodmanagement program identifes and
addresses reasons for wastage. However, targeted interventions may be
costly and may not have the
desired outcome of preventing waste. The authors conducted a study in which they
examined multiple low-cost
initiatives to reduce waste,
including educational outreach, print and digital messaging, and improved transportation and componentidentification modalities.
They compared blood component wastage rates for the 16
months following implementation of the low-cost interventions to rates during the 16
months prior to the interventions. The authors determined
that the most significant
changes were a reduction in
platelet wastage from 3.71
percent to 2.81 percent
(P=0.001) and a decrease in
red blood cell wastage from
0.67 percent to 0.56 percent
(P<0.001). Plasma wastage, on
the other hand, increased
from 1.14 percent to 1.40 percent (P<0.001), which the authors attributed to apheresis
procedures that were cancelled after the plasma was
thawed. The net cost savings
of these low-cost interventions was $131,520. The authors concluded that this
study demonstrates that relatively inexpensive interventions can have a direct impact
on reducing blood wastage
and improve utilization and
cost savings.
Collins RA, Wisniewski MK, Waters
JH, et al. Effectiveness of multiple
initiatives to reduce blood component wastage. Am J Clin Pathol.
2015;143:329335.
Correspondence: Dr. Mark H. Yazer
at myazer@itxm.org
CAP TODAY does not endorse any of the products or services named within. The webinar is made possible by a special
educational grant from Nanosphere.
Anatomic Pathology
Selected Abstracts
Editors: Michael Cibull, MD, professor emeritus, University of Kentucky College of
Medicine, Lexington; Rouzan Karabakhtsian, MD, attending pathologist, Department of Pathology, Montefore Medical Center, Albert Einstein College of Medicine,
Bronx, NY; Thomas Cibull, MD, dermatopathologist, Evanston Hospital, NorthShore
University HealthSystem, Evanston, Ill.; and Rachel Stewart, DO, resident physician, Department of Pathology and Laboratory Medicine, University of Kentucky.
Expanding the morphologic

spectrum of differentiated
VIN by mapping p53 loss
The pathogenesis of vulvar squamous cell carcinoma follows one of
two distinct pathways. A precursor
lesion in the human papilloma virusindependent pathwaydifferentiated vulvar intraepithelial neoplasia
(dVIN)was only recently characterized in detail and is diagnosed infrequently without an associated component of invasive carcinoma. Aberrant p53 immunostaining is seen
frequently in dVIN, and it manifests
as a complete loss or a p53-null pattern in about 25 to 30 percent of cases.
The abrupt transition between p53
loss and basal p53 expression in lesional versus nonlesional epithelium
allows clear demarcation between
neoplastic and non-neoplastic epithelium. The authors conducted a study
focusing on the accuracy of diagnosis
of dVIN. They identified for the
study 14 specimens from 10 patients
using the pathology archives of two
teaching hospitals. The specimens
were identifed on the basis of a diagnosis of dVIN, with or without invasive carcinoma, and p53-null immunostaining pattern in lesional cells.
Ten specimens had associated invasive carcinoma. All sections from
each specimen that showed the specimen resection margin were stained
for p53 and reviewed with all hematoxylin-and-eosin sections. Detailed
morphologic assessment of the p53null epithelium was made and compared with the adjacent benign squamous epithelium. The status of the
resection margins based on the original pathologic assessment was compared with that assessed with p53
immunohistochemistry. One specimen showed p53 loss in the invasive
carcinoma but patchy basal positivity
in the region originally diagnosed as
dVIN, supporting interpretation as a
benign hyperplastic focus rather than
dVIN. In the remaining 13 specimens,
the areas originally diagnosed as
dVIN, as well as the associated invasive carcinoma, if present, were p53null. In eight of these specimens,
dVIN was determined to be more
extensive than originally recognized,
based on the presence of p53-null
immunostaining and subtle morphologic abnormalities. The spectrum of
morphologic changes in p53-null regions that showed continuity with
areas originally recognized as dVIN

were subtle and typically consisted
of an abrupt change in maturation of
the squamous epithelium (loss of
keratohyaline granules and parakeratosis); tinctorial alterations in the keratinocytes, with cells containing
more abundant eosinophilic cytoplasm; and minimal basal nuclear
atypia. Margin status changed from
negative to positive in four of 13
specimens and from focally to more
extensively positive in an additional
three specimens. The authors concluded that better tools for the diagnosis of dVIN are needed. Until such
tools are developed, the limitations
in the current diagnosis of dVIN
should be recognized.
Singh N, Leen SL, Han G, et al. Expanding the
morphologic spectrum of differentiated VIN
(dVIN) through detailed mapping of cases
with p53 loss. Am J Surg Pathol. 2015;39:5260.
Correspondence information not provided.
Mitotic count by PHH3

immunohistochemical staining
in pancreatic WDNETs
Well-differentiated neuroendocrine
tumors of the pancreas are graded
on the basis of mitotic count or Ki67
index. Mitotic count has a narrow
cutoff; its assessment is time consuming and carries poor interobserver reproducibility. Phosphohistone H3 (PHH3) is a mitosis-specifc
marker for which the value has been
validated in several tumor types.
The authors conducted a study to
assess the utility of PHH3 in histologic grading of pancreatic welldifferentiated neuroendocrine tumors (WDNETs). Sixty-three cases
of surgically resected primary pancreatic WDNETs were retrieved, and
immunohistochemical analysis for
PHH3 and Ki67 was performed.
Mitotic rate was independently assessed by four pathologists using
hematoxylin and eosin (in 50 highpower felds [HPFs], expressed as
mitoses per 10 HPFs) and PHH3
stains (in 50 HPFs, one 10, and one
20 hotspot). PHH3 and Ki67 labeling indices were determined on a
single 20 hotspot and expressed as
the percentage of positive cells to
total cells. Mitotic counts by various
methods significantly correlated
with each other and with PHH3 and
Ki67 indices, with the best correlation seen within the three different
PHH3 counts (in 50 HPFs, one 10,

and one 20 hotspot). Moreover,
mitotic count on PHH3 was less
time consuming than on hematoxylin and eosin (1.68 versus 3.67 minutes for 50 HPFs; P<0.0001). Histologic grade determined by PHH3
significantly correlated with disease-specifc and disease-free survival, with the best cutoffs of 4
mitoses/10 HPFs (2 mm2), 7 mitoses/10 hotspot, 5 mitoses/20
hotspot (log rank test, P<0.0001),
and 0.16 percent for PHH3 labeling
index (log rank test, P<0.0006). Tumor grades based on PHH3 stain
also showed significant correlation
with patient survival in multivariate
Cox proportional hazards models
(P<0.05). Histologic grades by mitotic count on PHH3 demonstrated
high concordance and kappa agreement with grades determined by
mitotic count on hematoxylin and
eosin. PHH3 stain also showed improved interobserver agreement in
original mitotic count (intraclass

correlation, 0.98 versus 0.79) and
final grade assignment (Fleiss , 0.69
versus 0.46) as compared with hematoxylin and eosin. The authors
concluded that their data confirmed
that histologic grading by PHH3
stain has practical and prognostic
value and offers reduced time and
improved interobserver reproducibility in mitotic rate assessment and
grade assignment. Although larger
series are needed for validation,
mitotic rate potentially can be determined by counting one hotspot,
which will greatly facilitate the assessment of histologic grade in pancreatic WDNETs.
Voss SM, Riley MP, Lokhandwala PM, et al.
Mitotic count by phosphohistone H3 immunohistochemical staining predicts survival
and improves interobserver reproducibility in
well-differentiated neuroendocrine tumors of
the pancreas. Am J Surg Pathol. 2015;39:1324.
Correspondence information not provided.
continued on 100
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www.wakodiagnostics.com
Anatomic abstracts
continued from 99
Comparison of prostate
cancer markers in lymph node
and distant metastases
Prostate cancer is primarily diagnosed
at an early stage; however, some tumors are diagnosed in a metastatic
stage as cancer of unknown primary
origin. To allow specifc treatment for
prostate cancer presenting as cancer
of unknown primary origin, it is important to determine the tumors origin. Prostate-specifc antigen is used
as a diagnostic marker for prostate
cancer, but its expression declines

with progression to castration-resistant prostate cancer. The authors conducted a study to identify the most
informative marker constellation for
detecting metastatic prostate cancer
at high sensitivity. Widely used prostate cancer markers, such as prostatespecifc antigen, prostate-specifc acid
phosphatase, androgen receptor,
prostate-specifc membrane antigen,
prostein (also known as p501s or SLC45A3), and ETS-related gene, were
investigated for their sensitivity in
detecting the prostatic origin of metastases. Expression of prostate-specific antigen, prostate-specific acid
phosphatase, androgen receptor,

prostate-specifc membrane antigen,
prostein, and ETS-related gene was
determined on archived tissue specimens consisting of benign prostatic
tissue (n=9), primary prostate cancer
(n=79), lymph node metastases
(n=58), and distant metastases (n=39)
using immunohistochemistry. Staining intensity was categorized as negative (zero), weak (one), moderate
(two), and strong (three). All markers,
except ETS-related gene, were able to
detect at least 70 percent of lymph
node metastases and distant metastases, with prostate-specific antigen,
androgen receptor, and prostate-spe-
cifc membrane antigen having the

highest sensitivities (97 percent, 91
percent, and 94 percent, respectively).
Sensitivity could be increased up to
98 percent and 100 percent by combining prostate-specifc antigen, prostate-specifc membrane antigen, or
androgen receptor for lymph node
metastases and distant metastases,
respectively. The same level of sensitivity could be achieved by combining
prostate-specifc membrane antigen
and prostein. These data show that
combined staining of at least two
prostate markers should be used to
identify metastases as originating
from prostate cancer.
Queisser A, Hagedorn SA, Braun M, et al.
Comparison of different prostatic markers
in lymph node and distant metastases of
prostate cancer. Mod Pathol. 2015;28:138145.
Correspondence: Dr. S. Perner at sven.perner1972@
gmail.com
Evaluation of a new grading

system for laryngeal squamous
intraepithelial lesions
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Gale N, Blagus R, El-Mofty SK, et al. Evaluation of a new grading system for laryngeal squamous intraepithelial lesionsa
proposed unifed classifcation. Histopathol.
2014;65:456464.

23711.0615
The authors conducted a study to

verify the applicability, reproducibility,
and predictive value of a proposed
unifed classifcation (amended Ljubljana classification) for laryngeal
squamous intraepithelial lesions. Six
internationally recognized experts and
three pathologists from Ljubljana,
Slovenia, contributed to the study by
using the new system to evaluate a set
of laryngeal squamous intraepithelial
lesions, including low-grade SIL, highgrade SIL, and carcinoma in situ. The
overall agreement among reviewers
was good. Overall unweighted and
weighted -values and 95 percent
confdence intervals were 0.75 (0.65
0.84) and 0.80 (0.710.87), respectively.
The results were stratifed between the
international reviewers and the Ljubljana pathologists. The former had
good overall agreement, and the latter
had very good agreement. Kaplan
Meier survival curves showed a signifcant difference (P<0.0001) between
patients with low- and high-grade
SILs: 19 of 1,204 patients with lowgrade SILs and 30 of 240 patients with
high-grade SILs progressed to malignancy in two to 15 years and two to 26
years, respectively. The authors concluded that the proposed modifcation
to the Ljubljana classifcation provides
clear morphological criteria for defning the prognostic groups. The criteria
facilitate better interobserver agreement than previous systems, and the
retrospective follow-up study demonstrated a highly signifcant difference
in the risk of malignant progression
between low- and high-grade SILs.
cap.org
Correspondence: Dr. N. Gale at nina.gale@mf.uni-lj.si
Breast cancer assessment

based on levels of estrogen
receptor expression
Historically, nuclear staining of 10
percent or more of invasive tumor cells
has been used for estrogen receptor
positivity. In 2010, a joint guideline
from the American Society of Clinical
Oncology and CAP recommended the
cut-off value be changed to nuclear
staining of one percent or more. The
authors conducted a study to analyze
the relationships between levels of
estrogen receptor (ER) expression and
clinicopathological features and clinical outcomes, with an emphasis on the
ER expression one to 10 percent subgroup. They analyzed the clinicopathological features in five subgroups
based on ER expression levels in 1,700
consecutive invasive breast cancer
patients diagnosed and treated at their
institution between 2000 and 2011. Of
the cases, 24 percent had ER expression of less than one percent, two
percent had ER of one to 10 percent,
fve percent had ER of 11 to 50 percent,
fve percent had ER of 51 to 70 percent,
and 64 percent had ER of 71 to 100
percent. The authors observed four
subgroups of patient cohorts (ER expression of less than one percent, one
to 10 percent, 11 to 70 percent, and 71
to 100 percent) that were unique with
regard to Nottingham grade, nuclear
grade, progesterone receptor expression, and disease-free survival. For the

341 patients with follow-up data, they
found no significant differences in
pathological features between patients
in the subgroups with ER expression
of 11 to 50 percent and 51 to 70 percent.
These data support the important role
of ER in breast cancer, as well as the
importance of accurate testing and
quantitative reporting for ER. Tumors
with ER expression of one to 10 percent are not common, and additional
studies are needed to better understand this subgroup of breast cancer.
Zhang Z, Wang J, Skinner KA, et al. Pathological features and clinical outcomes of breast
Their assessment included 76 metastatic melanoma patients with only

one known primary melanoma who
previously had BRAF codon 600 pyrosequencing of either their primary
(n=19) or metastatic (n=57) melanoma,
or both (n=17). All melanomas (n=93)
were immunostained with the BRAF
VE1 antibody using a red detection
system. The staining intensity of these
specimens was scored from 0 to 3+ by
a dermatopathologist. Scores of 0 and
1+ were considered negative staining
while scores of 2+ and 3+ were considered positive. The assessment found
that VE1 antibody showed a sensitivity
of 85 percent and continued on 102
cancer according to levels of oestrogen receptor expression. Histopathol. 2014;65:508516.

Correspondence: Dr. P. Tang at ping_tang@urmc.
rochester.edu
Validation of the VE1

immunostain for the BRAF
V600E mutation in melanoma
BRAF mutation status, and therefore
eligibility for BRAF inhibitors, is determined by sequencing methods. The
authors assessed the validity of VE1, a
monoclonal antibody against the
BRAF V600E mutant protein, in detecting mutant BRAF V600E melanomas
as classifed by DNA pyrosequencing.
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Faculty:
2011 Winner
of ASTD
Excellence
in Practice
Award
Mark G. Hanly, MD, FCAP

Southeastern Pathology Associates
of Savannah
David K. Lieu, MD, FCAP
FNA Medical Group
Susan D. Rollins, MD, FCAP
Outpatient Cytopathology Center
Mikhail Tismenetsky, MD, FCAP
Englewood Hospital & Medical Center
Fall 2015 USFNA AP3 Workshop

October 1718
Englewood, New Jersey
I will start using USFNA with more confdence;

and I will teach my colleagues and students,
including cytotechs, to better prepare
FNA material.

23671.0615
cap.org
Anatomic abstracts
continued from 101
specifcity of 100 percent as compared

to DNA pyrosequencing results. There
was 100 percent concordance between
VE1 immunostaining of primary and
metastatic melanomas from the same
patient. V600K, V600Q, and V600R
BRAF melanomas did not stain positively with VE1. The authors concluded that this hospital-based study fnds
high sensitivity and specifcity for the
BRAF VE1 immunostain in comparison to pyrosequencing in detection of
BRAF V600E in melanomas.
Pearlstein MV, Zedek DC, Ollila DW, et al.
Validation of the VE1 immunostain for the
BRAF V600E mutation in melanoma. J Cutan
Pathol. 2014;41(9): 724732.
Correspondence: Dr. Nancy Thomas at nthomas@
med.unc.edu
Treatment-induced pathologic
necrosis in STS after
neoadjuvant chemoradiotherapy
Histologic response to chemotherapy
has been shown to be an independent
prognostic factor in patients with osteosarcoma and Ewing sarcoma.
However, in patients with soft tissue
sarcoma (STS), the prognostic impact
of histologic response to chemotherapy is less clear. The authors sought to
determine the prognostic signifcance
of treatment-induced pathologic necrosis in patients receiving neoadjuvant chemoradiotherapy for STS. Between 1989 and 2011, they identifed
113 patients with grade 2 or 3 (according to the National Cancer Institute
grading system using three tiers) extremity or truncal STS who received
neoadjuvant interdigitated chemoradiotherapy according to protocol followed by surgery. The extent of tumor
necrosis in the resected specimens was
quantifed and correlated with outcome. The authors found that the
median tumor necrosis rate was 90
percent, and 103 (91 percent) patients
received all three cycles of planned

neoadjuvant chemotherapy. The likelihood of achieving 95 percent or greater necrosis was not related to the number of preoperative cycles of chemotherapy received but was related to
tumor histology (62 percent for malignant fbrous histiocytoma versus zero
for synovial sarcoma [P<0.001]; 56
percent for myxoid liposarcoma versus zero for synovial sarcoma
[P=0.002]). At a median follow-up of
six years, no statistically signifcant
differences were noted in the fve-year
local control, disease-specifc survival,
and overall survival rates for patients
with 95 percent or greater necrosis (50
patients; 44 percent) and less than 95
percent necrosis (63 patients; 56 percent), even when stratifying by histology. The authors concluded that in a
homogeneous population of patients
with high-grade extremity and truncal
STS who were treated with neoadjuvant chemoradiotherapy, the extent of
pathologic tumor necrosis did not
correlate with outcome.
Mullen JT, Hornicek FJ, Harmon DC, et al.
Prognostic signifcance of treatment-induced
pathologic necrosis in extremity and truncal
soft tissue sarcoma after neoadjuvant chemoradiotherapy. Cancer. 2014;120:36763682.
Correspondence: Dr. John T. Mullen at jmullen@
partners.org
Features of hepatocellular
carcinoma arising in
hepatocellular adenoma
Well-differentiated hepatocellular carcinoma in noncirrhotic liver can show
morphological features similar to hepatocellular adenoma. In rare instances,
hepatocellular carcinoma can arise in
the setting of hepatocellular adenoma.
The authors conducted a study to compare the immunohistochemical and
cytogenetic features of the hepatocellular adenoma-like and hepatocellular
carcinoma portions of these tumors.
Immunohistochemistry for -catenin,
glutamine synthetase, serum amyloid
A protein, glypican-3, and heat-shock
protein 70 was performed in 11 cases of

hepatocellular carcinoma arising in
hepatocellular adenoma in noncirrhotic
liver. Tumors with nuclear -catenin or
diffuse glutamine synthetase, or both,
were considered -catenin activated.
Fluorescence in situ hybridization
(FISH) was performed in nine cases for
gains of chromosomes 1, 8, and MYC.
The study involved seven men (33 to
75 years old) and four women (29 to 65
years old). Focal atypical morphological features were seen in hepatocellular
adenoma-like areas in seven (64 percent) cases. Hepatocellular adenomalike areas showed features of infammatory hepatocellular adenoma in
seven (64 percent) cases; and four were
also serum amyloid A positive in the
hepatocellular carcinoma portion.
-catenin activation, heat-shock protein
70 positivity, and chromosomal gains
on FISH were seen in the hepatocellular
adenoma portion in 55 percent, 40
percent, and 56 percent of cases, and 73
percent, 60 percent, and 78 percent of
cases in the hepatocellular carcinoma
portion, respectively. The authors concluded that the hepatocellular adenoma-like portion of most cases of hepatocellular carcinoma arising in hepatocellular adenoma shows features typically seen in hepatocellular carcinoma,
such as focal morphological abnormalities, -catenin activation, heat-shock
protein 70 expression, and chromosomal gains. Hepatocellular adenomalike areas in these tumors, especially in
men and older women, may represent
an extremely well-differentiated variant of hepatocellular carcinoma, whereas the morphologically recognizable
hepatocellular carcinoma portion represents a relatively higher grade component of the tumor.
Kakar S, Grenert JP, Paradis V, et al. Hepatocellular carcinoma arising in adenoma:
similar immunohistochemical and cytogenetic features in adenoma and hepatocellular
carcinoma portions of the tumor. Mod Pathol.
2014;27:14991509.
Correspondence: Dr. S. Kakar at sanjay.kakar@
ucsf.edu
Utility of re-excising mildly

and moderately dysplastic
nevi: a retrospective analysis
The management of dysplastic nevi is
a highly debated and controversial
topic within the dermatology community. Clinicians agree that marginpositive severely dysplastic nevi (DN)
should be removed with a surgical
margin; however, there is disagreement surrounding the appropriate
management of this type of mole. The
authors evaluated the utility of re-excising margin-positive mildly and
moderately DN. They conducted a
retrospective chart review on all adult
patients given the diagnosis of a biopsy-proven DN from 2010 through 2011.
The primary outcomes were defned
as the presence of melanocytic residuum in re-excisional specimens and a
clinically signifcant change in diagnosis. A total of 1,809 mildly and moderately DN were diagnosed from 2010
through 2011. In all, 765 (42.3 percent)
of these lesions were found to have
positive surgical margins during biopsy, and 495 (64.7 percent) of the 765
lesions were subsequently re-excised.
Melanocytic residuum was present in
18.2 percent of re-excisional specimens.
Re-excision resulted in a clinically
signifcant alteration of the diagnosis
in only one case (0.2 percent). The authors acknowledged that their study
was limited by its retrospective design
and an inability to assess for malignant
transformation given limited followup. They concluded that re-excising
mildly and moderately DN results in
a low histopathological yield and rarely results in a clinically significant
change in diagnosis. Consequently,
clinical monitoring of margin-positive
lesions may be warranted.
Strazzula L, Vedak P, Hoang MP, et al. The
utility of re-excising mildly and moderately
dysplastic nevi: a retrospective analysis. J Am
Acad Dermatol. 2014;71:10711076.
Correspondence: Dr. Daniela Kroshinsky, Dept.
of Dermatology, Massachusetts General Hospital, 50 Staniford St., #200, Boston, MA 02114
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Molecular Pathology
Selected Abstracts
Editors: Donna E. Hansel, MD, PhD, chief, Division of Anatomic Pathology, and professor, Department of Pathology, University of California, San Diego; John A. Thorson, MD, PhD, associate professor of pathology, director
of the Clinical Genomics Laboratory, Center for Advanced Laboratory Medicine, UCSD; Sarah S. Murray, PhD,
professor, Department of Pathology, and director of genomic technologies, Center for Advanced Laboratory Medicine,
UCSD; and James Solomon, MD, PhD, resident, Department of Pathology, UCSD.
Inter- and intra-genomic heterogeneity

in localized, multifocal prostate cancer
Genomic heterogeneity in cancer is not a novel
finding; however, comprehensive studies to
evaluate intra- and inter-genomic heterogeneity
in prostate cancer are lacking. The
authors conducted such a study, in
which they investigated localized,
multifocal disease that is potentially
curable but treated as non-indolent
cancer. They studied 74 patients in
whom they frst analyzed index tumors with Gleason score 7 pathology
for copy number aberrations (CNAs)
using a single nucleotide polymorphism microarray platform. The results of that analysis demonstrated
overall heterogeneous profles with
variable percentages of genome alteration across the samples. Interand intra-genomic heterogeneity
were then assessed by investigating
single nucleotide variants, CNAs,
and genomic rearrangements in a
subset of fve of the patients using
whole-genome sequencing in 23 distinct tumor regions (two to nine
distinct foci from each patient). For
each patient, one frozen specimen
and one to eight formalin-fxed, paraffn-embedded (FFPE) specimens
were sequenced. From this analysis,
the authors identifed several abnormalities previously associated with
prostate cancer, including loss of 8p
containing NKX3-1, MYC amplifcation, loss of 17p13.1 containing
TP53 , and EGFR amplification.
They also identifed a novel gene
amplifcation at 1p34.2 encompassing MYCL that almost always occurred with TP53 loss. Fluorescence
in situ hybridization analysis of
polymerase chain reactionvalidated
MYCL amplifcations provided evidence of focal amplification in a
subset of localized prostate cancer.
When looking at overall structural
variation, extensive inter-tumor diversity was noted, as were large
observed differences between regions from the same prostate (intratumor diversity). The authors observed a marked reduction in the
number of genomic rearrangements
in the FFPE-derived specimens compared with the frozen specimens,
which they attributed to smaller insert sizes for the FFPE-derived libraries. The authors also found intrafocal heterogeneity of structural
variation. In one example they provided, the gene NKX3-1 was deleted
in two of the fve regions sampled
from a single patients tumor, providing different

predictions of patient prognosis depending on
which focus was sampled. When looking at
protein-altering somatic single nucleotide variants, they similarly found dramatic differences
between tumors. When they looked at intra-tu-
mor heterogeneity, they found several instances

where a clinically actionable mutation, such as
PIK3CA p.H1047R, was found in some but not
all of the subclones within a tumor, demonstrating the diffculty of choosing the best therapy on
the basis of a single focus. The authors concluded
that this study highlights a challenge of using
molecular assays to profle tumors for prognostic
and predictive biomarkers since specifc clones
within a tumor may yield very different results
used to help guide patient care.
Boutros PC, Fraser M, Harding NJ, et al. Spatial genomic
heterogeneity within localized, multifocal prostate cancer
[published online ahead of print May 25, 2015]. Nat Genet.
doi:10.1038/ng.3315.
Correspondence: Paul C. Boutros at paul.boutros@oicr.on.ca or
Robert G. Bristow at rob.bristow@rmp.uhn.on.ca
Deepen your
core pathology
knowledge with
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Advance your skills
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live and online learning options.
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Pharmacogenomics
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23472.0315
cap.org
Q&A
Editor: Frederick L. Kiechle, MD, PhD
Dr. Kiechle is medical director of clinical pathology, Memorial Healthcare, Hollywood,
Fla. Use the reader service card to submit your inquiries, or address them to Sherrie
Rice, CAP TODAY, 325 Waukegan Road, Northfeld, IL 60093; srice@cap.org. Those
questions that are of general interest will be answered.
Q.
We recently reorganized the workfow in our blood bank in hopes of

improving process control and reducing
distractions. In doing so, we increased the
potential for workplace injuries. The ergonomic issues are a major concern for a lot
of workers. Employees on all three shifts
are developing back and knee issues. We
are an 800-plus-bed hospital lab with more
than 30 people working in our department.
The following issues have arisen:
1. The racks that hold the specimens
are too far away for our reach, as are the
centrifuges. We are always leaning and
stretching forward to perform our work.
The benches dont have a lot of space, so
the materials are deep.
2. The main centrifuge sits atop the
registration bench and is two feet high.

Continuous sitting, standing, sitting goes
on. We perform about 150 type and screens
a day. The printers that print in-house orders are also on this registration bench
and, again, there is a lot of stretching and
leaning forward to get these orders.
3. We have a tech who stands at the
window issuing products all day. The
bench there has a higher chair but with no
room to ft a persons legs or knees when
sittingdrawers take up all the space, so
sitting is a rarity.
Work-related musculoskeletal
disorders, such as those affecting
the back and knees, are typically the
result of cumulative exposure to er-
A.
Fig. 1.
gonomic risk factors over a prolonged

period. The most common risk factors
that predispose an individual to those
disorders are exertions or excessive
force; awkward postures or static or
sustained postures; repetitive motions;
contact stresses; vibrations; and extreme temperatures, particularly cold
environments.
Employees should evaluate work
tasks, jobs, and equipment that could
result in these risk factors and attempt
to reduce exposure to them. The optimum neutral postures for standing
and sitting workstations are shown in
Figs. 1 and 2. While performing working tasks or jobs, the employee should
attempt to maintain these neutral
postures.
Suggestions for problem No. 1
If the work area is used for sitting
and standing, make sure the work
surface is 38 inches above the foor or,
ideally, adjustable up and down. This
is the standing elbow height of the 5th
percentile individual and will allow for
both standing and sitting postures. If
it is possible to sit, then knee spaces
need to be provided. Knee spaces

should be 27 inches wide and at least
18 inches deep at the knees and 45
inches at the feet.
Stand or sit close to the work surface to avoid reaching.
Keep frequently used items within
arms reach. Move items to the front
edge of the work surface. Eliminate the
need to reach across the body to retrieve supplies.
If horizontal real estate is at a premium, then place other supplies vertically in tilt-front bins.
The height of the work surface plus
the height of the centrifuge or printers
should be 38 inches above the foor or
slightly lower. An optimum solution
would be an adjustable work surface
so individual users can adjust the
height accordingly. This will reduce the
need to reach the hands above the
shoulders when moving tubes in and
out of the centrifuge. The keyboard,
mouse, and monitor should be height
adjustable to accommodate all users.
If the horizontal surface is limited,
Fig. 2.
consider placing the keyboard, mouse,

and monitor on a monitor arm.
Frequent changes in body position
will prevent sustained or static postures. A brief stretching break every 40
to 60 minutes or more frequent mini
breaks are recommended.
Alternate between sitting and
standing throughout the day.
If there is insuffcient knee space for
complete sitting, consider using a sitstand chair. These chairs allow you to
rest your buttocks on the seat and do
not require the leg space beneath the
counter that a typical chair or stool
requires.
Consider standing on an antifatigue mat to reduce the forces on the
lower extremities and feet.
Use a footrest while standing to
reduce back pressure. Place one foot
on the footrest to relieve pressure on
that foot and alternate feet regularly.
The Eastman Kodak Company. Kodaks
Ergonomic Design for People at Work,
2nd ed. Hoboken, NJ: Wiley; 2004.
Sandra M. Woolley, PhD, CPE

Ergonomist, Occupational Safety
Mayo Clinic Systems Quality Offce
Rochester, Minn.
Newsbytes
youve ever been through an LIS conversion, you know that client loss is
expected. Yet Sonora Quest beat the
odds when, after three years spent
converting to NetLIMS, the company
announced that it earned an A grade
according to its own criteria.
The one-year anniversary of what
was dubbed the big switch is all the
more momentous because of all the
work, planning, and troubleshooting
it took to effect the seamless transition, including six months of end-toend testing of the new system and a
series of dress rehearsals.
While an LIS conversion is never
easy, for Sonora Quest it was a daunting proposition. The integrated laboratory system is a joint venture between Banner Healths Laboratory
Sciences of America subsidiary and
Quest Diagnostics. It services more

than 7,000 Arizona physician practices, hospitals, and managed care
organizations, performing more than
75,000 diagnostic tests per day, and
has 76 patient service centers.
Moore said that to allay the fears of
colleagues and clients concerned
about Sonora Quest making the
switch on such a grand scale, he compared the conversion process to fying
an airplane. No engineer tries to fy a
plane before testing it, he told them.
You test, test, test, make sure its
perfectthen you fy.
In keeping with the airplane comparison, Sonora Quest undertook a
massive testing procedure before it
flew. The companys test menu
consists of 5,500 different orders,
Moore said. With eight testing sites
throughout the state, and each site
needing to run through its entire
menu flawlessly before going live
with the new system, that meant
44,000 orders to audit.
The real fun part, Moore added,

tongue in cheek, was what we called
trigger point validation. Theres a
subset of those 5,500 tests thatbecause of what the result waswe had
a subsequent action. The response to
a critical result, for example, could be
to run a confrmation or to print a
comment on another kind of test result. One test could have 30 different
actions or packets. We were comparing the [legacy LIS] result with what
came out of NetLIMS to make sure it
worked exactly the same way.
The objective was to do a test that
mirrors whats coming out of the
legacy system, Moore explains. We
had to build orders to be placed in
both test systems, then create the reports, and then have somebody who
understood them and could read
them side by side and validate that
the reports were of equivalent clinical
value, he told CAP TODAY. So the
people who do that process are the
continued on 106
people who are
receive (and before we implement)

new lots of reagents or calibrators, we
typically check fve to 10 patient samples, looking for signifcant (as defined in the previous paragraph),
systematic differences. In some cases,
even if these comparisons look acceptable, we follow the patient medians after implementation to ensure
ongoing consistency.
For lipid panels (as well as some
other measurands like hemoglobin
A1c, creatinine, bilirubin), in addition
to ensuring that there is no signifcant
shift over time, one should also ensure accuracy. Physicians interpret
values on these tests using national or

international guidelines, so getting an
accurate answer is as important as
getting consistent answers over time.
An excellent way to do this is to participate in one of the CAPs AccuracyBased Surveys, where commutable
material is used and your laboratorys
results are compared to the reference
method results. Benchmarks for
agreement for each of the components
are defned by the guidelines and by
the individual Surveys themselves.
For example, for total cholesterol, the
two components of total error, bias
and imprecision, should each be three
percent or less, meaning that the maximum deviation from the true value
should be less than 10 percent.2
Editors: Raymond D. Aller, MD, & Hal Weiner
Why Sonora Quest gave itself

high marks for LIS conversion
For laboratory chief information offcer David N. Moore, July marks a
frst anniversary worth celebrating.
Twelve months ago, his employer,
Phoenix-based Sonora Quest Laboratories, fipped the switch on its new
laboratory information system, effectively turning it on site-wide with one
clickand with barely a hitch or a
glitch.
To say that Sonoras LIS conversion
went perfectly is probably a bit of an
overstatement, but only by a smidge.
Our success criteria was that wed
give ourselves an A if we didnt lose
a client [due to the conversion] in the
frst 90 days, Moore said in a talk at
the Executive War College, in May. If
Q.
What is ideal or acceptable monthto-month variation or lot-to-lot variation in mean values in various clinical
chemistry tests such as lipid profles and
enzymes?
This is an interesting and important question. Unfortunately, it does not have a simple answer.
To start, we should define the
terms more specifcally. I am going to
infer that the question refers to the
mean of patient values (as opposed to
quality control material), a parameter
too few laboratories monitor on a
regular basis. Also, I would propose
that the mean value is not as good a
marker as the median value; mean
values will be affected by extreme
values much more than median values. Finally, it may be best to restrict
the analysis to outpatient values;
again, hospitalized patients are likely
to have many extreme values.
For some tests, like enzymes, electrolytes, and calcium, there should be
little variation in the median values
from outpatients over time. If the
medians change, in all likelihood, the
assays are not working properly, the
reference intervals are no longer appropriate, and too many healthy patients will appear to be abnormal.
Its diffcult to provide a single percentage of acceptable variation for all
tests. It might be better to look at the
percentage of patients who, with a
given percentage change, will be
called abnormal. For example, a fve
percent increase in alanine transaminase is unlikely to be terribly signifcant, whereas a fve percent change in
calcium would be signifcant.
It is important to point out that
preferred laboratory practice is to
check values on patient samples with
each lot number change.1 As an example, in our laboratory, when we
A.
1. College of American Pathologists. COM.30450

New reagent lot confrmation of acceptability.
In: All Common Checklist. April 21, 2014.
2. College of American Pathologists. Accuracy-Based Lipid Survey Participant Summary
(ABL-B); 2012.
Gary L. Horowitz, MD
Medical Director, Clinical Chemistry
Beth Israel Deaconess
Medical Center, Boston
Associate Professor, Pathology
Harvard Medical School
Chair, CAP Chemistry
Resource Committee
Newsbytes
continued from 105
r@
C
AA
Despite going off nearly perfectly,

an LIS conversion of this size and type
is as daunting a task as youll ever
do, Moore concludes. But the rewards are amazing if youre running
on a legacy system and you think you
can never get rid of that dinosaur.
Kevin B. OReilly
Pathologists share homegrown

software for infant autopsies
The University of Alabama at Birmingham has introduced software,
available at no cost, that can assist
with infant autopsy cases or provide
data for epidemiologic and quality
C 2015
DxMA
Se
in
running the lab. We had to work in

shifts. We had a dedicated training
room where people would come in
and review tons of reportspeople
doing the order entry, the resulting,
and printing the reports.
Most of the testing events and other initiatives undertaken to run the
replacement LIS through its paces
took place on weekends, and Moore
and his colleagues worked horrendous hours for weeks on end to
make the entire conversion process go
smoothly, he said.
Yet despite the magnitude of its

systemwide conversion approach,
there was little resistance to the decision to move from Sonora Quests
legacy LIS to NetLIMS in one fell
swoop. We were unifed in the approach that were not going to go live
until were all ready to go live together, Moore says.
The one hiccup Sonora Quest experienced after going live was with its
automated chemistry lines, which
required a middleware upgrade to
play well with the new LIS. We went
back in and we fxed it, and life got
smoothed out, Moore says. It took
one week to resolve that.
The Path to Adoption of Disruptive Technologies:

Integrating the Spectrum of Results from Research to
Pharmacy into Clinical Practice
Expert Panel from Industry and Hospital Systems

Join our discussion at the American Association for
Clinical Chemistry (AACC) annual meeting.
Monday, July 27, 2015, at 4:30 PM 6:30 PM
Moderator:
Bob McGonnagle, Publisher, CAP Today
Program Chair:
Narayan Krishnaswami, Senior Global Marketing
Manager - Diagnostics,
Sigma-Aldrich Corporation
Register today at www.dxma.org
2015 DxMA Professional Seminar Series on
Disruptive Technologies
DxMA Seminar @ ASM May 30 | New Orleans, LA
DxMA Seminar @ AACC July 27 | Atlanta, GA
DxMA Seminar @ AMP November | Austin, TX
Connect with DxMA on LinkedIn and Twitter
#DxMAatAACC
Opinion leaders from a national pharmacy chain, industry,

and academia will discuss issues and obstacles encountered
in the adoption and integration of test results garnered from
diverse locations, and how they are overcoming them to
benet healthcare systems and the patients they serve.
These quantum changes often come with disruptive
challenges that require new thinking and adaptation of
established practices. In some cases, the projection is that
the labs and healthcare systems will require reorganization
to accommodate processes that do not t the current
workow or reporting systematics. We have assembled a
panel that will discuss the mplications of disruptive practices
that promise to transform the healthcare paradigm and
ultimately improve patient
access as well
as patient
care.
assurance studies.
Recognizing that the most challenging aspects of infant autopsies
are assessing fetal and neonatal
growth parameters and features of
maturation, the software creators
developed a program that allows
pathologists to enter a variety of information, including total body
weight and the weight of various
organs, as well as the length of select
body parts, in metric measurements.
The program can then generate a
table that best estimates the infants
gestational age and highlights values
that fall outside the normal range,
allowing users to identify abnormalities. Data entered into the program can be stored, retrieved, and
edited, and the tables generated can
be inserted into pathology reports.
While the software developers
expected the program to be faster
than conventional methods for accessing data on infant gestational
age norms, such as books and Internet searches, We were pleasantly
surprised by the significant time
savings, says Matthew D. Cain,
MD, the University of Alabama at
Birmingham pathology resident
who devised the software. The developers found that the average time
for novice and experienced residents
to access data using conventional
means was 26.7 and 15 minutes, respectively, compared to an average
of 3.2 minutes via the software. But
its not just residents who fnd the
software useful. The ease of use of
the program and its reliability were
also recognized by staff pathologists
not specialty trained in pediatric
pathology, says Ona M. FayePetersen, MD, UAB professor of
pathology and obstetrics, who contributed to development of the
software.
Other benefts of the program are
that it allows institutions to evaluate
trends and compare data sets while
protecting patient identity. Knowing what is normal for a given gestational age is something that is limited by experience, and the program
allows the user to assess these parameters with confdence and accuracy and not to overlook something, Dr. Faye-Petersen told CAP
TODAY. [For example,] in a situation of extreme infant edema, the
weight of the baby is altered by fuid,
and this can result in an overestimation of the infants gestational age.
Excessive weight can result in spurious assignment of gestational or
postnatal age and underestimation
of heart enlargement or liver enlargement or relatively poor lung
growth.
The program also greatly reduces transcriptional error, she
continues. When confronted with
complex charts, it is easy to misread
them or enter the wrong values for
norms. Moreover, there are many
charts of norms, and fnding the

best one for a given case is diffcult.
The program norms are a composite
of many tables values and also include measurements for fetuses
who died in utero but who were
retained for many hours or days
before delivery.
The software is continuously being enhanced, adds Dr. Cain. Currently, the Web page [cainmd.github.io/
anthropometryData/] can only be used
through Google Chrome. However,
this will soon change so that any
browser can be used. The software
is also being rendered compatible
with mobile devices and will eventually include the normal weight ranges for placentas at various weeks of
Kimberly Carey
gestation.
port network, says Jacob Thaysen,

president of Agilents diagnostics and
genomics group. Together, Agilent
and Cartagenia can help remove
bottlenecks inherent in analysis, interpretation, and reporting [of] clinical dataresulting in faster answers
for patients.
Agilent Technologies, 800-227-9770
Database provides information

from next-gen sequencing
Qiagen and Inova Translational Medicine Institute have launched Inova
Genomes, a compendium of ethnically, phenotypically, and ancestrally
diverse whole-genome sequencing

data for disease researchers.
Qiagen will serve as the exclusive
distributor of the database, which
was built from a collection of more
than 7,000 whole genomes derived
from over 2,800 families.
In a separate announcement, Qiagen reported the commercial launch
of its Qiagen Clinical Insight bioinformatics content and software platform. The offering is intended to help
clinical testing labs interpret and report on genomic variants identifed
in next-generation sequencing. The
frst two supported applications for
the bioinformatics platform address
somatic and hereditary cancer

testing.
Clinical Insight is instrument- and
assay-agnostic and provides access to
the Allele Frequency Community
repository of ancestral and ethnic
diversity data.
Qiagen, 800-426-8157
Dr. Aller is director of informatics and
clinical professor in the Department of
Pathology, University of Southern California, Los Angeles. He can be reached
at raller@usc.edu. Hal Weiner is president
of Weiner Consulting Services LLC, Eugene, Ore. He can be reached at hal@
weinerconsulting.com.
CMS promotes innovation by

offering data to private sector
The Centers for Medicare and Medicaid Services has introduced a policy
that will allow the private sector to
use CMS data to spur innovation.
The announcement is aimed directly at shaking up health care innovation and setting a new standard
for data transparency, said acting
CMS administrator Andy Slavitt,
while introducing the policy last
month. We expect a stream of new
tools for benefciaries and care providers that improve care and personalize
decision-making, he added. Among
the technologies that could result
from the open-data arrangement are
predictive modeling and care-management tools, CMS reports.
Starting in September, CMS will
allow innovators and entrepreneurs
to request data via the CMS Virtual
Research Data Center, which provides access to granular CMS program data, including Medicare feefor-service claims data. Researchers
will be able to conduct CMS-approved analyses of de-identifed patient information in a secure environment. However, they will not be able
to remove patient-level data from the
data center. While patient identities
will not be disclosed, researchers will
have access to the identity of the providers of care.
The CMS also announced that it
will allow researchers to request data
on a quarterly basis, rather than limit
them to annual updates.
New from
CAP Learning
Evolving Practices of
Immunohistochemistry
in Breast, Genitourinary,
Gastrointestinal, and
Liver Pathology
Continue your learning with a new SAMeligible Archives Applied course offering
more credit (up to 4.75 CME/SAM) and
content than ever before!
This new course includes three
articles from An Update in
Immunohistochemistry published in the
December 2014 and January 2015 special
issues of the CAPs award-winning
journal, Archives of Pathology &
Laboratory Medicine. It includes SAM
questions written by article authors
Zongming Eric Chen, MD, PhD, FCAP,
Haiyan Liu, MD, FCAP, and
Myra L. Wilkerson, MD, FCAP.
Articles were selected for their expert
discussion of current, effective IHC
markers and panels and the diagnostic
utility of new markers in breast, GU, and
GI/liver pathology.
Archives Applied provides a convenient
way to gain new knowledge on different
topics, such as:
Breast pathology
Agilent purchases Cartagenia

Agilent Technologies has acquired
Cartagenia, a provider of software
solutions for variant assessment and
reporting of clinical genomics data
from next-generation sequencing and
microarrays.
We look forward to providing
Cartagenias software solutions to
our clinical genetics and molecular
oncology customers and to providing
Cartagenias existing customers with
access to our global service and sup-
Archives Applied
Gastrointestinal pathology
Genitourinary pathology
Molecular oncology
Visit learn.cap.org and search

Archives Applied to learn more.

23625.0615
cap.org
Classifed Advertising
Continuing Education
FINISH YOUR BACHELORS

DEGREE COMPLETELY ONLINE
The University of Cincinnati online Bachelor of Science in Medical
Laboratory Science is designed for working laboratory technicians
who want to complete their bachelors degree from a NAACLS*
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For classified advertising call 1-888-489-1555

or e-mail us at sales@kerhgroup.com
Professional Opportunities
CALIFORNIA
Veterans Affairs Desert Pacific Healthcare Network
Job Announcement:
MEDICAL TECHNOLOGIST
(LABORATORY INFORMATION MANAGER)
The Veterans Afairs Desert Pacifc Healthcare Network is seeking dynamic Medical Technologists
to work in our Laboratory Informatcs Secton of Pathology and Laboratory Medicine (San Diego,
Los Angeles, Long Beach, Loma Linda, and Vegas locatons). These positons will work in an exciting, fast-paced, team-based atmosphere to support all sectons of the Clinical Laboratory and
Laboratory Informaton System, interfaces and associated ancillary applicatons and systems. Job
opportunites at various locatons within southern California.
DUTIES: To be qualifed, you must be an experienced Medical Technologist who will be
assigned as the Laboratory Informaton Manager and Bar Code Expansion Coordinator and for
Laboratory Service. You will develop and recommend new policies and procedures regarding the
installaton and use of the laboratory informaton system (LIS) in conjuncton with the overall
hospital informaton system (HIS). You will provide authoritatve advice and consultaton on the
informaton system as they apply to the clinical laboratory. You will implement and maintain
coding and mapping for laboratory test ordering, reportng, billing and workload recording, taking
into account compliance principles. You will analyze emerging trends, sofware and technology and
adopt appropriate methods for local programs to meet agency goals.
Compettve salary and benefts package (Range $78,186-$102,486)
Job Announcement:
Lead Medical Technologist San Diego, CA

WORK SCHEDULE: Monday-Friday, PM and Midnight Shif full tme positons with rotatng
weekends and holidays.
The incumbent serves in multple sectons of a clinical laboratory working as a generalist. The
incumbent facilitates team or unit processes by working in collaboraton with team members of employees to ensure that tasks are completed and team priorites, goals, needs, and
achievements are coordinated with management.
Require at least one year experience in a clinical laboratory. MT(ASCP) or equivalent licensure
required.
Compettve salary and benefts package (Range $76,948 - $92,338, plus 10% for of-shif and
weekend coverage).
Are you looking to hire or

promote your product or service?
CAP TODAYS CLASSIFIED ADS WORK!
Call 1-888-489-1555
or e-mail us at
sales@kerhgroup.com
Send resumes to Dr. Jessica Wang-Rodriguez:

jwrodriguez@ucsd.edu
For information on placing a classifed advertisement, please call 888-489-1555
Professional Opportunities
KENTUCKY / OHIO
EXECUTIVE DIRECTOR, LABS - GLOBAL CENTRAL LABS

Global Central Labs are uniquely able to provide consistent data and results across the globe with our single Web-based database, eliminating
the need to merge and harmonize data. PPD InSite, our new, secure, Web-based platform for clinical lab investigator sites, provides access
to laboratory data, kit supply management and data queries. With strategic locations in Belgium, China, Singapore and the United States,
PPDs central labs are accessible to study sites anywhere in the world. PPD has expanded its testing capabilities at its central labs in
Brussels and Singapore, offering clients a full range of microbiology testing services for bacteriology, mycology, parasitology and testing of
micro-bioterrorism pathogens.
Targeting
Laboratory
Professionals?
Place a
classified ad:
Toll free: 888-489-1555
E-mail: sales@kerhgroup.com
THE EXECUTIVE DIRECTOR LABS - GLOBAL CENTRAL LABS will lead the growth of laboratory operations by integrating operational
processes, business development, research & development and quality assurance functions. Contributes to the scientific strategy and
implementation to support pharmaceutical-sponsored research protocols. This position is based in Highland Heights, KY (the great
Cincinnati, OH area).
Steers the strategic roadmap for Global Central Labs ensuring alignment with corporate goals and business development to
support client needs and future growth.
Develops the infrastructure to support advanced research through resource allocation including space, capital equipment, scientific
instrumentation and staff.
Drives operational excellence, establishing performance metrics and continuous improvement initiatives to increase efficiencies.
Monitors profit & loss performance for Global Central Labs.
Oversees the quality assurance functions of the labs to ensure compliance with regulatory standards.
Leverages advanced technology and scientific expertise to provide innovative, customized solutions to clients.
Directs the development of new programs for revenue enhancement & cost expense reduction.
REQUIREMENTS:
PhD, MD or DrPH required and a track record of success managing and leading multi-departmental clinical reference laboratories
(comparable to 11+years)
The ability to meet CAP requirements as laboratory director required; Current CAP certification preferred
The ability to meet requirements for NY State license for Laboratory Director required
Experience in protocol development and execution required
Experience serving as a principal investigator for sponsored research studies preferred
Broad knowledge of laboratory medicine including clinical chemistry, hematology and hemostasis
Proficient in molecular biology platforms and result interpretation
Knowledge of anatomic pathology, immunohistochemistry and molecular oncology assays

Interested candidates please email your resume to: daniel.rogers@ppdi.com
To learn more about PPD log onto our website www.ppdi.com
PEDIATRIC PATHOLOGY POSITIONS
THE DIVISION OF PATHOLOGY

CINCINNATI CHILDRENS HOSPITAL MEDICAL CENTER
The Division of Pathology at Cincinnati Childrens Hospital Medical Center is accepting applications for full-time faculty positions for an Assistant or Associate Professor
position, in afliation with the Department of Pathology, University of Cincinnati, to support an active surgical pathology and autopsy service which serves the entire
Greater Cincinnati region as well as many national and international clinical programs. The Division of Pathology provides a comprehensive and full service anatomic
diagnostic support for all clinical general and subspecialty pediatric programs. The Division of Pathology processes approximately 15,000 pediatric surgical specimens a
year and greater than 1,000 outside consultations. Approximately 125 autopsies are performed each year. Highly specialized clinical programs and services supported by
Pathology include, but not limited to, transplantation programs in bone marrow, liver, kidney, heart, small bowel, lung and fetal surgery.
Cincinnati Childrens Hospital is known for its stimulating environment providing ample opportunity for clinical and translational research collaboration. Cincinnati
Childrens Hospital Medical Center is ranked in the top three national pediatric cancer programs by US News and World Report. Special opportunities exist for
individuals with expertise or interests in our sarcoma program, renal biopsies (>400 in 2014), neuropathology and autopsy service. Among pediatric institutions,
Cincinnati Childrens Hospital Medical Center is the second-highest ranking recipient of research grants from the National Institutes of Health. There are several NIHfunded centers of excellence, including Immunology, Developmental Biology, Cardiovascular Biology, Pulmonary Biology, Cancer/Experimental Hematology, and the
Respiratory, Kidney and Digestive Disease Centers. Multiple cores support basic and translational research including genomics, high-density data informatics/systems
biology, mouse models of cancer and stem cell and gene/viral vector therapy. This gives us the unique opportunity to inuence future generations and develop leaders
in pediatric pathology. Applicants must have an M.D. or M.D./PhD or equivalent degree and have or be eligible for an unrestricted Ohio medical license. Qualied
applicants should be board eligible/board certied in anatomic pathology (with or without clinical pathology). Candidates with pediatric pathology board certication
are highly desirable. Teaching and mentoring of medical students, pathology residents and fellows will be an integral component of the position. Cincinnati is a vibrant
city with a metropolitan population of 2.1 million. Cincinnati features world-class cultural amenities and a very affordable cost of living, which together make Cincinnati
one of Americas most livable cities.
Interested candidates should send curriculum vitae and letter of interest to: David Witte M.D., Director, Division of Pathology, Cincinnati Childrens Hospital Medical
Center
urnet Avenue, MLC 10 5, Cincinnati, OH 45229- 0 9. Email: david.witte@cchmc.org
Cincinnati Childrens Hospital Medical Center is an Afrmative Action/ Equal Opportunity Institution.
For information on placing a classifed advertisement, please call 888-489-1555
EOE
Marketplace
Molecular standards
Microbiologics is expanding its line of
Helix Elite Molecular Standards with two
product formats: inactivated extraction
controls and genomic DNA extracts. Used
for validation, verifcation, profciency
testing, and quality control of molecular
assays, Inactivated and Genomic Extract
controls are available in multiple strains;
the frst genomic extracts are from low

passage mycoplasma strains sourced from
the National Collection of Type Cultures.
The Helix Elite brand now encompasses
three distinct formats supporting each
phase of the molecular testing process
synthetic nucleic acids and genomic extracts for amplifcation and detection and
inactivated controls for extraction through
detection.
Inactivated Helix Elite Molecular Standards are fully intact process controls
that are FDA-listed and CE-marked as in
vitro diagnostic medical devices for use
in clinical laboratories. These nonviable
viral and bacterial targets are produced
in the form of lyophilized pellets, which
are shipped and stored at room temperature. The quick-dissolving pellets may
be reconstituted in relevant buffers or
transport media and then processed using
the same protocols as the patient sample.
Respiratory and gastrointestinal targets
are available and additional respiratory
and sexually transmitted disease targets
will be added throughout the year.
Genomic Extract Helix Elite Molecular
Standards are dried, stabilized, and quantitated nucleic acid extracted from target
pathogens. Used as a positive control for
the amplifcation and detection steps in
molecular assays, each preparation is assessed for purity and integrity, and a gene
copy number is provided for quantitation.
Microbiologics, 320-253-7400
BRAF liquid biopsy data

Biocartis presented liquid biopsy data
from the companys BRAF mutation
study at the American Society of Clinical Oncology annual meeting in June.
The study, in collaboration with Bart
Neyns, MD, PhD, University Hospital
Brussels, showed that BRAF oncogene
mutations monitored in plasma from
metastatic melanoma patients on Biocartis Idylla system were signifcantly
associated with treatment response and
progression.
Idylla is a fully automated diagnostic
platform designed to offer fast access to
molecular diagnostic information from
virtually any clinical sample type. In the
current study, Biocartis developed a prototype product on its Idylla system for the
analysis of BRAF mutations in circulating
tumor DNA from plasma samples. The
prototype integrates and fully automates
extraction of ctDNA and powerful selec-
Halozyme, Ventana
global agreement
tive amplifcation enabling the sensitive

detection of BRAF V600 mutations from
1 mL of plasma. Liquid biopsies use circulating tumor DNA directly from patient
blood samples to determine a tumors
genetic makeup.
In collaboration with Dr. Neyns team
at the Department of Medical Oncology,
232 plasma samples from 41 patients with
metastatic melanoma were analyzed for
circulating levels of mutant BRAF using
Idylla. The fndings showed, among others, that BRAF V600 mutations in plasma
detected by Idylla were signifcantly associated with disease progression, and preceded or coincided with disease progression on imaging in 100 percent of cases,
while the mutations remained absent in
patients with a good prognosis.
Biocartis presented two other studies at
ASCO demonstrating signifcant progress
in the development of its Idylla colorectal
cancer menu: a study on a novel Idylla
prototype for fully automated detection of
homopolymers specifc for microsatellite
instability and a presentation of verifcation data and alpha trial results of the
Idylla KRAS Mutation Assay showing
highly specifc and sensitive detection of
21 mutations in biopsy tissue.
Biocartis, +32 15 632 600
ELISA kits for

TIMP-1 and HGH
Enzos TIMP-1 ELISA kit is designed to
provide a useful tool for investigating the
TIMP-1 levels in multiple human matrices and aims to advance the studies on
TIMP-1 function. The assay format allows
for quantitative detection of 30 pg/mL of
TIMP-1 in various sample types including serum, plasma, saliva, urine, and
tissue culture media. The highly sensitive
assay offers high-throughput analysis,
measuring up to 39 samples in duplicate
in two hours. The ELISA is thoroughly
validated to ensure excellent reproducibility between experiments, and low or
no cross-reactivity with related molecules
such as TIMP-2, TIMP-3, TIMP-4, MMP-1,
MMP-2, MMP-3, MMP-7, MMP-8, MMP9, and MMP-13.
For human growth hormone, Enzos
quantitative ELISA kit offers ultra-sensitive detection enabling quantifcation of
HGH with as little as 0.93 pg/mL. The
kit offers complete fexibility, validated
with various sample types including human and canine serum, human plasma,
Halozyme Therapeutics and Ventana

Medical Systems announced a global
agreement to collaborate on the development of a companion diagnostic assay for
use with Halozymes investigational new
drug, PEGPH20, which Ventana would
ultimately commercialize.
The Ventana assay will be used to
identify high levels of hyaluronan, or HA,
a glycosaminoglycan that can accumulate
around cancer cells. Halozyme announced
plans for a rollout of a global phase three
clinical study in 2016 targeting metastatic
pancreatic cancer patients with high HA
levels using its PEGPH20 in combination with Abraxane (nab-paclitaxel) and
gemcitabine.
Under the agreement, Ventana will develop an in vitro diagnostic, under design
control, using Halozymes proprietary HA
binding protein, with the intent of submitting it for regulatory approval in the U.S.,
Europe, and other countries.
Enzo, 800-942-0430
Verax Biomedical, 508-755-7029
Fingerprinting kits for

forensic labs
Qiagen launched two Investigator STR
assay kits for analysis of DNA evidence
in forensic laboratories in the United
Statesthe Investigator 24plex QS Kit
for amplifcation of the CODIS core and
European Standard Set marker sets from
Ventana, 520-887-2155
Halozyme, 858-794-8889
CE mark for real-time

PCR GI panels
Seegene announced that its Allplex
Gastrointestinal Full Panel Assay has
received the CE-IVD mark, enabling
marketing in Europe and certain other
countries. The test is based on Seegenes
proprietary MuDT technology for the
detection of multiple target genes in a
single channel without melt curve analysis. The assay covers 25 bacterial, viral,
and parasitic causes of gastrointestinal
infectious disease.
Seegene, 301-762-9066
Targeted liquid biopsy

mutation test
Biodesix launched GeneStrat, a targeted
liquid biopsy mutation test for genotyping tumors of patients with advanced
non-small cell lung cancer. Requiring
only a blood draw, the test aims to offer
a fast, minimally invasive alternative to
a high-risk tissue biopsy or re-biopsy in
patients with insuffcient tissue. Blood
test results are available within 72 hours,
providing physicians actionable diagnostic information prior to making treatment
decisions. GeneStrat is focused exclusively on the clinically actionable EGFR,
KRAS, and BRAF mutations often used
to guide targeted therapy treatment decisions. GeneStrat also captures the EGFR
T790M mutation, which can be used for
monitoring the emergence of the primary
resistance mutation in the EGFR gene.
The test uses the ddPCR platform to analyze cell-free tumor DNA and is highly
concordant with tissue analysis.
Biodesix, 303-417-0500
human saliva, and tissue culture media.

The assay provides quantitative results
with excellent reproducibility between
experiments and offers analysis of up to 36
duplicate samples in less than 2.5 hours.
The ELISA kit displays high specifcity to
HGH with low cross-reactivity to similar
molecules such as prolactin and human
placental lactogen.
contamination in platelets and protect

patients from receiving contaminated
transfusions.
The test can be used to check apheresis platelets in plasma and whole blood
derived platelets, and with this FDA clearance, it can be used as a safety measure
to check two additional platelet types:
pre-storage pool platelets (e.g. Acrodose
platelets) and apheresis platelets in PAS-C
additive solution and plasma.
FDA OKs expanded platelet

safety measure testing
Verax Biomedical has gained FDA clearance to expand the use of its Verax Platelet
PGD testa rapid test for the detection
of bacterial contamination in platelets
intended for transfusion. The test is an immunoassay used on the day of transfusion
at the point of care, a hospital or transfusion service, to quickly detect bacterial
casework samples and the Investigator

24plex GO! Kit for direct amplifcation
of the CODIS core and ESS marker sets
from reference samples. The kits comply
with the latest U.S. requirements that labs
must implement expanded marker sets
by 2017 as part of an FBI upgrade of the
Combined DNA Index System (CODIS)
and also comply with European and Interpol standards.
The genetic fngerprint kits provide
an integrated solution to simultaneously
analyze multiple key genomic markers
(short tandem repeats) for DNA matching.
They incorporate the Investigator Quality
Sensor to evaluate the quality of DNA in
each sample, a novel Qiagen technology
that enables labs to decide which evidence
may provide valuable results.
The kits, which will soon be approved
for use with the National DNA Index
System, are designed for forensic samples to be amplifed through polymerase
chain reaction and separated and detected
through capillary electrophoresis.
Qiagen, 240-686-7700
Studies support role of

BioTheranostics tests
BioTheranostics announced that clinical
study data disclosed at the American Society of Clinical Oncology annual meeting
in June demonstrate that its CancerType
ID molecular cancer classifer and CancerTreatment NGS+ biomarker tests provide
actionable genomic information to support an accurate diagnosis and treatment
of metastatic cancers.
A prospective, multicenter study that
included 444 patients assessed the utility
and impact of CancerType ID in treatment
decision-making in community clinical
practice. The study demonstrated signifcant clinical utility of the test, changing
treatment decisions in about half of patients. Clinical utility spanned a spectrum
of diagnostic uncertainty for oncologists
and pathologists and helped narrow the
differential diagnosis. Diagnosis of lung
or colorectal cancer by CancerType ID

commonly informed the use of additional
biomarker testing in the study.
A second retrospective study assessed
the actionability of a combinatorial approach using the CancerType ID assay
followed by multiplatform biomarker
profling with CancerTreatment NGS+
in a large series of cases with unknown
or uncertain origin that were identifed
as non-small cell lung cancer by CancerType ID. Results demonstrate the clinical
utility of a combinatorial approach using
molecular diagnosis of tumor type and
comprehensive multiplatform mutational
profiling to enable precision medicine
with tumor-specifc and molecularly targeted treatment options.
topathologically negative biopsy results

and ConfrmMDx-positive, DNA-methylation levels of the standard 12-core biopsies combined with clinical risk factors
were used to develop an epigenetic health
index, or EHI. The EHI was signifcantly
higher in patients with an aggressive cancer detected upon repeat biopsy. The EHI
of patients showed a strong correlation
with the National Comprehensive Cancer
Network score obtained on a second biopsy taken between three and 15 months
later. These fndings confrm the results
from previous studies that ConfrmMDx
is able to segregate aggressive from nonaggressive prostate cancer in histopathological negative biopsies.
In the second study, the newly devel-
oped EHI was validated in 12-core biopsies from 102 men with either no cancer,
insignifcant or signifcant cancer detected
upon biopsy. The EHI was signifcantly
higher in those men with high-grade cancer versus those with low-grade cancer.
Also in this study, a strong correlation between the EHI and the NCCN risk stratifcation for prostate cancer was observed.
MDxHealth, 949-812-6979
Linearity control assay

Strecks Calibration Verifcation Assessment (CVA) is now assayed for the Horiba
ABX Micros 60 instrument. CVA is an
assayed linearity control kit used to determine the patient reportable range of
three-part and fve-part hematology instruments. CVA also measures the linear
performance of the analyzer. Each kit
has customized ranges appropriate for
each instrument model and provides
instrument-specifc assay values for the
white blood cell, platelet, red blood cell,
and hemoglobin parameters. WBC and
platelet parameters have extended ranges,
providing values up to 410,000 and 3.5
million for instruments with extended
linearities. All kits include WBC, PLT, and
RBC/Hgb vials unless otherwise noted.
Streck also offers CVA for Cell-Dyn,
an assayed linearity control kit used to
determine the patient reportable range
of three-part and fve-part hematology
continued on 112
instruments.
BioTheranostics, 877-886-6739
Mass spectrometer,
software solutions
Thermo Fisher introduced the Thermo
Scientifc Orbitrap Fusion Lumos Tribrid
Mass Spectrometer, the newest addition to
its line of Orbitrap Tribrid mass spectrometers. Designed to expand researchers
capabilities in advanced proteomics and
metabolomics applications, including
targeted, data-independent acquisition
and top-down analyses, the Orbitrap
Fusion Lumos Tribrid has a high level of
sensitivity, delivering complete protein
sequence coverage and allowing scientists
to perform more inclusive analyses.
In response to customer requests for
tools designed to manage, analyze, and
share large volumes of scientifc data generated in proteomics, the Thermo Fisher
Cloud now supports proteomics-related
data to complement existing data modules
for Sanger sequencing and quantitative
polymerase chain reaction, connecting
scientists, instruments, and software in a
collaborative, multidisciplinary environment.
Thermo Scientifc Xcalibur 4.0 software
is a unifed platform for the acquisition
and analysis of MS data. The software
creates a convenient and organized launch
platform for new or previously installed
Thermo Scientifc software. It also provides direct access to the Xcalibur applications store, software updates, and links to
the mzCloud, Thermo Fisher Cloud, and
Planet Orbitrap to access spectral libraries
and new MS data.
Thermo Scientifc, 800-556-2323
Test predicts prostate

cancer aggressiveness
MDxHealth revealed data with the aim of
demonstrating the prognostic value of its
ConfrmMDx for Prostate Cancer test. The
data, offered in two presentations at the
American Urology Associations annual
meeting in May, show the tests ability to
identify patients likely to harbor clinically
signifcant prostate cancer from negative
biopsy tissue.
In histopathology-positive biopsies, the
test showed a better separation between
men with aggressive prostate cancer from
those with indolent disease. Previous
diagnostic studies have established the
utility of ConfrmMDx as a signifcant,
independent predictor of prostate cancer,
with a negative predictive value of 90
percent for all cancers and an NPV of 96
percent for signifcant cancers.
In the frst study, on 269 men with his-
Harness CAP
Learning for
Continuous
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CAP Clinical Pathology
Improvement Program (CPIP)
CPIP provides you with the opportunity
to improve your overall clinical pathology
performance. With 12 challenging online
casesone delivered per monthyou
can learn at a place and time convenient
for you and earn up to 15 CME/SAM
credits for the entire year. CPIP offers:
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background, images, lab fndings,
discussions, questions with feedback,
and references
1.25 CME/SAM credits
Interactive, immediate feedback to
test your diagnostic skills in real time
Cases that target a topic that helps
meet American Board of Pathology
(ABP) Maintenance of Certifcation
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To enroll in the series, call 800-323-4040
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Marketplace
continued from 111
Data can be submitted to Streck for a

comprehensive linearity report at no additional charge. Reports include a graph that
clearly displays the instruments linearity
and accuracy, a peer group comparison,
and an interpretive results sectiona tool
to demonstrate compliance with laboratory regulations.
Streck, 800-843-0912
Benchtop cryoembedding
station
The patented PrestoChill is an all-dry
cryoembedding system from Milestone
Medical that does not use liquid nitrogen, CO2, or isopentane. The 60-second
freezing time prevents the formation of
ice crystals. An automatic defrost cycle
is provided to eliminate the potential
World Health Organizations listing for

procurement for the Corgenix Ebola RDT,
making this test available to the health
care community worldwide.
Corgenix, 303-453-8903
PAML and Axela collaborate

on serologic assays
Pathology Associates Medical Laboratories has entered into a collaborative
agreement with Axela to develop multiplex assays focused on immune status
for vaccine preventable diseases. These
serologic assays will measure antibodies to a wide range of viruses including
measles, mumps, and rubella as an aid in
the determination of patient immunity.
Based on Axelas new generation of fowthrough arrays, these highly sensitive assays require a single microliter of sample.
The agreement also calls for expansion of
the offering to a range of multiplex targets beyond the initial serological assays.
PAML will provide the tests exclusively in
the U.S., while Axela will have the option
to commercialize its benchtop analyzer
and point-of-use formats throughout the
rest of the world.
PAML, 800-541-7891
FDA 510(k) clearance for

IFA evaluation system
formation of ice on the freezing platform.
It consists of a heater embedded in the
freezing platform and a vacuum pump
to extract water vapors from the chamber.
Vapors are condensed and collected in a
cold trap placed in the front of the unit
for easy handling. A HEPA flter is provided on the exhaust side of the pump.
Integrated software can set the defrost
cycle to take place during off hours, then
automatically restart the cooling cycle at
a preset time to ensure availability for the
frst case of the day.
Milestone Medical, 866-995-5300
Rabbit monoclonal
antibody
Bio SB announced a line of rabbit monoclonal antibodies, PD-L1/CD274, for
immunohistochemistry with extensive
protein immunogenicity analysis of targeted epitopes, high sensitivity specifcity,
and low background noise.
Bio SB, 805-692-2768
Emergency use Ebola

diagnostic test
Corgenix Medical has received U.S. FDA
emergency use authorization for its ReEBOV Antigen Rapid Test. The test is to
be used for the presumptive detection of
Ebola Zaire virus in individuals with signs
and symptoms of Ebola virus infection in
conjunction with epidemiological risk factors, including geographic locations with
high prevalence of Ebola infection.
The point-of-care test can be used in
any clinical facility adequately equipped,
trained, and capable of such testing, or in
any feld laboratory with trained personnel capable of such testing, to diagnose
suspected Ebola cases in 15 to 25 minutes. It is not intended for use for general
Ebola virus infection screening, such as
airport screening or contact tracing. The
U.S. regulatory authorization follows the
Euroimmun US announced the FDA

510(k) clearance of its EuroPattern System, which consists of a fuorescent microscope (oculars included for manual
interpretation) and software that acquires,
interprets, archives, and displays digital
images of stained IFA slides. The most
important application for EuroPattern,
the company says, is the antinuclear antibody screening using HEp-20-10 cells
(Euroimmun IFA 40: HEp-20-10 EuroPattern) as a substrate. HEp-20-10 cells are
a proprietary innovation of Euroimmun
as they demonstrate 10-fold more mitotic
cells than HEp-2 cells. Furthermore, they
contain the full antigen spectrum necessary for ANA diagnostics and are thus
well-suited for this purpose.
The system provides automated pattern recognition and endpoint titer suggestions, offers walkaway capability and
maximizes throughput for ANA evaluation via the automated processing of up
to 500 felds,
and reduces
turnaround
time by allowing for
batch validations of
negative results and by
abbreviating
the evaluation process
through consolidation of
all pattern
and titer results for each
patient on one screen. Sample traceability
is achieved through barcoded slide identifcation with bi-directional LIS interface.
EuroLabOffce is the embedded software
that allows the instrument to communicate seamlessly with the LIS and offers the
ability to send results and images to any
connected computer.
Euroimmun, 973-656-1000
Troponin test
spots MIs earlier
Beckman Coulter Diagnostics announced
the publication of research results in
Clinical Biochemistry (Storrow AB, et
al. 2015;48:254259; 260267) that identify the precise magnitude of change in
cardiac troponin required for early diagnosis of a heart attack using its Access
AccuTnI+3 troponin I blood test. Beckmans troponin-I assay has been clinically
proven through a large, multicenter study
and is FDA-cleared and directly aligned
with the FDAs October 2010 guidance to
manufacturers of troponin tests.
The Access AccuTnI+3 troponin I blood
test is a paramagnetic particle, chemiluminescent immunoassay for the quantitative
determination of cardiac troponin I levels
in human serum and plasma using the
Access 2 Immunoassay System or UniCel
DxI Access Immunoassay System to aid
in the diagnosis of myocardial infarction.
The precise magnitude of change in the
post-market cardiac troponin study data
was not evaluated by the FDA as part of
the products 510(k) clearance.
Current clinical guidelines for MI diagnosis require demonstration of a rise and/
or fall in troponin values between samples
collected in sequence following presentation to the emergency department. However, the guidelines do not quantify what
is a clinically signifcant rise or fall, referred to as delta in literature. Without
a defned delta, physicians do not have a
consistent approach for diagnosing MI.
The results of the study recommend
movement away from a percentagechange reading in troponin levels to using
an absolute difference by ng/mL change.
The study, which consisted of nearly 2,000
patients enrolled at 14 institutions, reports
representative diagnostic performance
that would be observed in clinical practice for early rule-in and rule-out of heart
attacks, and demonstrated that absolute
changes (0.01 or 0.02 ng/mL) performed
signifcantly better than relative (percentage) changes at all time intervals after
emergency department admission.
Beckman Coulter Diagnostics, 714-993-5321
Study published on
VeriStrat proteomic test
The journal Lung Cancer published a
paper demonstrating the economic implications to the U.S. health care system of
using VeriStrat in guiding treatment of patients with advanced non-small cell lung
cancer (Hornberger J, et al. 2015;88:223
230). The papers authors conclude that
using Biodesixs VeriStrat improves overall survival and decreases medical costs in
the U.S. payer system.
John Hornberger, MD, a clinical investigator who is among the studys authors,
said, Systems of care are gearing up for
bundled payment models in oncology.
With the evolving changes in payment
incentives, this state-of-the-art test analysis
was designed to address the questions
that administrators have to be aligned
with new incentives.
The study, an extended analysis of the
phase three, prospective VeriStrat stratifed PROSE trial, assessed the outcome
and economic implications of the use of a
clinically validated serum proteomic test
to guide treatment decisions in NSCLC.
By shifting patients away from ineffective
therapy, the use of VeriStrat resulted in

improvement in overall survival as well as
a total lifetime direct medical cost decrease
of $135 per patient.
The study evaluated clinical outcomes over the lifetime of a patient
with advanced NSCLC, using data from
randomized trials and clinical studies.
Based on the test results from the VeriStrat proteomic test, treatment recommendations for 27.3 percent of the patient population changed from erlotinib
to chemotherapy, resulting in a reduction of use of ineffective therapy. The
fve-year survival of advanced NSCLC
patients is one to fve percent, the implication of which is an average increase in
overall survival per patient of slightly
more than one month.
Biodesix, 303-417-0500
Conical tubes
Eppendorf has added two screw-cap
tubes in 15 mL and 50 mL sizes to its
line of Eppendorf Tubes. The newly
designed screw caps provide optimal
sealing properties, and their grooved
and multisurface side contour provide
a secure, slip-free grip. Safe opening and
closing of the tubes are facilitated via onehanded operation. The tubes are further
characterized by an expanded purity
grade: they are sterile and pyrogen-free
and free from DNases, RNases, and human and bacterial DNAfeatures that
make them suited for cell biology applications in a sterile environment as well
as for laboratory protocols in the felds
of microbiology and molecular biology.
Eppendorf, 516-515-2381
RUO molecular platform

Rheonix showcased in June its Encompass Optimum research-use-only platform at the 115th General Meeting of the
American Society for Microbiology.
The Encompass Optimum is an automated system for building and implementing molecular assays as a nonclinical tool. The versatile platform allows
users to configure their own testing,
control all aspects of assay performance,
and create their own sample-to-answer,
fully automated, complex molecular assays in an easy-to-use format using the
Rheonix Card cartridge. The size of a
smartphone, the card cartridge can run
several biological samples through a
fully integrated molecular analysis with
no user interventionit automatically
manipulates the network of microfuidic pumps to move fuids through the
channels of the card. The Encompass
Optimum can decrease the complexities
of creating user-defned testing while
increasing effciency and accuracy. Furthermore, the products automation,
capability for high-throughput and highcomplexity assays, and unique sampleto-result system will allow the platform
to solve workfow ineffciencies.
Rheonix, 607-257-1242
Put It on the Board

continued from 114
EGFR and ALK mutational analysis,

a new pathway expanded to look for
a number of other markers that the
National Comprehensive Cancer Network has tabbed as potentially useful
in targeting NSCLC treatment would
actually cost about $2,500 more. That
is likely due in part to the fact that this
alternative approach would boost
from six percent to 30 percentthe
proportion of patients receiving targeted therapy. However, the new
pathway would be expected to improve patient outcomes and dramatically reduce adverse events.
More information about AMPs
genomics pricing model, including a
step-by-step video tutorial for laboratories interested in using it, is available
at http://j.mp/amp_pricing. At press time, the
CMS was set to hold a July 16 meeting
in Baltimore to accept public comments
on payment for new test codes for
2016. The agency will post preliminary
pricing determinations in September,
to be followed by a 60-day comment
period. The fnal pay rates for the new
codes will be unveiled in November,
along with the fnal fee schedule.
It may be an uphill battle for nextgeneration sequencing to get its due
from payers, Dr. Bossler said.
It will have to be a lot of folks
speaking up, including the patients
who will beneft from these things,
before were going to get a whole lot
of traction.
KBOR
Liquid biopsy seen as one

disruptive technology
Forces potentially disruptive to mainstream clinical laboratory practice lie
ahead, Gregory J. Tsongalis, PhD, director of molecular pathology and
clinical genomics at Dartmouths
Geisel School of Medicine, said in a
War College presentation in May.
I want to share with you a couple
of things that are going to change everything, Dr. Tsongalis said. The frst
is the vast potential of the humble
blood test made possible by what is
being dubbed the liquid biopsy.
This whole idea that is now catching on pretty quickly is the idea of
cell-free DNA in the plasma. Weve
already seen it work very nicely for
noninvasive prenatal testing, and now
people are starting to look at it for other
types of variants in the genes. In your
plasma, theres DNA foating around
outside of a cell that represents some

tissue or some cell population in your
body. In cancer patients, we know that
the cell-free DNA refects the tumor,
and that we can fnd the same mutations in the cell-free DNA that are in
the patients tumor . . . and that will be
used to monitor patients, he said.
This is really a game-changing type
of technology for the way we assess
cancer patients, Dr. Tsongalis said.
The second trend on the riseand
one that may be even more diffcult
for laboratories to reckon with, he
saidis the emergence of wearable
and implantable diagnostics and technology that can make a diagnosis
based on breath.
Just like we can identify different
compounds by mass spectrometry, in
your breath there are different compounds that can mimic, or refect, or
correlate back to a particular disease
process you might be experiencing,
Dr. Tsongalis said. We have data in
the laboratory now with mice . . .
where we put a little cone over the
mouses nose and they breathe into
this little bag for about a minute. Then
we inject that breath into a mass spectrometer and we get profles of those
different compounds . . . that allow us
to determine what the bacteria is thats
infecting the mouses lung within
three minutes.
Moreover, chips implanted under
the skin could allow for ongoing blood
monitoring.
What happens if we put probes on
these chipswhich we know we can
doand put those probes in and inject
it, and it monitors the cell-free DNA in
your plasma? he asked. Those are
the types of things that I think will be
really disruptive.
Wearable and implantable diagnostic devices paired with smartphone
technology could threaten the laboratorys traditional role within the health
care encounter, Dr. Tsongalis added.
Whats happened is that weve
by the College of American Pathologists, 325 Waukegan Road, Northfeld, IL 60093. Subscriptions:
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Number 40016906.
Printed in U.S.A.
ISSN 0891-1525
OPKO to buy Bio-Reference

OPKO Health and Bio-Reference Laboratories have signed a definitive
merger agreement under which
OPKO will acquire BRLI. Under the
terms of the deal, already approved by
the two companies boards of directors, holders of BRLI common stock
will receive 2.75 shares of OPKO common stock for each share of BRLI common stock. Based on a closing price of
$19.12 per share of OPKO common
stock on June 3, 2015, the transaction
was valued at about $1.47 billion, or
$52.58 per share of BRLI common
stock. The companies expect the transaction to be completed during the
second half of 2015.
OPKO intends to leverage the national marketing, sales, and distribution resources of BRLI to enhance sales
of its 4Kscore testa blood test that
provides a patients specifc, personalized risk score for aggressive prostate
canceras well as other OPKO diagnostic products under development.
Through GeneDx and GenPath Diagnostics, BRLI has accumulated genetic

and genomics data that OPKO plans
to make available to industry and academic scientists to enhance their drug
discovery and clinical trial programs.
OPKO intends to allow BRLIs laboratory operations to continue seamlessly, but with enhancement from its
pipeline of diagnostic products. The
diagnostic services of OPKO will be
merged with BRLI operations.
Ventana gets OK for

crizotinib IHC companion Dx
Ventana Medical Systems announced
the FDAs approval of the Ventana
ALK (D5F3) CDx Assay as a companion diagnostic to help identify patients
for crizotinib, marketed as Xalkori by
Pfzer. The Ventana ALK Assay was
approved as a CE-IVD in Europe in
2012 and by the Chinese Food and
Drug Administration in 2013. With this
U.S. FDA class III approval, ALK IHC
testing is accessible on Ventana BenchMark immunohistochemistry instruments worldwide, can be integrated
into standard lab workfow, and offers
fast test results with a binary, straightforward scoring method.
The test provides physicians and
patients a fast and accurate method to
identify ALK protein expression, and
clinicians can be confdent knowing
that our FDA approval is based on data
resulting from collaboration between
Ventana and Pfizer, Mary Padilla,
MD, senior director of pathology and
medical director for Ventana Companion Diagnostics, said in a statement.
Ventana used the Ventana ALK
(D5F3) CDx Assay and scoring method
to retrospectively test patient samples
from Pfzer-sponsored clinical trials
and demonstrated that the test is effective in identifying patients with ALKpositive NSCLC who may benefit
from treatment with Xalkori. Ventana
is a member of the Roche Group.
Index to Advertisers
Abbott Diabetes Care, page 58
Cepheid, page 14
Magellan Diagnostics, page 68
Sebia, page 95
Abbott Molecular, pages 1213
Clarient | A GE Healthcare Co.,

page 66
MarketLab, page 90
Seegene, page 45
MBL International, page 10
SeraCare, page 70
Medical Chemical, page 62

Nikon Instruments, page 92
Siemens Healthcare
Diagnostics, pages 51, 65
NovoPath, page 88
Sigma-Aldrich, page 76
Orchard Software, page 25
Streck, pages 19, 89, 115
DxMA, page 106
OTIS by Nouvation, page 68
Symbiodx, page 114
Euroimmun US, page 77
PlatinumCode, page 18
Focus Diagnostics, page 8
Quantimetrix, page 9
Hologic, page 63
Quest Diagnostics, page 71
Inova Diagnostics, page 23
Randox Laboratories,
pages 47, 75
Abbott Point-of-Care, page 81

Advanced Instruments,
pages 24, 105
CompuGroup Medical, page 87

Conworx, page 59
Alere, page 17
Diagnostica Stago, page 61
Amgen, pages 2022
Digital Pathology Association

(DPA), page 94
Aspyra, page 98
Audit Micro Controls, page 6
BD Biosciences, page 39
CAP TODAY (ISSN 0891-1525) is published monthly
come an enormous way, and things

have gotten much, much smaller, much
quicker and much better. But I think the
role we play in the clinical laboratory
in how things get paid for, how things
get assessed, and how patients get
managedis going to change even
more dramatically as our role changes
from somebody thats a keeper of specimens to somebody
thats really a keeper
of data.
On that note, Dr.
Tsongalis said he
and his laboratory
colleagues at Dartmouth are moving
into a new, 11,000Dr.Tsongalis
square-foot laboratory space and that 25 percent of the
footprint is dedicated to data analysis.
It looks like Central Command,
he said.
KBOR
BD Diagnostics, pages 4, 116

Beckman Coulter, pages 31, 33
Bio-Rad Laboratories,
pages 7, 29, 83
BioFire Diagnostics, page 43
BioMrieux, page 97
California Society of
Pathologists, page 104
Instrumentation Laboratory,
page 73
Sysmex, pages 23
The Binding Site, page 41
Thermo Fisher Scientifc,
pages 60, 91
Kamiya Biomedical, page 72
Roche Diagnostics,
pages 8485, 93
Tosoh Bioscience,
pages 11, 57
Kronus, page 16
Sakura Finetek, pages 67, 69
Vacava, page 80
LGP Consulting, page 86
SCC Soft Computer, page 79
Wako, page 99
Put It on the Board

AMP puts a costand value
to sequencing procedures
Amid excitement about the groundbreaking work of unlocking the human genomes secrets to speed diagnosis and target oncologic treatment
comes the unpleasant reality that
much of this labor now goes unpaid.
Getting the American Medical Associations editorial panel to publish
nearly two dozen new genomicsrelated CPT codes for molecular pathology was a vital step, as was having
those codes accepted in the Medicare

clinical laboratory fee schedule.
But when the Centers for Medicare
and Medicaid Services determined
that the payment basis for those codes
would be gap-flled, that meant that
pricing would not be determined until
later this year and not take effect until
2016. With Medicaid and private payers following Medicares leador lack
thereoflaboratories fnd themselves
with a raft of CPT codes to use when
billing their genomic sequencing pro-
cedures but no price tag associated

with them.
Genomic testing is expanding in
CLIA laboratories, and its important
that these codes get prices, Aaron D.
Bossler, MD, PhD, said in a talk at this
years Executive War College. Dr.
Bossler is director of the molecular
pathology laboratory at the University
of Iowa Carver College of Medicine.
He also chairs the Association for
Molecular Pathologys Economic Affairs Committee.
Setting the right price depends on
understanding how much laboratories
spend to develop, perform, and maintain a genomic test, as well as the value
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including Molecular Pathology and Symgene our Next Generation Sequencing 68 Gene Panel Assay.
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844.SYMBIODX (796.2463)
that assay delivers for patients and for

payers, Dr. Bossler said. AMP has come
up with a method to do just that, formulating a model to help laboratories
calculate their genomic testing costs to
the penny while demonstratingin
the sometimes obscure specifcations
of health economicsthe financial
merit of these innovative assays.
The associations Genomic Sequencing Procedures Pricing Project
Oversight Committee gathered detailed protocols on 13 representative
genomic tests from nine laboratories
using the Illumina or Ion Torrent platforms. The committee examined the
costs associated with each step of the
process, such as consumables and
supplies, equipment, bioinformatics
and reporting, personnel time, and
test validation and maintenance.
Some assays, such as test code
81430a genomic sequence analysis
for hearing lossshowed relatively
little variation, with
the cost per test
ranging between
$1,899 and $1,949,
Dr. Bossler said.
Others showed a
much broader array
of costs. For example, code 81415for
Dr.Bossler
exome sequence
analysisfound laboratory expenses
ranging from $1,639 to $3,142.
AMP also examined the value proposition of three genomic sequencing
procedures, contrasting current pathways that leave genomic testing for last
with new paradigms in which sequencing is done earlier in the patients evaluation. In some areas, the proposed
pathway would save payers money,
Dr. Bossler said. If a targeted multiple
gene sequencing test were done immediately after hearing loss was confrmed, the cost per diagnosis would
add up to $4,106. That is less than a
third of the current tally of $15,498 per
diagnosis, says the AMP analysis.
This really helps on this problem
of the diagnostic odyssey, where its
not entirely clear what the diagnosis
is for the patient, and you end up
spending a lot of money on singlegene tests, procedures, imaging studies, all those sorts of things that add to
the cost of doing this, Dr. Bossler said.
In the case of an exome sequencingfrst approach to undiagnosed neurodevelopmental disorders, AMP estimates the cost per diagnosis would be
$9,484, less than half of what it costs
under the current care pathway.
Again, we are showing that using
this very powerful technology is extremely helpful for these patients.
And, hopefully, well be able to convince payers that that is the case, Dr.
Bossler said.
The economic case for expanding
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CAP Jul 2015

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