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8

MAY 2016 M L O - O N L I N E .C O M 2

CLINICAL ISSUES

14 Transforming the practice of pathology with digital technologyBy Robin Weisburger, MS, HTL(ASCP)

16 Anatomic pathology meets analyticsBy Eleanor Herriman, MD, MBA, and Tim Kuruvilla, MBA

LAB MANAGEMENT

18 The laboratory of the future moves outside the wallsBy Anthony Kurec, MS, H(ASCP)DLM

EDUCATION

26 Looming regulations and FDA oversight mean an uncertain reimbursement climate in 2016By Rina Wolf

28 PAMA and bundled payments force labs to feel a reimbursement shiftBy Kim Futrell, MT(ASCP)

THE PRIMER

30 Cost-effectiveness considerations with molecular diagnostics in oncologyBy John Brunstein, PhD

MANAGEMENT MATTERS

34 Increasing lab excellence with three principles of peak performanceBy Jeff Osborne

FUTURE BUZZ

36 Antibiotic stewardship

SPECIAL FEATURE

38 Using laboratory analytics to manage quality assurance and reduce errors in the laboratoryBy Thomas Joseph, MBA, MT (ASCP), Tim Bickley, MBA, MT (ASCP), CPHIMS, and Kristina Ziaugra, BA (Hons)

DEPARTMENTS

4 From the editor

6 The observatory

32 Washington reportGovernment addresses opioid addiction crisis

PRODUCT FOCUS

40 Diabetes

MARKETPLACE

37 Product spotlights

42 Advertiser index

EXECUTIVE SNAPSHOT

44 Multiplex testing for infectious disease enables prompt diagnosis and therapy

Homi Shamir President and CEO Luminex Corporation

CONTINUING EDUCATION

8 Automation advances microbiology to operational excellenceBy Nathan A. Ledeboer, PhD

12 CE TestTests can be taken online or by mail. See page 12 for testing and payment details.

MAY 2016 | Vol. 48, No. 5

FEATURES

Cover image courtesy of Roche Diagnostics.

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MLO - MEDICAL LABORATORY OBSERVER(ISSN: 0580-7247). Published monthly, with an additional issue in August, by NP Communications, LLC., 2477 Stickney Point Rd, Suite 221B, Sarasota, FL 34231 (941) 388-7050. Subscription rates: $127.60/year in the U.S.; $154.88 Canada/Mexico; Intl. subscriptions are $221.43/year. All issues of MLO are available on microfilm from University Microfi lms International, Box 78, 300 N. Zeeb Rd., Ann Arbor, MI 48106. Current single copies (if available) $15.40 each (U.S); and $19.80 each (Intl.). Back issues (if available) $17.60 each (U.S.); $22.00 each (Intl.). Payment must be made in U.S. funds on a U.S. bank/branch within the continental U.S. and accompany request. Subscrip-tion inquiries: [email protected]. MLO is indexed in the Cumulative Index for Nursing and Allied Health Literature and Lexis-Nexis. MLO Cover/CE, Clinical Issues, and Lab Management features are peer reviewed. Title® registered U.S. Patent Offi ce. Copyright© 2016 by NP Communications, LLC. All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopy, recording, or any information storage-and-retrieval system, without written permission from the publisher. Offi ce of publication: Periodicals Postage Paid at Sarasota, FL 34276 and at additional mailing offi ces. Postmaster: Send address changes to MLO MEDICAL LABORATORY OBSERVER, 2477 Stickney Point Rd, Suite 221B, Sarasota, FL 34231.Printed in U.S.A.

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MEDICAL LABORATORY OBSERVER Vol.48, No.5

Publisher/Executive Editor/PresidentKristine [email protected]

EditorAlan [email protected]

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MLO EDITORIAL ADVISORY BOARD

John Brunstein, PhD, Biochemistry (Molecular Virology)President & CSOPathoID, Inc., British Columbia, Canada

John A. Gerlach, PhD, D(ABHI)Laboratory DirectorMichigan State University, East Lansing, MI

Barbara Strain, MADirector, Supply Chain AnalyticsUniversity of Virginia Health System, Charlottesville, VA

Jeffrey D. Klausner, MD, MPHAssociate Clinical Professor of Medicine Divisions of AIDS and Infectious Diseases University of California, San Francisco, CA

Susan McQuiston, JD, MT(ASCP)Instructor, Biomedical Laboratory Diagnostics ProgramMichigan State University, East Lansing, MI

Donna Beasley, DLM(ASCP)ManagerHuron Healthcare, Chicago, IL

Anthony Kurec, MS, H(ASCP)DLMClinical Associate ProfessorSUNY Upstate Medical University, Syracuse, NY

Suzanne Butch, MLS(ASCP)CM, SBBCM, DLMCM

Administrative Manager, Blood Bank and Transfusion Service, University of Michigan Health System Department of Pathology, Ann Arbor, MI

Paul R. Eden, Jr., MT(ASCP), PhDMajor, United States Air ForceToxicology Program Manager, 711 HPW/RHDJWright-Patterson AFB, OH


A FEW ISSUES BACK (October 2015), I took up in this space the topic of “epigenetic inheritance”—the theory that envi-ronmental infl uences can affect genes and be passed on to the next generation. The context was a study that suggested that survivors of the Nazi Holocaust during World War II had passed on to their children genetic changes that predisposed them to stress disorders. The researchers analyzed one region of a gene that has been associated with the regulation of stress hormones. They found chemical “tags” on the same part of this gene in the Holocaust survivors and their children, but not in either generation of control subjects.

Epigenetic inheritance fl ies in the face of textbook genet-ics, which holds that genes contained in DNA are the only means for the transfer of biological information from genera-

tion to generation. And yet, Gregor Mendel did not know about the presence of genetic tags, and scientists today are only beginning to understand the biology of these chemical infl uences. Further research may in fact cause geneticists to rewrite the textbooks—and complicate further the age-old controversy of “nature versus nurture” as well.

Because the research keeps on coming. Recent studies indicate that chronic pain changes the immune system; that there is an epigenetic switch for obesity; and, in research published March 31 in the American Journal of Genetics, that maternal smoking alters fetal DNA.

That’s right. A study of more than 6,000 mothers and their newborn children has solidifi ed earlier evidence that smoking cigarettes while pregnant chemically modifi es a fetus’ DNA—mirroring patterns seen in adult smokers. The researchers also identifi ed new development-related genes affected by smoking. Their work suggests a potential explanation for the link between smoking during pregnancy and health complications in children.

“I fi nd it kind of amazing when we see these epigenetic signals in newborns, from in utero exposure, lighting up [no pun intended?] the same genes as an adult’s own cigarette smoking,” says co-senior author Stephanie London, an epidemiologist and physician at the National Institute of Environmental Health Sciences (NIEHS), part of the National Institutes of Health. There’s a lot of overlap. This is a blood-borne exposure to smoking—the fetus isn’t breathing it, but many of the same things are going to be passing through the placenta.”

Links between smoking and chemical modifi cations to DNA, or methylation, have been found for developing fetuses in smaller studies, but the larger analysis gives scientists more power to uncover patterns. An international team of research-ers pooled results from 6,685 newborns and their mothers around the world. Based on questionnaires, mothers were labeled as “sustained smokers” who smoked cigarettes daily throughout most of pregnancy (13 percent), “non-smokers” (62 percent), or those with “any smoking” during pregnancy (25 percent), which captured mothers who were occasional smokers or who quit smoking early on.

To analyze methylation in the newborns’ DNA, researchers collected samples mainly from blood in the umbilical cord after delivery. For the newborns whose mothers fell into the “sustained smoker” category, the research teams identifi ed 6,073 places where the DNA was chemically modifi ed differently than in the “no smoking” newborns. About half of these locations could be tied to a specifi c gene.

London and her colleagues found that this collection of genes related to lung and nervous system development, smoking-related cancers, birth defects such as cleft lip and palate, and more. “Many signals tied into developmental pathways,” says Bonnie Joubert, an epidemiologist at the NIEHS and a co-fi rst author on the paper. In a separate analysis, many of these DNA modifi cations were still apparent in older children whose mothers had smoked during pregnancy.

Epigenetics, defi ned as the regulation of gene expression beyond the primary information encoded by DNA, is established science. The extent of its infl uence may be far greater than geneticists had imagined.

Epigenetic inheritance and smoking moms

FROM THE EDITOR By A lan Lenhof f, Edi tor

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NE WS T RENDS A N A LYSIS

New Studies

Mount Sinai researchers assess ac-curacy of commercially available lab tests. Scientists from the Icahn School

of Medicine at Mount Sinai performed

an in-depth comparison of basic blood

tests run by commercial laboratories

to assess comparability of the tests

among the different laboratories, fi nd-

ing that testing service and time of

collection signifi cantly infl uenced re-

sults. The study highlights the impor-

tance of accuracy and variability of test

results.

The study, fi rst designed in early 2015

with data collected last July, analyzed

results from comparable blood tests on

healthy adults conducted at LabCorp,

Quest Diagnostics, and Theranos. Re-

searchers collected multiple samples

from the same individuals and controlled

for variables such as age, sex, and time

of blood collection, among many others,

but still found that more than half of test

results showed signifi cant differences

among test providers. Triglyceride levels

and red blood cell counts were among

the most consistent results, while white

blood cell counts and overall cholesterol

levels were among the most variable.

Test results from Theranos were fl agged

by Theranos as abnormal 1.6 times more

often than those from LabCorp or Quest.

Data from blood samples collected ear-

lier in the day also showed signifi cant

differences compared to samples from

the same subjects later in the day.

“While most of the variability we

found was within clinically accepted

ranges, there were several cases where

inaccurate results would have led to

incorrect medical decisions,” said Joel

Dudley, PhD, senior author on the paper.

The study focused on common blood

tests, which typically return a single data

point or a few data points. However, as

Mount Sinai scientists showed, even

standard blood tests can generate rich

data for statistical analysis: the study

collected 14 samples to generate 22 lab

results for each of 60 subjects, leading to

a total of more than 18,000 data points

in this project alone. While most results

were within normal ranges, having even

a small amount of inaccurate data mixed

in could lead to erroneous conclusions

from scientifi c or clinical studies.

Ebola

Research shows potential for emergence of new Ebolavirus. A team from the

University of Kent’s (England) School of

Biosciences examined the differences

between Ebolaviruses that cause severe

disease in humans and the Reston virus,

which does not.

The Reston virus, which is known to

circulate in domestic pigs in Asia and

occasionally infect humans, is currently

the only member of the Ebolavirus fam-

ily not to have been reported as caus-

ing life-threatening disease, including

hemorrhagic fever in humans.

Using computational analysis of the

sequences of the genomes of Ebolavi-

ruses and a computational prediction of

the effects of sequence variations on vi-

rus function, the researchers identifi ed

characteristic differences in a number of

virus proteins.

The results suggested that only a

few changes in one Ebolavirus protein,

VP24, may be necessary to turn the Res-

ton virus into a virus that can cause hu-

man disease. There may be a risk, there-

fore, that Reston viruses acquire the few

mutations necessary to cause disease

in humans and to develop into a novel

health threat.

New Zika Assay

First commercial serological tests avail-able for ZIKV detection. EuroImmun

AG, a manufacturer of test systems and

instruments for medical diagnostics with

headquarters in Luebeck, Germany, has

developed the fi rst system of compre-

hensive tests available for the serologi-

cal detection and differentiation of Zika

virus infections. The tests were granted

the CE mark in February, making them

eligible for sale in the European mar-

ket. They are available in the U.S. under

research use only labeling.

The EuroImmun anti-Zika virus tests,

formatted as an enzyme-linked immu-

nosorbent assay (ELISA) and an indirect

immunofl uorescence assay (IFA), allow

for the detection of specifi c antibodies

(IgM and IgG) in the blood of those who

may be infected. According to EuroIm-

mun representatives, the tests provide a

longer window for detection than the cur-

rently available quantitative polymerase

chain reaction-based assays alone, mak-

ing them particularly useful for disease

surveillance. The tests can be used to

diagnose patients with acute symptoms

and to manage asymptomatic cases that

fi t a risk profi le, particularly pregnant

women.

The highly specifi c viral antigen used

in the EuroImmun ELISA eliminates

cross-reactivity with other fl avivirus

antibodies, ensuring differentiation from

diseases such as dengue fever. The au-

tomated antibody detection test kits are

suitable for rapid screening of large pa-

tient volumes and therefore provide ef-

fi cient and effective monitoring of the

virus spread.

Serological analyses may help deter-

mine whether long-term consequences,

such as microcephaly and Guillain-Barré

syndrome, are a result of a previous

Zika virus infection, may be useful for

screening sample donations at blood

centers and blood banks in hospital

settings, and may monitor the growing

epidemiological reach of the Zika virus.

Infectious Diseases

New potent nanodrug to combat anti-biotic-resistant infections. A research

team led by University of Arkansas

scientists has developed an alterna-

tive therapeutic approach to fi ght-

ing antibiotic-resistant infections. The

novel method uses a targeted, light-

activated nanodrug consisting of an-

tibiotic-loaded nanoconstructs, which

are nanoscale cages made of gold and

coated with polydopamine. The antibi-

otic is loaded into the polydopamine

coating. The gold nanocages convert

laser irradiation to heat, resulting in

the photothermal effect and simultane-

ously releasing the antibiotic from the

polydopamine coating.

Microbial resistance to antibiotics

has become a growing public health

concern in hospitals and the commu-

nity at large, so much so that the Infec-

tious Diseases Society of America has

designated six bacterial species as “ES-

KAPE pathogens”: Enterococcus faeci-

um, Staphylococcus aureus, Klebsiella

pneumoniae, Acinetobacter baumannii,

Pseudomonas aeruginosa, and Entero-

bacter species. This designation refl ects

the limited availability of antibiotics that

can be used to treat infections caused

by these species.

The team used S. aureus as the proof-

of-principle pathogen to demonstrate

the potency of its nanodrug. The com-

bination of achieving a photothermal

effect and controlled release of antibiot-

ics directly at the site of infection was

achieved by laser irradiation at levels

within the current safety standard for

use in humans. The therapeutic effects

of this approach were validated using

planktonic bacterial cultures—bacterial

cells that are free-fl oating rather than

contained with a biofi lm—of both meth-

icillin-sensitive and methicillin-resistant

S. aureus strains. However, the method

was subsequently shown to be effective

even in the context of an intrinsically

resistant biofi lm.

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Receiving her STI result is the moment that could change everything. One wrong result can cause

a cascade of emotional and physical distress for patients, and raise the risk of infecting others.

Rely on layers of protection that make a world of difference

- Dual probe design increases sensitivity and specifi city1,2

- Internal control verifi es that amplifi cation has taken place

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MICROBIOLOGY

The past few years have seen signifi cant changes in clini-cal microbiology. On the regulatory front, as more assays receive FDA clearance, labs increasingly have the option

to replace laboratory-developed tests (LDTs) with commercial-ly available IVD tests. Respiratory panels are a good example. Second, technological advances continue to reduce turnaround time drastically, and, at the same time, a better understanding of how test results can be used to improve care is raising physician expectations. For example, while a turnaround time of eight to 24 hours for a fl u test was previously acceptable, a 20-minute to two-hour time to result is now standard of care. Likewise, while a turnaround time of >24 hours for generating a C. diffi cile result was previously acceptable, a 1½- to three-hour time to result is becoming the standard of care.

Patient management, the decision to admit, and infection control measures often hinge on test results, with signifi cant health outcome and cost ramifi cations. Microbiology results, once viewed as confi rmatory and often delivered after patient management decisions were made, are now integral to the clinical workfl ow. Patient-centric care, the mantra of today’s healthcare, translates into patient-centric testing in the microbi-ology lab, with far-reaching implications for the lab workfl ow, how the lab is structured, and even how patient specimens are delivered to the lab.

Along with this trend toward patient-centric testing has come a massive shift toward automation, driven by the need to better support clinical decisions with high-quality, timely results effi ciently and cost-effectively. This trend is enabled by advances such as molecular diagnostics, digital microbiology, and matrix-assisted laser desorption/ionization time-of-fl ight (MALDI-TOF) mass spectrometry (MS).1 These advances open the door to greater standardization of processes and results, au-tomation, and a new level of operational excellence and perfor-mance. Effi ciency gains in the lab are especially needed, with continuing pressure on reimbursement due to the Protecting Access to Medicare Act of 2014 (PAMA).

To earn CEUs, see test on page 12 or online at

www.mlo-online.com under the CE Tests tab.

LEARNING OBJECTIVESUpon completion of this article, the reader will be able to:1. Describe the trends in healthcare which have led to the

changes that the clinical microbiology laboratory is facing. 2. List and describe the technological advances that have

contributed to the evolution of the clinical microbiology laboratory.

3. Discuss the factors that must be addressed when implement-ing automation into the clinical microbiology laboratory.

4. Describe new and upcoming advancements that will continue to evolve the clinical microbiology laboratory.

Continuing Education

By Nathan A. Ledeboer, PhD

Enabling technologies continue to evolveClinical microbiology has traditionally been associated with a diversity of patient specimens and transport media, lengthy culture, and visual results requiring human review. These fac-tors, all of which hamper standardization, a prerequisite of automation, have left the microbiology lab in the dark ages. All this is changing with recent technological advances that are enabling automation at a time when microbiology most needs it—to meet the multiple challenges of today’s healthcare environment, declining reimbursement, and the shortage of trained personnel.

Molecular diagnostics has truly been a transformational force in microbiology. The sensitivity it offers has allowed us to detect and identify more organisms faster, without having to wait for culture results. Mycoplasma is a case in point. An-other example is testing for sexually transmitted infections like Chlamydia trachomatis and Neisseria gonorrhoeae. In many ways, molecular diagnostics has made diagnostics more relevant. Pre-viously, a patient suspected of chlamydia or gonorrhea would be treated empirically. Today, with faster time to result, treat-ment can begin after the pathogen is properly identifi ed, re-ducing the unnecessary use of antibiotics. A study comparing clinical and economic outcomes before and after initiation of molecular testing of methicillin-resistant Staphylococcus aureus(MRSA) in positive blood cultures demonstrated a mean reduc-tion of 6.2 days in hospital stays and a $21,387 savings when molecular testing was combined with timely infectious disease consult and appropriate antibiotics use.2

Molecular diagnostics offers other advantages—the availability of automated platforms, options in standalone specimen preparation and handling systems, and connectivity to the chemistry lab. All of these can help advance clinical mi-crobiology through automation and better integration with the rest of the healthcare system.

A second transformational technology is MALDI-TOF, fi rst commercially available for clinical microbiology in 2009. MALDI-TOF provides a cost-effective, standardized, and rapid method for identifi cation of clinically signifi cant bacteria, fungi, and mycobacteria. Importantly, MALDI-TOF procedures are relatively simple and do not vary based on organism. The in-tegration of MALDI-TOF into the clinical microbiology work-fl ow has decreased time to organism identifi cation from days to hours. The impact on patient care is signifi cant. One study on adult patients with bacteremia and candidemia demonstrated that the combination of MALDI-TOF diagnostic testing and an antimicrobial stewardship team decreased time to effective and optimal antibiotic therapy, which translated into lower mortal-ity rate, shorter intensive care unit stays, and reduced recurrent bacteremia (Figure 1, pg. 9).3 For the fi rst time, standardizing the identifi cation process of bacterial isolates is now possible, enabling automation, improving workfl ow, and increasing effi ciency.

The evolution of digital microbiology is changing the way in which culture plates are read, impacting not only turnaround time but also quality of results.4 Digital microbiology integrates

Automation advances microbiology to operational excellence

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9MAY 2016 M L O - O N L I N E .C O M

MICROBIOLOGY CE

automated imaging systems to capture images of culture plates at specifi ed time intervals, robotics to move specimens across the lab, and software to process captured images and determine the presence of positive colonies for review and confi rmation. For example, with digital imaging software, preset color thresh-olds, as defi ned by hue, saturation, and value, are employed to detect growth in chromogenic agar (Figure 2). In this way, negative plates can be identifi ed for quick screening to confi rm negative results, while only positive plates are reviewed one by one. This reduces substantially the number of plates reviewed and ensures better use of laboratorian time when trained personnel are scarce. The ability to rule out negative plates quickly not only saves personnel time but can expedite clinical decisions and reduce unnecessary intervention.

The advent of liquid transport media has been highly in-fl uential in improving specimen quality and enabling auto-mation. Elution of specimens from newer fl ocked-style swabs into liquid phase has been shown to increase the release of vi-able organisms from the swab, improving sensitivity. And the liquid-based transport enables inoculation of the speci-men with automated liquid-based specimen processors, an important step toward greater effi ciency and standardization.5

Microbiology automation—indications of successWhile microbiology automation is only at the early stages of implementation—an estimated 10 percent of labs in the U.S. having adopted some automation technology—quantifi able improvements in turnaround time, productivity, and quality have been reported.

In a multi-center study, molecular diagnostics was shown to reduce time to results for MRSA testing from 24 to 48 hours to less than two hours.6 A study comparing routine microbiology with automated identifi cation and susceptibility testing on patients with positive blood cul-tures found a mean reduction of 13 hours in turnaround time for identifi cation and 20 hours for susceptibility re-sults.7 The combination of automation of front-end speci-men processing with MALDI-TOF yielded a 30.6-hour time gain per isolate compared with conventional mi-crobiology.8 Another study reported that productivity, as measured by number of samples processed per FTE per day, showed a 2.5- to 2.7-fold improvement in three hospi-tals after the automation of plate handling and incubation (Figure 3, pg. 10).9

Automation enables workfl ow optimization, remov-ing unnecessary delays and better utilizing the skills of trained lab professionals. One example is the use of an automated system for plating and streaking of urines and other liquid specimens, while trained personnel perform

Gram stain review and the processing of more com-plex specimens. This saves time as well as improves consistency in urine plating while decreasing mo-notonous repetitive tasks for laboratorians. Another example is the ability to read cultures using an au-tomated imager following specifi ed incubation time rather than wait for the availability of personnel, a change that not only shortens time to result but also improves consistency of results and ensures that plates are not incubated beyond recommended duration, which can compromise specifi city.10,11

Quality improvement is an important benefi t of automation, which allows standardization of techniques and reduction of human errors. A re-cent study demonstrated that automating speci-men processing, specimen incubation, imaging of MRSA growth, and automated analysis reduced the number of false negatives. Compared with manual

screening, sensitivity was 100 percent across three sites using three different commercially available culture media, and spec-ifi city ranged from 90.7 percent to 92.4 percent.4 Automated analysis identifi ed all positives identifi ed manually, while 2.9 percent of the discrepant results (identifi ed as positive by au-tomated analysis and negative by manual reading) were found to be positive upon manual re-examination. In another study comparing automated imaging and analysis with manual re-view of 92 urine specimens, automated analysis identifi ed four additional positive cultures missed by manual reading due to overlooking a pathogen in heavily mixed cultures.12

Related to quality improvement are traceability and docu-mentation. By automating the confi rmation of multiple patient identifi ers at multiple steps from specimen transport vessel to plates, the lab can prevent medical errors due to incorrect pa-tient identifi cation. In combination with inexpensive electronic data storage, digital microbiology facilitates documentation with image archiving for further review, for correlating Gram stain images with cultures, for use in teaching, and to share with inquiring physicians.

Perhaps the most important benefi t of automation is its value in optimizing the lab workfl ow, which in turn positively im-pacts the clinical workfl ow. For example, changing from read-ing plates when personnel can get to them to reading them when they are ready to be read can make all the difference in optimizing turnaround time. In turn, this means availability

Figure 1. Kaplan-Meier survival analysis. “Intervention” is defi ned as MALDI-TOF identifi cation of positive blood cultures with antimicrobial stewardship team intervention. “Preintervention” represents a historical control group with identifi ca-tion performed by conventional methods over the same three calendar months in the previous year.3

Figure 2. Automated detection. Color thresholds are defi ned by hue (H), saturation (S), and value (V). Plates are marked negative if no pixel contains an HSV score outside the preset threshold.4



MICROBIOLOGY

of results when physicians need them. Knowing that the majority of specimens arrive at the lab between 8 PM and 2 AM, for example, the lab can plan to read plates until 10 PM, transition the staff to processing to get the plates to the incu-bator earlier, and start reading again at about 2 AM, when the plates are ready to be read by the automated imager. In this way, results from specimens that arrive the night before will be in the physician’s in-box the next morning. Another exam-ple is group A strep, with most specimens coming from Outpatient and arriving be-tween 8 PM and 2 AM. With automated molecular diagnostics, results can be waiting for physicians the next morn-ing. With the availability of technolo-gies that offer group A strep results in 20 minutes, physicians have the option to diagnose and begin treatment while the patient is still in the offi ce. These changes have a very positive impact on physician satisfaction ratings.

Implementing microbiology automationMicrobiology automation is not without challenges. Cost is a signifi cant barrier to automation, with the initial investment

in capital acquisition, facility modifi ca-tions, and, importantly, IT and connec-tivity to integrate the entire process from test requisition and specimen collection to fi nal result. Overcoming the initial resistance of lab personnel is also some-times a factor.

While many labs have implemented some automation solutions, especially

in molecular diagnostics, the majority of labs in the U.S. are still in the planning process or looking to build on what they have started. As with any signifi cant initiative, thorough need assessment, planning, and securing the buy-in of all stakeholders are key. In this con-text, it is diffi cult to overemphasize the importance of two areas of focus in the planning stage—workfl ow and IT.

Automation cannot be done in a vac-uum, and it is important to consider the overall workfl ow of the lab, not just spe-cifi c processes being automated. Studies have shown that implementing auto-mation without considering the overall workfl ow makes little impact on quality of care. To understand the overall lab workfl ow and the clinical workfl ow and how best to derive the maximum value from automation, labs need to review all facets of current lab operations. These in-clude, for example, the mix of specimen types (i.e., whether processing can be au-tomated), time they arrive at the lab, and expected time to result. A detailed snap-shot of current hourly workload and staffi ng needs will guide how staffi ng might be redistributed after automation. The goal is to make sure there is clear un-derstanding of how automation will be incorporated and how it will impact the overall workfl ow and, ultimately, patient care.

A second planning parameter that is sometimes left as an afterthought is IT. In the current imperfect world of connectiv-ity, making sure that computer systems—from automation technology to MALDI-TOF to LIS to HIS—talk to each other is paramount. The need for integrated information fl ow cannot be overempha-sized. Thus, getting the IT team involved from the beginning is a critical success

Figure 3. Productivity increase. Manual methods were compared against automated specimen processing, plate incubation, and digital imaging at three hospitals in the U.K. Productivity was measured by number of samples processed per FTE per day.9


11M L O - O N L I N E .C O M MAY 2016

MICROBIOLOGY CE

Nathan A. Ledeboer, PhD, is Associate

Professor of Pathol-

ogy; Medical Director,

Clinical Microbiology;

and Medical Director,

Molecular Diag-

nostics, at Medical

College of Wisconsin,

Milwaukee, WI.

factor. As higher-quality information is generated in a more timely manner, it is just as important to get it into the physi-cian’s hands without delay.

Of course, there are myriad oth-er factors to consider in planning automation—space planning is one example. Mapping out the post-automation workfl ow to reallocate staff time is another. A clear picture of the expected results and metrics for post-automation assessment will help track progress and guide adjustments once implementation begins.

Looking aheadEven as labs are implementing the many advances that are reshaping clinical microbiology today, new technologies are on the horizon. One example is the quick identifi cation of multidrug-resis-tant organisms and antibiotic suscepti-bility assessment directly from clinical samples, without the need for tradition-al enrichment, culture, or sample prepa-ration processes. Currently, a new sys-tem is being evaluated in multiple sites across the U.S. The system has automa-tion capabilities such as random access, familiar to the chemistry lab.

REFERENCES

1. Ledeboer NA. Automation as a benefi t in clinical mi-crobiology. J Clin Microbiol. doi: 10.1128/JCM.00686-14.

2. Bauer KA, West JE, Balada-Llasat J-M, Pancholi P, Stevenson KB, Goff DA. An antimicrobial stewardship program’s impact with rapid polymerase chain reaction methicillin-resistant Staphylococcus aureus/S. aureus blood culture test in patients with S. aureus bacteremia. Clin Infect Dis. 2010;51:1074-1080. doi: 10.1086/656623.

3. Huang AM, Newton D, Kunapuli A, et al. Impact of rapid organism identifi cation via matrix-assisted laser desorption/ionization time-of-fl ight combined with an-timicrobial stewardship team intervention in adult pa-tients with bacteremia and candidemia. Clin Infect Dis. 2013;57:1237-1245. doi: 10.1093/cid/cit498.

4. Faron ML, Buchan BW, Vismara C, et al. Automated scoring of chromogenic media for detection of methicil-lin-resistant Staphylococcus aureus by use of WASPLab image analysis software. J Clin Microbiol. 2016;54:620-624. doi:10.1128/JCM.02778-15.

5. Bourbeau PP, Ledeboer NA. Automation in clinical microbiology. J Clin Microbiol. 2013;51:1658-1665.

6. Peterson LR, Liesenfeld, O, Woods CW, et al. Mul-ticenter evaluation of the LIghtCycler Methicillin-Resis-tant Staphylococcus aureus (MRSA) Advanced Test as a rapid method for detection MRSA in nasal surveillance swabs. J Clin Microbiol. 2010;48:1661-1666.

7. Kerremans JJ, Verboom P, Stijnen T, et al. Rapid identifi cation and antimicrobial susceptibility testing reduce antibiotic use and accelerate pathogen-directed antibiotic use. J Antimicrob Chemother. 2008;61:428-435. pmid:18156278.

8. Mutters NT, Hodiamont CJ, de Jong MD, Overmeijer

HPJ, van de Boogard M, Visser CE. Performance of Kies-tra Total Laboratory Automation combined with MS in clinical microbiology practice. Ann Lab Med. 2014;34:111-117, http://dx.doi.org/10.3343/alm.2014.34.2.111.

9. Matthews S, Deutekom J. The future of diagnostic bacteriology. Clin Microbiol Infect. 2011;17:651-654. doi: 10.1111/j.1469-0691.2011.03512.x.

10. Joubrel C, Gendron N, Dmytruk N, et al. Compara-tive evaluation of 5 different selective media for Group B Streptococcus screening in pregnant women. Diagn Microbiol Infect Dis. 2014;80:282-284. doi: 10.1016/j.diag-microbio.2014.08.005.

11. Perez JM, Cavalli P, Roure C, Renac R, Gille Y, Frey-diere AM. Comparison of four chromogenic media and Hektoen agar for detection and presumptive identifi ca-tion of Salmonella strains in human stools. J Clin Micro-biol. 2003;41:1130-1134. pmid:12624041.

12. Riebe KM, Buchan BW, Ledeboer NA. Validation of the WASPLab system for urine specimens. Poster presented at American Society for Microbiology 115th General Meeting, 2015.

Sample transfer made safe

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AUTOMATION ADVANCES MICROBIOLOGY TO OPERATIONAL EXCELLENCE. CEUs or contact hours are granted by the College of

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TEST ANSWER FORM AUTOMATION ADVANCES MICROBIOLOGY TO OPERATIONAL EXCELLENCE

May 2016 [This form may be photocopied. It is no longer valid for CEUs after November 30, 2017.)

PRINT CLEARLY

CON TINUING EDUCATION T ES T - AUTOMATION ADVANCES MICROBIOLOGY TO

OPER ATIONAL E XCELLENCE

TEST QUESTIONS1. Which quality measure is

becoming a standard of care and raising physician expectations for the clinical microbiology lab?a. increased employee

competency documentationb. decreased nosocomial

infectionsc. decreased specimen

rejectiond. decreased turnaround times

2. What trend in healthcare has caused the microbiology lab to make changes with regard to the clinical workfl ow?a. overcoming access barriersb. change in Medicare

paymentsc. patient-centric cared. none of the above

3. According to the article, what is/are another trend(s) toward which the clinical microbiology lab is currently facing a massive shift?a. automationb. increased FTEs for more

timely plate readingc. both a and bd. neither a nor b

4. Factors that have hampered standardization in the micro lab include a diversity of patient specimens and transport media, lengthy culture time, and human review of visual results.a. Trueb. False

5. Examples of the advances in the microbiology lab includea. molecular diagnostics.b. digital microbiology.c. MALDI-TOF.d. all of the above.

6. What advantage(s) does the use of molecular diagnostics contribute, with regard to healthcare outcomes?a. faster turnaround timeb. reducing unnecessary use of

antibioticsc. both a and bd. neither a nor b

7. According to the MDx study on MRSA referred to in the article, the mean reduction in hospital stay was how many days when molecular testing was used?a. 6.2 daysb. 6.5 daysc. 6.9 daysd. 7.5 days

8. In what year did MALDI-TOF become commercially available for use in the clinical microbiology lab?a. 2015 b. 2005c. 2012d. 2009

9. MALDI-TOF has the capability of identifying all clinically signifi cant organisms, excepta. bacteria.b. parasites.c. fungi.d. mycobacteria.

10. The use of MALDI-TOF has decreased time to organism identifi cation from a. months to weeks.b. days to seconds.c. hours to minutes.d. days to hours.

11. According to the MALDI-TOF study, its use made a signifi cant impact on patient care in which way(s)?a. lower mortality rateb. shorter ICU staysc. reduced recurrent bacteremia d. all of the above

12. Digital microbiology technology captures images of culture plates at specifi ed time intervals and determines the presence of positive colonies for review and confi rmation.a. Trueb. False

13. Factors which make digital microbiology a useful tool for clinical microbiologists and clinicians include all buta. expedites clinical decisions.b. saves personnel time.c. reduces specimen rejection. d. reduces unnecessary

intervention.

14. The use of liquid transport media has been shown to decrease the release of viable organisms from the specimen swab, improving sensitivity.a. Trueb. False

15. What percentage (est.) of microbiology labs in the U.S. have adopted some form of automation technology?a. 50b. 25c. 10d. 5

16. Which factor(s) contribute to quality improvement through the use of automation?a. reduction of human errorsb. standardization of techniquesc. both a and bd. neither a nor b

17. What is the most signifi cant barrier to automation in the clinical microbiology lab?a. costb. resistance of lab personnelc. resistance by physiciansd. space

18. What new technology in clinical microbiology is currently on the horizon for implementation?a. electrophoresis for

identifi cation of mycobacteriab. quick identifi cation of multi-

drug resistant organisms without traditional culture media

c. ELISA testing of direct samplesd. none of the above

MLO201605-CETest_MECH_AL.indd 12MLO201605-CETest_MECH_AL.indd 12 4/11/2016 3:36:28 PM4/11/2016 3:36:28 PM

Screening with HPV-Alone invites more risk into women’s lives than you may think.

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ADS-01326-001 Rev. 001 © 2015 Hologic, Inc. All rights reserved. Hologic, Science of Sure, Pap+HPV Together, ThinPrep and associated logos are trademarks and/or registered trademarks of Hologic, Inc. and/or its subsidiaries in the United States and/or other countries. All other trademarks, registered trademarks, and product names are the property of their respective owners. This information is intended for medical professionals in the U.S. and is not intended as a product solicitation or promotion where such activities are prohibited. Because Hologic materials are distributed through websites, eBroadcasts and tradeshows, it is not always possible to control where such materials appear. For specific information on what products are available for sale in a particular country, please contact your local Hologic representative or write to [email protected].

MLO201605_AD Hologic-19325.indd 13MLO201605_AD Hologic-19325.indd 13 4/11/2016 9:03:57 AM4/11/2016 9:03:57 AM


CLINICAL ISSUES A N ATOMIC PAT HOLOGY

Transforming the practice of pathology with digital technologyBy Robin Weisburger, MS, HTL(ASCP)

fl ows reduce the handling of glass slides and improve pathologists’ fl exibility and productivity. These new workfl ows also reduce the risk of loss of important patient material and reduce costs for managing slide archives.

So, why isn’t everyone embracing dig-ital whole slide image technology? Cost is the primary reason. Although they’re trending down, investment costs for an image scanner and storage infrastructure can be formidable. In addition, support for implementation and operation of a digital pathology system requires team-work across departments to ensure suc-cess. Pathologists who are unfamiliar with whole slide imaging technology may be overwhelmed and not want to depart from their familiar processes.

In fact, change is diffi cult, and it may require an investment of time, money, and trust before rewards are seen. To achieve success in this new practice of pathology, we must help our colleagues and ourselves overcome this resistance to change.

Process: decision-making strategyIn the last fi ve years, whole slide scan-ners have improved in quality and come down substantially in cost. Larger med-ical centers fi nd them invaluable in the preparation of material for research and

Over the past three decades, the prac-tice of pathology

has evolved tremendous-ly. In the 80s and 90s, viewing microscopic images was limited to looking through a pair of microscope oculars. Publications and pre-sentations took hours of preparation using 35mm cameras that were adapt-ed to the microscope. The exposed fi lm was sent to a developer, and the re-sulting slides were sub-mitted for journal pub-lication or projected at a teaching conference on a standard carousel projector.

Some medical centers were fortunate enough to be able to invest in projection microscopes. A luxury for many, these “microscopes on wheels” could be trans-ported from the laboratory to lecture hall to conference room. Images were project-ed directly from the slides to the screen. There was no video cable or computer, just a microscope, light source, and projection lenses.

Twenty-fi ve years later, digital camer-as transmit images from microscopes to remote computers for rapid assessment of frozen sections and fi ne needle aspira-tion preps in real time. “Whole slide im-agers” are able to produce a high-quality digital image of a microscope slide with-in minutes which can be sent anywhere via the world-wide web for collaborative review. Whether for clinical, research, or educational applications, digital technol-ogy has transformed the way pathology is practiced today.

The pros and cons in a nutshellWhat is driving the trend toward digital whole slide image technology? The big-gest driver is the realization that being able to digitally capture an entire stained slide offers greater fl exibility and utiliza-tion of microscopic images. Images can be annotated and shared easily among network users. New laboratory work-

teaching, and for sup-port of many clinical applications such as quality assurance and tumor boards. Some of these centers are ready to take a bold next step by embrac-ing telepathology to support their remote practice partners by collaborating on dif-fi cult cases. How will these centers change their current practice paradigm so they can realize the full poten-tial of their digital pa-thology system?

A change of this magniude benefi ts by having a well-defi ned strategy that considers de-partmental and organizational goals. Knowing what needs to be achieved, when it needs to be achieved, and by whom it needs to be achieved pro-vides a framework to guide purchas-ing decisions, timelines, and even staffi ng decisions.

There is much to be considered when purchasing a whole slide imager. Qual-ity of images, magnifi cation options, throughput, cost, and service are key factors in the decision-making process. Also to be considered is the relative val-ue of each of these factors in case one needs to be compromised for another.

Other costs to be considered include that of an image storage server and of the technical staff to provide support for the service. Each whole slide im-age can range from 300 megabytes to several gigabytes. Adequate storage and backup of the image repository is critical to the long-term success of a digital pathology service. Staff sup-port from both the laboratory and hospital information services is also required. These partners are vital to ensure the smooth operation of the digital pathology service from image acquisition to workfl ow management to the archiving of the images and their associated cases.

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Robin Weisburger, MS, HTL(ASCP), serves as manager of

Corista’s Client Support Services

team.

ImplementationUsing a project management approach will assist with defi ning objectives, time-lines, responsibilities, and key players to help ensure a successful process from purchase through implementation. The project will require the collaboration of a multidisciplinary team including orga-nizational leadership, ancillary network experts, pathology staff, and, as needed, members from the vendor team.

The Team Leadership must provide a clear vision of what needs to be accom-plished and when. It is their responsi-bility to articulate the project goals and to provide the resources, support, and commitment needed for success.

All team members must collaborate to consider hardware needs, calculate storage needs, and create a reasonable timeline to complete each phase of the project. It is critical to clarify the param-eters of the project to prevent “scope creep.” Too often, implementation of a new work process can be sidetracked if time is spent on details not originally in-tended to be part of the project’s scope of work. Regular meetings to defi ne tasks, assign responsibility, and report prog-ress are vital to ensure the project stays on track.

Most team members will be juggling multiple priorities. Agendas, meeting notes, and updates to key stakeholders will assist in maintaining accountability for the work being done.

Key factorsMissteps can be avoided by focusing on a few specifi c considerations. Training, testing, standardization, and support are all key factors to ensure the success-ful implementation of a strong digital pathology service:

• Training: Do not underestimate the im-portance of proper training and support. Some staff may want to forego formal training, believing they can best learn by doing. Then, if the system does not per-form as expected, they may blame prod-uct inadequacies instead of lack of user knowledge. Training and written docu-mentation of processes for user reference are critical to success.

• Validation testing: Whole slide images must be validated to ensure that their quality is on par with glass slides, and the workfl ow platform must be validated for performance. Documentation of valida-tion testing must be completed and main-tained on fi le for regulatory inspections.

• Standardized workfl ows: Documentation of the new workfl ows is critical to ensure that all users and support staff know what steps happen and in what sequence. This documentation serves as a roadmap for how the workfl ows are navigated. At the technical level, work processes

for scanning slides, accessioning cases, and triaging the work must be defi ned, and all staff must follow them. If work is standardized and sound quality control measures are in place, these activities become part of the lab’s daily routine to support their pathologists’ digital service.

• Pathologist support: Some pathologists may be reluctant to change to using whole slide images for quality assurance, tumor board activities, case reviews, or other routine work. If a standardized high quality digital service is provided by the laboratory, pathologists will begin to gain confi dence in the new workfl ows. Users who become early adopters can support their colleagues as they come on board with this new way of work.

Pathology workfl owsA repository of whole slide images does not constitute a digital pathology service. It is the work that can be accomplished with these images that provides the real value.

Most whole slide scanners are pack-aged with proprietary software that facilitates pathology workfl ows. Anno-tation and measurement tools can assist with research, preparation of study sets, and tumor board presentations. Quality assurance activities can be streamlined and

documented for regulatory review. Collab-orative case reviews between colleagues can be performed in real time whether the pathologist partner is down the hall or across the continent.

Third-party platforms that are scan-ner agnostic and can integrate with a us-er’s laboratory information system (LIS) have been proven to expand the utility of an organization’s repository of whole slide images. No longer are laboratories constrained by proprietary software spe-cifi c to an individual scanner. Instead, pa-thologists and laboratories can take full advantage of the benefi ts offered by whole slide digital images regardless of the scan-ner that created them or the LIS storing the patient’s information.

These powerful new platforms contain the tools that elevate a digital pathology system to a truly comprehensive clinical workfl ow suite.

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CLINICAL ISSUES A N ATOMIC PAT HOLOGY

Anatomic pathology meets analyticsBy Eleanor Herriman, MD, MBA, and Tim Kuruvilla, MBA

articulate the value and impact of its services across the contin-uum of care. Here are ways in which AP labs can achieve that:

• Quantifying. Lab leaders should quantify the true cost and downstream impact of AP services both in the lab and across the care continuum. They need to know and be able to demonstrate the cost of a missed or inappropriate diagnosis, e.g., inappropri-ate work-ups and treatments for an inaccurate cancer diagnosis, and to be able to identify the cost of a delay in diagnosis. (In the case of cancer, this might include poor outcomes or malpractice consequences.) They need to measure and monitor performance on these key measures of value.

• Sharing. AP labs should proactively share information with key constituents: health plans, patients, and providers. Full transpar-ency on service levels which trends are occurring within the pa-tient population, and test utilization recommendations develop “stickiness” and trust among clinicians the lab serves. For ex-ample, payers developing oncology management and bundling programs are interested in accessing oncology AP results in a timely manner, enabling decision support interventions. Trans-parency and proactive, information-based communication are no longer luxuries; they are expectations.

• Engagement. Working collaboratively with other areas of the lab will allow a unifi ed, strategic approach to the health sys-tem. Laboratory testing is often misunderstood, and it’s critical that AP lab leaders drive awareness of how the laboratory can impact organization-wide goals. It is a good strategy to engage physician peers in discussions about the value of laboratory testing and share responsibility for system-wide outcomes and performance.

The value of analyticsThese initiatives are challenging to the AP lab, and many ques-tions remain unanswered. The information required to support these efforts is sometimes diffi cult to access, analyze, and share with the tools currently available to labs. However, AP labs are increasingly utilizing analytic solutions as organizations real-ize the importance of their data assets, including investments in electronic medical records. In fact, reports show that invest-ment in healthcare analytics is growing at a 26 percent plus CAGR (compound annual growth rate) over the next few years, and is expected to reach more than $18 billion in 2020. It’s time for AP laboratories to align with organizational strategies and invest in analytics to drive many of these key initiatives in the lab, as well as its impact outside of their walls.

What is anatomic pathology’s (AP) role in value-based healthcare? How can AP groups best position them-selves for what’s to come? How can pathologists de-

fi ne and ensure better transparency to add to the value and effi ciency that AP services deliver? These are questions being asked by many in the AP fi eld, and the answers are not trivial.

We’re all familiar with the challenges we face in our indus-try: declining reimbursement, policy changes, consolidation, and staff shortages. Let’s look at some of the measures AP labs are taking to navigate the challenges that are inevitably com-ing their way, including taking a patient-centric approach to quality, driving effi ciency, and highlighting AP value.

Patient-centered approach • Disease-based testing. Pathologists are at the center of the per-

sonalized medicine revolution, and realizing the value of this position requires expanding their role by offering intelligent services and analytics that provide rules-based test protocols for specifi c diseases and span tissue, molecular, and other tests.

• Patient-centered reporting. Overwhelmed clinicians sometimes struggle with interpreting asynchronous, complex test results when working up patients with a wide variety of tests. Patholo-gists can use analytics systems to integrate fi ndings and gener-ate patient-specifi c, summary diagnostic services.

• Minimizing follow-up errors. A frequent cause of diagnostic er-rors involves failure of clinicians to receive or appropriately act upon AP test results. Pathologists can add value to their services by using analytics systems to identify these potential errors and intervene to mitigate risk.

Driving effi ciencyLaboratories have to be as cost-effi cient as possible. However, multiple studies have proven that up to two-thirds of workfl ow process in AP labs is non value-added. While signifi cant efforts are being made on workfl ow improvement and cost improve-ment initiatives, it is critical to create sustainable performance improvements in the lab. Analytics enable AP labs to drive sustainable effi ciency in the following areas:

• People. Pathology lab leaders should staff by analyzing histori-cal trends from which they can more accurately predict their needs by day, hour, or month, rather than anecdotally. They also should ensure that team members know how their performance is measured, and that they have real-time insight into their per-formance metrics and the tools to be able to impact those metrics.

• Process. Using real-time analytics, lab leaders should empower the lab to identify and respond to errors in a timely manner. They should make sure they have detailed turnaround time in-formation, enabling them to identify points in the process where there may be opportunities without having to seek them out. To manage backlogs and reallocate resources appropriately, real-time workload analyses are critical; they enable labs to react in a timely fashion.

• Tools. Investments in laboratory equipment are made to le-verage people and process. It’s important to ensure that they optimize staff productivity. Ensuring that the use of those tools is synchronized with AP workfl ow can have tremendous impact on effi ciency.

Highlighting valueWhile AP has already experienced signifi cant declines in re-imbursement, the shift to bundled and value-based payments will be an even greater upheaval in the reimbursement model. Every healthcare service line, including AP, will have to

Eleanor Herriman, MD, MBA, serves

as Chief Medical Informatics Offi cer at

Viewics, Inc. She is a former Senior

Fellow at Harvard Business School’s

Institute for Strategy and Competitive-

ness. Her career experience includes

market research and strategy services to

the pathology and laboratory industries,

and healthcare strategy consulting.

Tim Kuruvilla, MBA, is Co-Founder

and Chief Commercial Offi cer at

Viewics, Inc. He has wide experience

in management consulting, private

equity, and entrepreneurship.

MLO201605-ClinicalIssues-Viewics_MECH_AL.indd 16MLO201605-ClinicalIssues-Viewics_MECH_AL.indd 16 4/11/2016 8:42:38 AM4/11/2016 8:42:38 AM

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LAB MANAGEMENT POC T A ND MORE

The laboratory of the future moves outside the wallsBy Anthony Kurec, MS, H(ASCP)DLM

While less than four percent of CLIA-certifi ed laboratories are within hospital settings, they perform the majority of lab-oratory tests (Figure 1).1 An estimated 12.8 billion laboratory tests are performed each year in the U.S.4 with approximate-ly one-third of these tests involving POCT.5 POCT is largely based on CLIA-waived testing, which has expanded over the past few years, making it a signifi cant testing modality within hospitals and other venues by working in concert with central laboratories (Table 1, pg. 20)24.

For example, in a survey of 317 U.S. hospitals, 100 percent of them were using POCT for glucose monitoring, 87 percent for coagulation monitoring, and 77 percent for blood gas/elec-trolytes monitoring—while 32 percent incorporated POCT for cardiac markers and 20 percent for HbA1c.6 In another study, 23 percent of hospitals had used six or more POCT instruments in 2011 compared to only fi ve percent in 2007.7

Concerns have arisen regarding the accuracy of POCT re-sults, especially when proper quality assurance protocols are not followed. Table 2, found on page 20, lists some common areas that have been identifi ed as sources for potential error.5,8,9 Yet POCT, when managed correctly, can provide accurate and timely diagnostic information that can improve patient care, decrease costs, and make better use of limited personnel re-sources.

Because of the relative ease of use and its portability, POCT can be done almost anywhere by anyone. Training is key to the proper use and maintenance of equipment used; so is imple-menting correct quality control procedures. Any deviation in protocol procedures, especially when multiple users are in-volved, can result in erroneous results. Also, use of multiple brands of POCT equipment can contribute to variable results;

thus the need to standardize to a single model. Other concerns in-volve environmental factors of excessive heat, cold, or humidity due to improper shipping or stor-age conditions, causing reagent damage.

Confusion may also occur when comparing POCT results with those obtained from the central laboratory, as differences may oc-cur due to variability in methodol-ogy. While there are many factors that lead to inaccurate POCT re-sults, proper training, equipment maintenance, identifying unique patient conditions, and strictly ad-hering to POCT policies and pro-cedures will minimize potential errors.

Telemedicine/telepathologyA number of healthcare areas have embraced telemedicine as an op-tion to provide services remotely

The clinical laboratory world has undergone signifi cant changes in technology, personnel training, and regula-tory mandates over the past several decades that have had

an impact on how patient care is provided. Laboratory testing has been recognized as an integral part in the diagnosis and treatment of diseases. Further, due to changes in payment reim-bursements, strategies in managing a clinical laboratory have shifted, making laboratory testing a commodity. Yet, as has been well documented, 70 percent of medical decision-making is based on diagnostic laboratory testing, but testing accounts for only 2.3 percent of total healthcare expenditures.1

In addition, there has been a tremendous shift in how and where patients want to receive their healthcare and related in-formation, thus placing a greater demand on physicians, nurs-es, and other healthcare practitioners to provide timely and ac-curate patient-focused services. Point-of-care testing, telehealth services, and direct access testing are three areas that have, in part, contributed to this ever-expanding desire for easy access, thus allowing individuals to have greater input in their health-care decisions. Studies indicate that better patient care is pro-vided when patients and their healthcare providers have easy access to clinical information.2

Point-of-care testingPoint-of-care testing (POCT), or near-patient testing, was in-troduced several decades ago and has, over time, been incor-porated into the daily procedures found in many emergency departments, physician offi ces, nursing homes, neighborhood clinics, drugstores, and even in the home. The intent of POCT is to offer a way to facilitate patient treatment by targeting health-care interventions in a more timely and convenient manner.3

continued on page 20

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2.56%

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.28%

Figure 1. Facility location of the 252,000 CLIA-certifi ed laboratories4

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to a larger community base, especially in rural areas and in healthcare facilities that may not have access to certain health-care specialists. Within the last few years, computer technology has improved to the level of meeting the needs of usable telepathology op-portunities. High-defi nition monitors and extremely large storage capaci-ties enable the transfer of image-rich pathology information that can be transmitted across the country and beyond.

There are a number of imaging for-mats used in telepathology (Table 3, pg. 22).10,11 Static image technology has been around for a number of years but is limited to a few screen shots preselected by the sending facility. A video imaging system allows for real time, direct connectivity between two workstations with the sending facili-ty controlling the microscopic images to be transmitted. Whereas, a robotic system gives a consulting pathologist the opportunity to directly manipu-late a microscope from a distance in Table 2. Some sample sources of concern with point-of-care testing4

continued from page 18


Table 1. CLIA-waived test categories24

CLIA-waived test categories listed alphabetically

AdenovirusAerobic/anaerobic organisms - vaginalAlbuminALTALPAmylaseASTBNPBasic Metabolic PanelBilirubin, totalBladder tumor associate AgBUNCalciumCalcium – ionizedCO2CatalaseChlorideCholesterolComprehensive Metabolic PanelCKCreatinineDrugs of abuseElectrolyte panelESREsterone-3-glucuronideEthanolFern testFollicle stimulating hormone (FSH)FructosamineGamma glutamyl transferase (GGT)GlucoseGlycosylated HgbHDLHeliocobacter pyloriHematocritHemoglobinHepatitis C Ab

HIVInfl uenzaKetonesLactic acidLDLLeadLipid profi leLithiumLuteinizing hormone (LH)Lyme diseaseMatrix metalloproteinases-9 (MMP-9)MicroalbuminMononucleosisNicotineOccult bloodOsmolarityOsteoporosis NTXOvulation testsPhPhosphorusPlatelet aggregation (aspirin)PotassiumPregnancy test (urine)ProtimeProtein, totalRenal function panelRespiratory syncytial virus (RSV)SemenSodiumStrep Ag testSyphilisTrichomonasTriglyceridesTSHUric acidUrinalysis

real time, thus allowing for expert review/interpretation of pa-thology slides. A fourth type of system is a whole slide imaging (WSI) system, which provides the option of scanning an entire slide, digitizing it, and transmitting a single fi le electronically via cloud technology.

Telepathology as part of pathology services has made some inroads in the past few years, though it is still not extensively used in the United States. It has been more readily accepted in other countries as a way to obtain second opinions and conduct pathology slide reviews and frozen section evaluations, espe-cially in underserved areas lacking certain types of expertise. Improved storage capacities and adequate transmission band-widths are paving the way for the expansion of telepathology in the U.S., yet some concerns remain (Table 4, pg. 22).25

The second generation of “Web 2.0” offers even more sup-port for telepathology.12 Web 2.0 offers a more robust interactive opportunity for pathologists to engage in editing, creating con-tent, and commenting on shared cases. This higher level of mu-tual participation can offer greater diagnostic, consultative, and educational experiences in a timely and widespread manner. User-generated pathology content can be shared in a virtual community where information can be discussed in conjunction with other tele-diagnostic modalities—including x-rays, CT im-ages, and ultrasound images—to provide overall better patient care.

Direct access testingThe gateway to proving direct access testing (DAT) began as early as the 1950s, when over-the-counter (OTC) test kits be-came available for measuring urine glucose and ketones in an effort to provide direct and timely access to a diabetic patient with potential health concerns.13,14 Web-savvy health consum-ers, who can seek out volumes of medical information and are generally better educated, want access to their own healthcare information in order to track health progress and treatment, and to advocate for themselves with their healthcare provider.

Further, maintaining a healthy lifestyle has been embraced by many and is often supported through employer-sponsored work-place wellness programs, such as smoking cessation, gym mem-berships, stress-control, weight loss, and nutritional offerings, es-pecially in companies with greater than 200 employees.15 This has stimulated public demands to know what is in the products we consume, such as saturated fat content, sugar levels, milligrams of sodium, whether products are gluten-free, and whether they

Erroneous resultsImproper equipment maintenance; dirty optical or sensor area; improperly calibrated; poor operator training

Reagents May produce erroneous results due to improper storage or are expired

Nosocomial infections Improper decontamination of instruments

Occult blood Sensitive to light, heat, humidity

Urine dipsticksCan degrade due to excessive light, heat, humidity; light source (such as fl uorescent light) may affect color discrimination

Blood gases May be affected due to changes in altitude

Pregnancy tests Antibodies may be denatured due to excessive hot or cold temperatures

Blood glucose

Abnormally high or low hematocrits can adversely affect glucose levels; small amounts of contaminant (lotion, dust, food particles, etc.) on fi nger; certain medications (acetominiphen, L-doppa, ascobic acid, etc.); patient conditions (ketoacidosis, lipemia,uremia, hyperosmolality, etc.)


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have been organically raised, or are vitamin-enriched. This “wellness revolution” has had an impact on the delivery of healthcare and laboratory services.16

The move to electronic health records (EHR) has also in-creased opportunities to easily share health information through secure web portals. Wireless technology through mo-bile apps and wearable devices can track and monitor basic health functions, providing additional ways to share health data. Subsequently, access to laboratory testing results has become a driving force behind the desire for the lay public to gain greater control of their healthcare information and not rely solely on their healthcare provider.

As of 2014, the Department of Health and Human Services (HHS) issued its fi nal rule amending CLIA’88 and HIPAA pri-vacy rules to allow patients to obtain their laboratory results directly from any CLIA-certifi ed laboratory.4,17 Some states re-quire the healthcare provider to send the results. Laboratories must release this information within 30 days of the patient’s re-quest. The estimated cost for administering this program is $59

Table 3. Weinstein Telepathology Classifi cation System10

Real-time imaging telepathology

Television microscopy

Research applications

Clinical applications

Dynamic/robotic telepathology

Static-imaging telepathology

Static imaging

Robotic imaging

Whole-slide imaging (WSI) automated or operator-directed

Multi-modality digital pathology

Hybrid dynamic robotic/static imaging

Dual image dynamic robotic/static imaging

Table 4. Current concerns with telepathology implementations25

LicensureState regulatory requirements that affect interstate diagnosis vs. interstate consultation and physician licensing.

CredentialingEstablishing privileges to practice medicine within a specifi ed facility.

JurisdictionLegal jurisdiction of any confl icts or medical improprieties.

Malpractice

Malpractice issues that must meet four requirements: 1) patient-physician relationship; 2) negligence; 3) cause of injury; 4) damage or direct harm to the patient.

ReimbursementRecognition by third-party payers for payment of telepathology services.

Medical DeviceRegulation

The hardware and software used for telepathology are considered medical devices and are subject to FDA pre-market approval.

Privacy and Security

As with all personal health care information, patient confi dentiality, informed consent, and diagnostic/consultative reports are to be subject to privacy regulations. This may also include information technol-ogy (IT) security concerns and access to patient information.



million over the fi rst fi ve years, which in part would be com-pensated for by charging patients nominal and reasonable fees for hard copy/mailing/labor costs. Implementation has been slow, with less than one-third of laboratories sharing direct ac-cess to clinical laboratory test results with patients, though that number is expected to grow quickly.2

More recently, consumer-directed laboratory test ordering has provided another opportunity for greater control over one’s own healthcare. As of this writing, 37 states and the District of Columbia allow for individuals to order their own laboratory tests without a healthcare provider’s input.18 This opportunity has not gone unrecognized by retail outlets, such as Walmart, Sam’s Club, Safeway, Costco, Walgreens, Concentra, and Whole Foods, which have paved the way to offering one-stop health-care services including eye clinics, blood pressure testing, fl u shots, and glucose and cholesterol POCT. Rite Aid Pharmacy has taken this a step further by introducing telemedicine kiosks in a limited number of stores to address minor health issues. These completely enclosed “health centers” offer basic services by connecting to a healthcare provider telephonically.19, ll

ConclusionsWith all this external technology available, it is not surprising that laboratory testing has extended beyond the traditional laboratory footprint that encompasses large pieces of testing equipment and highly trained personnel. Extra-laboratory test-ing has become a growing business, with major opportunities for hospital laboratory leaders and other enterprising health professionals to work together to improve patient access to healthcare.

Continuing advances in testing technology, miniaturization of equipment, improved connectivity, and overall easier access to healthcare services and information are on the rise. New con-cepts include “lab-in-a-briefcase,” where diagnostic testing us-ing a microfl uidic ELISA platform can be performed and trans-ported easily to any location in the world.20,21 Another evolving technology is “lab-on-a-chip” (LoC), which promises a wide range of laboratory analytics using a combination of nanotech-nology, biotechnology, and microelectronics. A single drop of blood can be placed on a chip that may be used in the analysis of genetic material and specifi c analytes, offering more complex testing then what POCT currently provides.22

Smartphones already provide some basic health-monitoring functions. Using LoC technology in combination with smart-phones is on the horizon.23 The synergy between these two technologies will use the advanced properties of communica-tion, social networking, computation, and imaging in ways that will potentially provide quick and simple diagnostic information.

Laboratory services are now being offered beyond the tra-ditional laboratory walls, using non-traditional methodologies in non-traditional locations. Continuing improvements in tech-nology will create an even greater demand for extra-laboratory testing options, empowering individuals by enabling them to play a more active role in managing their healthcare.

REFERENCES

1. Adva MeDx. A policy primer on diagnostics. June 2011. http://advameddx.org/download/fi les/sections/Policy/Innovation/AdvaMedDx-Policy-Primer-on-Diagnostics-June-2011.pdf.2. Swain M, Patel V. Patient access to test results among clinical laboratories. The Offi ce of the National Coordinator for Health Information Technology. ONC Brief #13, Feb 2014. https://www.healthit.gov/sites/default/fi les/onc-data-brief-13-labsurveydatabrief.pdf. 3. Kurec AS. Trends in point-of-care testing. Health Management. 14(4):76-80, October 6, 2014. http://healthmanagement.org/s/trends-in-point-of-care-testing.


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Orchard Trellis in a Small Practice

Orchard Trellis: EHR Connectivity Software for POC Analyzers With ACOs, PCMHs, and increased focus on patient-centered care, point-of-care testing (POCT) will increase as a way to effectively monitor patient health. But how will POC results get into the EHR? Because of low-volume, remote locations, and limited connectivity capabilities inherent to many POC devices, most POC test results are not being captured in the EHR, or are being entered manually—a time-consuming process subject to clerical errors. Orchard® Trellis™ is a cost-effective orders and results management software program that serves as a simple “review, click, and go” bridge for electronically passing orders and results between remote, low-volume POC analyzers and your EHR.

Document & Manage POCT Quality ControlQuality control for POCT has historically been paper-based and sporadically documented. However, with Trellis, you can now document and manage QC electronically to ensure compliance with all POCT QC requirements. QC can be manually ordered or configured to auto-order at the desired frequency. In addition, you can establish rules that will not allow results to be released without acceptable QC results.

A Flexible Solution Offering Many Deployment OptionsOrchard Trellis is very flexible and can be deployed in a variety of ways. The most basic installation is in a small practice where a single Trellis is utilized as a simple bridge between the EHR and a few low volume instruments. Orchard Trellis can also be deployed to connect the EHR with multiple POCT locations. For facilities where a centralized lab exists among a network of POCT locations, there are several deployment options. By implementing Trellis, you will help improve patient care and enhance the value of your point-of-care testing by providing real-time results to your EHR.

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4. Clinical Laboratory Improvement Amendments (CLIA). https://www.cms.gov/Regu-lations-and-Guidance/Legislation/CLIA/Downloads/factype.pdf. 5. Nichols JH. Point of care testing. Clin Lab Med. 2007;27:893-908. 6. Winter MC. Marketing trends in point-of-care testing 2007-2008. Point of Care: The J Near-patient Testing & Technol. 2010; 9(1):12-20.7. Malone B. Spotlight on point-of-care testing. Clin Lab News.Oct 1, 2012. https://www.aacc.org/publications/cln/articles/2012/october/point-of-care-testing.8. Ginsberg BH. Factors affecting blood glucose monitoring: Sources of errors in mea-surement. J Diabet Sci Technol 2009; 3(4):903-913. 9. Johnson S, Cushion M, Bond S, et al. Comparison of analytical sensitivity and wom-en’s home pregnancy tests. Clin Chem Lab Med. 2015; 53(3):3911-402. 10. Weinstein RS, Graham AR, Lian F et al. Reconciliation of diverse telepathology sys-tem designs. Historic issues and implications for emerging markets and new applica-tions. APMIS. 2012;120:256-275. 11. Pantanowitz L. American Telemedicine Association (ATA): New Telepathology Guidelines. Pathology Informatics Summit. 2014. http://www.pathologyinformatics.com/sites/default/fi les/archives/2014/Day2/20140514%201645%20-%20American%20Tele-medicine%20Association%20New%20Telepathology%20Guidelines.pdf. 12. LeFevre P. Digital pathology. Pathology innovators use Web 2.0 to boost productiv-ity and create clinical value. Dark Daily: Whitepaper. (2009) http://www.darkdaily.com/white-papers/digital-pathology-white-paper-pathology-innovators-use-web-2-0-to-boost-productivity-and-create-clinical-value#axzz3tTWxoE46. 13. American Society for Clinical Laboratory Science. Consumer access to laboratory testing and information classifi cation: A position paper. July 2012. http://www.ascls.org/position-papers/177-direct-access-testing. 14. Lab Testing Matters. Direct access to test results. July 2, 2015 http://www.labtest-ingmatters.org/direct-access-to-test-results/.15. Robert Wood Johnson Foundation. Workplace Wellness Programs. Healthcare Policy Brief. May 16, 2013. http://healthaffairs.org/healthpolicybriefs/brief_pdfs/health-policybrief_93.pdf. 16. Test Country.com. Direct access testing. http://www.testcountry.com/content/direct-access-testing.html/. 17. Department of Health and Human Services. Billing code 4120-01-P. http://www.hpm.com/pdf/blog/CLIA%20Program%20and%20HIPAA%20Privacy%20Rule.pdf/.

Anthony Kurec, MS, H(ASCP)DLM,

is Clinical Associate Professor,

Emeritus, at SUNY Upstate Medical

University in Syracuse, NY. Anthony

is also a member of the MLO

Editorial Advisory Board.


18. AACC Report: Direct-to-consumer test results should be more patient-friendly. Lab Medica International 2015;32(6):1. 19. Kirk P. Rite Aid’s New Telemedicine Kiosks in Select Ohio Pharmacies Allow Cus-tomers to Consult with Physicians for a Nominal Fee. Dark Daily: April 3, 2015. http://www.darkdaily.com/rite-aids-new-telemedicine-kiosks-in-select-ohio-pharmacies-allow-customers-to-consult-with-physicians-for-a-nominal-fee-403#axzz3ol0CHznK. 20. Barbosa AI, Castanheira AP. Edwards AD, et al. A lab-in-a-briefcase for rapid pros-tate specifi c antigen (PSA) screening from whole blood. Lab Chip 2014; 14:2918. http://pubs.rsc.org/en/content/articlelanding/2014/lc/c4lc00464g#!divAbstract.21. LabMedica Staff Writers. First lab-in-a-briefcase to boost global early diagnosis of cancer. LabMedica. Nov 18, 2015. http://www.labmedica.com/lab-technology/ar-ticles/294761397/fi rst-lab-in-a-briefcase-to-boost-global-early-diagnosis-of-cancer.html.22. Whitesides G. The lab fi nally comes to the chip! Lab Chip. 2014; 14:3125. http://pubs.rsc.org/en/content/articlelanding/2014/lc/c4lc90072c/unauth#!divAbstract.23. Erickson D, O’Dell D, Jiang L, et al. Smartphone technology can be transformative to the deployment of lab-on-a-chip diagnostics. Lab Chip. 2014;14:3159. http://pubs.rsc.org/en/content/articlelanding/2014/lc/c4lc00142g/Unauth#!divAbstract.24. Washington State Department of Health. Waived tests and CPT codes. Revised 4/01/2015. http://www.doh.wa.gov/portals/1/Documents/Pubs/681018.pdf.25. Cornish TC, McClintock DS. Medicolegal and regulatory aspects of whole slide image-based telepathology. Diag Histopathol. 2014;20(12):475-481.

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REIMBURSEMEN TEDUCATION

Looming regulations and FDA oversight mean an uncertain reimbursement climate in 2016By Rina Wolf

The FDA issued a draft guidance last year and has announced its intention to issue a fi nalized guidance sometime in 2016. The Association of Molecular Pathology and others have challenged the FDA regarding examples it provided in a recent report outlin-ing evidence supporting FDA oversight of LDTs. The American Medical Association, the American Clinical Laboratory Associa-tion, and numerous industry professionals and organizations sup-port modernizing the oversight framework for LDTs and services through reform of the CLIA versus involvement from the FDA. Many believe that any increased oversight must be done through rule making, rather than guidance, and Congress has conducted hearings on this issue.

The FDA estimates that half of the LDTs on the market would be classifi ed as low-risk under the agency’s proposed framework. The FDA’s initial focus will be on reviewing LDTs with the same intended use as an FDA-approved or cleared companion diagnos-tic or Class III medical device, and certain LDTs for determining the safety or effi cacy of blood or blood products.

Commercial payor challengesOn the commercial payor side, documentation is becoming more and more critical, and front-end requests for additional informa-tion to process claims are increasing. Back-end medical necessity audits are also increasing, with recoupment requests based on medical necessity being seen as much as 12 to 18 months after pay-ments are remitted.

Five of the most common commercial payor claim issues include: 1. Services billed with no medical necessity documentation to support the claim;2. Documentation for a service by a health professional deemed insuffi cient;3. Services provided to a patient deemed experimental or investigational;4. Claims for services coded incorrectly and/or claims that include NOC (Not Otherwise Classifi ed) codes; and5. Patient shares of cost not handled in a compliant manner.

While much progress has been made in molecular diagnostics and genetic testing, lack of consistent payor policy and adequate reimbursement is impeding availability of these innovative tests. Payors are increasingly reimbursing only for tests that they believe can clearly demonstrate “clinical utility” and improved outcomes.

While there are still considerable upfront investments in studies to demonstrate the clinical value of genetic tests, the continually raising bar is occurring during a time of decreasing reimburse-ment and pricing turmoil in the laboratory industry. This is cre-ating an environment of unrest and uncertainty just as precision medicine initiatives are gaining national attention.

As addressed in the Personalized Medicine Coalition’s report, “The Future of Coverage and Payment for Personalized Medicine Diagnostics” (http://www.personalizedmedicinecoalition.org/Userfi les/PMC-Corporate/fi le/pmc_the_future_coverage_payment_personalized_medicine_diagnostics.pdf), it is crucial that payor reimbursement be adequate enough to allow innovators and investors to recover the cost of development, and continue to develop a pipeline of innovative tests requiring substantial risk-based clinical research.

Importance of fi nancial management systemsThese new regulations, and particularly PAMA, will impose a sig-nifi cant burden on clinical laboratories, requiring an investment in

Laboratories continue to face numerous and unrelenting challenges driven by government and regulatory forces that leave many wondering how or if to move forward.

Here are some of the major issues currently impacting the future of lab reimbursement.

Medicare reimbursement revisionOn September 25, 2015, The Centers for Medicare & Medic-aid Services (CMS) published a proposed rule to the Protecting Access to Medicare Act of 2014 (PAMA) that will substantially re-vise the Medicare reimbursement methodology for clinical diag-nostic laboratory tests based on private sector payment rates to be phased in over a six-year period commencing in 2017.

Under these reforms, applicable clinical laboratories are to be-gin reporting private payor reimbursement rates along with as-sociated test volumes for each test on the clinical laboratory fee schedule (CLFS) that the laboratory performs. The current defi ni-tion of an applicable lab required to report includes independent and physician offi ce labs that receive more than $50,000 per year in Medicare revenues. However, the current proposal would elimi-nate most hospital laboratories, which most agree would unfavor-ably skew the fi nal rates and be less refl ective of the true market.

New rates for the CLFS would be determined using a weighted median from this private payor data. CMS proposes to apply dif-ferent reporting and payment requirements for advanced diag-nostic laboratory tests (ADLTs). The maximum reduction allowed to current payment rates for years 2017 through 2019 is 10 percent of the previous year’s rate, and 15 percent of the previous year’s rate for years 2020 through 2022, to achieve parity with private payor rates.

Under PAMA, applicable laboratories may be subject to civil monetary penalties of up to $10,000 per day for each failure to report or reporting error by Current Procedural Terminology (CPT) code.

Under the proposed rule, applicable laboratories were required to collect private payor data from July 1, 2015, to December 31, 2015, and to report the information to CMS by March 31, 2016, with new rates going into effect on January 1, 2017, and continuing through 2022. However, following the commentary period that ended in November 2015, as of this writing CMS has yet to publish a fi nal rule or announce an offi cial delay on PAMA, leaving the industry with no confi rmation on who is required to report, what they are required to report, and how to do it.

The FDA’s evolving role in LDTsLaboratory-developed tests (LDTs), many of which are genetic and genomic-based tests, are essential to the continued devel-opment of personalized medicine and patient-centered care. As practitioners have increasingly adopted the use of diagnostic tests to guide patient treatment decisions, concerns about the manage-ment and safety of LDTs have emerged.

The Food and Drug Administration (FDA) has proposed en-forcing what it believes is its right to regulate these tests. It plans to introduce new regulatory requirements to include registration, adverse event reporting, and 510K/premarket review over the course of the next decade under a risk-based framework consis-tent with the FDA’s approach for medical devices. The FDA has historically exercised “enforcement discretion” over LDTs, and oversight has been through CMS under the Clinical Laboratory Improvement Amendments (CLIA).

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resources to track, collect, and report private payor payment rates and implement the necessary fi nancial management and compli-ance systems. Labs should take advantage of every opportunity to ensure that they will be able to aggregate and report their data now, while the fi nal rules are pending.

It will be imperative to capture the necessary reporting infor-mation either through a billing system that properly accounts for allowable costs on paid claims, or directly from the electronic re-mittance advice. Lab leaders should review 2015 data to ensure ac-curacy of payments prior to reporting. To comply with deadlines, systems must routinely capture and retain historical payment de-tail and fl ag payments inconsistent with contract provisions. Data points will need to be refi ned when fi nal instructions are released.

At a minimum, systems must be able to capture: 1) date of ser-vice; 2) date paid; 3) payor type; 4) number of tests for each proce-dure code; 5) amount allowed and paid by insurer plus patient share of cost; 6) contractual rates, including volume and other discounts; and 7) aggregate data in timely buckets (e.g., 7/1/15–12/31/15).

To support the increased specifi city and comprehensiveness of the ICD-10 code set, it will be critical for providers to capture de-tailed documentation in patient charts in order to avoid potential claims denials and the risk of fi nes from audits going forward.

Laboratories should continue to monitor updates and guidance from CMS on reporting details while preparing for data gathering and implementation, and watch for fi nal rules from the FDA this year.

Bundled paymentsMedicare continues to press forward with alternative reimburse-ment models such as accountable care and bundled payments, with plans to move 30 percent of non-managed care spending

into contracts by the end of 2016, and 50 percent by 2018. It was recently announced that the 30 percent target benchmark has al-ready been reached for 2016. CMS also recently introduced its On-cology Care Model, which incentivizes cancer providers to reduce hospital and pharmacy costs.

Some healthcare institutions are beginning to develop their own bundled programs with payors, which requires a very detailed understanding of the cost drivers for particular diagnoses and episodes of care. While there is much discussion about the rising costs of pharmaceuticals and drug waste, estimated to be as much as 50 percent, little voice is being given thus far to the role that lab diagnostics can play in alleviating this waste.

As providers continue to move toward alternative payment models with the dual goal of reducing costs and improving pa-tient outcomes through patient-centered and personalized, genetically-guided care, lab diagnostics will become increasingly critical to these initiatives as a means to manage downstream costs and ensure the best possible treatment and patient-specifi c outcomes.

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EDUCATION REIMBURSEMEN T

PAMA and bundled payments force PAMA and bundled payments force labs to feel a reimbursement shiftlabs to feel a reimbursement shiftBy Kim Futrell, MT(ASCP)

based on the weighted median payments for private payers. If the newly calculated reimbursement rate is dramatically lower than the current rate, the decrease will be phased in over a six-year period. In the original rule, the maximum reduction for years 2017 through 2019 was listed as 10 percent of the previous year’s rate and 15 percent for years 2020 through 2022, equating to a potential total of a 75 percent decrease across six years.

The fi rst reporting period was intended to be from July 1, 2015, through December 31, 2015, due to CMS by March 31, 2016. How-ever, as there is no fi nal rule, this did not happen, nor has any new reporting period been announced. Industry experts posit that the lack of a fi nal ruling will likely delay the January 2017 start date to 2018.

The biggest controversy, which led to 1,300 comments, devel-oped after the law was refi ned and only certain applicable labs were designated as being required to submit their payer rates. Only in-dependent labs and physician offi ce labs (POLs) that receive more than $50,000 per year from Medicare were required to report payer reimbursements, while hospital labs and smaller labs (< $50,000 from Medicare) were considered exempt. Most hospital labs fell un-der the exemption as well because the law states that 50 percent of the entity’s total Medicare revenue must come from the Physician Fee Schedule (PFS) or the CLFS. This means that most large hospi-tals, about 50 percent of independent labs, and 90 percent of POLs were exempt. In the original wording, about half of the data used to create the new fee schedule would come from the largest fi ve labo-ratories (mainly LabCorp and Quest), who typically have largely discounted pricing.

While we do not know for certain, industry experts report that CMS is likely to respond to the outpouring of comments and make changes to the defi nition of an applicable lab to include hospital laboratories in the calculations so that the new payment rates will more accurately refl ect the market. While price transparency and the concept of a market-based approach to fee setting are good con-cepts, it is widely agreed upon by the laboratory industry that the methodology the CMS originally planned to use to set future CLFS pricing was severely fl awed.

PAMA and the futureMany labs are already feeling the transition in healthcare from FFS payments to value-based payments and are transitioning from profi t centers to cost centers. The $2.5 billion cuts in lab re-imbursement spell a signifi cant change in lab payments. Not only will many labs have to adjust to reporting volumes and reimburse-ments; they’ll also need to prepare for the long-term reimburse-ment changes as they see less revenue for the same volume of tests. While we do not know exactly what the future holds, it is time for lab leaders to think differently, plan ahead, and make sure they understand PAMA’s full fi nancial impact on their laboratory.

In order to face legislative changes like PAMA, laborato-rians must refocus their efforts and fi nd additional ways to demonstrate their value. The laboratory is central in supporting disease management and treatment, so it certainly will not go away. Rather, a shift in testing volumes, menus, and locations, and an expansion of the laboratorians’ role are predicted for the future. While the lab is not the problem in rising healthcare costs, it can be a huge part of the solution.

Laboratories are beginning to feel the effects of healthcare’s shift from fee-for-service (FFS) to value-based reimbursement sys-tems. New payment models are focused on patient outcomes

and eliminating the misaligned FFS incentives that can lead to overutilization. Healthcare’s new mission is to simultaneously re-duce costs and improve care. Labs are a part of this goal.

Labs are a crucial part of diagnostics in the overall healthcare pic-ture. Traditionally, labs have been revenue centers, but in the new healthcare model, lab testing will be considered an expense that is part of the cost of delivering care. We are beginning to see this unfold in new reimbursement models, such as bundled payments. Anoth-er looming element of this transition is the H.R. 4302—Protecting Access to Medicare Act of 2014 (PAMA), which labs have been awaiting with trepidation because it signals the beginning of big changes in reimbursement.

Even before PAMA, in 2014 the Centers for Medicare & Medicaid Services (CMS) began bundling payments for hos-pital outpatient visits. These bundled payments include lab testing, with the exception of molecular pathology tests. Tests are reimbursed according to the Hospital Outpatient Prospec-tive Payment System (OPPS), and are billed by the hospital rather than the lab. Of course, when testing takes place out-side of the bundled cases, reimbursements still depend on the Clinical Laboratory Fee Schedule (CLFS). This puts the onus on hospitals to develop budgets within this complex framework.

CMS also has implemented the Bundled Payments for Care Improvement (BPCI) initiative, which bundles payments across a continuum of care. The idea is to incentivize better care co-ordination. The BPCI initiative was developed by the CMS Medicaid Innovation, which was put in place by the Affordable Care Act to begin to pilot some of the value-based pay-ment models. As of January of this year, the BPCI initiative has 1,574 participants.

On the heels of these bundled payment initiatives rests PAMA. Many labs took a proactive stance by voicing their opinions to improve the law. Originally, CMS was expected to release the fi -nal rule on June 30, 2015. Instead, a proposed rule was released on September 25, 2015. Subsequently, more than 1,300 comments were sent in, many from laboratories expressing concern about the impact of the proposed reimbursement cuts and the defi nition of applicable labs (those required to report their data). These fi nal comments ended on November 24, 2015.

With CMS missing the initial rule release date and with (as of April 1, 2016) no sign of an offi cial format for labs to begin report-ing their payer reimbursements and testing volumes, the pro-posed effective date of January 1, 2017, for reimbursement cuts is highly unlikely.

The history of PAMA PAMA was responsible for repealing the 24 percent Sustain-able Growth Rate (SGR) cut and delaying ICD-10 implementa-tion. Additionally, Section 216 of PAMA, entitled “Improving Policies for Clinical Laboratory Tests,” is a plan to begin basing Medicare reimbursements for clinical lab tests on private sector payment rates. The Congressional Budget Offi ce estimated that these changes to the CLFS will reduce Medicare spending by $2.5 billion between 2014 and 2024, though this timeline is already beginning to shift.

Under the PAMA law, applicable labs must report their test vol-umes and private payer rates (for each test on the CLFS) to CMS. CMS plans to use this data to establish new Medicare payment rates

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A GUIDE TO MOL ECUL A R DIAGNOS TICS

Cost-effectiveness considerations with molecular diagnostics in oncologyBy John Brunstein, PhD

It is an unfortunate reality that costs and expected benefi ts of any medical process, including diagnostics, need

to be considered in determining the ap-propriateness of performing the process. The need for this consideration is equally relevant regardless of whether it is done in the context of a user-pay system (where the end user or patient needs to make a value judgement) or a centralized payer system, where diffi cult decisions must be made by administrators to attain maximal benefi t for all covered people with a fi nite pool of funds to work from. Either case demands responsible, informed decision-making based on the best available data for the associated costs and benefi ts.

Frequently, reports of a novel MDx method will provide detailed informa-tion on the analytical performance of the test (sensitivity, specifi city), turnaround times, throughput, and other “hard” metrics of performance. Costs, however, are often dealt with more vaguely; or, where fi rm per-test cost values are pro-vided, close review suggests the reported costs may only be relevant in the narrow situation as applied at a specifi c site, with questionable generalizability. Detailed, in depth analysis not just of the direct costs of a test method but also of its indirect costs (or cost savings) in terms of such factors as reduced length of hospital stay, reduced risk of nosocomial infections, and the like are rare.

This common weakness is not a refl ec-tion on study authors, who are aware of and generally at least allude to these issues; rather, it refl ects the complexi-ties involved in addressing MDx cost-effectiveness in a truly rigorous and de-fensible fashion. In this month’s Primer, we’ll briefl y consider what some of these complexities are and how they can pos-sibly be addressed; then we’ll consider, for the narrower subset of oncology-related MDx, a representative handful of publications that have attempted to shed light on this issue. Understanding their assumptions—implicit and explicit—can help in determining goodness of fi t of their conclusions to other situations.

Factors to considerWith that context in mind, let’s consid-er some of the inherent complexities in

assigning costs and values to an MDx test in an oncology setting.1. What is the probability of the test returning an “informative” result? Con-sider, for example, an oncogene panel, of the sort discussed in last month’s Prim-er installment. (Brunstein J. Oncogene panels: a window into the individuality of cancers. MLO. 2015;48(4):18-20.) If a patient sample is tested by MDx panel and the results don’t add any action-able information (i.e., information that dictates a change in treatment strategy) over what was indicated by classical identification and classification means, then it could be argued that the test cost is wasted. If zero is the value as-signed to this type of result, then a first step in assigning net value to the test is to know what fraction of samples will yield actionable information from the test. For example, if 20 percent of cases yield actionable results, then 80 percent do not and the immediate “value” of the test is only one-fifth of its possible max-imum. Knowing this fraction with any certainty requires significant sample population sizes, but the knowledge can probably be gleaned from pooled multi-site data if uniform population inclu-sion criteria are applied. 2. The term “informative” itself, as used in Point 1, is debatable and may not be applied equally in all settings. It may well be argued that even a non-action-able test result has value, in assuring the clinician that alternative treatment strategies are not warranted. If this line of reasoning is taken, then some partial value of a non-informative test result, as compared to an informative test result, must be applied. 3. Individual cancers may change mo-lecular characteristics over the course of disease progression, particularly if ap-proaches such as chemotherapies apply selective pressures to the cancer cells. Detecting this change may be useful in modifying therapy, but the concept of detecting change implies one or more prior “baseline” measurements for com-parison. If this sort of time course pro-gression data is desirable, then, similarly to Point 2, all measurements, regardless of “actionability” of result, have some intrinsic value.

4. Localized costs of assay performance can be highly variable. Particularly if a test is not a complete “sample to an-swer” system and relies on discrete steps or devices for nucleic acid prepa-ration, molecular manipulation such as qPCR, and detection/analysis of re-sults, then there exists a possibility that the laboratory may already have one or more of the required devices being used for other test functions. This, of course, amortizes the infrastructural cost over several test streams, making it cheaper per test. (This would also impact throughput considerations, our next point.)5. Test throughput and scale can dra-matically alter the per-test performance cost. Higher throughputs (utilizing instrumentation near capacity) and batching of specimens to optimize use of laboratorian time both can act to sig-nificantly reduce direct per-test cost. Reference 1 is a specific study of this, and suggests in the study setting (Bra-zil) that a 30 percent utilization rate for various MDx tests resulted in cost-per-test increases of between 169 percent and 412 percent over at-capacity costs, depending on test methodology.

Insights from studiesNow that we can appreciate what some of the challenges are in assigning both cost and value to a given MDx test, and in tak-ing cost/value data from one location to another, let’s consider a few representa-tive published studies from the oncology fi eld.

Our fi rst example relates to thyroid cancers. Najafzadeh and coauthors2 ex-amined adding MDx to fi ne needle aspi-rate biopsies (FNAB). The authors sug-gest that FNAB with classical methods alone may yield indeterminate results in up to 25 percent of cases, and prepare a model assuming 95 percent sensitivity and specifi city for the MDx test. Results of this model suggested the addition of MDx methods gained 0.046 quality ad-justed life years (QALY), with a per-pa-tient cost savings of $1,087 (assuming the MDx test cost nothing to perform). While this might at fi rst glance seem an odd way to present their fi ndings, it’s actually perhaps the clearest way to allow another

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THE PRIMER A GUIDE TO MOL ECUL A R DIAGNOS TICS

site to apply the results to their situation by directly inserting local cost-of-test es-timates. The authors conclude that if the test costs are less than $1,087, then there is both a net cost savings and a gain in QALY. (Recall that one QALY equals one year at “perfect” health; a year at less than perfect health, then, equates to something under one QALY, by whatever fractional decrease is associated with disease states.) The authors provide highly detailed de-scriptions of their model assumptions as well as clear graphic representations of the impact of different levels of MDx sen-sitivity and specifi city. Sensitivity more than specifi city is shown to impact the value outcomes.

Our second example is by Hagen and coauthors3 and focuses on MDx in the context of HNPCC (hereditary non-polyposis colorectal cancer). This is an in-teresting analysis of four different testing models with and without MDx compo-nents. While the body text is in German, the English language abstract indicates cost per patient life-year gained, with an optimal tiered methodology (application of MDx only in suggestive family his-tory contexts) showing roughly 3x better cost-effectiveness of the least effective ap-proach of blind population MDx screen-ing. While these are the rank order results one would expect a priori, the magnitude of the value is instructive. As the authors point out, however, decreases in assay cost will start to make blind screening more attractive. This highlights the im-portance of considering publication year of such studies, as the intervening eight years have made MDx methods signifi -cantly cheaper, with corresponding im-pacts on study conclusions.

Our third example, a study by Djalalov and coworkers4 in the context of NSCLC (non-small cell lung cancer), highlights additional complexities in making cost-benefi t analyses for MDx when it is ap-plied as a companion diagnostic. In this study, subsequent to a number of defi ned assumptions, the authors report that MDx (specifi cally, EML4-ALK fusion testing by FISH) did improve patient outcomes by an average of 0.011 QALY, with a rela-tively minimal cost differential of an ad-ditional $2,725 per patient—of which only a very modest $60 is directly attributable to the MDx assay component. The over-all interpretation of cost-benefi t in this situation, however, changes dramatically when the cost of the companion drug (crizotinib) is included. The authors’ fi nal conclusion, in fact, is that testing in this case is “not likely to be considered cost-effective,” but, also tellingly, “the model was not sensitive to the costs of molecular testing.” The generalizable message from this example is that where companion di-agnostic MDx is considered, these assays

are by nature tightly coupled to the cost of the specifi c associated drug.

In conclusion, if your facility is con-sidering introduction of an MDx method in an oncology setting, and wants to address cost-effectiveness issues in de-termining whether this is a good use of resources, the preceding provides some ideas on how to most logically go about doing so. While identifi cation of relevant publications is a critical fi rst step, assess-ing what assumptions to adjust in apply-ing the conclusions to another location is far from trivial but not impossible. As more sites add MDx protocols to their oncology diagnostics workfl ows, we should appreciate those that publish or otherwise share their cost/benefi t results; doing so is of great help to other sites in tackling the challenges of good economic stewardship.

As a fi nal note, readers interested in a more in-depth discussion of how to formalize assessment of clinical utility for MDx assays may be interested in the fi nal reference provided,5 which deals specifi cally with this issue.

REFERENCES

1. Schlatter RP, Matte U, Polanczyk CA, Koehler-Santos P, Ashton-Prolla P. Costs of genetic testing: supporting

Brazilian public policies for the incorporating of molecu-lar diagnostic technologies. Genetics and Molecular Biology. 2015;38(3):332-337.

2. Najafzadeh M, Marra CA, Lynd LD, Wiseman SM. Cost-effectiveness of using a molecular diagnostic test to improve preoperative diagnosis of thyroid cancer. Value Health. 2012;15(8):1005-1013.

3. Hagen A, Hessabi HK, Gorenoi V, Schönermark MP. Cost-effectiveness evaluation of predictive molecular diagnostics using the example of hereditary non-pol-yposis colorectal cancer (HNPCC). Gesundheitswesen. 2008;70(1):18-27.

4. Djalalov S, Beca J, Hoch JS, et al. Cost-effective-ness of EML4-ALK fusion testing and fi rst-line crizotinib treatment for patients with advanced ALK-positive non–small-cell lung cancer. Journal of Clinical Oncology. 2014;32(10):1012-1019.

5. Parkinson DR, McCormack RT, Keating SM. Evi-dence of clinical utility: an unmet need in molecular diagnostics for patients with cancer. Clinical Cancer Research. 2014;20(6):1428-1444.

John Brunstein, PhD, is

a member of the MLO

Editorial Advisory

Board. He serves as

President and Chief

Science Offi cer for

British Columbia-based

PathoID, Inc., which

provides consulting for development and

validation of molecular assays.

MLO201605-Primer_FINAL.indd 31MLO201605-Primer_FINAL.indd 31 4/12/2016 12:41:48 PM4/12/2016 12:41:48 PM


WASHINGTON

REPORT

Government addresses opioid addiction crisisBy MLO staff

It has been bubbling beneath the sur-face of widespread public awareness for years—though it certainly was

well known to laboratorians and other professionals involved in the health-care delivery system all along—but this past winter it emerged as a major national news story. It was widely dis-cussed by presidential candidates in both parties, particularly when they were campaigning in the New Hamp-shire primaries, and it made headlines nationwide. “It,” of course, is the cri-sis in opioid addiction that plagues not only hard-hit New England but all regions of the United States.

March was something of a watershed month for the issue. Legislation de-signed to reduce opioid overdose was introduced in the U.S. Senate. Two fed-eral agencies—the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA)—issued new directives on the crisis. And, in a major speech, President Obama drew attention to the crisis and suggested new approaches.

On March 11, Senator Ed Markey (D-MA) introduced S. 707: Opioid Over-dose Reduction Act of 2015. Its full title is “A bill to provide certain protections from civil liability with respect to the emergency administration of opioid overdose drugs.“According to the nonpartisan Congressional Research Service, “this bill exempts individuals from liability for harm caused by the emergency administration of an opioid overdose drug under certain circum-stances.” The bill has fi ve cosponsors: Sens. Kelly Ayotte (R-NH), Timothy Kaine (D-VA), Patrick Toomey (R-PA), Elizabeth Warren (D-MA), and Richard Blumenthal (D-CT). It was assigned to the Senate Judiciary Committee, which will consider it before possibly sending it on to the Senate as a whole.

CDC guidelineOn March 15, the CDC released the “CDC Guideline for Prescribing Opioids for Chronic Pain, United States, 2016.” The document was designed to help primary care providers ensure the safest and most effective treatment

for their patients. The guideline pro-vides recommendations on the use of opioids in treating chronic pain (that is, pain lasting longer than three months or past the time of normal tissue healing).

Among the 12 recommendations in the guideline, the CDC highlights three key principles to improving patient care:

• Non-opioid therapy is preferred for chronic pain outside of active cancer, palliative, and end-of-life care.

• When opioids are used, the lowest possible effective dosage should be pre-scribed to reduce risks of opioid use disorder and overdose.

• Providers should always exercise caution when prescribing opioids and monitor all patients closely.

“Doctors want to help patients in pain and are worried about opioid misuse and addiction,” said Debra Houry, MD, MPH, director of CDC’s National Center for Injury Preven-tion and Control. “This guideline will help equip them with the knowledge and guidance needed to talk with their patients about how to man-age pain in the safest, most effective manner.”

FDA warningsOn March 22, the FDA announced enhanced warnings for immediate-release (IR) opioid pain medications and that it is requiring class-wide safe-ty labeling changes for IR opioid pain medications. Among the changes are a new boxed warning about the serious risks of misuse, abuse, addiction, over-dose, and death.

The FDA is also requiring several ad-ditional safety labeling changes across all prescription opioid products to in-clude additional information on the risk of these medications. This is part of the agency’s overall effort to help in-form prescribers about the importance of balancing the serious risks of opioids with their role in managing pain.

As part of the boxed warning on IR opioid analgesics, the FDA now requires a precaution that chron-ic maternal use of opioids during

pregnancy can result in neonatal opi-oid withdrawal syndrome (NOWS), which may be life-threatening if not recognized and treated using pro-tocols developed by neonatology experts. NOWS may occur in a new-born exposed to opioid drugs for a prolonged period while in utero.

Presidential initiativesOn March 29, at the National Rx Drug Abuse & Heroin Summit in Atlanta, Georgia, President Obama announced that the Department of Health and Human Services (HHS) is issuing a proposed rule to increase the current patient limit for qualifi ed physicians who prescribe buprenorphine to treat opioid use disorders from 100 to 200 patients, with the goal of expanding access to this evidence-based treatment while preventing diversion. HHS is also fi nalizing a rule to strengthen ac-cess to mental health and substance use services for people enrolled in Medic-aid and Children’s Health Insurance Program (CHIP) plans by requiring that these benefi ts be offered at parity, meaning that they be comparable to medical and surgical benefi ts.

In addition, the Substance Abuse and Mental Health Services Administra-tion (SAMHSA) is releasing a new $11 million funding opportunity to states to purchase and distribute the opi-oid overdose reversal drug naloxone and train fi rst responders and others on its use, along with other overdose prevention strategies. Also, SAMHSA is releasing a new $11 million fund-ing opportunity for up to 11 states to expand their medication-assisted treatment services, and distributing 10,000 pocket guides for clinicians that include a checklist for prescrib-ing medication for opioid use disorder treatment.

The opioid addiction crisis has Washington’s attention. Will the mo-mentum to combat the crisis continue to build?

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MANAGEMENT MATTERS

Increasing lab excellence with three principles of peak performanceBy Jeff Osborne

Health systems are undergoing a major transformation. They are being evaluated and inspected to ensure they’re running at peak performance. Weak links are being identi-

fi ed, and in today’s competitive healthcare industry weak links in a growing value-based healthcare environment are consid-ered unacceptable. These transformative times make now more important than ever for clinical labs—some of which run well below capacity and effi ciency—to maximize performance and increase their value.

Typically the lab represents at most fi ve percent of a health system’s costs, but it is undeniably a critical link in the deliv-ery of patient care, with 80 percent or more of each patient’s medical record fl owing through the lab. A lab that’s running at peak performance—improving the continuum of patient care while showing increased effi ciency—can offer a health system a much-needed competitive edge as care delivery options con-tinue to expand in most communities.

To improve health system service and quality through lab operations, health systems must retain, optimize, and evolve their labs. This means keeping the lab in-house, rather than divesting—and investing—in processes and technologies that drive higher quality, better service, and demonstrable value. Broadly, this can be achieved by employing three principles of lab excellence: operate with speed, operate with accuracy, and operate with effi ciency.

Sounds like a no-brainer, right? The trick is fi nding a balance among these practices. They must all work together in harmo-ny, and none can be compromised, or the overall results will suffer greatly. As more than 3.5 billion tests are annually pro-cessed through health system-based clinical labs, not fi nding that balance is at the core when labs run into problems, and, via a domino effect, threatens the health system’s capacity and effi ciency.

SpeedData-driven operational intelligence and insights help speed real-time decision making in the clinical lab and foster best practices at their point of need. For example, visibility and transparency into the processing of a specimen from collection to result is critical. Ensuring everything from accurate specimen labeling, to reliable logistics, to an optimized process in the lab ultimately enables turnaround time. From the clinician’s per-spective, this is what enables him or her to deliver a patient’s diagnosis and begin care faster.

In many cases, in-house testing services enable speed to deci-sion, through support of broad test menus which reduce send-outs. When tests are sent to external labs, additional points of failure outside the control of the health system are introduced, which can result in delays in getting results to doctors.

AccuracyOf course, accuracy is crucial to patient care, and inaccurate lab results are likely to be detrimental to a patient and have major cost and effi ciency implications for a health system. An error in a test order entry can immediately render everything

Jeff Osborne serves as Chief

Executive Offi cer of Accumen,

a San Diego-based healthcare

transformation company.

subsequent in the testing process—specimen collection, pro-cessing, resulting, and reporting—meaningless if not corrected. Each of these stages depends on the accuracy of the preceding one. A lab’s accuracy is the foundation on which speed and effi ciency can be improved, not the other way around.

By maintaining an in-house lab, health systems can manage and tailor their testing capability to meet their specifi c needs, further ensuring control and accuracy of quality. And success-fully coupled with speed, labs can further increase physician satisfaction and reduce the amount of time to patient diagnosis and treatment, improving the patient experience and the health system’s overall value and effi ciency.

Effi ciency A comprehensive approach to people, process, and technol-ogy in the lab that optimizes and modernizes operations helps to achieve measurable improvements in effi ciency. All areas of the lab, from the bench to supplies and test menu, must be examined carefully to uncover ineffi ciencies.

For example, lab test menus continue to evolve and expand as testing technologies advance, challenging health systems to respond and adapt accordingly. A lab must have strategies in place for test menu optimization and utilization, as they are key drivers of lab effi ciency. Continual monitoring of lab tests ensures the right mix of local and reference testing.

Effi ciency must work in tandem with speed and accuracy. The right tests must be performed and run quickly, and the lab must provide accurate results.

ConclusionSo, how can we tell we’re improving on all fronts—speed, accu-racy, and effi ciency? Incorporating performance standards and benchmarks that gauge lab quality and service is an important starting point for measuring a lab’s effectiveness beyond the dollars. Then, understanding the cost stack will provide the greatest insight into opportunities and focus.

The lab is a critical hub of the patient care continuum, yet it is an aspect of the healthcare system that is often overlooked. By leveraging the best approaches to performance management, the lab can save health systems a signifi cant amount of money while accelerating lab performance to the highest standards of operational excellence. This is the best way to ensure the unity of speed, accuracy, and effi ciency—strengthening a key link in the chain of care that saves a health system money, while providing an immense benefi t to communities it serves.

MLO201605-MgmtMatters_FINAL.indd 34MLO201605-MgmtMatters_FINAL.indd 34 4/12/2016 12:11:00 PM4/12/2016 12:11:00 PM

novabiomedical.com

The New Definition of Simplicityfor Critical Care Testing

Introducing a new generation critical care blood gas analyzer that combines the revolutionary micro-electronics of the consumer world with Nova Biomedical’s innovative MicroSensor Card™ technology for a simpler, smaller, faster, and less expensive analyzer.

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MLO201605_AD Nova.indd 35MLO201605_AD Nova.indd 35 4/11/2016 1:44:29 PM4/11/2016 1:44:29 PM


FUTURE BUZZ A N T IBIOTIC S T E WA RDSHIP

What’s the buzz in antibiotic stewardship?

cian assistants, pharmacists, patients, and infectious disease professionals. Antibiotics are one of the most precious resources that we have in our medical arsenals and, as such, they must be treated with the utmost respect and diligence when prescribing.

—J. Hudson Garrett Jr., PhD, MSN, MPH, FNP-BC, PLNC,

VA-BC, IP-BC, CDONA, FACDONA, FAAPM

Vice President of Clinical Affairs

PDI, Inc.

Provider of Prevantics, a line of vascular

infection prevention solutions

Antibiotics continue to be powerful weapons to fi ght in-fection, but inappropriate use makes the treatment of microbial infections increasingly challenging. Success-

ful antibiotic stewardship can help mitigate the development of antimicrobial resistance and lead to better outcomes. Our

organization supports The Dec-laration by the Pharmaceutical, Biotechnology and Diagnostics Industries on Combating An-timicrobial Resistance, which was signed by 85 companies at the World Economic Forum in January 2016. It represents a commitment to invest in a range of innovative antibiotics, vac-cines, alternative technologies, and diagnostics for resistant infections.

We believe it will require a nationally coordinated effort among healthcare providers and partners to develop an effective antibiotic stewardship program. The lab will play a critical role, being uniquely positioned to provide data critical to bring key groups together, includ-ing patients, providers, policy makers, regulators, payers, and manufacturers.

Where do manufacturers fi t into this effort? One area is the development of state-of-the-art testing with high medical value. Some examples include procal-citonin, molecular markers of resistance, and rapid real-time polymerase chain reaction (PCR)

testing at the point of care that delivers highly accurate results for fl u, strep, respiratory syncytial virus (RSV), and more while the patient is still in the offi ce. Providing greater certainty about whether antibiotics are needed and, if they are, ensuring the right antibiotic is delivered will lead to more appropriate antibiotic use and potentially slow the development of antimicrobial resistance.

—Alan Wright, MD, MPHChief Medical Offi cer

Roche Diagnostics

Provider of the cobas Liat PCR System

for use at the point of care

One aspect of initiatives to aid antibiotic stewardship is to increase the development and use of rapid molecular diagnostic tests for identifying infections and also char-

acterizing the presence of any resistant bacteria. Within the area of sexually transmitted infections (STIs), Mycoplasma gen-italium (MG) can serve to illustrate the problems and promise of molecular diagnostic technology with regard to antibiotic resistance and stewardship.

MG is an STI that can cause symptoms including urethri-tis, cervicitis, and pelvic infl ammatory disease. It has been largely underreported due to the diffi culty of isolating and culturing the organism, as it can take months to do so. This means that molecular testing (qPCR, TMA) is the only practi-cal method of reliably identifying MG.

Identifi cation of the bacterium alone is no longer suffi cient to guide effective treatment due to increasing macrolide resistance. However, recent advances in multiplexed mo-lecular techniques are improving the sensitivity and selectivity of qPCR enough that detection of the organism can be peformed at the same time as detection of resistant mutations. There is now a multi-plexed qPCR test for MG that can target the fi ve mutations involved in azithromycin resistance in the 23S rRNA gene. Patients with de-tectable mutations at A2058 or A2059, who may fail azithromycin treatment, can be directed faster to a second-line treatment. Timely detection of antibiotic resistance will enable the development of better algorithms for the treatment of MG infection and promote responsible stewardship of antibiotics.

—Elisa Mokany, PhD

Vice President, Research and

Development

SpeeDx Pty Ltd.

Provider of the M. genitalium

ResistancePlus Kit

Antibiotic stewardship is one of the most critical compo-nents of reducing the inci-

dence of superbugs across the en-tire healthcare continuum of care. Given the signifi cant mortality and morbidity associated with antibiotic resistance, serious changes are necessary—most signifi cantly, collaboration and communication across the entire clinical care team. The Unit-ed States Centers for Disease Control and Prevention (CDC) has released new core elements of an antibiotic stewardship program that guide healthcare professionals and facilities in the proper steps to reduce resistance and improve antibiotic prescribing practices. Many antibiotics are also prescribed in outpatient settings, such as urgent/primary care, ambulato-ry surgery centers, and dental practices. The diversity of pre-scribers and healthcare settings requires collaboration across disciplines to include physicians, nurse practitioners, physi-

ANTIBIOTIC STEWARDSHIPIN YOUR FACILITY WILL

DECREASE INCREASE■ ANTIBIOTIC RESISTANCE

■ C. DIFFICILE INFECTIONS

■ COSTS

■ GOOD PATIENT OUTCOMES

PROMOTE ANTIBIOTIC BEST PRACTICES— A FIRST STEP IN ANTIBIOTIC STEWARDSHIP

■ ENSURE ALL ORDERS HAVE DOSE, DURATION, AND INDICATIONS

■ GET CULTURES BEFORE STARTING ANTIBIOTICS

■ TAKE AN “ANTIBIOTIC TIMEOUT” REASSESSING ANTIBIOTICS AFTER 48–72 HOURS

ANTIBIOTIC STEWARDSHIP PROGRAMS ARE A “WIN-WIN” FOR ALL INVOLVED

A UNIVERSITY OF MARYLAND STUDY SHOWED ONE ANTIBIOTIC STEWARDSHIP PROGRAM SAVED A TOTAL OF $17 MILLION OVER EIGHT YEARS

ANTIBIOTIC STEWARDSHIP HELPS IMPROVE PATIENT CARE AND SHORTEN

HOSPTIAL STAYS, THUS BENEFITING PATIENTS AS WELL AS HOSPITALS

Credit: CDC

MLO201605-FutureBuzz_MECH_AL.indd 36MLO201605-FutureBuzz_MECH_AL.indd 36 4/12/2016 9:28:29 AM4/12/2016 9:28:29 AM

CLINICAL SPOTLIGHTS


Deliver defi nitive CT/NG resultsThe cobas® CT/NG v2.0 Test

is the only third-generation

chlamydia/gonorrhea test

with dual targets for CT and

NG and an internal control,

providing high sensitivity

and specifi city for defi nitive

results.

Roche Diagnosticswww.rsleads.com/605ml-400

D-100™ cleared by FDA for Hemoglobin A1c testing

The D-100™ System is the future

of HbA1c testing. With innovative

solutions to maximize workfl ow

effi ciency, the D-100 System allows

high volume laboratories to quickly

and easily report HbA1c results

while also detecting hemoglobin

variants.

Bio-Rad Laboratorieswww.rsleads.com/605ml-404

Meet CLIA requirements with Randox Acusera

Supplied liquid ready-to-use in

varying levels the Acusera range

of linearity sets are designed to

chal lenge the inst rument ’s

complete reportable range while

remaining easy to use. Our

comprehensive analyte offering

covers cardiac markers, therapeutic drugs and specifi c

proteins for Roche and Beckman instruments.

Contact us: [email protected]

Randox Laboratories-US, Ltd.www.rsleads.com/605ml-401

Stat Profi le Prime® Critical Care Blood Gas Analyzer

Nova’s Stat Profi le Prime® features

ZERØ™ maintenance cartridges and

Mic roSensor t echno logy fo r

exceptional value in a critical care

whole blood analyzer. This design

optimizes the life of each cartridge;

improves uptime; and eliminates

waste, downtime, and higher costs of older

cartridgebased systems. The 10-test menu includes pH,

PCO2, PO2, Na, K, iCa, Cl, Glucose, and Lactate.

Nova Biomedicalwww.rsleads.com/605ml-405

Profi ciency Testing Results Automated with API DataDirect™!

DataDirect allows

you to upload

profi ciency results

from your LIS or

Middleware to

your online result

forms. It’s free, saves time, and eliminates clerical

errors!

American Profi ciency Institutewww.rsleads.com/605ml-402

Get POC Testing Results In Your EHRO r ch a r d ® Tr e l l i s ™

provides the optimal

means for electronic

connectivity to more

effectively manage your

POC testing. With today’s

healthcare challenges

surrounding effi ciency and accountability, Orchard

Trellis serves as a cost-effective bridge for electronically

passing orders and results between low volume, point-

of-care analyzers and your EHR.

Orchard Softwarewww.rsleads.com/605ml-406

BioFire Launches New Meningitis Panel for FilmArray

The FilmArray Meningitis/

Encephalitis (ME) Panel tests for

a comprehensive set of 14

bacteria, viruses and yeast,

identifying the most common

pathogens that cause infections

in the central nervous system

which in some cases can be life-

threatening.

BioFire Diagnosticswww.rsleads.com/605ml-403

1 HPV test, 3 screening optionsOffering HPV genotyping and three

results in one test, the cobas® HPV

Test is the only test approved by

the FDA and supported by three

major medical societies for

co-testing, ASC-US reflex and

primary screening.

Roche Diagnosticswww.rsleads.com/605ml-407

MLO201605-Spotlights.indd 37MLO201605-Spotlights.indd 37 4/11/2016 4:48:40 PM4/11/2016 4:48:40 PM


SPECIAL FEATURE Q A : REDUCING L AB ERRORS

Using laboratory analytics to manage quality assurance and reduce errors in the laboratoryBy Thomas Joseph, MBA, MT(ASCP), Tim Bickley, MBA, MT(ASCP), CPHIMS, and Kristina Ziagura, BA (Hons)

computerized physician order entry (CPOE), test formularies, ed-ucation, and audits. No one strategy is suffi cient, however, and an auditing capability plays a critical role. With the data from a real-time analytics system, laboratory managers will know the most important areas of unnecessary testing so rules can be developed for the EMR, providing soft stop guidance to physicians. A real-time analytics system also identifi es common categories of unnec-essary testing. These common categories range from screening/refl exing/normalcy, such as ordering an FT4 when the TSH is nor-mal, to redundant testing such as troponin and CKMBs ordered together, to excessive frequency of repeat testing (e.g., HbA1c should not be ordered more than once every 21 days). From this, laboratory management can identify benchmarks based on tests per inpatient admission, length of stay, and length of stay vs. tests per admission. Using this data and benchmarks, laboratories can develop strategies, and measures can be taken to limit obsolete tests, limit esoteric tests, and minimize bundles of tests.

Shifts and trends in analyzer resultsA laboratory analytics system can assist in reducing lab errors by providing a means to monitor Quality Control (QC) and assist in identifying shifts and trends in analyzer results. For example, analysis using either CVR (Coeffi cient of Variation Ratio) and SDI (Standard Deviation Index) or a standard analytical null hypothe-sis theory provides two different approaches to quickly determine if any instruments are reporting differently than others. An analyt-ics system’s QC system also supports laboratories implementing the CMS/CLIA prescribed Individualized Quality Control Plan (IQCP) based on CLSI EP23 guidelines. Best practices are identi-fi ed using sigma ratings of instruments for each analyte to deter-mine the appropriate number and frequency of QC samples to run. With real-time assessment of instrument performance, labo-ratories can know immediately if an instrument problem occurs and if their instruments are not reporting in line with other ana-lyzers. Access to this type of analytics ensures that QC practices are properly implemented so laboratories can avoid repeat testing, unnecessary follow-up testing, and misdiagnoses.

ConclusionWith data readily available, laboratory management can view all of their test results and not only identify errors but also retrace their root cause, delivering actionable information to monitor and improve QA processes. Subsequently, this improves the quality of laboratory measurements and enables management to verify that all processes are operating to set standards of performance. Daily management with a laboratory analytics system and an engaged leadership team are essential components in monitoring quality assurance and reducing lab errors. When laboratory data is man-aged daily, dramatic improvements can be made and errors can be eliminated, resulting in improved specimen quality, utilization, instrument/analyte performance, and patient safety.

Many laboratories today are still measuring their data manually, a time-consuming process easily subject to human error. Laboratory managers often struggle to

obtain timely metrics, as laboratory information systems pro-vide only limited management reports, and often the metrics received are a month old and thus of limited value in improv-ing quality and reducing errors. As a result, laboratories are in-creasingly turning to laboratory analytics/business intelligence as a solution to these challenges for their data mining needs. A laboratory analytics system, however, processes a wealth of laboratory data in seconds, not only ensuring that laboratory management has more time to focus on other tasks, but also providing the means for managers and supervisors to moni-tor and maintain higher standards of quality. Laboratory ana-lytics are proving to be a benefi cial tool in ensuring that large amounts of data can be analyzed and presented in meaningful reports that easily identify opportunities to catch and correct laboratory errors such as specimen defects, shifts in analyzer results, and inappropriate utilization of laboratory tests.

Specimen defects and reference range changesLaboratory business intelligence/analytics tools can assist in iden-tifying specimen defects, which is necessary to determine areas of improvement. Important specimen information can be captured, such as how many specimens are ranked Quantity Not Suffi cient (QNS), or the number of hemolyzed specimens, with detailed information such as who collected the specimen and where the specimen was collected. A hemolyzed or QNS specimen requires re-sticking a patient, and it can create a delay in result reporting.

With an effective laboratory analytics system in place, man-agers can easily view all specimens for hemolysis and QNS rates and take necessary corrective action. The laboratory busi-ness intelligence/analytics system provides insight into where a hemolyzed specimen came from, what clinic, which ward, and even the nurse or phlebotomist who drew the specimen. By performing hemolysis and QNS audits to identify patient locations and collection staff members with the highest num-ber and proportion of occurrences, laboratory management can take action to identify which staff members require retraining to improve quality. While it may not be possible to retrain ev-eryone for all quality problems, it is possible to identify where most QA issues originate, providing management with the insight to focus retraining for the greatest effect.

Defective test results can pose signifi cant fi nancial implica-tions to the health system when lab tests are misinterpreted and misused. An analytics system can generate a comparison of test results that allows lab management to see defi nitive analytic results to quickly answer questions about instrument perfor-mance over time. With data available daily, management can ensure that a performance problem never goes undetected and that quality managers and lab directors are kept aware of the source of laboratory problems.

Inappropriate test utilization The consequences of unnecessary testing for patient care can in-clude latrogenic anemia, time spent on insignifi cant abnormal results, incorrect diagnoses, and longer length of stay. Various strategies can be employed to reduce overutilization of test-ing, including requisition redesign, hard and soft stops in the

Thomas Joseph, MBA, MT(ASCP), serves as President

and CEO of Visiun, Inc., provider of the Performance

Insight lab analytics system. Tim Bickley, MBA, MT(ASCP), CPHIMS, serves as Director of Sales for

Visiun, Inc., and Kristina Ziagura, BA (Hons), serves as

Marketing Manager for Visiun, Inc.

MLO201605-SpecialFeature_MECH_AL.indd 38MLO201605-SpecialFeature_MECH_AL.indd 38 4/11/2016 8:53:49 AM4/11/2016 8:53:49 AM

HDL3 INTRODUCING

IMPROVE YOUR CARDIAC RISK PROFILE

Automated assay for the quantitative determination of HDL3 cholesterol in human serum or plasma

CARDIAC RISK PROFILE

The need for a more extensive

truly identify the risk of disease and as

such provide the necessary tools to

prevent and reduce the risks.

CLINICAL SIGNIFICANCE

molecule. Elevated levels of certain

WHAT IS HDL3-C?

[email protected]

randox.com/hdl3

+1 304 728 2890 Toll Free 866 4 RANDOX

MLO201605_AD Randox.indd 39MLO201605_AD Randox.indd 39 4/11/2016 9:07:26 AM4/11/2016 9:07:26 AM


DIA BE T ESPRODUCT FOCUS

Automated hemoglobin A1c analyzerEKF Diagnostics’ Quo-Test ana-

lyzer has been designed for

easy and reliable HbA1c mea-

surement for the monitoring

and management of diabetes

in point-of-care settings such

as diabetes clinics and doctors’

offi ces. The Quo-Test HbA1c is

a fully automated hemoglobin

A1c analyzer that uses pat-

ented boronate fl uorescence

quenching technology to mea-

sure glycated hemoglobin from a 4 μl sample taken from a fi n-

ger prick or venous whole blood. Sample results are available

within four minutes and are reported in IFCC and DCCT stan-

dard units. Quo-Test is unaffected by most hemoglobin variants.

EKF Diagnostics, www.rsleads.com/605ml-154

Rare blood control for glucose metersEurotrol’s CueSeeGlucose

is a real blood control for

validating precision and ac-

curacy of glucose meters.

Its real blood matrix makes

it highly commutable and

compatible with all glucose

devices with minimal ma-

trix effects. Low impreci-

sion makes it comparable

to human blood. The ACU-

Drop II packaging form is

a dual-chambered device keeping the fractions separated, pre-

venting reactions between components of the desired matrix.

Push a button to combine fractions, mix, and the sample is ready

to use from the built-in dropper bottle or by attaching a syringe.

Use for QC, calibration verifi cation, profi ciency testing, compe-

tency assessment, method validations, and lot comparisons.

Eurotrol, www.rsleads.com/605ml-155

Zinc autoantibody ELISA assay kit The KRONUS Zinc Transporter

8 Autoantibody (ZnT8Ab) ELISA

Assay Kit is for the semi-quan-

titative determination of auto-

antibodies to zinc transporter

8 (ZnT8) in human serum, and

may be useful as an aid in the

diagnosis of type 1 diabetes

mellitus (autoimmune medi-

ated diabetes). Autoantibodies

to ZnT8 (ZnT8Ab) have been

detected in approximately 60 percent to 80 percent of patients at

T1D onset and are more prevalent in children than in adults. Au-

toantibodies to ZnT8 have been found in T1D patients previously

classifi ed as autoantibody-negative, and when ZnT8Ab mea-

surement is combined with the measurement of GADAb, IA-2Ab

and IAA, the rate of detection of autoimmunity at diagnosis may

increase. KRONUS, www.rsleads.com/605ml-156

Automated in vitro test of albumin, creatineAlere Afi nion ACR is a fully automated

in vitro diagnostic test for quantitative

determination of albumin, creatinine,

and albumin/creatinine ratio (ACR) in

human urine. The measurements of

these ratios aid in early diagnosis of

nephropathy. The sample material is

collected using the sampling device in-

tegrated in the test cartridge. Albumin

is quantifi ed using a solid phase immunochemical assay. The

sample is automatically diluted and aspirated through a mem-

brane coated with anti-albumin antibodies, which concentrates

and immobilizes the albumin from the sample. A gold-antibody

conjugate then binds to the immobilized albumin, resulting in a

red-brown colored membrane. Excess gold-antibody conjugate

is removed in a washing step. Creatinine is quantifi ed using an

enzymatic colorimetric test that involves four enzymatic steps.

The test requires incubation with two distinct enzyme solutions.

A colored end product is measured in one of the cartridge wells.

The concentration of albumin, the concentration of creatinine,

and the calculated ACR are displayed on the Alere Afi nion AS100

Analyzer within six minutes. The AS100 Analyzer can also mea-

sure HbA1c in three minutes using the Alere’s CLIA-waived Afi n-

ion HbA1c assay. Alere, www.rsleads.com/605ml-151

Assayed quality control material AUDIT MicroControls Linear-

ity LQ Special Diabetes is

intended to simulate human

patient serum samples for

the purpose of determining

linearity, calibration verifi ca-

tion, and verifi cation of re-

portable range. It is a ready-

to-use liquid product, consisting of fi ve levels that demonstrate

a linear relationship to each other when assayed for C-peptide,

fructosamine, and insulin. This product has an open vial stability

of 7 days when stored at 2-8°C. It also provides Auditor QC, a

free on-line, real time data reduction program that offers Levey-

Jennings charts and peer group analysis for daily quality con-

trol product users, as well as linearity graphs and peer group

analysis. Report results are given immediately in an “inspector

friendly format” and stored on the Auditor QC website for future

reference. AUDIT MicroControls, www.rsleads.com/605ml-152

Hemoglobin A1c testing systemBio-Rad’s D-100 Hemoglobin A1c testing sys-

tem is a combination of high-performance

liquid chromatography (HPLC) technology

and innovative solutions to maximize work-

fl ow effi ciency for laboratories that demand

an accurate HbA1c result rapidly and effort-

lessly. The D-100 is fully automated and de-

signed to meet the needs of medium- and

high-volume clinical laboratories, for greater

throughput, high quality results, and sim-

plifi ed workfl ow for A1c testing. The system delivers rapid re-

sults without sacrifi cing the ability to detect hemoglobin vari-

ants, which can interfere with interpretation of test results.

BioRad, www.rsleads.com/605ml-153


MLO201605-ProductFocus_MECH_AL.indd 40MLO201605-ProductFocus_MECH_AL.indd 40 4/12/2016 9:30:21 AM4/12/2016 9:30:21 AM

...what, exactly,are you measuring?

200 40 60 80 100 120 140 160 180 200 220 240 260 280 300

HbA0

Other HbAHbA1c HbA2

The Next Generation HbA1cIf your HbA1c result does not look

as Clear-Cut and Precise as this one...

For fast, accurate, and automated HbA1c results contact Sebia at [email protected]

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DIA BE T ESPRODUCT FOCUS

INDEX OF ADVERTISERS

This index is provided as a service. The publisher does not assume liability for errors or omissions.

ADVERTISER WEB PAGE ADVERTISER WEB PAGE

Automated adiponectin assayBody Mass Index (BMI) has been used

to measure health for years; however,

debates surrounding its accuracy high-

light that muscle, age, gender, or fi tness

are not accounted for. Patients with a

“healthy” BMI could still be at risk of

developing heart diseases, cancers,

and type 2 diabetes mellitus (T2DM).

Research suggests that abdominal visceral fat (AVF) has a stron-

ger link to these chronic diseases, perhaps even predicting

T2DM. The analyte adiponectin is inversely correlated with AVF,

and allows a more accurate measurement of risk. The Randox

automated adiponectin assay can be used on most biochemistry

analyzers. Randox, www.rsleads.com/605ml-157

HbA1c control Streck’s A1c-Cellular is an HbA1c control with intact

red blood cells. It tests the entire HbA1c procedure,

including the lysing of the red blood cells—a step

omitted with other controls. This important step

ensures the instrument, reagents, and technolo-

gist’s process are accurate. A1c-Cellular is ready-

to-use; it reduces prep time with no reconstitution

and no thawing required. It is appropriate for im-

munoassay and ionic exchange HPLC method-

ologies and assayed for popular chemistry instru-

ments. It is available in plastic cap-pierceable vials

which allow for autosampling by an analyzer. A1c-

Cellular has 180-day closed-vial stability and 30-day open-vial

stability. Streck, www.rsleads.com/605ml-158

HPLC analyzerThe Tosoh G8 (Tosoh Automated Gly-

cohemoglobin Analyzer HLC-723G8) is

an FDA-cleared HPLC analyzer to aid in

diagnosis of diabetes and identify pa-

tients who may be at risk for develop-

ing diabetes. HPLC methodology allows

for the visual identifi cation of hemoglo-

binopathies that can interfere with the

HbA1c result. NGSP-Certifi ed, the Tosoh

G8 has demonstrated high pass rates

and CVs of less than two percent in profi ciency tests.

Tosoh, www.rsleads.com/605ml-159


American Profi ciency Institute .........................www.api-pt.com ...................................................................3

Bio-Rad Laboratories ..........................................www.bio-rad.com/diabetes .............................................43

BioFire Diagnostics ..............................................BioFireDX.com ....................................................................25

Cepheid ...................................................................www.diagnosticsfi rst.com .............................................IFC

CHEMBIO Diagnostics Systems Inc ................www.chembio.com ............................................................21

CLSI, Clinical Laboratory Standards Institute ..www.clsi.org........................................................................27

Eppendorf ...............................................................www.eppendorf.com ...........................................................1

Hologic, Women’s Health ...................................PapPlusHPV.com ................................................................13

Hologic-HIV ............................................................USAptimaVirology.com .......................................................5

ITL Biomedical.......................................................itlbiomedical.com/scu .......................................................11

Kamiya Biomedical Co. .......................................www.k-assay.com/MLO.php ........................................IBC

Nova Biomedical ..................................................novabiomedical.com .........................................................35

NovoPath Inc. ........................................................www.novopath.com ..........................................................15

Orchard Software .................................................www.orchardsoft.com ......................................................23

Quantimetrix Corp.................................................quantimetrix.com ................................................................19

Randox Laboratories ...........................................www.randox.com/hdl3 ......................................................39

Roche Diagnostics ...............................................www.usdiagnostics.roche.com ......................................29

Roche Diagnostics ...............................................www.usdiagnostics.roche.com ........................................7

Roche Tissue Diagnostics .......................................www.ventana.com .............................................................17

Sebia Inc .................................................................www.sebia-usa.com .........................................................41

Sigma-Aldrich........................................................sigma-aldrich.com/clinical .............................................BC

Thermo Scientifi c - Clinical Diagnostics .........www.thermoscientifi c.com .............................................33

Verbatim Americas LLC .......................................www.pathfast.com .............................................................24

Vista Technology Inc ...........................................www.vistatechnology.com ..............................................10

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By A lan Lenhof f, Edi torEXECUTIVE SNAPSHOT

How would you characterize Luminex Corporation’s primary areas of exper-tise? Luminex Corporation develops, manufactures, and markets proprietary biological testing technologies, with appli-cations throughout the life sciences indus-try. Our mission is to empower companies and laboratories to deliver reliable, timely, and actionable answers, and help provid-ers identify and treat diseases effectively, thereby advancing healthcare.

What are the major categories of so-lutions that Luminex provides for its customers? As a pioneer in multiplexing, our xMAP Technology has been used by customers since 1999 across a wide range

HOMI SHAMIR

President and CEO

Luminex Corporation

ProfessionalI joined Luminex Corporation in October

2014. Previously, I served as President and

CEO of Given Imaging from 2006 to 2014.

Prior to that, I was the Corporate Vice Presi-

dent at Eastman Kodak Company and Presi-

dent of Eastman Kodak´s Transaction and

Industrial Solutions Group. I served for more

than 10 years at Scitex Corporation, including

as its President and CEO from 2003 to 2004.

EducationI hold a Bachelor of Science from Hebrew

University of Jerusalem and a Masters

of Public Administration from Harvard

University.

PersonalMy responsibilities allow me to travel all over

the world, so I spend a lot of time visiting

employees, customers, and partners. When

I am able to take a little time off, I mostly

enjoy relaxing and spending time with my

family. We’ve lived in Hong Kong, Singa-

pore, and now the United States, so we have

developed a wide variety of cultural interests.

of applications and markets. In fact, xMAP technology-based systems are already in use by leading research laboratories as well as major pharmaceutical, diagnostic, and biotechnology companies. We continue to provide solutions for both clinical diagnos-tics and research markets with application areas such as infectious diseases, genetics, genomics, and proteomics research.

The company is well-known for its infectious disease multiplex panels, including the recently FDA-cleared NxTAG Respiratory Pathogen Panel. How can this product enhance the of-ferings of clinical labs? Many common-ly encountered respiratory pathogens are diffi cult to diagnose based on symptoms alone, as they have similar clinical presen-tation. This presents a problem since clini-cians need to be able to accurately identify an illness in a patient in order to effectively defi ne treatment and control the spread of infection.

The NxTAG Respiratory Pathogen Panel enables laboratories to easily and simulta-neously detect 20 respiratory pathogens in a single closed tube system, including the atypical bacteria Chlamydophila pneumoniae and Mycoplasma pneumoniae. The panel re-quires only minutes of hands-on time with no upstream reagent preparation, and has a simplifi ed workfl ow that allows ex-tracted samples to be added directly to pre-plated, lyophilized reagents. The closed tube format easily scales to accommodate changes in throughput needed to respond to seasonal changes in demand, especially during fl u season.

With advantages such as rapid time to results and target masking for panel customization, the NxTAG Respiratory Pathogen Panel offers clear benefi ts.

ARIES System and ARIES HSV 1&2 Assay were also approved by the FDA last year. What are their key features? There has never been more pressure on clinical laboratories to increase effi ciency while improving the overall quality of pa-tient care through the delivery of accurate and timely data. The ARIES platform was designed to streamline workfl ow and raise the performance bar for all laboratory pro-fessionals, no matter how big or small the setting.

The ARIES System is a sample-to-answer molecular diagnostic system de-signed to increase laboratory effi ciency, ensure results accuracy, and fi t seamlessly into today’s lean laboratory environ-ment. In order to minimize errors, it uses

Multiplex testing for infectious disease enables prompt diagnosis and therapy

internal barcode scanning and other ad-vanced features. Two independent mod-ules each support from one to six cassettes, allowing for both STAT and batch testing. Both IVD and MultiCode Analyte Specifi c Reagents can be run simultaneously with a common Universal Assay Protocol.

Luminex supplies molecular reagents for a number of assays. How do you serve the clinical lab through that segment of your business? Luminex distributes reagents and instruments to exclusive partners spanning a wide range of industries and specialties, including clinical diagnostics. These partners add value to our technology, create powerful, customizable kits, and deliver service and support. They also offer the industry, mar-ket, and application expertise necessary to respond to customer needs quickly and effectively.

What are your chief functions as lead-er of a rapidly expanding biotechnol-ogy company? What impact have you had on Luminex since you became president and CEO in October 2014? How has it impacted you? I believe the main priorities of a CEO differ depending on the company’s stage of development. I joined Luminex at a time when its general business model had been established, had more than $200 million in revenue, and was profi table—yet the company’s domi-nance in multiplex testing technology had waned over the last few years. Therefore, my main focus has been getting Luminex back to that leadership role; making smart resource allocation decisions that prioritize projects to get us back in the role of “indus-try innovator” and that enable us to regain leadership in the markets we address.

Now in my third position as President and CEO of a publicly traded company, I have learned over the years that my job is like being a conductor of an orches-tra. A good conductor will set the tempo, unify performers, and ultimately shape the sound of the ensemble. He or she will know how to get the best out of each in-strument, and ensure that each one is syn-chronized with the rest of the orchestra. Take the violin, for example; it’s my role to ensure that the strength of the violin is harmonized with the rest of the ensemble. Conductors and leaders inspire the high-est possible performance from the groups that they lead. I strive to continue to bring out the best in my team to ensure the best results for our customers, employees, and investors.

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