PATHOLOGY X LABORATORY MEDICINE X LABORATORY MANAGEMENT DECEMBER 2019

No dawdle in switch to high-sensitivity troponin

Karen Titus Karon’s word), and the Gen 5 went Mayo is no drama queen (a scarce to Abbott’s Architect Stat High Sensi-
At Mayo Clinic, the latest generation live. “Anybody who had a panel trait in Minnesota generally). Henne- tivity Troponin-I assay, likely early
of cardiac troponin assay was an started got it finished with 4th Gen, pin Healthcare/Hennepin County next year, “It will be a switch that we
overnight success. Literally. and then we just switched whole Medical Center, Minneapolis, is also flip in one day,” says Fred S. Apple,
For months, the institution had hog—the whole practice—to 5th planning a decisive cardiac troponin PhD, DABCC, principal investigator,
been preparing to switch to Roche Gen,” he says. assay launch. When Hennepin moves cardiac biomarkers —continued on 18
Diagnostics’ Elecsys Troponin T Gen
Ackerman + Gruber

5 Stat assay, says Bradley S. Karon,

MD, PhD, chair of the Division of Labs size up options
Clinical Core Laboratory Services,
Department of Laboratory Medicine for unpredictable flu
and Pathology. Charna Albert
As the time of the rollout neared, There aren’t good flu seasons; there
an internal medicine colleague who are just varying degrees of how bad
was involved in overseeing the transi- they are.
tion asked, “‘What will the burn-in That’s the message the CDC wants
period be?’” recalls Dr. Karon, who is people to hear, says Lynnette Brammer,
also co-director of Mayo’s stat labs and MPH, lead for the CDC’s domestic
point-of-care testing programs. Surely influenza surveillance team. It’s what
clinicians would be able to continue laboratories know well and why plat-
ordering the Gen 4 assay for a time, forms, panels, and prescribing pat-
right? So how long would that last? terns are top of mind.
Dr. Karon’s dramatic-sounding The 2018–2019 flu season was un-
answer? “Zero hours.” usually long, Brammer says. “That
The switch occurred in March was probably the biggest standout.
2018. At midnight on the day the new Influenza-like illness was elevated for
assay was implemented, the Gen 4 21 weeks. Our previous long was 20.”
order was obsoleted (to use Dr. When the season began, H1N1
viruses were predominant, Brammer
Dr. Amy Saenger and Dr. Fred Apple at Hennepin County says. “It looked like it wasn’t going to
Medical Center, where they and an ED colleague are leading be a terrible season. And then it
the launch of a high-sensitivity cardiac troponin assay. It switched over to H3N2, which made
will require “education, sometimes a lot of education, and the season long. We had never seen a
certainly ongoing education,” says Dr. Saenger. season where —continued on 56

For gestational diabetes, one step or two?

Amy Carpenter Aquino Deaconess Medical Center, Boston, the two-step criteria after the Ameri-
The controversy surrounding the favors the use of the one-step Inter- can College of Obstetricians and Gy-
approved methods for screening national Association of Diabetes and necologists reaffirmed its position to
gestational diabetes mellitus took Pregnancy Study Groups (IADPSG) use the two-step method in a 2013
the form of a debate at this year’s criteria to detect GDM. practice bulletin “That continues to
Vol. 33, No. 12 Moving? Fax a copy of the below
address with corrections to CAP TODAY: 847-832-8153.

AACC annual meeting, with two “My position today is we should be the case.”
speakers defending the one-step or use the one-step IADPSG criteria to Dr. Brown presented the case of a
two-step method. detect gestational diabetes,” Dr. 33-year-old —continued on 32
Florence M. Brown, MD, assistant Brown said. Her insti-
professor of medicine at Harvard tution began using the
Medical School and co-director of the criteria shortly after
diabetes in pregnancy program at the they were published in Case report
Joslin Diabetes Center and Beth Israel 2011 but returned to Identification of
a single exon
deletion using NGS
in a patient with
Perlman syndrome
Page 52
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[Internet]. Jan, 2015. pp. e5–e8. [cited 2016 Jul 8] Available from: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4353274/pdf/idmm-26-e5.pdf.
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 DECEMBER 2019 | CAP TODAY 5

Dodging point-of-care testing potholes in PT, IQCP

Charna Albert instruments. And if a single IQCP five with plasma, you can’t do that ples, or order a plasma PT/INR sur-
For point-of-care testing, perform is written for more than one POC for PT if you’re crossing a CLIA li- vey and use a PT/INR plasma Qual-
proficiency testing on only one testing location, account for all cense—and there is some risk for ity Cross Check product to test each
method or instrument unless your variations. doing this within a CLIA lab unless of the nonwaived meters.
testing procedure says all patient These and other tips come from a the SOP is very clear on what situa- “Only perform PT on one method
samples must be tested on multiple CAP19 session, “Point-of-care test- tions require a lab confirmation of or instrument unless your procedure
ing pitfalls: what you don’t know POC INR.” There are also practical states that all patient specimens get
CAP TODAY DECEMBER 2019 Vol. 33, No. 12 can hurt you,” presented by Deborah considerations and limitations to tested on multiple instruments,” he
Copyright 2019 by the College of American Pathol- A. Perry, MD, medical director of confirmatory testing, he added. PT said. “This applies to regulated,
ogists. All rights reserved. None of the contents of this pathology at Methodist Hospital in materials designed for whole blood nonregulated, and waived ana-
publication may be reproduced, stored in a retrieval sys-
tem, or transmitted without prior written permission Omaha, Neb., and Bradley S. Karon, INR may not work well for labora- lytes.” If a lab enrolls in a waived
of the publisher. Views and opinions expressed in CAP
TODAY are not necessarily endorsed by the CAP.
MD, PhD, chair of the Division of tory methods. glucose PT survey and a nonwaived
President: Patrick Godbey, MD Clinical Core Laboratory Services, plasma/serum glucose PT survey
President-Elect: Emily E. Volk, MD, MBA Department of Laboratory Medicine Second of two parts. Last month: under the same CLIA certificate, the
Secretary-Treasurer: Richard R. Gomez, MD
Immediate Past President: R. Bruce Williams, MD and Pathology, Mayo Clinic. They Personnel paradox and more: POC pitfalls PT products will be different, and
Governors: Timothy Craig Allen, MD, JD; Alfred Wray used scenarios to illustrate how best that is acceptable. “But if it’s the
Campbell, MD, MBA; Rajesh C. Dash, MD; Mary Eliza-
beth Fowkes, MD, PhD; Eric F. Glassy, MD; Jennifer L. to approach PT, the IQCP, and CAP Also tricky, he said, is how labora- same PT material, you can’t test
Hunt, MD, MEd; Donald Steven Karcher, MD; Jonathan
Louis Myles, MD; Raouf E. Nakhleh, MD; Richard M. inspections for POC testing. (Part tories should handle PT for POC both.” This affects labs that have
Scanlan, MD; Nancy A. Young, MD; Qihui “Jim” Zhai, MD one is published in the November programs when they’re under the multiple instruments and split lab/
President, CAP Foundation Board: Guillermo G.
Martinez-Torres, MD
issue.) same CLIA certificate as the lab, and POC programs.
Speaker, House of Delegates: Kathryn T. Knight, MD PT has unique aspects related to when they’re not. In 2017 the CAP accreditation pro-
Vice Speaker: Sang Wu, MD
Residents Forum Chair: Adam Lee Booth, MD point of care because point-of-care With these two issues raised, he gram stopped requiring enrollment
Chief Executive Officer: Stephen Myers
programs tend to employ high num- introduced this situation: You are a in PT for waived whole blood glu-
Medical Editorial Board to CAP TODAY: Marilyn M.
Bui, MD, PhD, chair; Dorothy M. Adcock, MD; Philip T. bers of devices, said Dr. Karon, who laboratory director for a stat lab and cose or waived whole blood INR
Cagle, MD; Sarah Amelia Donnell, MD; Donna E. Han-
sel, MD, PhD; Frederick L. Kiechle, MD, PhD; Samuel
is also co-director of Mayo’s stat labs POC program (operating under the testing, “in recognition of the fact
McCash, MD; Deborah Ann Sesok-Pizzini, MD, MBA; and point-of-care testing programs. same CLIA number), both doing that we have lots of glucose meters,
Mary K. Washington, MD, PhD; Shi Wei, MD, PhD;
Thomas L. Williams, MD; Carla S. Wilson, MD, PhD And in 2016 the Centers for Medi- plasma PT/INR, and your POC INR meters, and i-Stats in our institu-
Contributing Editors: Raymond Aller, MD; Tauangtham care and Medicaid Services said labs program supports several dozen non- tions, specifically for glucose and
Anekpuritanang, MD; S. Emily Bachert, MD; Nancy
Cornish, MD; Robert DeCresce, MD; Hassan Ghani, MD; are “not allowed to report PT on waived whole blood POC INR INR, and the CMS will only allow
Sounak Gupta, MBBS, PhD; Donna Hansel, MD, PhD; more than one instrument or method meters. you to buy one kit and test it on one
Shaomin Hu, MD, PhD; Rouzan Karabakhtsian, MD,
PhD; Frederick Kiechle, MD, PhD; Mark Lifshitz, MD; unless that’s how all patient results The laboratory director in this glucose meter” per cycle, he said. “If
Nicole Panarelli, MD; Richard Press, MD, PhD; Deborah
Ann Sesok-Pizzini, MD, MBA; James Solomon, MD, PhD; are reported.” situation could avoid sanctions re- an institution has 500 meters, it
Hal Weiner; Fei Yang, MD “We always say treat and monitor lated to performing PT on more than wouldn’t make sense to require that
Editorial Office: College of American Pathologists
325 Waukegan Road, Northfield, IL 60093 PT like a patient specimen,” he said, one method by ordering unique laboratory to buy a kit to test one of
847-832-7000; CAP TODAY fax 847-832-8153 adding, “It’s complicated because whole blood and plasma PT kits, Dr. 500 meters every cycle. It would take
Publisher: Bob McGonnagle, 847-832-7476
Editor: Sherrie L. Rice, 847-832-7504, srice@cap.org there are times when you cannot Karon said. Other options: Order a 30 years to get through all the meters
Managing Editors: Kimberly Carey
847-832-7249, kcarey@cap.org; Karen Titus
treat your PT like a patient sample. plasma PT/INR survey and do a with PT.”
Senior Editor: Amy Carpenter Aquino You certainly can’t refer it between comparison between laboratory “But,” he said, “this is where it
847-832-7245, aaquino@cap.org
Associate Editor: Kristen Eberhard labs A and B if they operate under plasma and whole blood POC INR gets tricky.” Nonwaived glucose is
847-832-7649, keberha@cap.org
Associate Contributing Editor: Charna Albert
separate CLIA licenses. Even if you (alternative assessment for the non- regulated, and CLIA requires that
847-832-7274, calbert@cap.org confirm all point-of-care INRs over waived meters) using patient sam- labs be enrolled in —continued on 6
Circulation Director: Kimberly Gilfillan
847-832-7456, fax 847-832-8153, subscription@cap.org
Digital Production Editor:
Mary Lindsay, 847-832-7377, mlindsa@cap.org
Managing Periodicals Editor:
Keith Eilers, 847-832-7528, keilers@cap.org
Production Editor: Jane Ure
In this issue
847-832-7980, jure@cap.org

14
Periodicals Production Assistant: Reimbursement in 2020 is estimated to remain steady.
Tracy Erski, 847-832-7514, terski@cap.org
Publisher/Sales Office: Bob McGonnagle
Medicare physician fee schedule In 2021, large cuts expected
847-832-7476, fax 847-832-8153, bmcgonn@cap.org

28
Advertising Directors: The conversation continues:
East—Hally Birnbaum, 914-218-1943,
captodayeast@gmail.com
LIS roundtable lab consolidation and IT labor in the laboratory
Midwest—Lori Prochaska, 402-290-7670,
P G
R U

captodaycentral@cox.net

42
O I

Panel explores instrument solutions, rules, point-of-care testing,

D D

West—Diana Kelker, 847-832-7749, dkelker@cap.org

Urinalysis
U E
C

and more. Plus CAP TODAY product guide, page 47

T

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52 Case report Identification of a single exon deletion using NGS
in a patient with Perlman syndrome
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 6 CAP TODAY | DECEMBER 2019
Point-of-care testing
continued from 5
PT for regulated analytes. INR is not
a regulated analyte, but the Labora-
tory Accreditation Program requires
PT enrollment for nonwaived INR
testing. If a laboratory’s POC pro-
gram is under a separate CLIA cer-
tificate and performs nonwaived
glucose or INR testing, “even if you
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have 400 nonwaived point-of-care
glucose or INR meters, you still must
enroll in a PT survey,” Dr. Karon
said. In this case, only report results
from one of the instruments/meters
per PT event.
A laboratory that uses more than
one method for the same test should
use the primary instrument for PT.
As a general rule, Dr. Karon said,
whichever instrument performs the
higher test volume is considered
primary, but ultimately it’s up to the
laboratory director to designate
which instruments are primary and
which are secondary. “You can cross-
check against the primary,” he said.
Labs can use the CAP Quality Cross
Check programs or develop their
own cross-check procedure.
Multiple kits can be ordered under
the same CLIA number, but the lab
polymedco.com
has to ensure it doesn’t run the same
PT material on any other instruments
before the due date provided on the
result form. “That gets risky,” Dr.
Karon said, “but some labs will do
that as a way to make sure they’re
checking their systems without vio-
lating PT referral.”
D r. Karon turned to POC lab in-
spections and shared the fol-
lowing scenario: You are inspecting
a hospital POC program (or leading
a team and have asked a team member
to inspect). The POC program has
seven sites performing POC test-
ing, five tests/instruments/methods
(two nonwaived), and 30 nonwaived
testing personnel. During the POC
inspection you visit three sites (all
doing just waived glucose meter test-
ing), speak with three operators (all
nurse managers familiar with POC
procedures), and find no deficiencies.
Two months later a CMS validation
inspection of the POC program goes
to the cath lab (a site you did not visit)
and finds expired reagents, multiple
unqualified testing personnel, and
testing staff generally not knowledge-
able about procedures. Among other
citations, a condition-level citation
is given to the lab director for failing
to ensure quality system functioning
and lack of oversight. What went
wrong with your inspection?
The inspector should have sam-
pled sites in order to observe each of
the five POC tests offered, rather
than have visited only sites perform-
ing waived glucose meter testing, Dr.
Karon said.
Inspectors “do have to sample,”
because it often isn’t possible to visit
every testing site, especially with
larger programs, he said. “Six months
ago, I inspected a site that had point
of care at 55 to 60 sites under three
different CLIA certificates. I’d still be
there if I were going to visit every
site.” If an inspector is going to sam-
ple, he advises picking higher-vol-
ume, higher-risk areas—his favorites
are the ED and catheterization lab—
and visiting waived and nonwaived
testing sites. Some programs get so
engaged in their nonwaived regula-
tions they forget about their waived.
“It’s rare, but it has happened in my
inspections,” Dr. Karon said.
He noted that planning for point-
of-care inspections is more difficult
than it is for lab inspections because
the inspection information packet
doesn’t always reveal which tests are
performed at which site. “As a point-
of-care inspector, I wait until I’m on
site to talk to a coordinator.”
A few of Dr. Karon’s tips for in-
spectors: Ask the —continued on 8
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 8 CAP TODAY | DECEMBER 2019

Point-of-care testing manually. “What we care about is study,” the number and frequency

Quick Takes continued from 6

“We’re missing almost two-
thirds of the pregnancy.”
—David Sacks, MB, ChB, on screening for
gestational diabetes mellitus at 24 to 28 weeks
but the first trimester being when the majority of
the fetus’ organ systems are at risk. (“Diagnosing
GDM in the first trimester,” page 38)
“The more the merrier. You
don’t want to have anyone feel
like they weren’t consulted.”
—Fred Apple, PhD, on the need for people outside
the lab as well as inside to be involved in the
work of switching to a high-sensitivity cardiac
troponin assay. (“No dawdle in switch to
high-sensitivity troponin,” page 1)
“It really is a safe place for
someone to go into for their
career.”
—J. Mark Tuthill, MD, on business analytics
and data scientist and data analyst positions.
(“The conversation continues: consolidation,
IT labor force,” page 28)
POC coordinator to direct you to
testing sites, but “don’t let the coor-
dinator select the sites for you.
They’ll take you to sites they know
are very compliant.” At each site, ask
a nurse to run through procedures
for the testing performed at that site,
“but again, don’t allow the coordina-
tor to bring you the charge nurse
who’s a trainer for the test method.
The trainer always knows the an-
swers. Talk to the nurses who are
doing testing but are not in charge of
the platform. Jot down the names of
nurses you talk to in order to look up
their competency and training mate-
rials, especially for nonwaived test-
ing.” Ask what-if questions from the
SOP: When do you need to confirm
the INR? What do you do if capillary
glucose results are greater than 400
mg/dL? Ask testing personnel to
locate the procedure for you.
Visit sites where POC instruments
aren’t interfaced and data are entered
that the results get in the electronic
medical record,” Dr. Karon said.
Typically, he asks to see results in the
EMR from the three most recent tests
performed at the site.
Observe testing, if possible. “I’ve
had success getting time from the
cath lab nurse to walk me through
the steps of testing,” Dr. Karon said,
and he’s had the same success in the
ED. It’s busy but “be patient. Find a
nurse to take you to an empty trauma
pod and walk you through the test.”
H
“ ow do you know if a new de-
vice for your point-of-care pro-
gram is eligible for an IQCP?” Dr.
Perry asked, in her presentation on
individualized QC plans. “First of
all, if it’s a waived test, you don’t
need it,” she said, advising direc-
tors to find waived tests for point of
care, if possible, because the require-
ments are easier. Any nonwaived
testing that employs an internal QC
system is eligible for an IQCP. “And
even if you do your own internal
of controls tested cannot be less than
indicated by the manufacturer’s QC
instructions, Dr. Perry said. Labo-
ratories that don’t write IQCPs for
nonwaived instruments are respon-
sible for two levels of QC per day.
“In point of care, we know that’s
a lot of money and a lot of wasted
cartridges.”
Most laboratorians are familiar
with the three-part basics of IQCPs—
risk assessment, quality control plan,
quality assessment. But point of care
has unique considerations. Dr. Perry
presented this scenario: A 200-bed
community hospital in California
offers POC testing in the ED and
ICU, which is performed by nursing
staff. EPOC and bedside glucose test-
ing are performed. A CAP on-site
inspection cited no deficiencies related
to POC testing, but a follow-up CMS
validation inspection identified two
POC testing-related citations: The
technical consultant performing the
competency assessment was not qual-
ified, and the risk —continued on 11

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Candida auris mecA/C and MREJ (MRSA)
Candida glabrata
Candida krusei Vancomycin Resistance
Candida parapsilosis vanA/B
Candida tropicalis
Cryptococcus neoformans/gattii

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1219_TABs-Agena-BioFire-10.indd 10 FILE— 1019-13 DECEMBER 2019 page 10 11/26/19 3:37 PM
 DECEMBER 2019 | CAP TODAY 11

from the
President’s Desk
Patrick Godbey, MD
If we can build on the momentum that’s giving
laboratories more influence today, we will find
that administrators will take more interest in our
laboratories. They will be more inclined to direct
more resources to them and to us. This is because

Looking ahead to 2020

This time of year, it’s easy to find ourselves caught
up in holiday planning and the challenges of manag-
ing a busy team’s hectic vacation schedule. But it is
also the appropriate time to look ahead to the com-
ing year and think about the opportunities as well
as the challenges we should expect.
Here’s what I can say for sure
about next year and the years after
that: The importance of patholo-
gists and the laboratories that we
direct will increase. Already, the
majority of diagnoses and therapies
are greatly influenced, if not out-
right dictated, by pathologists and
our laboratories.
I have often heard various people
in medicine say that 70 percent of all
medical decisions are made owing
to the laboratory. That may have
been true at one time, but I strongly
believe that number is too low. Many
of the advances in modern medicine
have taken place because of what
has happened in pathologist-driven
laboratories. We can generate more
information, with more accuracy,
that is more important to the care of the patient
than ever before.
Much has come our way in the form of new
technology. New systems can be intimidating, but
it is essential that pathologists embrace them. Pa-
thologists need to not only guide the performance
of these technologies but also participate in the
decisions on their use. We must not shy away from
new advances—and there will always be new
advances. More and more, we choose the pharma-
ceutical treatment for malignancies. Companion
diagnostics make it possible to match
the right patient to the right therapy
through genetic analysis. In the fu-
ture, our laboratories will continue
to have the opportunity to bring in
new assays. This is an exciting time
to work in this field.
Our embrace of new technologies
and tests means we have a real op-
portunity to embrace our increasing
responsibility in health care and to be
recognized for it also. It is no longer
enough for pathologists to just diag-
nose patients. We can and must do
so much more. Our role now in-
volves the diagnosis, management,
and treatment of the patient.
My fear is that pathologists will not
take this opportunity and run with it.
I remember interviewing a candidate
whose career goal was to “name the
meat and hit the street.” To say this is inadequate is
being kind. Our increasing responsibilities in patient
management push some pathologists out of their
comfort zone. But the new technologies at our dis-
posal offer real benefit to our patients and our deci-
sions should be based on what is best for them.
the laboratories for which pathologists are respon-
sible increasingly direct the way health care dol-
lars are spent. We should champion our labora-
tories and our team’s capabilities. We should
anticipate that because of the dollar amounts in-
volved, forward-thinking hospital CEOs and
CFOs will spend a larger percentage of their
budgets in our laboratories. Our increasing role
in the determination of how health care dollars
are spent should also mean that pathologists will
need to play an important role in alternative pay-
ment models.
That’s why I am looking forward to a new year
where pathology and the laboratories that patholo-
gists direct will continue to grow at a rapid pace,
and where our influence over not just diagnosis
but also treatment selection will increase. I am
looking forward to our growing importance in the
health care team, with the ultimate beneficiary be-
ing the patient.
I’d like to sign off by wishing all CAP members,
and everyone involved with the CAP, a happy
holiday season. To me, the most important part of
the holidays is being able to spend quality time
with loved ones. I am looking forward to spending
time with my family, who will be gathered on an
island off the coast of South Georgia, accompanied
by some reasonably friendly alligators and one
300-plus-pound wild boar that has never liked me.
I hope everyone who reads this will be able to do
the same—minus the boar, of course. Happy holi-
days to you and yours.
Dr. Godbey welcomes communication from CAP mem-
bers. Write to him at president@cap.org.

Point-of-care testing assessment portion.

continued from 8
assessment portion of the IQCP was
incomplete.
The laboratory had written an
IQCP for the nonwaived EPOC, but
the CMS was concerned because the
lab had written only one IQCP for
two testing locations—the ED and
the ICU. “Each lab with a separate
CAP/CLIA number must do its own
risk assessment,” Dr. Perry said. “If
there are multiple sites with the same
instrument and device within one
CAP/CLIA number, you have a cou-
ple of options.”
One is to write a single risk assess-
ment but account for all variations.
“You’re certainly going to have dif-
ferent people performing testing in
the OR than in the ED or ICU. The
environment will also be different.
You can either write different IQCPs
for each location,” or write one large
IQCP, documenting the differences
in location and personnel in the risk
The CMS cited the laboratory in
the preceding scenario for failing to
have all five components of testing
in its risk assessment. Risk assess-
ments are “very prescriptive,” and
must include the preanalytic, ana-
lytic, and postanalytic testing
phases and the five components of
testing: reagent, environment, speci-
men, test system, and testing per-
sonnel. “If you miss even one of the
five,” Dr. Perry said, “the risk as-
sessment portion will be considered
inadequate.”
Developing risk assessments for
new POC devices poses an addi-
tional challenge when “there isn’t
any equivalent testing in the lab to
compare it to,” she said. Laboratories
can use the data gathered during the
test method verification process.
“And sometimes you have to use the
default QC for a period of 20 to 30
days to collect enough data to imple-
ment an IQCP.”
An IQCP’s quality control plan
should “define all aspects of every-
thing you’re going to do,” Dr. Perry
said. “So the number of QC, the type
of QC, whether it’s external or inter-
nal, the frequency of your controls,
your acceptability criteria. Some-
times in point of care we forget to
write whether a test is qual or quant,
and what exactly
will be acceptable
QC. As we know,
point of care is of-
ten not in the lab,”
so it’s critical to
document a plan
for monitoring the
Dr.Perry
testing environ-
ment and reagents.
“Make sure those reagents are in the
fridge if they need to be and that the
fridge is monitored.”
For quality assessment monitor-
ing, the laboratory medical director
or a designee should review QC, in-
strument maintenance, and function
check records at least monthly. “Any
complaints from clinicians or other
health care providers regarding the
quality of testing also must be re-
viewed monthly,” she said.
In addition, reevaluate the quality
control plan. If there are changes in
the environment or with specimen
testing, “document those in your
IQCP and note the change to your
quality control plan.”
Quality assessment monitoring “is
sometimes not well documented and
not well done,” Dr. Perry said. The
most common IQCP citations—
“evaluation of errors relating to all
phases of the testing process” and
“evaluation of corrective actions
taken if problems are identified”—
are related to quality assessment
monitoring (COM.50600). “If you do
those things correctly,” she said,
“you won’t get citations. And, more
importantly, the patients will be
taken care of right. That’s our ulti-
mate goal.”
Charna Albert is CAP TODAY associate
contributing editor.

1219_5-11_TOC-POCT2-Prezdesk.indd 11
DECEMBER 2019 page 11 12/4/19 11:09 AM
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DECEMBER 2019 page 13
11/27/19 8:07 AM
 14 CAP TODAY | DECEMBER 2019
Millions at stake in ’21; CAP fights Medicare cuts
cms finalizes proposal that will lower payments for non-e/m services billed by specialists
Charles Fiegl
Medicare reimbursement to patholo-
gists in 2020 is estimated to remain
steady, but significant cuts in pay-
ments to pathologists and other spe-
cialists are expected in 2021 owing to
a dramatic shift in how primary care
physicians will be paid.
The CAP is already fighting the
scheduled cuts to pathologists in
2021 as a result of a new plan that
reimburses evaluation and manage-
ment office visit services at a higher
rate and lowers payments for non-
E/M services billed by specialists.
The Centers for Medicare and Med-
icaid Services finalized the proposal
that will lead to an estimated eight
percent reduction in Medicare pay-
ments to pathologists in 2021 when
it published on Nov. 1 the 2020 Medi-
care physician fee schedule final
regulation. At the same time, the
CMS made favorable changes in re-
sponse to the CAP’s advocacy on the
practice expense components related
to payment for pathology services,
positively impacting payment rates
for 2020.
Cuts tied to E/M services. The
2021 implementation of the CMS’
changes to evaluation and manage-
ment office visit services redistrib-
utes $7 billion under Medicare’s
budget-neutral physician fee sched-
ule. Physicians who commonly bill
E/M services stand to benefit the
most while physicians who rarely
bill E/M services will see their re-
imbursements reduced. According
to CMS estimates, pathology will
lose $97 million, or eight percent, in
2021. Providers that bill Medicare
as independent laboratories will
lose $24 million, or four percent, in
2021. The impact on individual pa-
thologists will vary depending on
their case mix.
DECEMBER 2019 | CAP TODAY 15
The CMS updated 36
direct practice expense
imburse the work worse. Surgical prices for more than 2,000 medical The CAP will continue to pro-
associated with supply and equipment specialties and the supply and equipment items that are vide to the CMS as needed addi-
furnishing com- prices, adding $30 million AMA advocated used to calculate payments for ser- tional clarification on appropriate
plex office visit for increases to vices on the Medicare physician fee pricing for pathology supplies and
services.
to Medicare payment for surgical proce- schedule. These pricing inputs are equipment.
The changes to E/M services go The CAP and pathology services. dures that have used for the practice expense compo- Values for cytopathology services
beyond recommendations proposed the AMA have op- a global period nent of physician services, used to reduced. In the 2020 Medicare physi-
by a workgroup led by the American posed this add-on to also reflect the calculate the technical component cian fee schedule, the CMS reduced
Medical Association. The CAP par- code because it accounts for an ad- E/M changes as surgeons typically and global payment of pathology the physician work relative value
ticipated in the workgroup, which ditional $2.6 billion that will be redis- conduct pre-op and post-op office services. units used to calculate the payment
advocated for the CMS to align its tributed to physicians furnishing visits as part of surgeries. The CAP Because of the CAP’s advocacy for cytopathology services. The CAP
E/M payment policy with coding office visits and further reduces pay- opposed this effort, and the CMS and efforts to correct errors affecting had recommended maintaining the
changes outlined by the AMA CPT ments to physicians who do not bill agreed with the CAP and opted not Medicare reimbursements for pathol- current physician work RVU of 0.42
editorial panel and values recom- E/M services. For pathologists, three to make changes to the global sur- ogy services, the CMS updated 36 for four cytopathology services
mended by the AMA/Specialty So- out of the eight percentage point re- gery codes at this time. direct practice expense supply and (listed on page 16) identified as po-
ciety Relative Value Scale Update duction is attributable to the add-on A $30 million increase. Earlier in equipment prices, adding $30 million tentially misvalued. The CMS dis-
Committee, known as RUC. The code as such an increase must not 2019, the CAP submitted an exten- to Medicare payment for pathology agreed and decreased the physician
CMS accepted the AMA-RUC recom- increase Medicare spending for sive list of pathology supplies and services. Twenty-six of these price work RVU to 0.26. The reduced pay-
mendations but then tacked on an physicians. equipment invoices to the CMS to increases are owing to the direct ment rates will be phased in over two
additional E/M add-on code, which Cuts to pathologists under this correct errors the CAP found in sev- work of the CAP’s engagement to years, starting in 2020.
the agency believes is needed to re- policy change could have been eral prices. Previously, the CMS reset correct previous CMS errors. The CAP had —continued on 16

Modifier

Modifier
2020 Medicare physician
physician fee
fee schedule
schedule relative
relativevalue
valueunits
units
Non- Facility Mal- Non- Non- Facility Mal- Non-
CPT/ Status Work facility PE practice facility Facility CPT/ Status Work facility PE practice facility Facility
HCPCS Short Description code RVU PE RVU RVU RVU total total HCPCS Short Description code RVU PE RVU RVU RVU total total

Modifier
Conversion factor for 2020 = $36.0896, released Nov. 1, 2019 Non-
Non- Facility
Facility Mal-
Mal- Non-
Non-
88307 26 Tissue exam by pathologist A 1.59 0.78 0.78 0.03 2.40 2.40 88361 TC Tumor immunohistochem/comput A 0.00 2.28 NA 0.01 2.29 2.29

CPT/
CPT/ Status Work
Status Work facility
facility PE
PE practice facility
practice facility Facility
Facility
Below are listed the pathology-related Medicare relative value units for 88307 TC Tissue exam by pathologist A 0.00 5.37 NA 0.03 5.40 5.40 88361 Tumor immunohistochem/comput A 0.95 2.61 NA 0.02 3.58 3.58

HCPCS
HCPCS Short Description
Description code RVU
code RVU PE RVU
RVU RVU
RVU RVU
RVU total
total total
88307 Tissue exam by pathologist A 1.59 6.15 NA 0.06 7.80 7.80 88362 26 Nerve teasing preparations A 2.17 1.04 1.04 0.06 3.27 3.27

2020, as detailed in the Centers for Medicare and Medicaid Services physi-
cian fee schedule relative value file, released Nov. 1, 2019. 86335
86335 Immunfix e-phoresis/urine/csf X 0.00 0.00
e-phoresis/urine/csf X 0.00 0.00 0.00 0.00
88309 26 Tissue exam by pathologist A 2.80 1.38 1.38 0.05 4.23 4.23 88362 TC Nerve teasing preparations A 0.00 3.15 NA 0.02 3.17 3.17
0.00
0.00 0.00
0.00 0.00 88309 TC Tissue exam by pathologist A 0.00 7.59 NA 0.03 7.62 7.62 88362 Nerve teasing preparations A 2.17 4.19 NA 0.08 6.44 6.44

87164
87164 26
26 Dark field examination
examination AA 0.37
0.37 0.19
0.19 0.19
0.19 0.01
0.01 0.57
0.57 0.57 88309 Tissue exam by pathologist A 2.80 8.97 NA 0.08 11.85 11.85 88363 Xm archive tissue molec anal A 0.37 0.28 0.18 0.02 0.67 0.57

87164
87164 Dark field examination
examination XX 0.00
0.00 0.00
0.00 0.00
0.00 0.00
0.00 0.00
0.00 0.00 88311 26 Decalcify tissue A 0.24 0.11 0.11 0.01 0.36 0.36 88364 26 Insitu hybridization (fish) A 0.70 0.29 0.29 0.01 1.00 1.00
Non- Facility Mal- Non-
Modifier

87207
87207 26
26 Smear special stain
stain AA 0.37
0.37 0.14
0.14 0.14
0.14 0.02
0.02 0.53
0.53 0.53 88311 TC Decalcify tissue A 0.00 0.24 NA 0.01 0.25 0.25 88364 TC Insitu hybridization (fish) A 0.00 2.88 NA 0.01 2.89 2.89
CPT/ Status Work facility PE practice facility Facility

87207
87207 Smear special stain
stain XX 0.00
0.00 0.00
0.00 0.00
0.00 0.00
0.00 0.00
0.00 0.00 88311 Decalcify tissue A 0.24 0.35 NA 0.02 0.61 0.61 88364 Insitu hybridization (fish) A 0.70 3.17 NA 0.02 3.89 3.89
HCPCS Short Description code RVU PE RVU RVU RVU total total

88104
88104 26
26 Cytopath fl nongyn smears
smears AA 0.56
0.56 0.24
0.24 0.24
0.24 0.01
0.01 0.81
0.81 0.81 88312 26 Special stains group 1 A 0.54 0.22 0.22 0.01 0.77 0.77 88365 26 Insitu hybridization (fish) A 0.88 0.37 0.37 0.02 1.27 1.27

88104
88104 TC
TC Cytopath fl nongyn smears
smears AA 0.00
0.00 1.11
1.11 NA
NA 0.01
0.01 1.12
1.12 1.12 88312 TC Special stains group 1 A 0.00 2.19 NA 0.01 2.20 2.20 88365 TC Insitu hybridization (fish) A 0.00 3.81 NA 0.02 3.83 3.83

10004 Fna bx w/o img gdn ea addl A 0.80 0.57 0.34 0.11 1.48 1.25 88104
88104 Cytopath fl nongyn smears
smears AA 0.56
0.56 1.35
1.35 NA
NA 0.02
0.02 1.93
1.93 1.93 88312 Special stains group 1 A 0.54 2.41 NA 0.02 2.97 2.97 88365 Insitu hybridization (fish) A 0.88 4.18 NA 0.04 5.10 5.10

10005 Fna bx w/us gdn 1st les A 1.46 2.08 0.48 0.13 3.67 2.07 88106
88106 26
26 Cytopath fl nongyn filter
filter AA 0.37
0.37 0.18
0.18 0.18
0.18 0.01
0.01 0.56
0.56 0.56 88313 26 Special stains group 2 A 0.24 0.10 0.10 0.01 0.35 0.35 88366 26 Insitu hybridization (fish) A 1.24 0.54 0.54 0.02 1.80 1.80

10006 Fna bx w/us gdn ea addl A 1.00 0.61 0.33 0.09 1.70 1.42 88106
88106 TC
TC Cytopath fl nongyn filter
filter AA 0.00
0.00 1.26
1.26 NA
NA 0.01
0.01 1.27
1.27 1.27 88313 TC Special stains group 2 A 0.00 1.78 NA 0.01 1.79 1.79 88366 TC Insitu hybridization (fish) A 0.00 5.98 NA 0.02 6.00 6.00

10021 Fna bx w/o img gdn 1st les A 1.03 1.64 0.44 0.13 2.80 1.60 88106
88106 Cytopath fl nongyn filter
filter AA 0.37
0.37 1.44
1.44 NA
NA 0.02
0.02 1.83
1.83 1.83 88313 Special stains group 2 A 0.24 1.88 NA 0.02 2.14 2.14 88366 Insitu hybridization (fish) A 1.24 6.52 NA 0.04 7.80 7.80

36430 Blood transfusion service A 0.00 0.97 NA 0.02 0.99 0.99 88108
88108 26
26 Cytopath concentrate techtech AA 0.44
0.44 0.20
0.20 0.20
0.20 0.01
0.01 0.65
0.65 0.65 88314 26 Histochemical stains add-on A 0.45 0.18 0.18 0.01 0.64 0.64 88367 26 Insitu hybridization auto A 0.73 0.25 0.25 0.01 0.99 0.99

36440 Bl push transfuse 2 yr/< A 1.03 NA 0.36 0.08 1.47 1.47 88108
88108 TC
TC Cytopath concentrate techtech AA 0.00
0.00 1.09
1.09 NA
NA 0.01
0.01 1.10
1.10 1.10 88314 TC Histochemical stains add-on A 0.00 2.08 NA 0.01 2.09 2.09 88367 TC Insitu hybridization auto A 0.00 2.19 NA 0.01 2.20 2.20

36450 Bl exchange/transfuse nb A 3.50 NA 1.20 0.23 4.93 4.93 88108
88108 Cytopath concentrate techtech AA 0.44
0.44 1.29
1.29 NA
NA 0.02
0.02 1.75
1.75 1.75 88314 Histochemical stains add-on A 0.45 2.26 NA 0.02 2.73 2.73 88367 Insitu hybridization auto A 0.73 2.44 NA 0.02 3.19 3.19

36455 Bl exchange/transfuse non-nb A 2.43 NA 0.69 0.56 3.68 3.68 88112
88112 26
26 Cytopath cell enhance techtech AA 0.56
0.56 0.23
0.23 0.23
0.23 0.01
0.01 0.80
0.80 0.80 88319 26 Enzyme histochemistry A 0.53 0.24 0.24 0.01 0.78 0.78 88368 26 Insitu hybridization manual A 0.88 0.31 0.31 0.01 1.20 1.20

36460 Transfusion service fetal A 6.58 NA 2.48 1.04 10.10 10.10 88112
88112 TC
TC Cytopath cell enhance techtech AA 0.00
0.00 1.09
1.09 NA
NA 0.01
0.01 1.10
1.10 1.10 88319 TC Enzyme histochemistry A 0.00 2.36 NA 0.01 2.37 2.37 88368 TC Insitu hybridization manual A 0.00 2.49 NA 0.02 2.51 2.51

36511 Apheresis wbc A 2.00 NA 1.02 0.13 3.15 3.15 88112
88112 Cytopath cell enhance techtech AA 0.56
0.56 1.32
1.32 NA
NA 0.02
0.02 1.90
1.90 1.90 88319 Enzyme histochemistry A 0.53 2.60 NA 0.02 3.15 3.15 88368 Insitu hybridization manual A 0.88 2.80 NA 0.03 3.71 3.71

36512 Apheresis rbc A 2.00 NA 0.99 0.13 3.12 3.12 88120
88120 26
26 Cytp urne 3-5 probes ea spec spec AA 1.20
1.20 0.45
0.45 0.45
0.45 0.02
0.02 1.67
1.67 1.67 88321 Microslide consultation A 1.63 1.12 0.72 0.09 2.84 2.44 88369 26 M/phmtrc alysishquant/semiq A 0.70 0.23 0.23 0.01 0.94 0.94

36513 Apheresis platelets A 2.00 NA 0.91 0.24 3.15 3.15 88120
88120 TC
TC Cytp urne 3-5 probes ea spec spec AA 0.00
0.00 14.64
14.64 NA
NA 0.02
0.02 14.66
14.66 14.66 88323 26 Microslide consultation A 1.83 0.67 0.67 0.02 2.52 2.52 88369 TC M/phmtrc alysishquant/semiq A 0.00 2.28 NA 0.01 2.29 2.29

36514 Apheresis plasma A 1.81 17.21 0.79 0.15 19.17 2.75 88120
88120 Cytp urne 3-5 probes ea spec spec AA 1.20
1.20 15.09
15.09 NA
NA 0.04
0.04 16.33
16.33 16.33 88323 TC Microslide consultation A 0.00 0.73 NA 0.01 0.74 0.74 88369 M/phmtrc alysishquant/semiq A 0.70 2.51 NA 0.02 3.23 3.23

36516 Apheresis immunoads slctv A 1.56 53.63 0.63 0.25 55.44 2.44 88121
88121 26
26 Cytp urine 3-5 probes cmptr
cmptr AA 1.00
1.00 0.39
0.39 0.39
0.39 0.02
0.02 1.41
1.41 1.41 88323 Microslide consultation A 1.83 1.40 NA 0.03 3.26 3.26 88371 26 Protein western blot tissue A 0.37 0.19 0.19 0.01 0.57 0.57

36522 Photopheresis A 1.75 52.74 0.96 0.11 54.60 2.82 88121
88121 TC
TC Cytp urine 3-5 probes cmptr
cmptr AA 0.00
0.00 11.06
11.06 NA
NA 0.01
0.01 11.07
11.07 11.07 88325 Comprehensive review of data A 2.85 1.99 1.21 0.12 4.96 4.18 88371 Protein western blot tissue X 0.00 0.00 0.00 0.00 0.00 0.00

36600 Withdrawal of arterial blood A 0.32 0.51 0.10 0.03 0.86 0.45 88121
88121 Cytp urine 3-5 probes cmptr
cmptr AA 1.00
1.00 11.45
11.45 NA
NA 0.03
0.03 12.48
12.48 12.48 88329 Path consult introp A 0.67 0.79 0.33 0.05 1.51 1.05 88372 26 Protein analysis w/probe A 0.37 0.14 0.14 0.02 0.53 0.53

38205 Harvest allogeneic stem cell R 1.50 NA 0.85 0.09 2.44 2.44 88125
88125 26
26 Forensic cytopathology
cytopathology AA 0.26 0.13 0.13
0.26 0.13 0.13 0.01
0.01 0.40
0.40 0.40 88331 26 Path consult intraop 1 bloc A 1.19 0.60 0.60 0.02 1.81 1.81 88372 Protein analysis w/probe X 0.00 0.00 0.00 0.00 0.00 0.00

38206 Harvest auto stem cells R 1.50 NA 0.84 0.09 2.43 2.43 88125
88125 TC
TC Forensic cytopathology
cytopathology AA 0.00 0.34 NA
0.00 0.34 NA 0.01
0.01 0.35
0.35 0.35 88331 TC Path consult intraop 1 bloc A 0.00 0.96 NA 0.01 0.97 0.97 88373 26 M/phmtrc alys ishquant/semiq A 0.58 0.18 0.18 0.01 0.77 0.77

38220 Dx bone marrow aspirations A 1.20 3.39 0.63 0.18 4.77 2.01 88125
88125 Forensic cytopathology
cytopathology AA 0.26 0.47 NA
0.26 0.47 NA 0.02
0.02 0.75
0.75 0.75 88331 Path consult intraop 1 bloc A 1.19 1.56 NA 0.03 2.78 2.78 88373 TC M/phmtrc alys ishquant/semiq A 0.00 1.31 NA 0.00 1.31 1.31

38221 Dx bone marrow biopsies A 1.28 3.10 0.63 0.09 4.47 2.00 88141
88141 Cytopath c/v interpret
interpret AA 0.26
0.26 0.46
0.46 0.46
0.46 0.01
0.01 0.73
0.73 0.73 88332 26 Path consult intraop addl A 0.59 0.30 0.30 0.01 0.90 0.90 88373 M/phmtrc alys ishquant/semiq A 0.58 1.49 NA 0.01 2.08 2.08

38222 Dx bone marrow bx & aspir A 1.44 3.39 0.69 0.11 4.94 2.24 88160
88160 26
26 Cytopath smear other source
source AA 0.50
0.50 0.24
0.24 0.24
0.24 0.01
0.01 0.75
0.75 0.75 88332 TC Path consult intraop addl A 0.00 0.63 NA 0.01 0.64 0.64 88374 26 M/phmtrc alys ishquant/semiq A 0.93 0.34 0.34 0.01 1.28 1.28

38230 Bone marrow harvest allogen A 3.50 NA 1.75 0.67 5.92 5.92 88160
88160 TC
TC Cytopath smear other source
source AA 0.00
0.00 1.25
1.25 NA
NA 0.01
0.01 1.26
1.26 1.26 88332 Path consult intraop addl A 0.59 0.93 NA 0.02 1.54 1.54 88374 TC M/phmtrc alys ishquant/semiq A 0.00 8.36 NA 0.01 8.37 8.37

38232 Bone marrow harvest autolog A 3.50 NA 1.70 0.56 5.76 5.76 88160
88160 Cytopath smear other source
source AA 0.50
0.50 1.49
1.49 NA
NA 0.02
0.02 2.01
2.01 2.01 88333 26 Intraop cyto path consult 1 A 1.20 0.59 0.59 0.02 1.81 1.81 88374 M/phmtrc alys ishquant/semiq A 0.93 8.70 NA 0.02 9.65 9.65

80500 Lab pathology consultation A 0.37 0.25 0.17 0.02 0.64 0.56 88161
88161 26
26 Cytopath smear other source
source AA 0.50
0.50 0.22
0.22 0.22
0.22 0.01
0.01 0.73
0.73 0.73 88333 TC Intraop cyto path consult 1 A 0.00 0.73 NA 0.01 0.74 0.74 88375 Optical endomicroscpy interp A 0.91 0.46 0.46 0.05 1.42 1.42

80502 Lab pathology consultation A 1.33 0.70 0.61 0.08 2.11 2.02 88161
88161 TC
TC Cytopath smear other source
source AA 0.00
0.00 1.19
1.19 NA
NA 0.01
0.01 1.20
1.20 1.20 88333 Intraop cyto path consult 1 A 1.20 1.32 NA 0.03 2.55 2.55 88377 26 M/phmtrc alys ishquant/semiq A 1.40 0.45 0.45 0.02 1.87 1.87

83020 26 Hemoglobin electrophoresis A 0.37 0.14 0.14 0.02 0.53 0.53 88161
88161 Cytopath smear other source
source AA 0.50
0.50 1.41
1.41 NA
NA 0.02
0.02 1.93
1.93 1.93 88334 26 Intraop cyto path consult 2 A 0.73 0.36 0.36 0.01 1.10 1.10 88377 TC M/phmtrc alys ishquant/semiq A 0.00 9.52 NA 0.02 9.54 9.54

83020 Hemoglobin electrophoresis X 0.00 0.00 0.00 0.00 0.00 0.00 88162
88162 26
26 Cytopath smear other source
source AA 0.76
0.76 0.34
0.34 0.34
0.34 0.01
0.01 1.11
1.11 1.11 88334 TC Intraop cyto path consult 2 A 0.00 0.50 NA 0.00 0.50 0.50 88377 M/phmtrc alys ishquant/semiq A 1.40 9.97 NA 0.04 11.41 11.41

84165 26 Protein e-phoresis serum A 0.37 0.14 0.14 0.02 0.53 0.53 88162
88162 TC
TC Cytopath smear other source
source AA 0.00
0.00 1.67
1.67 NA
NA 0.02
0.02 1.69
1.69 1.69 88334 Intraop cyto path consult 2 A 0.73 0.86 NA 0.01 1.60 1.60 88380 26 Microdissection laser A 1.14 0.44 0.44 0.02 1.60 1.60

84165 Protein e-phoresis serum X 0.00 0.00 0.00 0.00 0.00 0.00 88162
88162 Cytopath smear other source
source AA 0.76
0.76 2.01
2.01 NA
NA 0.03
0.03 2.80
2.80 2.80 88341 26 Immunohisto antb addl slide A 0.56 0.25 0.25 0.01 0.82 0.82 88380 TC Microdissection laser A 0.00 2.20 NA 0.02 2.22 2.22

84166 26 Protein e-phoresis/urine/csf A 0.37 0.14 0.14 0.02 0.53 0.53 88172
88172 26
26 Cytp dx eval fna 1st ea site
site AA 0.69
0.69 0.34
0.34 0.34
0.34 0.01
0.01 1.04
1.04 1.04 88341 TC Immunohisto antb addl slide A 0.00 1.79 NA 0.00 1.79 1.79 88380 Microdissection laser A 1.14 2.64 NA 0.04 3.82 3.82

84166 Protein e-phoresis/urine/csf X 0.00 0.00 0.00 0.00 0.00 0.00 88172
88172 TC
TC Cytp dx eval fna 1st ea site
site AA 0.00
0.00 0.53
0.53 NA
NA 0.01
0.01 0.54
0.54 0.54 88341 Immunohisto antb addl slide A 0.56 2.04 NA 0.01 2.61 2.61 88381 26 Microdissection manual A 0.53 0.18 0.18 0.01 0.72 0.72

84181 26 Western blot test A 0.37 0.14 0.14 0.02 0.53 0.53 88172
88172 Cytp dx eval fna 1st ea site
site AA 0.69
0.69 0.87
0.87 NA
NA 0.02
0.02 1.58
1.58 1.58 88342 26 Immunohisto antb 1st stain A 0.70 0.31 0.31 0.01 1.02 1.02 88381 TC Microdissection manual A 0.00 4.32 NA 0.03 4.35 4.35

84181 Western blot test X 0.00 0.00 0.00 0.00 0.00 0.00 88173
88173 26
26 Cytopath eval fna report
report AA 1.39
1.39 0.63
0.63 0.63
0.63 0.03
0.03 2.05
2.05 2.05 88342 TC Immunohisto antb 1st stain A 0.00 1.94 NA 0.01 1.95 1.95 88381 Microdissection manual A 0.53 4.50 NA 0.04 5.07 5.07

84182 26 Protein western blot test A 0.37 0.14 0.14 0.02 0.53 0.53 88173
88173 TC
TC Cytopath eval fna report
report AA 0.00
0.00 2.29
2.29 NA
NA 0.02
0.02 2.31
2.31 2.31 88342 Immunohisto antb 1st stain A 0.70 2.25 NA 0.02 2.97 2.97 88387 26 Tiss exam molecular study A 0.62 0.17 0.17 0.01 0.80 0.80

84182 Protein western blot test X 0.00 0.00 0.00 0.00 0.00 0.00 88173
88173 Cytopath eval fna report
report AA 1.39
1.39 2.92
2.92 NA
NA 0.05
0.05 4.36
4.36 4.36 88344 26 Immunohisto antibody slide A 0.77 0.33 0.33 0.01 1.11 1.11 88387 TC Tiss exam molecular study A 0.00 0.19 NA 0.01 0.20 0.20

85060 Blood smear interpretation A 0.45 NA 0.22 0.03 0.70 0.70 88177
88177 26
26 Cytp fna eval ea addl
addl AA 0.42
0.42 0.21
0.21 0.21
0.21 0.01
0.01 0.64
0.64 0.64 88344 TC Immunohisto antibody slide A 0.00 3.74 NA 0.01 3.75 3.75 88387 Tiss exam molecular study A 0.62 0.36 NA 0.02 1.00 1.00

85097 Bone marrow interpretation A 0.94 0.99 0.43 0.05 1.98 1.42 88177
88177 TC
TC Cytp fna eval ea addl
addl AA 0.00
0.00 0.20
0.20 NA
NA 0.00
0.00 0.20
0.20 0.20 88344 Immunohisto antibody slide A 0.77 4.07 NA 0.02 4.86 4.86 88388 26 Tiss ex molecul study add-on A 0.45 0.23 0.23 0.01 0.69 0.69

85390 26 Fibrinolysins screen i&r A 0.75 0.29 0.29 0.03 1.07 1.07 88177
88177 Cytp fna eval ea addl
addl AA 0.42
0.42 0.41
0.41 NA
NA 0.01
0.01 0.84
0.84 0.84 88346 26 Immunofluor antb 1st stain A 0.74 0.29 0.29 0.01 1.04 1.04 88388 TC Tiss ex molecul study add-on A 0.00 0.34 NA 0.01 0.35 0.35

85390 Fibrinolysins screen i&r X 0.00 0.00 0.00 0.00 0.00 0.00 88182
88182 26
26 Cell marker study
study AA 0.77
0.77 0.34
0.34 0.34
0.34 0.01
0.01 1.12
1.12 1.12 88346 TC Immunofluor antb 1st stain A 0.00 2.51 NA 0.01 2.52 2.52 88388 Tiss ex molecul study add-on A 0.45 0.57 NA 0.02 1.04 1.04

85396 Clotting assay whole blood A 0.37 NA 0.19 0.02 0.58 0.58 88182
88182 TC
TC Cell marker study
study AA 0.00
0.00 2.74
2.74 NA
NA 0.03
0.03 2.77
2.77 2.77 88346 Immunofluor antb 1st stain A 0.74 2.80 NA 0.02 3.56 3.56 89060 26 Exam synovial fluid crystals A 0.37 0.14 0.14 0.02 0.53 0.53

85576 26 Blood platelet aggregation A 0.37 0.14 0.14 0.02 0.53 0.53 88182
88182 Cell marker study
study AA 0.77
0.77 3.08
3.08 NA
NA 0.04
0.04 3.89
3.89 3.89 88348 26 Electron microscopy A 1.51 0.68 0.68 0.02 2.21 2.21 89060 Exam synovial fluid crystals X 0.00 0.00 0.00 0.00 0.00 0.00

85576 Blood platelet aggregation X 0.00 0.00 0.00 0.00 0.00 0.00 88184
88184 Flowcytometry/ tc 1 marker
marker AA 0.00
0.00 1.87
1.87 NA
NA 0.02
0.02 1.89
1.89 1.89 88348 TC Electron microscopy A 0.00 8.65 NA 0.06 8.71 8.71 96931 Rcm celulr subcelulr img skn A 0.80 4.03 NA 0.04 4.87 4.87

86077 Phys blood bank serv xmatch A 0.94 0.57 0.47 0.05 1.56 1.46 88185
88185 Flowcytometry/tc add-on
add-on AA 0.00 0.62 NA
0.00 0.62 NA 0.00
0.00 0.62
0.62 0.62 88348 Electron microscopy A 1.51 9.33 NA 0.08 10.92 10.92 96932 Rcm celulr subcelulr img skn A 0.00 3.56 NA 0.01 3.57 3.57

86078 Phys blood bank serv reactj A 0.94 0.57 0.47 0.05 1.56 1.46 88187
88187 Flowcytometry/read 2-8 2-8 AA 0.74 0.30 0.30
0.74 0.30 0.30 0.05
0.05 1.09
1.09 1.09 88350 26 Immunofluor antb addl stain A 0.59 0.24 0.24 0.01 0.84 0.84 96933 Rcm celulr subcelulr img skn A 0.80 0.47 NA 0.03 1.30 1.30

86079 Phys blood bank serv authrj A 0.94 0.57 0.46 0.05 1.56 1.45 88188
88188 Flowcytometry/read 9-159-15 AA 1.20 0.57 0.57
1.20 0.57 0.57 0.06
0.06 1.83
1.83 1.83 88350 TC Immunofluor antb addl stain A 0.00 1.76 NA 0.01 1.77 1.77 96934 Rcm celulr subcelulr img skn A 0.76 2.18 NA 0.03 2.97 2.97

86153 26 Cell enumeration phys interp A 0.69 0.27 0.27 0.03 0.99 0.99 88189
88189 Flowcytometry/read 16 & > > AA 1.70
1.70 0.67
0.67 0.67
0.67 0.09
0.09 2.46
2.46 2.46 88350 Immunofluor antb addl stain A 0.59 2.00 NA 0.02 2.61 2.61 96935 Rcm celulr subcelulr img skn A 0.00 1.73 NA 0.00 1.73 1.73

86255 26 Fluorescent antibody screen A 0.37 0.14 0.14 0.02 0.53 0.53 88291
88291 Cyto/molecular report
report AA 0.52 0.41 0.41
0.52 0.41 0.41 0.03
0.03 0.96
0.96 0.96 88355 26 Analysis skeletal muscle A 1.85 0.52 0.52 0.01 2.38 2.38 96936 Rcm celulr subcelulr img skn A 0.76 0.45 NA 0.03 1.24 1.24

86255 Fluorescent antibody screen X 0.00 0.00 0.00 0.00 0.00 0.00 88300
88300 26
26 Surgical path gross
gross AA 0.08
0.08 0.04
0.04 0.04
0.04 0.01
0.01 0.13
0.13 0.13 88355 TC Analysis skeletal muscle A 0.00 1.49 NA 0.01 1.50 1.50 G0124 Screen c/v thin layer by md A 0.26 0.46 0.46 0.01 0.73 0.73

86256 26 Fluorescent antibody titer A 0.37 0.14 0.14 0.02 0.53 0.53 88300
88300 TC
TC Surgical path gross
gross AA 0.00
0.00 0.30
0.30 NA
NA 0.01
0.01 0.31
0.31 0.31 88355 Analysis skeletal muscle A 1.85 2.01 NA 0.02 3.88 3.88 G0141 “Scr c/v cyto,autosys and md” A 0.26 0.46 0.46 0.01 0.73 0.73

86256 Fluorescent antibody titer X 0.00 0.00 0.00 0.00 0.00 0.00 88300
88300 Surgical path gross
gross AA 0.08
0.08 0.34
0.34 NA
NA 0.02
0.02 0.44
0.44 0.44 88356 26 Analysis nerve A 2.80 0.86 0.86 0.05 3.71 3.71 G0416 26 “Prostate biopsy, any mthd” A 3.60 1.48 1.48 0.06 5.14 5.14

86320 26 Serum immunoelectrophoresis A 0.37 0.14 0.14 0.02 0.53 0.53 88302
88302 26
26 Tissue exam by pathologist
pathologist AA 0.13
0.13 0.06
0.06 0.06
0.06 0.01
0.01 0.20
0.20 0.20 88356 TC Analysis nerve A 0.00 2.90 NA 0.05 2.95 2.95 G0416 TC “Prostate biopsy, any mthd” A 0.00 4.47 NA 0.03 4.50 4.50

86320 Serum immunoelectrophoresis X 0.00 0.00 0.00 0.00 0.00 0.00 88302
88302 TC
TC Tissue exam by pathologist
pathologist AA 0.00
0.00 0.66
0.66 NA
NA 0.01
0.01 0.67
0.67 0.67 88356 Analysis nerve A 2.80 3.76 NA 0.10 6.66 6.66 G0416 “Prostate biopsy, any mthd” A 3.60 5.95 NA 0.09 9.64 9.64

86325 26 Other immunoelectrophoresis A 0.37 0.14 0.14 0.02 0.53 0.53 88302
88302 Tissue exam by pathologist
pathologist AA 0.13
0.13 0.72
0.72 NA
NA 0.02
0.02 0.87
0.87 0.87 88358 26 Analysis tumor A 0.95 0.48 0.48 0.02 1.45 1.45 G0452 26 Molecular pathology interpr A 0.37 0.14 0.14 0.02 0.53 0.53

86325 Other immunoelectrophoresis X 0.00 0.00 0.00 0.00 0.00 0.00 88304
88304 26
26 Tissue exam by pathologist
pathologist AA 0.22
0.22 0.10
0.10 0.10
0.10 0.01
0.01 0.33
0.33 0.33 88358 TC Analysis tumor A 0.00 2.31 NA 0.01 2.32 2.32 P3001 Screening pap smear by phys A 0.26 0.46 0.46 0.01 0.73 0.73

86327 26 Immunoelectrophoresis assay A 0.42 0.21 0.21 0.01 0.64 0.64 88304
88304 TC
TC Tissue exam by pathologist
pathologist AA 0.00
0.00 0.82
0.82 NA
NA 0.01
0.01 0.83
0.83 0.83 88358 Analysis tumor A 0.95 2.79 NA 0.03 3.77 3.77

86327 Immunoelectrophoresis assay X 0.00 0.00 0.00 0.00 0.00 0.00 88304
88304 Tissue exam by pathologist
pathologist AA 0.22
0.22 0.92
0.92 NA
NA 0.02
0.02 1.16
1.16 1.16 88360 26 Tumor immunohistochem/manual A 0.85 0.36 0.36 0.01 1.22 1.22

86334 26 Immunofix e-phoresis serum A 0.37 0.14 0.14 0.02 0.53 0.53 88305
88305 26
26 Tissue exam by pathologist
pathologist AA 0.75
0.75 0.33
0.33 0.33
0.33 0.01
0.01 1.09
1.09 1.09 88360 TC Tumor immunohistochem/manual A 0.00 2.30 NA 0.01 2.31 2.31 An “NA” indicates that this procedure is rarely or never performed in that setting.

86334 Immunofix e-phoresis serum X 0.00 0.00 0.00 0.00 0.00 0.00 88305
88305 TC
TC Tissue exam by pathologist
pathologist AA 0.00
0.00 0.88
0.88 NA
NA 0.01
0.01 0.89
0.89 0.89 88360 Tumor immunohistochem/manual A 0.85 2.66 NA 0.02 3.53 3.53 An RVU of “NA” will usually be paid at the other setting’s rate. CPT codes and descriptions only are

86335 26 Immunfix e-phoresis/urine/csf A 0.37 0.14 0.14 0.02 0.53 0.53 88305
88305 Tissue exam by pathologist
pathologist AA 0.75
0.75 1.21
1.21 NA
NA 0.02
0.02 1.98
1.98 1.98 88361 26 Tumor immunohistochem/comput A 0.95 0.33 0.33 0.01 1.29 1.29 copyright 2019 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Apply.

1219_14-16_RVU.indd 14
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DECEMBER 2019 page 15 12/4/19 1:24 PM

 16 CAP TODAY | DECEMBER 2019
Physician fee schedule
continued from 15
secured the support of the AMA and
worked with the CMS to protect the
value of these services. However,
the agency finalized its initial rec-
ommendation for the following
services:
J Cytopathology, cervical, or vagi-
nal (any reporting system), requiring
interpretation by a physician (code
88141).
J Screening cytopathology, cervical,
or vaginal (any reporting system),
collected in preservative fluid, auto-
mated thin layer preparation, requir-
ing interpretation by a physician
(code G0124).
J Screening cytopathology smears,
cervical, or vaginal, performed by an
automated system, with manual re-
screening, requiring interpretation by
a physician (code G0141).
J Screening Papanicolaou smear,
cervical, or vaginal, up to three
smears, requiring interpretation by a
physician (code P3001).
The CAP remains opposed to
these reductions and will continue to
advocate for their accurate valuation.
(See “Pathology values,” this page.)
Two proposals shelved. In a sepa-
rate regulation for the Medicare Hos-
pital Outpatient Payment System
also released Nov. 1, the CMS agreed
with the CAP’s advocacy by shelving
two proposals.
The CAP turned back the CMS
proposal to specify that the ordering
physician would determine whether
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the results of the advanced diagnos-
tic laboratory tests (ADLTs) or mo-
lecular pathology tests are intended
to guide treatment provided during
a hospital outpatient encounter. If
the ordering physician had consid-
ered the test would guide treatment
during the hospital outpatient en-
counter, the test would have been
regarded as a hospital service. The
agency had also proposed removing
molecular pathology tests from the
laboratory date-of-service exception
and limiting it only to ADLTs. The
CMS said it no longer believes the
beneficiary access concerns that ap-
ply to ADLTs also apply to molecular
pathology tests.
The CAP disagreed and advo-
cated for the exception to continue to
apply to molecular pathology tests,
highlighting that the tests are still not
commonly performed by hospitals,
as they are not always practical or
cost-effective due to lower test
volumes.
In another date-of-service proposal,
the CAP worked with the AABB to
urge the CMS to finalize a date-of-
service proposal for laboratory test-
ing. In the final Hospital Outpatient
Payment System regulation, the CMS
decided that the date on which blood
banks perform the laboratory test on
specimens collected during a hospital
outpatient encounter will be the date
of specimen collection. As a result, the
hospital will bill Medicare for the
laboratory test, and the blood bank
performing the test would seek pay-
ment from the hospital.
cap.org
The CMS also agreed to define a
blood bank as an entity whose pri-
mary function is the performance or
responsibility for the performance of
the collection, processing, testing,
storage, and/or distribution of blood
or blood components intended for
transfusion or transplantation.
Outpatient payment for 88307.
After threatening another cut, the
CMS retained its payment assign-
ment for the surgical pathology code
88307 in the Hospital Outpatient
Payment System. Initially, the CMS
had proposed lowering the hospital
ambulatory payment classification
for 88307 by 46 percent. After consid-
ering the CAP’s comment and analy-
sis of the updated claims data for the
final rule, the CMS decided to main-
tain the ambulatory payment classi-
fication assignment for 88307 in 2020.
MIPS scoring tougher in 2020.
For pathologists participating in
Medicare’s Merit-based Incentive
Payment System in 2020, the CMS
increased its performance threshold
to 45 points, from 30 points in 2019,
to avoid a payment penalty. MIPS
scores based on 2020 performance
will affect Medicare reimbursement
in 2022. MIPS-eligible physicians
who score fewer than 45 points in
2020 will receive a nine percent pay-
ment cut in 2022. The CMS detailed
these changes Nov. 1 in a regulation
for its Quality Payment Program,
which includes MIPS.
The CMS had sought to remove
four pathology quality measures, but
the CAP demonstrated the need for
more appropriate measures for pa-
thologist participation in MIPS. As a
result, the CMS retained the four
pathology measures that otherwise
would have been removed and
added a dermatopathology measure
to the pathology measures set.
Starting in 2019, Medicare Part B
claims measures could only be sub-
mitted via claims by pathologists in
a small practice (15 or fewer eligible
clinicians) and can be submitted with
individual or group participation.
Pathologists in a group of 16 or more
can no longer submit quality mea-
sures using claims, regardless of
whether participating as an indi-
vidual or group, and must submit
using a qualified registry or qualified
clinical data registry. These rules will
again be in effect for 2020. The CAP’s
Pathologists Quality Registry is a tool
that provides both reporting options
for MIPS-eligible pathologists, prac-
ticing in either small or large prac-
tices, to meet MIPS requirements.
Pathology values. The CAP advo-
cates for the appropriate valuation of
pathology services as the pathology
representative on the RUC advisory
committee. The AMA RUC is an ex-
pert panel that uses its independent
judgment to assist specialties in ap-
propriately valuing their work. It
provides physicians with a voice to
shape how they are paid for their
services, and the CAP participates in
the RUC process to advocate for ap-
propriate payment of pathology
services.
CAP members can participate di-
rectly in the RUC process by partici-
pating in the CAP’s RUC survey
process. These surveys assist the
CAP in assessing the time, intensity,
complexity, and ultimate value of
pathologists’ work. The CAP’s advo-
cacy staff conducts periodic physi-
cian work surveys to gather data
used to advance the specialty and to
accurately account for the patholo-
gists’ work efforts. These surveys
may be associated with new, revised,
or potentially misvalued pathology
services in need of valuation or
revaluation.
Pathologists chosen for a physi-
cian work survey receive an email
requesting completion of a 10- to
15-minute online survey. CAP
members are encouraged to take all
AMA RUC physician work surveys
and to be honest about the typical
time and work spent on an indi-
vidual service.
A July 2017 Advances in Anatomic
Pathology article, “Current valuation
of pathology service,” coauthored by
Jonathan L. Myles, MD, who served
previously as the CAP’s member on
the AMA RUC advisory committee
and is now a member of the CAP
Board of Governors, explains how
pathology services are valued and
notes that the work RVU component
represents a “physician’s time to
perform the service, the technical
skill and physical effort, the required
mental effort, and judgement, as well
as the stress due to potential risk to
the patient” (Myles JL, et al.
24[4]:222–225).
Charles Fiegl is the CAP’s director for
advocacy communications, Washington,
DC.
Do you have a
laboratory medicine
or pathology-related
question that is of
general interest?
Submit your question at www.
captodayonline.com/q-a-submission/ or
email your question to srice@cap.org.
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 18 CAP TODAY | DECEMBER 2019

High-sensitivity troponin course, no matter how matters might

continued from 1
trials laboratory, Hennepin Healthcare
Research Institute. “If you start offer-
ing the option of either high-sensitiv-
ity or contemporary troponin assays,
it will be confusing to providers.”
look on the surface. For years U.S.
labs had looked with envy at Eu-
rope’s widespread use of high-sen-
sitivity cardiac troponin assays. The
exciting news now is that with the
relatively recent FDA clearance of
four high-sensitivity cardiac troponin
assays, “Everything is in play in the
cine and pathology, University of
Minnesota, and co-director, clinical
and forensic toxicology laboratory,
Hennepin Healthcare/Hennepin
County Medical Center. Siemens
Healthineers and Beckman Coulter
also offer high-sensitivity troponin
I assays, and more are likely on the
way. Laboratories have begun of-
group, which was led by a hospitalist
and included two cardiologists, Dr.
Karon, and the practice chair of emer-
gency medicine. Beyond that core
group, “We pulled in representatives
from the outpatient practice, surgery,
anesthesia—pretty much every area
of practice,” Dr. Karon says.
The group began its work in fall

T here’s actually nothing “over-

night” about any of this, of
U.S. right now,” says Dr. Apple, who
is also professor, laboratory medi-
fering hs-cTn assays or are at least
considering the switch.
As they should be, says Dr. Apple.
“Everyone who is using a contempo-
rary assay should, as soon as possible,
consider implementing a high-sensi-
tivity troponin assay, whether you’re
an I or a T user,” he says. “The wealth
of clinical data for early rule-outs and
earlier rule-in of myocardial infarc-
tion, within a two- or three-hour
window, is a very positive patient
2017. The laboratory’s first step was
collecting 1,500 samples, from
slightly more than 800 patients, and
measuring both 4th Gen and 5th Gen
troponin T. “That allowed us to pres-
ent to the implementation group the
implications of moving to the 5th
Gen T,” Dr. Karon says. “We had
discussions on what our reference
intervals would be, and those were
all up to the implementation group
to decide.”

Transfusion ready care incentive to bring these assays to

practice, especially for females.”
(Note: Gen 5 was not designated
Ultimately they went with fairly
low intervals—10 ng/L for females
and 15 ng/L for males—based on the

platelets. by the FDA as a high-sensitivity as-

say, though it is considered to be a
hs-cTn in Europe. It is, however,
more sensitive compared with the
European guideline, and forgoing the
package insert.
They adopted a zero-, two-, and
six-hour panel to replace the previous

No bacterial Gen 4 cTnT assay, “so it’s in be-

tween,” says Dr. Karon. This has not
created problems for his clinical col-
panel of zero-, three-, and six-hour
measurements. The implementation
group “was constantly asking ques-

testing required. leagues, he says. “It doesn’t seem to

bother them. I think they’ve gotten
the fact that this is an FDA labeling
issue,” and that the Gen 5 is being
used in clinical protocols that are
based on hs-cTn assays.)
The assays also provide welcome
risk stratification, which hadn’t been
possible with previous assays, Dr.
Apple says. High-sensitivity cardiac
troponins provide a reference inter-
val, similar to that offered by high-
sensitivity C-reactive protein, he says,
“where we’re actually able to look at
a continuum of risk in patients to
Comply with the FDA bacterial guidance determine separately for males and
using a complete solution females what their relative risk is,
both for all-cause mortality as well as
that goes beyond bacteria: major adverse cardiac events over,
say, a 180-day period.”
The INTERCEPT® Blood System The switch was a logical choice at
Mayo, says Dr. Karon. For years, the
pathogen reduction system. institution has had active research
programs in cardiovascular medicine
and troponin testing. So once 5th Gen
became approved in the United
States, “there was a desire to imple-
tions” about the number of patients
available for comparison; since there
were no previous two-hour samples,
“as we designed the protocols we
assumed the two-hour value would
behave more or less like the three-
hour value from our sample set,” Dr.
Karon says.
A one-hour measurement was
even more appealing, says Mayo’s
Allan S. Jaffe, MD, but ultimately the
group decided against it. The preci-
sion of the new assay and the tight,
very small differences that needed to
be detected made it “very likely, if not
absolutely clear, that we would mis-
classify some patients” in the course
of shaving an hour off the protocol.
“So we went with a two-hour proto-
col to avoid that specifically,” says Dr.
Jaffe, professor of cardiology, profes-
sor of laboratory medicine and pa-
thology, and former chair of the clini-
cal core lab services division of the
Department of Laboratory Medicine
and Pathology. An expert on the use
of cTn, he has been responsible for the

LEARN MORE. ment that into our practice.” troponin component of the universal
definition of myocardial infarction.

HCP.INTERCEPT-USA.COM D esire alone sustains only poets,

however. Ardor needs action.
At both Mayo and Hennepin, the
Among the key questions that
arose, Dr. Karon says, “was how
many patients in the ED will have an
Rx Only. See package inserts at http://hcp.intercept-usa.com/resources for full prescribing information. work has been taken up by those elevated value compared to the cur-
CONTRAINDICATIONS. Contraindicated for preparation of platelet components intended for patients with a
history of hypersensitivity reaction to amotosalen or other psoralens. Contraindicated for preparation of outside as well as inside the labora- rent state.” The lab had an answer,
platelet components or plasma intended for neonatal patients treated with phototherapy devices that emit a
peak energy wavelength less than 425 nm, or have a lower bound of the emission bandwidth <375 nm, due
tory. As Dr. Apple puts it, “The based on those 1,500 samples: About
to the potential for erythema resulting from interaction between ultraviolet light and amotosalen. WARNINGS more the merrier. You don’t want to 30 percent of patients in the ED had
AND PRECAUTIONS PLATELETS : Pulmonary events: Acute Respiratory Distress Syndrome (ARDS). INTERCEPT
processed platelets may cause the following adverse reaction: Acute Respiratory Distress Syndrome (ARDS). have anyone feel like they weren’t elevated 4th Gen T, and slightly more
An increased incidence of ARDS was reported in a randomized trial for recipients of INTERCEPT processed consulted.” than 60 percent had an elevated 5th
platelets, 5/318 (1.6%), compared to recipients of conventional platelet components (0/327). Monitor patients
for signs and symptoms of ARDS. ©2019 Cerus. MKT-EN 00413-12. Mayo formed an implementation Gen T, he says. —continued on 20

1219_1-58_Troponin-Diabetes-Flu_v3.indd 18
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20 CAP TODAY | DECEMBER 2019
High-sensitivity troponin
continued from 18
“It actually didn’t concern the ED
as much as it has in most other insti-
tutions,” says Dr. Karon. That’s be-
cause for a decade the lab had already
been relying on a troponin panel that
included calculated delta values be-
tween time points reported directly
into the EMR, as well as information
from Dr. Jaffe and recommendations
from national and International Fed-
eration of Clinical Chemistry and
Laboratory Medicine guidelines
about best practices for fifth-genera-
tion implementation.
Under the new protocol, most
patients in the ED get a zero- and
two-hour value; 80 to 90 percent do
not need a six-hour measurement.
“So the ED can make decisions
faster,” Dr. Karon says. “It makes
them very happy.”
At Mayo Rochester, adopting the
new protocol has been a seamless
transition, he says. “I think six, eight
months in we got it to work quite
well. We don’t hear many issues or
complaints or confusion.” This is due
in part to the fact that “we’re operat-
ing in the world of panels, where you
need to look at the individual abso-
lute panels and the deltas between
time points. And the lab, in the EMR,
provides an interpretation of the delta
as changing or not changing.” A full
decade before the switch to 5th Gen,
clinicians had been using panel test-
ing with the 4th Gen—the approach
was a familiar one, in other words.
Adoption has hit a few potholes at
‘I think six, eight months in we got it to
work quite well. We don’t hear many
issues or complaints or confusion.’
Bradley Karon, MD, PhD
Mayo’s other sites, which have less
experience using panels, he says.
Values are reported as whole
numbers in ng/L, while previous
assays used ng/mL. Mayo’s clini-
cians adapted with relative ease, Dr.
Karon says. “We have very good in-
ternal education, so prior to imple-
mentation Dr. Jaffe and others in
cardiology presented at many, many
practice groups.” Mayo also uses a
real-time point-of-care information
system internally, called Ask a Mayo
Expert, which included information
developed by cardiology and emer-
gency medicine. That, too, helped
smooth the path.
High-sensitivity cardiac troponin,
like a fringe religious sect, seems to
both excite the imagination and
arouse fear. On his listening tour, Dr.
Jaffe did hear plenty of the-world-is-
going-to-end angst. “Of course that
didn’t happen,” he laughs.
Clinicians asked about running
both tests side by side, but Dr. Karon
and colleagues were adamant. As the
aforementioned pilot study made
clear, the logistics of running both
tests and reporting results is not triv-
ial, Dr. Jaffe says.
It also confirmed that the correla-
tion between the Gen 4 and Gen 5 is
not precise. “A less than .01 on a Gen
4 could be less than six on a 5th Gen.
It could also be a 20, it could be a 30.
The tests don’t correlate well at val-
ues [5th Gen] below 100 ng/L,” says
Dr. Karon. “My concern on a burn-in
is one patient would have less than
.01 with a less than six, and this next
patient would have less than .01 with
a 25, and somebody’s going to call the
lab and say, ‘Which one is right?’
Well, they’re both right. They don’t
correlate well at those levels.”
I t’s also becoming evident that
using the same cutoff for women
and men is not an ideal match. The
decision to use sex-specific cutoffs
follows recommendations by the
IFCC Committee on Clinical Ap-
plications of Cardiac Biomarkers
and the AACC Academy, says Amy
K. Saenger, PhD, DABCC, and is
endorsed in clinical guidelines, pri-
marily the “Fourth universal defini-
tion of myocardial infarction (2018)”
(Thygesen K, et al. J Am Coll Car-
diol. 2018;72[18]:2231–2264). Her
support for sex-specific cutoffs is
unwavering. “It is clear that males
and females have different cutoffs,
with females having a lower 99th
percentile,” says Dr. Saenger, medical
director of the clinical laboratories,
Hennepin County Medical Center,
and associate professor, Department
of Laboratory Medicine and Pathol-
ogy, University of Minnesota.
“You’re probably missing some
elevations in women if you’re not
using them,” Dr. Karon says.
Dr. Apple agrees that incentive to
use sex-specific cutoffs is strong.
“There are data to show that women
will benefit much more strongly
than men because we will be picking
up a greater percentage of women
who would have been missed for
smaller MIs.”
“My thought on this,” he contin-
ues, is “it’s no different than CK-
MB,” the assay of choice two test
generations ago. “We had statistically
different male versus female cutoffs,
and we implemented and used those
in practice.”
Not to put too fine a point on it, he
adds, this is the norm of working in
laboratory medicine. “What do we
do?” he asks. “We do the appropriate
validation to look for reference
ranges that are statistically different.
I think it’s a disservice to any patient
population not to use those.”
The lower 99th percentile for
women makes sense from a patho-
physiological standpoint, says Dr.
Saenger, given that the amount of
myocardium differs —continued on 22
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 22 CAP TODAY | DECEMBER 2019
High-sensitivity troponin
continued from 20
between the sexes. Nevertheless, she
says, “Reporting sex-specific cutoffs
is more controversial on the clinical
side,” with many cardiologists think-
ing they’re unnecessary or that a
randomized controlled trial is
needed to prove their usefulness.
Echoing Dr. Apple, she says, “We do
not do that for any other assay. If
there are studies that show there are
sex-specific differences, like in the
case of creatinine, we validate or
verify this with our assay and report
the reference intervals in that man-
ner. High-sensitivity troponin assays
should be no different.”
Dr. Jaffe notes the variety of opin-
ions in the field, and then points out
that much of it depends on the as-
say—some have a large difference
between the 99th percentile values in
women and men. “My concern has
always been, and still is, that many
of the studies done in Europe did not
include an adequate cohort of
women to know if sex-specific cut-
offs are or are not important.” Re-
member, he says, the majority of
European studies included only pa-
tients whose symptoms were typical,
which restricted the involvement of
women, who often present atypically.
“So they decided they didn’t need to
use it. I think in retrospect that it’s
very likely that if they had had a
broader screen, and been more open
to the idea” of the sexes presenting
differently, “they may well
KR3Screen_2thridCAPToday_banner1910_x1a.pdfhave
1 4:22 PMrates.” She is confident that
10/1/19
come to a different conclusion.”
1219_1-58_Troponin-Diabetes-Flu_v3.indd 22
Moreover, with many of the popula-
tion studies done in Europe, patients
were not as sick as those typically
seen in U.S. EDs.
Dr. Saenger agrees: “Data now
indicates that MI is underdiagnosed
in females not because their symp-
toms are more vague or they present
later in life, but largely due to the fact
that we were using the wrong cut-
off.” Labs couldn’t distinguish ana-
lytical differences in 99th percentiles
before the advent of hs-cTn, she says.
When sex-specific cutoffs are used,
MI rates for males and females are
nearly the same, though she too
notes that it depends on the assay.
M uch of the literature is based
  on European experience, but
the data globally are overwhelming
for rule-outs, Dr. Apple says. That,
plus multiple guidelines, should
persuade labs to adopt the newer
high-sensitivity assays. “It’s a huge
patient safety positive impact when
you bring this assay up,” he says.
“You bring it up, and you eventually
have enough of your own data. You
analyze your own data to see how
it’s doing.”
Hennepin is fortunate in the data
department, says Dr. Saenger, noting
that the majority of the U.S. data for
Abbott’s hs-cTnI assay is based on
the Hennepin UTROPIA study co-
hort. On both the lab and clinical
side, “We have seen some of the nu-
ances and can predict how imple-
menting this test will impact our
positivity
the upcoming move from contempo-
rary cTnI using an overall 99th per-
centile to hs-cTn using sex-specific
percentiles “will not result in a major
increase in the number of patients
with an ‘abnormal/flagged’ value.”
European traditions, while fine
for Europe, can benefit from a bit of
tweaking on American shores (a
point not lost on colonial Ameri-
cans). Dr. Jaffe noted some of the
differences in a paper he co-wrote on
implementing the Gen 5 assay (San-
doval Y, Jaffe AS. Am J Med. 2017;
130[12]:1358–1365). Several Euro-
pean studies, for example, advo-
cated using an absolute baseline
cutoff value of 52 ng/L (for hs-cTnT)
as a positive one-hour rule-in for
acute myocardial injury. “It’s not that
it doesn’t work in an ideal circum-
stance,” says Dr. Jaffe. But the United
States is not an ideal controlled
study population, and the European
experience “didn’t take into account
that in the United States we draw
troponins on a much larger number
of patients.”
In Europe, studies were oriented
to patients with chest pain—and
those who present with typical chest
pain at that. “And the older you are,
the less typical you become,” says Dr.
Jaffe. “As an obligatory rule-in, 52
ng/L would sweep half of critically
ill patients into the hospital,” he says,
as well as older individuals with
comorbidities.
That hasn’t happened at Mayo,
though Dr. Jaffe heard his fair share
of doomsday scenarios from worried
colleagues before the implementa-
tion. There’s been no great uptick in
DECEMBER 2019 page 22
patients admitted or additional pro-
cedures, he reports. The majority of
patients—more than 80 percent—are
triaged within a couple of hours, he
says, and 10 to 20 percent require
later samples.
Some gaps have occurred. “We
used an absolute delta of 10. And as
you start getting values that are
higher and higher and higher,” Dr.
Jaffe says, “that’s just too low. So we
would argue for changing that, and
simply say that when the value is
over 100, start using a percentage
criteria of, say, 20 percent.”
A second gap—“We alerted peo-
ple, but obviously we didn’t educate
adequately,” Dr. Jaffe says—con-
cerned patients who present late after
the onset of their MIs. “We guessed
12 hours, but that may not always be
the ideal number,” Dr. Jaffe says.
“They’re on the downslope of the
time-concentration curve for tropo-
nin, which is much slower than the
upslope.” As result, it’s easy to miss
a delta.
In fact, he continues, “I have a
whole collection of such cases,”
where the MI was missed and ele-
vated troponin values were instead
attributed to ischemic heart disease.
Finally, Dr. Jaffe says, physicians
need to be sensitized to the fact that
“there are many more type two MIs
now. Using sex-specific cutoffs,
we’re finding more modest, or
small, MIs, particularly in women.”
Some, though not all, fit into the
category of myocardial infarction
with nonobstructed coronary arter-
ies, a constellation —continued on 24
12/3/19 3:46 PM
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 24 CAP TODAY | DECEMBER 2019
High-sensitivity troponin
continued from 22
of microvascular dysfunction, some
of which can be due to unseen
plaque ruptures. “This is an increas-
ing commonality that we need to be
careful about.”
The major lab-related issue at
Mayo, says Dr. Karon, involves ana-
lytical outliers. “We have made
somewhat of a hobby out of studying
them,” he says. Data so far show the
frequency of analytical outliers is
higher with the 5th Gen than with
the 4th Gen.
“The issue is you’re making deci-
sions on much smaller changes in
troponin concentration,” he says.
That could give rise to analytical
outliers due to fibrin strands or acti-
vated platelets, for example, or cen-
trifugation conditions or instrument-
to-instrument/platform-to-platform
differences. (Mayo has a benchtop
immunoassay analyzer in the stat lab
and large, automated equipment in
the core lab.) “You need to worry
about those more, because now we’re
saying a change, or at least an inde-
terminate delta, is 4 to 9 ng/L. So if
a change is over 3 ng/L over two
hours, we’re saying potentially that
it’s significant. It’s called indetermi-
nate in our practice.”
Yet he fully recognizes that this
represents a very tiny change in con-
centration. “We’re asking this assay
to do more when we’re using it for a
panel and trending over time,” Dr.
Karon says. “So the two issues we’ve
found to be more significant, and we
spend more time on, is detecting our
analytical outliers and looking at
how our different instruments and
platforms agree with each other.”
Dr. Jaffe calls these fliers. “We had
a little more than three percent non-
repeatables, which is high. These as-
says are highly sensitive. And conse-
quently, little things can cause bigger
signals than we’re used to seeing.”
Dr. Apple, who is familiar with
Mayo’s data on outliers, says instru-
ment/platform differences can be
vexing. A three-hospital system may
have three different instruments,
which can present different results.
And yet clinicians can’t be expected
to know why. “It’s tough to educate
clinicians,” Dr. Apple says, “because
they don’t give a rip if it’s instrument
A, B, or C. They just want a reliable
number.”
Preanalytical issues like hemolysis
and biotin may present challenges
when reporting results, Dr. Saenger
says. If the hemolysis threshold is
fairly low and/or subject to visual
interpretation, then hs-cTn results
1219_1-58_Troponin-Diabetes-Flu_v3.indd 24
might be reported as falsely low or
falsely high. “This would obviously
affect interpretation of a single hs-
cTn result,” she says, “but also could
affect interpretation of serial results.”
Some commercially available tro­
ponin assays are sensitive to biotin
interference at fairly low biotin con-
centrations, Dr. Karon says, “though
there is not great evidence about how
often patients are presenting with
biotin levels that would pose a sig-
nificant risk to interpretation of tro-
‘There are many more type two MIs now.
Using sex-specific cutoffs, we’re finding more
modest, or small, MIs, particularly in women.’
Allan Jaffe, MD
ponin values.” As with hemolysis, he
adds, biotin effects will change over
time, potentially confounding inter-
pretation of tro­ponin panels.
The IFCC committee on clinical
applications of cardiac biomarkers
routinely updates several tables on
its website (http://j.mp/2qKSK25) with
analytical information related to all
hs-cTn, contemporary, and POC
troponin assays, Dr. Saenger says;
one of these tables lists analytical
specificity information for each
troponin assay related to interference
from hemolysis and biotin.
The various hs-cTn assays also
have their own differences. Dr. Apple
is principal investigator of the CON-
TRAST study, a comparison of the
Roche T and Abbott I hs-cTn assays
involving about 2,000 participants.
“There are considerable differences
between positives and negatives be-
tween the two assays,” he says.
“There’s a subgroup of maybe 10, 15
percent of patients who don’t match
up at all.” It’s unclear why.
But one thing is clear already, he
says: Switching from one assay to
another “will have to be looked at
very carefully if that’s what you de-
cide to do, as troponin assays are not
standardized.”
He’s also finalizing another clini-
cal study, called Scorecard, which
involves 1,000 emergency depart-
ment patients from three cohort
sites—Scotland, Mayo, and Henne-
pin—and is looking at measurement
of only baseline samples and 30-day
outcomes. “We’re just starting to ana-
lyze the data to see what percent of
patients would be able to be safely
discharged based on each assay,” Dr.
Apple says.
“As more people start studying
troponin, we’re going to see a lot
more good data coming out that will
solidify within 12 months in the
U.S.,” he predicts. “That literature
will become more robust with evi-
dence-based information.”
In the meantime, Drs. Apple and
Jaffe helped write an article that
serves as a starting point for labs
making the switch to hs-cTn (Wu
AHB, et al. Clin Chem. 2018;64[4]:
645–655). In addition, Dr. Apple
urges labs to do their due diligence
when deciding on an upper refer-
ence limit (URL), since they vary
based on population. He sounds a
cautionary note: A URL based on a
data set from a package insert may
or may not take into account exclu-
sions due to, say, surrogate biomark-
ers, such as increased hemoglobin
A1C, elevated natriuretic peptides,
or statin use, which would eliminate
silent pathophysiologies and lower
sex-specific URLs.
L ooking back over Mayo’s experi-
   ence, Dr. Karon suggests that
time is the laboratory’s best friend.
“Work toward implementation well
ahead of when you say you’re going
to bring this up,” he says. “Analyti-
cal validation took a lot longer than
even I expected it would.” The pro-
tocols were developed over the fall of
2017, and the implementation group
kicked into high gear in January/
February 2018.
It also took time to get the IT right
and to train the lab staff. The clinician
orders a zero- and two-hour value,
and the LIS calculates whether a six-
hour sample (ordered reflexively) is
needed. That six-hour order appears
from nowhere, or so it seemed to lab
staff. “It’s probably one of the more
complicated, and maybe the most
complicated, sort of reflex lab proto-
col to support,” says Dr. Karon. “So
it does take some efforts from our
phlebotomists, our laboratories to
work together to do this right. It’s
fairly well automated now, but it can
be challenging to support. There’s
always weird exceptions that hap-
pen—you know, how did somebody
get a six-hour sample collected be-
fore their two-hour?”
“The biggest impediment we had
was trying to get our IT systems to
accommodate something new,” Dr.
Jaffe agrees.
IT issues and clinical buy-in are
DECEMBER 2019 page 24
also influencing the pace of the roll-
out at Hennepin, Dr. Apple says. “It
takes time to change order sets in
LIS/Epic, and it takes time to meet
with all the different clinical divi-
sions to discuss how practice pat-
terns may change based on a new
assay.” The assay is hardly new in
Hennepin’s lab. But, he says, “As
much as we know about hs-cTnI, we
need to gain the confidence of all the
providers—clinicians, nursing, et
cetera—of what the new world of a
new troponin assay will entail.”
Hennepin has started working on
the rollout. A three-person team that
includes Dr. Apple, Dr. Saenger, and
Stephen Smith, MD, an emergency
medicine colleague, is leading the
launch. Educational discussions are
being scheduled, similar to the Mayo
pathway. It will require “education,
sometimes a lot of education, and
certainly ongoing education,” says
Dr. Saenger.
“We’re going to essentially put
together a teaching deck based on
our own experiences and the lit-
erature,” Dr. Apple says. The group
will meet with emergency medicine
physicians, cardiologists, surgeons,
and hospitalists and talk about how
the assay will be implemented. Even
with all the experience, it’s not a mat-
ter of flipping the switch the lab’s
finger has been hovering over for
six years. (To be fair, even Riccardo
Muti occasionally glances at his
Verdi score.)
The primary teaching, says Dr.
Apple, is “not to be fearful that there’s
going to be a lot more positives.”
If everything goes according to
plan, Hennepin will likely roll out
the new assay in the first quarter of
2020, using a zero-/two-hour algo-
rithm, “with an additional six-hour
draw for patients you’re not sure
about,” Dr. Apple says.
A zero-/one-hour protocol was
tempting, but—like Roger Maris’
home run record—its use carries an
asterisk. The algorithms for early
presenters are particularly problem-
atic, Dr. Apple says. “So we don’t
want to miss an early presenter with
a potential worse sensitivity, or nega-
tive predictive value. And to be hon-
est, it’s going to be easier to draw a
blood sample and not miss the time
window at zero-/two-hours.”
Once hs-cTnI is in place, Dr. Apple
says, “We hope to be able to dis-
charge, conservatively, 20 percent of
patients based on their zero-hour and
zero-/two-hour measurements—a
substantial financial savings to the
hospital.”
Nevertheless, physicians are ner-
vous, he acknowl- —continued on 26
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 26 CAP TODAY | DECEMBER 2019

High-sensitivity troponin in positive findings, especially in

continued from 24
edges. “I think one fear factor with
clinicians is they have [the] miscon-
ception that they’re going to have a
hundred more consults a day be-
cause of additional increases in tro-
ponin,” he says. He downplays the
scope while acknowledging there
will indeed be at least some increase
CAP TODAY Webinar
Current and Emerging Biomarkers:
Optimizing Testing Strategies
in Metastatic NSCLC
Wednesday, January 15, 2020, 1:00 pm–2:00 pm ET
females. Even if it’s not an indication
of an MI, the elevation would be
important as a marker of myocardial
injury with an underlying need for
risk assessment. “It’s a flag that’s
being waved,” he says. Perhaps an
outpatient cardiology consult is in
order—a patient with a primary
neurological problem, for example,
and an elevated troponin is at in-
creased risk for an adverse event.
Sorting through this is going to be a
learning curve for providers but
significantly better for patient care,
he says.
Fears about a soaring number of
abnormals, especially for cardiac
troponin T, has led many institutions
to implement a cutoff above the 99th
percentile, Dr. Saenger reports. While
many clinicians think these are false-
positives, she says, the hs-cTn assays
actually are detecting subtle but rel-
evant changes. “It just takes some
time for them to feel comfortable
interpreting these changes and deter-
mining appropriate treatment.” That
being said, however, it can be diffi-
cult to identify a relevant serial
change for troponin, given that each
assay is different and serial changes
can vary due to timing of collection
protocols, early versus late patient
presentation to the ED, and comor-
bidities, Dr. Saenger notes.
Has Dr. Apple faced pushback,
even despite his years of advocacy at
Hennepin? “Let’s say I have 10 car-
diologists in a room,” he says.
“There’s always going to be one or
two who fight it.” Indeed, there are
still cardiologists carrying the Lost
Cause banner for CK-MB, he says. In
the case of hs-cTn, however, he ex-
pects reluctance to fade in a matter
of weeks once it’s implemented. “It’s
awesome,” he reiterates. There may
be more questions about what to do
with results, but he doesn’t expect
people to push back against having
those results. “I think clinicians will
grow to like it,” he predicts. “And
there will be less worry once it’s in
place six months to a year.”
The ED is excited, Dr. Apple says.
So are cardiologists who under-
stand the field of troponin. The ones
who haven’t paid attention, he says,
who dismiss the need for biomark-
ers and cling to the older version,
are less thrilled.
It sounds as if he barely cares. “I
embrace it,” Dr. Apple says. “It’s the
next step in better patient care.”
Dr. Apple takes it one step further,
in fact. “I’m hoping manufacturers
will stop producing those old assays,”
he says. Alluding to an old Seinfeld
episode, he compares conventional
and hs-cTn assays to cinnamon and
chocolate babkas, respectively. “There
are people out there who love cin-
namon,” he acknowledges. But com-
pared with the chocolate versions, “It
is an inferior babka.”
Karen Titus is CAP TODAY contributing
editor and co-managing editor.

High-sensitivity cardiac
troponin in the outpatient setting
At least for now, Mayo Clinic does not offer the panel in the outpatient
setting. While there is evidence that anything above the upper reference
limit, or even a rising level within the URL, on an outpatient implies
greater risk, “there’s not a lot of information on what you do about it,”
says Dr. Karon.
Might there be a role for individual test orders? The data to support such
Geoffrey R. Oxnard, MD Lauren Ritterhouse, MD, PhD use is strong, Dr. Jaffe says, and single orders will likely grow. Nevertheless,
Associate Professor of Medicine Associate Director, Center for Integrated Diagnostics
Dana-Farber Cancer Institute Assistant Pathologist, Massachusetts General Hospital next steps are unclear. “Some clinicians are reluctant to go there, because
Harvard Medical School Assistant Professor, Harvard Medical School they say, ‘I don’t know what to do.’ Others say, ‘If a person has an elevated
troponin, I ought to know about it.’” Perhaps that information can be useful
if the patient goes to the ED, goes the thinking, or can be integrated into
Why should you register now for this webinar? the patient history/physical exam to help prevent disease.
Hear national thought leaders discuss the following topics: As for himself, “I use it very commonly in patients with atrial fibrilla-
n Rationale for biomarker testing in patients with mNSCLC
tion,” Dr. Jaffe says. “I think eventually we’ll be using this a lot in the
outpatient setting.”
n Near-term prospects for changes in biomarker testing recommendations
Dr. Saenger points to cardio-oncology data on the use of high-sensitiv-
n Strategies to maximize identification of actionable mutations
ity cardiac troponins to evaluate cardiotoxicity from chemotherapeutic
Brought to you by CAP TODAY agents. She also foresees a time in the (much more standardized, much
Moderated by Bob McGonnagle, Publisher, CAP TODAY more harmonized) future when hs-cTn could be used over long periods
Presenters: Geoffrey R. Oxnard, MD, and Lauren Ritterhouse, MD, PhD of time to monitor health, similar to glucose/HbA1c, creatinine/eGFR,
You will have the opportunity to ask questions of our distinguished presenters. or lipid testing, for example.
One of the biggest discussions going on today, says Dr. Apple, is in
Register FREE of charge at http://www.captodayonline.com/011520webinar noncardiac surgery: Should baseline and post-op troponins be measured?
“There’s a great wealth of data showing that patients are at risk—even
without an MI—when they have post-op elevations,” he says. The big
question, of course, is medicine’s evergreen query: What do you then do
with these patients? “Because not every pathophysiology has a treatment
mode.” There is, Dr. Apple says cheerfully, “only one way we’re going to
learn—we kind of live it.” —Karen Titus
CAp TODAY does not endorse any of the products or services named within. ©2019 AstraZeneca. All rights reserved.
US-34494 Last Updated 11/19

1219_1-58_Troponin-Diabetes-Flu_v3.indd 26
DECEMBER 2019 page 26 12/3/19 3:46 PM
 28 CAP TODAY | DECEMBER 2019

lis roundtable

The conversation continues: consolidation, IT labor force

IT as it relates to laboratory consolidation and the labor supply for lab IT were some the same as that of a 25-bed critical- try to get involved and make an im-
of what came up when CAP TODAY publisher Bob McGonnagle convened a panel access hospital. Looking at what pact. So it’s critical for all laboratori-
in September to talk about laboratory information systems. Part one of the discus- might be best for a large organization ans to understand their role within
sion is in the November issue (with the LIS product guide); part two begins here. takes time, and you have to be in- the ecosystem of their organization
On the panel were J. Mark Tuthill, MD, of Henry Ford Health System, Curt vested in understanding the clients to and how to work with executives to
Johnson of Orchard Software, Wally Soufi of NovoPath, Michelle Del Guercio of understand how you can integrate make sure they understand the value
Sunquest Information Systems, Nick Trentadue of Epic, Sepehr Seyedzadeh of
with other systems and what’s best the laboratory is bringing and ask to
Siemens Healthineers, and Tony Barresi of Beckman Coulter.
for the overall organization from an provide input in those decisions.
We recently read a news release about through mergers and acquisitions. IT and a laboratory perspective. If it’s
the continuing consolidation of impor- Not only are they dealing with the hospital to hospital, it’s typically go- Michelle, I’m sure you’re largely in
tant laboratory systems within not-for- combining of various cultures from ing to be a full consolidation unless agreement with what Curt said. Would
profit systems. South Bend Medical the different hospitals, but they have one is a very large academic center you care to add something in terms of
Foundation decided to sell its clinical to deal with the different systems and and one’s a rural critical-access hos- how important it is for the laboratory to
laboratory operation to LabCorp. This is the different processes associated pital. Then flexibility is needed. be at the table early?
one of a number of large deals an- with that. So we try to provide them When hospitals purchase physi- Michelle Del Guercio (Sunquest):
nounced within the past year or so. with ways in which they can reduce cian groups, integration is a different I definitely agree with what Curt has
I mention this to underscore how the disruption from the interoperabil- issue because now you’re talking said. Often, historically, LIS vendor
much consolidation we’re seeing of ity of the systems. about ambulatory care and different relationships have been within the
laboratories and of systems. We know billing issues. If the clinics have labo- laboratory. Our customers are asking
already we have a lot of consolidation in Wally, what is your experience at Novo- ratories and are doing their own test- us for help in how to get the lab into
instrument vendors, and we’ve seen a Path in this environment of consolida- ing, the workflow there is not the more of a strategic position within the
fair amount of consolidation among the tion of laboratories and the changes in same as that of a hospital. organization and elevate it to a level
IT vendors, particularly lab information pathology groups, most of which would So where does that fall in the pic- of being involved in those discussions
system vendors. Michelle, how does this be getting bigger and consolidating in ture and how do you account for at the C-suite level. Lab leaders are
consolidation look from the perspective ever greater geographic areas? How are that? In any of these scenarios, point- looking for ways to do that. Histori-
of Sunquest? If three or four hospitals you meeting that, and do you have a of-care testing also has to play a role cally they have not had the business
decide to join in a system in a large single answer or does it depend on the in where that testing is going to be training; they’ve very much been in
geographical area, for example, cer- individual case you encounter? done and what kind of systems are the lab. Often, they don’t know what
tainly not all of them share the same LIS Wally Soufi, chief executive officer, needed to integrate with it. to do, and so we are providing them
platform. I’m sure you get calls and NovoPath: It is case by case. What So communication is needed be- guidance to get them to have those
questions about how to deal with mul- typically drives the consolidation tween the C-level suites of these or- discussions, to collaborate with other
tiple LISs in the various laboratories of decision are the vision and priorities ganizations and the leaders of the departments, using lab data to show
the newly consolidated enterprises. Is articulated by the combined entity. laboratory—in consultation with the support for the enterprise. We’re
that a typical question, and is there a Unfortunately, lab needs don’t usually IT vendors and the personnel at the starting to see that shift and helping
typical, or in fact a not typical, response figure prominently on the priorities sites—to figure out what is going to them get through those discussions.
or action that you recommend? list. That enterprisewide consolida- have the greatest positive impact, not
Michelle Del Guercio, vice presi- tion is going to continue for a while. only on patient care but on the orga- It’s all very well for us to talk about
dent of marketing, Sunquest Informa- However, lab leaders will realize soon nization. When you figure that out, these great plans, but we know we
tion Systems: To answer your first enough that their workflow and busi- when the path forward is pretty have great constraints in terms of a
question, yes, it is something we see ness objectives are not a primary focus straight and everyone seems to agree labor supply. In addition, we increas-
as the merger and acquisition trend of the enterprisewide vendor. At that on it, you can proceed. ingly find that the laboratory itself has
continues. My response sounds like point, lab leaders will want to partner more limited IT staff time, money, and
the same answer each time but it of- with LIS vendors that help them Do you find yourself at Orchard spend- capability than it had in some years
fers a very different result and out- achieve their departmental goals. ing a lot of time helping to organize past because there’s so much central
come, and that is we do meet the those discussions and set directions for IT that goes on in these large systems.
customer where they are. Curt, you’ve spoken many times about those futures? Dr. Tuthill, can you comment on the
Sometimes it’s a Sunquest LIS; the consolidation. Do you find the rate Curt Johnson (Orchard): Not as state of play at Henry Ford of both top-
sometimes it’s not and instead it is is increasing, and is that putting addi- much as we would like. If you’re not ics: central IT control versus lab, and
ancillary components of what Sun- tional pressure on customers that then having conversations above the lab the impact of labor on anybody’s de-
quest offers. We meet the customer have a desire to standardize but in some level, by the time you find out a con- sired lab operations?
where they are and provide them cases may not have the capital or the solidation or a merger is taking place, J. Mark Tuthill, MD, division head,
with the tools with which they can cultural deftness to be able to do that it’s late. So you have to educate your pathology informatics, Henry Ford
continue to provide service to their across a consolidated system? clients within the laboratory to get Health System: I’ll start with the cen-
physician community, either the in- Curt Johnson, chief operating offi- involved with their executives and tral IT/local IT question and then talk
ternal affiliated physicians or the ex- cer, Orchard Software: I’m not seeing administration to understand where about labor in general. One of the
ternal outreach physicians, by getting consolidation pick up speed. What that health care system is headed and interesting things I have seen over my
those orders into the appropriate we are seeing is consolidation across how the lab can benefit the whole 20-year career in informatics is that
laboratory for testing. Whether the broader areas of laboratory medicine. organization. When those conversa- there are oftentimes places where it’s
multiple different labs are sharing What I mean by that is large hospital tions take place and you’re at the viewed that the local LIS team should
different test strategies and test dic- organizations are merging, but they forefront of an organization, then you be part of central IT. And that lab
tionaries or if they’re not, it’s about are also either merging or purchasing have a role and you’re able to partici- team is brought in and then, interest-
allowing them to get those orders in smaller hospital groups or they’re pate in a more positive manner. ingly, it becomes utterly distracted
without the chaos that might other- buying physician practices. Consoli- When you find out after a consoli- with every other problem outside the
wise occur. dation across the laboratory medicine dation has taken place, and they’re laboratory. And so that team ends up
That’s one of the key areas that spectrum, I believe, is increasing. It contemplating changing to one sys- getting put back in place in a labora-
seems to be a pain point for many of does create opportunities. The work- tem, and it may not be the one your tory. We’ve had good interaction with
these organizations as they go flow of a 500-bed hospital may not be lab is using, it’s late at that point to our central IT —continued on 30

1219_28-30_LISround2.indd 28
DECEMBER 2019 page 28 12/3/19 3:40 PM
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 30 CAP TODAY | DECEMBER 2019
LIS roundtable
continued from 28
group, where we view ourselves as
a peninsula of the IT team. But be-
cause we are funded by cost centers
in the laboratory, our day-to-day fo-
cus is on laboratory issues.
We’re often asked by central IT to
address those laboratory issues when
IT is strapped for labor to carry out
other large projects. An interesting
recent example was that all Windows
servers on Windows 2008 had to be
upgraded by January 2020 to a dif-
ferent version of that Windows
server. If IT had to take care of all of
the pathology servers, they would
have never made it. They were
highly reliant on our laboratory-
based informatics team to carry out
that work. Since that team knows the
applications well, they were able to
do that job relatively inde-
pendently without depend-
ing on project managers
‘ In general, the labor force for IT has into
from central IT. It always
behooves the laboratory to
probably never been a safer job.
have that dedicated staff
within its walls.
In general, the labor force for IT
has probably never been a safer job.
There is so much work to be done,
and it is so difficult to recruit talented
people. Interestingly, it’s even harder
to recruit senior people because a lot
of the folks who have come into these
jobs have come into the industry rela-
tively young. I have a relatively easy
time bringing in junior informaticists,
but I have a much harder time bring-
ing in senior people who have had
10 to 15 years of experience because
the labor market just hasn’t existed
that long and people have not had
that length of career available to
them. So it is a challenge. And when
you get to nuanced areas like busi-
ness analytics, these folks don’t even
exist yet. So if you want to hire some-
one to come in and be a data scientist
or a data analyst, good luck finding
that individual. It really is a safe
place for someone to go into for their
career.
Nick, I’d like you to speak to the same
topic—centralized IT versus laboratory
IT—and to talk a little about the labor
force, for laboratories and for IT. I’m well
aware that Verona, Wisconsin is this
incredible story, as is the entirety of
Epic. Still, I’d like you to talk about cen-
tral IT versus IT with specific people
dedicated to lab and to the labor that’s
needed to make any and all of this work
optimally.
Nick Trentadue, product manager,
Beaker, Epic: I agree with much of
what Dr. Tuthill said, and he is in
1219_28-30_LISround2.indd 30
both worlds, using a different LIS but
having Epic as the comprehensive
EHR at Henry Ford. So we have
groups that run the gamut from hav-
ing lab-owned resources supporting
Beaker, to groups that are almost all
centralized. We see a bell-shaped
curve type distribution.
Most commonly, we see groups
consolidating on Epic as a single
platform, not only for laboratory but
also for the entire patient record for
the organization. Those groups and,
with Epic being an integrated sys-
tem, the Beaker folks who work to
support the lab are brought into
some of those integrated decisions
and changes so that we can use the
lab data, use those results, and merge
them into the greater workflow of
those health care organizations. They
do have exposure to some of the
goals of the health system as they’re
J. Mark Tuthill, MD
using that common platform across
the patient’s touchpoints throughout
the organization.
In terms of the talent that’s out
there, yes, there are quite a few IT
people in Madison, Wisconsin. To Dr.
Tuthill’s point, with IT, we see a
younger labor market excited about
health care IT. But I have seen a lot of educating them on the clinical as-
laboratorians, whether they’re early
or late in their career, make the move
into IT. They might be new to the IT
side of things, but they’re quite expe- Wally, would you agree that this addi-
rienced in the laboratory and bring a
wealth of knowledge about their
organization over to IT. Having that
operational experience is an impor-
tant bridge to have. We see groups
having a lot of success filling their IT agree with Sepehr. There is a clear
team with laboratorians.
We know there are many people who
started in the laboratory and who are
important players in our LIS world.
Sepehr and Tony, from your respective
perches at Siemens and Beckman Coul-
ter, do you find that your increasingly role of the IT specialist will eventu-
dedicated headcount to issues around
IT, data management, and workflow
management is a growing segment of
the employed base?
Tony Barresi, senior marketing
manager, workflow and automation
business, Beckman Coulter: Yes, I
would say from an investment stand-
point, you’re spot-on. And Sepehr
put it well earlier when he men-
tioned that data is king (part one). We on the labor shortage and on the same
at Beckman Coulter understand that,
believe in that, and are committed to
delivering our customers greater in-
sights through clinical informatics.
You’re seeing commensurate invest-
ment in technology and people re-
lated to data, data analytics, and how
that can be leveraged to result in
superior workflow and additional
value delivery from the laboratory.
We have an entire approach that
we are launching that is dedicated to
workflow optimization achieved by
networked combinations of our
products. The underpinning of each
combination is data management,
data analytics, physical automation,
and automation of data flow. To put
a fine point on it, we are fully in-
vested in what you’ve described, and
it is reflected internally here.
Sepehr Seyedzadeh, senior director,
global marketing and product man-
agement for automation and diagnos-
tics IT, Siemens Healthineers: I echo
that. As our products grow
different areas, like data
analytics, we also need to
’ grow our expertise in those
areas. These people are hard
to find. It’s one thing to find
IT qualified people who are
good with coding and security and
so on. It’s a whole other ballgame to
find people who are good clinical
application specialists, people who
can harness the power of IT for a
clinical routine workflow. Even if we
find very good people with IT exper-
tise, we need to spend a lot of time
pects so they can be useful in
deployment.
tion of the clinical insight into the IT
makes some of the labor issues particu-
larly challenging for you? Do you have
that experience at NovoPath?
Wally Soufi (NovoPath): Yes, I
distinction between somebody who
is very good at IT and hardware, and,
as Dr. Tuthill mentioned, upgrading
servers and things like that, versus
someone who is knowledgeable in
the running of the LIS itself. How-
ever, with the shift to the cloud, the
ally and naturally morph into an
application or product specialist.
We have been successful in find-
ing and training people who work
well with us or for us. Clearly, there’s
a lot of competition for talent. We all
see and share the same experiences
when it comes to recruitment.
Michelle, I’d like to ask you to comment
question your colleagues have—on
outfitting technically expert people with
DECEMBER 2019 page 30
clinical insights so they can make an
optimal contribution.
Michelle Del Guercio (Sunquest):
Staffing is a huge pain point labora-
tories are facing and customers are
expressing. We’ve talked to a number
of customers that are using creative
ways to engage more people to go
into the laboratory space. The same
customers are also encouraging those
in the lab to move into the technol-
ogy and IT side because having that
balance is such a nice mix and helps
to support the lab and the interoper-
ability within the organization and
beyond. So having that lab talent
move forward is a bonus. But most
definitely the labor shortage in the
laboratory space is causing concern.
Things like middleware and other
rules and validations, and places
where you can automate and trust
that automation, are helping to coun-
ter that labor staffing shortage.
Curt, please speak to us about this
same question, maybe leading with the
problem of labor in the laboratory be-
cause whether it’s a laboratory person
with a lot of IT expertise, or a general
laboratory technologist or other, a
shortage has to affect the entire opera-
tion. What are you seeing in some of the
Orchard sites?
Curt Johnson (Orchard): Technol-
ogy, from the diagnostic vendors
and from IT, does a lot to offset the
labor shortage, which I’ve heard
about in the laboratory marketplace
for more than 20 of my 31 years in
the industry.
At one point in the late 1980s or
early 1990s, you needed eight to 10
people to run a microbiology depart-
ment. You needed 10 to 15 people to
run the EIA part of the business. You
now need two automation lines with
some laboratory expertise. So you
need the laboratory and the labora-
tory expertise, but over the years,
automation has helped.
There will come a point, though,
where you run out of being able to
solve the problem with diagnostic
equipment or the LIS. Are we reach-
ing that point? Many people think
we are. All of us in the laboratory
industry are looking for the best and
most experienced talent. For labora-
tory information specialists, at Or-
chard, we believe in taking the labo-
ratorian and teaching the IT point of
view. We have found it more critical
and more important for our custom-
ers and our ability to continue to
grow to have laboratorians who can
learn the IT function than to try to
find IT specialists and teach them the
laboratory. To us, it’s critical to have
the laboratory knowledge.
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Additionally, a number of other GI assays are
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PD-L1 immunohistochemical assays to address a
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Leveraging Genetic Expertise
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In addition to its robust array of ancillary test
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12/4/19 5:09 PM
12/4/19 3:27 PM
 32 CAP TODAY | DECEMBER 2019
Gestational diabetes She had passed two other GLT tests counseled on lifestyle management
continued from 1
earlier in pregnancy. and management with ongoing titra-
“She had pronounced fasting hy- tion of insulin for the remainder of
pregnant woman with a prior history perglycemia, which the glucose load her pregnancy.”
of gestational diabetes. The patient tolerance screen did not pick up,” Dr. “Even though the obstetrician had
was referred to Dr. Brown because of Brown said. The patient’s fasting done the ACOG-recommended
an elevated amniotic fluid level, a blood sugar level was greater than screening for this patient, why do a
fetal abdominal circumference greater 110 mg/dL and she had additional screening test on somebody who al-
than the 90th percentile, and a one- risk factors for GDM: a strong family ready has a 50 percent chance of de-
hour glucose loading test (GLT) of history of type two diabetes and veloping gestational diabetes just on
151 mg/dL at 31 weeks of gestation. obesity with a BMI of 39. “She was the basis of having had gestational
diabetes in her previous pregnancy?”
she asked.
Diagnosing GDM in the
first trimester, page 38
Innovations in Clinical Diagnostics
GDM diagnosis is controversial be-
cause of the differences between the
Diabetic
Marker
two screening methods, Dr. Brown
said. The two-step method involves
a nonfasting one-hour 50-g GLT. If the
result is positive, the GLT is followed
by a diagnostic fasting three-hour
100-g oral glucose tolerance test, with
values checked at fasting and one,
two, and three hours. GDM is diag-
nosed if there are two or more abnor-
Assays for Monitoring Diabetes mal values. “The
thresholds that are
currently in use are
Diazyme Laboratories, Inc. presents assays that are the NDDG [Na-
useful for the monitoring of diabetic patients. Assays tional Diabetes Data
can be run on most general chemistry analyzers Group] or the Car-
penter and Coustan
available in clinical labs. criteria,” Dr. Brown
said. ACOG, the Dr.Brown
• Direct HbA1c Assay* National Institutes
(Enzymatic, on-board lysing, single channel, no separate of Health consensus conference, and
hemoglobin assay needed, no cuvette contamination by the American Diabetes Association
endorse the two-step method.
latex particles)
The ADA also endorses the one-
• Glycated Serum Protein (GSP; Glycated Albumin) Assay* step IADPSG screening criteria,
which is a single diagnostic fasting
(Q]\PDWLFPRUHVSHFLĠFWKDQIUXFWRVDPLQH
75-g two-hour OGTT, with blood
colorimetric method) sugars checked at fasting, one hour,
and two hours, she said. GDM is
• 1,5-Anhydroglucitol (1,5-AG) Assay
diagnosed if one or more values is
(Q]\PDWLFH[FHOOHQWSHUIRUPDQFHFRPSDULQJ positive. The Endocrine Society,
with the existing predicate method) World Health Organization, and In-
ternational Federation of Gynecol-
ogy and Obstetrics endorse the one-
step method.
All assays listed are 510(k) Cleared That the ADA endorses the two-
* ; Health Canada Registered step method with two different sets
of thresholds and the one-step
method with one set of thresholds “is
very confusing and we need consen-
sus,” Dr. Brown said.
The two-step method got its start in
a 1964 study of 752 pregnant women
who received a 100-g three-hour
OGTT with whole blood samples
checked at fasting and one, two, and
three hours (O’Sullivan JB, et al. Dia-
betes. 1964;13:278–285).
“The glucose thresholds they
chose were two standard deviations
above the mean of 97.7th percentile,
and they required two abnormal
888-DIAZYME | www.diazyme.com | sales@diazyme.com
values,” she said. “They had been
following a group of women who
had been getting a glucose tolerance
test routinely, and they applied these
thresholds to these women.” Eight
years after they were diagnosed with
GDM, 29 percent of the women had
developed type two diabetes. At 16
years it was 60 percent. “The gesta-
tional diabetes prevalence, based on
the thresholds they chose, was 2.5
percent, at a time when the diabetes
prevalence in the United States was
just 1.24 percent.”
In 1973, the authors recommended
a nonfasting 50-g glucose loading
test to identify high-risk women in a
very low prevalence population. The
threshold was a one-hour whole
blood glucose of 130 mg/dL, and
with that they had 80 percent sensi-
tivity. “Later, a one-hour plasma
threshold of 140 mg/dL was found
to have approximately the same sen-
sitivity,” Dr. Brown said.
“At a time when the prevalence
of gestational diabetes was 2.5 per-
cent, a false-negative rate of 20 per-
cent was acceptable at an absolute of
0.5 percent.”
The diagnostic 100-g OGTT thresh-
olds now are the NDDG and the
Carpenter and Coustan criteria for
measuring plasma, and two abnor-
mal values are needed for a GDM
diagnosis.
Dr. Brown posed two questions to
help determine whether there is a
benefit to treating GDM: Does treat-
ment of mild gestational diabetes
reduce adverse outcomes, and are
adverse outcomes in pregnancy in-
dependently related to maternal hy-
perglycemia, or are other factors—
such as maternal BMI or age—the
main drivers?
The Australian Carbohydrate Intol-
erance Study in Pregnant Women (24
to 34 weeks’ gestation) trial addressed
whether treatment of mild GDM
makes a difference in fetal and mater-
nal health (Crowther CA, et al. N Engl
J Med. 2005;352[24]:2477–2486). The
two-step inclusion criteria were an
abnormal 50-g glucose loading test
(≥140 mg/dL) or risk factors, and a
75-g OGTT with a two-hour value
≥140 mg/dL. Women with fasting
glucose levels ≥140 mg/dL, or a two-
hour value on the 75-g OGTT ≥198
mg/dL, were excluded because they
were considered to have diabetes.
Treating women for GDM was
found to lead to fewer composite
serious perinatal outcomes and di-
minished depression at 12 months
postpartum. Reductions were seen
in birth weight and in rates of in-
fants who were large for gestational
age and had —continued on 34
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 34 CAP TODAY | DECEMBER 2019

Gestational diabetes
continued from 32
T he IADPSG convened an inter-
  national consensus conference in
2008 with the goal of using the HAPO
with these outcomes for maternal
fasting, one-hour, and two-hour glu-
cose across increasing levels of hy-
for all pregnant women between
24 and 28 weeks of gestation,” and
that they be screened and diagnosed
(5
wa
th
macrosomia. The rate of induction study outcomes data to determine perglycemia. “So where do we draw using a one-step fasting two-hour dL
of labor increased. thresholds for a glucose tolerance test the thresholds when this is a linear 75-g OGTT. The glucose thresholds gl
The Maternal-Fetal Medicine Units (Diabetes Care. 2010;33[3]:676–682). relationship? There’s no inflection were determined by choosing the fo
Network study of nearly 960 women “They chose neonatal outcomes: point to help us know where to make glucose values when the odds ratio
addressed the same question (Landon greater than 90th percentile for birth these thresholds.” for the neonatal outcomes of HAPO th
MB, et al. N Engl J Med. 2009;361[14]:​ weight, body fat, and cord-blood C- “They had to draw the line some- were 1.75, compared with mean co
1339–1348). Inclusion criteria began peptide,” Dr. Brown said. Conference where,” Dr. Brown continued, “so glucose values. Based on this odds IA
with a one-hour GLT with a value of members found linear relationships they recommended one-step testing ratio, the fasting level was 92 mg/dL qu
135–199 mg/dL. Women who met
that threshold then had a three-hour
100-g OGTT in which a fasting glu-
cose result of <95 mg/dL and two or
three abnormal values above the
thresholds of a one-hour 180 mg/dL,
a two-hour 155 mg/dL, or a three-
hour 140 mg/dL would be consid-
ered mild gestational diabetes. “These
would be the Carpenter and Coustan
thresholds,” Dr. Brown said.
The MFMU Network study found
reductions in birth weight, macroso-
mia, and fat mass in women treated
for GDM, in addition to a lower prev-
alence of cesarean delivery, lower
frequency of shoulder dystocia, and
reductions in preeclampsia and ges-
tational hypertension.
So the answer to the question of
whether treatment of mild GDM re-
duces adverse outcomes is yes, Dr.
Brown said.
Are adverse outcomes in preg-
nancy independently related to ma-
ternal hyperglycemia or are other
factors, such as BMI or age, the main
drivers? Here Dr. Brown referenced
the Hyperglycemia and Adverse Preg-
nancy Outcome (HAPO) study (N The advertising that appeared in this space
Engl J Med. 2008;358[19]:1991–2002). in the printed edition has been removed here from
More than 23,000 women underwent the digital edition, as requested by the advertiser.
a 75-g OGTT between 24 and 32 weeks
of gestation (fasting and one and two
hours). The primary outcomes evalu-
ated across different increasing glu-
cose categories were birth weight
greater than the 90th percentile, pri-
mary cesarean section, clinical neona-
tal hypoglycemia, and cord-blood
serum C-peptide level greater than the
90th percentile. “For all these adverse
outcomes,” she said, “there is a linear
relationship between the adverse out-
comes and the glucose levels.”
There was a similar linear relation-
ship between fasting, one-hour, and
two-hour glucose levels and the sec-
ondary adverse outcomes: premature
delivery, shoulder dystocia, hyper-
bilirubinemia, preeclampsia, and a
need for intensive neonatal care.
“And these associations of the
primary and secondary outcomes
with glucose were independent of
BMI,” Dr. Brown said, so, yes, “ad-
verse outcomes in pregnancy are
independently related to maternal
hyperglycemia.”

DSP_1219_34-47_GestationalDiabetes.indd 34
DECEMBER 2019 page 34 12/2/19 3:57 PM

 DECEMBER 2019 | CAP TODAY 35

en (5.1 mmol/L), the one-hour level pared with women who had one children and mothers undergoing a metabolic status 10 to 14 years later,”
nd was 180 mg/dL (10 mmol/L), and abnormal glucose value. “Every sin- 75-g two-hour OGTT. The study Dr. Brown said (Scholtens DM, et al.
ed the two-hour level was 153 mg/ gle one of these adverse outcomes found continuous linear associations Diabetes Care. 2019;42[3]:381–392).
ur dL (8.5 mmol/L). One abnormal was lower in women below the between maternal glucose during When researchers dichotomized
ds glucose level result was required threshold compared to women who pregnancy with childhood adiposity, the subjects based on post hoc diag-
he for diagnosis. had one or more abnormal values,” skin-fold thickness, percent body fat, nosis of maternal GDM by IADPSG
tio The HAPO study clearly showed Dr. Brown said. waist circumference, and markers of criteria, in which 14.3 percent of the
PO that women who had a normal glu- A HAPO follow-up study looked childhood glucose metabolism. mothers had GDM versus mothers
an cose tolerance test rate based on at long-term outcomes in more than “There is a strong relationship be- who did not have GDM, “they found
ds IADPSG criteria had a lower fre- 4,500 mothers and offspring 10 to 14 tween the mother’s metabolic status that children of those mothers were
dL quency of all adverse outcomes com- years after the HAPO study, with in pregnancy and the offspring’s more likely to have impaired glucose
tolerance, higher 30-minute, one-
hour, and two-hour glucose levels on
a 75-g two-hour OGTT, and reduced
insulin sensitivity and oral disposi-
tion index,” she said. The children
also had higher odds ratio of obesity,
body fat percent, waist circumfer-
ence, and skin fold thickness than
children of mothers who did not
have GDM.
“For the mothers, the odds ra-
tio was 3.44 for long-term diabetes
or prediabetes,” she said. “In terms
of absolute numbers, 52 percent of
the mothers who made criteria by
IADPSG criteria had either diabetes
or prediabetes, and 20 percent of
mothers who did not have gestational
diabetes had diabetes or prediabetes.”
Dr. Brown referred to her pub-
lished report of the prevalence of
GDM by country, which showed that
the IADPSG criteria “does definitely
increase the prevalence of gestational
diabetes” (Brown FM, et al. Curr Diab
Rep. 2017;17[10]:85).
To sum up, she presented a com-
parison of the 1964 study of 762
patients at a single center, “at a time
The advertising that appeared in this space when the prevalence of diabetes
in the printed edition has been removed here from was 1.24 percent,” with the HAPO
the digital edition, as requested by the advertiser. studies, in which there were 23,000
women and more than 4,500 pairs
in the follow-up from multiple cen-
ters across the globe. “Both dem-
onstrated increased maternal risk
for diabetes in the population, but
only the one-step method looked at
pregnancy, neonatal, and long-term
offspring outcomes.”

A my Valent, DO, a maternal fetal

   medicine specialist and assis-
tant professor of obstetrics and gy-
necology, Oregon Health and Science
University, and director of the OHSU
diabetes in pregnancy program, de-
fended the two-step method to screen
for gestational diabetes.
“We have these two diagnostic
methods, and they’re both appropri-
ate per the guidelines of several of
our major groups,” Dr. Valent said.
“What will it take for us to change
and choose one or the other?”
Dr. Valent said she advises her
patients to think of their gestational
diabetes diagnosis as “a crystal ball
into your future —continued on 36

4 DSP_1219_34-47_GestationalDiabetes.indd 35
DECEMBER 2019 page 35 12/2/19 3:57 PM
 36 CAP TODAY | DECEMBER 2019

Gestational diabetes GDM diagnoses threefold, the one-

step approach would result in in-
risk for stillbirth.”
Does the test identify a problem,
and large-for-gestational-age neo-
nates among women treated after
be
ea
continued from 35
creased interventions, maternal and and if the problem is treated, are the diagnosis of GDM with Carpenter hig
metabolic health” because more than neonatal evaluations, loss in produc- outcomes better? The Maternal-Fetal and Coustan or NDDG criteria, sug- am
50 percent of women with GDM de- tivity, and anxiety and stress for the Medicine Units Network study dem- gesting that using Carpenter and wo
velop type two diabetes in the five to patient. “We have to consider the onstrated improved outcomes for Coustan criteria, a more sensitive test GD
10 years after diagnosis. costs of testing supplies and medica- mother and baby with treatment of than NDDG, has the ability to reduce wh
She called the HAPO study a tions, clinic time, provider time, pa- mild GDM. A secondary analysis of maternal and neonatal risks and is pr
“wakeup call to providers to realize tient time, social work time, dietician, the MFMU Network study demon- more commonly used. an
that women were at ultrasounds, and then antenatal sur- strated decreased rates of pregnancy- The Diabetes Prevention Program Pa
higher risk for ad- veillance because they are at a higher induced hypertension, macrosomia, trial of the National Institute of Dia- rec
verse pregnancy
outcomes—not nec-
essarily type two
diabetes—in the fu-
ture, at lower glyce-
mic targets than we
previously thought. Dr.Valent
Before 2008, we
didn’t have this recognition, and
HAPO homed in on that to make us
realize that even at lower glycemic
ranges, women are still at higher risk.”
The one-step IADPSG criteria that
uses the 1.75 odds ratio came out in
2010, and while the method increases
the prevalence of GDM diagnoses,
“the [2013] NIH consensus of experts
didn’t think that the cost was justified
with the potential improvement in
outcomes,” she said. The U.S. Preven-
tive Services Task Force, however,
recognized through evidence that
there was enough of a risk factor of
GDM among women and in 2014
recommended universal screenings
at 24 weeks of gestation.
“Where are we now?” she asked.
The two-step approach is a non-
fasting 50-g oral glucose challenge
test. “You can use the Carpenter- The advertising that appeared in this space
Coustan criteria of 135, but most in- in the printed edition has been removed here from
stitutions will use population-based the digital edition, as requested by the advertiser.
prevalence to determine if they’re
using a 130, 135, or 140 cutoff.”
Women who fail this step continue
to the diagnostic standard of a fasting
100-g OGTT. The Carpenter and
Coustan or the NDDG criteria, both
of which use plasma, can be used.
An effective screening test must
detect a condition in a high propor-
tion of the population, be safe and
reasonably cost-effective, and dem-
onstrate improved health outcomes,
Dr. Valent noted.
The two-step method, using the
Carpenter and Coustan criteria, has
demonstrated relatively good sensitiv-
ity between 85 and 99 percent, and a
specificity between 77 and 86 percent,
Dr. Valent said. “Of course, your pop-
ulation prevalence drives your posi-
tive predictive values, so that can vary.
But it has very high negative predic-
tive values” of 98 to 100 percent.
The two-step approach is more
immediately cost-effective, she said,
since the majority of women are not
diagnosed with GDM. By increasing

DSP_1219_34-47_GestationalDiabetes.indd 36
DECEMBER 2019 page 36 12/2/19 3:57 PM

 DECEMBER 2019 | CAP TODAY 37

o- betes and Digestive and Kidney Dis- vention, metformin, or placebo. providing preventive care, “we can In summary, the two-step ap-
er eases studied men and women at Women with a history of GDM who make an impact on their develop- proach was designed to detect
er high risk for type two diabetes, and had lifestyle intervention or used ment of type two diabetes.” women at high risk for the develop-
ug- among them was a group of 350 metformin had similar reductions of “We have to think about physiol- ment of type two diabetes, she said.
nd women with a previous diagnosis of 35 to 40 percent in the incidence of ogy,” Dr. Valent said. “How do lipids, “If we consider the women diag-
est GDM, and 1,400 pregnant women type two diabetes over 10 years, Dr. adiponectin, leptin, and other things nosed with gestational diabetes, those
ce who did not have diabetes in their Valent said. influence women who have gesta- are women who have the potential
is pregnancies but had elevated BMI By identifying women during tional diabetes? Should it change our for developing type two diabetes. If
and impaired fasting glucose levels. pregnancy who are at risk for devel- glucose-centric focus on how we treat we intervene now, that is called pri-
m Participants were randomized to oping type two diabetes in the near women with diabetes to a more broad, mary prevention.”
ia- receive either intense lifestyle inter- future, following up with them and individualized health care program?” Thinking about the fetus, “which
is the part that I love about my job
because I get to think about two peo-
ple,” she said, “then I have primary
preventive capacity for that fetus if I
can help improve the overall health
condition of the mother.”
Treating GDM improves perinatal
outcomes. But a screening test is sup-
posed to be followed up on, and the
challenge is that only 40 percent of
women diagnosed with GDM return
after delivery for a GTT. Whether
they follow up with their primary
care physicians is unknown. “We
have a huge potential to be able to
make an impact on these women if
we can follow them a little more
closely,” Dr. Valent said.

Amy Carpenter Aquino is CAP TODAY

senior editor. This session was also pre-
sented at the American Diabetes Associa-
tion annual meeting in June.

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6 DSP_1219_34-47_GestationalDiabetes.indd 37
DECEMBER 2019 page 37 12/2/19 3:57 PM
 38 CAP TODAY | DECEMBER 2019
Diagnosing GDM in the first trimester
Amy Carpenter Aquino
“If you thought that diagnosing gestational diabetes
at 24 to 28 weeks was unsettled, you haven’t seen
anything yet.”
That was David B. Sacks, MB, ChB, of the Na-
tional Institutes of Health, speaking this year in the
AACC session on gestational diabetes mellitus
(GDM) with his co-presenters who debated the use
of the one-step and two-step methods for diagnosing
GDM in the second and third trimesters (see story,
page 1). His talk: “Let’s Not Wait: Diagnosing GDM
in the First Trimester.”
“Why do we need to identify gestational diabetes
in the first trimester?” asked Dr. Sacks, senior inves-
tigator and chief of the clinical chemistry service in
the Department of Laboratory Medicine, NIH. “Hy-
perglycemia in late pregnancy leads to adverse
outcomes. It’s thought that women with early ges-
tational diabetes are at higher risk for complica-
tions,” Dr. Sacks said, “and it’s also
thought that early therapy would
be beneficial. This has clearly been
shown for pregnant women with
preexisting diabetes, and these are
women who have diabetes already
who became pregnant.”
A study published this year that
Dr.Sacks
looked at adverse outcomes in
women with preexisting diabetes
showed an odds ratio of 3.5 for preeclampsia and
cesarean delivery, he said (Alexopoulos AS, et al.
JAMA. 2019;321[18]:1811–1819). The odds ratios are
increased for all the child adverse outcomes, ranging
from about 1.9-fold to almost 27-fold. Most are be-
tween a three- and four-fold odds ratio.
The first trimester is when fetal development is
most rapid and “when the majority of the fetus’ or-
gan systems are at risk,” yet the current screening
recommendation for GDM is at 24 to 28 weeks.
“We’re missing almost two-thirds of the pregnancy,”
Dr. Sacks said, and there are now recommendations
for screening for diabetes early in pregnancy.
Several organizations, among them the American
Diabetes Association, American College of Obstetri-
cians and Gynecologists, Diabetes Canada, and
World Health Organization, have identified selected
populations in which screening should be done early
in pregnancy, he said, adding, “The guidelines are
very different.” (Johns EC, et al. Trends Endocrinol
Metab. 2018;29[11]:743–754.) Diabetes Canada rec-
ommends early screening for one population, while
ACOG lists nearly a dozen populations.
The ADA and WHO have the same recommenda-
tions, which are, for women with risk factors, to
evaluate for undiagnosed diabetes at the first prena-
tal visit (first trimester) using the standard diagnostic
criteria: increased hemoglobin A1c, increased fasting
glucose, or a two-hour glucose tolerance test, Dr.
Sacks said. “If this is positive, the mother is diag-
nosed with diabetes in pregnancy.” If the result is
negative, the mother should be screened for gesta-
tional diabetes at 24 to 28 weeks.
Hyperglycemia in pregnancy is divided into two
groups: diabetes in pregnancy or GDM, and either
one can be type one or two. Diabetes in pregnancy
can be diagnosed before the start of pregnancy, even
during childhood years, or during pregnancy for the
first time.
Women diagnosed with GDM early are more
1219_1-58_Troponin-Diabetes-Flu_v2.indd 38
likely to have adverse outcomes. “Maternal out-
comes for GDM diagnosed in the first trimester are
similar to those with preexisting diabetes,” Dr. Sacks
said (Sweeting AN, et al. Diabetes Care. 2016;39[1]:75–
81). Similar to the maternal complications, the neo-
natal complications are significantly higher when
the gestational diabetes is diagnosed earlier. “That
raises the question as to how we predict gestational
diabetes in the first trimester,” Dr. Sacks said.
F or biochemical predictors, “People have looked
  at glucose, either fasting, oral glucose tolerance
test, or even continuous glucose monitors. They’ve
looked at different kinds of glycated proteins, in-
flammatory markers, insulin resistance markers,
placenta-derived markers, adipocyte-derived mark-
ers—the list goes on,” he said. Judging by the litera-
ture, most of the evidence has been directed toward
fasting plasma glucose and glycated proteins in the
first trimester, Dr. Sacks said.
A 2009 study found a progressive increase in
adverse maternal and fetal outcomes with increas-
ing fasting plasma glucose in the first trimester
(Riskin-Mashiah S, et al. Diabetes Care. 2009;32[9]:
1639–1643).
The IADPSG initially recommended a fasting
plasma glucose ≥ 92 mg/dL (5.1 mmol/L) in early
pregnancy as diagnostic of GDM, Dr. Sacks said, but
these criteria were not derived from data in the first
half of pregnancy. “The study measured glucose at
24 to 28 weeks, so the diagnosis of gestational dia-
betes in early pregnancy by fasting glucose or OGTT
is not evidence based. There is no evidence at all.”
The only evidence critical to this discussion is that
“fasting plasma glucose at the first antenatal visit is
not always consistent with fasting plasma glucose
at 24 to 28 weeks,” Dr. Sacks said, referencing a study
of 13 hospitals in China (Zhu WW, et al. Diabetes
Care. 2013;36[3]:586–590). “The average of the first
visit for these data was about 13.4 weeks, and it is a
very large study, more than 17,000 individuals.”
With the cutoff of 92 mg/dL, “the sensitivity in
this study showed subsequent gestational diabetes
was only 0.24,” Dr. Sacks said. “The specificity was
better, 0.92, but the positive predictive value was
only 0.39.”
What is unknown about glucose in early preg-
nancy is whether glucose concentrations in women
with GDM increased in early pregnancy, and, if so,
when is the onset of maternal hyperglycemia. How
soon after conception?
Data from the same study in China show the fast-
ing plasma glucose level drops substantially from
five weeks of gestation to just over 20 weeks.
Other unknowns: Are the current GDM diagnos-
tic criteria for glucose valid before 24 weeks of gesta-
tion, and, if not, what cutoff values should be used?
A study conducted in New Zealand found that an
HbA1c threshold of 5.9 percent was the best predictor
of GDM at less than 24 weeks of gestation (Hughes
RCE, et al. Diabetes Care. 2014;37[11]:2953–2959).
As with fasting plasma glucose, HbA1c is com-
plicated, Dr. Sacks said. Data published in 2018 by
Cuilin Zhang, MD, PhD, MPH, senior investigator,
National Institute of Child Health and Human De-
velopment, Division of Intramural Population
Health Research, NIH, showed changes in HbA1c
concentrations at four different stages of pregnancy:
enrollment (eight to 13 weeks of gestation), first
DECEMBER 2019 page 38
study visit (16 to 22 weeks of gestation), second
study visit (24 to 29 weeks of gestation), and just
before delivery (34 to 37 weeks of gestation) (Hinkle
SN, et al. Sci Rep. 2018;8[1]:12249). HbA1c concentra-
tions fell between enrollment and the first study visit,
then rose through the final study visit. This happens
in women diagnosed with GDM and in those who
did not subsequently develop GDM. “But at all time
periods, HbA1c is higher in the women who subse-
quently develop gestational diabetes,” Dr. Sacks said.
Dr. Zhang and colleagues found that the optimal
HbA1c threshold for diagnosing GDM in the first
trimester was 5.7 percent, slightly lower than the 5.9
percent cutoff reported in the New Zealand study.
The diagnostic value of glycated albumin, which
represents average glycemia over the preceding 14
to 21 days, has also been considered. “In theory, it is
potentially useful in diagnosing gestational diabetes
including the first trimester,” Dr. Sacks said, though
further studies are needed.
The unknown issues regarding glycated proteins
in early pregnancy are as follows: What are the refer-
ence intervals for HbA1c and glycated albumin in
pregnancy, are these tests realistic alternatives to
glucose measures for early diagnosis of GDM, is the
predictive value of HbA1c for GDM useful in early
pregnancy, and does HbA1c and/or glycated albu-
min predict adverse outcomes in GDM?
“The important question is, does predicting ges-
tational diabetes in the first trimester make a differ-
ence? As of August 2019,” Dr. Sacks said at the meet-
ing, “the answer is, Who knows? Nobody knows.”
He cited four limitations of the data on early iden-
tification of GDM, the first of which is that no criteria
had been validated. Second, in most of the published
studies, the outcome is usually GDM at 24 to 28
weeks, “but not maternal or fetal outcomes, which
is the important question.” Third, there is no consen-
sus on whether one should test or how to test, and,
fourth, there is no evidence that testing has clinical
value, “which at this stage is the important issue.”
The National Institute of Diabetes and Digestive
and Kidney Diseases published an executive sum-
mary of a workshop that examined research gaps in
GDM (Wexler DJ, et al. Obstet Gynecol. 2018;132[2]:
496–505). It identified two gaps: therapy and early
pregnancy diagnosis and treatment. “Clearly, this
has been identified by the NIH as a very important
topic,” Dr. Sacks said.
At the workshop, unanswered questions were
identified: Which techniques should be used to iden-
tify GDM in early pregnancy? Is diagnosis of GDM
early in pregnancy of clinical value? Will identifica-
tion and/or treatment of GDM in early pregnancy
improve outcomes for the mother and baby? Several
studies of early diagnosis and/or treatment of GDM
are ongoing, he said, “so presumably these questions
will be answered in the not-too-distant future.”
Dr. Sacks’ take-home message: There is no con-
sensus or evidence regarding the important issues
surrounding predicting GDM early in pregnancy,
which are how to identify individuals with GDM in
the first trimester and whether prevention or treat-
ment is effective. The latter is the key question, he
said, and “until it can be answered, it will be hard to
justify screening.” And last: Can it make a difference
in outcome?
Amy Carpenter Aquino is CAP TODAY senior editor.
The GDM session was also presented at the American
Diabetes Association annual meeting in June.
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Six problems with urinalysis controls
Running controls for any instrument is
intended to identify problems that could
impact the instrument’s ability to accurately
detect parameters in a patient sample. The
control’s purpose is to prove readiness and
alert technicians about the need to service that
instrument in order to preserve the accuracy
of diagnostic interpretations made from that
instrument’s readings. Though they all strive
toward the same purpose, not all controls are
made alike — and this is especially true for
controls for urine analyzers.
With critical patient outcomes in the balance,
clinical reputation, and laboratory accreditation
on the line when using automated black-box
sample-in/answer-out instrumentation, it
is of utmost importance to be certain any
results relayed back to doctors and patients
is trustworthy. When treatment is dependent
on the proper diagnosis and monitoring of
problems like inflammation, infection, cancer,
and trauma, it is imperative to do more than
trust the instrument.
Here are the 6 biggest problems that exist with
many commercially available controls:
1. Preparation time – Many controls require
hydration prior to usage. In an effort to
reduce costs and artificially extend an
unstable shelf life, this time-consuming step
provides a benefit to the manufacturer while
creating inconvenience and costly delay for
the user. Improper handling, like pre-dilution,
can also lead difficult to detect to erroneous
results or costly false service calls.
2. Non-cellular materials – Urinalysis
instrumentation is finely tuned to detect
and classify cellular materials across wide
biological variation. Each different target
of interest can lead to different medically
relevant indications. Each input parameter
may also be processed differently by
urinalysis instrumentation. This means that
an individual bacterium in an infection is
enumerated differently than casts.
1219_TABs-Streck-Hse-10.indd 40
Streck FILE— NEW
Latex simulacrum of cellular material may
mask errors and may not reflect errors
in instrumentation that require cellular
material for detection, such as missing dye
components or ineffective lytic reagent
packages. Many commercially available
controls utilize size-specific, manufactured
latex beads in place of real, cellular materials
to lower costs and extend shelf-life at the
expense of testing patient-like materials.
3. Limited Control Mode – For a control
to really evaluate the capabilities of
the instrument, it should challenge the
instrument. Pre-stained controls run
in control mode may skip entire critical
elements of the analysis pathway while
controls designed to be run in patient mode
represent how the instrument examines a
real patient sample.
4. A Free Pass – Many controls are not
designed to challenge the instrument, but
instead are designed to have a long shelf
life and, simply, to pass. Though they are a
requirement, controls are much more than
a “necessary evil” as they are often depicted.
A control assists in identifying issues with
instrumentation early, saving re-runs,
preventing inaccurate reporting, and limiting
downtime. A control should test every
aspect that is utilized when evaluating
a patient sample.
5. Availability problems – Because of the
low priority placed on controls by some
manufacturers, availability of urine
analyzer controls may fluctuate. For a
reliable control, that sample should
demonstrate consistent availability
over several years and maintain
a spotless product delivery
record over that time.
DECEMBER 2019 page 40
A complete
urinalysis control
6. Missing Critical Targets – Your urine
analyzer is designed to detect more
sediment parameters than simply
WBCs and RBCs; unfortunately, many
commercially available controls do not
test for all parameters reported by your
instrument. Further, for the ones that
UA-Cellular® Complete
are testing your instrument’s ability to
Combined chemistry and sediment control
identify these urine components, many
of them utilize 100% imitation cellular
material instead of any biological material. Contains real cellular material
Streck’s UA-Cellular® Complete contains
both chemistry analytes and cellular Ready-to-use format – no thawing, no rehydration
components to more closely mimic a
patient sample.
Controls are meant to put you in control.
Their use is critical in ensuring the
appropriate outcome for patients and the
integrity of your laboratory data. When
selecting a control for your urine analyzer,
choose one that challenges your instrument
and ensures that you are getting everything
you are supposed to get out of the
instrument. If your control is only “checking
the box,” you might be missing critical
insight into the true condition of your
patient-critical instrument.
streck.com
12/2/19 10:38 AM
Streck FILE— NEW
1219_TABs-Streck-Hse-10.indd 41
DECEMBER 2019 page 41 12/2/19 10:38 AM
42 CAP TODAY | DECEMBER 2019
Panel explores urinalysis solutions, rules, POC testing
What do users of urinalysis systems
want? According to those in the know,
the answer is instruments that are scal-
able and modular, maximize automation,
reduce hands-on time, improve workflow,
and more. CAP TODAY publisher Bob
McGonnagle convened a panel in Oc-
tober to discuss these topics and other
aspects of urinalysis testing. On the panel
were Megan Nakashima, MD, of Cleve-
land Clinic; Michelle Dumonceaux, of
Beckman Coulter; Maya Daaboul, of Sie-
mens Healthineers; and Jason Anderson,
MPH, MT(ASCP), of Sysmex. What
they said follows.
CAP TODAY’s guide to urinalysis
instrumentation begins on page 47.
E T
C
ID U
U D
Dr. Nakashima, in these discus-
G O
R
P
sions, we tend to focus on three
areas: workflow, the importance
of scalability for instrument solutions
across a wide network and of maximiz-
ing automation, and reducing manual
tasks, in part due to labor shortages.
Are these factors applicable in the
urinalysis area?
Megan Nakashima, MD, staff
hematopathologist, Department of
Laboratory Medicine, Cleveland
Clinic: Absolutely. Those are things
that I consider when I’m looking at
urinalysis instruments.
Can you expand on reducing manual
examination? What are you doing in the
clinic to eliminate that bottleneck?
Dr. Nakashima (Cleveland Clinic):
We have an automated microscopy
system that does the dipstick, reads
it, and then reflexes to the micro-
scopic analysis if needed. The only
time manual work is needed is if re-
sults from the automated microscopy
are unclear or the sample volume or
type is not sufficient for the auto-
mated analyzer.
Michelle, are you, at Beckman Coulter,
hearing these same themes from your
customers as you discuss your solutions
with them?
Michelle Dumonceaux, senior
manager of product management and
global marketing, urinalysis, Beck-
man Coulter: Yes, those are the three
top items we discuss from a global
perspective: workflow, scalability,
and reducing tech hands-on time.
The market continues to move to-
ward full automation with efforts to
greatly reduce microscopic work.
This all moves toward standardiza-
tion between technologists and labo-
ratories. Ideally we want to minimize
the number of times the sample is
handled while providing consistent
results quickly.
What are one or two of the highlights or
initiatives at Beckman Coulter to help
solve some of these issues?
Michelle Dumonceaux (Beckman
Coulter): Our instruments use digital
flow morphology with auto particle
recognition. We can autoclassify 12
particle types with 27 subcategories
with onscreen digital imaging to re-
duce the need for manual review.
We look at the holistic problem:
What do customers need as health
care continues to evolve? The needs
of customers in the United States vary
a little from customer needs viewed
Urinalysis instrumentation, pages 47–51
from a global perspective. So we also
need to consider how we can meet
global needs as best as possible.
Maya, I’m assuming you’re hearing
many of these same themes from Sie-
mens Healthineers’ customers and
potential customers. How is Siemens
fulfilling the needs of folks in the uri-
nalysis market?
Maya Daaboul, global marketing
manager of centralized urinalysis-
POC, Siemens Healthineers: I agree
mainly with the
three pain points
you brought up:
workflow, scalabil-
ity, and reducing
manual work. And
I would like to add
standardization as
Daaboul
well, as we hear
more about it from
our high-volume labs. They want to
make sure they have standardized
processes and results. From Siemens’
perspective, by offering a solution
such as the Clinitek AUWi Pro system,
which combines the Clinitek Novus
chemistry analyzer and Sysmex UF-
1000i flow cytometry analyzer, we pro-
vide our customers with an integrated
system that—like Dr. Nakashima men-
tioned—reflexes from the chemistry
into the sediment and, by doing so,
reduces the need for the operators to
do that manual work while maintain-
ing a standardized workflow.
Do you envision this reflex capability
from chemistry into the urinalysis and
flow cytometer occurring on an auto-
mated line?
Maya Daaboul (Siemens Health-
ineers): The Clinitek AUWi Pro is an
integrated system between the chem-
istry and sediment parts. We have
also been working with our lab-
diagnostic counterparts in Siemens
to have a solution partially or fully on
an automation track.
Jason, what can you tell us about Sys-
mex’s approach to these challenges in
urinalysis raised by your customers?
Jason Anderson, MPH, MT(ASCP),
manager of product-urinalysis solu-
tions, Sysmex: We hear the same
things from our customers—work-
flow, scalability, modularity, maximiz-
ing automation, reducing manual pro-
cesses—themes that are important to
laboratories dealing with staffing
shortages, increasing workloads, and
budget constraints. By pairing the ac-
curacy, precision, and standardization
of fluorescent flow cytometry particle
counting with digital imaging, the new
Sysmex UN-Series is a unique solution
that helps address these challenges
that laboratories are facing. For ex-
ample, our system is modular and
scalable, which allows us to tailor a
configuration that best suits the work-
flow needs of our customers. In addi-
tion, the reflexive and complementary
combination of technology allows labs
to harness the walkaway efficiency of
automated particle counting via flow
cytometry but still allows for reflexing
to digital image review for those ab-
normal samples that require it. The
result is less “screen time” and more
freedom to address other critical labo-
ratory tasks.
As we all know, urinalysis is one of the
more tedious areas in the clinical lab, in
part because of the high testing vol-
umes. It doesn’t have the caché of the
advanced-technology tests we associ-
ate with next-generation sequencing, or
other types of tests that might be top of
mind to people looking for new labora-
tory technologies. Dr. Nakashima, do you
think that the clinical yield of urinalysis
can be improved through some new
directions in testing, perhaps new prod-
uct innovation?
Dr. Nakashima (Cleveland Clinic):
I think so. One thing that can be dif-
ficult in the interpretation of urinaly-
sis is that some clinicians forget that
the UA dipstick is meant to be sort of
a screening test. Some clinicians—
when you report, for example, in
specific units—believe that the result
you’re giving them is precise. I’ve had
clinicians say, “Can we stop ordering
urine protein by chemistry and just
use the dipstick?” Considering the
types of targets they’re looking for, I
don’t think just a dipstick is necessar-
ily precise enough to guide them. So,
in terms of expanding the scope of
what can be done by basic urinalysis,
I’m not sure we need to go much
further unless the technology im-
proves to the point where the results
are reliably precise.
Let me ask our experts from the three
companies: Do you hear from customers
that they have difficulty communicating
with their clinicians the value of urinaly-
sis as a screening test, as opposed to a
confirmatory-type diagnostic test?
Michelle Dumonceaux (Beckman
Coulter): Yes, that is something we
hear. We get a lot of requests about
what is the specificity, sensitivity—how
customers can tweak it and make more
decisions off it. We
have to constantly
remind them that it
is a screen. We find
people are utiliz-
ing a feature on our
instrument, which
is our urine culture
indicator checklist, Dumonceaux
which combines the
urine chemistry and some of the par-
ticle tests of urine microscopy, to help
decide if samples should go to micro-
biology for culture testing.
Jason Anderson (Sysmex): Semi-
quantitative result information and
subjective particle identification by
nature come with challenges when
compared to quantified methods.
From my experience, clinicians have
found value in the insights provided
by automated urinalysis analyzers,
such as the UN-2000, notably with
RBC, WBC, and bacteria enumeration,
assisting the clinician in the diagnostic
pathway. Our customers have shared
with us that they greatly value the
standardized quantified results that
fluorescent flow cytometry brings to
patient care in their facilities.
Maya, I’m hearing that urinalysis might
be ripe for additional studies into its
value and into areas of rules, standard-
ization, and interpretation. Do you be-
lieve that to be the case based on deal-
ing with Siemens’ customers?
Maya Daaboul (Siemens Health-
ineers): It depends on where on the
globe they are located. The system is
used for screening. However, when
you have a flow cytometry-based in-
strument, you can significantly reduce
urine culture in the lab due to the
technology precision. There are al-
ways going to be areas in the lab
where the skills of the operators need
to still be used; therefore, we need to
free their time —continued on 44
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 44 CAP TODAY | DECEMBER 2019
Urinalysis of the instrument and laboratory infor- able software, which is what we have
continued from 42 mation system interfaces? on the WAM middleware solution on
Maya Daaboul (Siemens Health- the Clinitek AUWi Pro system, for
wisely. So, yes, I agree that it is a ineers): The rules are never the same instance, we can meet the various
screening analyzer and that customers from one lab to the other. They’re customer rules. This allows the ap-
basically want to see a reduced urine dependent on patient population, for plication personnel from Siemens to
culture rate. one, depending on the lab processes work with the customer to under-
and how they want to reflex, for in- stand their needs, to write rules, and
Some of you mentioned testing rules. stance. But at a higher level, some to implement them in the software.
Are the rules in urinalysis changing, and things remain common. When the For instance, if blood is negative on
are those rules being reflected in some system uses a flexible and customiz- the Clinitek Novus chemistry ana-
lyzer, yet RBCs are seen on the sedi-
ment analyzer, the user would want
to have this result flagged, and a
simple rule can be created in the sys-
If your fentanyl assay is not tem. Examples of rules that may be
different from one lab to the other
detecting norfentanyl... could be rules to reflex to urine cul-
ture or rules to reflex to sediment.
Dr. Nakashima (Cleveland Clinic):
I would totally agree with that. Even
True positive samples could be within the Cleveland Clinic, we have
a urinalysis instru-
slipping through your fingers. ment in the main
lab, as well as a ded-
icated urinalysis lab
within our Glick-
man Urological and
Kidney Institute.
And we have differ-
ent rules because Dr.Nakashima
those two patient
populations are quite different. We
have also conducted studies that
The opioid epidemic is a serious global crisis affecting public health as well as
found that different manufacturers’
social and economic welfare. Fentanyl abuse, misuse and diversion is a major strips show varying levels of sensitiv-
contributor to this crisis. ity and specificity for things like find-
ing blood or bacteria, however, so
Fentanyl is metabolized to norfentanyl and other metabolites. About 90% of laboratories may want to do internal
the dose is excreted in urine as norfentanyl, while parent fentanyl accounts for studies before instituting a workflow
less than 7%. Detection of both parent and this major metabolite is essential heavily based on reflex testing. Inter-
to determine fentanyl use and is an integral part of combating the opioid
estingly, a few years ago, we were
epidemic.
asked to start a reflex urinalysis-to-
culture workflow because of the issue
ARK Diagnostics, Inc. now offers an FDA 510(k) cleared, of how much catheter-associated
UTIs are being tracked in the hospi-
CE-marked immunoassay that detects fentanyl in urine.
tals, and the clinicians don’t use it
Exceptional analytical sensitivity at a 1ng/mL cutoff level very much, so I’m not sure what that
says about those types of rules.
Detection of both the parent and major metabolite to identify more true
positives
Jason, please comment on some of
Crossreactivity to norfentanyl extends the window of detection these different rules seen in different
parts of a health care system.
Liquid, ready-to-use convenience improves lab efficiency
Jason Anderson (Sysmex): Flexibil-
Three suitable kit sizes for low, moderate and high volume laboratories ity is a very important consideration
when it comes to creating decision
Application protocols for most general chemistry analyzers and reflex rules in urinalysis. Custom-
ers need to be able to easily create
rules that standardize patient care
If your fentanyl assay does not detect the major compounds that and have access to expert resources to
are present in urine, your facility may already be losing optimize their rules and enhance their
the fight against fentanyl abuse. workflows as needed. Whether it be
more standardized rules like reflexing
to visual sediment examination based
on a positive dipstick result, or creat-
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NEXT GENERATION ASSAYS be flexible to accommodate labora-
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UN-2000 provides a user interface
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and customize rules that standardize
the urinalysis testing process and cre-
ate workflow efficiency.
Michelle, please comment on the same
question from the perspective of Beck-
man Coulter.
Michelle Dumonceaux (Beckman
Coulter): I completely agree with
Maya and Jason in terms of the flex-
ibility that’s needed and the stan-
dardization that is not necessarily
seen throughout the various labs.
Urology, oncology, and the ED have
somewhat different parameters for
what they’re looking to test and why
they’re testing a urine sample.
At Beckman Coulter, we offer a
software solution called iWARE that
provides flexibility for the laboratory.
It is designed to streamline the techni-
cal and clinical validation procedures
by consolidating all processes into a
single system. It also minimizes the
number of computers required to
manage each data release point. Lab-
oratories can use iWARE to custom-
ize rules based on test type, result
value, patient demographics, and
more. It helps provide flexibility and
define when to reflex to microscopy.
One thing we mentioned at the outset
was scalability, and this goes across
many testing disciplines, whereby you
have a concentrated core lab-like opera-
tion for high-volume testing—automa-
tion is maximized, labor is minimized in
relation to the volume of testing that’s
done—yet we still see a great deal of
testing in offices and clinics. Do we have
that same distribution in urinalysis, or is
there something unique about the way
urinalysis testing is evolving?
Dr. Nakashima (Cleveland Clinic):
I think that scalability is very impor-
tant if you’re dealing with a large
system that, as you were saying, has
a core lab, as well as smaller facilities.
For example, I’m medical director for
urinalysis at this main hospital but
also lab director at several smaller
sites. If you want to truly harmonize
your reporting and testing, you would
want to have a scalable system.
One thing that we haven’t really
addressed and is not my area of ex-
pertise is point-of-care testing. Our
ED does point-of-care urinalysis, and
when they send it to the lab, they
send it to always get microscopy be-
cause they already know that the
chemistry’s abnormal.
Are you happy with the quality of that
result and that request, or do you think
they often are overcalling the need for
microscopy? —continued on 46
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 46 CAP TODAY | DECEMBER 2019
Urinalysis resented have people who do a lot future, laboratory systems will con-
continued from 44 with point-of-care testing. You may or tinue to value and even demand
may not be particularly conversant scalable standardized urinalysis test-
Dr. Nakashima (Cleveland Clinic): with the point-of-care part of urinaly- ing solutions that work in harmony
I think most of the results end up being sis, but let me ask you, Jason, if you from the bedside to the core lab.
positive, and it’s not a huge burden to would agree that there’s still a consid-
the laboratory. So it’s probably helpful erable amount of point-of-care testing Michelle, what are your thoughts on
for them to screen out some of the done in urinalysis. urinalysis at the point of care?
samples they’re not as worried about. Jason Anderson (Sysmex): Abso- Michelle Dumonceaux (Beckman
lutely, especially when it comes to Coulter): When you look at the broad
I realize that all three companies rep- urine chemistry strip testing. In the spectrum of urinalysis, manufactur-
ers are trying to develop a solution
that can be used from point of care—
even from having testing done in the
home—up to a high-volume refer-
ence lab. So there is a need for consis-
tency across all spectrums, so when
the clinician interprets the tests, there
are consistent results and standard-
ization. But the technology is very
different from a visual read strip all
the way up to a fully automated, and
you’ve got smaller types of analyzers
in between. So how do you bridge
these in? That is a challenge we con-
Nominations Sought for Editorship of tinue to assess.
Archives of Pathology &Laboratory Medicine Maya, I know Siemens has a dedicated
point-of-care testing division. Does uri-
A Search Committee has been appointed to recommend a new nalysis have a home in that part of
editor-in-chief of the Archives of Pathology & Laboratory Medicine. Siemens Healthineers?
Candidates for the position should have demonstrated prior Maya Daaboul (Siemens Health-
journal experience as authors, reviewers, editorial board service, ineers): This is our favorite topic at
and/or as an editor; demonstrated scholarly achievements; Siemens—point-of-care testing and
end-to-end solutions. We have 75-
and a familiarity with the programs of the College of American
plus years of innovation in urinalysis
Pathologists along with the needs of its members. Women and testing, from the very first manual
minority candidates are encouraged to apply. strips. We understand that our cus-
tomers are looking for scalability of
The successful candidate will become the next editor-in-chief of results, same reference range, same
the Archives. Funding is available for partial salary support for this quality of results, and same perfor-
appointment. The Archives editorial office in Northfield, Illinois mance whether the patient is in a
will continue as the principal resource for editorial assistance. small clinic with a satellite lab or in a
large hospital. By having an end-to-
Nominations and self-nominations should include a brief end solution, from the single visual-
statement of interest in the position, a summary of relevant read manual strips all the way to our
experience, and an indication of institutional support should the Clinitek Advantus and Clinitek No-
candidate be appointed. A CV and a list of 3 references who may vus analyzers found in the central
lab, our customers basically get the
be contacted should also be included. Nominations should be
same results on all platforms. The
mailed by March 30, 2020 to the address shown below: same dry pad chemistry is being used
on every test no matter the setting.
Patrick Godbey, MD, Chair We even have incidents where Clini-
Search Committee for Archives Editor tek Novus was placed in the ER.
c/o Archives of Pathology & Laboratory Medicine Editorial Office
College of American Pathologists Jason, Michelle, and Maya, do you
325 Waukegan Road have any final thoughts you’d like to
Northfield, IL 60093 share with our readers about this topic
of urinalysis?
Questions? Send an e-mail to: archivesofpathology@cap.org Jason Anderson (Sysmex): Stan-
dardization is critically important in
An Equal Opportunity Employer all testing processes, and urinalysis is
no exception. In addition to benefit-
ing from a highly standardized flow
cytometry and digital imaging-based
urinalysis solution, customers can
benefit from the BeyondCare quality
monitor, an innovative quality man-
agement software program that can
help laboratories standardize and
streamline their urinalysis quality
control processes, simplify record-
keeping, and en-
hance compliance
activities. It’s excit-
ing to see urinalysis
technology evolve,
and I look forward
to the future inno-
vations that will
Anderson
continue to enhance
patient care.
Michelle Dumonceaux (Beckman
Coulter): We’re trying to reduce sub-
jectivity. We utilize digital flow mor-
phology with auto particle recogni-
tion to classify different particles
based on size, shape, contrast, and
texture. We have software solutions
that can assist with rule writing to
offer flexibility for the lab. In addition
to testing a urine sample, laboratories
can run body fluids on our analyzer.
Maya Daaboul (Siemens Health-
ineers): My final thought is that we
need to continue listening to our
customers and understanding their
needs so we can build products that
meet those needs. We are committed
to investing in urinalysis, whether in
North America or outside, by provid-
ing various platforms and listening
to our customers’ suggestions for
short-term updates as well as long-
term changes and solutions.
Dr. Nakashima, as you know, urinalysis
may be the oldest type of laboratory
test. Do you have final comments about
urinalysis testing and the role it plays in
the life of the laboratory and the health
of patients?
Dr. Nakashima (Cleveland Clinic):
Going back to what you were saying
earlier, we probably do have more
things that we could find out from
urinalysis, with or without microscopy,
that could have clinical impact. But
what we’re lacking in somewhat is
prospective studies because, as you
alluded to, it’s not an “exciting” field.
It’s not as “sexy” as NGS, for example.
So if we really want to push that enve-
lope, we have to get people more inter-
ested in doing prospective projects.
I’d also like to say that the use of
urine preservative tubes has in many
ways become standard, just because
of the distances some of these sam-
ples have to travel and the inability in
many cases to document proper spec-
imen storage—i.e. refrigeration. And
I’ve noticed that a lot of the manufac-
turers have been validating their in-
struments on nonpreserved urine. I
hope that moving forward, they will
consider that most samples coming
into a laboratory are going to be in
preservative and take that into ac-
count with their validations.
 URINALYSIS INSTRUMENTATION DECEMBER 2019 | CAP TODAY 47

Part 1 of 4 ARKRAY ARKRAY Beckman Coulter

Angie Howe howea@arkrayusa.com Jane Nichols nicholsj@arkrayusa.com John Ebbs jhebbs@beckman.com
See captodayonline.com/productguides Edina, MN Edina, MN Miami, FL
for an interactive version of guide 952-646-3224 arkrayusa.com/clinical-diagnostics 952-646-3231 www.arkrayusa.com 352-647-0176 www.beckmancoulter.com

Name of urinalysis instrument AUTION ELEVEN AE-4022 AUTION MAX AX-4030 iQ Workcell Series
Type of instrument urine chemistry urine chemistry urine chemistry and microscopy/sediment combined
Instrument list price — — —
First year instrument sold in U.S. 2017 2011 2018
No. of units installed in U.S./No. of units installed outside U.S. — (also sold via Cardinal Health, Beckman Coulter, — (also sold via distribution partners) — (also sold via McKesson, Henry Schein)
Medline Industries)
Foreign countries where company markets instrument worldwide worldwide worldwide
Country where instrument designed/manufactured Japan/Japan Japan/Japan U.S. and Japan/U.S. and Japan
Intended urine sample volume per day — >15 70–600
Dimensions (HxWxD)/Weight fully loaded with reagents 6.5 × 8.3 × 12.9 in./7.9 lbs. 21 × 21 × 21 in./82 lbs. 22 × 48 × 26 in./200 lbs.
Power requirements 100–240 VAC (50–60 Hz) 100–240 VAC (50–60 Hz) 100–240 VAC
Mean time between failure of instrument 1,230 days 364 days —
Events that cause instrument to lock or stop analysis user ID failure, result error short sample, result error, sampling error QC failure, short sample, barcode/sample ID misread, result
error, sampling error, consumables replacement/expiration

Urine chemistry: (Information in this box is specific to urine chemistry)

• Testing methodology: specific gravity/color/clarity
• Urine chemistry tests available on instrument in the U.S.
• Color compensation pad included
• Flagging thresholds customizable
• Test strip configuration
• Calibration required after each test strip lot No. change
• Frequency of customer-performed calibration
• Form of calibration
• How results are displayed for urine chemistry
• Reporting format customizable
• No. of results that can be held in internal memory
• Specific gravity correction for protein/glucose
test strip/test strip/visual read, manual entry refractometer/wavelength of absorbance within an refractometer/wavelength of absorbance within an
analyzer well/turbidity within an analyzer well analyzer well/turbidity within an analyzer well
bilirubin (0.5–14 mg/dL), hemoglobin (0.03–1.0 mg/ bilirubin (0.5–10 mg/dL), hemoglobin (0.03–1.0 mg/ bilirubin (0–>10 mg/dL), hemoglobin (0–>1 mg/dL),
dL), glucose (30–1,000 mg/dL), ketone (5–150 mg/ dL), glucose (30–1,000 mg/dL), ketone (5–150 mg/dL), glucose (0–>1,000 mg/dL), ketone (0–>150 mg/dL),
dL), leukocyte esterase (25–500 leukocytes/µL), nitrite leukocyte esterase (0–500 leukocytes/µL), nitrite (0.08– leukocyte esterase (0–500 leukocytes/µL), nitrite (–, 1+,
(0.08–0.5 mg/dL), pH (5–9), protein (10–1,000 mg/dL), 0.5 mg/dL), pH (5–9), protein (10–600 mg/dL), specific 2+), pH (5–9), protein (0–>600 mg/dL), specific gravity
specific gravity (1.005–1.030), urobilinogen (2–16 mg/dL) gravity (1.000–1.050), urobilinogen (2–12 mg/dL) (1.000–1.500), urobilinogen (0–≥12 mg/dL)
yes yes yes
— no no
loosely packed in bottles loosely packed in bottles loosely packed in bottles
no no no
— — —
— — —
semiquantitative semiquantitative semiquantitative
no no no
520 (sample results and control results combined) 2,500 sample results/200 control results 2,500 sample results/200 control results
no (protein)/no (glucose) yes (protein)/yes (glucose) yes (protein)/yes (glucose)

Microscopy/sediment: (Information in this box is specific to microscopy/sediment)

• Microscopy/sediment technology
• Microscopy/sediment analysis parameters
• Flagging thresholds customizable
• Instrument eliminates amorphous crystal interference before sample analysis
• How results are displayed for microscopy/sediment
• Reporting format customizable
• No. of results that can be held in internal memory
— — digital flow morphology (digital imaging)
— — all of the following quantitative: pathological casts,
crystals, yeast-like cells, mucus, sperm, RBCs, WBCs,
epithelial cells, bacteria, hyaline casts, WBC clumps,
yeast, squamous and nonsquamous epithelial cells, others
— — yes
— — no
— — numeric values
— — yes
— — 10,000 sample results/200 control results

Reagent shelf life/storage temperature for unopened containers 2 years/1–30°C 2 years/1–30°C varies based on reagent type
Reagent shelf life/storage temperature for opened containers 31 days/1–30°C 31 days/1–30°C varies based on reagent type
Reagent barcode-reading capability no no yes

How often quality control samples are run daily (can use other vendors’ QC products) daily (can use other vendors’ QC products) daily
Sample throughput per hour/Time to first result for chemistry 514/1 min. 225/1 min. cycle time up to 225/<1 min.
Sample throughput per hour/Time to first result for microscopy/sediment — — up to 70 or 101, depending on model/<2 min.
Analyzer has stat mode no yes (minimum sample volume, 2 mL) yes (minimum sample volume, 2 mL for chemistry/2 mL
for sediment)
Sample dilutions required for urinalysis/body fluid analysis no (urinalysis)/— (body fluid analysis) no (urinalysis)/— (body fluid analysis) no (urinalysis)/yes (body fluid analysis)
• Special sample handling required for body fluid analysis — — yes (Lyse reagent)
Minimum width of sample tube/Minimum length of sample tube — 15.8 mm/105 mm 15.8 mm/105 mm
Conditions or substances that prevent a sample from being run — — grossly visible turbidity
Means of sample ID entry barcode scan, manual entry barcode scan, manual entry barcode scan, manual entry
Built-in liquid-level sensing for samples no yes yes

Information that can be barcode scanned on instrument operator identifier, specimen identifier specimen identifier specimen identifier, reagent lot No., reagent expiration
How LOINC codes for results are made available — e-mail query e-mail query, manual transmission
Software includes reflex testing/cross-check functionality no (reflex testing)/no (cross-check functionality) no (reflex testing)/no (cross-check functionality) yes (reflex testing)/yes (cross-check functionality)
Instrument automatically generates consolidated report* no no yes
Instrument connections to transfer information directly to LIS or via ­commercial middleware (Data directly to LIS or via ­commercial middleware (Data directly to LIS or EHR
Innovations) Innovations)
Interface standards supported ASTM 1394-91, ASTM 1381 ASTM 1394-91, ASTM 1381 ASTM with proprietary message layer
Bidirectional interface no yes (to other companies’ LISs–Cerner, Epic, Meditech, yes (to other companies’ LISs and EHRs)
Orchard, SCC Soft Computer, Sunquest)
• Tests can be transmitted to LIS as soon as completed yes yes —
Connection to LIS to upload patient and QC results direct serial or hospital network direct serial or hospital network direct serial or hospital network
Connection to EHR to upload patient and QC results option not available — direct serial or hospital network
Information included in transmission from instrument to device unique identifier, specimen ID, result, QC identifier device unique identifier, specimen ID, result device unique identifier, operator ID, patient ID, specimen
data-management software ID, result, QC identifier

No. of days of training with instrument purchase 0 1–2 days at customer site 1 day at customer site, 3 days at vendor office
Approximate scheduled maintenance time required 5 min. daily <5 min. daily; <5 min. weekly; <10 min. monthly —
• Maintenance records kept onboard instrument no no yes

Provide list of client sites to potential customers on request no (information is confidential) yes (partial list of comparable sites) yes (complete list with no restrictions regarding its use)
Clients restricted from sharing their experience with company or software no no no

Distinguishing instrument features (supplied by company)
*chemistry and microscopy results in one report
Note: a dash in lieu of an answer means company did not answer
question or question is not applicable
• standardized test strip technology across all ARKRAY
platforms
• clinically significant reporting ranges
• small semi-automated footprint
• proven reliability with less than one unscheduled service • advances urinalysis and body fluid testing through
event per year digital flow morphology using proprietary auto-
• abnormal color detection alerts operators to potential particle-recognition software
false-positive results • increased productivity through improved workflow,
• easy to use; strips easy to load; does not require reduced urine cultures, lower review rates, and review
calibration by exception
• advanced technology allows for testing of body fluids
and urine samples in a preservative tube

All information is supplied by the companies listed. The tabulation does not represent an endorsement by the CAP.  Product guide editors: Raymond D. Aller, MD, and Hal Weiner

DECEMBER 2019 page 47

1219_47-51_Urinalysis-PG.indd 47 12/3/19 2:35 PM

 48 CAP TODAY | DECEMBER 2019 URINALYSIS INSTRUMENTATION
Part 2 of 4 Beckman Coulter Roche Diagnostics Roche Diagnostics
John Ebbs jhebbs@beckman.com Brittany Greiner brittany.greiner@roche.com Brittany Greiner brittany.greiner@roche.com
See captodayonline.com/productguides Miami, FL Indianapolis, IN Indianapolis, IN
for an interactive version of guide 352-647-0176 www.beckmancoulter.com 317-521-2000 roche.com 317-521-2000 roche.com

Name of urinalysis instrument iQ200 Series: SELECT, ELITE, SPRINT † cobas u 411 cobas u 601
Type of instrument microscopy/sediment urine chemistry urine chemistry
Instrument list price — $13,500 —
First year instrument sold in U.S. 2003 2006 2019
No. of units installed in U.S./No. of units installed outside U.S. >2,000††/>4,000†† globally (also sold via McKesson, >400/>2,300 globally —/1,200 globally
Henry Schein)
Foreign countries where company markets instrument worldwide worldwide worldwide
Country where instrument designed/manufactured U.S./U.S. Switzerland/Switzerland Hungary/Hungary
Intended urine sample volume per day 70–600 10–100 ≥50
Dimensions (HxWxD)/Weight fully loaded with reagents 22 × 21 × 24 in./118 lbs. 10.24 × 16.73 × 13.34 in./~26 lbs. 25.35 × 42.48 × 20.94 in./207.5 lbs.
Power requirements 90–240 VAC, 200 watts maximum 110 VAC 100–125 VAC
Mean time between failure of instrument — — 160 days
Events that cause instrument to lock or stop analysis QC failure, short sample, barcode/sample ID misread, result — opening front cover
error, sampling error, consumables replacement/expiration
Urine chemistry: (Information in this box is specific to urine chemistry)
• Testing methodology: specific gravity/color/clarity — test strip/wavelength of absorbance within an analyzer refractometer/test strip/turbidity within an analyzer well
well/—
• Urine chemistry tests available on instrument in the U.S. — bilirubin (neg.–6 mg/dL), red blood cells (neg.–250 bilirubin (neg.–6 mg/dL), red blood cells (intact RBCs up to
erythrocytes/µL), hemoglobin (neg.–250 erythrocytes/ 50 erythrocytes/µL), hemoglobin (neg.–250 erythrocytes/µL),
µL), glucose (normal–1,000 mg/dL), ketone (neg.–150 glucose (normal–1,000 mg/dL), ketone (neg.–150 mg/dL),
mg/dL), leukocyte esterase (neg.–500 leukocytes/µL), leukocyte esterase (neg.–500 leukocytes/µL), nitrite (positive/
nitrite (positive/negative), pH (5–9), protein (neg.–500 negative), pH (5–9), protein (neg.–500 mg/dL), specific
mg/dL), specific gravity (1.000-1.030), urobilinogen gravity (1.000-1.030), urobilinogen (normal–12 mg/dL)
(normal–12 mg/dL)
• Color compensation pad included — yes yes
• Flagging thresholds customizable — no yes
• Test strip configuration — loosely packed in bottles cartridge
• Calibration required after each test strip lot No. change — no no
• Frequency of customer-performed calibration — 28 days 28 days
• Form of calibration — dry dry
• How results are displayed for urine chemistry — semiquantitative semiquantitative
• Reporting format customizable — yes yes
• No. of results that can be held in internal memory — 1,000 sample results/300 control results 10,000 sample results/300 control results
• Specific gravity correction for protein/glucose — — —

Microscopy/sediment: (Information in this box is specific to microscopy/sediment)

• Microscopy/sediment technology
• Microscopy/sediment analysis parameters
• Flagging thresholds customizable
• Instrument eliminates amorphous crystal interference before sample analysis no
• How results are displayed for microscopy/sediment
• Reporting format customizable
• No. of results that can be held in internal memory
digital flow morphology (digital imaging)
all of the following quantitative: pathological casts,
crystals, yeast-like cells, mucus, sperm, RBCs, WBCs,
epithelial cells, bacteria, hyaline casts, WBC clumps,
yeast, squamous and nonsquamous epithelial cells, others
yes
numeric values
yes
10,000 sample results/200 control results
— —
— —
— —
— —
— —
— —
— —

Reagent shelf life/storage temperature for unopened containers varies based on reagent type —/2–30°C —/2–30°C
Reagent shelf life/storage temperature for opened containers varies based on reagent type —/2–30°C —/2–30°C
Reagent barcode-reading capability yes no yes

How often quality control samples are run daily — (can use other vendors’ QC products) — (can use other vendors’ QC products)
Sample throughput per hour/Time to first result for chemistry — 600/1 min. 240/1 min.
Sample throughput per hour/Time to first result for microscopy/sediment up to 40, 70, 101, depending on model/<2 min. — —
Analyzer has stat mode yes (minimum sample volume, 2 mL) no (minimum sample volume for sampler or track mode yes (minimum sample volume, 1.5 mL)
is ­minimum amount necessary to immerse pads)
Sample dilutions required for urinalysis/body fluid analysis no (urinalysis)/yes (body fluid analysis) no (urinalysis)/— (body fluid analysis) no (urinalysis)/— (body fluid analysis)
• Special sample handling required for body fluid analysis yes (Lyse reagent) — —
Minimum width of sample tube/Minimum length of sample tube 16 mm/100 mm — 13 mm/65 mm
Conditions or substances that prevent a sample from being run grossly visible turbidity preservatives preservatives
Means of sample ID entry barcode scan, manual entry barcode scan, bidirectional download from host, barcode scan, manual entry, worklist download from
worklist download from host, manual entry host, bidirectional download from host
Built-in liquid-level sensing for samples yes — yes

Information that can be barcode scanned on instrument specimen identifier, reagent lot No., reagent expiration specimen identifier specimen identifier, reagent lot No.
How LOINC codes for results are made available manual transmission website, e-mail query website, e-mail query
Software includes reflex testing/cross-check functionality yes (reflex testing)/yes (cross-check functionality) no (reflex testing)/no (cross-check functionality) — (reflex testing)/yes (cross-check functionality)
Instrument automatically generates consolidated report* yes no —
Instrument connections to transfer information directly to LIS or EHR data-management system that connects to LIS data-management system that connects to LIS
or EHR, or data-management system that cannot or EHR, or data-management system that cannot
further transmit data, or directly to LIS or EHR, or via further transmit data, or directly to LIS or EHR, or via
commercial middleware (Data Innovations) commercial middleware (Data Innovations, Infinity)
Interface standards supported ASTM with proprietary message layer ASTM 1394-91, ASTM 1238-95 ASTM 1394-91, ASTM 1381
Bidirectional interface yes (to other companies’ LISs) yes (to other companies’ LISs and EHRs) yes (to other companies’ LISs and EHRs)
• Tests can be transmitted to LIS as soon as completed — yes yes
Connection to LIS to upload patient and QC results direct serial or hospital network direct serial hospital network
Connection to EHR to upload patient and QC results direct serial or hospital network — hospital network
Information included in transmission from instrument to device unique identifier, operator ID, patient ID, specimen specimen ID, result device unique identifier, operator ID, patient ID, specimen
data-management software ID, result, QC identifier ID, result

No. of days of training with instrument purchase 1 day at customer site, 2.5 days at vendor office 0 —
Approximate scheduled maintenance time required — 5 min. daily; 10 min. monthly 10 min. daily; 10 min. weekly; 10 min. monthly
• Maintenance records kept onboard instrument yes — —

Provide list of client sites to potential customers on request yes (complete list with no restrictions regarding its use) no (information is confidential) no (information is confidential)
Clients restricted from sharing their experience with company or software no no no

Distinguishing instrument features (supplied by company)
*chemistry and microscopy results in one report
Note: a dash in lieu of an answer means company did not answer
question or question is not applicable
• digital flow morphology using auto-particle-
recognition software
• increased productivity through improved workflow,
reduced urine cultures, lower review rates, more
• advanced technology allows for testing of body fluids
and urine samples in a preservative tube
†answers in listing apply to all three systems unless
otherwise indicated; ††combined total for iQ200 series
• fast, efficient processing of urine strips; analyzer
ready to test every six seconds
• Chemstrip 10UA strip has virtually no interference with
ascorbic acid, minimizing false-negative glucose and
hemoglobin results
• flexible sample ID entry options let user choose
barcode scan, download from host, or manual entry
options
• cobas u pack strips have virtually no interference with
ascorbic acid, minimizing false-negative glucose and
hemoglobin results
• innovative photometer with improved reflectance
technology differentiates lysed and intact erythrocytes
• 19-in. HD touchscreen monitor with an intuitive user
interface and convenient QC management

All information is supplied by the companies listed. The tabulation does not represent an endorsement by the CAP. 

1219_47-51_Urinalysis-PG.indd 48 12/3/19 2:35 PM

DECEMBER 2019 page 48
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1219_TABs-Agena-BioFire-10.indd 49 FILE— NEW DECEMBER 2019 page 49
11/26/19 12:23 PM
11/26/19 3:37 PM
 50 CAP TODAY | DECEMBER 2019 URINALYSIS INSTRUMENTATION
Part 3 of 4 Siemens Healthineers Siemens Healthineers Sysmex America
Maya Daaboul maya.daaboul@siemens-healthineers.com Maya Daaboul maya.daaboul@siemens-healthineers.com Jason Anderson andersonja@sysmex.com
See captodayonline.com/productguides Norwood, MA Norwood, MA Lincolnshire, IL
for an interactive version of guide 781-269-3000/www.siemens-healthineers.com/en-us/urinalysis 781-269-3000/www.siemens-healthineers.com/en-us/urinalysis 888-879-7639 www.sysmex.com

Name of urinalysis instrument CLINITEK AUWi PRO Automated Urine Workstation† CLINITEK Novus Automated Urine Chemistry Analzyer UF-5000 Fully Automated Urine Particle Analyzer
Type of instrument urine chemistry and microscopy/sediment combined urine chemistry microscopy/sediment
Instrument list price — — $95,000
First year instrument sold in U.S. 2015 2015 2019
No. of units installed in U.S./No. of units installed outside U.S. — (also sold via Cardinal Health, Fisher, Medline, McKesson) — (also sold via Cardinal Health, Fisher, Medline, McKesson) 3/>1,000 globally
Foreign countries where company markets instrument worldwide worldwide worldwide
Country where instrument designed/manufactured U.S./England U.S./England Japan/Japan
Intended urine sample volume per day 50–500 50–1,000 40–75 microscopic analyses
Dimensions (HxWxD)/Weight fully loaded with reagents 27 × 63 × 35 in./~425 lbs. 21 × 25 × 27 in./~100 lbs. 35 × 26 × 36 in./232 lbs. (main unit)
Power requirements 100–240 VAC (50–60 Hz) 100–240 VAC (48–62 Hz) 100–240 VAC; 15 amps; 600 VA or less (main unit)
Mean time between failure of instrument — — —
Events that cause instrument to lock or stop analysis user ID failure, QC failure, short sample, barcode/sample user ID failure, QC failure, short sample, barcode/sample user ID failure, short sample, barcode/sample ID
ID misread, result error, sampling error, consumables ID misread, result error, sampling error, consumables misread, result error, sampling error, consumables
replacement/expiration, calibration failure, other events replacement/expiration, calibration failure, other events replacement/expiration

Urine chemistry: (Information in this box is specific to urine chemistry)

• Testing methodology: specific gravity/color/clarity refractometer/test strip/turbidity within an analyzer well refractometer/test strip/turbidity within an analyzer well —
• Urine chemistry tests available on instrument in the U.S. bilirubin (0.5–2.7 mg/dL), red blood cells (trace level), bilirubin (0.5–2.7 mg/dL), red blood cells (trace level), —
hemoglobin (0.013–0.3 mg/dL), glucose (36–820 mg/ hemoglobin (0.013–0.3 mg/dL), glucose (36–820 mg/
dL), ketone (3.6–156 mg/dL), leukocyte esterase (6–91 dL), ketone (3.6–156 mg/dL), leukocyte esterase (6–91
cells/mL), nitrite (positive/negative), pH (5.3–8.7), protein cells/mL), nitrite (positive/negative), pH (5.3–8.7), protein
(10.8–1,000 mg/dL), specific gravity (1.000–1.099), (10.8–1,000 mg/dL), specific gravity (1.000–1.099),
urobilinogen (0.24–6.24 mg/dL)†† urobilinogen (0.24–6.24 mg/dL)†
• Color compensation pad included yes yes —
• Flagging thresholds customizable yes yes —
• Test strip configuration cartridge cartridge —
• Calibration required after each test strip lot No. change yes yes —
• Frequency of customer-performed calibration with every Novus cassette change or every 24 hours when with every Novus cassette change or every 24 hours when —
multiple same-lot Novus cassettes are used within 24 hours multiple same-lot Novus cassettes are used within 24 hours
• Form of calibration liquid and dry liquid and dry —
• How results are displayed for urine chemistry semiquantitative semiquantitative —
• Reporting format customizable yes yes —
• No. of results that can be held in internal memory 7,500 sample results/400 control results 7,500 sample results/400 control results —
• Specific gravity correction for protein/glucose no (protein)/no (glucose) no (protein)/no (glucose) —

Microscopy/sediment: (Information in this box is specific to microscopy/sediment)

• Microscopy/sediment technology
• Microscopy/sediment analysis parameters
• Flagging thresholds customizable
• Instrument eliminates amorphous crystal interference before sample analysis yes
• How results are displayed for microscopy/sediment
• Reporting format customizable
• No. of results that can be held in internal memory
flow cytometry with fluorescent stain
flagged: pathological casts, crystals, small round cells,
yeast-like cells, mucus, sperm; quantitative: RBCs,
WBCs, epithelial cells, bacteria, hyaline casts
yes
numeric values, scattergrams
yes
up to 2 years worth (sample results)/up to 2 years worth
(control results)
— flow cytometry with fluorescent stain
— flagged: pathological casts, crystals, yeast-like cells,
mucus, sperm; quantitative: RBCs, WBCs, epithelial
cells, bacteria, total casts
— yes
— yes
— numeric values, scattergrams
— yes
— 1,000 (sample results, including scattergrams)/2
concentrations × 3 lots, or 120 plots/lot (control results)

Reagent shelf life/storage temperature for unopened containers 365 days/15–30°C 365 days/15–30°C varies based on reagent type
Reagent shelf life/storage temperature for opened containers 180 days; onboard stability of cassette, 14 days/15–30°C onboard stability of cassette, 14 days/— varies based on reagent type
Reagent barcode-reading capability yes yes yes

How often quality control samples are run daily (can use other vendors’ QC products) follow government regulations or accreditation daily (cannot use other vendors’ QC products)
requirements (can use other vendors’ QC products)
Sample throughput per hour/Time to first result for chemistry 240/~2 min. 240/— —
Sample throughput per hour/Time to first result for microscopy/sediment 80 at 100% sediment/~4 min. — up to 105/<1 min.
Analyzer has stat mode yes (min. sample volume, 2 mL chemistry/1 mL sediment) yes (minimum sample volume, 2 mL) yes (minimum sample volume, 1.6 mL)
Sample dilutions required for urinalysis/body fluid analysis no (urinalysis)/— (body fluid analysis) no (urinalysis)/— (body fluid analysis) no (urinalysis)/— (body fluid analysis)
• Special sample handling required for body fluid analysis — — —
Minimum width of sample tube/Minimum length of sample tube 16 mm/95 mm 16 mm/95 mm 12 mm/95 mm
Conditions or substances that prevent a sample from being run mucus, high fluorescence, grossly bloody samples, others mucus, high fluorescence, grossly bloody samples blood, mucus, high fluorescence, visible turbidity
Means of sample ID entry barcode scan, worklist download from host, manual entry barcode scan, worklist download from host, manual entry, barcode scan, worklist download from host, manual entry
RFID tag on cassette for automatic entry of lot and expiration
Built-in liquid-level sensing for samples yes yes yes

Information that can be barcode scanned on instrument specimen identifier, reagent lot No., more
How LOINC codes for results are made available website, e-mail query, communications from Siemens
Software includes reflex testing/cross-check functionality yes (reflex testing)/yes (cross-check functionality)
Instrument automatically generates consolidated report* yes
Instrument connections to transfer information data-management system that connects to LIS
or EHR, or data-management system that cannot
further transmit data, or directly to LIS or EHR, or via
commercial middleware (WAM)
Interface standards supported ASTM 1394-91, HL7
Bidirectional interface yes (to other companies’ LISs and EHRs)
• Tests can be transmitted to LIS as soon as completed yes
Connection to LIS to upload patient and QC results direct serial or hospital network
Connection to EHR to upload patient and QC results direct serial or hospital network
Information included in transmission from instrument to device unique identifier, operator ID, patient ID, specimen
data-management software ID, result, QC identifier
operator identifier, specimen identifier, reagent lot No. specimen identifier, reagent lot No.
website, e-mail query, communications from Siemens website, e-mail query
yes (reflex testing)/yes (cross-check functionality) yes (reflex testing)/— (cross-check functionality)
— —
data-management system that connects to LIS data-management system that connects to LIS or EHR,
or EHR, or data-management system that cannot or directly to LIS or EHR
further transmit data, or directly to LIS or EHR, or via
commercial middleware (WAM)
ASTM 1394-91, ASTM 1381, HL7 ASTM 1381, ASTM 1894-97
yes (to other companies’ LISs and EHRs) yes (to other companies’ LISs and EHRs)
yes yes
direct serial or hospital network hospital network
direct serial or hospital network hospital network
device unique identifier, operator ID, patient ID, specimen device unique identifier, patient ID, specimen ID, result
ID, result, QC identifier

No. of days of training with instrument purchase 1–3 days at customer site, 4 days at vendor office 1–2 days at customer site, 3 days at vendor office based on configuration–virtual instructor-led training†
Approximate scheduled maintenance time required 10 min.: per shift, daily, weekly, monthly 5–10 min.: per shift, daily, weekly, monthly 20 min. daily; 10 min. weekly
• Maintenance records kept onboard instrument no no yes

Provide list of client sites to potential customers on request yes (partial list of comparable sites) yes (partial list of comparable sites) yes (partial list of comparable sites)
Clients restricted from sharing their experience with company or software no no no

Distinguishing instrument features (supplied by company)
*chemistry and microscopy results in one report
Note: a dash in lieu of an answer means company did not answer
question or question is not applicable
• can upgrade CLINITEK Atlas to CLINITEK Novus and
have CLINITEK solution for dry pad chemistry
• no sample pretreatment or on-screen review required
• fluorescent flow cell technology with dedicated channels
for bacteria and sediment to drive clinical outcomes
†comprises
CLINITEK Novus and Sysmex UF-1000i
††system
does not report numeric values for most tests;
it reports negative, trace, small, moderate, large, etc.
• digital color camera for improved accuracy of result
measurement, including detection of intact RBCs
• reagent cassette format with RFID that provides
complete traceability and 14 days onboard stability
• utilizes same dry pad reagent chemistry as CLINITEK
family of analyzers—that is, Multistix 10SG
†system does not report numeric values for most tests;
it reports negative, trace, small, moderate, large, etc.
• fluorescent flow cytometry methodology offers
accuracy, precision, efficiency, and standardization
• highly modular and scalable system offering flexibility
to add additional modules to meet increasing
workload demands
• BeyondCare quality monitor for urinalysis provides a
streamlined and automated QC experience
†no limit on No. of times customer can sign up

All information is supplied by the companies listed. The tabulation does not represent an endorsement by the CAP. 

1219_47-51_Urinalysis-PG.indd 50 12/3/19 2:35 PM

DECEMBER 2019 page 50
 URINALYSIS INSTRUMENTATION DECEMBER 2019 | CAP TODAY 51

Part 4 of 4 Sysmex America

Jason Anderson andersonja@sysmex.com
See captodayonline.com/productguides Lincolnshire, IL CAP TODAY product guides
for an interactive version of guide 888-879-7639 www.sysmex.com

Name of urinalysis instrument UN-2000 Automated Urinalysis System

help you weigh your options when
Type of instrument microscopy/sediment
Instrument list price
First year instrument sold in U.S.
—
2019
it's time for a new instrument
No. of units installed in U.S./No. of units installed outside U.S.
Foreign countries where company markets instrument
3/~275 globally
worldwide
or software system
Country where instrument designed/manufactured Japan/Japan
Intended urine sample volume per day 50–150 microscopic analyses
Dimensions (HxWxD)/Weight fully loaded with reagents 35 × 52 × 36 in./428 lbs. (main unit) 22 CAP TODAY | JANUARY 2018

Power requirements varies by configuration Lab needs driving coagulation analyzer market
Mean time between failure of instrument —
Valerie Neff Newitt
Customer wish lists help to define
every generation of coagulation ana-
lyzers, test menus, and related tech-
nologies. That’s evident in the recent
North America for Siemens Health- ity, eliminating reconstitution time, another 20 minutes to get the blank.
ineers’ chronic disease portfolio,acclimation time, and repetitive man- But we are now down to a time frame
notes that many customers are ex- ual pipetting.” HemosIL ReadiPlastin of under 10 minutes to have the two
panding and gaining more oversightfor prothrombin time testing on ACL different samples that are needed. 58 CAP TODAY | OCTOBER 2018 AUTOMATED MOLECULAR PLATFORMS
of their hospital-affiliated offices and
Top and ACL Top Family 50 Series Since platelets are what we do, cen-

Events that cause instrument to lock or stop analysis user ID failure, short sample, barcode/sample ID and upcoming launches and the on-
going work of the companies whose
analyzers are profiled in this issue in
the 2018 coagulation analyzer prod-
clinics. “They need simple solutions

They want small analyzers that can

systems, for example, has onboard
that don’t require a lot of training.
stability of 10 days, she says.

transmit data, directly or indirectly

William Trolio, MBA, MT, vice
president and chief scientific officer,
trifugation is getting a lot of attention
from us.” He expects the new centri-
fuge will come to the market as a
second-generation unit in the first
Part 11 of 17

See captodayonline.com/productguides
for an interactive version of guide
Hologic
Glenn Sawyer glenn.sawyer@hologic.com
San Diego, CA
858-410-8000 www.pantherfusion.com, www.hologic.com
Hologic
Glenn Sawyer glenn.sawyer@hologic.com
San Diego, CA
858-410-8000 www.hologic.com
Name of instrument Panther Fusion System Panther System

misread, consumables replacement/expiration uct guide.

At Helena Laboratories, “We hear
demands for easier connectivity,
via middleware, into their hospital
information system and ultimately
of Bio/Data, says shortening process-
ing time is paramount to his custom-
ers. “Specimen processing time is
part of this year.
“The health care industry is con-
solidating, hospitals are forming
Country where designed/Manufactured/Reagents manufactured
Instrument FDA cleared or approved/Platform
First year sold in U.S./Sold internationally/Installed
U.S./Switzerland/U.S.
yes/preanalytical and analytical
2017/2017/2017
U.S./Switzerland/U.S.
yes/preanalytical and analytical
2012/2010/2010

E T
Dimensions in inches (H × W × D)/Footprint in square feet/Noise generated in dB 69 × 76 × 32/16.8/<60 69 × 48 × 32/10.6/<55

C
smaller sample sizes, greater avail- one of the more frustrating parts groups, groups are joining together

ID U
U D
Coagulation Analyzers, pages 25–34 Supplied with UPS/BTU yes/3,412 yes/1,878 per hr.

G O
R
ability of more specialty tests, like of platelet testing,” he says. and reconfiguring, purchasing is in a Physical contamination control features closed system, liquid level sensing, pressure-dispense verification closed system, liquid level sensing, pressure-dispense verification, onboard deactiva-

low-molecular-weight heparin and
direct thrombin inhibitors,” says The-
resa Peveto, BSCLS, MT, hemostasis
P
into their electronic medical record
systems. Additionally, they want
“Platelets are only good for about constant state of flux,” says Susan L. tion, deep-well reaction tube, single sample aspiration and dispense, penetrable cap
List price/Price for sample extraction and amplification detection modules — —
four hours. . . . And you may beat up Taylor, MS, MT(ASCP), director, STA Purchase options/Minimum test volume requirements straight purchase, reagent rental, lease/— straight purchase, reagent rental, lease/variable
the platelets so much during the marketing, Diagnostica Stago, “and Co. performs installation, operation, and performance qualifications/Electrical requirements yes/190–240 VAC, 50–60 Hz, 1,800 VA single phase yes/100–240 V ± 10%

Urine chemistry: (Information in this box is specific to urine chemistry) product manager. “And everyone
wants a good activated partial throm-
boplastin time point-of-care test that
is as reliable as an in-laboratory test.”
technology that does not disrupt
flow, be it patient flow or workflow
in an office or clinic.”
For the health care networks that
preparation that you won’t get the
right results due to platelet activation
or compromised sample conditions—
icterus, hemolysis, or lipemia.”
it is all changing how the laboratory
must respond. Labs, now recognized
as business units, are expected to be
centers of value.”
Labor and parts warranties/Advanced operator training
Delivery time/Delivery charges/Installer/Time to install on site
Training location/No. of techs that can receive initial training/
Length of training/Retraining at company facility
Test menu
1 year/yes
~1 week/variable at origin and destination/Hologic/1–2 days
off site/2/2–3 days/yes

CT-GC, CT, GC, HPV, HPV genotyping, trich, HIV-1 viral load, HCV viral load, HBV
1 year/yes
~1 week/variable at origin and destination/Hologic/1–2 days
on and off site/2/3 days/yes

CT-GC, CT, GC, HPV, HPV genotyping, trich, HIV-1 viral load, HCV viral load, HBV
viral load, M. gen, HSV 1&2, Zika, GBS, MRSA, Flu A/B/RSV, Paraflu, AdV/hMPV/RV viral load, M. gen, HSV 1&2, Zika

• Testing methodology: specific gravity/color/clarity —

Toward that end, Peveto says Helena
Laboratories is well into the develop-
ment of a new analyzer with an espe-
cially broad platform that will include
want to standardize equipment Bio/Data is working to modify the
across the network, “our customers centrifugation process “to minimize
52 CAP TODAY | FEBRUARY 2019
want an end-to-end enterprisewide the amount of g-
solution,” Peluso-Lapsley says. forces applied and
“‘Easy-to-use, reliable, high-
No. of tests for which analyzer has FDA-cleared applications/CE mark 13/17 9/12
throughput equipment that promotes Tests available on instrument in U.S./Outside U.S. CT-GC, HPV, HPV genotyping, trich, HIV-1 viral load, HCV viral load, HBV viral load, CT-GC, HPV, HPV genotyping, trich, HIV-1 viral load, HCV viral load, HBV viral load
efficiency and flexibility’ cannot be a HSV 1&2, Zika, GBS, Flu A/B/RSV, Paraflu, AdV/hMPV/RV/CT-GC, CT, GC, HPV, HSV 1&2, Zika/CT-GC, CT, GC, HPV, HPV genotyping, trich, HIV-1 viral load, HCV
sales pitch,” Taylor says. “Whereas HPV genotyping, trich, HIV-1 viral load, HCV viral load, HBV viral load, M. gen, viral load, HBV viral load, M. gen, HSV 1&2, Zika

AP-LIS vendors on AI, practice complexity, the cloud

HSV 1&2, Zika, MRSA, GBS, Flu A/B/RSV, Paraflu, AdV/hMPV/RV
“new assays not normally seen.” At Instrumentation Laboratory, shorten the time so we used to demonstrate the skills and Tests not available in U.S. but submitted to FDA/Available in other countries only —/CT, GC, MRSA, Bordetella, M. gen —/CT, GC, M. gen
For instrumentation, the smaller “We have asked customers, ‘What do that labs get decent the attributes of an instrument, now Research-use-only assays/Tests in development —/BV, CV/TV, M. gen —/BV, CV/TV, M. gen
the better. “We will see the industry you need and what would make your Open-channel capabilities/Start-up and preparation time yes/<15 min. yes/<15 min.
Practice consolidation andsamples,”
complexity, Trolio
Web-based we andmust
cloudalso demonstrate
computing, and ar-how theyity, new technologies and instruments, We provide labs with the option to
move toward smaller devices, some- life better?’” says Venita Shirley, says. “Right now Model type of sample-handling system/Maximum sample load capacity automated onboard/120, with continuous and random access automated onboard/120
tificial intelligence. That and more is what writer actually
Valerie Neffserve a specifi
Newitt c customer
asked six newin reporting requirements and docu- combine many Minimum different lab testing
specimen volume/Sample volume flexibility/Other sample volumes available 400 μL/yes (varies by sample type with open channel capability)/yes 400 μL/no/—
thing like a glucometer—quick, MBA, MT(ASCP), director of hemo- people tend
AP-LIS companies about recently. Here to do they
is what their
hadwork environment, in real time,
to say. mentation are all standard business specialties inMinimum
a single deadcloud-based
volume/Pediatricplat- sample volume/Primary tube sampling 250 μL/no/yes 250 μL/—/yes

• Urine chemistry tests available on instrument in the U.S. — smaller sample sizes, smaller strips,
less dependent on technique and
technology,” Peveto predicts.
Maria Peluso-Lapsley, MBA, se-
stasis marketing in North America.The profiles of their AP very
One answer, she says, is time-saving
convenience. “In response we have
on page Trolio

reengineered many reagents tonologies,be

55, along with those

and that is only

instruments,
begin
minutes
How is the increasing complexity
slow spins
information

to prepare
reporting
systems
with—20
of 16 other
or longer—
of tech-
toare inand
thewith

prioritizeright
require-half ment
their
product

to expect
software
the in such an environment?
lab that
guide team. That is very
begins
companies.different for us, but customers have a
it.” develop-
and system
within labs. We look at such develop-
ments in a three-phased approach.
First, what do we have to do now for
our clients to make the versions they
form. Having
Sample tube sizes/Sample barcode reading/Autodiscrimination in 1D or 2D
Sample
laboratoriesClot
revenue streams,
adapt to the
that
barcode
thedetection/Open
Amplification
No. markets
grow
flexibility
languages/Sample
power toextraction
reagents
of different assays
quickly,
they
or methods
onboard
wish
gives

and
types available in open mode
createplatform/Sample
new
supported
at once/Programmed
to
types (open extraction)

or calibrated at once
various/yes (automated onboard scanner to maintain positive sample ID)/—
Codabar codes 39 and 128, Interleaved 2 of 5, JAN13, code 93, UPC, NW7/—
yes/no/—
transcription-mediated amplification, real-time TMA, real-time PCR, Invader Plus
up to 32/up to 32
various/yes/no
Codabar codes 39 and 128, Interleaved 2 of 5, JAN13, code 93, UPC, NW7/—
yes/no/—
transcription-mediated amplification, real-time TMA
4/4

• Color compensation pad included —

nior product marketing manager in liquid, ready to use with robust stabil- sample.
ments, etc., Thenpathology
in anatomic they have
ing the marketplace? And how do you
iemens
to spin it forCurt Johnson,
chang-
Orchard Software:
chieflaunched
point-of-care S
operatingin
Increasing PT/INR
offi2016
cer, its fialready
complex- device.
The Xprecia Stride is a handheld
rst have better? What new fea-
tures and tools can we add? Are there
new modules we can provide to clients
serve. We use
Tests per container set/Multiple reagent configurations supported

where we evaluate
and the latest
an outside-in
Reagent

Monitors
container placedapproach

emerging
market
Determines reagent volume
expiration technologies
directly on system/Onboard test auto inventory
demands
in container/Reagent barcode reading/Reagents barcoded
date/Auto lot recognition or calibration
12, 100, or 250/yes
yes/yes
yes/yes/yes
yes/yes
100 or 250/yes
yes/yes
yes/yes/yes
yes/yes
coagulation analyzer that mimicsto thekeep them up to date, move them to develop our
Auto detection of adequate reagent or specimen/Reagents available
product roadmap. We contamination control
yes/liquid and dry yes/liquid

REVENUE CYCLE SERVICES look of a smartphone and provides Reagent reconstitution required/Chemical no/yes yes/yes

• Flagging thresholds customizable — TELCOR results in 60 seconds or under, Pelu-

forward, and benefit them? Next we
consider a mid-term solution: What do
prioritize using
Onboardan
System is
testobjective
open
method; development items with the to
scoringof inventory monitoring by barcode
auto inventory/Capable
homebrew/General-purpose reagents allowed
yes/yes
yes/yes
yes/yes
yes/yes

We’re
Using our same powerful RCM so-Lapsley says. “While the handheld we need for the next install in the next highest scores Same capabilities when third-party reagent used/Lot sequestering available
are developed first. — —
concept is not new to the industry, Closed-vial stability for amplification reagents/Extraction reagents assay dependent/assay dependent assay dependent/assay dependent
18 to 24 months? What new instrumen- Wally Soufi , chief
temp.executive
requirement foroffi cer, reagents/Extraction reagents
software, our billing service— what is new is that this device uses tation is coming out? What will new
Storage
NovoPath: IShipment
wouldtemp. add government
requirement
amplification
for amplification reagents/Extraction reagents
refrigeration/refrigeration
assay dependent/assay dependent
refrigeration/refrigeration
room temperature/room temperature

• Test strip configuration — ACCESSIBLE TELCOR Revenue Cycle Services— the same reagents for PT/INR that reports look like? What new interfaces regulations Minimum/Maximum
and reimbursement reagent shelf-life guarantee
prac- —/up to 2 years —/up to 2 years

Your
*DLQHI¿FLHQFLHVDQGDEHWWHU are used in the large analyzer portfo- will be required? Where will digital
Autocalibration or autocalibration alert/Multipoint calibration supported
tices to the list of items that are increas-
yes/no yes/—

XQGHUVWDQGLQJRI\RXU$5ZLWKIXOODFFHVV gives laboratories unmatched access lio. This feature ties into customers’ pathology fall? Finally, we take a long- ing complexity
Assay calibrations required by end user/Calibrants can be stored onboard
Multipleincalibrant
AP labs. Weforhave
lots stored same assay/Required calibration frequency
yes/yes
no/24 hrs.
yes/yes
no/24 hrs.
desire to standardize equipment and
WR\RXUGDWDDQGFRPSOHWHWUDQVSDUHQF\ to their AR data for complete control term look: What will laboratory needs found, overLength of assay
25-plus calibration/Typical
years in the AP calibration frequency can be user-defined (assay dependent)/24 hrs. 24 hrs./24 hrs.

• Calibration required after each test strip lot No. change — reagents and better correlate results.” Onboard real-time QC/Supports multiple QC lot numbers per assay —/yes —/yes
EHWZHHQ\RXDQG7(/&25 look like 36 months from now? Where marketplace, that listening to our cli-time/Onboard software reviews QC

Team
Auto shutdown*/Instrument warm-up yes/<15 min./yes yes/<15 min./yes
and transparency. With metrics to Another example of coagulation Total numberentsof controls
and anticipat-
per batch for 24 tests/48 tests/72 tests/96 tests — (not a batch analyzer) — (not a batch analyzer)

E T
innovation is preanalytical checks,

C
METRICS successfully manage their business, Walkawaying their needs is (both for batch of 96 samples)

ID U
capacity/Tech hands-on time 120 samples/<15 seconds per sample 120 samples/<15 seconds per sample

U D
Anatomic pathology computer systems, pages 55–64

G O
which “have been on chemistry ana- Uses disposable pipette tips/Maximum number of pipette tips stored yes/1,152 yes/576 (2.2 tips per sample)

R
one of the best prac-

P
)URPGDLO\ELOOLQJVWDWXVWRPRQWKO\ ODEVKDYHFRPSOHWHFRQ¿GHQFH lyzers forever,” Taylor says. “Now Time between start and initial result/Instrument automatic shutdown 2.4 hrs./yes 2.7–3.5 hrs. (assay dependent)/no

• Frequency of customer-performed calibration — SUR¿WDELOLW\DQDO\VLVWR\HDUO\VDOHVWUHQGV

\RXFRQWUROWKHPHWULFVQHHGHGWRHIIHFWLYHO\
PDQDJH\RXUEXVLQHVV
working with our trained billing
WHDPZLWKH[SHULHQFHVSHFL¿FWR
coagulation analyzers are startingis to
respond in kind.” Diagnostica Stago
has developed a module that’s inics
presubmission stage with the FDA;
pathology going? Where will artifi-
cial intelligence be? Where will genet-
theand molecular testing be? What
that enables Windows
us to exceed
tations. Ultimately,
best compass No.when
tices we engage
Startup programmable/Remote
technology/Mouse
Service contracts
clients’ orexpec-
available/Mean
our clients
of U.S. fieldit comes
reps/Service
system

new tools will be out there? What will
are our
to priori-
in monitoring/Waste required for disposables
touchscreen/Modular add-on capability
time between failures/To repair failures
Turnaround time for problem solving by phone/Email/Field service
engineer on-site response time/Hours and days available
tizing new modules, features, and
yes/yes/plastics and cardboard
yes/touchscreen/yes
on-demand, PM only, standard, standard plus, premium, premium plus/—/—
—
—/standard and standard plus: within 24 hrs., premium and premium plus:
yes/yes/plastics and cardboard
yes/touchscreen/yes
on-demand, PM only, standard, standard plus, premium, premium plus/—/—
—
—/standard and standard plus: within 24 hrs., premium and premium plus:
within 18 hrs./on-demand, PM only, and standard: M–F, 5 AM–5 PM, PT; within 18 hrs./on-demand, PM only, and standard: M–F, 5 AM–5 PM, PT;

• Form of calibration — FLEXIBLE

$VSD\HUUHTXLUHPHQWVFRQWLQXRXVO\
FKDQJHRXUVROXWLRQLVFRQ¿JXUHGWRPDNH
laboratory billing.
Cortex Pathology
Discover the laboratory billing service giving
Comprehensive Anatomic
the company is aiming for a 2019we
try into the market. The checks, which
will run on the company’s STA Max
generation instruments, will detect
en-need in terms of voice recognition?
We are developing those tools right
now so that we are ahead of the curve.
enhancements.
Chad Meyers,
uct management
Guaranteed response time/Modem servicing avail./System diagnose own malfunctions
Order partsvice via president,
modem/Onboard
and strategy,
Average maintenance
prod-
error codes/Maintenance training demo module
Sun-
time for lab personnel/Onboard maintenance records
Preventive maintenance per year for sample extraction/Amplification detection
standard
yes/yes/yes
no/yes/no
plus, premium, premium

weekly: <5 min.; monthly: <45 min./yes

2/2
plus: 24–7 standard plus, premium, premium plus: 24–7
yes/yes/yes
no/yes/no
weekly: <5 min.; monthly: <45 min./yes
2/2
We evaluate quarterly what percentage quest Information Systems: Effective
complete access to your data and unrivaled
• How results are displayed for urine chemistry — hemolysis, icterus, and lipemia (HIL). Downtime for preventive maintenance/Spare parts on site <1 day/yes <1 day/yes
VXUH\RXUFODLPVDUHFRPSOLDQW
transparency. Discover TELCOR.
Pathology Reporting Software Taking a somewhat different on
of our development time is to be spent
ap-current, mid-term, and long-term
and transparent
our customers
communication with
Software and LIS interface:
leads
• Patient to clear prioritiza-
demographics and insurance data available via rules-based architecture no no
proach, the ACL Top 50 Series sys- concerns to make sure our resources tion of the critical issuesorthey
• Data retrieval Internetdeal with
connectivity yes yes
EXPERIENCE
855-489-1207
Streamline your workflow
sales@telcor .com
tems from Instrumentation Labora- are dedicated properly, in alignment daily. We • Online real-time help, QC, stats, and management reports/Evaluates results validity
know we have
• Priority processing
to support yes/yes
yes
yes/yes
yes
tory identify and measure the allow-

• Reporting format customizable — 2XULQGXVWU\H[SHUWVXQGHUVWDQGWKHXQLTXH

QXDQFHVRIODERUDWRU\ELOOLQJDQGUHYHQXH
F\FOHPDQDJHPHQWUHJDUGOHVVRIODEW\SH
RUVL]H
©
and enhance efficiency
2018 TELCOR Inc. All rights reserved. For more information
about all TELCOR solutions, please visit telcor.com.
ACL Top 50 Series —continued ondent
with our clients’ goals and our goals.
able threshold for HIL. “With theJoseph Nollar, associate vice presi-
24 of clinical product development,
high-quality,• Supports
while also
cost-effective
•reducing
accession No.
Unique barcodewaste.
labredundancy/Specimen
testing
per container/Multistop
Future
carrier and level identification
routing (1 tube to many workstations)
• Specimen scheduling/Routes test to workstation/Automatic reflex, repeat, dilutions
development is not enough if it is not
Xifin: Pathology is becoming a profes- being done in a thoughtful
• LIS(s) interfaced liveand
with specifi
yes/no
yes/no
yes/—/yes
• Sample storage and retrieval software supports CLSI standards
c systems/How LIS(s) interfaced with LAS
lab automation
no
yes/LIS1-A and LIS2-A2 (ASTM)
yes/no
yes/no
yes/no/yes
no
yes/LIS1-A and LIS2-A2 (ASTM)
• QC resultsevolving
transferred automatically
customerto LIS/Data-management capability yes/yes yes/yes
Cortex Also Offers: sion where physical geographic loca- manner to support

• No. of results that can be held in internal memory — Cortex Courier

Stand-alone web-based report delivery.
tion is diminishing in importance. With
the albeit slow acceptance and adop-
tion of digital pathology and shared
revenue programs such as technical
requirements,
• Interfaces operational in active user sites
and having
• Rules-based
and honest•prioritization
critical to controlling
a rigorous control via control subsystem
control subsystem/Process
process
LIS operates simultaneously
scope and elimi-
is running
with assays
• Uses LOINC to transmit orders and results/Unidirectional interface capability
yes
yes/yes
yes
no/yes
• Results immediately transmitted to LIS/Interface available to auto specimen-handling system yes/—
nating redundancy
yes
yes/yes
yes
no/yes
yes/—
• Stores QCof function.edit capability/Viewable PCR graphs
lot files/Worklist —/yes/yes —/yes/—

• Specific gravity correction for protein/glucose — Fast, secure lab results instantly available
at your client’s fingertips.
component and professional compo-
nent splits, it is imperative to have lab
systems that are accessible anywhere
and can be integrated with digital pa-
There are•so
ments that are
AP lab space—EMR
their evolving
Canmany
print, archive, transmit
exciting
having an impact on the

Note:standards,
interfaces
*for calibration and controls
data
develop-
Distinguishing features (supplied by company)

a dash in lieu of multidisci-

and
an answer means company did not answer
yes
full sample to result automation; random and continuous access; scheduled/
automated maintenance for rapid startup; no return visits required for up to
120 samples/day; no batching requirements; multiple assays from a single
sample; ready-to-use reagents for PCR assays; 5-color fluorescence detection;
yes
full sample to result automation; random and continuous access; scheduled/
automated maintenance for rapid startup; no return visits required for up to
120 samples/day; no batching requirements; runs multiple assays from a
single sample; true positive sample ID; consolidated testing menu on a single
Cortex Medical Billing thology systems. Xifin’s philosophy is question or
plinary reporting question
that is not applicable
crosses organi-
12 independent onboard thermocyclers platform; highest throughput per sq. ft.

Comprehensive and flexible medical billing to leverage open application program- zational divides, and digital pathology,
All information is supplied by the companies listed. The tabulation does not represent an endorsement by the CAP.
software for your lab. ming interfaces [APIs] and build tool just to name a few. All of these help the
sets where all possible laboratory test- customer to be more successful and
Get paid faster and reduce errors and ing can be configured and performed, sustainable during the marketplace’s
denials on claims.

Microscopy/sediment: (Information in this box is specific to microscopy/sediment) Inspire Collaborate Integrate

whether clinical, AP, molecular, or ge-
nomics. APIs allow us to provide sin-
gle sign-on to digital pathology plat-
forms so that a pathologist can launch
evolution. We must stay focused on
the critical problems our software
needs to solve and on our customers’
long-term objectives as they evolve.

• Microscopy/sediment technology flow cytometry with fluorescent stain and digital image
directly to an image viewer from a case
of interest. Our tool sets allow labs to
have control over their test menus, link
that test to defined workflows, or con-
figure their own workflow process
Nick Trentadue, product manager,
Beaker Laboratory, Epic Systems: Tech-
nology in the lab space is always
evolving, including the software that
runs it. We work with our customers

analysis www.cortexmed.com 800.278.4645

2107 Elliott Avenue Suite 207 Seattle, WA 98121
around the type of testing performed,
design or configure screens that cap-
ture the data required for each test, and
configure the final report.
to identify what technologies are the
most promising and drive our devel-
opment to support them. In the past it
was voice recognition, real-time Health

• Microscopy/sediment analysis parameters flagged and qualitative: pathological casts, crystals,

yeast-like cells, mucus, sperm; qualitative: small round
cells; quantitative: RBCs, WBCs, epithelial cells, bacteria,
total casts; qualitative and quantitative: hyaline casts
• Flagging thresholds customizable yes
VISIT
• Instrument eliminates amorphous crystal interference before sample analysis yes
• How results are displayed for microscopy/sediment numeric values, scattergrams captodayonline.com /productguides
• Reporting format customizable yes
• No. of results that can be held in internal memory 400 (sample results, including captured image and to view, print, and compare
extracted particle image information)/3 files per
analyzer, or 120 plots per file (control results) product information for the
Reagent shelf life/storage temperature for unopened containers
Reagent shelf life/storage temperature for opened containers
varies based on reagent type
varies based on reagent type
following guides:
Reagent barcode-reading capability yes
INSTRUMENTS • AP automation: tissue processors, embedders, microtomes, stainers
How often quality control samples are run daily (cannot use other vendors’ QC products)
Sample throughput per hour/Time to first result for chemistry —
• Automated molecular platforms • Bedside glucose testing systems • Chemistry
Sample throughput per hour/Time to first result for microscopy/sediment varies by configuration/<1 min. and immunoassay analyzers for mid- and high-volume laboratories • Chemistry and
Analyzer has stat mode yes (minimum sample volume, 2.1 mL) immunoassay analyzers for point-of-care and low-volume laboratories • Coagulation
analyzers • Coagulation analyzers—point of
Sample dilutions required for urinalysis/body fluid analysis no (urinalysis)/— (body fluid analysis) care, self-monitoring • Hematology analyzers
• Special sample handling required for body fluid analysis — 42 CAP TODAY | APRIL 2018

• In vitro blood gas analyzers • Laboratory POC glucose: views on volume, critical care, ACOs
Minimum width of sample tube/Minimum length of sample tube 12 mm/95 mm Test volume, limitations on devices used in critical care, continue to be well positioned should the bar be formity in their glucose measurements so there’s

automation systems and workcells

consolidation, and population health is what CAP TODAY raised even further. consistency in their care path and mode of treating
asked about when it spoke in March with the makers of three Corrine Fantz, PhD, director of medical and scien- the patients. When we discuss this with European

Conditions or substances that prevent a sample from being run
blood, mucus, high fluorescence, visible turbidity bedside glucose testing systems. Their systems and those
of two other companies are profiled on pages 44-49.
“The customers are more aware than ever of the limita-
tions that are in the package inserts from the glucose
tific affairs for POC testing, Roche: Generally, the
customers are more aware than ever of the limitations
in the package inserts from the glucose manufacturers.
What we’ve seen is that they’re dedicated to determin-
colleagues, what’s important is the alignment of the
glucose meter method with a definitive method. If
you read carefully the FDA Oct. 11, 2016 guidance
for bedside glucose monitoring systems, they must

Means of sample ID entry barcode scan, worklist download from host, manual entry • Next-generation sequencing instruments manufacturers,” says Corrine Fantz, PhD, director of
medical and scientific affairs for point-of-care testing,
Roche Diagnostics. But she and Kevin Peacock, clinical
marketing manager, HemoCue America, say there is still
confusion. Here is more of what they and others told senior
ing the best testing approach for their specific popula-
tion by first defining the right patient and the right
sample in order to achieve high-quality glucose re-
sults. We recently sponsored a webinar for customers
show alignment to a definitive method. Not all of the
glucose meters on the market have demonstrated,
through FDA submission, alignment to definitive
methods. They were approved prior to the guidance.
that allowed the different integrated hospital networks They’re still in the market. Nova StatStrip was not

Built-in liquid-level sensing for samples yes • Urinalysis instrumentation

editor Amy Carpenter Aquino.
How has the decline in reimbursement coupled with a retreat
from tight glycemic control affected test volume for patients at
the bedside?
Courtney Sweeney, group marketing manager for
point-of-care testing, Roche Diagnostics: Yes, the
hospital blood glucose market growth has slowed
down, likely due to the overall financial pressures in
the industry. Hospitals are looking for the most ef-
to share their approaches, best practices, and lessons
learned while undergoing changes in the systems that
had them, or trying to adapt what they were doing to
the new limitations with these meters in critical care
settings. They said they have to have the right people
at the table and understand what the issues are in their
particular setting and what’s relevant to physicians,
the nursing group, and the laboratory. There needs to
be solid communication at all phases with the project.
only cleared under FDA for use in the hospitals, in-
cluding critically ill patient care settings, but also for
use in the home. Now you have a product that can
go home to clinic to hospital to clinic to home, and
there’s uniformity in glucose measurement.
Sweeney (Roche): Generally, we do see growth in
the ambulatory environment. Consolidation may be
driving a connected and standardized approach
across the health system, which allows for better data

Information that can be barcode scanned on instrument
specimen identifier, reagent lot No.
SOFTWARE SYSTEMS • Anatomic
42 CAP TODAY | OCTOBER 2019
fective ways to manage costs but also optimize pa-
tient outcomes. We do see that point-of-care blood
glucose testing remains a critical part of patient care
in health systems.
The laboratory directors are the bridge between the
point-of-care and hospital medical staff responsible
for the testing. Being more collaborative works, rather
than the laboratory directing or being an authoritarian
management as well as point-of-care oversight.

How does glucose testing and the management of patients with

diabetes fit into the concern laboratories have now for population

How LOINC codes for results are made available
website, e-mail query Hematology panel: bridging gaps, staffing, Lab 2.0
The other general trend is toward outpatient
versus inpatient care, and this is attributable to many
type to the clinical staff. You need manufacturers, the
clinical staff, and the laboratory all working in a col-
health and accountable care organizations?
Peacock (HemoCue): As medicine becomes less

pathology computer systems

variables that could drive this, including declining laborative environment. centralized and more personal, there’s not a one-size-
Automation, the workforce shortage, man-reimbursement, Reference Laboratories; hospitalOlga Pozdnyakova,
incentives Danette, what
to do interven- are Sysmex’s
All glucose meters have the table,
latestlimitations andbut they needfits-all
no meter education on
blueprint for patient care. For instance, a
ual review rates, and Laboratory 2.0 weretionsMD, thatPhD, of Brigham and Women’s
as well Hos- initiativescurrently
and howishave customers what it is, what it’s measuring, andpart of our population cannot be diag-

Software includes reflex testing/cross-check functionality yes (reflex testing)/— (cross-check functionality)
impact outcomes, as modifying approved for use with capillary samples considerable
some of what came up in CAP TODAY’stightpital; glycemic Danette controlGodfrey and Simon Shorter
protocols. responded? in that critically ill population. There how is it some
can impact
confu-theirnosed
workflor ow.effectively monitored with HbA1c alone.
latest gathering of hematology experts of Sysmex; and Matt Rhyner, PhD, MBA, DanettesionGodfrey,
Jeffrey A. DuBois, PhD, MBA, MS, vice presi- arounddirector
that still.of IVD We’re also anticipating the immi-
Plasma blood glucose continues to be reliable in ef-
for a roundtable on what’s new, pressing, and Rachel Burnside, PhD, MBA, of Beck- product marketing, Sysmex: We added nent launch of the DxHfectively
690T, which
dent, medical and scientific affairs, Nova Biomedical: Dr. DuBois (Nova): Our customers are adapting diagnosing and managing our growing

Instrument automatically generates consolidated report* — • Billing/accounts receivable/ and in play. CAP TODAY publisher Bob
McGonnagle convened a panel in AugustI don’t The
consisting of Cordelia Sever, MD, of TriCoreagement
man Coulter. What they said follows.
think
guideprotocols.
2019 people
begins on They
hematology are abandoning
page 51.

made adjustments to the cutoff levels. That is form.

have modified them slight-
ly, so they’re not as stringent. Some institutionsdifferentiation
a
glycemic man-
analyzer product
new

have
module
automation StatStrip
system
not a At the
to

than
low end
StatStrip
our
labeling
hematology

our existing
to measure
of the
and
requirements.
glucose
marketXpress2
StatStrip we
is a
with a focus on patient safety, while conforming to
lines to bring even greater
tabletop
laboratories
When using
plat- on critically
the DxHill900,
Sepsis
analyzer
thatthe
for

the capability
patients,
Indicator.
are cleared for use
mid-volume
diabetic population.
will have,
Dr.asFantz
able for
does(Roche): What we see is that account-
careEarly
organizations are being incentivized to
develop health care delivery models that impact the
retreat from glycemic management; that’s just made refin- substantial
with arterial, changes
venous,for the heel stick, and neona-
neonatal patient population as a whole. This includes preven-

Instrument connections to transfer information data-management system that connects to LIS or EHR, RCM systems • Blood bank   



 
 

 
ing the treatment protocol. Where hypoglycemia
may have been defined at 75 mg/dL and below,
some institutions now have moved the hypoglyce-
mia threshold to 100 mg/dL and below. And markets
point-of-care
solutions glycemic
and changes
there we
market
tal arterial
in the area
to thesafety
patient
with scalable
specimens.
of the XW-100
management
instrument
reasons,
serve.or a venous whole blood
arterial
The standard

andfocuses
Dr. Pozdnyakova,
would
protocols
the on having
of care in most
we’velike seen,
Olga Pozdnyakova,
associate
either an
is theretive,
to raisefor
anything

MD,
tions
pathologist, Brigham
glucose measure-
chronic
at thehospitalized
outset?
PhD,
that
mic control
youor outpatient care, and acute care, or the
inpatient groups. They have interven-
are being implemented to improve glyce-
andand other outcomes. Glucose testing and
We’re ment.
pleased with what we’re no Women’s
knownHospital;
clinicallyassociate professor,

or directly to LIS or EHR

are some people who still want to be aggressive and StatStrip demonstrated managing diabetic patients are essential parts of

information systems • Laboratory have the glycemic range between 70 to 110. Many
the institutions have moved the range so that
hearing
of well
XN-20,
it’s to
into the
significant launch of our
interferences Harvard
that could cause Medical
erroneous
de- results contributing to patient adverse events. director,
glucose
School; andinterventions.
these medical For example, they are expanding
B&W data management solutions to the
point-of-care
E T
C
ID U

above 100, and it’s referred to as safe and effective liver next level Not all bedsideHematology are Harbor Medical
U D

glucose monitoring systems

analyzers, pages 51–64 outpatient environment. That helps the providers
G O
R

with equal. Other devices in the marketplace have Physician

flagging,created Di-report on outcomes they could not
P

glycemic management. capture and

Interface standards supported ASTM 1381, ASTM 1894-97 information systems • Laboratory-
If you’re focusing on total glycemic control
cardiothoracic surgical patients, it depends on
institution. With the increasing number of diabetic
patients admitted to the hospital, the demand
thefornew limitations
precursor
the
technology
grown
white
channel
the peer-reviewed
and issues that have been addressed in agnostics

that our customers have

inserts.
for to love. Being able to offer more
similar andwould
based onliterature in device likepackage
gaps. We use Sysmex hematology
analyzers in all labs across
previously
to commenthelpful on bridging
I
Lab:capture and report, and those data are
for achieving their goals and targets.
Dr. DuBois (Nova): It is probably best addressed
Partners.
by looking at the numbers. When ISO 15197:2003

Bidirectional interface yes (to other companies’ LISs and EHRs) monitoring patients at the bedside has not come
down. It’s increasing.
differentiation
How has
tainly helping
to precursor
our
clinics, ERs,markets,
cells is cer-
system consolidation—including
whichphysician
and acquired
These are modern,
established
lyzers that allowPOC
find practices—affected
systemsophisticated ana- and accepted as the guidance for the
was published
us to measure
FDA priora to lotOct. 11, 2016, that guidance permitted

provider links software • Positive I’m not aware of any decline in reimbursement value in highly
glucosesensitive and specifi
testing for ambulatory patient of clinical parameters and
c testing? fiveadvanced
percent of results—below 75 mg, an absolute
having an effect on bedside glucose testing. We flagging
are of abnormal white blood cells,
Peacock (HemoCue): clinicalconsolidation
We see system parameters. I would likeofto15 mg—and above 75 mg, plus or mi-
difference

• Tests can be transmitted to LIS as soon as completed yes seeing an increase in bedside glucose testing. automaticas reflan exadvantage
testing, andfor the infor-
the mentionand
health systems immature
the pa- platelet
nus 20fraction
percent. If that only has to occur 95 percent





 mation technologists need to and immature
reduce professionals reticulocyte
tients they serve. Laboratory have a of thefraction
time, then that poses a significant public
ChromaCode is rapidly introducing How a are
menu your customersof cost-effective, adapting to the manual slide
limitations on glucose
high- review
greater understanding of point-of-care parameters, which we health
testing, includ- are currently
risk. When you look at the number of glucose
rates. At the
inglow end risks, compliancevalidating andand planningteststoperformed
report. on these devices globally, we’re in

patient identification products

throughput and flexible multiplexdevices infectiousfor critical disease care applications?
PCR tests using regulatory requirements,
our HDPCR™ multiplexing technology. Kevin Peacock, clinical marketing manager, of the market we limitations.
testing see As ambulatoryHowever,
sites integratethere with is a great need to
the neighborhood of 5.6 billion tests. If you multiply

Connection to LIS to upload patient and QC results hospital network 1
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capillary
get the
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strip meters.
role,
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clinicians may
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erroneous
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that are allowed to be acceptable
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glucose results published off these devices
not fiaffect
that could nd patient care. If there is a device that

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are uncertain


as to what devices are appropriate
use with which patients. HemoCue, having accuracy

levels more associated with central lab results,we
kets we serve
We to
vances there
communicate
will
Dr. there.
have consistency
made ad- in
in to
clinic
DuBois (Nova): What is of

how
glucose measurement
Godfrey
hospital and back to home.
this to our
care providers
them
creating
useful
interest
from
laboratory
a big
and
is to
home
One of thetechnologies
discussing is implementation
arecustomers that they want uni-
will not
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orderboth
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criteria and they’re held to [accuracy] 98
percent of the time, then that risk has gone
andsignificantly,
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Matt, what, if anything, has changed in the system who need to understand new
 

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data-management software 34 CAP TODAY | JUNE 2018

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the perspective of Beckman Coulter?
Matt Rhyner, PhD, MBA, senior
director of product management and
global marketing for hematology, Beck-
the information you provide. Are rules-
based applications within instruments
and IT systems helpful there? Do you
need to do in-service and visits and

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Instrument acquisition, skilled labor on the table

MAKERS OF CHEMISTRY, IMMUNOASSAY ANALYZERS ANSWER OUR QUESTIONS

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volume analyzer, the DxH 520, and
the other for our Early Sepsis Indica-
information about the new features and
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based on configuration–virtual instructor-led training†




 
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tor. Both have really added clinical Dr. Pozdnyakova (Brigham and

No. of days of training with instrument purchase




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interest in standard- #
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talked to CAP TODAY about when we spoke to four companies whose analyzers are cover all hospitals. Trying to do ization and a growing when we have worked with custom- sometimes with their help. This is one


 need to have ?
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profiled in the following product guide (pages 40–46). Details about their analyzers more with less and having a single a large assay menu on an integrated ers, we have had to help them bridge of the ways to accomplish that. We do

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analyzer that meets the needs platform. Specifically, when it comes their own gaps between emergency have a general broadcast to commu-
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across the hospital system is ideal to software interface and assays, it’s



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care markets. (See “Simpler and condensed,” page 38, for more on the revised product that’s been an interesting journey. which I do not find helpful because
guide and what to expect next month.) for purchasing agents as well as important to have the same menu,
clinicians. If you’re changing from measuring ranges, and reagents for
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Rachel Burnside, PhD, MBA, se- we see several each day. I find the
“The fun part of being a manufacturer,” says Nova Biomedical product manager

• Maintenance records kept onboard instrument yes one analyzer to another, there can all the platforms.#&
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Brad Bullen, “is trying to keep two and three steps ahead of clinical needs while
be subtle differences in the way hematology, Beckman Coulter: It’s tion and doing in-service and going
providing quality diagnostic results that impact patient care now.” Here is more of
results are produced and the timing Can the industry’s success with auto-
what he and others shared with senior editor Amy Carpenter Aquino.
What are two key trends in instrument
acquisition?
Wayne Brinster, CEO, MedTest
Dx: Our customers are looking for
flexibility, with the ability to run a
Provide list of client sites to potential customers on request yes (partial list of comparable sites) broad menu of tests that allow them
to create an efficient workflow.
They want the instrument to change
with the test mix
Clients restricted from sharing their experience with company or software no
E T
C
ID U
they’re seeing,
U D
Chemistry and immunoassay analyzers pages 40–46
G O
R
and they want the
P
flexibility to re-
spond to new tests and not have to
do testing offline. They haven’t re-
linquished the requirement for the
instrument to be efficient as far as
the use of reagents, low mainte-
Distinguishing instrument features (supplied by company) • powerful combination of fluorescent flow cytometry
nance, and a long time between
failures. All of those things come
into play to help the laboratorian
increase the throughput of the highly
and digital image analysis allows for rapid screening automated core instruments.
of UA samples
NEXT GENERATION ASSAYS
• highly modular and scalable system offering flexibility
to add additional modules to meet increasing THERAPEUTIC DRUG MONITORING ASSAYS & URINE DRUG TESTS
ARK introduces its homogeneous enzyme immunoassay
technology for the next generation of clinical laboratory testing.
ARK assays are in liquid, stable, ready-to-use formulations that deliver
workload demands convenience for routine use.
ARK produces assays of high-quality that yield rapid and reliable results on
automated clinical chemistry analyzers.
• BeyondCare quality monitor for urinalysis provides a EPILEPSY URINE DRUG TESTS
FDA Cleared Forensic Use Only
Levetiracetam Pregabalin
Lamotrigine
streamlined and automated QC experience
In Development
Gabapentin
EtG
Topiramate
Fentanyl
Zonisamide
Tramadol
Oxcarbazepine Metabolite
Meperidine
In Development Ketamine
Lacosamide Methylphenidate Metabolite
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877.869.2320
*chemistry and microscopy results in one report
Note: a dash in lieu of an answer means company did not answer
question or question is not applicable †no limit on No. of times customer can sign up captodayonline.com /productguides
All information is supplied by the companies listed. The tabulation does not represent an endorsement by the CAP.
Laboratories are getting drugs-of-
abuse screening tests from the emer-
gency department or saliva samples
from their occupational health
group. If these samples are just
added into the normal throughput,
they tend to slow down the larger,
highly automated instruments.
We’re seeing a desire to take differ-
ent types of samples and tests while
continuing to have a highly efficient
core laboratory. They can put one of
our instruments inside their core lab
and dedicate it to offload these less
efficient tests.
Brad Bullen, product manager,
Nova Biomedical: The first trend is
standardization of the hospital plat-
New Oxcarbazepine Metabolite Assay
CANCER
FDA Cleared
Methotrexate
Zolpidem ANTIRETROVIRAL
Zopiclone CE Mark, Not FDA Cleared
Gabapentin Efavirenz
In Development
Lopinavir
Nevirapine
of the results. Hospitals want a
singular fix for their point-of-care
diagnostic needs.
The second trend is cybersecu-
rity. Somebody at a large university addressed by others (in the systems,
hospital in California said their
laboratory receives about 3,000
external attempts to access their
network daily. Hospital systems
have had their patient health infor- ting into this career path, we’re
mation accessed and held for ran-
som. Hospital systems and patients
have to have confidence that the
systems manufacturers provide are
not going to be susceptible to mali- Nova is developing analyzers that
cious software. For a long time,
diagnostic companies relied on the
hospital’s firewall to protect patient with plug-and-play technology
data. Nowadays we can’t do that;
we need to provide multiple tiers
of defense.
Brittany Greiner, marketing man-
ager, low-volume and specialty sys-
ANTIBIOTIC
In Development
Linezolid
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CE Mark, Not FDA Cleared
Voriconazole
customersupport@ark-tdm.com
www.ark-tdm.com
6
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)))/$!!/! the Early Sepsis Indicator brings to what we do and —continued on 44
match the worrying decline in skilled
labor availability, or does there become
a point at which this problem must be
schools, societies)?
Bullen (Nova): As the mean age
of laboratorians is increasing every
year, and with fewer enrollees get-
seeing staff having to do more with
less. We are not necessarily looking
at what’s going to happen 12
months from now but in five years.
don’t require as much hands-on
time to provide quality results,
Coming in
and no maintenance. Basically,
take it out of the box, put it on the
shelf, load it up with limited con-
sumables, have a 15-minute train-
ing session, and you should be
good to go. That’s the approach we
take when developing our ana-
lyzer platform.
January:
Everyone is being asked to do
more without an increase in staffing
or reimbursement. Industry has to
come to the table with an analyzer
that provides outstanding quality
results with limited or no hands-on
time. Providing a flexible analyzer
platform is a necessity because what
might be perfect for one group or
department may not meet the clini-
Coagulation
cal demands of another.
Brinster (MedTest): The industry
has made tremendous strides in
ease of use. At the same time, there’s
this bifurcation of lab testing. You
have some testing that’s going to-
ward the patient in the format of
waived testing; conversely, there are
analyzers
other testing situations where a
laboratory is needed, such as in the
larger walk-in clinics. If the current
trend in reduction of med techs
continues, we will have a real short-
age and it will become a problem.
There is a need for organizations to
continue to work with schools and
government to try to promote get-
ting more people into medical
technology. —continued on 36
 52 CAP TODAY | DECEMBER 2019
Identification of a single exon deletion using
NGS in a patient with Perlman syndrome
CAP TODAY and the Association for
Molecular Pathology have teamed
up to bring molecular case reports
to CAP TODAY readers. AMP mem-
bers write the reports using clinical
cases from their own practices that case report
show molecular testing’s important
role in diagnosis, prognosis, and
treatment. The following report comes from Children’s
Hospital of Philadelphia and Driscoll Children’s Hos-
pital, Corpus Christi, Tex. If you would like to submit
a case report, please send an email to the AMP at amp@
amp.org. For more information about the AMP and all
previously published case reports, visit www.amp.org.
Jinhua Wu, PhD; Jeffrey Schubert, PhD
Xiaonan Zhao, PhD; Elizabeth Fanning, MS
Zhiqian Fan, MS; Lisa Sutton, MD; Marilyn M. Li, MD
We report a case of a 34-week-gestation male infant
with prenatal overgrowth born to a 19-year-old
G1P0 mother. No significant family history or con-
sanguinity were reported. The infant was delivered
emergently by cesarean section due to pregnancy-
induced hypertension and polyhydramnios. At
birth, the infant was noted to have anasarca and
ascites with a massively distended abdomen and
enlarged kidneys. Despite resuscitative efforts, the
infant expired at one day of life. A complete au-
topsy demonstrated clinical and histologic features
suggestive of Perlman syndrome. There were sig-
nificant urinary tract abnormalities, including
massive nephromegaly, hydronephrosis with
megaureters, bilateral diffuse nephroblastomatosis,
and renal dysplastic changes (Fig. 1). Also noted
was organomegaly of the liver, spleen, and thymus.
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A
The lungs showed mild pulmo-
nary hypoplasia with diffuse
hyaline membrane disease. A
skin biopsy was sent to our
laboratory for genetic testing
with suspicion of Perlman syn-
drome (mutation in DIS3L2
gene) or other potential causes for diseases with
elevated cancer risk in an overgrown fetus, such as
Simpson-Golabi-Behmel syndrome (GPC3). For B
these reasons, a comprehensive hereditary cancer
panel of 130 genes (including DIS3L2) was
performed.
The comprehensive hereditary cancer panel did
not identify a pathogenic or likely pathogenic vari-
ant according to the American College of Medical
Genetics and Genomics/Association for Molecular
Pathology germline variant classification guide-
lines,1 and no variants were observed in the
DIS3L2 gene. However, analysis of regions with
low sequence coverage on the panel discovered no
sequence reads aligned to the genomic region of Fig. 1. Renal histology from patient’s autopsy. A. Disorganized renal
chr2:233028163-233028348, corresponding to exon 9 parenchyma and diffuse nephroblastomatosis (20×). B. Higher power
of DIS3L2 (NM_152383.4), indicating a homozy- view of a small foci of blastema (40×).
gous deletion of DIS3L2 exon 9 as visualized using
Integrative Genomics Viewer (IGV) (Fig. 2A). The sanger.ac.uk/). The deletion of exon 9 is predicted to
deletion was confirmed by PCR specifically target- result in an in-frame mRNA product, and it may
ing DIS3L2 exon 9 using exon 6 as a positive PCR be mediated by nonallelic homologous recombina-
control (Fig. 2B). Precise breakpoints could not be tion between LINE-1 repeats located in the introns.3
determined due to the nature of the targeted assay The identification of the DIS3L2 exon 9 homozy-
used. Homozygous deletions of exon 9 in DIS3L2 gous deletion is diagnostic of Perlman syndrome
have been reported in multiple individuals from for the patient.
at least four families with Perlman syndrome2-4 Next-generation sequencing technology allows
and are listed in DECIPHER (#318416, https://decipher. interrogation of multiple genes in parallel to evalu-
ate multiple variant types, including
SNVs, small indels, exonic deletions/
duplications, and gross copy number
changes, as well as fusions and alter-
native splicing, through a single test,
using DNA and RNA. PCR was used
to confirm the exon 9 homozygous
deletion in this case since we knew
what we were looking for; however,
this method would have had limited
utility as a first-line test because it can-
not detect the same spectrum of vari-
ants in as many genes as can NGS-
based tests.
Perlman syndrome, first described
in the 1970s,5-7 is a rare, autosomal
ANTICOAGULANTS recessive overgrowth syndrome that
In Development can present prenatally with fetal mac-
Apixaban rosomia and polyhydramnios. Pa-
Rivaroxaban
Dabigatran
tients also show characteristic dys-
Edoxaban morphic facial features, including
deep-set eyes, low-set ears, inverted
V-shaped upper lip, prominent fore-
URINE DRUG TESTS
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CE Mark, Forensic Use Only (USA) CE Mark, FDA Cleared
There is a high rate of neonatal mortal-
AB-PINACA NEW EDDP NEW
UR-144/JWH-018 NEW Fentanyl NEW ity in patients with Perlman syn-
Ethyl Glucuronide NEW Tramadol NEW
drome. Those who do survive com-
Ketamine NEW
Meperidine NEW
In Development monly exhibit developmental delay
Methylphenidate Metabolite NEW Gabapentin and renal abnormalities and are at a
High Sensitivity Benzodiazepines
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high risk for developing nephrobla-
Zolpidem stomatosis and Wilms tumor at an
Zopiclone early age.8,9 —continued on 54
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www.ark-tdm.com
 NCCN Guidelines® iwCLL Guidelines

The NCCN Clinical Practice Guidelines in

Oncology (NCCN Guidelines®) and iwCLL
Guidelines recommend FISH and molecular
genetic testing before CLL treatment1,2

The majority (>50%) of CLL patients Tests for Prognostic Factors1

have at least one high-risk factor.3-5 Molecular Analysis

IGHV mutation status

FISH
The iwCLL Guidelines now recommend del 17p
always testing for these important, high-risk del 11q
prognostic factors2: Genetic Sequencing
IGHV unmutated, del 17p/TP53 mutation, del 11q TP53 mutation status

iwCLL recommends testing before you treat

CLL=chronic lymphocytic leukemia, del=deletion, FISH=fluorescent in situ hybridization, IGHV=immunoglobulin heavy-chain variable region gene, iwCLL=International Workshop on CLL,
NCCN=National Comprehensive Cancer Network, PFS=progression-free survival.
References: 1. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
V.2.2020. © National Comprehensive Cancer Network, Inc. 2019. All rights reserved. Accessed October 8, 2019. To view the most recent and complete version of the guideline, go online to
NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. 2. Hallek M,
Cheson BD, Catovsky D, et al. iwCLL guidelines for diagnosis, indications for treatment, response assessment, and supportive management of CLL. Blood. 2018;131(25):2745-2760.
3. Fischer K, Bahlo J, Finket AM, et al. Long-term remissions after FCR chemoimmunotherapy in previously untreated patients with CLL: updated results of the CLL8 trial. Blood.
2016;127(2):208-215. 4. Eichhorst B, Fink AM, Bahlo J, et al. First-line chemoimmunotherapy with bendamustine and rituximab versus fludarabine, cyclophosphamide, and rituximab
in patients with advanced chronic lymphocytic leukaemia (CLL10): an international, open-label, randomised, phase 3, non-inferiority trial. Lancet Oncol. 2016;17:928-942.
5. Kröber A, Seiler T, Benner A, et al. VH mutation status, CD38 expression level, genomic aberrations, and survival in chronic lymphocytic leukemia. Blood. 2002;100:1410-1416.

© Pharmacyclics LLC 2019 © Janssen Biotech, Inc. 2019 10/19 PRC-05893b

 54 CAP TODAY | DECEMBER 2019
Case report
continued from 52
Astuti, et al., established a molecular basis for
Perlman syndrome in 20122 by identifying regions
of homozygosity in consanguineous Perlman
syndrome families. With further genetic mapping,
germline homozygous deletions of DIS3L2 exons
were found in multiple consanguineous families,
and additional biallelic DIS3L2 single nucleotide
variants, including splice-site and missense muta-
tions, were found to segregate with disease in
non-consanguineous patients. The authors further
demonstrated through functional in vitro studies
that recombinant DIS3L2 protein with exon 9
homozygous deletion displayed substantially
reduced ribonuclease activity compared with
wild-type DIS3L2. Additionally, loss of this gene
in cell lines led to increased rates of aneuploidy,
errors in mitosis, and abnormal expression of
mitotic proteins.
In this case, a confirmed molecular diagnosis of
Perlman syndrome has two primary impacts on
patient care. First, in a situation of a neonatal
death, a definitive diagnosis can help bring closure
to the pregnancy for this family by providing a
direct answer to what caused their loss. Second,
and most significantly, this diagnosis has impor-
tant clinical implications for this couple’s family
planning and future pregnancies. As part of the
report issued in this case, we recommended ge-
netic testing for this family to aid in the assessment
of recurrence risk. If both parents are found to be
A deletions and insertions, and copy number variations.
Fig. 2. Next-generation sequencing and PCR results showing homozygous deletion of DIS3L2 exon 9. A. Upper panel: screenshot from Integrative
Genomics Viewer showing DIS3L2 exons 8, 9, and 10 of the patient’s sequencing data compared with a normal control. Sequence reads (red and blue
boxes) are seen as expected in exons 8 and 10 of DIS3L2 in the patient, but no reads for exon 9 are present. Lower panel: zoom-in screenshot of exons
8, 9, and 10 of DIS3L2 in the patient compared with a normal control. B. PCR confirmation visualized by TapeStation: A1, ladder; B1, patient’s sample
DIS3L2 exon 9 (no band); C1, control sample exon 9; D1, patient’s DIS3L2 exon 6 (patient intragenic control); E1, control sample exon 6; F1, blank.
1219_52-54_AMP-Li_v3.indd 54
asymptomatic carriers for heterozygous patho-
genic variants in DIS3L2, there is a 25 percent
chance of their having another child with Perlman
syndrome and a 50 percent chance of their having
a child who is a carrier.
In sum, we identified a homozygous deletion
of a single exon of DIS3L2 gene using an NGS-
based hereditary cancer panel in a patient who
died soon after birth. This result not only provides
a molecular diagnosis of Perlman syndrome but
also carries important implications for the family
in its decision-making for future pregnancies. Our
experience demonstrates that an NGS-based assay
can detect copy number variants at the single
exon level through use of a carefully designed
bioinformatics pipeline and thorough sequence
data investigation.
1. Richards S, Aziz N, Bale S, et al. Standards and guidelines
for the interpretation of sequence variants: a joint consensus
recommendation of the American College of Medical Genetics
and Genomics and the Association for Molecular Pathology.
Genet Med. 2015;17(5):405–424.
2. Astuti D, Morris MR, Cooper WN, et al. Germline mutations
in DIS3L2 cause the Perlman syndrome of overgrowth and
Wilms tumor susceptibility. Nat Genet. 2012;44(3):277–284.
3. Higashimoto K, Maeda T, Okada J, et al. Homozygous
deletion of DIS3L2 exon 9 due to non-allelic homologous
recombination between LINE-1s in a Japanese patient with
Perlman syndrome. Eur J Hum Genet. 2013;21(11):1316–1319.
4. Henneveld HT, van Lingen RA, Hamel BC, Stolte-Dijkstra
I, van Essen AJ. Perlman syndrome: four additional cases and
review. Am J Med Genet. 1999;86(5):439–446.
5. Liban E, Kozenitzky IL. Metanephric hamartomas and
B d. Perlman syndrome is a genetic disorder due to loss of function
DECEMBER 2019 page 54
nephroblastomatosis in siblings. Cancer. 1970;25(4):885–888.
6. Perlman M, Goldberg GM, Bar-Ziv J, Danovitch G. Renal
hamartomas and nephroblastomatosis with fetal gigantism: a
familial syndrome. J Pediatr. 1973;83(3):414–418.
7. Perlman M, Levin M, Wittels B. Syndrome of fetal gigantism,
renal hamartomas, and nephroblastomatosis with Wilms’
tumor. Cancer. 1975;35(4):1212–1217.
8. Alessandri JL, Cuillier F, Ramful D, et al. Perlman syndrome:
report, prenatal findings and review. Am J Med Genet A.
2008;146A(19):2532–2537.
9. Perlman EJ. Pediatric renal tumors: practical updates for the
pathologist. Pediatr Dev Pathol. 2005;8(3):320–338.
Dr. Wu and Dr. Schubert are clinical genomic scientists,
Dr. Zhao is genomic section lead scientist, Fanning is
NGS analyst, Fan is clinical laboratory section super-
visor, and Dr. Li is vice chief—all in the Division of
Genomic Diagnostics, Department of Pathology and
Laboratory Medicine, Children’s Hospital of Philadelphia.
Dr. Sutton is a pediatric pathologist, Department of
Pathology and Laboratory Medicine, Driscoll Children’s
Hospital, Corpus Christi, Tex.
Test yourself
Here are three questions taken from the case report.
Answers are online now at www.amp.org/casereports and
will be published next month in CAP TODAY.
1. What sequencing technology was used in this case
report? What types of variants can be detected by this
method?
a. Next-generation sequencing. It detects single nucleotide variants,
small deletions and insertions, and copy number variation (DNA),
and it can also detect alternative splicing and gene fusions (RNA).
b. Sanger sequencing. It detects single nucleotide variants, small
c. Third-generation sequencing using Nanopore technology. It de-
tects single nucleotide variants and small deletions and insertions.
It does not detect copy number variations.
d. Sanger sequencing. It detects single nucleotide variants only.
2. What is Perlman syndrome? A mutation in what
gene causes this disease?
a. Perlman syndrome is a congenital overgrowth syndrome inherited
in an autosomal recessive manner that is associated with Wilms
tumor susceptibility. DIS3L1 and DIS3L2.
b. Perlman syndrome is a genetic disorder due to loss of function
of specific genes. In newborns, symptoms include weak muscles,
poor feeding, and slow development. DIS3L2.
c. Perlman syndrome is a congenital overgrowth syndrome inherited
in an autosomal recessive manner that is associated with Wilms
tumor susceptibility. DIS3L2.
of specific genes. In newborns, symptoms include weak muscles,
poor feeding, and slow development. RET.
3. What is the inheritance pattern of Perlman syndrome?
What is the recurrence risk of having another child with
Perlman syndrome in this family?
a. It follows an autosomal recessive pattern of inheritance. There-
fore, there is a 25 percent chance of the couple having another
child with Perlman syndrome and a 50 percent chance of having
a child who is a carrier.
b. It follows an autosomal dominant pattern of inheritance. Since
only the proband was tested in this family, parents should be
tested for this variant as well to determine whether this variant
is inherited or de novo.
c. It follows an autosomal recessive or autosomal dominant pattern
of inheritance. The risk for another child with Perlman syndrome
is 100 percent for this family.
d. It follows an autosomal recessive pattern of inheritance. Since
only the proband was tested in this family, parents should be
tested for this variant as well to determine if both parents are a
carrier of this deletion.
12/3/19 9:16 AM
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 56 CAP TODAY | DECEMBER 2019
Influenza testing
continued from 1
we had two pretty much equal influ-
enza A waves, but we did last year.
And we didn’t have much B activity,
which we frequently see toward the
end of the season.”
The lesson reinforced by the last
flu season? “Flu is unpredictable. I
don’t think any of us understands the
interplay of factors well enough to
say, ‘This happened because of this,’”
Brammer says of last season’s atypi-
cal influenza A pattern. “The best
explanation I have is, ‘It’s flu, and flu pheid Xpert Xpress Flu/RSV test,”
is unpredictable.’”
As for this season,
“Here in the U.S.,
we’ve seen the H3N2
viruses, H1N1 at a
slightly lower level,
and influenza B vi-
ruses. We’ve got every-
thing out there; all our
options are open,” she
said in an interview in
late September.
Australia’s flu sea- Childress (l), Dr.Boyanton (r)
son this year, re-
ported to be severe, was actually
moderate but early, Brammer says.
“It did happen early, so activity was
high for the time of year it was hap-
pening, and from what I understand
there were increases in testing. When
you only look at positives, it looks
bad, but people were just testing
more,” she says, adding that in gen-
eral, “there is more and more testing
done.”
As a whole the Southern Hemi-
sphere was a “mixed bag.”
“In South America, some countries
saw more H1 than H3, some saw
more H3 than H1,
some saw more B
than others.” Aus-
tralia was H3 pre-
dominant, she says,
and New Zealand
had more B than A.
“So there’s just a
Brammer
mix. It’s hard to say says. “We could only do about 16
this probably pre-
dicts what we’re going to see because
sometimes it does and sometimes it
doesn’t.”
Meanwhile, laboratories are
weighing options and making
changes.
For Arkansas Children’s at Little
Rock and Springdale, the goal was to
pilot a CLIA-waived rapid molecular
PCR influenza A/B test (to replace the
Quidel Sofia Influenza A+B fluores-
cent immunoassay) in the emergency
department by the end of 2019, most
likely the Cepheid Xpert Xpress Flu,
said Sherry Childress, BSMT(ASCP),
1219_1-58_Troponin-Diabetes-Flu_v3.indd 56
section manager of molecular diag-
nostics and immunology, and Bobby
L. Boyanton Jr., MD, pathologist-in-
chief and section medical director of
molecular pathology, in a recent
interview.
“This rapid molecular flu test will
be used for patients presenting with
influenza-like illness who are not sick
enough to be admitted,” Childress
says. “For patients with bronchiolitis
or sick enough to be admitted, the
BioFire FilmArray respiratory panel
will be the front-line test.”
“We initially considered the Ce-
Dr. Boyanton adds. “However, RSV
is not the only respira-
tory virus that causes
bronchiolitis. Our
emergency room phy-
sicians felt the BioFire
Film­Array panel was
more helpful in this
setting.”
The laboratory
implemented the Bio-
Fire panel first, “but
the Sofias came on
board through point
of care,” Childress says. If the point-
of-care program hadn’t purchased
the Sofias, there’s a good chance the
laboratory would already have im-
plemented rapid molecular testing,
she says. “In truth, the pieces weren’t
all put together as part of the big pic-
ture right from the beginning.”
Between 2018 and 2019, the labora-
tory upgraded to the BioFire Film­
Array Respiratory Panel Two (RP2)
and high-throughput Torch system.
This allowed interfaced results with
the laboratory information system,
automatic verification of negative
specimens, and trained staff on off-
shifts to provide around-the-clock
testing.
Before implementing the Torch
and RP2, the molecular laboratory
day staff fed RP tests through two
FilmArray instruments. The RP test
had a 65-minute run time, Childress
tests on the extended day shift, and
we’d always have a substantial test
queue each morning. The RP2 assay,
which we validated with the new
Torch instrument, runs in 45 min-
utes. With four modules on our
Torch, we could run up to 45 assays
on day shift.”
The laboratory began offering
24/7 RP2 Torch testing at the begin-
ning of 2019 and it has become a
“fast favorite,” Childress says. “Of
course, now we’ve given a mouse a
cookie. Within a couple months of
24/7 coverage, emergency depart-
ment staff were calling the lab to ask
for results, indicating they couldn’t
let patients go home until RP2 testing
was complete.” Test use from Janu-
ary to August 2019 increased 45 per-
cent compared with the same period
in 2018.
Autoverifying negative specimens,
which went live in August, is a first
for the molecular lab, Childress says.
“Lab technicians no longer have to go
into the laboratory information sys-
tem [Epic Beaker] and manually
verify negative test results. We’re
surprised by the difference even this
small change has made in workflow.
Our average TAT is currently 1.4
hours, and that’s without offering the
test on a stat basis.”
Memorial Sloan Kettering Cancer
Center has used only the BioFire
Film­Array respiratory panel since
2011. “During the outrageous 2017–
2018 flu season, we were on calls
every day trying
to result things,”
says Esther Babady,
PhD, MSK’s direc-
tor of microbiol-
ogy services. That
flu season sparked
closer consideration
of flu testing algo- Dr.Babady
rithms. “Should we
implement flu RSV separate from
the respiratory panel?” In a cancer
hospital, “should we only test for
flu,” especially if the patient is going
to be admitted and put in isolation
because of respiratory symptoms?
“Should we know what it is? And
that conversation has been ongo-
ing.” For now, patients get the full
panel. “And as it gets faster,” Dr.
Babady says, “there’s less incentive
to add an algorithm to make it more
complicated.”
MSK implemented the BioFire RP2
assay and Torch system in 2018 in
conjunction with other changes:
MSK’s laboratory moved at the end
of 2017 from the main hospital to a
new location only a few blocks
away—but a sufficient distance in
busy Manhattan to affect TAT signifi-
cantly. “Most clinicians were quite
familiar with how long the BioFire
panel takes to run and expected re-
sults in 90 minutes or less. Because of
the move we added 20 minutes, 30
minutes, sometimes an hour for the
specimen to get to the laboratory,”
she says. “The experience made ev-
eryone start thinking about imple-
menting flu testing options outside
the lab.” Part of what makes the Torch
system attractive, she says, is that
laboratory leadership is comfortable
implementing the platform outside
the clean microbiology lab and train-
ing non-microbiology staff to run it.
DECEMBER 2019 page 56
The plan is to install a Torch in
2020 at a new inpatient/outpatient
center that will open in January at
74th Street, 10 blocks from the main
laboratory. “That’s the first step in
bringing micro outside the comforts
of the clinical micro lab,” she says.
In the next few years, Dr. Babady
and colleagues will think about a
strategy for implementing CLIA-
waived testing, with the aim being to
provide the same level of care
throughout the MSK system. If all of
the challenges are addressed and the
testing is implemented well, she
says, “it can have a positive impact
on any sort of algorithm we could
put together.”
O
“ ne and done” is what made the
Roche Cobas Liat appealing to
the laboratory at Highpoint Health,
a 79-bed acute care hospital in Law-
renceburg, Ind., says laboratory di-
rector Sandy Hoff, MLS(ASCP). “We
realized we could provide better treat-
ment to the patients.” Two were pur-
chased in 2017 for testing ED patients.
“The physician director was more
confident that he was treating patients
appropriately because of the test’s
specificity and sensitivity” and de-
spite the 2018–2019 flu season giving
the two Liats “a run for their money,”
Hoff says. An added bonus, she says,
is that the Liat also performs a group
A strep nucleic acid assay. “It provides
results in a time frame that works with
the ED. Patients can be tested and
sent home with the
appropriate treat-
ment. They really
appreciate that,”
she says of the ED
physicians and the
lab’s switch from
the prior antigen
Hoff
test. “It also helps
with antimicrobial
stewardship.” The lab now has a third
Liat. “The ER collects the swabs, and
they tube them down to us. The turn-
around time is short and allows us to
complete the test during the ED visit.”
The laboratory also recently ac-
quired the BioFire and added the
RP2. “We’re trying to educate the
physicians not to double test: ‘Don’t
order the flu if you’re going to order
the RP2 testing on it. Just order the
RP2 if that’s what is needed. But if it’s
flu season and it looks like flu, order
the Liat,’” the lab advises.
Highpoint Health decided to ex-
pand its use of the Liat after Roche
released its CLIA-waived version, so
23 Liats were placed in Highpoint
Health-owned physician offices in
fall 2019. Point-of-care staff will moni-
tor for false- —continued on 58
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 58 CAP TODAY | DECEMBER 2019

Influenza testing
continued from 56
positives and other potential prob-
lems. “I think there might be a little
sticker shock, but they’ll realize the
value of treating quickly and appro-
priately and not using the antivirals
when they’re not needed. That will
come with time,” Hoff says.
NorthShore University HealthSys-
tem in suburban Chicago imple-
mented the Cobas Liat influenza A/B
and RSV assay in all urgent care
centers and EDs during the 2017–
2018 season. This followed the labora-
tory’s study of 620 patients from
January to June 2017 in which it im-
plemented the Liat assay at one ur-
gent care center and compared anti-
microbial prescribing for respiratory
disease with that of five other North-
Shore urgent care centers that contin-
ued to use the Quidel QuickVue In-
fluenza A+B assay, with confirmatory
PCR testing for negative results
(Benirschke R, et al. J Clin Microbiol.
2019;57[3]:e01281-18).
The centralized clinical laboratory
evaluated the negative rapid antigen
specimens by batched reflex confir-
matory PCR testing using the Dia-
Sorin Molecular Simplexa Flu A/B
and RSV assay. Median TATs for
specimen collection to result verifi-
cation for the Quidel assay were 16
minutes and for the Liat 29 minutes
(results were available during the
patient visit). For the reflex PCR in
the central lab, the median TAT was
21 hours.
Liat testing resulted in a 12.5 per-
cent increase in antiviral prescrip-
tions for patients with positive re-
sults, from 69.9 percent with rapid
antigen testing and reflex PCR to 82.4
percent with Liat, according to the
study. Only 2.3 percent of patients
who tested negative by Liat were
prescribed antiviral medication, com-
pared with 13.1 percent using the
rapid antigen test with reflex PCR.
“Both were statistically significant
improvements in prescribing pat-
terns,” the authors write. “Our re-
sults suggest that the higher sensitiv-
ity and negative predictive value
provide confidence in the test results
provided during the patient encoun-
ter, thus positively impacting antimi-
crobial stewardship.”
Antimicrobial stewardship is one
reason why Erin McElvania, PhD, a
coauthor of the
study, believes rapid
molecular PCR test-
ing is worth its
price. Moreover, a
Liat test isn’t neces-
sarily more expen-
sive than the cost of
Dr.McElvania
rapid antigen test-
ing along with PCR
testing to confirm negative results.
“It’s going to be somewhat institution-
dependent, but at [NorthShore] we
specifically priced our Liat at the same
level as our batched PCR testing,”
says Dr. McElvania, director of clinical
microbiology at NorthShore.
On the other hand, says coauthor
Robert Benirschke, PhD, director of
POC testing at NorthShore, for hos-
pitals in a resource-limited environ-
ment, or where a large number of
patients are paying out of pocket,
rapid molecular PCR testing may be
prohibitively expensive.
“The cost is a lot cheaper if you
perform rapid antigen testing with-
out backing it up with PCR,” Dr.
McElvania says. “It just has horrible
sensitivity. But if the difference is
between having zero testing and
rapid antigen, I’d probably go with
rapid antigen.”
Charna Albert is CAP TODAY associate
contributing editor.
Want to print a story?
Would you like a PDF of an
article in this issue? Go to
www.captodayonline.com, click on
this month’s issue, and then
select the article of interest.
The Adobe PDF button can
be found at the top of each
article page.

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 60 CAP TODAY | DECEMBER 2019
Reflections on biomarkers: so far along, so far to go
Lynn Nye, PhD
Presentations at the recent Cancer
Biomarkers Conference IV, sponsored
by the University of Mississippi Med-
ical Center, prompt reflection on how
far we have come since the introduc-
tion of Rituxan, the first monoclonal
antibody to be approved by the Food
and Drug Administration for the
treatment of cancer in 1996. Before the
launch of Rituxan, physicians were
Commentary
skeptical about the efficacy and safety
of monoclonal antibody therapy be-
cause of the history of failures. In the
early days, nurses had to learn how
to manage the short-term side effects
related to the IV infusion. But pa-
tients, many of whom I met, had ex-
hausted all of their treatment options
for non-Hodgkin lymphoma, and
Rituxan gave them a new lease on
life. At the time, because of the skepti-
cism, it was hard to see the big op-
portunities for monoclonal antibody
therapy and for Rituxan in the mul-
tiple indications for which it was
subsequently approved.
Today, almost a quarter of a century
later, targeted monoclonal antibodies
as well as small molecules are stan-
dard therapy, extending overall sur-
vival for many cancer survivors. At
Cancer Biomarkers Conference IV in
October, researchers from most of the
major academic centers in the United
States presented the latest findings in
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1219_60-63-CBC-Boca-Clinical Abstracts.indd 60
biomarkers and advances in targeted
therapy. Many of the presentations
focused on targeted therapy, using
small-molecule tyrosine kinase inhibi-
tors, immunotherapy by means of
treatment with the checkpoint inhibi-
tors PD-1 and PD-L1 monoclonal an-
tibodies, and drugs that target the ge-
netic abnormalities ALK, EGFR,
BRAF, ROS1, and, most recently,
NTRK. It was evident from discus-
sions with the audience of patholo-
gists, oncologists, and patient advo-
cates that our understanding of disease
mechanisms and associated biomark-
ers is advancing at an exponential pace
that is making it difficult for the oncol-
ogy community to keep up.
Although some patients are benefit-
ing from these new discoveries, many
challenges remain, as with the intro-
duction of Rituxan. How do we make
sure every patient receives biomarker
testing and the appropriate first-line
and subsequent therapy? Is there a
way to predict which patients are
likely to have severe and possibly fatal
side effects from immunotherapy, and
how can we mitigate the side effects?
Should we perform next-generation
sequencing on every patient to better
understand the treatment options
when a patient relapses on a specific
targeted therapy?
In the late 1990s, Genentech funded
the National Coalition for Cancer Sur-
vivorship’s development of the Can-
cer Survival Toolbox, a unique self-
advocacy program for cancer survi-
cap.org
9/13/19 3:40 PM
vors. We have worked on this program
for more than 20 years, and over the
years almost every major pharma
company has supported its produc-
tion and distribution. That the Cancer
Survival Toolbox has been accessed by
more than a million cancer survivors
and is still available today is evidence
of the importance of self-advocacy.
At the boot camp that preceded the
biomarkers conference, the continuing
need for education and patient advo-
cacy was made clear in the moving
story told to us by a young woman
who has two young children. She is a
nonsmoker who after several months
of severe illness was
diagnosed with non-
small cell lung can-
cer. Once diagnosed,
her oncologist was
so concerned about
her failing health
that he wanted to
Dr.Nye
start chemotherapy
immediately, but her
husband, who is not a medical profes-
sional, searched the Internet for infor-
mation and made sure that her health
care team tested her biomarker profile.
Fortunately, she is with us today in
good health because the tests revealed
that her tumor was positive for ALK
and she was able to receive targeted
therapy. Every cancer patient needs an
advocate, even those of us familiar
with oncology, because a cancer diag-
nosis is scary and it’s hard to find the
right information and make the right
decisions under stress.
Conference keynote speaker John
C. Ruckdeschel, MD, a University of
Mississippi Medical Center oncologist,
reviewed the proliferation of tumor
markers that can identify actionable
mutations. The guidelines (CAP/
IASLC/AMP) are inevitably lagging
behind the pace of research develop-
ments. For example, standard panels
of single-gene tests—EGFR, ALK,
ROS1, and others such as BRAF—are
proving to be insufficient to diagnose
and successfully treat all NSCLC. Dr.
Ruckdeschel and other speakers in-
sisted that NGS has to be embraced in
order for the best available treatment
to be selected, particularly for tumors
amenable to immune therapy. Reflex
testing, even though performed in
accordance with guidelines and stan-
dard practice, is proving inadequate
in many cases.
Single-gene assays are well estab-
lished, the data are easier to report
and interpret, and the assays are less
costly than NGS. Therefore, the NGS
approach has to be justified by the
requester and, in particular, how ex-
DECEMBER 2019 page 60
tensive the NGS testing (sequence
limitation) is to be for a particular
case. However, selecting the wrong
treatment by failing to identify the
chief tumor driver causes a delay in
implementing the optimum treat-
ment and may introduce complica-
tions. For example, the incidence of
the rare but serious complication of
interstitial pneumonitis following
immune checkpoint inhibition ther-
apy varies with tumor type. Also,
recently published data suggest that
patients treated with immune check-
point inhibitors who are concomi-
tantly or sequentially treated with
TKIs are at greater risk for developing
pneumonitis.
As was clear from the presentation
on regulation and billing for molecular
testing by Timothy C. Allen, MD, JD,
professor and chair of the Department
of Pathology at the University of Mis-
sissippi Medical Center, the new para-
digm for cancer therapy is not only
presenting major challenges for diag-
nostic and treatment guidelines but
also revealing serious deficiencies in
current health care regulations, sys-
tems, and procedures for reimburse-
ment. Failure to conform to current
treatment guidelines and up-to-date
standards of care exposes the medical
practitioner to potential tort litigation
for negligence or malpractice.
All of which contributes to a grow-
ing need for rapid and effective com-
munication between pathologists,
oncologists, and patients. Pathology
is the foundation for targeted therapy
and patient-centered care in oncology.
As Dr. Allen wrote recently in The
Pathologist, it is important for pa-
thologists to become better commu-
nicators to meet new responsibilities
as more engaged medical team play-
ers, advocating for adoption of new
biomarker tests and supporting on-
cologists in delivering optimal out-
comes for patients. As the late Ellen
Stovall of the National Coalition for
Cancer Survivorship said often, our
vision is “to transform each and ev-
ery person’s experience of living
with, through, and beyond the diag-
nosis of cancer.”
Dr. Nye, whose doctoral degree is in im-
munology, began her career developing
immunodiagnostic tests in London, Eng-
land. She and her team at Medical Minds
specialize in physician and patient educa-
tion and have developed medical commu-
nications in almost every disease category,
including oncology diagnostics and thera-
peutics, during the past 25 years. She led
the launch of Rituxan at the BioGenesis
Group/Torre Lazur, the agency of record.
She is a cancer survivor.
12/11/19 1:32 PM
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 62 CAP TODAY | DECEMBER 2019
Three inside one: biobank, CRO, reference lab
Valerie Neff Newitt
Don’t even try to put Boca Biolistics into a box. The
Pompano Beach, Fla., company is the rare outside-
the-box model of three levels of service under one
roof: an expansive biorepository, a contract research
organization, and a reference laboratory that earned
CAP accreditation in March.
Joseph Mauro, president and CEO of Boca Biolis-
tics, has been developing the “new” model for two
decades. “The thing that makes us different is that
we’re a vertically integrated company encompassing
a biobank, CRO, and reference lab. There aren’t
many players in this space. Lab-
Corp and Quest have been buying
CRO companies, so they are mov-
ing into that area, but they are not
biobanks. They do not have all of
the platforms we have.”
Mauro lists the benefits to what
he describes as “one-stop shop-
Mauro
ping”: a shortened turnaround
time between collecting and test-
ing samples and generating and providing data, cost
consolidation and package discounting, and less
stress on the clients’ own staff.
One of its clients is Hologic, where Sree Panu-
ganti, PhD, is a scientist who develops diagnostic
assays. “At Hologic, we have considered all three
levels of service that Boca provides for various proj-
ects, and we’ve selected one or two based on our
project-specific requirements,” Dr. Panuganti says.
“It’s hard to pick one service that we find most use-
ful. Some projects use the biobanking services more
than other services. For our current project we find
the reference testing is the most important service.”
For that, she says, she’s impressed with the turn-
around time and high-quality results.
Frederick L. Kiechle, MD, PhD, is chief medical
director of Boca Biolistics Reference Laboratory. Hav-
ing spent 33 years directing clinical laboratory divi-
sions at the University of Pennsylvania, William
Beaumont Hospital in Michigan, and, most recently,
Memorial Healthcare System in South Florida, Dr.
Kiechle says, “I’ve experienced it all—academia, staff
pathologist at a health care facility,
and private practice—and I under-
stand the value this model brings
to pathologists, labs, hospitals, di-
agnostic companies, and others.”
Often tasked with serving as
principal investigator, Dr. Kiechle
guides projects bound for the Food
and Drug Administration through Dr.Kiechle
Boca Biolistics’ CRO division. “I
oversee specimens when they arrive, what we do
with them, and their final disposition; comparative
testing; data collection and handling. I’ve had plenty
of experience with CRO and FDA projects, and it’s
a big job to make sure it all runs smoothly and stays
on deadline,” he says.
When CRO work is done in a busy clinical lab
setting, he says, it can paralyze normal operations.
“A great deal of extra time is required of the PIs,
usually a PhD or an MD running that section of the
lab, as well as the technologists and technicians who
must run the tests. Consider that some of these proj-
ects require testing 10,000 specimens in a short pe-
1219_60-63-CBC-Boca-Clinical Abstracts.indd 62
riod. It can shut down normal service activity.” Once
this work is done within a busy hospital lab, the staff
will never want to do it again, Dr. Kiechle says, add-
ing that all of it can be handed over to a CRO.
Sharon Stosur, MS, MLS(ASCP)cm, founder and
president of the nonprofit Preeclampsia Paradoxol-
ogy for Professionals and a former specimen acquisi-
tion specialist for a large IVD manufacturer, says
Boca’s multiple levels of service are a plus for sample
integrity. “Specimens can be procured, tested, ali-
quoted, and stored, which offers greater assurance
that the specimens have not been subjected to exces-
sive shipping and handling, with the added risk of
diminished sample integrity.”
T he client journey typically begins with Biobanx,
  the company’s biorepository. “When a diag-
nostics company or a lab is developing a new assay
or revamping an existing assay,” Mauro says, “they
first need to do research and development, which
requires specimens from archives in a biobank. We
can provide them with the specimens they need.”
Once clients know their assay or platform works,
they prepare to take it to clinical trials. “We can help
them with specimens there, too. We ask clients what
they are looking for. They may say, for example, they
need to prospectively collect a thousand HIV patients
and the associated clinical data to test on their plat-
form. In this case, they do not want biobank speci-
mens but instead prospectively collected patients like
in any normal setting.”
The CRO department handles the regulatory
components of prospectively collecting samples,
getting them consented, and gathering the paper-
work required for FDA submission.
The CRO differs from others in that it is full ser-
vice, Dr. Kiechle says. “Sometimes that includes
helping to design and write proposals. Or, if you
hand us a proposal, we’ll show you a budget and
how we can help you get it done most efficiently.”
The specimen collection process is extensive. “We
are distinguished by our very large global reach in
specimen acquisition,” Mauro explains. “For exam-
ple, if you are conducting an HIV study, you need
HIV samples from around the world to make sure
you have a valid assay that is picking up all the dif-
ferent strains and subtypes in HIV-1 and HIV-2. The
only true way to do that is to get samples from Africa,
Latin America, Asia, the United States, et cetera. We
currently gather samples from more than 50 coun-
tries around the world.”
Such widespread geographic sample gathering is
difficult for many laboratories, he says. “It’s complex
and takes time and effort. They have to get those
countries set up to be able to provide them with
samples. They have to get export approval, and they
must deal with the foreign ministries of health to get
permission from each country. Then a CDC import
permit also must be maintained.”
Gulrez Singh, MS, formerly of Roche Molecular
Systems as director of biospecimen management,
began using Boca in its early days. “They were one
of our key suppliers, sourcing a variety of well-
characterized biological materials of human origin,
from geographically diverse populations, with rea-
sonably short turnaround times,” she says. “In those
days biobanking was a novelty, and their service was
DECEMBER 2019 page 62
C
unique. Though more vendors have since entered
the global material acquisition scene, these guys went
into tough environments, such as West Africa when E
there was civil unrest, for example, and they always D
successfully worked around it.” New companies are M
still on the learning curve, Singh says. “These guys P
have perfected their work. Experience matters.” fu
Boca’s collection gathering prowess was fully
demonstrated during the height of the Zika outbreak
in 2016. The company found itself in the enviable posi-
In
tion of having already collected a mountain of samples an
from the Dominican Republic. “When Zika started to Pa
explode, we started doing longitudinal draws from for
patients,” Mauro says. “We collected serum and m
plasma and urine. We had monstrously deep involve- on
ment in Zika as it got more and more active.”
That year Mauro was invited to a worldwide Zika
conference in Washington, DC. “Keep in mind that
ca
bin
su
a company like mine and people like me normally str
do not get invited to events like that,” he says, noting wi
that such spots are usually reserved for academicians, sa
researchers, and makers of diagnostic tests. “How- ah
ever, I presented all of the specimens that we were of
collecting.” At that point, Boca Biolistics had already as
been in discussion with the FDA as diagnostic com- era
panies were clamoring to get Emergency Use Autho- go
rization approvals. 2,9
He says about a dozen assays became available wh
relatively quickly because of the samples they pro- ao
vided, which allowed for EUAs. “I feel we are indi- tem
rectly making a contribution to patient testing and reg
clinical evaluations. We’re not making the tests, and od
we’re not doing the research, but we’re providing op
important resources for both.”
“It’s an incredible story,” Dr. Kiechle says. “In the
year and a half I’ve been here, I’ve already written
two abstracts for Zika and one abstract for dengue
B
con
based on data we’ve collected in the Dominican
Republic. And there is still so much more information pr
to pull out. It is like sitting on a gold mine.” pa
tor
W hen proposals have been considered and
 samples gathered, clients can elect to have
testing done at Boca Biolistics Reference Laboratory.
it?
cli
rea
“Our newly acquired CAP accreditation is help-
ing this part of the business to grow. It took us a lot M
of time and effort to get it, and we are very proud of bu
that distinction,” Mauro says. “Diagnostics compa- in
nies are now saying, ‘You’ve given us the research ba
samples and you are doing clinical trial collection. ne
Now can you also do testing for us as part of the to
submission package?’ The answer is yes. We can do
all manner of comparative testing.” qu
Clients can specify the platform or platforms on co
which they want an assay tested—Abbott, Roche, Ho- wa
logic, DiaSorin, Bio-Rad, Cepheid, Accelerate, and Gold tha
Standard Diagnostics. “We are bringing on new plat- ne
forms from new manufacturers in 2020,” he says. so
“We proceed to test the samples in our lab, gener- it.
ate the data, and provide it to the client along with lab
the rest of the samples we collected. Now they can an
take that entire package and, if they don’t need any- co
thing further, submit it to the FDA,” Mauro says. do
Boca can handle submissions to the FDA on be- wo
half of a company, he says. “We do have the capabil- tic
ity to do the biostats on the data that come out. We ica
are able to submit to FDA and we have done that an
12/3/19 2:19 PM
 DECEMBER 2019 | CAP TODAY 63

Clinical Pathology tions in flight are under investigation. Therefore, the

authors examined treatment for acute blood loss in
such austere settings as Antarctica, military units,
ed Selected Abstracts and ships at sea to provide insight into establishing
ent type of transfusion was associated with a more than protocols for transfusion during spaceflights. They
en Editor: Deborah Sesok-Pizzini, MD, MBA, professor, three-fold increased risk of 30-day mortality. Patients performed a literature review using PubMed and
ys Department of Clinical Pathology and Laboratory in the highest quartile of probability of transfusion Google Scholar and identified 27 articles on this
are Medicine, Perelman School of Medicine, University of were older and had a higher Euro­SCORE and lower topic, which encompassed three controlled trials, six
ys Pennsylvania, Philadelphia, and chief, Division of Trans- preoperative hemoglobin levels. They also had retrospective cohort analyses, 15 reviews, one case
fusion Medicine, Children’s Hospital of Philadelphia. combined surgery more often and a longer duration report, and two experimental studies. Alternatives
lly of surgery. The adjusted risk factor (odds ratio, 2.6) to blood transfusion in austere settings included
ak continued to show an association between intra- lyophilized blood products, hemoglobin-based
si-
Intraoperative red blood cell transfusion operative transfusion and mortality. The authors oxygen carriers, and fresh whole blood. Walking
les and mortality after cardiac surgery demonstrated that intraoperative transfusion of red blood banks provided methods to screen and acti-
to Patients with underlying cardiac disease are at risk blood cells is associated with increased mortality in vate donors and transfuse and monitor for adverse
om for myocardial ischemia if they have untreated ane- adults undergoing cardiac surgery. They suggested reactions. Other factors identified as barriers to
nd mia at the time of cardiac surgery. During surgery, that future work focus on optimizing preoperative transfusion in space were microgravity, difficulty
ve- ongoing blood loss and hemodilution as a result of cardiac care by treating anemia before surgery. in reconstituting lyophilized products, baseline
cardiopulmonary bypass (CPB) cause low hemoglo- Vlot EA, Verwijmeren L, van de Garde, EMW, et al. Intra-opera- physiologic changes, risk of air emboli, equipment
ka bin levels. The optimal transfusion trigger for cardiac tive red blood cell transfusion and mortality after cardiac surgery. constraints, and limited escape and surgical options.
hat surgery patients continues to be debated. A more re- BMC Anesthesiol. 2019;19(65). https://doi.org/10.1186/s12871-019-0738-2. The authors proposed an algorithm for activating
lly strictive RBC transfusion strategy is used in patients Correspondence: Dr. Eline A. Vlot at e.vlot@antoniusziekenhuis.nl a floating blood bank that includes directions that
ng with stable cardiovascular disease and is considered consider spaceflight requirements that are mission
ns, safe. However, coronary surgery patients may have and microgravity specific. The algorithm provides
w- a higher risk of anemia and adverse events because Blood transfusion for deep space exploration steps for medical decision-making, prepping donor
ere of a fixed coronary stenosis. The authors conducted Astronauts on exploration missions in space are and patient, blood donation, and blood transfusion.
dy a study to examine the association between intraop- at risk for traumatic injury during launch, land- The authors concluded that medical planning for
m- erative transfusion and mortality in patients under- ing, docking, and extravehicular activities. Even space exploration should include risk mitigation
ho- going cardiac surgery. They retrospectively studied fall and crush injuries on planetary surfaces are for acute blood loss. They noted that the value of
2,933 adult patients at a hospital in the Netherlands a possibility. To assess austere conditions during floating blood banks would depend on such factors
ble who underwent coronary surgery with or without spaceflight and available resources for acute blood as the number of people per mission, length of the
ro- aortic valve replacement from June 2011 until Sep- loss, the authors conducted a review of alternative mission, and speed of planetary surface operations.
di- tember 2014. A propensity score based on logistic blood product administration and walking blood
Nowak ES, Reyes DP, Bryant BJ, et al. Blood transfusion for
nd regression analysis was calculated to estimate the banks in austere terrestrial environments. Only 4 L deep space exploration. Transfusion. 2019. doi:10.1111/trf.15493.
nd odds ratio for mortality in patients receiving intra- of normal saline is available in the International
ng operative transfusion. The authors found that this Space Station. Methods to generate crystalloid solu- Correspondence: Dr. David P. Reyes at dpreyes@utmb.edu

he
en
ue
an
Boca Biolistics
continued from 62
M ost of the testing currently falls into three
  categories: tropical diseases (much of which
revolves around dengue studies), oncology, and in-
Would that help? Of course. So again, we’re back to
the concept of trying to be that one-stop shop.”
Boca is also guiding other labs to mine the value
on process, though infrequently, for some smaller com- fectious diseases. It is oncology services that Mauro in their own specimens. “More and more frequently,
panies. The larger companies have their own regula- foresees enabling the company’s expansion. “The hospital labs and other reference labs are looking to
tory staff and typically do it in-house. But can we do oncology space is hot—has been for years—but develop or implement a biobank for themselves that
nd it? Sure. Everything from selling research samples, recently it’s through the roof. Our clients are put- would allow an additional stream of income,”
ve clinical trials, and then comparative testing. That’s ting a great deal of money into oncology research, Mauro says. “Instead of just testing samples, they
ry. really what makes us different.” liquid biopsy specifically. As a result, we are putting could be selling samples that are valuable for re-
p- Offering a closer look at the reference laboratory, a substantial amount of our resources—revenue and search. Right now they are throwing those samples
lot Mauro says: “We don’t do a lot of clinical testing yet, staffing—into oncology. Then we will drill down a out. We don’t see it as a conflict. Helping a lab to
of but now with CAP accreditation we hope to expand little more, mainly looking at doing liquid biopsy.” generate extra income or just preserve a resource it
pa- in that area. But most of the testing we do is research He and others at Boca are talking now with com- already has instead of discarding it definitely pushes
ch based or in response to diagnostic companies that panies about three or four contract projects of more research forward.”
on. need us to do testing on their samples or their assays than $1 million each. “Initially we are going to help Turning the sale of specimens into a new income
he to make sure they work.” with the collection of solid tumors—biopsies or stream for labs requires minimal work and re-
do For comparative testing, sometimes clients’ re- resections—from all over the world,” Dr. Kiechle sources, he says. “We have one lab that employs a
quests are instrument specific. “For example, a says. “We’re also going to collect plasma specimens licensed tech to pull samples and ship samples to
on company might say, ‘We need to do testing but we over a period of six months or five years, depending clients. But when the tech is not doing that, he’s
Ho- want it done on the GeneXpert.’ Great. We’ve got on the client. In those specimens we’ll be looking working for the lab in other capacities. So it’s a full-
old that,” Mauro says. “Sometimes they’ll say, ‘We just for circulating tumor DNA to see how well they time salaried employee who is generating even more
at- need another competitor that is an approved assay, predict disease and/or relapse versus using usual money for the lab—a financially viable asset.”
so tell me what you’ve got.’ If we have it, we have cancer biomarkers. So that’s phase one.” Mauro calls this revenue “bottom-line” money
er- it. If we don’t, we network with another reference Boca is partnering with a next-generation se- because it is selling samples that otherwise would
ith lab that does. We’ll work with one of our partner labs quencing laboratory (one Mauro hopes to acquire) be discarded. “And just throwing them out, logging
an and say, ‘We’ve got this study, we’re going to do this so that collected specimens can undergo genomic biohazards, and so on, adds up to revenue that you
ny- component, then we’ll send the samples to you to testing. “That’s the last piece of the puzzle for us—to have to spend to get rid of the samples. So a lab is
do the other component.’ The reference labs we’re have a component of our lab that can do NGS test- saving a little bit. And in today’s health care econ-
be- working with see that as good revenue. It’s diagnos- ing. This way we can add value to specimens,” omy of diminishing reimbursements, every single
bil- tic. They’re not billing insurance, Medicare, or Med- Mauro says. “If a researcher is looking for 100 breast dollar counts.”
We icaid. They’re basically getting a check from industry cancer tissue sets with specific biomarkers, the
hat and that’s very attractive.” whole genome sequencing will already be done. Valerie Neff Newitt is a writer in Audubon, Pa.

2 1219_60-63-CBC-Boca-Clinical Abstracts.indd 63
DECEMBER 2019 page 63 12/3/19 2:19 PM
 64 CAP TODAY | DECEMBER 2019
Anatomic Pathology
Selected Abstracts
Editors: Rouzan Karabakhtsian, MD, PhD, professor of pathology and director of the Women’s Health Pathology
Fellowship, Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, NY; Nicole Panarelli, MD,
associate professor of pathology, Albert Einstein College of Medicine, Montefiore Medical Center; Shaomin Hu, MD,
PhD, gastrointestinal/liver pathology fellow, University of Chicago; and S. Emily Bachert, MD, pathology resident,
Department of Pathology and Laboratory Medicine, University of Kentucky, Lexington.
Evaluation of tumor quantitation as an
aid in predicting biochemical recurrence
in organ-confined prostate cancer
In the eighth edition of the AJCC Cancer Staging
Manual, all organ-confined disease is assigned
pathologic stage T2, without subclassification. The
authors investigated whether total tumor volume
(TTV) or maximum tumor diameter (MTD) of
the index lesion, or both, enhance the ability to
predict biochemical recurrence in pT2 patients.
They identified 1,657 patients using digital tumor
maps and quantification of TTV/MTD who had
pT2 disease on radical prostatectomy. Multivari-
able Cox regression models were used to assess
whether TTV or MTD, or both, are independent
predictors of biochemical recurrence when adjust-
ing for a base model incorporating age, preopera-
tive prostate-specific antigen, radical prostatectomy
grade group, and surgical margin status. If either
tumor quantification added significantly to the
base model, the authors calculated and reported
the c-index. Ninety-five patients experienced bio-
chemical recurrence after radical prostatectomy.
The median follow-up for patients without bio-
chemical recurrence was 5.7 years. The c-index
was 0.737 for the base model. Although there was
some evidence of an association between TTV and
biochemical recurrence (P = .088), this did not meet
conventional levels of statistical significance and
only provided a limited increase in discrimination
(0.743; c-index improvement, 0.006). MTD was not
associated with biochemical recurrence (P > .9).
In analyses excluding patients with grade group
one disease on biopsy, who would be less likely to
undergo radical prostatectomy in contemporary
practice (622 patients; 59 with biochemical recur-
rence), neither TTV nor MTD added significantly
to the base model (P = .4 and P = .8, respectively).
Without evidence that tumor quantitation, in the
form of TTV or MTD of the index lesion, is use-
ful for predicting biochemical recurrence in pT2
prostate cancer, the authors do not recommend
routinely reporting it.
Ito Y, Vertosick EA, Sjoberg DD, et al. In organ-confined
prostate cancer, tumor quantitation not found to aid in pre-
diction of biochemical recurrence. Am J Surg Pathol. 2019;
43(8):1061–1065.
Correspondence: Dr. Samson W. Fine at fines@mskcc.org
Cytomegalovirus reactivation in IBD:
an uncommon occurrence related
to corticosteroid dependence
Cytomegalovirus promotes mucosal injury in
patients with inflammatory bowel disease, histori-
cally affecting 10 to 25 percent of ulcerative colitis
patients with refractory disease. Viral reactivation
1219_64-65_Anatomic-Molecular_Abstracts.indd 64
M
upper gastrointestinal adenocarcinomas obtained
from The Cancer Genome Atlas and the Gene
Expression Omnibus database to train a machine-
learning algorithm. The resulting classifier cor-
rectly classified all samples from a validation
cohort of 680 primary pulmonary, colorectal, and E
upper gastrointestinal adenocarcinomas, dem- P
onstrating the ability of the algorithm to reliably J
M
distinguish these three entities. The authors then
c
used the algorithm to analyze methylation data
p
from 15 pulmonary enteric adenocarcinomas, p
is likely related to long-term corticosteroid therapy, four pulmonary metastases, and four primary D
which is no longer central to the maintenance of colorectal adenocarcinomas. The 15 pulmonary
patients with inflammatory bowel disease. The enteric adenocarcinomas were reliably classified as Pe
authors hypothesized that viral detection rates primary pulmonary tumors, and the four metas-
have decreased in the modern era, reflecting tases and four primary colorectal cancer samples
th
widespread use of immunomodulatory agents to were identified as colorectal adenocarcinomas. a
control inflammation. They performed a study to In a t-distributed stochastic neighbor-embedding A
evaluate the relationships between medical regi- analysis, the pulmonary enteric adenocarcinoma lab
mens and cytomegalovirus detection rates among samples did not form a separate methylation sub- ag
patients with inflammatory bowel disease. The class but rather diffusely intermixed with other in
authors searched their database for all patients pulmonary cancers. Additional characterization tre
with established inflammatory bowel disease of the pulmonary enteric adenocarcinoma series un
and severe flares diagnosed from 2002 to 2017. using FISH, next-generation sequencing, and copy by
Patients maintained with corticosteroid therapy number analysis revealed KRAS mutations in nine pa
were considered to be corticosteroid dependent, of 15 (60 percent) samples and a high number of ina
and those treated with other agents were classified structural chromosomal changes. Except for an pe
as corticosteroid independent provided they had unusually high rate (67 percent) of chromosome 20 ne
not received corticosteroids within six months of gain, the molecular data were mostly reminiscent ap
colonoscopy. Biopsy samples were reviewed for of standard pulmonary adenocarcinomas. The au- efi
viral inclusions and subjected to cytomegalovirus thors provided sound evidence of the pulmonary In
immunohistochemistry, and rates of viral detec- origin of pulmonary enteric adenocarcinomas ton
tion were compared between groups. There were and a publicly available machine-learning–based th
135 corticosteroid-dependent patients, and most algorithm to reliably distinguish these tumors from an
had ulcerative colitis flares between 2002 and metastatic colorectal cancer. nifi
2009. Patients with ulcerative colitis and Crohn giv
Jurmeister P, Schöler A, Arnold A, et al. DNA methyla-
disease were equally represented in the corticoste- tion profiling reliably distinguishes pulmonary enteric ad- wi
roid-independent group (n = 133), and most were enocarcinoma from metastatic colorectal cancer. Mod Pathol. co
evaluated for disease flares during the 2010–2017 2019;32(6):855–865. ing
interval. Cytomegalovirus was detected in 13 cases, m
Correspondence: Dr. P. Jurmeister at philipp.jurmeister@charite.de
nine of which were diagnosed from 2002 to 2009, ca
and all involved corticosteroid-dependent patients ge
(P = < .001). The authors concluded that rates of Methotrexate-associated pa
cytomegalovirus-related enterocolitis are declin- tro
ing among inflammatory bowel disease patients,
lymphoproliferative disorders in by
reflecting a shift away from corticosteroid-based patients with rheumatoid arthritis on
maintenance therapy in lieu of more effective Methotrexate carries a risk of lymphoproliferative th
agents that do not promote viral reactivation. disorders, but methotrexate-associated lympho- fo
proliferative disorders (MTX-LPD) can resolve tre
Hissong E, Chen Z, Yantiss RK. Cytomegalovirus reactiva-
tion in inflammatory bowel disease: an uncommon occur-
spontaneously after MTX withdrawal. However, 7(
rence related to corticosteroid dependence. Mod Pathol. the precise clinicopathologic features of MTX- di
2019;32(8):1210–1216. LPD remain unclear. The authors investigated rec
the clinicopathologic characteristics, outcomes, Th
Correspondence: Dr. Erika Hissong at emh9016@med.cornell.edu
and prognostic factors for histologic types of co
MTX-LPD. They analyzed paraffin-embedded in
DNA methylation profiling to distinguish tissue samples from 219 patients with MTX-LPD. tw
In total, 30, 33, 106, and 26 had reactive lymphoid to
pulmonary enteric adenocarcinoma hyperplasia (RH), polymorphic-LPD (poly-LPD), rot
from metastatic colorectal cancer diffuse large B-cell lymphoma (DLBCL), and
Pulmonary enteric adenocarcinoma is a rare non- classic Hodgkin lymphoma (CHL), respectively.
small cell lung cancer subtype. It is poorly charac-
terized and cannot be distinguished from meta-
The clinicopathologic features of RH, poly-LPD,
DLBCL, and CHL were extranodal involvement
A
con
static colorectal or upper gastrointestinal adeno- in 13.8 percent (four of 29), 36.4 percent (12 of 33),
carcinomas using routine pathological methods. 69.5 percent (73 of 105), and 15.4 percent (four of res
Because DNA methylation patterns are known 26), respectively; Epstein-Barr virus-encoded RNA ce
to be highly tissue specific, the authors aimed to positivity in 55.2 percent (16 of 29), 71.9 percent (23 (14
develop a methylation-based algorithm to differ- of 32), 45.3 percent (48 of 106), and 76.9 percent (20 10
entiate these entities. To this end, they developed of 26), respectively; necrosis in zero (zero of 29), fro
a reference cohort from genome-wide methylation 51.5 percent (17 of 33), 34.3 percent (36 of 105), 10
profiles of 600 primary pulmonary, colorectal, and and 12 percent (three of 25), —continued on 65 DL
DECEMBER 2019 page 64 12/3/19 12:01 PM
 DECEMBER 2019 | CAP TODAY 65

Molecular Pathology
ed a very small number of diseases with generation sequencing of their pre-
ne a splice-switching molecular patho- treatment tumor. After therapy, the
ne- genesis. From a societal perspective, somatic mutation with the highest
or- cost is an issue. This treatment model variant allele fraction was targeted
on
Selected Abstracts also raises the questions, How should for ultra-sensitive plasma-based
nd Editors: Donna E. Hansel, MD, PhD, chair of pathology, Oregon Health and Science University, individualized drugs be regulated by ctDNA detection by a patient-specific
m- Portland; Richard D. Press, MD, PhD, professor and director of molecular pathology, OHSU; the FDA? Should safety and efficacy assay that used an error-corrected
bly James Solomon, MD, PhD, assistant professor, Department of Pathology and Laboratory benchmarks be loosened? Even for polymerase chain reaction–based
en Medicine, Weill Cornell Medicine, New York; Sounak Gupta, MBBS, PhD, senior associate a progressive fatal disease, how can sequencing method. Circulating tu-
consultant, Mayo Clinic, Rochester, Minn.; Tauangtham Anekpuritanang, MD, molecular
ata patient safety be ensured? The ability mor DNA was identified in 20 of 96
pathology fellow, Department of Pathology, OHSU; Hassan Ghani, MD, molecular genetic
as, pathology fellow, Department of Pathology, OHSU; and Fei Yang, MD, assistant professor, to answer these important questions (21 percent) patients after surgery
ry Department of Pathology, OHSU.  will impact whether N-of-1 clinical and 15 of 88 (17 percent) patients
ry trials can be applied to larger groups after adjuvant chemotherapy. After
as Personalized oligonucleotide known to evolutionarily “jump” be- of patients. a median follow-up of 29 months,
as- tween genes. This intronic insertion, 24 patients experienced disease re-
es
therapy for treatment of which had not been described pre-
Kim J, Hu C, El Achkar CM, et al. Patient-
currence. Circulating tumor DNA
as. a rare genetic disease viously, could cause the disease by
customized oligonucleotide therapy for a
rare genetic disease. N Engl J Med. 2019; positivity at both post-treatment time
ng A variety of molecular diagnostic generating an abnormally spliced 381:1644–1652. points was strongly, significantly, and
ma laboratory tools are available to di- mRNA and, ultimately, an abnor- independently prognostic for subse-
Correspondence: Dr. Timothy Yu at timothy.yu@
ub- agnose diseases caused by mutations mal downstream protein. Previous quent disease recurrence. However,
childrens.harvard.edu
her in the human genome. However, few studies have shown that abnormally the overall diagnostic sensitivity of
on treatments are available to correct the spliced RNA can be treated using this ctDNA assay was suboptimal,
es underlying pathophysiology driven antisense oligonucleotides that mask Detecting recurrent colon with only 42 percent of disease recur-
py by these mutations. This is due, in the pathogenic cryptic splice site and, rences having been preceded by a
ne part, to pharmaceutical companies’ therefore, promote use of the normal
cancer using circulating positive ctDNA result after surgery.
of inability to justify, from a business gene’s functional splicing sites. The tumor DNA analysis In comparison, traditional carcinoem-
an perspective, the expense and time authors of the study on the six-year- Colon cancer typically is initially bryonic antigen (CEA) tumor marker
20 necessary to develop and obtain FDA old girl, reported herein, designed an treated with surgery and, for a subset monitoring, which is traditionally
nt approval for novel therapies that ben- antisense oligonucleotide that target- of patients, adjuvant chemotherapy. used in invasive colon cancer follow-
u- efit only a small number of patients. ed the DNA sequence of the patient’s While treatment improves the overall up, was positive in only seven of the
ry In a recent study, investigators at Bos- unique pathogenic cryptic splice ac- survival for patients with advanced 96 patients, compared to 20 of 96 for
as ton Children’s Hospital showed that ceptor site. This antisense oligonucle- colon cancer, no reliable post-treat- ctDNA. This suggests that ctDNA is
ed the conventional drug development otide drug (Milasen) was shown to ment biomarker can predict which likely a more analytically sensitive
m and approval paradigm can be sig- partially correct the splicing defect patients have minimal residual dis- method for detecting residual tumor
nificantly disrupted and accelerated, and consequent lysosomal pathology ease, which can lead to disease recur- cells and possibly informing the need
given the right set of circumstances, in the patient’s cells grown in culture. rence. Reliable identification of this for additional therapy. The ability of
la-
ad- without involving pharmaceutical After the investigators conducted a high-risk patient population could this ctDNA assay to detect minimal
hol. companies. According to their find- rapid series of animal tests to confirm provide an opportunity to treat these residual disease after treatment has
ings, within 12 months of the initial safety, the FDA granted them permis- patients with additional therapy to obvious utility for the clinical man-
molecular diagnosis of a disease- sion to test Milasen in a single-patient decrease disease burden or delay or agement of colon cancer patients. The
e
causing mutation, an effective tar- clinical trial. The first intrathecal injec- prevent disease recurrence. Identi- availability of sensitive, prognostic,
geted therapy applicable to a single tions began within eight months of fication of tumor-specific mutations blood-based assays for minimal re-
patient can be designed; tested in vi- the child’s diagnosis. After one year in circulating tumor DNA (ctDNA) sidual disease may provide solid
tro, in vivo, and for safety; approved of treatment, the patient’s number that has leaked into the blood may tumor oncologists with a laboratory
by the FDA; administered; and dem- and duration of seizures significantly allow early and accurate detection tool akin to those in the standard di-
onstrate therapeutic efficacy. The au- decreased, with no serious adverse of minimal residual disease. In this agnostic toolkit of leukemia-focused
ve thors reported on a six-year-old girl events, although she continued to study, the authors measured patient- hematological oncologists who have
o- for whom a drug was designed to lose brain volume. This landmark specific ctDNA mutations after sur- been monitoring minimal residual
ve treat ceroid lipofuscinosis, neuronal, proof of concept N-of-1 clinical trial is gery for advanced colon cancer and, disease-based leukemic disease bur-
er, 7 (CLN7), which is a form of Batten’s the first instance of an FDA-approved again, after adjuvant chemotherapy. dens via a variety of methods for
X- disease, a rare and fatal autosomal drug being created and administered They showed that the detectable many years.
ed recessive neurodegenerative disease. for a single patient. Although this presence of these mutations in post- Tie J, Cohen JD, Wang Y, et al. Circulating
es, The child’s disease was caused by study provides hope for patients with treatment plasma-derived DNA was tumor DNA analyses as markers of recur-
of compound heterozygous mutations rare genetic diseases, there are many a strong and significant prognostic rence risk and benefit of adjuvant therapy
ed in the CLN7 gene. One of the child’s obstacles to applying this model to biomarker for future disease recur- for stage III colon cancer. JAMA Oncol. 2019.
D. two CLN7 mutations was found other syndromes. From a scientific rence. The patients enrolled in the doi:10.1001/jamaoncol.2019.3616.
id to be an intronic insertion of a ret- perspective, antisense oligonucle- study had at least one tumor-specific Correspondence: Dr. Jeanne Tie at tie.j@wehi.
D), rotransposon, a rogue section of DNA otide therapeutics will only apply to somatic mutation identified by next- edu.au 
nd
ly.
D,
nt
Anatomic abstracts drawal, progression-free survival was the great-
est for RH, followed by poly-LPD, DLBCL, and
dex risk for DLBCL. The authors concluded that
histologic categorization and histology-specific
continued from 64
3), CHL (all, P < .05). Overall survival did not differ factors could be useful for predicting MTX-LPD
of respectively; and Hodgkin Reed-Sternberg–like significantly between the groups. On univariate progression after MTX withdrawal.
NA cells in 17.2 percent (five of 29) of RH, 50 percent analysis, the predictive factors for progression- Kurita D, Miyoshi H, Ichikawa A, et al. Methotrexate-associat-
23 (14 of 28) of poly-LPD, and 19.8 percent (21 of free survival included plasma cell infiltrate for ed lymphoproliferative disorders in patients with rheumatoid
20 106) of DLBCL, respectively. The median duration CHL, eosinophil infiltrate, age above 70 years, and arthritis: clinicopathologic features and prognostic factors. Am
9), from MTX withdrawal to disease regression was extensive necrosis for poly-LPD. On multivariate J Surg Pathol. 2019;43(7):869–884.
5), 10.4, 3.0, 4.2, and 2.7 months for RH, poly-LPD, analysis, they were Epstein-Barr virus-encoded Correspondence: Dr. Hiroaki Miyoshi at miyoshi_​hiroaki@med.
65 DLBCL, and CHL, respectively. After MTX with- RNA positivity and International Prognostic In- kurume-u.ac.jp

4 1219_64-65_Anatomic-Molecular_Abstracts.indd 65
DECEMBER 2019 page 65 12/3/19 12:01 PM
 66 CAP TODAY | DECEMBER 2019
Q&A
Editor: Frederick L. Kiechle, MD, PhD
Dr. Kiechle is consultant, clinical pathology, Cooper City, Fla. Submit your inquiries
to Sherrie Rice, srice@cap.org. Questions that are of general interest will be answered.
Q. When reviewing a smear, we ob-
served scattered (rare) immature
granulocytes during a scan. But when the
100-cell differential was performed, the
immature granulocytes were not reflected.
How do you report the presence of the im-
mature granulocytes?
A. The immature granulocyte (IG)
fraction—metamyelocytes, my-
elocytes, and promyelocytes—can
be quantified on modern peripheral
blood analyzers as part of the six-part
automated differential of the white
blood cell count. The total number
of cells counted for differentials is, of
course, much higher by automated
methods (30,000 cells on Sysmex plat-
forms, for example) compared with a
manual method (standardly 100 cells).
Therefore, as noted in the question,
a low proportion of IGs detected by
automated differential may not
best
of
Q &A In this “Best of Q&A” series, we
reprint select coagulation-related
questions and answers. All have been cho-
sen for their timeliness and relevance today.
The following question and answer were
published in August 2016.
Q. Should a patient with a hematocrit
greater than 55 percent be redrawn
for correction always or only when pro-
thrombin time and partial prothrombin
time are elevated?
A. Accurate hemostasis and throm-
bosis results rely heavily on
proper collection and processing (pre-
analytic phase) of the citrated blood
specimen. Guidelines from many
sources, including the Clinical and
Laboratory Standards Institute,1 indi-
cate that blood collection into nonacti-
vating containers (e.g. polypropylene
plastic or silicone-coated glass) with
proper blood-to-anticoagulant ratio is
required. Trisodium citrate tubes are
available in a 3.2 percent or 3.8 percent
concentration. A laboratory should
choose a single concentration and
not use the two citrate concentrations
interchangeably.2 The World Health
Organization and the CLSI recom-
mend using 3.2 percent sodium citrate
(105–109 nm/L), as the thromboplastin
International Sensitivity Index val-
ues applied in the INR calculation are
based on specimens collected in 3.2
percent citrate.2,3
1219_66-68_Q&A.indd 66
be reflected in a random 100-cell man-
ual differential. This discrepancy may
occur not only because of significant
differences in the total cell count but
also because of other factors affecting
the peripheral blood smear. For ex-
ample, immature cells, because of
their relatively large size, tend to con-
centrate at the feathered edge, so their
distribution may be less random
across a slide than in a fluid state.
One strategy used by our hospital-
based laboratory to address rare IGs
is to add a white blood cell morphol-
ogy comment to the manual differ-
ential of “slight left shift.” This sig-
nals that immature granulocytes are
present but that they represent less
than one percent of WBCs—that is,
less than one cell per 100 on a stan-
dard manual differential. A paren-
thetical or footnoted statement with
this additional information could
The proper blood-to-anticoagulant
ratio, commonly referred to as the “fill
volume,” results in a 9:1 ratio of blood
to anticoagulant. Underfilled tubes,
defined as less than 90 percent of the
fill volume, may result in prolongation
of calcium-dependent, clot-based test-
ing such as the PT and activated partial
thromboplastin time (APTT) assays.
Citrate’s anticoagulant effect is due to
chelation of calcium in the specimen.
When calcium is unavailable, coagula-
tion cannot occur. During the analytic
testing phase, a premeasured amount
of calcium is added back, which allows
coagulation to occur. If the citrate anti-
coagulant concentration is too high, the
amount of calcium available during
the testing phase is decreased, and the
resulting time to clot formation is
prolonged.
Underfilled sodium citrate tube.
Citrate distributes only in plasma, and
if a tube is underfilled, the reduced
plasma volume will contain more ci-
trate anticoagulant, leading to in-
creased calcium chelation (see citrate
tubes A–E, at right). Furthermore, there
is an increased proportional volume of
anticoagulant due to the lower plasma
volume, which results in a potential
dilution effect.2
The net effect is prolongation of clot-
based assays (e.g. APTT, PT, protein C/
protein S clot-based activity assays,
and clot-based factor activity assays).
The potential for erroneous results is
also be included.
A related strategy is to avoid man-
ual review for low IG fractions alone
when using analyzers that produce
an IG count. (With analyzers that only
generate a flag that IGs are present,
manual review is always recom-
mended.) Recent studies highlight the
accuracy of modern analyzers in iden-
tifying IGs and advocate for reflex
release of these automated values
without a flag for manual review at
low IG fractions (less than three per-
cent to less than 10 percent, as sug-
gested by varying sources). Auto-
mated IG fractions may be overesti-
mated due to a systematic positive
error, and flag for manual review is
appropriate at high proportions, re-
gardless of whether the analyzer
quantifies IGs. On the other hand,
there is significant interobserver vari-
ability in manually distinguishing
between metamyelocytes and band
neutrophils, with the latter best in-
cluded in the neutrophil fraction and
not separately reported, and less so by
automated methods.
Barnes PW, McFadden SL, Machin SJ; Interna-
tional Consensus Group for Hematology. The
International Consensus Group for Hematol-
often more pronounced in specimen
tubes containing 3.8 percent sodium
citrate or in smaller-volume containers
such as half-draw or pediatric collec-
tion tubes.2,3
Hematocrit greater than 55 percent.
Laboratories must also monitor for
specimens with a hematocrit greater
than 55 percent. In this situation, the
plasma volume is reduced, resulting in
a reduced plasma volume similar to
that of an underfilled tube. The CAP
hematology and coagulation checklist
requires that laboratories have a writ-
ten procedure for detection and special
handling of specimens with elevated
hematocrits.4 The amount of antico-
A B C D E
Citrate tubes illustrating various collection volumes,
hematocrits (Hct), and the corresponding plasma
volumes. A and B: Appropriately filled citrate tube
and corresponding plasma volume (Hct: 42.3
percent). C and D: Underfilled citrate tube and
corresponding plasma volume (Hct: 42.3 percent). E:
Appropriately filled citrate tube with reduced plasma
volume from a sample with an increased hematocrit
(Hct: 65.6 percent). Note: The reduced plasma volume
is similar to that of an underfilled tube (tube D).
DECEMBER 2019 page 66
ogy review: suggested criteria for action fol-
lowing automated CBC and WBC differential
analysis. Lab Hematol. 2005;11(2):83–90.
Bourne S, Ma N, Gulati G, Florea AD, Gong
J. Evaluation of automated versus manual
immature granulocyte counts. Lab Med.
2013;44(3):282–287.
Chabot-Richards DS, George TI. White blood
cell counts: reference methodology. Clin Lab
Med. 2015;35:11–24.
Eilertsen H, Hagve TA. Do the flags related to
immature granulocytes reported by the Sys-
mex XE-5000 warrant a microscopic slide re-
view? Am J Clin Pathol. 2014;142(4):553–560.
MacQueen BC, Christensen RD, Yoder BA,
et al. Comparing automated vs manual leu-
kocyte differential counts for quantifying the
‘left shift’ in the blood of neonates. J Perinatol.
2016;36(10):843–848.
Maenhout TM, Marcelis L. Immature granu-
locyte count in peripheral blood by the Sys-
mex haematology XN series compared to
microscopic differentiation. J Clin Pathol.
2014;67(7):648–650.
Sireci A, Schlaberg R, Kratz A. A method for
optimizing and validating institution-specific
flagging criteria for automated cell counters.
Arch Pathol Lab Med. 2010;134(10):1528–1533.
Alexandra E. Kovach, MD
Assistant Professor of Pathology,
Microbiology, and Immunology
Vanderbilt University Medical Center
Nashville, Tenn.
Member, CAP Hematology/Clinical
Microscopy Committee
agulant may require an adjustment in
samples containing a hematocrit above
55 percent. The most efficient method
to determine the appropriate citrate
volume is to include a table in the labo-
ratory specimen collection procedure
indicating the modified volume of ci-
trate for hematocrits greater than 55
percent. The formula to determine the
correct volume of citrate for a given
hematocrit is as follows5:
C = (1.85×10-3)(100−Hct)(V blood),
where C indicates the volume (mL) of
citrate needed in the tube; Hct (%), the
hematocrit of the patient; and V, the
volume (mL) of whole blood. Note: In
a 3.5-mL specimen tube, the volume of
blood drawn is 3.15 mL (i.e. V=3.15 mL
in this equation).
In theory, should an underfilled
tube or specimen with a hematocrit
greater than 55 percent show normal
screening PT or APTT coagulation re-
sults, one can conclude the patient has
normal hemostatic results. However,
this may be a deviation from standard
operating procedure, so the medical
director should make the final decision.
Only the laboratory medical director or
a qualified laboratory physician should
approve deviations from an SOP. Be-
fore a laboratory physician approves
the results from an improperly filled
specimen collection tube, an investiga-
tion into the patient’s clinical situation
and indication for testing should be
reviewed. There —continued on 68
12/3/19 12:03 PM
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 68 CAP TODAY | DECEMBER 2019
Q&A
continued from 66
are situations in which re-collection
may pose increased risk to a patient (a
neonate, for example). In such cases,
performing the basic screening coagu-
lation assays is indicated, and if the
results are within normal limits, the
laboratory physician may choose to
release those results. Coagulation as-
says that do not rely on clot formation
are often acceptable for testing, yet ap-
proval for testing should also be deter-
mined by the pathologist.
Other calcium-dependent, clot-
based special coagulation assays, such
as the protein C (PC) and protein S
(PS) activity assays, which use PT or
APTT methodology, should not be
performed on an over-citrated speci-
men. In the PC and PS assays, falsely
prolonged clotting times may result in
overestimation of PC or PS activity.
Thus, an over-citrated specimen sec-
ondary to an underfilled tube or he-
matocrit greater than 55 percent may
be misinterpreted as having normal
PC or PS activity. In the clot-based PC
and PS activity assays, a short time to
the clotting endpoint (fibrin forma-
Find your balance
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© 2019 College of American Pathologists. All rights reserved. 27949.1019
1219_66-68_Q&A.indd 68
27949_PathPark_CT_F_Ad_Design_Final.indd
1
tion) correlates to abnormally low PC
and/or PS activity. Therefore, low PC
and/or PS activity results from speci-
mens that are underfilled or have he-
matocrit greater than 55 percent may
represent a true, “qualitatively” low
value, yet the accuracy (i.e. exact
value) of the activity would be in ques-
tion. If testing is performed, the pa-
thologists must review these results
and determine how (or if) the result
should be reported. Clot-based factor
activity assays are also subject to these
preanalytic errors. Over-citrated speci-
mens may cause falsely prolonged
clotting times in the factor activity
assays, resulting in erroneously low
factor activity levels.
Overfilled sodium citrate tube.
Overfilled specimen collection tubes
can also occur. A common cause for
overfilled specimen tubes is when
whole blood is first drawn into a sy-
ringe and then forcibly injected into a
specimen tube. Overfilled citrate tubes
can also occur when the stopper (cap)
is removed and additional blood is
added. This may be an indication that
a specimen from one collection tube
was poured (added) into a second
collection tube, and this practice is
Get the details at cap.org and search Pathology in the Park.
unacceptable.2 Overfilled tubes may
result in poor mixing of the anticoagu-
lant and lead to inaccurate results.
Regardless of the cause of an over-
filled tube, it violates the 9:1 ratio, and
testing should be approved only by
the pathologist.
In conclusion, improperly filled
specimen tubes should call into ques-
tion the collection process. The guide-
lines provided by CLSI H21-A5 clearly
state, “Specimens that are clotted, col-
lected in the wrong anticoagulant type
(e.g., EDTA, sodium heparin), have
other than a 9:1 blood to anticoagula-
tion ratio, or are collected or stored in
a container with an activating surface,
are not suitable for testing and should
be rejected [italics added].”1 One must
be cautious when accepting an im-
properly collected specimen. Approv-
ing the specimen for testing often un-
dermines the strict specimen-collection
requirements designed for accurate
coagulation test results and patient
safety. Making exceptions to these
rules may falsely reassure clinical med-
ical providers that improperly filled
citrate specimen tubes are acceptable.
Exceptions to re-collection for under-
filled tubes or patients with hematocrit
DECEMBER 2019 page 68
greater than 55 percent should be con-
sidered only when screening PT and/
or when APTT test results are normal,
or when specimen re-collection is not
possible.
1. Clinical and Laboratory Standards Institute.
Collection, Transport, and Processing of Blood
Specimens for Testing Plasma-Based Coagula-
tion Assays and Molecular Hemostasis Assays;
Approved Guideline—Fifth Edition (H21-A5).
Jan. 23, 2008.
2. Kitchen S, Olson JD, Preston FE, eds. Qual-
ity in Laboratory Hemostasis and Thrombosis.
2nd ed. Chichester, West Sussex, U.K.: Wiley-
Blackwell; 2013:45–56.
3. Bennett ST, Lehman CM, Rodgers GM, eds.
Laboratory Hemostasis: A Practical Guide
for Pathologists. 2nd ed. Cham, Switzerland:
Springer International; 2015:173–175.
4. College of American Pathologists. Hematol-
ogy and coagulation checklist. July 28, 2015.
5. Kottke-Marchant K. An Algorithmic Ap-
proach to Hemostasis Testing. 2nd ed. North-
field, Ill.: CAP Press; 2016:46–47.
Andrew Jackson Goodwin IV, MD
Currently Associate Professor
Department of Pathology
University of Vermont
College of Medicine
Burlington
Member of the CAP Coagulation
Resource Committee at time of
original publication
12/3/19
10/8/19 12:03 PM
3:56 PM
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Newsbytes
Editors: Raymond D. Aller, MD, & Hal Weiner
generally the frontline staff, who
were dealing with this issue on a day-
to-day basis, who were able to give
SlideTrack serves as a gatekeeper,
Schaan says. “The system first asks
where the slides are going,” Bushell
the best input. That allowed us a re- adds. “For an internal request, we
ally deep dive into the problem, and only need to know which pathologist
How a local startup solved a lab’s slide-management issues at the end of the day we ended up it’s heading to. But if it’s being sent
When Alex Bushell, the young CEO mate the process, Bushell says, “the with a much more well-rounded so- off site, the requestor needs to enter
of a Canadian startup, approached [provincial] Ministry of Health and lution.” Two key lessons from the site key information about where it’s go-
Bernard Schaan, the now-retired Long-Term Care caught wind of our visits, Bushell adds, were that “no ing, how it’s being used, and for how
laboratory manager at Peterborough plans. They said if you’re going to one has any space, and no one wants long it will be off site. All this infor-
Regional Health Centre, in 2017, to spend money on this, let’s expand to revamp their storage infrastruc- mation is logged, and an alert is is-
ask what problem they might tackle the scope and develop something ture.” Consequently, the final product sued if the slides are not returned
together, Schaan mentioned an is- that’s not only going to work in Pe- is about the size of a microwave and within this time. Now the charge tech
sue that had nagged him for years: terborough but also in larger and designed to work with a laboratory’s has all the information they need in
histology slide filing cardboard storage, order to follow up and chase down
and retrieval. Tasked which, according to the overdue slides.”
with filing between Bushell, “is by far the The new retrieval procedure ini-
125,000 and 135,000 most common media tially sparked some pushback from
slides per year, “I for slide storage.” pathologists who were accustomed
thought the process Rather than manu- to pulling their own slides, but
could be automated ally scanning each they’re getting used to it, Schaan says.
and had been asking slide, Bushell says, a And the time spent by lab staff to file
various sales reps if laboratorian can load slides has been reduced from up to
there’s anything out up to 200 slides at a six hours a day to approximately an
there—and they said time into SlideTrack hour, freeing staff for other tasks.
no, there wasn’t,” and walk away. The “There is no longer a need to form
Schaan says. device then sorts the urgent search parties to try to find a
Bushell, the CEO of slides and files them misplaced slide,” Bushell jokes.
Peterborough, On- into long-term storage Schaan and Bushell emphasize
tario-based Lab Im- containers. “The ma- that constant communication, includ-
provements, an engi- chine grabs one slide ing frequent in-person meetings, was
neering firm focused at a time, checks the key to the success of their collabora-
on laboratory automa- label for barcodes and tion. “It was fantastic to work with a
tion, embraced the other identifying in- site that was 15 minutes away from
challenge of solving formation, such as our office,” says Bushell. “We were
the PRHC laboratory’s key characters or col- able to go in multiple times just to
dilemma as part of its ors, and files the ap- test one feature to make sure we got
goal of working with propriate slides in it right. It wouldn’t have worked for
the local institution. containers based on us to disappear for six weeks and
Less than two years that information,” he come back and find that we had been
later, the vendor- explains. “When all of going completely down the wrong
provider undertaking the slides have been path. [At the beginning,] a lot of it
has culminated in the sorted and loaded in was very hands-on: How many
installation of a bench- slides are you doing on a daily basis?
top device at PRHC How would you want to load them?
that has greatly re- And we tried a couple different tech-
duced the staff time niques and methods and styles of
required to file and re- Alex Bushell (left) and Bernard Schaan in the slide storage vault at Peterborough loading up the machine.” As Bushell
trieve slides, and it has Regional Health Centre, where SlideTrack (at right) has increased the speed and learned from previous visits to other
showcased the benefits accuracy of slide management. institutions, “It’s great to have a man-
of such a partnership. ager or director tell you that there’s a
Before the device, called Slide- smaller hospitals across Ontario and problem, but to truly understand it,
Track, was installed, laboratory staff worldwide.” Through a now-defunct you have to sit down with the front-
at PRHC manually filed slides, in government/private sector collabo- line people and see what’s happen-
numerical order, in cardboard boxes ration, Lab Improvements secured the appropriate containers, the ma- ing on a day-to-day basis and what
for storage, a less than foolproof $25,000 for development of the de- chine lets the operator know it’s fin- will make their life easier. Their input
system, Schaan says. And when vice and PRHC secured $15,000 for ished. The operator then unloads the resulted in a lot of the features that
pathologists pulled slides from stor- procurement. now-filled magazines and puts them we ended up incorporating.”
age for review, he adds, “they some- Among the conditions for obtain- into the lab’s long-term storage vault. Lab Improvements’ small size and
times left them in their office for ing the funding, which covered a SlideTrack’s database manages the nimble response to whatever issues
unexpected periods of time or mis- portion of the development costs, location where each slide is stored.” cropped up was also key to the suc-
placed them. And there was no doc- was that Lab Improvements perform SlideTrack can then transfer slide cess of the endeavor, Schaan says. “I
umentation that they’d been pulled “peer review” at other institutions, information to a histology tracking think this came together quite
by anyone.” Bushell explains. “We visited a total system, or it can operate as a stand- quickly, with few challenges. If I had
The original plan was to develop of six or seven hospitals [twice ac- alone slide-inventory manager. When been working with a large interna-
a device customized for PRHC, companied by Schaan] that were operating as a standalone device, tional vendor, it may not have gotten
which performs more than 1.82 mil- quite varied in size and met the lab laboratorians can view case and slide off the ground as easily because you
lion laboratory tests per year. But directors, who would give us a walk- history and place retrieval requests would need to get the okay from this
shortly after Schaan and Bushell through and show how their labs using the interface to their work director and that director, and the VP
began discussing how best to auto- addressed the problem. But it was terminals. who is over in —continued on 72

1219_70-72_Newsbytes.indd 70
DECEMBER 2019 page 70 12/2/19 1:25 PM
 2019 AWARDEES / GENE AND JEAN HERBEK HUMANITARIAN AWARD Dina R. Mody, MD, FCAP
Houston Methodist Hospital / LEADERSHIP DEVELOPMENT AWARDS Alain Cagaanan, DO University

of Wisconsin Hospitals and Clinics Daniel Forsythe, DO University of Wisconsin Hospitals and Clinics

Mariam Molani, DO, MBA University of Nebraska Medical Center Chace Moleta, MD, MS University of

California-San Diego Health Damodaran Narayanan, MBBS,

PhD University of Wisconsin Hospitals and Clinics Kenechukwu

Ojukwu, MD, MPP Harbor-UCLA Medical Center Jasmine Saleh,

MD, MPH Loyola University Medical Center / MEDICAL STUDENT

TRAVEL AWARDS Mary Bailey University of Mississippi Medical Center Grant Fischer McGovern Medical

School at UTHealth Precious Fortes UCLA David Geffen School of Medicine Nathaniel Giles University of Texas

Medical Branch Emily Huang University of Connecticut School of Medicine Clarissa Jordan Baylor College of

Medicine Melanie Kwan Texas A&M University College of Medicine Vanessa Nascimento University of Miami Miller

School of Medicine Jane Persons University of Iowa Carver College of Medicine Natalya Ramirez The University

of Texas Medical Branch at Galveston Ashley Scholl West Virginia University School of Medicine Vivian Tang

University of California, Davis School of Medicine / INFORMATICS AWARDS Alex Clavijo, MD Augusta University

Huiya Huang, MD, PhD Medical College of Wisconsin Clayton LaValley, MD University of Vermont Medical Center

Mona Wood, MD, PhD Stanford Hospital & Clinics /TRANSLATIONAL DIAGNOSTICS ADVANCED TRAINING GRANT
Simone Arvisais-Anhalt, MD UT Southwestern Medical Center Mona Wood, MD, PhD Stanford Hospital & Clinics

INSPIRING TOMORROW’S PATHOLOGY LEADERS

CAP Foundation awards and grants provide opportunities for new pathologists and medical students to enhance
their education preparing the pathologist leaders of tomorrow. Join us in our commitment to growing our
profession and ensuring that the dedication of today’s pathologists will continue into the next generation.

Show your support. Visit foundation.cap.org to donate.

© 2019 College of American Pathologists Foundation. All rights reserved. 28125.1219

zz-Foundation Award Winners

28125_CAPF_Award_Winner_CT_A_Ad_1219_Final.indd
1219_TABs-Streck-Hse-10.indd 71 1
FILE— 28125 DECEMBER 2019 page 71 11/18/19 12:31 AM
12/2/19 10:38 PM
 72 CAP TODAY | DECEMBER 2019
Newsbytes
continued from 70
Europe, and so on.” Yet he stresses
the need to get support from the
hospital C-suite before taking the
first step toward collaboration. Bush-
ell concurs. “The best advice I can
give to someone who wants to at-
tempt this kind of collaboration,” he
says, “is getting executive-level sup-
port—someone who can champion
the project from a high level. In our
case, it was their director of labora-
tory and diagnostic testing. Also, we
had a signed letter of support from
one of the vice presidents of the hos-
pital, and we kept management ap-
prised of our progress.”
As a result of its success at PRHC,
Lab Improvements is getting calls
from “all over the world” seeking
more information about SlideTrack,
Bushell says. “Our current focus is
scaling production so we can meet
demand and expand into other
regions.” —Jan Bowers
Sysmex and Optim forge
another partnership
The diagnostics device firm Sysmex
and artificial intelligence company
Optim have announced plans to es-
tablish a joint venture to develop digi-
tal medicine platforms and services.
The companies had formed a busi-
ness alliance last February under
Advanced Optical Technology for
Pathology and Cytology
The BX53 upright microscope combines a
range of ergonomic components with an LED
illuminator that delivers outstanding brightness,
so you can comfortably view your samples in
their true-to-life colors.
• Bright LED illuminator with a color temperature
optimized for purple, cyan, and pink dyes
• Light Intensity Manager automatically adjusts
brightness when you switch objectives, helping
minimize eye fatigue
• Easily acquire multi-color fluorescence images
• Work comfortably with ergonomic components
Contact your local sales representative or visit olympus-lifescience.com/bx53 to learn more.
1219_70-72_Newsbytes.indd 72
BX53_Cap_Today_201905.indd 1
which they are collaborating on ini-
tiatives that combine Sysmex’s exper-
tise in the medical field and global
sales and service network with Op-
tim’s Optim Cloud IoT OS Internet of
Things operating system and other
data-management and AI technolo-
gies and services.
Through the new partnership, the
companies plan to develop diagnostic
methods that combine image infor-
mation from gene testing and AI
analysis. They will use AI for image
processing of data from Sysmex ana-
lyzers. They also will collaborate with
pharmaceutical companies, medical
device manufacturers, and others to
create “ecosystems for medical IT
solutions” by placing those compa-
nies’ medical applications on their
platform, according to a press release
from Sysmex.
Sysmex and Optim aim to estab-
lish the joint venture next month and
are already holding discussions with
pharmaceutical companies and medi-
cal device manufacturers about
mounting medical applications on
the platform.
Sysmex, 888-879-7639
UPS expanding drone service
to University of Utah Health
United Parcel Service recently an-
nounced that University of Utah
Health, in Salt Lake City, will be the
second medical campus to participate
Olympus is a registered trademark, and Your Science Matters is a trademark of Olympus Corporation.
in its drone delivery service, UPS
Flight Forward.
“Flight operations at University
of Utah Health will be geared to-
ward building out a more cost-
efficient medical delivery system as
the campus undergoes tremendous
growth,” according to a press release
from UPS. The unmanned drones
will follow a predetermined flight
path to a delivery point on the hos-
pital campus.
UPS has been delivering blood
products and laboratory specimens
to the Raleigh, NC, campus of
WakeMed Health and Hospitals since
last spring.
The company’s UPS Flight For-
ward subsidiary was awarded an
airline certification by the Federal
Aviation Administration in Septem-
ber. The certificate eliminates restric-
tions on UPS pertaining to the num-
ber of drones it flies and number of
remote operators in command. The
certification also allows the drones to
fly at night and exceed 55 pounds
when loaded.
Proscia and Dell undertake
digital pathology venture
The digital pathology software ven-
dor Proscia reported that it is col-
laborating with Dell Technologies to
deploy digital pathology solutions
and that it introduced the fall 2019
release of its Concentriq image- and
DECEMBER 2019 page 72
data-management platform.
To support the newly expanded
Concentriq platform, Proscia has
collaborated with Dell to provide
a scalable information technology
infrastructure for digital pathology
products. The companies will offer
reference architectures for whole slide
image viewing and management
combined with high-performance
computing, scalable storage, and
multi-cloud capabilities via Dell.
The latest release of Concentriq
includes capabilities that allow bio-
technology, pharmaceutical, and
contract research organizations to
streamline the launch and manage-
ment of concurrent studies involving
millions of images across diverse
multi-site organizations.
The enriched Concentriq platform
provides the following:
 standard field libraries, project
templates, and expanded roles and
permissions intended to simplify
study management and enhance the
control of IT administrators and proj-
ect coordinators.
 a unified display in Concentriq
Workspaces that presents data from
multiple sources.
 enhanced global search capabil-
ity for pathology data within a health
care organization.
 expanded image format sup-
port with the addition of Zeiss CZI to
the formats supported by Concentriq,
which include those of Akoya Biosci-
ences, Epredia, Hamamatsu, Huron,
Leica, and Ventana Roche.
Proscia, 877-255-1341
Dr. Aller teaches informatics in the De-
partment 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.
On your mobile device
captodayonline.com/mobile
19-05-10 10:26
12/2/19 1:25 PM
 DECEMBER 2019 | CAP TODAY 73

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sequencing and microarray technology. The laboratories are staffed by 750 technical staff,
staff, with annual case volumes of 12 million clinical laboratory tests that include 30,000 fe
with annual case volumes of 12 million clinical laboratory tests, over 180,000 surgical Molecular and Genetic samples; and 5200 Hematopathology specimens, including Bone
pathology specimens, 80,000 cytopathology cases and over 30,000 molecular and T
Marrows, Peripheral Smears, Lymph Nodes, Soft Tissue, and flow cytometric examinations. a
cytogenomic tests. Cytopathology is a Core Laboratory located at Henry Ford Hospital that Hematopathology is a Core Laboratory located at Henry Ford Hospital that serves all delivery
serves all delivery sites. In addition to professional duties, participation and growth in quality A
sites. In addition to professional duties, participation and growth in quality improvement,
improvement, Lean management, education and research initiatives is expected. s
Lean management, education and research initiatives is expected.
N

Interested applicants should submit CV, a statement describing previous Interested applicants should submit CV, a statement describing previous M
accomplishments and future direction, with names of 3 references to: accomplishments and future direction, with names of 3 references to: h
Richard J. Zarbo, M.D., DMD Richard J. Zarbo, M.D., DMD it
CHAIRMAN, DEPARTMENT OF PATHOLOGY AND CHAIRMAN, DEPARTMENT OF PATHOLOGY AND A
LABORATORY MEDICINE LABORATORY MEDICINE
Henry Ford Hospital Henry Ford Hospital
2799 West Grand Blvd, 2799 West Grand Blvd,
Detroit MI 48202 Detroit MI 48202
Rzarbo1@hfhs.org Rzarbo1@hfhs.org
Richard J Zarbo, MD Richard J Zarbo, MD
Senior Vice President and KD Ward Chair Senior Vice President and KD Ward Chair
Pathology and Laboratory Medicine Pathology and Laboratory Medicine
Henry Ford Health System Henry Ford Health System
Detroit, MI 48202 Detroit, MI 48202
www.henryford.com/hfproductionsystem www.henryford.com/hfproductionsystem

INTERNATIONAL

The Hospital Authority is a statutory body established and financed by the Hong Kong Government to operate and provide an
efficient hospital system of the highest standards within the resources available. Th
su
Fo
pe
no
Associate Consultant Positions for Experienced Doctors without Full Registration ca
(Anaesthesia / Anatomical Pathology / Cardiothoracic Surgery / Nuclear Medicine /Obstetrics & Gynaecology / Ophthalmology / Otorhi- a
re
nolaryngology / Radiology) Th
(Ref: HO1904001) he
sy
ou
Service Resident Positions for Experienced Doctors without Full Registration en
po
(Anaesthesia/ Clinical Oncology / Emergency Medicine / Family Medicine / Intensive Care / Internal Medicine /Nuclear Medicine / Ob- fie
an
stetrics & Gynaecology / Ophthalmology / Orthopaedics & Traumatology /Otorhinolaryngology / Paediatrics / Pathology - Anatomical se
Pathology / Pathology - Chemical Pathology /Pathology - Clinical Microbiology and Infection / Pathology - Haematology / Psychiatry / an
sp
Radiology / General Surgery / Cardiothoracic Surgery / Neurosurgery / Plastic Surgery) Su
si
(Ref: HO1904002) m

The Hospital Authority (HA) invites applications from experienced doctors who are not fully registered with the Medical Council of Hong
Kong and yet have acquired relevant postgraduate qualifications set out in the Requirements to serve the community of Hong Kong.
For details, please visit http://www.ha.org.hk (choose English language, click Careers Medical).

Application
Application should be submitted on or before 31 March 2020 (Hong Kong Time) via the HA website http://www.ha.org.hk.

Enquiries
Please contact Ms. Melanie TAM, Hospital Authority Head Office at + 852 2300 6542 or send email to tml128@ha.org.hk.

For information on placing a classified advertisement, please call 888-489-1555

CAP1219_CT.indd 74
SEPTEMBER 2019 page 74 12/4/19 12:21 PM
 DECEMBER 2019 | CAP TODAY 75

NORTH CAROLINA
Marketplace
North Carolina
East Carolina University
Agilent CDx gets Seek Panel for Illumina platforms are
available in Europe and will be available
T expanded approvals soon in the United States.
ASSISTANT PROFESSOR The FDA approved Agilent Technolo-
L
Menarini Silicon Biosystems, 877-837-4339
The Department of Pathology and Labo- gies’ PD-L1 IHC 22C3 pharmDx assay
ratory Medicine of the Brody School of
Medicine is seeking an AP or AP/CP board ARE YOU LOOKING TO
as an aid in identifying patients with
esophageal squamous cell carcinoma
CellaVision buys
rd
certified or eligible surgical pathologist for
PROMOTE YOUR PRODUCTS for treatment with Keytruda (pem- RAL Diagnostics
a fixed term position at the title of Clinical
brolizumab), an anti-PD-1 therapy On Oct. 1, CellaVision completed the ac-
ry
al
Assistant Professor or higher. Training and OR SERVICES? manufactured by Merck. Keytruda quisition of RAL Diagnostics (Martillac,
experience in surgical pathology, includ-
ge ing gross supervision, and intraoperative is approved for patients with recur- France). RAL develops and sells products
ry diagnosis/frozen section. Approximately Place Your Ad Here! rent locally advanced or metastatic for sample preparation in hematology,
o- 19,900 surgical and 7,000 cytology cases
se Reach Lab Professionals ESCC whose tumors express PD-L1 microbiology, cytology, and pathology.
including 1,300 fine needle aspirates are (combined positive score ≥10), as de- CellaVision, +46 (0)46 - 460 16 00
ed
accessioned into the department annually.
ed termined by an FDA-approved test,
ne The candidate will be expected to partici-
To place a classified ad:
a- pate in surgical pathology service respon- Toll free: 888-489-1555
with disease progression on or after
one prior line of systemic therapy.
Nova Biomedical introduces
al
00
sibilities and in medical student/resident/ Email: sales@kerhgroup.com The assay also gained approval electrolyte analyzer
fellow education and clinical research.
ne as an aid in identifying patients with Nova Biomedical announced the release
The applicant must qualify for a faculty
s. appointment at East Carolina University. head and neck squamous cell carcino- of its Stat Profile Prime ES Comp Plus.
ry Academic title and salary will be commen- ma for treatment with Keytruda. Key- The analyzer offers a complete electrolyte
t, truda as a single agent is indicated for profile, including ionized magnesium,
surate with qualifications and experience.
NC Medical License required.
Targeting Laboratory the first-line treatment of patients with
metastatic or with unresectable, recur-
and optional serial batch testing on whole
blood, serum, or plasma. The cartridge
Minimum Qualifications: Candidates must Professionals? rent HNSCC whose tumors express system consists of individual cartridges
have an MD or DO degree from an accred-
CLASSIFIED ADVERTISING WORKS PD-L1 (combined positive score ≥1) as for sensors and
ited institution, and be board certified in
AP or AP/CP or eligible. • JOB OPENINGS • CME PROGRAMS determined by an FDA-approved test. calibrators.
• PRACTICE FOR SALE • AND MORE... Agilent Technologies, 800-227-9770 Each main-
http://www.ecu.edu/pathology
Contact us today for recruitment tenance-free
Please apply online at:
HTTP://WWW.ECU.EDU
and classified advertising:
Toll free: 888-489-1555 DiaSorin VZV swab cartridge is
ready to use
Position Number: 600023 E-mail: sales@kerhgroup.com
test gets CE mark and can be re-
DiaSorin Molecular received the CE placed in sec-
MICHIGAN mark for its Simplexa VZV Swab Di- onds. Nova’s
rect assay. The molecular diagnostic MicroSensor
SENIOR STAFF SURGICAL test enables the direct detection of
varicella-zoster virus DNA from cu-
Card offers sodi-
um, potassium, chlo-
PATHOLOGIST taneous and mucocutaneous swab
specimens. The assay is used with the
ride, ionized calcium,
ionized magnesium, pH, and hematocrit.
HENRY FORD HOSPITAL Liaison MDX instrument and comple- The card is automatically calibrated and
ments the company’s Simplexa HSV 1 delivers a complete electrolyte profile in
AND MEDICAL GROUP & 2 Direct kit. DiaSorin has submitted about 60 seconds. Stat Profile Prime’s
The Henry Ford Department of Pathology and Laboratory Medicine is seeking a board certified the Simplexa VZV Swab assay to the Clot Block sample flow path is designed
subspecialized Surgical Pathologist to join the senior staff of our academic practice at Henry FDA for 510(k) clearance. to protect the MicroSensor Card from
Ford Hospital to support a multitude of rapidly growing clinical programs. Desired areas of ex-
pertise include breast, gastrointestinal/liver, renal pathology and neuropathology. Pathology is DiaSorin Molecular, 562-240-6500 blockages and prolonged downtime
notable as a cohesive, friendly and collegial employed group practice of the Henry Ford Medi- caused by blood clots.
cal Group, the nation’s 3rd largest clinic-based group practice. The ideal applicant would be Nova Biomedical, 781-894-0800
a compatible fit and have a strong interest in resident education, and clinical or translational
research.
Menarini launches
The Henry Ford Health System, Detroit, is a leading US academic medical center, the largest MSBiosuite High-yield liquid biopsy
healthcare delivery system in Southeast Michigan. The Pathology Department is an integrated Menarini Silicon Biosystems launched
system laboratory overseeing testing at 5 system hospitals, 30 clinic delivery sites, and a large
outreach program. It is further recognized as the world’s leading Lean management laboratory MSBiosuite, a cloud-based solution that sample prep platform
enterprise and the only ISO 15189 accredited laboratory in Michigan. The Department is com- automates next-generation-sequencing nRichDX introduced its Revolution Sys-
posed of 47 senior staff pathologists and clinical scientists. The Department has 8 board certi-
fied molecular pathology staff in the Division of Molecular Pathology and Genomic Medicine data analysis for liquid biopsy and tem, a high-yield sample prep platform
and the Henry Ford Center for Precision Diagnostics who leverage the latest next generation formalin-fixed, paraffin-embedded designed to increase liquid biopsy–based
sequencing and microarray technology. The laboratories are staffed by 750 technical staff, with workflows. The solution, developed test sensitivity by delivering more target
annual case volumes of 12 million clinical laboratory tests, over 180,000 surgical pathology
specimens, 80,000 cytopathology cases and over 30,000 molecular and cytogenomic tests. in partnership with BlueBee, provides input for molecular assays. The target
Surgical Pathology is a Core Laboratory located at Henry Ford Hospital that serves all delivery NGS data processing, analysis, inter- yield increase is accomplished by com-
sites. In addition to professional duties, participation and growth in quality improvement, Lean pretation, and reporting for users of bining the ability to process a range of
management, education and research initiatives is expected.
Menarini NGS library preparation kits. sample volumes (3–50 mL) with recovery
Interested applicants should submit CV, a statement describing previous A clinical interpretation report is avail- rates of 70–90 percent.
accomplishments and future direction, with names of 3 references to: able optionally with the Ampli1 and “After three years of development, we
Richard J. Zarbo, M.D., DMD
DEPArray OncoSeek pipelines. are very excited to introduce our Revo-
CHAIRMAN, DEPARTMENT OF PATHOLOGY AND
The company also introduced the lution System,” William Curtis, CEO of
LABORATORY MEDICINE
Henry Ford Hospital Ampli1 OncoSeek Panel, an NGS li- nRichDX, said in a company press re-
2799 West Grand Blvd, brary preparation kit, for Illumina plat- lease. “The data that we’ve developed in
Detroit MI 48202 forms. The panel allows simultaneous collaboration with early adopters like Dr.
Rzarbo1@hfhs.org detection of single nucleotide variants, Greg Tsongalis of Dartmouth-Hitchcock
Richard J Zarbo, MD indels, and focal copy number ampli- Medical Center and Dr. Ryan Corcoran
Senior Vice President and KD Ward Chair
Pathology and Laboratory Medicine
fication in 60 clinically relevant, oncol- of Massachusetts General Hospital are
Henry Ford Health System ogy-related genes starting from DNA highly compelling. We are confident
Detroit, MI 48202
www.henryford.com/hfproductionsystem amplified with the Ampli1 WGA kit. that our Revolution System will advance
The MSBiosuite and Ampli1 Onco- the promise of —continued on 76
For information on placing a classified advertisement, please call 888-489-1555

4 CAP1219_CT.indd 75
1219_75-78_Market-OTB-2.indd 75
SEPTEMBER 2019 page 75 12/4/19
12/4/19 12:17 PM
1:03 PM
 76 CAP TODAY | DECEMBER 2019
Marketplace
continued from 75
precision medicine by enabling a signifi-
cant increase in liquid biopsy–based test
sensitivity.”
The system’s initial application is for
the extraction of cfDNA from plasma and
urine. Applications for CTCs, exosomes,
and total cell-free nucleic acid are in
development.
nRichDX, 949-341-1980
QIAstat-Dx Gl panel
study results
Qiagen announced the publication of a
multicenter clinical study demonstrating
the accuracy of its QIAstat-Dx syndrom-
ic testing solution for diagnosing the
causes of acute gastroenteritis (Hannet I,
et al. Eur J Clin Microbiol Infect Dis. 2019;
38[11]:2103–2112).
The study evaluated 385 patient sam-
ples at university hospital laboratories
across Europe and showed the QIAstat-
Dx Gastrointestinal Panel was highly
sensitive (98.2 percent positive) and spe-
cific (99.9 percent negative). Multiple
pathogens were identified in nearly one-
third of the patient samples that tested
positive. The study also cited the ability
of the panel to provide cycle threshold
values and amplification curves to aid
in interpreting results.
The QIAstat-Dx GI panel provides
differential detection of more than 20
bacterial, viral, and parasitic pathogens
implicated in gut infections and is avail-
able in Europe.
Qiagen, 800-426-8157
NeuMoDx to add
CE-IVD assay for HPV
NeuMoDx Molecular announced an
agreement with Amsterdam-based
biotech company Self-screen BV to im-
plement a CE-IVD-marked molecular
diagnostic test for high-risk strains of
human papillomavirus on the Neu-
MoDx 288 and NeuMoDx 96 molecular
systems.
The HPV assay developed by Self-
screen is a real-time PCR-based test
that detects 15 high-risk genotypes of
human papillomavirus DNA. Under
the agreement, Self-screen will handle
regulatory processes to obtain the CE-
IVD mark while NeuMoDx will manu-
facture and sell the assay.
NeuMoDx Molecular, 888-301-6639
FDA-cleared esophageal
balloon cell collection device
Lucid Diagnostics received FDA 510(k)
clearance for its EsoCheck Cell Col-
lection Device. EsoCheck is a sterile,
single-use disposable non-endoscopic
balloon capsule catheter designed to
collect and retrieve surface cells of the
esophagus. The device is indicated for
use in the general population of adults
22 years and older.
Lucid Diagnostics, 212-949-4319
1219_75-78_Market-OTB-2.indd 76
FDA clears Abbott high
sensitivity troponin-I test
Abbott announced that its Architect Stat
High Sensitivity Troponin-I blood test
has received clearance from the FDA for
use on the Architect analyzer.
The test measures very low levels of
troponin, allowing clinicians to evaluate
heart attack in patients within two to four
hours of admission.
”As one of the most widely researched
high sensitivity troponin tests, this tech-
nology could help address several chal-
lenges in emergency departments to-
day, including overcrowding and more
accurately identifying heart attacks in
women,” Agim Beshiri, MD, Abbott’s
senior medical director of global medical
and scientific affairs, diagnostics, said in
a company press release.
Abbott, 224-667-6100
Beckman Coulter DxA 5000
gets 510(k) clearance
Beckman Coulter announced that its DxA
5000 total laboratory automation solution
has received FDA 510(k) clearance and
is available for sale in the United States.
The DxA 5000 helps eliminate preana-
lytical errors by automatically detecting
patient tube
parameters such as sample identifica-
tion, tube type, orders pending, and
tube weight in the first three seconds.
The system screens each sample at mul-
tiple points to help reduce the risk of
errors and alerts laboratorians if action
is needed. It reduces the number of
manual steps in sample processing from
32 to four. By understanding the tests
requested, sample volume available, and
real-time analyzer capacity and status,
the DxA 5000 continuously calculates
the most expeditious route for stat and
routine patient samples.
Beckman Coulter, 714-993-5321
Prolaris test IDs who can
choose active surveillance
Myriad Genetics announced the pub-
lication of results from a clinical out-
comes study that demonstrated the
Prolaris genetic test can identify men
with low-risk prostate cancer who can
safely select active surveillance and
defer treatment (Kaul S, et al. Per Med.
2019;16[6]:491–499).
The study evaluated the safety and
durability of active surveillance among
664 men newly diagnosed with low-
risk prostate cancer and who received
a low Prolaris test score in combination
with other clinical information. Of these
patients, 82.4 percent selected active
surveillance for their initial treatment,
and the median follow-up period was
2.2 years. The results show that among
those who selected active surveillance,
only 0.4 percent experienced disease
available in the U.S. for criminal justice
and forensic use only. It is not intended
asp
mu
progression. Additionally, the active for clinical diagnosis of disease or other dis
surveillance decision was durable with conditions, including a determination
91.2 percent of men remaining on active of the state of health, in order to cure,
surveillance at year one and 65.2 percent mitigate, treat, or prevent disease or its
at year four. sequelae or patient management. The Qu
Myriad Genetics, 801-584-3600 510(k)-cleared DRI Tricyclics Serum Tox Qu
Assay can help clinicians detect the use no
of tricyclic antidepressants in potential be
Direct HbA1c testing overdose victims. at
in whole blood Ortho Clinical Diagnostics, 800-421-3311 lan
The Randox RX series provides labora-
tories with the capabilities of onboard
HbA1c testing in whole blood on three
Sysmex, LabCorp an
to
fully automated RX analyzers—RX extend agreement no
Modena, RX Imola, and RX Daytona+ — Sysmex America and LabCorp an- Hu
to accommodate rapid and reliable mea- nounced an extension of their hematol- too
surement of HbA1c in different labora- ogy automation agreement, to provide to
tory settings. LabCorp Diagnostics’ primary reference
Direct HbA1c testing on the RX series laboratories with Sysmex America’s lat-
allows samples to be analyzed imme- est, upgraded XN-Series technology; the
diately as there is no incubation step, XN-9100 is a scalable, modular automa-
and no offline preparation stage ensures
accurate sample and QC recovery, the
tion system that incorporates sample
sorting robotics from Yaskawa Motoman. vit
company reports. Sysmex and LabCorp entered into bio
Randox, 866-472-6369 their first hematology instrument agree- Pla
ment in 2006. LabCorp has integrated the sin
XN-9100 system in its Atlantic division
T2Resistance Panel regional laboratory in Burlington, NC, Ple
available as RUO test and plans to install it in 11 additional an
T2 Biosystems announced that its T2Re- regional laboratories by early 2021. als
sistance Panel is available as a research Sysmex America, 847-367-3503 sp
use only test in the United to
States. The panel is expected
to receive the CE mark by
MilliporeSigma acquires an
infl
the end of 2019. FloDesign Sonics
In a separate release, T2 MilliporeSigma has acquired FloDesign
Biosystems and CARB-X, a worldwide
nonprofit partnership dedicated to ac-
Sonics, Wilbraham, Mass., developer of
an acoustic cell processing platform for
FD
celerating the development of novel an- cell and gene therapy manufacturing. M
tibiotics and other approaches to address “Our acquisition of FloDesign Sonics Lu
the threat of drug-resistant bacteria, an- will industrialize the manufacturing of cle
nounced that the T2Resistance Panel autologous cell therapy, allowing these Th
is the first diagnostic to graduate from types of potentially life-saving treatments po
CARB-X’s portfolio of projects. to reach more patients, faster,” Udit Batra, tat
T2 Biosystems, 781-457-1200 CEO of MilliporeSigma, said in a com- dir
pany press release. St
EC approves Tecentriq-based MilliporeSigma, 314-771-5765 sal
co
combo therapy for NSCLC
Roche announced that the European
Hematogenix BCMA flow
cytometry, IHC assays
Commission has approved and granted
marketing authorization for Tecentriq Hematogenix announced the availability
Ca
(atezolizumab) in combination with of the assessment of B-cell maturation br
chemotherapy (carboplatin and Abrax- antigen by flow cytometry and immu- Th
ane [albumin-bound paclitaxel]) for the nohistochemistry at its facilities in China, de
initial treatment of adults with meta- Asia, Europe, and the United States. (IN
static non-squamous non-small cell lung “We have successfully validated pa
cancer who do not have EGFR mutant multiple BCMA assays by both flow sk
or ALK-positive NSCLC. Approval is cytometry and immunohistochemistry ca
based on results from the phase three in selected indications, including mul- ba
IMpower130 study. tiple myeloma. With the use of these the
two platforms to assess BCMA, we can
Roche, 317-521-2000
consistently provide a broad menu of
Ortho Clinical expands testing services to support cancer re-
Ke
search,” Hytham Al-Masri, MD, CEO
testing menu and founder of Hematogenix, said in a ac
Ortho Clinical Diagnostics, in collabora- company statement. Th
tion with Thermo Fisher Scientific, has The BCMA IHC assay has been vali- gr
expanded the menu on MicroTip-capable dated on FFPE tissue blocks, including co
Vitros systems to enable testing for fen- decalcified bone marrow core biopsies tru
tanyl and tricyclic antidepressants. as a single stain and as a dual stain Eis
The DRI Fentanyl Assay has a sen- with other biomarkers such as CD138. ad
sitivity of 100 percent and cross-reacts Multiple BCMA flow cytometry assays is
with various analogs of fentanyl. It is have been validated on bone marrow mi
DECEMBER 2019 page 76 12/4/19 1:03 PM

aspirate, alone or as part of a broader
multiple myeloma minimal residual
disease panel.
Hematogenix, 708-444-0444
Quansys Q-Plex technology
Quansys Biosciences (Logan, Utah) an-
nounced that its Q-Plex technology has
been selected as a featured innovation
at the Geneva Health Forum in Switzer-
land, March 24–26, 2020.
Quansys has partnered with PATH,
a nonprofit global health organization,
to develop and bring to market two
novel multiplexed assays. The Q-Plex
Human Micronutrient Array (7-Plex) is a
tool designed
to quantify
vitamin A, iron, and iodine deficiency
biomarkers, as well as inflammation and
Plasmodium falciparum malaria, using a
single, small sample.
The Q-Plex Human Malaria Array (5-
Plex) is a tool designed to measure HRP2
and pLDH at low concentrations and
also quantify P. vivax- and P. falciparum-
specific lactate dehydrogenase epitopes
to distinguish between malaria species
and C-reactive protein as an indicator of
inflammation.
Quansys Biosciences, 435-752-0531
FDA clears Luminex
MRSA assay
Luminex Corp. has received FDA 510(k)
clearance for the Aries MRSA Assay.
The assay is an integrated, real-time
polymerase chain reaction–based, quali-
tative, in vitro diagnostic test for the
direct detection of methicillin-resistant
Staphylococcus aureus DNA from na-
sal swabs in patients at risk for nasal
colonization.
Luminex, 512-381-4397
Capmatinib designated as
breakthrough therapy
The FDA granted breakthrough therapy
designation to Novartis’ capmatinib
(INC280) as a first-line treatment for
patients with metastatic MET exon14
skipping-mutated non-small cell lung
cancer. The designation was granted
based on positive primary results from
the GEOMETRY mono-1 study.
Novartis, 862-778-2100
Keytruda combo gets
accelerated approval
The Food and Drug Administration
granted accelerated approval to the
combination of pembrolizumab (Key-
truda, Merck) plus lenvatinib (Lenvima,
Eisai) for the treatment of patients with
advanced endometrial carcinoma that
is not microsatellite instability high or
mismatch repair deficient and who have
disease progression following prior sys-
temic therapy but are not candidates for
curative surgery or radiation.
Efficacy was investigated in Study
111/KEYNOTE-146, a single-arm, mul-
ticenter, open-label, multicohort trial
that enrolled 108 patients with meta-
static endometrial carcinoma that had
progressed following at least one prior
systemic therapy in any setting. Pa-
tients were treated with lenvatinib 20
mg orally once daily in combination with
pembrolizumab 200 mg administered
intravenously every three weeks until
unacceptable toxicity or disease progres-
sion. Among the 108 patients, 94 had tu-
mors that were not MSI-H or dMMR, 11
had tumors that were MSI-H or dMMR,
and in three patients the tumor MSI-H
or dMMR status was not known. Tu-
mor MSI status was determined using
a polymerase chain reaction test. Tumor
MMR status was determined using an
immunohistochemistry test.
Merck, 908-740-4000
Roche launches Cobas
EBV, BKV tests
Roche announced the commercial avail-
ability of the Cobas EBV (Epstein-Barr
virus) and Cobas BKV (BK virus) tests
for use on the Cobas 6800/8800 systems
in countries accepting the CE mark. The
tests are used to assess if transplant pa-
tients are at risk of developing disease by
these pathogens, which can contribute to
organ rejection.
The Cobas EBV and Cobas BKV tests
provide robust coverage with an ex-
panded linear range from 35 IU/mL to
1E+08 IU/mL and from 21.5 IU/mL to
1E+08 IU/mL, respectively.
Roche, 41 61 6881111
INDEX TO ADVERTISERS
Agena Bioscience, page 27
Alcor Scientific, page 79
Archives of Pathology &
Laboratory Medicine, page 46
ARK Diagnostics, pages 44, 52
AstraZeneca, pages 12–13
Beckman Coulter, page 49
Binding Site, page 17
Bio-Rad Laboratories,
pages 21, 43
Biocare Medical, page 45
BioFire Diagnostics, page 10
Cepheid, page 57
Cerus, page 18
DiaSorin Molecular, page 25
Diatherix Eurofins, page 8
Diazyme Laboratories, page 32
Hardy Diagnostics, page 20
Hologic, page 59
Put It on the Board
continued from 78
Leica launches ‘Future of
Pathology’ initiative
Leica Biosystems launched on Nov. 13
“The Future of Pathology”—the cata-
lyst for a conversation that brings to-
gether pathologists, hospital adminis-
trators, and others to discuss the goal
of improving cancer diagnostics.
The Future of Pathology will iden-
tify the challenges, opportunities, and
trends pathologists and other provid-
ers face in improving and transform-
ing cancer diagnostics.
A panel that will lead the initiative
has identified four priority areas:
J How can we raise the profile and
improve the perception of pathology?
J How do we train and retain the
new generation of pathologists?
J How can we use technology to
improve cancer diagnostics?
J How can we use molecular pathol-
ogy to unlock the accessibility of
personalized medicine?
Members of the panel in the UK
are Matthew Clarke, MBBS, clinical
fellow, Institute of Cancer Research,
and Bethany Williams, MBBS, PhD,
digital pathology research fellow,
Leeds Teaching Hospitals NHS Trust
and the University of Leeds. In the
U.S., the members are Jerad Gardner,
MD, associate professor of pathology
and dermatology, University of Ar-
kansas for Medical Sciences, and
Tiffany Graham, MD, gastrointestinal
and hepatobiliary/surgical patholo-
Instrumentation Laboratory, page 23
Janssen Biotech, page 53
Kronus, page 22
Mayo Clinic, page 31
Nova Biomedical, page 39
Olympus Life Science, page 72
Orchard Software, page 7
Pathology Informatics Summit, page 69
Polymedco, page 6
Qiagen, page 29
Quantimetrix, page 9
Randox Laboratories, page 33
Roche Diagnostics, pages 19, 67
Stemline Therapeutics, pages 34–37
Streck, pages 40–41
Sysmex, pages 2–3
Telcor, page 4
Thermo Fisher Scientific, page 80
DECEMBER 2019 | CAP TODAY 77
gy clinical instructor, Medical Uni-
versity of South Carolina. They will
explore the issues and themes
through interviews with C-suite ex-
ecutives, cancer stakeholders, and
pathology leaders, and share their
perspectives and insights through
blogs, articles, and a report to be
available early in 2020.
Visit www.FutureOfPathology.com or Tweet
@LeicaBio and use the hashtag #Futureof
Pathology to be part of the conversation.
Inflammatix to receive
BARDA funding
Molecular diagnostics company In-
flammatix announced Nov. 14 an
agreement with the Biomedical Ad-
vanced Research and Development
Authority (BARDA), part of the U.S.
Department of Health and Human
Services’ Office of the Assistant Sec-
retary for Preparedness and Re-
sponse, to further develop its HostDx
tests. Inflammatix will receive $6 mil-
lion in the first phase of a cost-sharing
contract worth up to $72 million
based on achieving milestones.
The contract will advance devel-
opment and commercialization of
Inflammatix’s point-of-care HostDx
test system, which will produce re-
sults in under 30 minutes. The first
phase of work will focus on the Host-
Dx Fever test, which reads gene ex-
pression patterns in the immune sys-
tem to identify whether a suspected
infection is bacterial or viral.
The contract may optionally sup-
port two other Inflammatix tests:
HostDx Sepsis and HostDx FeverFlu.
HostDx Sepsis measures the expres-
sion of multiple immune genes to
determine if the patient has a bacte-
rial or viral infection and whether the
patient has or is likely to develop
sepsis. HostDx FeverFlu will be per-
formed on nasal swab samples and
combine traditional influenza testing
with host-response biomarkers.
Inflammatix received in August
the AACC’s Disruptive Technology
Award for its HostDx tests, based on
the company’s presentation during
the AACC annual meeting. It was one
of three finalists selected to present to
a panel of expert judges.
CAP TODAY (ISSN 0891-1525) is published monthly
by the College of American Pathologists, 325 Wau-
kegan Road, Northfield, IL 60093. Subscriptions:
$100 U.S. (single copy: $20), $125 Canada (single
copy: $25), $225 foreign
(single copy: $30). Periodi-
cals postage paid at Win-
netka, Ill., and at additional
mailing offices. POSTMASTER: Send address
changes to CAP TODAY, 325 Waukegan Road, North-
field, IL 60093-2750. Mailed under Canada Post
International Publication Mail Sales Agreement
Number 40016906.
Printed in U.S.A. ISSN 0891-1525
 78 CAP TODAY | DECEMBER 2019

Put It on the Board in a single test. It is the first HIV-1

FDA grants de novo
designation to NGS HIV-1
genotyping assay
Vela Diagnostics received FDA autho-
rization to market its in vitro diagnos-
tic test for the detection of HIV-1 ge-
Imagine…a panel of experts at your side.
nomic drug resistance mutations.
The Sentosa SQ HIV-1 Genotyping
Assay uses the plasma of patients in-
fected with HIV-1 to detect HIV-1
Group M drug resistance mutations
in the protease, reverse transcriptase,
and integrase regions of the pol gene,
genotyping NGS assay to receive mar-
keting authorization from the FDA.
In a Nov. 5 statement, Vela acting
CEO and chairman of the board Sam
Dajani called the FDA’s granting of
the de novo designation to the NGS
assay “a major milestone in HIV
diagnostics.”
“With the Sentosa SQ HIV-1 Geno-
typing Assay, laboratories will now
have a sample-to-report solution to
aid in monitoring and treating HIV-1
infection,” he said.
The assay is validated on the Sen-
tosa NGS workflow that enables au-
tomated RNA extraction, PCR setup,
library construction, template prepa-
ration, sequencing, data analysis, and
automated reporting. The workflow
also offers clear sample traceability,
with LIS integration and connectivity,
Vela said in the statement.
The system generates a clinical
interpretation report that provides
information on drug resistances as-
sociated with the detected mutations,
using a standalone version of the
curated Stanford University HIV
Drug Resistance Database to ensure
traceability of the drug resistance
mutations report.
Compared with Sanger bidirec-
tional sequencing and other nonauto-
mated NGS alternatives, Vela says, the
Sentosa SQ HIV-1 Genotyping Assay
using the Sentosa NGS workflow is
highly sensitive and delivers clinically
relevant results with reduced hands-on
time (less than two hours combined)
and turnaround time (two days).
In 2017, an earlier version of the
Sentosa SQ HIV Genotyping Assay
received the CE mark and was ap-
proved by the Australian Therapeutic
Goods Administration and Singapore
Health Sciences Authority. In August
2019, the assay received approval
from the Thai FDA. The current con-
figuration of the assay is pending
review for the CE mark and from the
Singapore HSA.

Paige announces CE mark

for prostate AI solution
Paige announced on Nov. 12 the CE
mark for Paige Prostate, along with
Paige Insight, its AI-native digital
pathology viewer, both for primary
Evaluate the quality of your laboratory’s histologic preparations with HistoQIP. diagnosis. These solutions will now
be available to European pathology
Submit your own laboratory’s slides and have the histologic technique graded by an practices.
expert panel of histotechnologists, histotechnicians, and pathologists. You’ll receive Paige said in a Nov. 12 statement
an evaluation, a participant summary report that includes peer comparison and that Insight allows pathologists to
benchmarking data, and access to online continuing education courses. view, process, and collaborate on
whole digitized slides from different
New HistoQIP programs for 2020 include—HQIP Central Nervous System IHC (HQNEU), sites and scanners while leveraging
HQIP In Situ Hybridization, Kappa/Lambda (HQISH), and HQIP Melanoma IHC (HQMEL). the power of Paige’s AI-based mod-
ules. The first such module, Paige
HistoQIP programs are developed in conjunction with the National Society for Prostate, “has achieved clinical grade
Histotechnology (NSH). accuracy,” according to the company,
“demonstrating equivalent perfor-
mance in images taken with multiple
scanners and on slides prepared at
To learn more or to order, hundreds of institutions.”
visit cap.org and click on SHOP. Paige said it found, in a usability
study of Paige Prostate and the In-
sight viewer, that the technology
proved most impactful in the detec-
© 2019 College of American Pathologists. All rights reserved. 27977.0819 cap.org tion of small, well-differentiated foci
of cancer. —continued on 77

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