oCtoBeR 2010 - American Association for Clinical Chemistry

news brief 

IVD Market Set For 

ContInueD Growth 

A new report released by Boston 

Biomedical Consultants, Inc. (BBC) 

at the AACC Annual Meeting in July 

found that the in vitro diagnostics 

market (IVD) grew by 6% from 2008 

to 2009, putting the total worldwide 

market at $42 billion. The consulting 

group predicts continued steady 

growth for the industry over the next 

several years, especially from emerging 

areas of the world. 

In the report, “Worldwide In Vitro 

Diagnostics Tests, Products, Industry 

Update and Review,” analysts at BBC 

projected a 5% compound annual 

growth rate for the IVD market over 

the next 4 years to $54.5 billion. 

Growth estimates ranged from a low 

of +1% for diabetes diagnostics to a 

high of +11% for the emerging/other/ 

novel IVD test category. Growth for 

other major IVD segments included: 

immune disease (+4%), hematology 

and coagulation (+5%), immunoassay 

(+8%), clinical chemistry (+3%), and 

infectious disease (+9%). 

Overall, laboratory testing constitutes 

the largest end-user segment of 

the total IVD market. Currently this 

segment stands at 75% of the $42 

billion market, followed by patient self 

testing (20%), and ambulatory (5%). 

“New technologies have enabled a 

better understanding of critical disease 

processes, resulting in new markers 

useful in the diagnosis, treatment, and 

monitoring of diseases affecting the 

world’s aging populations, including 

heart disease, cancer, and diabetes, 

all of which is driving the diagnostic 

testing demand,” said David O’Bryan, 

chief executive officer and president of 

BBC. “Test unit growth is also increasing 

everywhere.” O’Bryan also points 

to the spread of automation as a driver 

of market growth. 

The health of the IVD industry was 

reflected in the attendance at this year’s 

AACC Annual Meeting and Clinical 

Lab Expo, the largest ever with more 

than 21,000 attendees, a 17 % increase 

over 2009. 

nonprofit org. 

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greenfield, oH 

permit no. 436 

2 0 1 0 a a C C a n n u a l M e e t i n G H i G H l i G H t s 

snapshoT 

Worldwide Revenue by End-User 

Ambulatory 

Ambulatory 

5% 

5% 

Laboratory 

75% 

PST* 

20% 

Laboratory 

76% 

PST* 

18% 

2009 

2014 

$42 billion 

$54.5 billion 

*Patient Self Testing 

Source: Boston Biomedical Consultants, Inc. 

Clinical 

Laboratory 

News 

The Transformation 

of Medicine 

Labs Key to New Paradigms 

By Genna Rollins 

Tackling an emotionally, financially, and physically 

draining disease poised to exact a huge toll on society 

in the coming decade. Harnessing the power of the 

most sophisticated biological, analytical, and mathematical 

constructs to understand wellness and disease 

parameters for individual patients. Using cutting-edge molecular 

science to reprogram cells and bring personalized and regenerative 

medicine closer to reality. These were the visionary concepts put 

forward by plenary speakers at the 2010 AACC Annual Meeting, 

held July 25-29 in Anaheim, Calif. The three speakers, Leroy Hood, 

MD, PhD, James Thomson, VMD, PhD, and John Trojanowski, 

MD, PhD, projected a future in which laboratory medicine will 

play a vital role in transforming healthcare and improving patient 

outcomes. 

“You’d have to be very narrow and prejudiced indeed to say that 

the complete human genome sequences of patients aren’t going to 

provide transformational opportunities, both for prediction and 

prevention,” Hood observed. “Diagnostics are going to be key.” 

A New Paradigm of Healthcare 

What do you get when you toss together a systems approach to biology, emerging nanotechnology, and powerful 

computational tools? In Hood’s view, these are the key ingredients of what he calls P4 medicine, a new 

See future of medicine, continued on page 3 

The Future of Lab Leadership 

What Will it Take to Navigate the Changes Ahead? 

By Bill Malone 

everyone working in clinical labs today knows that the field faces a huge challenge as the baby boom 

generation starts to retire in growing numbers. However, what is less obvious about coming changes 

in laboratory practice may have just as great of an impact. Demands on laboratorians from inside 

and outside the lab are forging a new kind of workforce in an atmosphere of intense pressures from 

an economic recession, shifting business models, and stepped-up scrutiny from regulators. Added to 

these strains, upcoming generations of laboratorians in the lab are bringing new expectations of what work is all 

about, an especially stressful environment considering that this is the first time that four distinct generations of 

laboratorians are in the workforce at the same time. 

At a symposium at the 2010 AACC Annual Meeting in Anaheim, Calif., three lab leaders took the podium 

to make the case that all of these challenges make effective leadership more important—and more rewarding— 

than ever. Titled “Leadership Skills for the Laboratory Professional: 

Generational Differences, Leadership Styles, Conflict Resolution, and 

Change Management,” the seminar engaged a packed room of attendees 

with ideas about how current and future generations of lab leaders 

will be able to plot a course through a dynamic and uncertain era in 

healthcare. Speakers included moderator Carmen Wiley, PhD, Brad 

Karon, MD, PhD, and James Hernandez, MD. 

Leaders who can’t cope with these changes risk not only their personal 

success but the ability of their labs to fulfill their mission in health- 

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care, according to Hernandez. “We’re moving essentially from a cottage 

industry in all of healthcare, and particularly labs, to what is really a 

See lab leadership, continued on page 6 

The auThoriTaTive 

source for The 

clinical laboraTorian 

ocTober 2010 

volume 36, number 10 

www.aacc.org 

in This issue 

8 

Lab 2010 

Detecting Autoantibodies 

in Type 1 Diabetes 

Patient Safety Focus 

12 Interview 

—Specimen Processing 

What Lab Directors Can 

13 Learn from Baseball 

Ask the Expert 14 —Incident Reports 

Patient Safety Concepts 

—Hindsight Bias 

15 

17 

20 

21 

22 

23 

Clinical Lab Expo 

Highlights 

Regulatory Profiles 

Industry Profiles 

Diagnostic Profiles 

News from the FDA

The right diagnosis 

affects more than just treatment. 

Am I okay? What do I do? Dealing with uncertainty stops life in its tracks. When doctors and 

patients know more, they can make better choices sooner and plan next steps. Those decisions 

hinge on reliable lab results. Ortho Clinical Diagnostics supports your goals for improving patient 

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The science of knowing shapes the art of living. 

www.orthoclinical.com All trademarks are the property of Ortho-Clinical Diagnostics, Inc. © Ortho-Clinical Diagnostics, Inc. 2008-2010 CL11250

P4 Medicine on the Horizon 

future of medicine, continued from page 1 

paradigm that incorporates analysis of vast 

data inputs to consider the complexity of 

biological systems and their responses to 

wellness and disease, in aggregate and for 

individual patients. “Medicine has become 

an informational science, and my view of 

medicine is one that is information-based 

and data-driven,” he explained. “In the future, 

each patient will be surrounded by a 

virtual cloud of billions of data points and 

the question will be, how can we use that 

complexity to find parameters for wellness 

that are unique to each individual?” Hood 

is co-founder of the Institute for Systems 

Biology (ISB), a research institute dedicated 

to the integration of technology, computation, 

biology, and medicine. 

Hood believes the P4 approach—predictive, 

personalized, preventive and participatory 

medicine—will drive the health- 

care system in the 21st Century, and he sees 

it as nothing short of revolutionary. “Many 

people don’t understand technology, but 

it’s what drives all of science. That’s why 

the advance of science is often thought of 

as being terribly incremental—and that’s 

true when technology isn’t changing too 

rapidly. But today it’s changing enormously 

quickly. We’re seeing exponentially higher 

throughput, more accurate data, and costs 

being driven down,” he explained. 

A Mere Drop of Blood 

Hood envisions that within 10 years, most 

everyone will have had a complete genomics 

analysis run at a reasonable cost. This 

information will enable a data mining of 

sorts that will provide a clear picture of 

health and disease for each individual, effectively 

shifting the focus of medicine 

from disease to wellness. On top of that, he 

sees a time when biannually, patients will 

provide a one-drop blood sample from 

which about 2,500 protein measurements 

will be taken, and these also will be used to 

assess health as opposed to disease for 50 

major organ systems. 

If this seems pretty far removed from 

today, Hood pointed to several projects 

ISB has underway that are planting seeds 

to achieve the P4 medicine model. Scientists 

at ISB recently completed an entire 

genome sequence for a family of four. This 

effort identified 230,000 new rare variants 

within the family and enabled investigators 

to create a precise recombinant map. “That 

gave us exactly the haplotypes of the parental 

chromosomal regions that conjoin 

together to make up the chromosomes of 

the children,” he explained. “What was fascinating 

is that about 70 percent of these 

recombinations fell in hotspots of recombination, 

and that has important implications 

for genetics.” 

ISB researchers also have been studying 

prion disease in mice, analyzing its behavior 

as a network from a state of wellness 

through neuronal degeneration. The first 

set of analyses involved nearly 50 million 

data points. “This required creation of 

entirely new computational and integrative 

methods for dealing with a significant 

amount of data,” said Hood. The researchers 

also employed subtractive biological 

analyses to address “absolutely overwhelming” 

signal-to-noise problems. Hood believes 

this type of analysis can help investigators 

understand how biological networks 

become perturbed, and to eventually develop 

interventions to modify disease progression 

in humans. 

In addition, ISB scientists have a goal to 

create within the next few years mass spectrometry 

assays for about 20,000 human 

proteins. Already they have developed such 

assays for 97% of yeast proteins, according 

to Hood. 

Overcoming the Skeptics 

ISB is beginning to tie the themes of its 

work together in a pilot project with Ohio 

State University Medical Center. “With 

lung cancer we plan to develop very early 

diagnostic markers and be able to stratify 

patients into different types so we can 

match them with appropriate drugs,” 

Hood explained. “In wellness, we hope to 

develop molecular and cellular parameters 

for evaluating each individual’s wellness 

status and use that to optimize behaviors to 

achieve greater wellness.” 

This effort will be essential to moving 

the P4 medicine paradigm forward, according 

to Hood. “Scientists are trained to 

be inherently skeptical, cynical, and conservative, 

and they don’t feel comfortable with 

new ideas, so you just have to overwhelm 

leroy hood, md, phd, says the emergence of p4 medicine will revolutionize 

the healthcare system in the 21st century. 

James Thomson, vmd, phd, presented his research on human-produced 

pluripotent stem cells and potential medical applications. 

them with success,” he observed. 

As P4 medicine gains ground—an 

eventuality about which Hood is utterly 

confident—it will transform the entire 

healthcare landscape. “This will force every 

sector of healthcare to rewrite business 

plans in major ways,” he predicts. Laboratories 

will be part of this sweeping change. 

“My own feeling is that specialty diagnostic 

companies will emerge that have finetuned 

technologies that enable us to do 

what can’t be done today. There’ll be real 

opportunity for economic advances for 

these new companies,” said Hood. 

Stem Cell Therapy Coming of Age 

Pioneering stem cell researcher Thomson 

gave a compelling presentation about developments 

in and the promise of stem 

cell research in transforming medicine. 

The first scientist to isolate and culture 

an embryonic stem (ES) cell line in 1998, 

Thomson is the John D. MacArthur professor 

and director of regenerative biology at 

the Morgridge Institute for Research at the 

University of Wisconsin. 

In 2007, his lab made history again by 

deriving eight new cell lines from human 

skin cells aided by four transcription factors. 

Like ES cells, these induced pluripotent 

stem (iPS) cells are capable of differentiating 

into any of the 220 cell types in the 

human body and proliferating indefinitely. 

However, they do not carry the same ethical, 

legal, or political controversies that surround 

ES cells. 

A Profound Change 

The remarkable achievement of creating 

ES and iPS cell lines will open wide the 

doors of scientific discovery in ways that 

can’t even be foreseen right now, Thomson 

predicted. A comparable situation existed 

with the advent of recombinant DNA research 

in the 1970s. “Everyone knew that 

DNA was really important, but no one 

got the details right. We thought gene 

therapy was going to be easy, and we’re 30 

to 40 years into it now and there’s no gene 

therapy to speak of. It profoundly changed 

everything, but the specifics were not accurate,” 

he observed. 

Thomson also suggested that the breakthroughs 

made by his and other labs would 

pick up the pace of discovery in the field. 

“A relatively small number of genes allowed 

us to do this, and it’s clear the work 

has implications beyond making the functional 

equivalent of human embryonic 

stem cells,” he indicated. “My sense is that 

things are going to move forward even 

faster now.” 

Many Challenges Ahead 

Even as the field advances rapidly, Thomson 

cautioned that a number of challenges 

still need to be worked out for both ES and 

iPS cell-based transplantation therapy. For 

example, researchers need to be able to reliably 

make the type of cells of interest, such 

as neurons or hematopoietic cells. Concerns 

exist as well about whether stem cells 

introduced into a patient’s body can provoke 

an immune rejection response. 

In 2009, Thomson’s lab tackled a key 

safety concern associated with viral vectors, 

the method he used initially to deliver 

genes into skin cells in order to make iPS 

cells. The concern was that iPS cells created 

by this approach carried residual genetic 

material that could have triggered 

mutations in the induced cells. However, 

Thomson successfully used plasmids to 

introduce genetic material into the target 

cells. These circles of DNA that can replicate, 

but lack the complexity and efficiency 

of chromosomal DNA, can be engineered 

to introduce genetic material into cells and 

then be subsequently eliminated, thereby 

creating a line of iPS cells free of exotic genetic 

material. “We believe this was the first 

time human-induced pluripotent stem 

cells have been created that are completely 

free of vector and transgene sequences,” 

said Thomson. “It’s another important step 

along the way toward developing cells in 

sufficient quantity and quality to explore 

the possibility of human therapeutic use.” 

Edging Towards Everyday Use 

As Thomson’s lab continues its groundbreaking 

work, he looks forward to the 

practical application of stem cell therapy in 

areas such as drug discovery and regenerative 

medicine. The hope is that stem cells 

can improve the drug development process 

by helping researchers identify candidate 

compounds that are likely to be effective 

in specific patients. “If you already know 

See future of medicine, continued on page 4 

CliniCal laboratory news oCtoBeR 2010 3

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Laboratory 

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McMaster University Medical Center 

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Siemens Healthcare Diagnostics, Newark, Del. 

Mary Kimberly, PhD 

CDC, Atlanta, Ga. 

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Mayo Clinic, Rochester, Minn. 

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Complex Problems Require Teamwork 

future of medicine, continued from page 3 

what population responds in a certain way 

to a drug, you can tailor it better to different 

populations. It’s not easy to manufacture 

drugs in a way that’s tailored to particular 

parts of the market. This will allow that to 

be done in the future,” Thomson explained. 

Already, several promising treatments 

based on stem cell therapy have been announced, 

and at least two received Food 

and Drug Administration (FDA) approval. 

For instance, in July, FDA approved the 

first-ever clinical trial in humans for an ES 

cell-based therapy that has worked in mice. 

This therapy, based on one of the cell lines 

Thomson developed in the 1998, will be 

used to treat patients paralyzed because of 

severe spinal cord injuries. 

These developments are but the start of 

many exciting and groundbreaking discoveries 

ahead, according to Thomson. Stem 

cell therapy “is a very powerful, pervasive, 

enabling research tool and where creative 

people will take that, I have no idea. But I 

would be shocked if these cells aren’t found 

to be important 10 to 20 years from now,” 

he said. 

Unlocking the Mystery 

of Alzheimer’s Disease 

Trojanowski, recipient of AACC’s 2010 

Wallace H. Coulter Lectureship Award, 

painted an exciting and optimistic portrait 

of future diagnostics and treatments for 

Alzheimer’s disease, which some consider 

the disease of the 21st Century owing to the 

fact that people are living longer than ever 

before. “We’re in the midst of a longevity 

revolution. There’s been a nearly doubling 

of life expectancy over the past century,” he 

explained. “From the time Dr. Alzheimer 

made his initial presentation about the disease 

in 1906, people thought it was an odd 

disorder and certainly didn’t appreciate 

that it would become epidemic 100 years 

later.” 

The ‘silver tsunami’ of baby boomers 

who will start turning age 65 in 2011 will 

escalate the incidence of the already prevalent 

neurodegenerative disorder. An estimated 

13 million people in the U.S. will 

have Alzheimer’s disease by 2025, up from 

about 5 million today. However, treatments 

that would slow the disease by even 5 years 

would decrease both the prevalence of and 

costs associated with the condition by about 

50% by 2050, according to Trojanowski. He 

is co-director of the Center for Neurodegenerative 

Disease Research and William 

Maul Measey-Truman G. Schnabel, Jr. MD 

professor of geriatric medicine and gerontology 

at the University of Pennsylvania in 

Philadelphia. 

Slowing down the disease is what researchers 

are striving for, and after years 

of investigation, Trojanowski finally believes 

it’s about to happen. “When I first 

started working on Alzheimer’s disease in 

the 1980s, I thought it would be 100 years 

after I was dead that people would be having 

conversations about the tremendous 

research focused on the disease, but the 

advances of science have been spectacular 

in the last 30 years,” he said. “We’re within 

striking distance of having biomarkers that 

can ‘go live’ in clinics, and within striking 

distance of having disease-modifying 

therapies.” 

A Landmark Investigation 

Trojanowski’s lab has been on the forefront 

of Alzheimer’s-related research, and is the 

biomarker core lab for the Alzheimer’s 

Disease Neuroimaging Initiative (ADNI), 

a landmark, 6-year, $67 million clinical 

trial aimed at studying changes in cogni- 

tion, brain structure and function, and biomarkers 

in elderly controls, subjects with 

mild cognitive impairment, and subjects 

with Alzheimer’s disease. Although the first 

phase of ADNI just concluded in September, 

the trial already has made significant 

contributions to the field. In Trojanowski’s 

view, one of the most notable has been 

standardization of procedures and analytics 

involving collection and processing of 

cerebrospinal fluid. “There had been a lot 

of informative work done in the past, but it 

was hard to see how the data could be used 

clinically, because people had been using 

different collection procedures, reagents, 

and assays. ADNI has achieved standardization 

of all things necessary to have reliable 

biomarkers,” he explained. 

ADNI researchers also published results 

in August reporting the presence of an Alzheimer’s 

disease biomarker signature of 

β-amyloid protein 1–42, total tau protein, 

and phosphorylated tau181P in 90% of Alzheimer’s 

disease patients, three-quarters 

of those with mild cognitive impairment, 

and one-third of normal controls (Arch 

Neurol 2010;67:949–56). In patients with 

mild cognitive impairment followed for 5 

years, the signature also showed a sensitivity 

of 100% in patients who progressed to 

Alzheimer’s. “We now know that Alzheimer’s 

is probably present in the brain about 

10 years before evidence of impairment, 

and we can see the signal of biomarkers 

in people who are cognitively normal but 

have that pathological profile. It makes us 

think they’ll convert to Alzheimer’s over 

time,” said Trojanowski. 

ADNI also lead to a world-wide network 

of Alzheimer’s disease-related clinical 

trials, and in one of the first such arrangements, 

data from the trial are being posted 

and regularly updated on a publicly accessible 

website available to researchers world- 

wide. ADNI organizers expect the open 

data policy will speed additional Alzheimer’s-related 

research. 

A Minor Setback 

Although right now there’s little physicians 

can offer patients who have the Alzheimer’s 

disease biomarker signature, Trojanowski 

sees only blue skies for the development of 

treatments. He even is undaunted by the recent 

failure of a highly anticipated drug trial. 

“We’re within striking distance of having biomarkers that can ‘go live’ in 

clinics, and within striking distance of having disease-modifying therapies,” 

said John Trojanowski, md, phd. 

In August, Eli Lily & Company halted study 

of semagacestat after it became evident that 

the drug not only did not slow progression 

of the disease, but was associated with 

worsening cognition. With more than $1 

billion invested in at least 100 clinical trials, 

Trojanowski anticipates that sooner or later 

there will be a successful candidate therapy. 

The first drug that shows even modest benefits 

over symptomatic treatment will shift 

the focus towards finding treatments that 

will have a more significant therapeutic effect 

earlier in the disease process. 

All of this has important implications 

for labs, according to Trojanowski. “The 

public demand is there, and people will line 

up for lumbar punctures so they’ll know if 

they take the drug it will help them. Prepare 

now for long lines at a lab in your neighborhood,” 

he joked. 

Science as a Team Sport 

Treatment or even prevention of Alzheimer’s 

disease in our time. Successful 

use of iPS cells in regenerative medicine, 

drug discovery, and other applications not 

envisioned today. A new paradigm that 

harnesses powerful computational and 

analytic tools to provide completely personalized, 

wellness-focused medicine. On 

the surface, these visions, although equally 

ambitious, complex and compelling, have 

little in common. However, they share the 

philosophy that breakthrough science is a 

team undertaking. 

“The same thing that’s been happening 

in my lab is the same thing that’s happening 

in science as a whole,” said Thomson. “The 

problems we are addressing have become 

so complex that we have to collaborate, 

we have to reach out to other disciplines, 

and bring engineering and computational 

biology together if we want to solve these 

greater problems.” CLN

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Four Generations Rub Shoulders in Labs 

lab leadership, continued from page 1 

medical-industrial complex. And whether 

we like it or not, we are going to be practicing 

in a more complex, interdependent environment 

and it’s going to put pressure on 

lab directors and other supervisors to boost 

their leadership abilities,” he predicted. “A 

system is only as strong as its weakest link, 

so if someone in the lab is stressed and not 

attentive, or for whatever reason not a part of 

the team, that creates a very dangerous situation 

and could compromise patient safety.” 

Hernandez is assistant professor of laboratory 

medicine and pathology at Mayo Clinic 

College of Medicine, and medical director of 

laboratories and chair of laboratory medicine 

at Mayo Clinic in Scottsdale, Arizona. 


New Generations, New Challenges 

In addition to the forces outside the walls 

of the lab pushing change, Wiley emphasized 

that understanding each of the four 

generations present in today’s lab is essential 

to building strong teams and healthy 

communication. Each of the generations 

has its own distinct worldview that helps 

determine their business focus, motivation, 

loyalties, and values (See Figure, right). She 

defined the generations as traditionalists 

(1922–1945), baby boomers (1946–1964), 

Xers (1965–1977), and millennials (1978– 

2003). “We need to understand what motivates 

each generation of workers in the 

lab and how to retain great employees from 

all generations,” she said. Wiley is director 

of chemistry and immunology at Sacred 

Heart Medical Center and PAML reference 

laboratory in Spokane, Wash. 

Although understanding each of these 

generations in a lab is far from hard science, 

Wiley underscored the fact that leaders with 

poor people skills will find that their technical 

knowledge is not enough to get them 

through in today’s clinical labs. “I would 

argue that we all have to know the hard science, 

but a lab is not a robot,” she said. “A lab 

is made up of a system of individuals, and 

we need to be able to make our employees 

feel valued and enjoy the work that they’re 

doing. They can’t do that, in my opinion, 

without leaders that understand them.” 

Currently, most managers are baby 

boomers, which in many cases can put 

them out of sync with the values of Xers 

and millenials who are working for them. 

This can lead to managers perceiving their 

younger employees as having a poor work 

ethic, less commitment to their jobs, or less 

respect for their employer than they actually 

do, Wiley explained. One such conflict 

is work hours. Boomers tend to emphasize 

longer hours, while Xers emphasize 

productivity. “A lot of boomers have really 

dedicated themselves to their jobs and really 

take pride in putting in very long hours. 

But today, they’re working with other generations 

who are more interested in being 

very efficient and highly productive while 

they’re at work, but don’t see the value in 

being the first person at work and the last 

person to go home,” she said. This effect 

goes both ways, however, and younger 

workers need to understand where their 

managers are coming from in the same 

way, Wiley added. 

The generational difference extends beyond 

the basics like work hours, though. 

For example, millenials tend to be technologically 

savvy, highly creative, and enjoy 

working in teams. They also are more likely 

to be relatively impatient and expect instant 

rewards and respect. This means that millenials 

won’t expect to pay their dues in the 

way that other generations did, and they 

expect constant feedback and the ability to 

express their opinions, Wiley said. These 

characteristics can add up to a profile that 

seems overly demanding to generations 

with different values. 

“Millenials might seem high-maintenance 

when you’re not used to working 

in that way,” Wiley said. “I don’t necessarily 

believe that we have to accommodate 

all their requests at all levels, but trying to 

meet some of their needs will go a long way. 

On the flip side, an Xer might find it annoy- 

figure 1 

generational differences 

in the Workplace 

Traditionalist Baby Boomer Xer Millennial 

Birth Years 1922–1945 1946–1964 1965–1977 1978–2003 

Business Focus Quality Long hours Productivity Contribution 

Motivator Security Money Time off Time off 

Company 

Loyalty 

Highest High Low Low 

Money is Livelihood Status Symbol Means to an End Today’s Payoff 

Value Family & Success Time Individuality 

Community 

Source: Carmen Wiley, PhD 

ing when dealing with a boomer that the 

emphasis is all about title and recognition 

and making sure they get kudos for what 

they’ve done—so from another perspective 

they’re high-maintenance too.” 

Keeping excellent employees of each 

generation satisfied with benefits and compensation 

also has its challenges, as not 

everyone is equally motivated by money, 

time off, or the ability to be an individual 

at work. “We know that when we’re dealing 

with our millennial population, they are 

very interested in their quality of life and 

making sure that they have enough time for 

their families and other civic opportunities 

in the community, whereas with our baby 

boomers, they are very focused on monetary 

rewards for a job well done,” Wiley 

said. “So maybe our millenials would prefer 

to accrue vacation at a greater rate, which 

would be more satisfying to them than a 

raise, whereas you have an older generation 

that might put more value on the raise.” 

Rewarding employees with a wide variety 

of incentives is not easy, however, even if 

an institution’s human resources department 

is very flexible, though some labs have 

managed to pull it off (Read more in CLN 

Online, www.aacc.org/publications/cln). 

Even though most lab directors and 

managers will not have the flexibility to 

offer all the benefits that please everybody, 

lab leaders do possess the ability to employ 

“softer” types of benefits and leadership 

strategies that keep these generational differences 

in mind, Wiley said. 

“It is well within your power, if you 

know that you are working with a group of 

millenials, to make sure that they are getting 

feedback on their performance or assign 

a project to a group of people instead 

of an individual. These are things that don’t 

require monetary resources that you can 

implement by improving communication 

with your staff,” she said. “Perhaps, if your 

institution permits it, you can allow people 

to wear their iPods while they’re working 

on the bench because it gives them a little 

personal freedom, or maybe you can make 

your boomers a little more comfortable 

working with millenials by setting some 

basic guidelines on dress codes and enforcing 

them consistently.” 

Culture and Conflict 

If nothing else, the constant change in labs 

and the new demographic realities mean 

that tackling conflict will be a top priority 

for any lab leader. Managers must know 

how to think strategically to avoid conflict 

or to seek it, depending on the circumstances, 

stressed Karon, who is associate 

professor of laboratory medicine and pathology 

and director of the hospital clinical 

laboratories and point-of-care testing at 

Mayo Clinic in Rochester, Minn. “Effective 

leaders not only have to be able to resolve 

conflict, but at other times effective leaders 

have to be able to create conflict,” he said. 

Karon noted that dealing with conflict 

successfully begins with understanding the 

nature of the conflict, a process laid out by 

Warren H. Schmidt and Robert Tannenbaum 

in two seminal articles in the Harvard 

Business Review—“How to Choose a 

Leadership Pattern” (1958) and “Management 

of Differences” (1960), which both set 

records for reprint requests in publications 

worldwide. “A good leader can define and 

sharpen where the conflict lies, and separate 

out the personal feelings and politics 

from the nature of the conflict,” Karon said. 

“The bottom line is that conflicts can be 

prolonged if the leader doesn’t identify the 

nature of the disagreement.” 

Schmidt and Tannenbaum point to 

conflicts of four basic natures: fact, goals, 

methods, and values. Knowing which is the 

source of conflict helps parties operate under 

the same assumptions and keeps egos 

from getting in the way, Karon said. After 

ascertaining the nature of the conflict, a 

leader must decide whether he or she wants 

to try and minimize the conflict or promote 

it, depending on the circumstances. 

If the harmony of a team is judged to 

be more important than the outcome of 

their decisions, a leader may chose to avoid 

conflict by putting together a team of like 

minded individuals, Karon said. The downside 

to this approach is that, in the long run, 

it can stifle creativity. In a different situation, 

a leader may actually want to promote 

conflict when the issues at hand need to be 

clarified, when members of a team need to 

learn from each other in order to make better 

decisions, or when there is enough time 

for a group to creatively come up with new 

solutions to a problem. 

When choosing to highlight differences 

or seek conflict, however, leaders do risk 

creating worse interpersonal conflicts and 

draining energy from a group if the conflict 

does not become resolved successfully, 

Karon said. “I think the most important 

variable to consider is the importance of 

the question or conflict to long-term goals 

and values of the organization. Creating 

conflict takes time and energy, and should 

be limited to conflicts or questions that are 

fundamental to long-term goals or values.” 

To help leaders navigate among these 

strategies to suppressing or creating conflict, 

Karon further elaborated five ba-

James hernandez, md emphasized that communicating core values is 

essential to coping with change. 

sic conflict resolution styles a leader can 

choose from based upon two factors—the 

problem sparking the conflict and who’s 

involved. The conflict resolution styles include 

retreat, harmonize, battle, bargain, 

and collaborate. “All leaders come into a 

situation with inherent traits and styles,” 

Karon said. “So, you need to recognize your 

inherent style for conflict resolution as well 

as the other styles out there, and the most 

effective leaders can go into a meeting and 

quickly chose the most appropriate style, 

even when it’s not necessarily the most 

natural to them.” 

In the retreat style, withdrawal is the 

dominant behavior, and the conflict is not 

truly solved. As an example, Karon described 

a situation where a physician calls the lab 

insisting that an unfamiliar test be sent out. 

In this case, a laboratorian may not say yes 

or no, but instead ask for time to learn more 

about the test before going forward. The 

second style, harmonizing, aims to preserve 

a relationship by accommodating the other 

party. This style is useful when it’s more important 

to maintain a relationship than tackling 

the issue at hand. However, this runs the 

risk that the source of the conflict is not really 

solved, and that other parties may come 

to assume that they will always get their way. 

Third, battling your way through a conflict 

can be appropriate in times of crisis or extreme 

time pressure. In this style, individuals 

choose to pursue the correctness of their 

position in a competitive way. Obviously, 

the disadvantage here is that such a style can 

create a negative and competitive aftermath. 

“Battling is appropriate when there is a core 

value at stake, and somebody has to lose, 

such as if someone refuses to label a specimen 

correctly, or some other issue of patient 

safety,” Karon explained. 

In the fourth style, bargaining, a person 

approaches a conflict as an opportunity to 

negotiate. A good example of this style is 

when a physician asks the lab to run a test 

stat when it’s not normal to do so. In this 

situation, a laboratorian could offer to go 

ahead and run the test stat, as long as the 

physician agreed to come down to the lab 

and discuss the need for the test and help 

the laboratorian understand the medical 

urgency. The danger with this style is that, 

over time, others learn to assume an inflated 

posture when approaching a conflict, 

watering down the result, Karon said. “It’s 

like going to buy a car. If you’re a leader and 

make it a habit to always bargain, that’s how 

people that interact with you are going to 

react.” 

Finally, collaboration as a conflict resolution 

style seeks a win-win solution. For 

this style to work, parties must perceive the 

process as mutual problem solving where 

the needs and interests of everyone are considered 

equally. This approach can build 

trust and integrate viewpoints, but tends to 

be very time consuming and energy intensive, 

so it can’t be applied to every situation. 

Although self-awareness and a solid 

understanding of different approaches to 

conflict will help a leaders guide their labs 

through future changes and stresses, creating 

organizational cultures based on core 

values, trust, and personal integrity is still 

the most important factor, Karon said, 

whether looking at leadership now or the 

future. “Certainly healthcare is changing 

rapidly, and generational challenges appear 

to have risen acutely as the fourth 

generation has entered the workforce,” he 

said. “However I wonder if you turned the 

clock back 100 years, whether you might 

hear the same comments being made. I 

think on the whole, a different set of skills 

will be needed, as the apprenticeship model 

of healthcare training and leadership will 

give way to a model demanding recognition 

and respect for workers from day one. 

As healthcare leaders we are not prepared 

to do that now.” 

Managing Change 

A theme running through the entire symposium, 

whether in examining generational 

values or conflict resolution styles, was that 

change is constant, stressful, and demanding 

of lab leaders. “There have been more 

changes since 1900 than in all of recorded 

history prior to 1900, and this can lead to 

overload. This is actually what’s happening 

to a lot of us in the laboratory,” said Hernandez. 

“It’s more complex to run the lab 

and it’s more difficult. Laboratorians are 

having to do more work with less resources, 

and we are one of the most highly regulated 

sectors of healthcare, and those regulations 

cause stress. We also have a lot of bureaucracy, 

and lots of policies and procedures, 

which tend to de-motivate people. Also, 

since labs are more distant from patient 

care, we can become commoditized, and all 

those things lead to stress.” 

People always seem to resist change, 

no matter where they are, and usually respond 

with stress and fatigue that can drag 

down a lab, Hernandez noted. To cope with 

change, Hernandez recommends lab leaders 

work to improve their communication 

skills and build on a solid foundation of 

core principles that keep people grounded. 

“Leaders who are advancing change have 

to communicate the vision and the reasons 

for the changes very clearly, and sometimes 

that means repetition in different formats: 

visual, newsletters, and face-to-face meetings,” 

he said. “People always say ‘what’s in 

it for me,’ so that’s a real priority for leaders 

to reframe the issue and try to tailor a message 

for a specific audience about what is in 

it for them. But there is no magic: change 

is one of the most difficult things we deal 

with in the lab.” 

Since change is persistent, Hernandez 

underscored the fact that any institution 

must have a core of higher-order values 

that can guide laboratorians’ decisions even 

when circumstances constantly seem to 

shift around them. Hernandez described 

the work of Leonard Berry who wrote “Discovering 

the Soul of Service.” Berry pictures 

the values of an organization as three concentric 

rings with core values at the center 

that never change. The innermost ring is 

core strategies, which rarely change; the second 

ring is integrated sub-strategies, which 

undergo frequent change; and the final ring 

is execution, which changes continuously. 

If a lab leader effectively communicates a 

lab’s core values, laboratorians will be able 

to better manage shifts in the outer rings of 

strategy and execution without losing sight 

of what really matters, Hernandez said. 

Lab leaders get into trouble when they 

fail to focus on core values and instead only 

emphasize execution. “If we only tell people, 

‘just do this,’ that’s just the execution 

part, and it leaves the person not really sure 

about why they’re doing what they doing,” 

Hernandez said. “On the other hand, with a 

focus on the core values, like patient safety, 

the reasons why the lab does something remains 

steadfast, even as the way things are 

done may change.” 

Leveraging core values can only go so 

far, however, if a leader is not perceived 

as authentic and trustworthy. Hernandez 

used the example of a well-known U.S. 

Navy commander, Mike Abrashoff, who 

wrote about his unique leadership style 

on his ship. Abrashoff credits his success 

with two basic ideas: replace command 

and control with commitment and cohesion; 

and engage the hearts, minds, and 

loyalties of workers with conviction and 

humility. Following this advice and leading 

by example can work in a lab to build 

better teams, Hernandez said. “I think the 

biggest part of what Abrashoff was doing 

just boils down to authenticity. He walked 

the walk and talked the talk. So once people 

understood that he was authentic—that he 

was not trying to manipulate them—they 

would follow,” he said. “And he was listening 

aggressively. I love that term, because 

the leader is the thermostat for the lab, so 

if there is a climate of trust, people feel safe 

to evaluate errors in the lab.” CLN 

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Type 1 Diabetes 

Autoantibodies 

Prediction and Diagnosis of Autoimmune Diabetes 

By PatRiCia W. MuelleR, PHD, PeteR aCHenBaCH, MD, Vito laMPasona, MiCHael sCHlosseR, PHD, 

anD alistaiR J. K. WilliaMs 

in 2007, the economic burden of diabetes was a staggering $116 billion for direct medical costs and $58 

billion for indirect costs, such as disability, work loss, and premature mortality. today, the disease affects 

more than 23.6 million people in the u.s., or 7.8% of the population, with those numbers rising dramatically 

(1). the autoimmune forms of diabetes, which affects 2 to 4 million people, include type 1 diabetes 

(t1d), an estimated 5% to 10% of those with diabetes, and latent autoimmune diabetes in adults (lada), 

estimated to be 5% to 10% of those diagnosed with type 2 diabetes (t2d) (2). t1d, previously called insulindependent 

diabetes mellitus or juvenile onset diabetes, occurs when the body’s immune system destroys the 

pancreatic β-cells that produce the hormone insulin involved in blood glucose regulation. to survive, affected 

individuals must take insulin. 

Identifying diabetes early is critical because 

the disease places affected individuals 

at increased risk of many complications 

and even death. The risk of stroke or death 

from heart disease is 2–4 times higher than 

those without the disease. Diabetes is also 

the leading cause of new cases of blindness 

among adults age 20 to 74 years, and the 

leading cause of kidney failure, accounting 

for 44% of new cases in 2005. About 60% 

to 70% of people with diabetes have mild 

to severe forms of nervous system damage, 

and more than 60% of nontraumatic 

lower-limb amputations occur in people 

with diabetes. 

This article will describe the latest advances 

in testing for autoantibodies predictive 

of T1D. Current assay standardization 

efforts by the Diabetes Autoantibody Standardization 

Program (DASP) will also be 

discussed. 

Clinical Assessment and Trials 

Traditionally, clinicians have differentiated 

between T1D and T2D based on phenotypic 

characteristics, including age at onset, 

abruptness of onset of hyperglycemia, keto- 

sis-proneness, degree of obesity, prevalence 

of autoimmune disease, and the need for 

insulin replacement therapy. Studies of autoantibodies 

in diabetes patients now suggest 

that there can be some overlap between 

T1D and T2D, the latter of which is more 

commonly diagnosed in adults. A subset of 

adult patients diagnosed with T2D, actually 

have LADA. Now recognized as a slowly 

developing form of autoimmune diabetes 

found in people over 35 years old, LADA is 

often misdiagnosed as T2D. These patients 

present clinically without ketoacidosis and 

weight loss but progress more rapidly to insulin 

dependence than typical T2D patients 

(3). Other labels have also been applied to 

this subset of diabetes, including slowly 

progressive type 1, latent type 1, double, 

and type 1.5 diabetes. 

Clinical trials are currently in progress 

to identify ways to prevent or reverse the 

autoimmunity of T1D. The Type 1 Diabetes 

TrialNet consisting of 18 clinical centers 

in the U.S., Canada, Europe, and Australia 

seeks to stop or delay the immune destruction 

of the insulin-producing pancreatic 

β cells. It will include trials of oral insulin, 

glutamic acid decarboxylase (GAD), Rituximab 

(Anti-CD20), metabolic control, as 

well as a nutritional prevention study of the 

omega-3 fatty acid, docosahexaenoic acid 

(DHA). The Immune Tolerance Network 

also conducts clinical trials for T1D, as well 

as other autoimmune diseases, including 

trials of thymoglobulin, interleukin-2 and 

sirolimus, and intranasal insulin. 

Autoantibodies Predictive of T1D 

The model proposed by Eisenbarth for T1D 

development has been in use for more than 

20 years (4). It describes T1D as a chronic, 

progressive autoimmune disorder in which 

subjects at genetic risk experience an as yet 

undefined environmental insult that initiates 

the destruction of the insulin-producing 

pancreatic islet β-cells (5). Destruction of the 

β-cells occurs over many years and results in 

metabolic abnormalities such as impaired 

glucose tolerance and ultimately symptomatic 

hyperglycemia. It is this process of β-cell 

destruction that is accompanied by production 

of autoantibodies to β-cell antigens. 

In 1974, researchers first identified pancreatic 

islet cell autoantibodies (ICAs) in 

T1D patients who had multi-endocrine 

deficiencies associated with organ-specific 

autoimmunity (6). In fact, this study established 

T1D as an autoimmune disease. 

Other researchers subsequently reported 

ICAs at a high frequency in children with 

newly diagnosed T1D. Now quantified in 

Juvenile Diabetes Foundation Units (10), 

the ICA levels are difficult to standardize 

because the assay depends on human pancreatic 

tissue as a substrate. Consequently 

labs have replaced ICA tests with tests for 

specific autoantibodies. 

Autoantibodies in T1D 

Clinicians order autoantibody tests to help 

distinguish between autoimmune T1D and 

diabetes due to other causes. Described 

below are the three most common autoantibody 

tests (Table 1), as well as a fourth 

autoantibody recently shown to be useful 

for T1D testing. 

Insulin autoantibodies. While it had long 

been recognized that treatment with exogenous 

forms of insulin could induce antibodies 

directed against insulin peptides, 

in 1983 researchers described insulin autoantibodies 

(IAA) in T1D patients before

they received insulin therapy (7). IAAs are 

diverse, and in general these high-affinity 

autoantibodies are more predictive of T1D 

and share certain characteristics, including 

appearance at a young age, association with 

HLA DRB1*04, subsequent progression to 

multiple autoantibody positivity, binding 

to human insulin A chain residues 8-13, 

and binding to proinsulin. 

IAAs are usually the first autoantibodies 

to appear in young children who develop 

T1D and can persist for many years before 

the appearance of T1D clinical symptoms. 

While they are considered one of the most 

important autoantibodies for predicting 

T1D in young children, current assays produce 

highly variable results, and only a few 

clinical laboratories consistently perform 

the assay with high sensitivity and specificity 

for the disease. 

GAD65 autoantibodies. The next major 

autoantigen to be characterized was a 65kDa 

isoform of glutamic acid decarboxylase 

(GAD65) (8). Cloning of the GAD65 

gene enabled researchers to synthesize the 

protein with radioisotopically labeled amino 

acids in an in vitro transcription/translation 

reaction and to use the product as the 

antigen in radiobinding assays (RBAs). In 

the early stages of GAD65 autoimmunity, 

the epitopes recognized by GADA are primarily 

in the middle region of the protein, 

but later they may include regions at the 

middle/C-terminal region of the protein. 

Autoantibodies to GAD65 are particularly 

important in late onset autoimmunity, 

such as that seen in LADA patients. 

IA-2 or ICA512 autoantibodies. In 1995, 

researchers characterized two tryptic digest 

fragments of islet antigens from individuals 

with T1D. One, a 40-kDa fragment 

from the intracellular portion of a tyrosine 

phosphatase-like protein (PTPRN gene), is 

now referred to as IA-2ic or ICA512ic (9). 

Although IA-2 autoantibodies (IA-2A) 

can be detected early in the course of autoimmunity, 

they often appear after other 

autoantibodies and have a higher positivepredictive 

value for T1D than GADA. 

Researchers have also characterized the 

other 37-kDa tryptic fragment as IA-2β or 

phogrin. Since almost all autoantibodies 

that react with IA-2β also react with IA-2, 

clinical labs typically do not use IA-2β autoantibodies 

as a first line test. However, it 

may be useful for identifying individuals at 

high risk of disease progression. 

ZnT8 autoantibodies. There is growing interest 

in autoantibodies to a member of the 

zinc transporter protein family, ZnT8, for 

autoimmune diabetes testing. Researchers 

discovered ZnT8 autoantibodies by screening 

for highly expressed proteins in islet 

β-cells of the pancreas (10). ZnT8 is one of 

a large family of zinc transporter proteins 

that is associated with the membrane of 

secretory granules of islet β-cells. The zinc 

within these granules forms a complex with 

insulin to develop storage crystals. Human 

ZnT8 exists in three major polymorphic 

forms with amino acid differences at position 

325: arginine, tryptophan, or glutamine. 

The arginine and tryptophan forms 

are the most common, and the glutamine 

form is rare. Sera from some T1D patients 

recognize ZnT8 epitopes not affected by 

the polymorphism at position 325. Their 

sera react with all polymorphic antigen 

forms, but some patients’ sera are specific 

to the polymorphic antigen. The latter sera 

are from T1D patients who are homozy- 

gous for either the arginine or tryptophan 

polymorphism. Other patients may have 

autoantibodies that are specific for the glutamine 

polymorphism, but very few T1D 

patients are homozygous for this polymorphism 

because it is not common. 

Biochemical Assays and Standardization 

ICAs measured by indirect immunofluorescence 

are still among the most sensitive 

markers of T1D; however, they have been 

largely replaced by biochemical autoantibody 

assays for the major specific protein 

antigens described above. While most labs 

use various forms of fluid phase RBAs for 

biochemical autoantibody assays, some 

commercial ELISAs now perform as well or 

better than RBAs in detecting GAD65 (11) 

and IA-2ic (unpublished data). 

RBAs generally begin with the synthesis 

of 35 S-methionine labeled protein antigens. 

For assay, the laboratorian incubates the 

test serum with labeled antigen and precipitates 

the resultant autoantibody-bound 

antigen with Protein-A Sepharose. Each serum 

sample is usually tested in duplicate on 

a 96-well plate. The laboratorian must then 

wash the plates to remove unbound labeled 

antigen and measure the radioactive label. 

For the IAA assay, commercial 125 I-labeled 

insulin is generally used as the substrate. 

Standardizing these assays is challenging. 

To improve comparability of measurements 

among laboratories, the World 

Health Organization (WHO) adopted a serum 

reference standard for GADA and IA- 

2A assays. These standards have assigned 

values of 250 units/mL for each autoantibody 

(12). Progress on an international 

standard for IAA, however, has been slow 

because of difficulties obtaining suitable 

IAA-positive sera. Standards for ZnT8 autoantibodies 

are also being developed. 

Given the need for standardized autoantibody 

testing for diabetes, the Immunology 

of Diabetes Society (IDS) and the U.S. 

Centers for Disease Control and Prevention 

(CDC) established the Diabetes Autoantibody 

Standardization Program (DASP) in 

2000 to improve comparability and to act 

as a mechanism to evaluate new autoantigens 

and test methodologies. The goal of 

table 1 

common autoantibody Tests 

Test Abbreviations Description Comments 

glutamic acid 

decarboxylase 

autoantibodies 

gada protein antigen found in 

neuroendocrine cells. 65Kd 

isoform in islet β-cells. 

islet antigen-2 ia-2a islet β-cell insulin granule 

membrane protein. also 

found in other neuroendocrine 

cells. 

insulin 


Zinc transporter 8 


iaa autoantibodies targeted to 

(pro)-insulin. Highly specific 

for β-cells. 

Znt8 autoantibodies targeted to 

β-cell membrane protein 

of insulin storage granules. 

predominantly in β-cells. 

these tests are used to distinguish between t1d and diabetes due to other causes. 

Modified from Lab Tests Online (www.labtestsonline.org). Reprinted with permission. 

the organization is to improve detection 

and diagnosis of autoimmune diabetes by: 

1) providing technical support, training, 

and information about the best methods; 

2) providing proficiency testing to evaluate 

laboratory performance; 3) supporting development 

of highly sensitive and specific 

measurement technologies; and 4) developing 

reference materials. 

Since its inception, DASP has conducted 

six international workshop in which 

laboratories assay blinded samples from 50 

patients with new onset T1D and up to 100 

controls. This format provides an evaluation 

of the sensitivity and specificity of each 

test and enables DASP to assess implementation 

of assay methods and to document 

any improvement in performance. Among 

the major accomplishments to date, DASP 

demonstrated that the performance of 

ELISAs for measuring T1D autoantibodies 

can equal that of RBAs and validated 

ZnT8 as the fourth major T1D autoantigen. 

Other activities include: validation of 

IA-2β autoantibody assays; evaluation of 

the stability of the WHO GADA and IA-2 

autoantibody standard; validation of affinity 

measurements to improve IAA test performance 

(13); and evaluation of standard 

method protocols for GADA and IA-2A. 

Laboratories that have participated in 

multiple DASP workshops have improved 

the quality of their autoantibody assays. In 

2009, participating labs found the majority 

of new-onset patient samples were positive 

for multiple autoantibodies, including all 

four major autoantigens, followed by patient 

samples positive for the combination 

of GADA, IA-2, and ZnT8 autoantibodies. 

DASP is also looking at new technology 

to measure autoantibodies. Several 

DASP 2009 autoantibody assays used a new 

non-radioactive assay format, the luciferase 

immunoprecipitation system (LIPS), that 

looks promising. 

To further improve quantitative agreement 

of assays for GAD65 and IA-2ic, a 

harmonization effort led by NIH research 

consortia labs and DASP committee members 

developed a standard method protocol 

(15), which is now available to all DASP participants. 

The National Institute of Diabetes 

the most commonly used test. autoantibodies 

detected in about 70–80% of newly 

diagnosed t1d patients. often persist after 

diagnosis. 

antibodies to intracellular portion detected 

in about 60–70% of t1d children at onset. 

levels often fall soon after diagnosis. 

detected in about 70% of t1d children (and 

90% of those age

figure 1 

stratification of diabetes risk 

a. Based on Numbers of Autoantibodies b. Based on Autoantibody Combination 

developing T1D. When an effective way 

to reintroduce tolerance in autoimmune 

diabetes becomes available, high-quality, 

high-throughput autoantibody tests will 

be essential for identifying individuals who 

can benefit from such treatment. 

Future therapeutic intervention trials 

for disease will need to consider the characteristics 

of the population and assay performance 

in screening for the disease. These 

strategies will likely evolve as researchers 

devise new interventions and develop new 

tests. Two early intervention trials for which 

recruitment was based on ICA and/or IAA 

have already proven the efficacy of islet autoantibodies 

for T1D prediction (18, 19). 

Researchers have also used the presence of 

IAA, GADA, and IA-2A as a criterion for recruiting 

individuals into prevention studies 

and for identifying initiation of autoimmunity 

in natural history studies of T1D, such 

as the The Environmental Determinants of 

Diabetes in the Young (TEDDY) Study. CLN 

REFERENCES 

1. CDC Diabetes Fact Sheet, 2007, (http:// 

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2. Naik RG, Brooks-Worrell BM, Palmer 

J. Latent autoimmune diabetes in adults. 

J Clin Endocrinol Metab 2009; 94:4635– 

4644. 

3. Zimmet PZ. The pathogenesis and prevention 

of diabetes in adults: genes, autoimmunity, 

and demography. Diabetes Care 


c. Based on IA-2A Epitopes 

stratification of diabetes risk in islet autoantibody (iaa, gada, and/or ia-2a)-positive first-degree relatives of t1d patients (n = 180) based on 

autoantibody number (a), target antigen specificity (b), and ia-2a reactivity against ia-2β (c). 

Reprinted with permission from The American Diabetes Association. Copyright 2004, from Diabetes 2004;53:384–392. 

1995;18:1050–1064. 

4. Eisenbarth GS. Type 1 diabetes mellitus. 

A chronic autoimmune disease. N Engl 

J Med 1986;314:1360–1368. 

5. Taplin CE, Barker JM. Autoantibodies 

in type 1 diabetes. Autoimmunity 2008;41: 

11–18. 

6. Bottazzo GF, Florin-Christensen A, 

Doniach D. Islet-cell antibodies in diabetes 

mellitus with autoimmune polyendocrine 

deficiencies. Lancet 1974;304:1279–1283. 

7. Palmer JP, Asplin CM, Clemons P, et 

al. Insulin antibodies in insulin-dependent 

diabetics before insulin treatment. Science 

1983;222:1337–1339. 

8. Baekkeskov S, Aanstoot HJ, Christgau 

S, et al. Identification of the 64K autoantigen 

in insulin-dependent diabetes as the 

GABA-synthesizing enzyme glutamic acid 

decarboxylase. Nature 1990;347:151–156. 

9. Payton MA, Hawkes CJ, Christie MR. 

Relationship of the 37,000- and 40,000- 

Mr tryptic fragments of islet antigens in 

insulin-dependent diabetes to the protein 

tyrosine phosphatase-like molecule IA-2 

(ICA512). J Clin Invest 1995;96:1506–1511. 

10. Wenzlau JM, Moua O, Sarkar SA, et 

al. S1C30A8 is a major target of humoral 

autoimmunity in type 1 diabetes and a 

predictive marker in prediabetes. Ann NY 

Acad Sci 2008;1150:256–259. 

11. Torn C, Mueller PW, Schlosser M, et al. 

Diabetes Antibody Standardization Program: 

evaluation of assays for autoantigens 

to glutamic acid decarboxylase and islet antigen-2. 

Diabetologia 2008;1:846–852. 

12. Mire-Sluis AR, Gaines Das R, Lernmark 

A. The World Health Organization 

International Collaborative Study for islet 

cell antibodies. Diabetologia 2000;43:1282– 

1292. 

13. Achenbach P, Schlosser M, Williams 

AJK, et al. Combined testing of antibody 

titer and affinity improves insulin autoantibody 

measurement: Diabetes Autoantibody 

Standardization Program. Clin Immunol 

2007;122:85–90. 

14. Burbelo PD, Groot S, Dalakas MC, et al. 

High definition profiling of autoantibodies 

to glutamic acid decarboxylases GAD65/ 

GAD67 in stiff-person syndrome. Biochem 

Biophys Res Commun 2008;366:1–7. 

15. Bonifacio E, Yu L, Williams AK, et al. 

Harmonization of glutamic acid decarboxylase 

and islet antigen-2 autoantibody 

assays for National Institute of Diabetes 

Digestive and Kidney Diseases consortia. J 

Clin Endocrinol Metab 2010;95:3360–3367. 

16. Bingley PJ. Clinical applications of diabetes 

antibody testing. J Clin Endocrinol 

Metab 2010;95:25–33. 

17. Achenbach P, Warncke K, Reiter J, et al. 

Stratification of type 1 diabetes risk on the 

basis of islet autoantibody characteristics. 

Diabetes 2004;53:384–392. 

18. Bingley PJ, Gale EAM. The European 

Nicotinamide Diabetes Intervention Trial 

(ENDIT) Group, Diabetologia. Progression 

to type 1 diabetes in islet cell antibody- 

positive relatives in the European Neicotinamide 

Diabetes Intervention Trial: the role 

of additional immune, genetic and metabolic 

markers of risk. 2006;49:881–890. 

19. Orban T, Sosenko JM, Cutherbertson 

D, et al. For the Diabetes Prevention Trial- 

Type 1 Study Group. Pancreatic islet autoantibodies 

as predictors of type 1 diabetes 

in the Diabetes Prevention Trial-Type1, 

Diabetes Care. 2009;32:2269–2274. 

Patricia W. Mueller, PhD, is chief of the 

Molecular Risk Assessment Laboratory at the 

Centers for Disease Control and Prevention, 

Atlanta, Ga. Address all correspondence to: 

pwm2@cdc.gov. 

Peter Achenbach, MD, is a physician 

and clinical scientist at the Institute of 

Diabetes Research, Helmholtz Center, 

Munich, Germany. 

Vito Lampasona is a senior scientist at the 

Center of Genomics, Bioinformatics, and 

Biostatistics, San Raffaele Scientific Institute, 

Milan, Italy. 

Michael Schlosser is a senior scientist in 

medical biochemistry and molecular 

biology, University of Greifswald, 

Karlsburg, Germany. 

Alistair J. K. Williams is a research fellow in 

clinical science at North Bristol, University of 

Bristol, Bristol, U.K.

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PATIENT SAFETY FOCUS 

TAkING AIM AT REDUCING LAB ERRORS 

Organizing Specimen Processing for High Quality and Efficiency 

An Interview with Linda Nesberg 

Patient Safety Focus first interviewed linda 

nesberg, operations manager at mayo medical 

laboratories, in July 2009. in that interview, she 

described a system for reducing errors related to 

handling manual requisitions. the system follows 

lean principles that ms. nesberg used in the 

computer manufacturing industry before she 

switched to the healthcare field. a version of the 

mayo processing system has been successfully 

implemented in a variety of labs in the u.s., including 

the lab of the physicians who conducted 

the current interview. in this follow-up interview, ms. nesberg speaks 

more generally about proper receipt and processing of specimens and 

their associated test orders. 

erin grimm, md, and michael astion, md, phd 

conducted this interview. 

When you arrived at Mayo, how was 

specimen receipt and processing 

organized? 

The Mayo Reference Laboratory was growing 

rapidly when I arrived. At the time, 

there were three job categories: laboratory 

assistants, lead technologists, and supervisors. 

The laboratory assistants processed 

specimens, and when they encountered a 

problem, they either attempted to resolve 

the issue or they referred it to a lead tech or 

a representative within our client services 

section. Common problems at the time 

were those confronting any lab, such as 

missing data on the requisition, specimen 

mislabeling, and improper specimen containers. 

The lab did not have a standardized 

process for dealing with specimens that required 

extra work before processing. 

Why was a change in workflow necessary 

and what benefits did you hope to 

realize? 

The reference laboratory was experiencing 

double-digit growth per year. Further 

defining duties and separating tasks were 

necessary to efficiently deal with the increasing 

workload. My goal was to separate 

the problem cases from the general 

work flow so that the routine work moved 

through more efficiently and with fewer errors 

(Figure 1). 

When looking at workflow issues, do 

you use any particular approach to 

problem solving? 

Yes, we incorporate Lean principles. One 

of the general principles of Lean is to remove 

bottlenecks in order to reduce delays, 

which is one of the main forms of waste in 

processes. Therefore, we wanted to create 

a system in which problem cases did not 

block the flow of routine cases. 

What organizational changes did you 

institute to help workflow? 

I defined additional job categories to separate 

the duties of the employees responsible 

for keeping the pace of specimen processing 

moving from those who were specifically 

selected to deal with problem cases. 

The current organization of specimen processing 

is that a supervisor is in charge of 

35-40 people. Also under a supervisor are 

three or four lead techs. The lead techs are 

divided into two categories, slow-lane lead 

techs, who handle exceptions, and fast-lane 

lead techs, who are in charge of facilitating 

the work flow of the laboratory assistants 

and keeping the pace of routine processing 

on target. There are also other job classifications. 

One is the lab specialty assistant, 

who while supporting the lead techs, also 

aliquots all specimens. Another is the operation 

scheduler, who monitors daily volumes 

and determines appropriate staffing 

schedules to handle those volumes. In this 

system, the laboratory assistants are on the 

front-line, and they can process cases without 

dealing with delays caused by problem 

cases. The supervisor’s job is to ensure employee 

well-being. Supervisors help administer 

training for new employees, provide 

employee counseling, and triage personnel 

issues, such as time away from work. They 

also organize and administer process improvements 

and quality initiatives. 

How did you accomplish the reorganization? 

Was it hard for the lab staff to 

accept this organizational change? 

Change is always difficult for some people, 

but there were also benefits to graduated 

positions in the system. Previously, a career 

track for job advancement was not welldefined. 

Now, there are job classes with 

increasing levels of responsibility and in- 

creased pay. In addition, the more specific 

job descriptions allow personnel to gravitate 

towards the type of work they most enjoy. 

In terms of managing the more difficult 

changes, the largest initial change was that 

laboratory assistants no longer handled 

problem cases. Some were delighted, but 

others saw the problem solving as an integral 

part of their responsibility and missed 

that aspect of the job. We made a concerted 

effort to help everyone understand how the 

new system improved patient care, and we 

emphasized that above all high-quality patient 

care is our goal. Patients benefit from 

efficient, high-quality laboratory results. 

While specimen processing is not the area 

of the lab actively reporting test results, 

our contribution to patient care is efficient, 

error-free processing. 

How do you provide feedback to staff on 

how the lab is doing? 

We have large display monitors that show 

employees our success at reaching our processing 

timeline goals. The monitors provide 

real-time feedback to our laboratory 

assistants, showing them their contribution 

to our goal of providing rapid, highquality 

results. 

You mentioned that you created a 

special job category called operations 

schedulers. What is their role in the 

laboratory? 

When I first arrived, I noticed that predicting 

daily processing volumes was not a 

priority. When I investigated and created 

some reports, I found that workload followed 

predictable patterns. For example, 

we first estimated work volume on a Tuesday 

by looking back at the data for the last 

four to six Tuesdays and found that these 

numbers were a reasonably accurate predictor 

of volume. Since then, we have also 

predicted volumes based on orders, many 

of which are interfaced into our laboratory 

information system. We pull this data 

shortly after midnight and create a report 

that indicates our incoming volume for the 

day. A hospital with computerized physician 

order entry could have access to similar 

data since morning blood draws can be 

pre-ordered. 

Why do you have a special job category 

for aliquoting? 

There are two reasons why I separated this 

task into its own job category. First, I wanted 

to ensure quality care. Manual aliquot- 

figure 1 

sorting routine specimens into a 

fast lane lets value flow

ing is prone to error. In a Lean workspace 

with a 5S process, this type of task receives 

greater emphasis so as to eliminate any unnecessary 

materials and/or objects from 

the work flow. Second, I wanted a record 

of the number of aliquots performed, and 

there was no way to quantify this metric 

until the job category was separated out 

from the other processing duties. 

How do you handle error reporting? 

An important characteristic of our error 

reporting system is that we separate external 

errors, such as incomplete client orders 

or client errors, from errors that are true 

processing errors. Both types of errors are 

recorded using a similar software tool, but 

the systems are separate. We do this because 

knowing the rates of pre-analytic 

errors or exceptions helps us accurately 

predict our overall processing times. Both 

error reporting systems rely on a software 

application that assigns an individual is- 

What Can Laboratory Directors Learn from Baseball? 

By JaMes s. HeRnanDez, MD, Ms 

Major league baseball pitchers are masters 

at controlling the location of their 

pitches, and sometimes they throw balls 

with the intent of intimidating batters. The 

slang term, “chin music,” refers to a pitch 

that comes perilously close to the batter’s 

head, often causing the batter to move away 

from home plate and even to fall down. 

When the baseball actually hits the batter, it 

is called a “bean ball.” Pitchers are often so 

accurate that they can literally throw at the 

batter’s chin, causing the batter to jerk back 

or even fall down before he gets hit. Sometimes 

the pitcher’s manager or coach even 

orders the pitcher to throw a bean ball. This 

can result in both the manager and pitcher 

being ejected from the game. 

Like it or not, chin music and bean balls 

are part of the game of baseball. They entertain 

the crowd and boost the pitcher’s 

ego, especially if the umpire goes easy and 

lets him off without a warning or ejection. 

Successful Lab Leaders 

So how does baseball’s chin music tie into 

lab leadership? You might ask yourself 

which type of batters—weak or strong— 

are the pitcher’s target for this menacing 

pitch. 

In my opinion, lab managers who are 

not at the receiving end of a few bean balls 

or a little chin music are like weak batters 

and probably are not really leading the lab. 

As management guru John Kotter stated, 

“Management is about coping with complexity…leadership, 

by contrast, is about 

coping with change” (1). True leaders take 

the laboratory to new heights and guide the 

lab team through the lowest lows. Getting 

knocked down a few times in the process 

or taking it on the chin for an unpopular 

decision is part of leading. 

sue number to each problem case. That 

issue number references a file containing 

the error report and a log of all information 

related to that case. We record the issue 

number from our issue tracker with 

the specimen identification number in the 

LIS. This way, the LIS can reference a more 

detailed report. This is particularly helpful 

when you need to determine the reason 

behind quality issues. 

How do you assure that information 

about problem cases is not lost at the 

shift change? 

The error-reporting software is an issuetracker 

system that allows us to transmit 

information between shifts. It works as follows: 

problem cases are removed from the 

fast lane and handed, with preliminary information, 

to the slow-lane lead tech. This 

tech then submits the problem to client services 

by opening a new issue report in the 

system. Specimens with unresolved issues 

laboratory leaders face many challenges. but few situations are 

as trying as receiving unjust criticism for making an unpopular 

decision, even when that decision meets the needs of patients 

and staff. as a baseball fan, i think laboratorians can learn some 

valuable lessons about leadership from the sport. 

Patient safety is a non-negotiable matter 

that demands strong leadership in the 

lab, especially today. The six Institute of 

Medicine aims for improving the medical 

system call for all aspects of healthcare to 

be safe, effective, patient-centered, timely, 

efficient, and equitable (2). Even the suspicion 

of a patient safety issue should cause 

lab leaders to jump out of their chairs and 

respond with urgency and concern. 

Unfortunately, some laboratorians still 

seem to be opposed to the concepts of 

patient safety. As lab leaders, we need to 

understand why. In my experience, some 

laboratorians simply don’t understand why 

they are being asked to change how they 

process blood samples. Maybe their leaders 

haven’t effectively communicated or shared 

the vision of how protecting patients’ safety 

is at the heart of lab operations. 

In other instances, laboratorians might 

not be properly equipped or trained to respond 

to the Institute of Medicine’s goals. 

Maybe there are conflicting goals in the 

organization or patient safety is not a high 

priority in the institution. Some may resist 

because they simply aren’t willing to follow 

the new direction. They may be comfortable 

with the status quo, or there may be 

too much inertia or a lack of trust in the 

leaders. Lab leaders need to respond to each 

of these scenarios differently, just as batters 

respond in various ways to balls thrown by 

the pitcher. 

Charging the Mound 

Similar to the crowd at a major league 

baseball game, lab staff watch how the lab’s 

leaders respond to bean balls and chin music. 

While some batters lose control and 

“charge the mound” after being on the receiving 

end of an intimidating pitch, we, as 

at the end of the shift are moved physically 

to specific hold areas inside the lab. Client 

services continuously monitors the documented 

issues until they are resolved, and 

they only close an issue in the software after 

it is resolved. As long as the issue is open, 

client services will work on it, no matter the 

shift. Lead techs who are concerned about 

a case in the hold area can check the most 

recent status of each issue by looking up the 

specimen ID or issue number in the errorreporting 

software. At the shift change, the 

lead tech only needs to communicate nonspecimen 

specific issues. This communication 

is done via a short checklist designed 

in-house to ensure that nothing of importance 

is missed. 

Does the approach to specimen processing 

that you describe here apply mostly 

to large-volume labs, or could it be 

applied in any size lab? 

Lean as the umbrella approach to problem- 

lab leaders and professionals, want to avoid 

coming unglued and attacking when the 

pressure is on. If we lose control, the results 

in the laboratory, as in baseball, are often 

not pleasant and may live on to taint our 

career. 

On the other hand, it is natural to want 

to be liked and to respond to chin music 

by backing off— in essence, staying on the 

ground. True leaders cross the bridge from 

wanting to be liked to earning the respect 

of the laboratory staff (3). Patient safety issues 

require strong and swift action from 

the lab’s leadership, even if the measures are 

unpopular. 

Loving the Game 

In my opinion, William Howard “Willie” 

Mays, Jr. was one of the best baseball players 

ever. Famous for his ebullient love of 

the game, he was known as the “The Say 

Hey Kid.” Mays got a lot of chin music in 

his career, particularly in his early days as 

one of the first African-Americans to play 

solving is applicable to any size lab. In addition, 

the specific principles discussed 

above—separating problem cases from 

the routine work flow, tracking problem 

cases without loss of information, predicting 

workload and matching staffing to 

that workload, organizing staff into logical 

groupings, and isolating and standardizing 

error-prone work—will help any lab 

improve efficiency, decrease turnaround 

times, and reduce errors. 

REFERENCES 

Smoothing workflow and reducing errors 

in specimen processing. Clinical Laboratory 

News. 2009. 35(7) x. 

Engineers in the clinical laboratory. Clinical 

Laboratory News. 2009: 35 (1) x. 

Erin Grimm, MD, is a resident in the 

Department of Laboratory Medicine and 

Anatomic Pathology at the University of 

Washington, Seattle. 

lab leaders might do well to think of themselves as batters facing a tough 

pitcher when it comes to patient safety. 

after the major leagues were integrated. He 

frequently would dust himself off after getting 

some intimidating chin music, smile, 

and hit the next pitch. 

How we respond as lab leaders to chin 

music is a matter of what happens in the 

five-and-a-half inches between our ears. 

We can lose control and charge the mound, 

or we can do what Mays did. The choice is 

ours. 

REFERENCES 

1. Kotter, John P. What Leaders Really Do. 

In: Harvard Business Review on Leadership. 

Boston: Harvard Business School 

Publishing, 1998: 37. 

2. Institute of Medicine, Crossing the Quality 

Chasm. Available at http://iom.edu/Reports/2001/Crossing-the-Quality-Chasm-A- 

New-Health-System-for-the-21st-Century. 

aspx, accessed July 21, 2010. 

3. Hernandez JS. Crossing the leadership 

bridge. Physician Exec 2009 Sep–Oct; 35 

(5):92–4. 


ask tHe expert 

How to Categorize Incident Reports to Fuel Quality Improvement 

A Model-Based Approach for Process and Behavior Incidents 

PeGGy a. aHlin, Bs, Mt(asCP) anD Bonnie MessinGeR 

Peggy Ahlin is director of quality and 

compliance and Bonnie Messinger is 

quality manager at ARUP Laboratories in 

Salt Lake City, Utah. 

What is a practical approach to categorizing 

incident reports so that incident 

reporting fuels quality improvement? 

As with any task, it is important first to 

define the goal. What information do you 

wish to capture? And more important, 

what do you plan to do with it? 

The obvious intent is to facilitate process 

improvement and/or promote behavior 

change. Some incidents can be traced 

to poor process design, while others are 

the result of human fallibility. In general, it 

makes sense to categorize process improvement 

changes by areas of focus, such as 

process control systems; however, behavior 

change categories should center on interventions. 

Table 1 provides an example of a useful 

model for categorizing behavioral incidents. 

This model is helpful because it 

provides guidance for the most appropriate 

interventions. For example, lab managers 

would respond to employee judgment 

errors related to the lack of rules by creating 

the necessary rules and training to those 

incidents involving reckless violations 

of rules, like destruction of 

computers in the laboratory, usually 

mean that the employee is not a 

good fit for the workplace. 


rules. Judgment errors related to reckless or 

intentional behavior would be reduced or 

eliminated by disciplining or terminating 

the employee, or finding a better fit for the 

employee in a position with less risk. 

Likely candidates for the process improvement 

categories are those used in 

your organization’s quality systems. This 

approach allows you to focus on improvement 

strategies that match the quality system 

you want to improve. 

For example, according to the Clinical 

Laboratory and Standards Institute’s Qual- 

ity Essentials model, mislabeled specimens 

would fall within the process control system. 

Adding tiers of categories such as preanalytic 

(mislabeled specimen), analytic 

(testing of a mislabeled specimen), and 

post-analytic (reporting a result inconsistent 

with a historical value) could also help 

refine the focus of your response. Other 

possibilities for categories are the major 

steps in your organizational flow chart or 

value stream map. 

The number of tiers you choose will 

determine the granularity of your process 

review. One caution: with each higher level 

of granularity, the number of categorization 

choices will increase exponentially. 

If there are too many choices, users will 

have difficulty finding the most descriptive 

sub-category. If this happens, the data is 

less valuable for focusing your quality improvement 

efforts. 

In summary, the best approach to categorizing 

incident reports enables users 

to accurately categorize both process- and 

behavior-based incidents, significantly help- 

ing your quality improvement efforts. 

table 1 

model for categorizing behavioral incidents 

Judgment error—involves choosing between possibilities; requires synthesis 

Description 

Why 

Response 

No rule Rule doesn’t fit Reasonable rule violation Reckless rule violation 

No rule in place; employee made 

the best decision based on the 

information at hand 

Event is rare or has never happened 

before and no rule is in 

place. Rules cannot cover every 

scenario. 

Console the employee; relieve the 

employee of taking unreasonable 

risk or being responsible for decisions 

above their level of authority 

Rule is in place, but is commonly 

not followed (takes too much 

time, is difficult, a workaround is 

a better process and is commonly 

used) 

Benefit of breaking the rule 

exceeds the risk of being caught 

Revise the rule or remove the 

incentive for violating the rule 

Rule is in place, but employee 

chose not to follow because doing 

so would cause more harm than 

violating the rule 

Rule doesn’t cover every scenario; 

employee’s judgment failed to 

take all variables into account 

Coach the employee. If the 

employee was right, support the 

employee’s decision and consider 

revising the rule 

Rule is in place, but employee 

chose not to follow. Reason for 

that choice was not patientcentered 

Sabotage; willful disregard for 

patient safety; social proof; 

dilution of responsibility 

Employee is not a good fit for this 

job; terminate the employee or 

move to a different job without 

risk potential 

Knowledge error—involves learning, application of knowledge and memory; requires cognition 

(If the employee knows what to do, but acted in error, consider judgment-based error) 

Description 

Why 

Response 

Didn’t know Should have known Would have known Couldn’t know 

This event is covered in training, 

but was not covered with this 

employee 

Employee was not trained for this 

task or this module was missed 

during training 

This event is covered in training This event is covered in training in 

a general sense; under different 

circumstances, the knowledge 

would have been applicable 

Employee was inattentive at this 

moment in training or forgot; 

mental blink 

Employee did not synthesize the 

training to related scenarios 

Train Retrain; consider memory aids Train for synthesis; consider ways 

to judge level of or capacity for 

synthesis 

This event is not covered in training; 

there is no training module; 

no SOP 

Training module is incomplete; 

event is rare and is not included; 

training module/SOP has not been 

developed 

Consider adding to training or 

(better) training for synthesis; 

develop training module/SOP 

skill-based error—involves automatic task or manual manipulation of an object; requires dexterity 

(If the employee has demonstrated proficiency and has been trained, consider knowledge-based or judgment-based error) 

Description 

Why 

Response 

Inept (low effort) Inept (best effort) Proficient (best effort) Proficient (low effort) 

Employee struggles to perform; 

attempts to train are ineffective 

and unwelcome 

The employee’s physical or mental 

faculty is not a good fit for this 

job; the employee is unwilling to 

train for better performance 

Consider a different assignment; 

explore employee’s unwillingness; 

look for goal conflicts, poor leadership 

and personal stress; consider 

that employee’s motivation may 

not be a good fit for this job 

Employee struggles to perform; 

attempts to train are welcomed 


faculty is not a good fit for this 

job; the employee is willing to 

train for better performance 

Train for better performance; 

consider ergonomics, environmental 

conditions (light, heat, 

noise), fatigue, breaks. Consider a 

different assignment 

Employee has demonstrated the 

ability to perform; attempts to 

train are welcomed 


faculty is a good fit; the employee 

is willing to train for better performance 

Train for better performance; 

consider ergonomics, environmental 

conditions (light, heat, noise), 

fatigue, breaks 

Employee has demonstrated 

the ability to perform; attempts 

to train are ineffective and 

unwelcome 


faculty is a good fit; the employee 

is unwilling to train for better 

performance 

Explore employee’s unwillingness; 

look for goal conflicts, poor leadership 

and personal stress; consider 

that employee’s motivation may 

not be a good fit for this job

patient safetY concepts 

The Monday Morning Quarterback 

Hindsight Bias in Medical Decision Making 

By KaRen aPPolD 

Have you ever heard someone say, “I knew 

that was going to happen?” But everyone 

knows that predicting the future always becomes 

much easier once the future is in the 

past. Sayings like “hindsight is 20/20” and 

“Monday morning quarterback” are also 

popular ways to describe such predictions. 

These expressions refer to what psychologists 

call hindsight bias, the tendency for 

people to regard past events as expected or 

obvious, even when in real time the events 

perplexed those involved. 

Safety analysis experts are now applying 

the hindsight bias model to medical decision 

making. Here hindsight bias describes 

the tendency to judge the events leading 

up to an accident as errors because the bad 

outcome is known (1). 

Take, for example, the way in which 

clinicians interpret a lab result. The clinician 

has a certain amount of information 

that allows him to assess the probability of 

a diagnosis or likelihood that a condition 

will worsen. He then makes decisions based 

on those probabilities. However, when authorities, 

like a consulting clinician or an 

expert witness, assess whether or not the 

treating physician made a good decision, 

and the outcome is unknown, the experts 

will often support the decision. But if the 

experts learn that a patient had a negative 

outcome, then they are more likely to think 

that the decision was poor. In other words, 

knowing the outcome in the present affects 

the experts’ analysis of events in the past. 

This thinking process is a universal human 

phenomenon. “Cognitive psychologists 

have realized that hindsight bias is 

almost unavoidable. When a negative outcome 

occurs, the tendency is to think that if 

a different action would have been taken, the 

outcome could have been prevented,” explained 

Rodney A. Hayward, MD, director 

of the Robert Wood Johnson Foundation 

Clinical Scholars Program and professor of 

medicine and public health at the University 

of Michigan in Ann Arbor. “Ultimately, a decision 

is made with the intent to reduce the 

risk of something bad happening. But any 

action bears certain costs and risks.” 

Hayward recalls a particular scenario 

involving a lab test result that shows how 

hindsight bias can easily happen. A patient’s 

creatinine level increased from 1.3 to 1.6 

units over 3 months. The patient appeared 

to be fairly stable, so the clinicians weren’t 

too concerned and scheduled a follow-up 

visit in 3 months. Three weeks later, however, 

the patient was hospitalized because his 

creatinine level spiked. Upon reflection, the 

clinicians questioned whether they should 

have re-checked the patient sooner. 

“But the reality is that the difference between 

those two creatinine levels is not that 

unusual and is almost within the range of 

lab error,” Hayward said. “In addition, it is 

unclear if that slight bump was a warning 

sign. If we re-checked everyone with such a 

slight increase, we would constantly inconvenience 

patients and it would be costly.” 

This is a good example of hindsight 

bias in medical decision making because 

when something negative happened (the 

patient was hospitalized), the original decision 

(to not re-check him earlier) was questioned. 

But if the decision was evaluated in 

monday morning quarterbacking in medical decision making can be minimized 

if decisions are evaluated based on the information available at the 

time of the decision, and not after the outcome is known. 

examples of hindsight bias 

® “i knew they were going to lose.” 

® “that’s exactly what i thought was going to 

happen.” 

® “i saw this coming.” 

® “that’s just common sense.” 

® “i had a feeling you might say that.” 

real-time, most likely everyone would have 

agreed that a routine 3-month follow up appointment 

was appropriate and the slightly 

higher creatinine level was not of concern. 

To minimize hindsight bias in this instance, 

clinicians should question whether 

a patient with such a small change in creatinine 

level in a 3-month period should be 

rechecked weekly. In general, a good technique 

for minimizing hindsight bias is to 

formally consider alternative explanations 

that do not involve errors. 

In fact, making too many changes based 

on small random errors in lab tests can actually 

have negative outcomes. “Some research 

suggests that if you check an international 

normalized ratio (INR) to monitor 

warfarin therapy too frequently and make 

constant adjustments, you will actually do 

less good than if you check it at slightly 

longer intervals and make smaller adjustments. 

This is because you may overcorrect 

for random variations in INR by getting 

too much information from lab tests,” 

Hayward explained. 

To some degree, hindsight bias can’t 

be completely avoided. “When we criticize 

certain decisions and policies, we need to 

consider the cost, as well as the risk and 

consequences of alternative actions.” 

One problem with hindsight bias is 

that it leads us to criticize or even punish 

healthcare workers who make decisions 

that lead to poor patient outcomes. To 

avoid the negative consequences of hindsight 

bias, Hayward advises against adopting 

new policies or punishing employees 

without reflecting on the full process. It is 

better to evaluate whether the decision was 

reasonable and determine the best action 

to take in the future. 

REFERENCE 

1. Hindsight bias. Available at: http://psnet. 

ahrq.gov/glossary.aspx#hindsightbias. 

Accessed August 13, 2010. 

Karen Appold is an editorial consultant for 

the clinical laboratory industry. 

Email: karenappold@comcast.net 

patient safety focus 

editorial board 

chair 

michael astion, md, phd 

department of laboratory medicine 

university of washington, seattle 

members 

peggy a. ahlin, bs, mT(ascp) 

arup laboratories 

salt lake City, utah 

James s. hernandez, md, ms 

mayo Clinic arizona 

scottsdale and phoenix 

devery howerton, phd 

Centers for disease Control 

and prevention 

atlanta, ga. 


A/C Diagnostics LLC • AAFP- PT • Aalto Scientific, Ltd. • AB SCIEX • Abaxis • Abbiotec • ABBIS bio process automation • Abbott Diagnostics • AbD Serotec • Accel Biotech, Inc. • Access Bio, Inc. • Access Biologicals, LLC • AccuBioTech Co., Ltd. 

Accumetrics, Inc. • Accuri Cytometers • Acon Laboratories, Inc. • Adaltis • Adaptive Mfg. Technologies, Inc. • ADEMTECH • Adhesives Research, Inc. • Adicon Clinical Laboratory Inc. • ADS, Corp. • Advance • Advanced Instruments, Inc. • Advanced 

Microdevices Pvt. Ltd. • Aesku Diagnostics • Agappe Diagnostics Switzerland GmbH • Agilent Technologies • Ahlstrom Filtration LLC • AID GmbH • Ajinomoto Co., Inc. • Alere - Inverness Medical • Alfa Scientific Designs, Inc. • ALIFAX SPA • ALPCO Diagnostics 

Alternative Biomedical Solutions • Amano Enzyme USA Co., Ltd. • Amedica Biotech, Inc. • American Board of Clinical Chemistry • American Diagnostica Inc. • American Medical Technologists • American Proficiency Institute • American Society for Clinical 

Laboratory Science • American Society for Clinical Pathology • Anaerobe Systems • Analis • Analyticon Biotechnologies • Andover Healthare Inc. • Ani Biotech Oy/Ani Labsystems Ltd. • Antek HealthWare, LLC • Anthro Corporation • Antibodies Inc. 

Applied Biocode, Inc. • APTEC Diagnostics • Arab Health • Arbor Pak Co. Inc. • Aries Filterworks • Arista Biologicals Inc. • ARK Diagnostics, Inc. • ARKRAY, Inc. • Arlington Scientific Inc. • Artel • ARUP Laboratories • Asahi Kasei Pharma Corporation 

ASCO Numatics • Aspyra • Associates of Cape Cod, Inc. • Atlas Link, Inc. • Audit MicroControls, Inc. • Autobio Diagnostics Co. Ltd. • AutoGenomics, Inc. • Awareness Technology, Inc. • AWEX • AXA Diagnostics s.r.l • Axela, Inc. • Axis-Shield • Axxin 

Azalea Health Innovations • AZOG, Inc. • B&E Scientific Instrument Co., Ltd. • BBInternational • BD • BD Lee Laboratories • Beaufort, LLC • Beckman Coulter • Beijing Chemclin Biotech Co., Ltd. • Beijing Kinghawk Pharmaceutical Co. Ltd • Beijing Steellex 

Scientific Instrument Company • Beijing Strong Biotechnologies, Inc. • Berthold Detection Systems GmbH • BERTHOLD TECHNOLOGIES GmbH & Co. KG • BG Medicine • Big C/Dino-Lite Scopes • Binding Site Inc., The • BioAssay Works, LLC • BioCheck, Inc. 

Bio-Chem Fluidics • BIOCRATES Life Sciences AG • BioDot, Inc. • BIOHIT, Inc. • BioKit S.A. • Biolabo SA • BIOLYPH, LLC • Biomaric • Biomat Srl • BioMed Resource Inc. • BioMedica Diagnostics Inc. • Biomedix, Inc. • Biomerica, Inc. • bioMerieux, Inc. 

Bioneer Corporation • Bionostics Inc./RNA Medical • Biophor Diagnostics, Inc. • BioPorto Diagnostics A/S • BioProcessing, Inc. • Bio-Rad Laboratories • Biosearch Technologies • BiosPacific • Bio-Synthesis, Inc. • Biotage • Biotechniques • BioTek 

Instruments • BIOTRON DIAGNOSTICS INC • BIT Analytical Instruments • BloodCenter of Wisconsin • Blue Ocean Biomedical • BODITECH MED Inc. • Bruker Daltonics • BSD Robotics • Burkert Fluid Control Systems • Cadence Science Inc. • CalBioreagents 

Calbiotech, Inc • Caldon Bioscience • California MedTech • Calzyme Laboratories, Inc. • Cambridge Consultants • CapitalBio Corporation • Capp ApS • Capralogics Inc • Capricorn Products LLC • Cardinal Health • CardioMed International • Caretium 

Medical Instruments Co, Ltd • Carley Medical Lamps • Carolina Liquid Chemistries • Carr & Ferrell LLP • Carville Ltd • CBC Diagnosis • Cedarlane Laboratories, Ltd. • CellaVision • Cenbimo • Centerchem Inc. • Centers for Disease Control & Prevention, 

TTO • Centers for Medicare, Medicaid Services • Cepheid • Ceragem Medisys, Inc. • Cerilliant • CERTEST BIOTEC • Chemagen USA • Chemtron Biotech Inc. • CHROMSYSTEMS • Chuncheon Bioindustry Foundation • CIS Biotech & Grace Laboratories, 

LLC • Cisbio US Inc. • Claremont BioSolutions • Cleveland Clinic Laboratories • Clinical and Laboratory Standards Institute • Clinical Diagnostic Solutions, Inc. • Clinical Lab Products • CLINIQA Corporation • CLTech Corp. • CMEF/IVD - China Int’l Med. 

Equip. Fair • COLA • College of American Pathologists • Comp Pro Med, Inc. • Comtron Corp. • Conductive Technologies Inc. • Convergent Technologies • Cooper - Atkins Corporation • Copan Diagnostics, Inc. • Corgenix • Coris Bioconcept • CORMAY & 

Orphee • Creative Laboratory Products Inc. • CSP Technologies, Inc. • CTK Biotech, Inc. • Current Components Inc. • Cylex Inc. • DAAN DIAGNOSTICS LTD. • DAS Srl • Data Innovations, Inc. • Dawning Technologies, Inc. • Delta Industrial Services • Deltalab 

DENKA SEIKEN CO., LTD. • DenLine Uniforms, Inc. • Desert Biologicals/Omega Biologicals • DFI Co., Ltd. • diaDexus, Inc. • Diagam • Diagnostic Automation/Cortez Diagnostics • Diagnostic Consulting Network, Inc. • Diagnostic Systems Corporation 

Diagnostica Stago, Inc. • DIALAB G.m.b.H • Diamedix, Corp. • Diamond Diagnostics Inc. • DiaSorin, Inc. • Diasource • DiaSys Diagnostic Systems • Diatron Ml Plc. • Diazyme Laboratories • DIBA Industries, Inc. • DIESSE Diagnostica Senese S.p.A • Digital Bio 

Dirui Industrial Co., Ltd. • DLD Diagnostika GmbH • DNA Genotek • DOCRO, Inc. • Drew Scientific, Inc. • DRG International, Inc. • Drucker Company, The • Drummond Scientific Co. • D-Tek • Dwyer Products • DYNEX Technologies Inc. • EastCoast Bio, Inc. 

Egemin Automation • Electra Medical Corporation • Electronic Imaging Materials, Inc. • Elekta Impac Software • Elitech Group Company • Elsevier • EMD Chemicals, Inc./Estapor • Emdeon • Enigma Diagnostics Limited • ENPLAS Corporation 

Entrocomponent Solutions (ECS) • EntroGen • Epitomics, Inc. • Epitope Diagnostics, Inc. • Epocal Inc • Eppendorf North America • Equal Access to Scientific Excellence ( EASE) • Equitech Bio Inc. • ERBA Diagnostics Mannheim GmbH • Ercon Inc • ESA 

Lead Care • ESE GmbH • EuroDiagnostica • Eurogentec North America, Inc. • Euroimmun US • Eurotrol, Inc. • EVERGREEN SCIENTIFIC • Excel Scientific, Inc. • Express Diagnostics Int’l, Inc. • Fapon Biotech Inc. • Far East Bio - Tec Co., Ltd. • Filtrona Porous 

Technologies • Fine Care Biosystems • Fitzgerald Industries Int’l • Flanders Investment & Trade • FlandersBio • FlexLink Systems, Inc. • Fluid Metering, Inc. • Focus Diagnostic, Inc. • Foliage • Fujirebio Diagnostics, Inc. • Fuller Laboratories • Furuno 

Electric Co., Ltd. • G&L Precision Die Cutting, Inc. • Gale Force Software Corporation • Gemmy Industrial Corp. • Gems Medical Sciences • GENEBIO (Geneva Bioinformatics) • GeneFluidics • Genisphere, LLC • GenMark Diagnostics, Inc. • GenomeWeb 

LLC • Genomica • GenPrime, Inc. • Gen-Probe • GenVault Corporation • GenWay Biotech, Inc. • Genzyme Diagnostics • Gerresheimer Wilden Plastics (USA), L.P. • Globe Scientific Inc. • Gold Standard Diagnostics • Golden West Biologicals, Inc. • Greiner 

Bio-One, Inc. • GRI Pumps • Grifols USA- Diagnostic Division • Guangzhou Improve Medical Instruments • H & H Systems, Inc. • Hamamatsu Corporation • Hamilton Company • Hangzhou Genesis Biodetection & Biocontrol Co., Ltd. • Hanlab Corporation 

Hardy Diagnostics • Harlan Bioproducts for Science, Inc. • Haydon Kerk Motion Solutions, Inc. • HB Optical Technology Co., Ltd. • Healgen Scientific LLC • Health Advances, LLC • HealthPoint Solutions, LLC. • Heathrow Scientific • Helena Laboratories 

HELMER • Hemagen Diagnostics, Inc. • HemoCue Inc. • Hemosure, Inc. • HEPA CORPORATION • Hoover Precision Products, LLC • HORIBA Medical • HRA Research • HTL-Strefa Inc. • Human GmbH • Huntington Hospital • Hycor Biomedical • HyTest Ltd. 

IBL - America • IBL- International Corp. • Idaho Technology Inc. • IDEX Health & Science • IFCC - International Federation of Clinical Chemistry • IFCC - Worldlab - EuroMedlab Berlin 2011 • ILS Innovative Labor Systeme GmbH • IMMCO Diagnostics 

Immucor, Inc. • Immundiagnostik AG • Immuno Concepts • Immuno-Cell • Immunodiagnostic Systems • Immunology Consultants Laboratory, Inc. • Immunospec Corp. • Immunostics Inc. • InBios International, Inc. • Innogenetics • Innovize • INOVA 

Diagnostics, Inc. • Instrumentation Laboratory • InTec Products, Inc. • Integrated DNA Technologies, Inc. • Integrated Laboratory Automation Solutions • Inter Bio-Lab, Inc. • International Immuno-Diagnostics • International Immunology Corporation • Invetech 

Ionics Mass Spectrometry Group • IQuum, Inc. • IRIS International Inc. • Isensix, Inc. • Isonic, LLC • IT4IP • ITC • IVD Industry Connectivity Consortium • IVD Research, Inc. • IVD Technologies • IVD Technology/Canon Communications • IVEK Corp. • Iwaki 

America Inc. • Jackson ImmunoResearch Laboratories, Inc • Jadak, LLC • JAJ International • Jant Pharmacal Corp. • Japan Association for Clinical Laboratory Automation • JAS Diagnostics • JENOPTIK Laser, Optik, System GmbH • JEOL Ltd. • Jiangsu Zhengji 

Instruments Co. Ltd • Joint Commission, The • JRC - IRMM • JSR Corporation • K & K Consultant Group, Inc. • Kaiser Permanente • Kamiya Biomedical Company • Kem-En-Tec Diagnostics • Kinematic Automation Inc. • Kingmed Diagnostics • KMC Systems, 

Inc. • KNF Neuberger Inc. • KPL, Inc. • KRONUS, Inc. • Lab Medica • Lab21 Inc. • Labconco Corporation • LabCorp - Esoterix • LABiTec GmbH • Labnovation Technologies, Inc • Laboratory Data Systems, Inc. • Labotix Automation, Inc. • LabProducts, Inc. • Labs 

are Vital • Labtest • Lampire Biological Laboratories, Inc. • LasX /Precision Medical Coverting Group • Lathrop Engineering Inc. • Lattice Inc • Lee Company, The • Leica Microsystems • Life Technologies • LifeSign LLC • LipoScience • LRE Medical/Esterline 

Company • Lumigen, Inc. • Luminex Corporation • LW Scientific • M/S. Tarsons Products PVT. Ltd. • Magellan Biosciences • MagnaBioSciences • MagneMotion • Magnisense • Magsphere Inc. • Maine Biotechnology Services • Maine Standards Co. LLC. • Man & 

Machine, Inc. • Market Diagnostics International • MATEST Systemtechnik GmbH • McKesson • Medica 2010/ Messe Duesseldorf • Medica Corporation • Medical Automation Systems • Medical Device Consultants, Inc. • Medical Device Safety Service 

GmbH(MDSS) • Medical Electronic Systems, LLC • Medical Laboratory Evaluation(MLE) • Medical Laboratory Observer • Medical Wire & Equipment Ltd. • Medicon GmbH • Medix Biochemica • MEDTOX Laboratories • MEGA TIP • Mercy Ships • Meridian 

Bioscience, Inc. • Meridian Life Science, Inc. • MGM Instruments, Inc. • Michigan Diagnostics, LLC • Micro Q • Microbix Biosystems Inc. • MicroFluidic - ChipShop GmbH • Microliter Analytical Supplies, Inc. • Microscan Systems, Inc. • Microsens Biotechnologies 

Midland BioProducts Corp • Millipore • Miltenyi Biotec, Inc. • Mindray • MiniFab (Aust) Pty Ltd. • MiniGrip • Minitubes • Mitsubishi Chemical Medience Corporation • Mo Bio Laboratories, Inc. • Moduline Systems, Inc. • Monobind Inc. • Moss, Inc. • Motoman Inc. 

MP Biomedicals • MT Promedt Consulting GmbH • Multisorb Technologies • mut-AG • Nanjing Perlove Radial-Video Equipment Co., Ltd. • Nano-Ditech Corporation • Nanoq • Nanosphere, Inc. • Nath Law Group, The • National Academy of Clinical 

Biochemistry • National Jewish Health • National Registry of Certified Chemists • Neogen Corporation • NeuroScience, Inc. • New England Biolabs, Inc. • New 

England Small Tube • NewScen Cost Bio-Pharmaceutical Co., Ltd • Next Control Systems • Nexus Dx • NICHIREI BIOSCIENCES, INC. • NIHON KOHDEN • Nikon 

Instruments Inc. • NIST • NOEMALIFE • NOF CORPORATION • Norgren/Kloehn • Nor-Lake Scientific • Nova Biologics, Inc. • Nova Biomedical • Novatec 

Immundiagnostica GmbH • NuAire Inc • Oak Ridge Products • Ocean Optics • Omega Diagnostics Group PLC • Omnica Corp.-Product Development • OPERON 

OPTI Medical • Opticon • OraSure Technologies, Inc. • Orchard Software Corp • OriGene • Ortho Clinical Diagnostics • Otsuka America Pharmaceutical, Inc. 

Owen Mumford • OYC Americas, Inc. • Oyster Bay Pump Works, Inc. • PAA Laboratories, Inc. • Pacific iD • Pall Life Sciences • Pango Medical Devices, Inc. 

Paradigm 3 Software • Parker Hannifin, Precision Fluidic Division • PDCI Medical/Pacific Die Cut Industries • PEAK-Service USA • Peking Union Lawke 

Biomedical Development. Ltd. • Peripheral Resources, Inc. • PerkinElmer, Inc. • Phadia US Inc. • Pharmigene, Inc. • Phenomenex • Philosys, Ltd. • Plasti Lab 

S.A.R.L. • Pointe Scientific • Polymed Therapeutics, Inc. • Polymedco, Inc. • POLYMICROSPHERES • Polysciences/Bangs Labs, Inc. • Pozzetta Inc. • PrimeraDx 

Princeton BioMeditech Corp. • Prior Scientific, Inc. • Progeny Software, LLC • Proliant Health and Biologicals • Propper Manufacturing Co., Inc. • ProSci, Inc. 

Protos Immunoresearch • PVT LabSystems, LLC • Qarad • Qualigen, Inc. • Quantimetrix Corporation • QuantiScientifics LLC • Quantum Analytics • Quest 

Diagnostics • Quidel Corporation • Radim SpA • Radiometer America • Randox Laboratories • Rayto Life & Analytical Sciences Co, Ltd • R-Biopharm 

Rees Scientific • ReLIA Diagnostic Systems, Inc. • Research Organics, Inc. • Rheonix, Inc. • RND Group, Inc., The • Roche Diagnostics • ROHM CO., Ltd. • Rotek 

Industries • RTEmd • Runlab Labware Manufacturing Co., Ltd • S&P Consultants, Inc. • SA Scientific LTD • SAFC • Saladax Biomedical • Sanyo North 

America • Sarstedt, Inc. • Sartorius Stedim North America Inc. • Scantibodies Laboratory Inc. • SCC Soft Computer • SCETI K.K. • Schott North America, Inc. 

Schuyler House • Scientific Device Laboratory • Scimedx Corporation • Scipac Ltd. • Scripps Laboratories • ScyTek Laboratories, In • Sebia Electrophoresis 

Seegene, Inc. • Sekisui Medical Co. Ltd. • Selective Micro Technologies LLC • Sensor Electronic Technology • SENTINEL CH SpA • Sepmag Tecnologies • Sequenom Center for Molecular Medicine • SeraCare Life Sciences • Sero AS • Seyonic SA • Shanghai 

Kehua Bioengineering Co., Ltd. • Shanghai Dishi Medical Instrument Co. Ltd. • Shanghai Fosun Long March Medical Science Co. Ltd. • Shanghai ZJ Bio-Tech Co., Ltd. • Shentex • Shenzhen Emperor Electronic Technology Co., Ltd • Shenzhen Genius Electronics 

Co., Ltd. • Shenzhen Landwind Industry Co., Ltd. • Shenzhen Procan Electronics Inc. • ShinJin Medics Inc. • Sias AG • Siemens Healthcare Diagnostics • Siemens Water Technologies • Sigris Research, Inc. • Siloam Bioscience • SimPort • Skannex • SLR Research 

Corporation • SMC Corporation of America • SNIBE Co, Ltd. • Solulink • Source Scientific, LLC • Southern Biotech • Span Diagnostics Ltd. • Spherotech, Inc. • Spinreact • Stanbio Laboratory • Standard Diagnostics, Inc. • STARLIMS • Statens Serum Institut 

STI (Separation Technology, Inc.) • STRATEC Biomedical Systems AG • Strategic Diagnostics Inc. • Stratos Product Development • Streck Laboratories, Inc. • SUD-Chemie Performance Packaging • Sunostik Medical Technology Co., Ltd. • Sunquest Information 

Systems • Super Brush LLC • SurModics • Swisslog • Syntron Bioresearch, Inc. • Sysmex America, Inc. • Systelab Technologies • Taigen Bioscience Corporation • Tcoag • Tecan • Technidata America Medical Software • Techno Medica Co. Ltd. • Teco 

Diagnostics • Tecom Science Corporation. • TELCOR • Tetracore, Inc. • Therapak Corporation • Thermo Fisher Scientific • Thermo Scientific • thinXXS Microtechnology AG • Tianjin Era Biology Engineering Co., Ltd • Tosoh Bioscience • Toyobo Co. Ltd • Trek 

Diagnostics Systems, Inc. • Tricontinent • TriLink Biotechnologies, Inc., • TRINA BIOREACTIVES AG • Trinity Biotech • Turklab A.S. • U.S. Export Pavilion • UCLA Health System • Ulti Med Products GmbH • Union Medical & Pharmaceutical Technology (Tianjin), 

LTD • United Products & Instruments, Inc./UNICO • URIT Medical Electronic Co., Ltd • UTAK Laboratories, Inc. • ValuMax International • VEDALAB • Veracity Group, Inc. • ViraLab Inc • Vircell • ViroStat, Inc. • Vital Diagnostics • ViveBio • Vonco Products • Wako 

Diagnostics • WAMA Diagnostica • Warde Medical Laboratory • Warm Point Alarm, Inc. • Waters Corporation • Web Industries, Inc. • Weidmann Plastics Technology AG • Wescor, Inc. an Elitech Group Co. • WesTgard QC, Inc. • Whatman, Part of GE Healthcare 

Wheaton Industries Inc. • WHPM Bioresearch & Technology Co., Ltd • Wi • Wiener Laboratorios SAIC • Wisepac Active Packaging Components Co. • Women & Infants Hospital of Rhode Island • Wondfo Biotech Co., Ltd. • Worthington Biochemical 

Corporation • WSLH Proficiency Testing • Xiril AG • Yayatech Co, Ltd • YD Diagnostics Corporation • Zentech • ZeptoMetrix Corporation • Zeta Corporation • Zhejiang Gongdong Medical Plastic • Zhejiang Huawei Scientific Instrument Co • ZheJiang U-Real 

Medical Technology Co. • Zhongshan Chuangyi Biochemical Engineering Co., Ltd. • Zyomyx, Inc. 

2010 Annual Meeting Organizing Committee 

Mike Hallworth, MSc FRCPath, Royal Shrewsbury Hospital 

Dennis Dietzen, PhD, DABCC, FACB, Washington University School of Medicine 

Paula Santrach, MD, FACB, Mayo Clinic 

Robert Christenson, PhD, DABCC, FACB, University of Maryland Medical Center 

Jim Faix, MD, Stanford University School of Medicine 

Gwen McMillin, PhD, DABCC, FACB, University of Utah and ARUP Laboratories 

Patti Jones, PhD, DABCC, FACB, Children’s Medical Center 

Paul Jannetto, PhD, DABCC, Medical College of Wisconsin 

Paul D’Orazio, PhD, Instrumentation Laboratory 

Shannon Haymond, PhD, DABCC, Children’s Memorial Hospital 

Amy Saenger, PhD, DABCC, FACB, Mayo Clinic 

AACC 2010 Board of Directors 

President: Catherine A. Hammett-Stabler, PhD, DABCC,FACB 

President-Elect: Ann M. Gronowski, PhD, DABCC, FACB 

Past President: Barbara M. Goldsmith, PhD, FACB 

Secretary: Anthony W. Butch, PhD, DABCC, FACB 

Treasurer: D. Robert Dufour, MD 

Board of Directors: 

David E. Bruns, MD, FACB 

Elizabeth L. Frank, PhD, DABCC, FACB 

David D. Koch, PhD 

Greg Miller, PhD, DABCC, FACB 

Robert L. Murray, JD, PhD, DABCC, FACB 

Gregory J. Tsongalis, PhD, FACB 

AACC thanks 

all the exhibitors, and all the 

thousands of attendees who made 

the 2010 AACC Annual Meeting 

and Clinical Lab Expo a success! 

SAVE THIS DATE

2010 AACC Annual Meeting and 

Clinical Lab Expo Set New Records 

What a week! the setting could not have been more 

perfect for the 2010 aaCC annual meeting and Clinical 

lab expo. beautiful southern California weather 

contributed to the sunny atmosphere for attendees 

and exhibitors who filled the anaheim Convention 

Center, July 25–29, to exchange ideas, learn new clinical concepts, and view 

the latest in clinical laboratory products. 

with signs of the economy coming out the recession, the meeting surpassed 

all previous aaCC records. the total numbers of attendees for the 

first time exceeded 20,000, and the Clinical lab expo was officially aaCC’s 

largest ever with almost 2,000 booths and more than 700 companies 

exhibiting. 

with so many companies displaying the newest products for labs, it’s 

hard to do justice to the expo. featured here are highlights from the five 

largest ivd manufacturers. 

Roche Launches Interactive 

Lab Design Tool, New Analyzer 

Roche Diagnostics showcased a diverse 

portfolio of diagnostic testing solutions 

along with new technology to help labs 

plan for the future. The booth featured the 

launch of Roche’s high-tech DreamLab 

display, an interactive program that provided 

lab professionals with the opportunity 

to design their ideal labs. Visitors were 

given the chance to custom-design analyzer 

systems, right down to the module configuration, 

reagent channels, and system 

throughputs to help identify the most successful 

solutions for their own labs. Roche 

also featured an array of new technologies 

for laboratory and point-of-care testing, 

including integrated clinical chemistry 

and immunoassay analyzer platforms, and 

chemistry, immunoassay, and molecular 

diagnostic tests. One of Roche’s featured 

new products, the cobas 8000 analyzer, is 

designed for labs processing more than two 

million clinical and immunoassay tests per 

year. The system consists of four analytical 

chemistry/immunoassay modules that can 

be configured into 24 different combinations 

to fit the needs of a wide variety of 

testing platforms. For POCT, visitors got to 

see the newest member of the CoaguChek 

XS family of meters, the CoaguChek XS 

Pro system, and the ACCU-CHEK Inform 

II blood glucose monitoring system (pending 

clearance). The new CoaguChek has a 

bar code reader and provides test results 

from 8 µL of blood in about 1 minute, and 

the ACCU-CHEK features wired and wireless 

communication to lab information 

systems. 

Beckman Coulter Offers Expanded 

Portfolio of Lab Solutions 

Beckman Coulter displayed a wide array of 

lab systems and automation, featuring the 

now fully integrated Olympus product line. 

The company also highlighted more ways 

to improve lab performance. Expo visitors 

got a firsthand look at the AU480 and 

AU690 chemistry systems, plus a preview 

of the AU5840 (pending clearance). This 

latest analyzer in the AU series represents 

the fastest AU analyzer ever designed. It will 

be available in four different scalable models, 

positioned for the very high to ultra 

high test volume segments. Also in advance 

showing was the DxH 300 Coulter cellular 

analysis system and UniCel DxH Slidemaker 

Stainer (both pending clearance). 

Other product introductions included the 

AU PowerCel, a space conscious automation 

line for medium to large size laboratories. 

Beckman Coulter’s workshops, led by 

industry and company experts, focused on 

Continued on page 18 

people lined up early in the anaheim convention center to get a chance to 

visit the world’s largest exposition of clinical lab products under one roof. 


Expo Attracts Large Crowds 

five largest exhibitors, from page 17 

insight into current laboratory trends and 

methods to maximize productivity. 

Abbott Features Advances in 

HIV Testing, Platform Upgrades 

Amid an array of analyzers, Abbott featured 

the launch of a first-of-its-kind HIV 


test that can detect the disease faster than 

ever before. Abbott’s newly FDA approved 

Architect HIV Antigen/Antibody Combo 

Assay is a novel diagnostic tool that can 

detect infection days earlier than other 

antibody-only tests currently used in the 

U.S. because the test can identify both HIV 

antigens and antibodies. The company also 

The wide variety of products for clinical laboratories attracted record- 

breaking numbers of attendees to this year’s aacc clinical lab expo. 

Coagulation Reagents 

for Chemistry Analyzers K-ASSAY The Assay You Can Trust... 

® 

Coagulation / Hemostasis assays can now be 

performed on most chemistry analyzers ! ! 

(including Abbott Aeroset ® , Bayer Advia ® , Beckman 

AU series, Synchron CX ® and LX ® , Dade Dimension ® , 

Roche / Hitachi, and many others) 

• Anti-Thrombin III 9-35 mg/dL 

• D-Dimer 0.5-30 µg/mL 

• Fibrinogen 100-900 mg/dL 

• Plasminogen 3-14 mg/dL 


• Factor XIII (plasma) 2.3%-140% 

• FDP (serum) 0.2-80 µg/mL 

• FDP (urine) 0.02-3.2 µg/mL 

• P-FDP (plasma) 2-80 µg/mL 

• FDP-E (serum) 22-1,920 ng/mL 

• FDP-E (urine) 6-192 ng/mL 

• Soluble Fibrin (plasma) 3-80 µg/mL 

For research use only. Not for use in diagnostic procedures. 



800-526-4925 206-575-8068 FAX: 206-575-8094 


Coagulation CLN 10-2010.indd 1 9/8/2010 10:26:15 AM 

aacc’s clinical lab expo featured more than 700 exhibitors, giving attendees 

a first-hand look at all the newest lab analyzers. 

introduced a recently cleared molecular assay 

for identification of two common sexually 

transmitted diseases, chlamydia and 

gonorrhea. Abbott’s ARCHITECTPLUS 

enhanced family of immunochemistry analyzers 

was also showcased. The upgraded 

system includes features that will help labs 

streamline operations. In workshops sponsored 

by Abbott, experts spoke on the future 

of HIV testing, the role of the laboratory 

in management of acutely ill patients, 

and transforming laboratory operations 

with six sigma quality, informatics, and 

automation. 

OCD Unveils New Products and Services 

Ortho Clinical Diagnostics’ booth focused 

on maximizing laboratory productivity by 

showcasing the company’s latest additions 

to menu and process solutions. The company 

featured demonstrations of what true 

integration by design can do for laboratories 

by introducing two new Vitros systems, 

as well as how more than 550 blood banks 

in the U.S. have automated using Ortho 

ProVue analyzers. OCD also launched a 

new initiative highlighting personal stories 

from Vitros customers. Highlighted 

services included OCD’s e-Connectivity 

Technology and Remote Monitoring Centers. 

During the in-booth presentations, 

speakers described several case studies and 

laboratory experiences aimed at supporting 

the value of their products and services. 

The case studies included an in-depth look 

at assays, the value of technical support 

services, and laboratory LEAN implementations. 

Siemens Showcases Broad Array 

of Diagnostic Solutions 

Siemens displayed a wide range of new 

products, services and solutions designed 

to meet the growing needs of clinical laboratories. 

Under the theme, “The Power of 

Possibilities,” the exhibit featured customized 

diagnostic solutions that were designed 

to give customers a competitive edge. Siemens 

introduced a number of new and innovative 

instruments and automation solutions, 

as well as assays. Highlights include 

the CLINITEK Status Connect System, a 

point-of-care instrument. In conjunction 

with the Multistix family of urinalysis test 

strips, CLINITEK provides flexible connectivity, 

data integration and operational 

control to reduce risk in POC testing environments. 

The LabPro Information Man- 

ager, a single database and interface connection 

for multi-user access, expands 

microbiology data analysis and reporting 

capabilities. Forty new analyte specific reagents 

for allergen testing have been added 

to the IMMULITE test menu, and assays 

for the Dimension systems now include an 

automated immunosuppressive drug panel 

and myeloperoxidase. Siemens also hosted 

several educational presentations, which 

focused on process management, vitamin 

D assessment, procalcitonin monitor- 

ing, parathyroid hormone standardization, 

healthcare reform, and allergy testing. CLN 

in 2011, the aacc annual meeting and clinical lab expo will be held in 

atlanta, ga., July 24–28.

Our new advances in VITROS ® technology 

are driven by your impact on patients. 

Quality lab results touch lives. Millions of them, every day. 

That’s the global magnitude of what you do—and the reason 

why Ortho Clinical Diagnostics supports you with innovative 

systems that help you do it better than ever. To make your lab 

more productive without compromising quality results, we 

studied laboratories around the world and created two new 

high-capacity VITROS ® systems. 

All trademarks are the property of Ortho-Clinical Diagnostics, Inc. © Ortho-Clinical Diagnostics, Inc. 2009, 2010 CL10968 

As the next generation in our standardized family of systems, 

the VITROS ® 5600 Integrated System and the VITROS ® 

3600 Immunodiagnostic System feature patented enabling 

technologies, innovative sample handling, and a world-class 

menu for exceptional accuracy, efficiency, and result integrity. 

We’re committed to shaping the future of diagnostics, because 

what you do shapes the future of countless lives around the 

world. Learn more at www.orthoclinical.com. 

The science of knowing shapes the art of living.

slow progress on 

electronic health records 

The federal government’s push for widespread 

implementation of electronic 

health records (EHR) has so far not led to 

swift adoption by U.S. hospitals, although 

a new government effort to help hospitals 

choose EHR systems that meet govern- 

reguLatory 


p r o f i L e s 


ment standards is on track. A new study 

released by Health Affairs found that while 

the number of U.S. hospitals that have 

adopted either basic or comprehensive 

EHRs rose modestly between 2008 and 

2009, from 8.7% to 11.9%, only 2% of the 

country’s hospitals reported having records 

that would meet the federal government’s 

meaningful use criteria and be eligible for 

extra Medicare and Medicaid incentive 

payments. The authors of the study went 

on to note that “policy makers need to consider 

ways to make it easier for hospitals to 

adopt EHRs and meet the criteria for their 

meaningful use—especially in the case of 

smaller, rural, and public hospitals… to ensure 

that all Americans, regardless of where 

they receive care, derive the benefits that 

health IT has to offer.” 

On the other hand, the federal government 

recently announced two EHR certification 

bodies that will be authorized to test 

and certify EHR systems for compliance 

with the standards and certification criteria 

that were issued by the U.S. Department 

of Health and Human Services earlier this 

year. The Certification Commission for 

Health Information Technology (CCHIT), 

Chicago, Ill. and the Drummond Group 

Inc. (DGI), Austin, Texas, were named by 

the Office of the National Coordinator for 

Health Information Technology (ONC) as 

the first such technology review bodies. 

Announcement of these ONC-authorized 

testing and certification bodies 

(ONC-ATCBs) means that EHR vendors 

can now begin to have their products certified 

as meeting criteria to support meaningful 

use, which ONC described as a key 

step in the national initiative to encourage 

adoption and effective use of EHRs. 

More about the ONC-ATCBs is available 

at www.cchit.org and www.drummondgroup.com. 

More information about 

the ONC certification programs is available 

at http://healthit.hhs.gov/certification. 

fda, cms to Work more closely 

on post-market research 

The Food and Drug Administration 

(FDA) and Centers for Medicare and 

Medicaid Services (CMS) announced a 

plan to improve their collaboration on 

post-market research, a move that lab industry 

observers hope can cut the time between 

FDA approval of a device and a CMS 

decision to pay for it. 

The Memorandum of Understanding 

(MOU), published in the Federal Register, 

aims to enhance knowledge and efficiency, 

and sharing of information and expertise 

between the two agencies. The goals of the 

collaboration are to explore ways to: further 

enhance information sharing efforts 

through more efficient and robust interagency 

activities; promote efficient utilization 

of tools and expertise for product 

analysis, validation, and risk identification; 

and build infrastructure and processes that 

meet the common needs for evaluating the 

safety, efficacy, utilization, coverage, payment, 

and clinical benefit of drugs, biologics, 

and medical devices. Unless terminated 

before by FDA or CMS, the MOU will remain 

in effect for 5 years. 

The MOU is available from the Federal 

Register, www.gpoaccess.gov/fr/. 

cms cuts hospital 

inpatient payments 

cMS announced it will cut Medicare 

inpatient payments to hospitals in 

2011 by $440 million compared to 2010, 

nearly $300 million more than the agency 

estimated in April in a proposed rule. The 

cuts mean an overall 0.4% reduction in reimbursement 

rates to acute care hospitals 

for inpatient stays. This reduction reflects 

the balance of a range of adjustments, 

mainly a positive 2.4% update for inflation 

coupled with a 2.9% cut aimed at recouping 

payments in 2008 and 2009 that CMS 

says did not accurately reflect the severity of 

patients’ illness. 

CMS has replaced its Diagnosis-Related 

Group (DRG) system with the new Medicare 

Severity DRGs (MS-DRGs), which 

indicate the severity of a patient’s illness in 

addition to the diagnosis. However, CMS 

believes it got a bad deal on payments it 

made while this change was being rolled 

out, and has determined that a 5.9% adjustment 

is needed to recover overpayments. 

Part of this adjustment is coming out of the 

2011 payment system rule, with more cuts 

expected for 2012. 

CMS published the final Inpatient Prospective 

Payment System rule in the Federal 

Register, www.gpoaccess.gov/fr/. 

productivity cuts imperil 

future of medicare 

in a recent report, the Medicare Board of 

Trustees admitted that CMS productivity 

cuts, expanded by healthcare reform to 

include cuts to the lab fee schedule, could 

eventually make it difficult for providers 

to offer care to Medicare beneficiaries as 

costs to providers rise faster than payment 

increases. The board raised concerns that, 

in the long run, these cuts could result in 

lower provider participation, less access to 

care, and reduced quality of services. Statutory 

changes to correct this problem would 

require congressional action. 

Because the productivity adjustments 

are tied to the over-all economy, the ensuing 

cuts to providers do not take into account 

the unique factors in each area of 

medicine, the report explained. “Since the 

provision of health services tends to be 

labor-intensive and is often customized to 

match individuals’ specific needs, most categories 

of health providers have not been 

able to improve their productivity to the 

same extent as the economy at large,” the 

board wrote. “Overtime, the productivity 

adjustments mean that the prices paid for 

health services by Medicare will grow about 

1.1 percent per year more slowly than the 

increase in prices that providers must pay 

to purchase the goods and services they 

use to provide health care services. Unless 

providers could reduce their cost per service 

correspondingly, through productivity 

improvements or other steps, they would 

eventually become unwilling or unable to 

treat Medicare beneficiaries.” 

It is possible that providers could reduce 

waste and take other steps to keep 

their cost growth within the boundaries 

imposed by the Medicare payment limitations, 

the board suggested. “Similarly, the 

implementation of payment and delivery 

system reforms…could help constrain cost 

growth to a level consistent with the lower 

Medicare payments. These outcomes are 

far from certain, however.” 

The Board of Trustees report is available 

on the CMS website, www.cms.gov/.

labcorp to purchase 

genzyme genetics for $925m 

laboratory Corporation of American 

Holdings announced it will acquire 

Genzyme Genetics for $925 million. The 

acquisition is aimed at expanding the firm’s 

capabilities in several testing areas, including 

reproductive, genetic, and hematologyoncology. 

According to David King, chairman 

and CEO of LabCorp, the purchase 

of Genzyme Genetics will also increase the 

company’s ability to perform clinical trials 

as a central laboratory. 

beckman coulter’s ceo resigns 

scott Garrett, chairman, president, and 

chief executive officer of Beckman 

Coulter, announced his resignation, effective 

September 6, 2010. Garrett had been 

with the company since 2005 and had recently 

led the integration of Olympus labbased 

diagnostics business into Beckman 

Coulter. J. Robert Hurley has been named 

interim president and CEO until the firm 

finds a permanent successor to Garrett. 

salk, sanford-burnham to 

use $21m grant for hiv effort 

salk Institute of Biological Studies and 

the Sanford-Burnham Medical Research 

Institute have announced that they 

will conduct systems biology-based studies 

of the earliest immune system responses 

to HIV infection with a $21 million grant 

from the National Institutes of Health. 

The multi-center research project will include 

DNA sequencing, expression analysis, 

RNAi analysis, and mass spectrometry, 

designed to discover the cellular protein 

mechanisms that protect against HIV. 

nih awards rheonix grant to 

develop poc Test for uTis 

rheonix, a microfluidics firm, has received 

a $233,044 supplemental grant 

from the National Institutes of Health, 

which will be used to develop a point-ofcare 

test for urinary tract infections (UTI). 

According to the firm, the test will allow all 

components of a multiplex molecular diagnostic 

to be integrated onto a 1-mm thick, 

palm-sized polystyrene chip. The grant 

supplements an earlier NIH award to develop 

a fully automated molecular diagnostic 

for identifying sexually transmitted infections 

and increases the scope of the work 

to include the molecular detection of UTI. 

nih to fund neurobiological 

assay research 

The National Institutes of Health announced 

that beginning in 2011 it will 

provide as much as $5 million in grants 

to develop molecular and cellular assays 

that can measure and analyze changes 

iNdustry 



in the function of brain cells. According 

to NIH, this grant program will fund research 

projects that seek to develop new 

technologies that can optimize, automate, 

standardize, and validate measures 

of molecular and cellular events that are 

relevant to brain function. These highthroughput 

tools should enable efficient 

screening of small molecules, peptides, or 

genetic perturbations. 

mlc dx to Target biomarkers 

nih to fund sigma-aldrich’s 

With dna Technologies 

cardiovascular disease research 

m s 

LC Dx, a San Francisco-based mo- igma-Aldrich has signed an agreement 

lecular diagnostics firm, has raised with the National Heart, Lung, and 

almost $6 million in private financing, it Blood Institute (NHLBI) of the National 

disclosed in a document filed with the U.S. Institutes of Health, and Boston University 

Securities and Exchange Commission. Ac- (BU) to develop methods to measure sevcording 

to the firm, it currently has a pateral potential biomarkers of atherosclerotic 

ent application for a method that uses cardiovascular disease (CVD) using plasma 

DNA sequencing technology to identify samples from NHLBI’s Framingham Heart 

biomarkers of autoimmune disorders and Study. Sigma-Aldrich will work with NHLother 

diseases. The method includes isolat- BI and BU to provide analysis of plasma 

ing samples from a subject, one or more samples from 7,000 participants that will 

rounds of nucleic acid amplification, spa- examine 180 potential biomarkers for CVD. 

tially isolating individual nucleic acids, and The project will be funded by NHLBI under 

sequencing nucleic acids. 

a research subaward agreement with BU. 

Presents a Conference 

Practical Applications of Mass Spectrometry 

In the Clinical Laboratory 

November 15, 2010 

Johns Hopkins Medical Institution’s Owens Auditorium 

Baltimore, MD 

Mass spectrometry is fast becoming the analytical method of choice 

for many clinical assays. This program will tackle and attempt to 

demystify some of the issues that have arisen as this technology 

evolves into a routine laboratory tool. 

Lab professionals often describe “mass spec” as a complimentary 

method to immunoassay, but no one doubts it has technological 

advantages over immunoassay for certain applications. Attend this 

conference to � nd out if mass spec has a place in your lab, and learn 

about clinical applications where it is now routinely used. 

Leading clinical mass spec experts will show you: 

• Advantages and challenges of mass spec 

• Basics of MS method evaluation 

• Pros and cons of mass spec vs. immunoassay 

In addition, conference faculty will examine some current applications in the clinical 

lab, including: 

• Therapeutic drug monitoring 

• Toxicology screening and con� rmation 

• Steroid and vitamin D analyses 

• Thyroid, thyroglobulin, and catecholamine testing 

For more information or to register, please visit 

the AACC web site at www.aacc.org. 

This educational event is supported, 

in part, by a generous educational 

grant from Thermo Fisher Scienti� c. 


detecting il-2 and ifn-γ 

discriminates between active 

and latent Tb infection 

new research indicates that detecting 

interleukin-2 (IL-2) in addition 

to interferon-γ (IFN-γ) discriminates active 

from latent Mycobacterium tuberculosis 

infection (Clin Microbiol Infect 

2010;16:1282-1284). The research builds 

diagNostiC 




on recent studies demonstrating the utility 

of assays that measure IFN-γ release in 

blood cells stimulated with M. tuberculosis 

antigens, according to the authors. IFN-γ 

release assays accurately diagnose tuberculosis 

(TB) infection, but do discriminate active 

from latent TB. 

The researchers stimulated whole blood 

with M. tuberculosis-specific antigens and 

used the QuantiFERON-TB Gold In Tube 

test to measure IFN-γ release and a commercially 

available ELISA assay to measure 

IL-2 release after 18 and 72 hours of incubation. 

The specimens came from patients 

hospitalized in an infectious diseases unit 

and from control subjects without known 

exposure to TB. Participants also underwent 

tuberculin skin testing (TST); those 

with positive test results and positive M. 

tuberculosis culture from sputum were considered 

to have active TB. Latent infection 

was defined as positive tests in exposed individuals 

with no signs of active disease. 

The investigators found that subjects 

with either latent or active TB had significantly 

higher levels of IFN-γ than controls. 

However, IFN-γ levels between individuals 

If you want to be known as an expert, 

you have to become an expert. AACC’s 

online certificate program is the way. 

““ 

• Clinical Laboratory Leadership and Management 

• Laboratory Support for Diabetes Testing 

• Point-of-Care Specialist 

• Basic Principles and Architecture of Laboratory 

Information Systems 

• Fundamentals of Molecular Pathology 

• Statistical Methods for Clinical Laboratorians 

• Using Tandem Mass Spectrometry in the 

Clinical Laboratory 

To learn more and enroll, visit 

aacc.org and click on “Events,” 

then “Online Education.” 

7 

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Certificate Programs 

from 

CLN_online_cert_jnr_isl_ad_7x10.indd 1 7/16/10 12:44:07 PM 

with latent or active TB were not significantly 

different at 18 or 72 hours after incubation. 

In contrast, after 72 hours’ incubation, 

IL-2 levels were significantly higher 

in patients with latent TB infection than either 

active TB or healthy controls. The area 

under the receiver operator characteristic 

curve was 0.99, and a threshold of 2.0 U/ 

mL yielded a sensitivity of 90% and specificity 

of 97.5%. 

The authors speculate that the increased 

levels of IL-2 observed in latent TB infection 

likely reflect more IL-2 secreting and 

IL-2/IFN-γ-secreting central memory Tcells 

along with fewer IFN-γ-secreting effector 

memory T-cells in individuals with 

latent as opposed to active TB. 

bnp levels do not predict 

intracranial hemorrhage in 

pediatric Trauma patients 

researchers at Children’s Hospital Los 

Angeles found that B-type natriuretic 

peptide (BNP) levels measured during an 

emergency visit do not predict intracranial 

hemorrhage (ICH) in pediatric trauma 

patients (J Trauma 2010;68:1401–5). They 

conducted the study to determine whether 

BNP might help identify children most in 

need of computed tomography (CT) scans. 

Emerging evidence indicates there is a significantly 

increased risk of cancer among 

pediatric patients who have CTs, and protocols 

to deploy CT more selectively have 

been implemented. At the same time, 

emerging evidence suggests that BNP levels 

are elevated in adults with head injuries. 

Since BNP tests are readily available and 

can be performed quickly, the researchers 

hypothesized that this analyte might predict 

ICH and help guide physicians in determining 

whether a CT would be needed. 

They enrolled 100 consecutive pediatric 

patients presenting at the emergency 

department who were classified as Level I 

trauma status with the most critical injuries 

and physiologic parameters. However, 

of 95 patients who remained in the study 

for analysis, they did not find a relationship 

between BNP levels and the presence 

of various trauma injury measurements 

such as injury severity score, Glasgow coma 

scale, or loss of consciousness. In fact, BNP 

levels for 57.9% of patients were below the 

assay’s lower limit of detection, and mean 

BNP levels among patients in the positive 

ICH group were slightly less than those 

who were negative for ICH. 

While the researchers conclude that 

based on their study, BNP levels are not 

clinically relevant to predict CTs with positive 

results for ICH, they underscored that 

specimens drawn for the study were taken 

only upon arrival at the emergency department. 

However, evidence in adults indicates 

that BNP levels in aneurysm and subarachnoid 

hemorrhage did not rise significantly 

until hours or days later. The authors suggest 

that further investigation of pediatric 

BNP levels outside the emergency setting is 

warranted. 

visit aacc.org

news from the fda 

fda approves first automated 

molecular Test for hbv 

abbott has received FDA approval to 

market an assay for measuring viral 

load, the amount of hepatitis B virus 

(HBV) in a patient’s blood. The Abbott RealTime 

HBV assay is the first and only FDAapproved 

test capable of automating HBV 

viral load testing from sample extraction 

to final results. The test provides sensitive 

measurement of HBV in human plasma 

or serum from individuals chronically infected 

with HBV and is designed for use as 

an aid in the management of patients with 

chronic HBV infection undergoing antiviral 

therapy. 

bd gets moderate complexity 

status for group b strep assay 

becton Dickinson has received moderate 

complexity status from the FDA for 

its BD MAX GBS Assay for Group B Streptococcus 

(GBS) on the BD MAX System. 

With the new test status, the BD MAX GBS 

Assay will be available as a cost-effective 

molecular test for a wider range of laboratories 

performing GBS screening. 

fda clears new Test system to 

detect Torch infections 

ZEUS Scientific has announced clearance 

of its AtheNA Multi-Lyte ToRCH 

IgG Plus Test System. This new test system 

is designed for the qualitative detection 

of specific human IgG class antibodies to 

Toxoplasma gondii, rubella, cytomegalovirus 

(CMV), and HSV 1 and 2 (type 

specific) in human sera (TORCH). According 

to the company, the assay’s results are 

meant to be used as an aid in assessing the 

serological status of individuals, including 

pregnant women. Serological testing for 

infection by TORCH organisms in fetuses 

and newborns can aid in identifying individuals 

who are at significant risk of adverse 

outcomes. 

arrayit seeking pma for 

ovarian cancer Test 

arrayit, a microarray firm, announced 

that it will be seeking pre-market approval 

from FDA for its OvaDx ovarian 

cancer test. According to the firm, the test is 

based on Arrayit’s proprietary microarray 

platform that detects close to 100 protein biomarkers 

in serum. The company claims that 

the OvaDx test can identify ovarian cancer 5 

years before there are any signs or symptoms. 

fda clears radiometer’s new 

abl90 fleX poc analyzer 

radiometer has received FDA clearance 

for its ABL90 FLEX analyzer. The new 

cassette-based analyzer is the latest addition 

to the company’s blood gas line, offering 

speed and high-throughput in a compact 

instrument. The ABL90 FLEX analyzer 

delivers results on 16 parameters in 35 seconds 

from 65 µL of whole blood. 

c A ll FOr A b S trA ctS 

Deadline: January 31, 2011 

43rd Annual 

Emerging Technologies for 

21st Century Clinical Diagnostics 

April 14 & 15, 2011 

baltimore, Md. 

Abstracts on all areas of pre-commercial technology 

for clinical diagnostics are welcome! 

$500 Outstanding Poster Award 

The Oak Ridge Conference is the American Association for Clinical Chemistry’s annual forum 

for emerging clinical diagnostic technologies. With presentations focusing on novel technologies 

and systems, the meeting brings together thought leaders from industry, academia, and clinical 

laboratories. The conference focuses exclusively on pre-commercial technologies, and session 

topics are updated each year to reflect diagnostic trends. Now in its 43rd year, the Oak Ridge 

Conference is firmly established as the premier forum for next generation clinical diagnostics 

developers. 

Last year, the conference attracted more than 80 abstracts. You can be a part of this highly regarded 

conference by submitting an abstract for the poster session. The conference committee will select 

abstracts for brief oral presentations. 

Sessions 

l New Sequencing Technologies for Clinical Diagnostics 

l Innovative Technologies for Infectious Disease Diagnostics 

l New Technologies for Quantitative Pathway Mapping in Tissues 

l Novel Nanotechnology Approaches for Diagnostics 

For more information and to submit an abstract, go to: www.aacc.org/events/ 

American Association for Clinical Chemistry, Inc. 

1850 K Street, NW, Suite 625, Washington, DC 20006 

Attendees rate this the best poster session for emerging diagnostic technologies. 

indeX To adverTisers 

Please visit these websites to learn more about the products in this issue. 

bio-rad laboratories ........................................ 5 

www.bio-rad.com/diagnostics 

fujirebio diagnostics ........................................ 24 

www.taketherightpath.com 

Kamiya biomedical company .......................... 7, 18, 23 


Kronus ....................................................... 20 

www.kronus.com 

midland bioproducts corp. .................................. 6 

www.midlandbio.com 

ortho-clinical diagnostics ............................. 2, 11, 19 

www.orthoclinical.com 

Wako diagnostics ........................................... 17 

www.wakodiagnostics.com 

K-ASSAY ® 

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� Adaptable to most chemistry analyzers including: 

Abbott Aeroset 

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Alfa Wassermann ACE ® 

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Beckman Synchron CX ® / DX ® 

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Beckman / Olympus AU series 

Horiba ABX Pentra 400 

Mindray BS-200 




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Roche Cobas c501 / 6000 

Roche Cobas Mira ® / Fara ® 

Roche / Hitachi 700 & 900 series 

Siemens / Bayer Advia ® 1650 / 2400 

Siemens / Bayer Dimension ® 

Siemens / Bayer Opera ® 

Stanbio Sirrus ® / Prestige 24i 

Vital Diagnostics Envoy 500 

Others . . . 

CliniCal laboratory news oCtoBeR 2010 23 

Ferritin CLN 08-2010A.indd 1 6/29/2010 5:24:42 PM

From the company who brought you CA125 

A New 

Biomarker for 

Ovarian Cancer 

HE4 

HE4 is available in the United States for use as an aid in 

monitoring recurrence or progressive disease in patients 

with epithelial ovarian cancer. 

• 75% of patient samples with no change in HE4 value correlated with no 

progression of disease 1 

• 60% of patient samples with a positive change in HE4 value correlated with 

disease progression 1 

• HE4 should be used in conjunction with other clinical methods to determine 

disease status 

Coming soon...the only multi-constituent 

control containing the novel bio-marker HE4 

for improved performance and accuracy. 

For more information visit: www.taketherightpath.com 

FDI-235 04/10 

References: 1. HE4 EIA Kit Package Insert. Fujirebio Diagnostics, Inc. 

© 2009 Fujirebio Diagnostics, Inc.

oCtoBeR 2010 - American Association for Clinical Chemistry

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