lab matter

Fall 2013, Issue 4
LABMATTERSanalysis|answers|action
ASSOCIATION OF PUBLIC HEALTH LABORATORIES
INSIDE
5 Cyclosporiasis2013:AnExampleofPHLSkillandDedication
8 NewbornScreeningCelebrates50Years
23 EmergingTechnologiesinSentinelClinicalLaboratoriesPoseChallengestoLRNProcedures
NANOTECHNOLOGY:
THETHIRDINDUSTRIALREVOLUTION

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contents
FEATURE ARTICLE: 12
NANOTECHNOLOGY:
The Third Industrial Revolution
Nanotechnology—the science of engineering functional
materials on an atomic scale—was the foreseeable result
of the relentless miniaturization of electronics compo-
nents and tools. As this technology continues to advance,
so does monitoring potential health implications. Striking
a balance between encouraging scientific progress and
protecting public health will be key in the years to come.
APHL LAB MATTERS STAFF
Hilary Strahota, Editor
Emily Mumford, Associate Editor
Steven Oatmeyer, Art Director
Jody DeVoll, Advisor
Caprice Retterer, Contributor
APHL BOARD OF DIRECTORS
Christine Bean, President
Dan Rice, President-Elect
Judith Lovchik, Secretary –Treasurer
Ewa King, Member-at-Large
Chris Whelen, Member-at-Large
Joanne Bartkus, Member-at-Large
Mimi Lachica, Local Institutional
Member Representative
Tammy Theisen, Local Institutional
Member Representative
Charles Brokopp, Past President
Scott J. Becker, Ex-Officio
The Association of Public Health
Laboratories (APHL) is a national, non-
profit dedicated to working with members to
strengthen laboratories with a public health
mandate. By promoting effective programs
and public policy, APHL strives to provide
public health laboratories with the resources
and infrastructure needed to protect the
health of US residents and to prevent and
control disease globally.
8515 Georgia Avenue, Suite 700
Silver Spring, MD 20910
Phone: 240.485.2745
Fax: 240.485.2700
E-mail: info@aphl.org
Web: www.aphl.org
This publication was supported by
Cooperative Agreement # U60HM000803
and # U2GPS001799 from CDC and/or
Assistant Secretary for Preparedness and
Response and # U22MC24078 from HRSA.
Its contents are solely the responsibility
of the authors and do not necessarily
represent the official views of HRSA,
CDC and/or Assistant Secretary for
Preparedness and Response. 95% of the
total cost of projects/programs were paid
for with federal funds. 5% of the total cost
of projects/programs were paid for with
non-federal funds.
To submit an article for consideration,
contact Editor Hilary Strahota at hilary.
strahota@aphl.org.
COLUMNS
2 President’s and Executive Director’s Column
SECTIONS
Infectious Diseases
4 A New Paradigm: How Public Health Laboratories Perceive the Future of TB Testing
5 Cyclosporiasis 2013: An Example of PHL Skill and Dedication
Food Safety
6 Launching Whole Genome Sequencing in the Public Health Realm
Newborn Screening and Genetics
7 NewSTEPs Data Repository: Now Live!
8 Newborn Screening Celebrates 50 Years
Environmental Health
16 International Efforts to Monitor Nanotechnology
19 Embracing New Standards for Occupational Blood Lead Levels
Global Health
20 First International LIMS Workshop in Sub-Saharan Africa
Public Health Preparedness and Response
21 The Hype About the Middle Eastern Respiratory Syndrome (MERS-CoV):
Should We Be Worried?
22 Behind the Scenes: A Technical Overview of LIMS Integration for LRN-B Laboratories
23 Emerging Technologies in Sentinel Clinical Laboratories Pose Challenges to
LRN Procedures
Laboratory Systems and Standards
24 APHL Hosts Teleconference on Media Preparation and Inventory Difficulties
Informatics
26 Technical Assistance Team Troubleshoots IT Issues for New VPD Reference Centers
Member Spotlight
28 Nation’s ‘Healthiest Laboratory’ Elevating the Health of Arkansans
30 Thinking Big in Tulare County, CA: Giant Trees, Large-scale Farms, and a
Grand Year for the PHL
Fellows
32 APHL Initiates New Class of Emerging Infectious Diseases Laboratory Fellows
Digital Extra
33 Tools You Can Use
Digital Extra!
Don’t miss out on multimedia and bonus content in the digital version
of Lab Matters.This issue features a new section called Meet the APHL
Staff, where readers can learn more about the different programs at
APHL and their respective staff. Subscribe to the digital edition by
emailing subscribelm@digital.com. Contact caprice.retterer@aphl.org
to learn more.
Fall 2013, Issue 4
LABMATTERSanalysis|answers|action
ASSOCIATION OF PUBLIC HEALTH LABORATORIES
NANOTECHNOLOGY:
INSIDE
5 Cyclosporiasis2013:AnExampleofPHLSkillandDedication
8 NewbornScreeningCelebrates50Years
23 EmergingTechnologiesinSentinelClinicalLaboratoriesPoseChallengesto LRNProcedures

president’s and executive director’s column
2 LAB MATTERS Fall 2013
Scott Becker: In this issue of Lab Matters, please take a
moment to look at the photos and read the stories from
our 50th
anniversary celebration of newborn screening. It
was an honor for both of us to help host these events on
Capitol Hill in September.
Christine Bean: We hope the anniversary celebrations
help garner the attention that newborn screening pro-
grams deserve. Newborn screening is a core public health
laboratory function, and we test 97% of American babies.
Becker: During the anniversary celebration, we had
newborn screening advocates and families join us to talk
about the importance of renewing the Newborn Screening
Saves Lives Act, including Jim Kelly, NFL Hall of Famer.
Bean: We hosted a panel discussion, moderated by
Dr. Richard Besser of ABC News, to shed light on the
importance of newborn screening, to put a human face
on it by introducing some of the impacted families to our
representatives. We want them to understand that this
laboratory science helps our most vulnerable, the babies.
Becker: We also had a national Twitter chat via ABC News,
with 1,700 tweets in an hour, resulting in 13.3 million
exposures. For that matter—while I am talking statistics—
we shouldn’t forget that 10.2 million people viewed our
public service announcements about newborn screening
in New York’s Times Square earlier this year.
Celebrating Core Public Health Laboratory Functions
Food Safety Takes the Front Row at the InFORM Meeting
Bean: And as this year of newborn screening celebration
ends, we are turning the spotlight to other core laboratory
functions, including food safety. This is a critical time for
food safety in the United States. As we talk, we are in the
midst of a government shutdown that imperils the work
of our food safety system. Food inspectors are furloughed
and critical support at CDC is off line.
Becker: While the local and state portions of the public
health system are still hard at work, we no longer have our
essential federal partner, CDC, to take the disparate pieces
of information from each region of the country and piece
it together. It is CDC’s role to identify and address national
outbreaks of influenza or foodborne illness.
Bean: The idea that any of this work is “non-essential” is
disturbing. Just as you can’t interrupt an electrical circuit
and still expect the lights to come on, Congress can’t
expect the remaining pieces of the public health system to
simply close the gap and keep all of our health protections
operational. The services provided by CDC, the FDA—all
of the federal agencies—are essential to our nation’s
well-being.
Becker: As we sit here and wait for Congress to turn the
lights back on, we are vulnerable. We are unable to use
the health systems that have been designed and proven
to keep us safe, and are instead in the untenable position
of having to cross our fingers and hope we’re lucky, that
nothing terrible happens.
Bean: In light of the government shutdown, it is more
appropriate than ever that this year, for the first time,
there is an integrated food safety meeting for all of the
professionals who respond to foodborne outbreaks.
Becker: Meetings have usually been separate—PulseNet
for the laboratorians and OutbreakNet for the epidemiolo-
gists. This year, they are combined; and local food and
health inspectors have joined too, adding the
environmental health component.
Bean: This is still a technical meeting for laboratorians.
Sessions on PFGE, gene sequencing and new technologies
are still on the agenda, just as they were at the PulseNet
meetings. New this year are overarching sessions that
highlight the multidisciplinary nature of foodborne
outbreak detection and response.
@APHLPublicHealthLabs APHL.org
APHL President Christine Bean, PhD, MBA, MT (ASCP) and Executive Director
Scott Becker, MS took a moment to discuss some of the recently completed 50th
anniversary newborn screening events, as well as the importance of the
Integrated Foodborne Outbreak and Response Management (InFORM)
meeting, in San Antonio, TX.
exposures. For that matter—while I am talking statistics—
we shouldn’t forget that 10.2 million people viewed our
public service announcements about newborn screening
in New York’s Times Square earlier this year.
lights back on, we are vulnerable. We are unable to use
the health systems that have been designed and proven
to keep us safe, and are instead in the untenable position
of having to cross our fingers and hope we’re lucky, that
nothing terrible happens.
Bean:
appropriate than ever that this year, for the first time,
there is an integrated food safety meeting for all of the
professionals who respond to foodborne outbreaks.
Becker:
for the laboratorians and OutbreakNet for the epidemiolo
gists. This year, they are combined; and local food and
health inspectors have joined too, adding the
environmental health component.
Bean:
Sessions on PFGE, gene sequencing and new technologies
are still on the agenda, just as they were at the PulseNet
meetings. New this year are overarching sessions that
highlight the multidisciplinary nature of foodborne
outbreak detection and response.

Becker: InFORM is co-sponsored by a number of federal
agencies and partners, including APHL, CDC, the Food
Safety Inspection Service, FDA, the Council for State and
Territorial Epidemiologists (CSTE), the National Environ-
mental Health Association (NEHA), and the Association of
Food and Drug Officials (AFDO). It’s like FSMA (the Food
Safety Modernization Act) come to life. It’s about partner-
ships, not just detection or sourcing; it’s the system.
Bean: And it’s how we actually respond to food emergen-
cies. In New Hampshire, we had a potential outbreak
situation recently when an employee of a small restaurant
was diagnosed with Hepatitis A. The response to this
diagnosis required everybody to work together—laboratori-
ans, epidemiologists, and health inspectors—to immunize
the 1,000 people who may have been exposed. The
InFORM meeting reflects the reality of the workplace.
It’s a smart idea.
Becker: Yes. Hats off to Dr. Chris Braden and others at
CDC for expanding this meeting to be inclusive and dem-
onstrating integrated food safety systems. All of this is in
harmony with APHL’s efforts to encourage labs of all kinds
to come forward and work with us, whether they’re food,
agricultural or veterinary. Where our work overlaps, has
common goals, or shares technology, we should be a team.
Bean: And we have made progress there. We are excited
to have Dan Rice, who is the director of the state food
laboratory at the New York State Department of Agricul-
ture and Markets, as our APHL President-Elect. He will
bring the very important perspective of the food safety
community to our leadership.
Becker: And truly, food safety is still living on the edge.
Although there have been many improvements over the
years, it is still not funded appropriately and there is al-
ways a risk that we could lose ground without
proper support.
Bean: Our laboratories perform a service that is not
replicated elsewhere. Within our global food community,
foodborne illness is a significant and growing problem. We
must ensure that we continue to improve, that we work
together and that we seek the support, both financial and
otherwise, that we need.
MeetingMaterials
Integrated Foodborne Outbreak and
Response Management Meeting
November 18-21, 2013
San Antonio, TX
Following the meeting, presentations and
materials will be available on APHL’s
website at: http://www.aphl.org/conferences/
proceedings/#pulsenet

infectious diseases
Laboratory diagnosis of TB has long been
performed with the conventional methods
of microscopy and culture. Now, however, new
diagnostic methods are providing more detailed
and nuanced information than ever before.
These methods are causing TB laboratories to
reevaluate their use of well-proven testing
paradigms against the advent of
promising technology.
In August, more than 150 members of the US TB
laboratory community gathered in San Diego,
CA, for APHL’s 8th National Conference on
Laboratory Aspects of Tuberculosis.Throughout
the meeting, participants discussed different
approaches to handling the field’s changes, most
of which involved a mixture of collaboration,
innovation and practical thinking.
The questions addressed at the conference were
straightforward: How do laboratories provide
accurate information quickly and more cost-
effectively? How can new and emerging tech-
nologies be integrated into an existing system?
Keynote speaker Dr. Maduhkar Pai, of the McGill
International TB Centre, urged attendees to be
cautious about building a paradigm around
the power of technology alone, referencing the
recent FDA market approval of the Cepheid
Xpert MTB/RIF assay. [See sidebar.] In order to
be effective, all diagnostic methods require both
the appropriate interpretation of test results
and timely patient intervention. Without those
components, the value of any test—no matter
how ground breaking—is limited. Pai’s presenta-
tion framed the broader discussion about why
laboratories are critical partners in the effective
implementation of new diagnostics.
A New Paradigm: How Public Health Laboratories
Perceive the Future of TB Testing
by William Murtaugh, MPH, specialist, TB program
4 LAB MATTERS Fall 2013 @APHLPublicHealthLabs APHL.org
Much of the discussion in the following days
touched on the issues caused by the integration
of new methods for drug susceptibility testing
(DST). Dr. Edward Desmond and Dr. Grace Lin,
from the California Public Health Laboratory,
shared some of the challenges associated with
reporting the level of detail available within
molecular DST results; these presentations
revealed the complexity of the interpretation
and reconciliation of phenotypic results of
conventional DST with genotypic results of mo-
lecular DST. Through examples of discordance
between conventional and molecular testing,
conference participants were encouraged to
consider how they might harness molecular
technologies to make all available information,
including clinical evidence, work together.
Other clinicians and researchers at the meet-
ing shared perspectives on emerging technolo-
gies that have applications to TB testing, with
several of them identifying bioinformatics as an
area where increased public health capacity is
needed. Dr. Tony Catanzaro (UC San Diego) and
Dr. Faramarz Valafar (San Diego State) described
ongoing work in whole genome sequencing (and
sequencing’s database-building) that further
characterizes globally circulating multi and
extensively drug-resistant strains of M. tuber-
culosis, aimed at improving applications such
as deeper understanding of tuberculosis drug
treatment failure.
Dr. Adam Barker of ARUP Laboratories described
applications of a chemistry-based assay, matrix-
assisted laser desorption/ionization time of
flight (MALDI-tof), for identification and compar-
ative speciation of mycobacteria, also requiring
comprehensive databases to maximize its value.
In July 2013, the FDA granted market
approval for the Cepheid Xpert MTB/RIF
assay, capable of detecting Mycobacterium
tuberculosis complex (MTBC), as well as
mutations associated with resistance to the
ﬁrst-line treatment drug, rifampin, from raw
sputum within two hours. This development
is likely to provide unprecedented access to
TB nucleic acid ampliﬁcation tests (NAAT)
in clinical laboratories, potentially
changing the way TB laboratory services
are delivered in the US.
The conference emphasized that the value of
test results is driven, not by the technologies
themselves, but by the quality of the interac-
tions among laboratorians, TB controllers,
physicians and other partners as a whole.
Through discussions like these, public health
laboratorians are ensuring that changes are
implemented thoughtfully, with a deep
understanding of the inherent complexities.
The presentations discussed above, as well as
others from the 8th
National Conference on
Laboratory Aspects of Tuberculosis, can be
viewed at www.aphl.org/conferences/proceed-
ings/Pages/8th-National-Conference-on-
Laboratory-Aspects-of-Tuberculosis-2013.aspx.
Keynote speaker Dr. Maduhkar Pai responds to a participant’s question. From left to right:
Ed Desmond (conference chair), Madhukar Pai, Philip Hopewell
Conference participants discuss their work during the poster session

infectious diseases
Fall 2013 LAB MATTERS 5@APHLPublicHealthLabs APHL.org
In 2012, the Iowa State Hygienic Laboratory conducted just nine Cyclospora
tests. In 2013, red flags were raised when the lab received two confirmed
cases of Cyclospora a few days apart, on June 25 and 28.The lab notified CDC
of a potential outbreak and then, over the next month and a half, performed
a volume of testing that challenged the limits of the laboratory and public
health department.
Table 1 shows the stark contrast between normal specimen volumes
and the extraordinary levels handled in July 2013. With dedicated staff
conducting approximately five times the typical number of parasitology
tests each day (15-25 normally; 85-115 in July 2013)1
and working 10- or
12-hour days, seven days a week, it was clear that Iowa needed assistance
from other laboratories.
Mary DeMartino, Iowa’s interim laboratory manager, used APHL’s Survey
Resource Center to find laboratories in neighboring states that could help
with parasitology testing. After finding that a few of the surveyed labo-
ratories had been forced to drop parasitology due to budget cuts, Mary
DeMartino reached out to APHL staff members Kelly Wroblewski and Jane
Getchell, who were able to identify laboratories with current parasitology
programs. Ultimately, the Veterans Affairs Medical Center in Iowa City, and
public health laboratories in Missouri, Wisconsin, Maryland and Georgia,
were able to provide surge capacity testing.
Cyclosporiasis 2013:
An Example of PHL Skill
and Dedication
by Jessica Monmaney, associate specialist, food safety
and infectious diseases
The 2013 Cyclospora outbreak is the largest
since 1997 with 643 cases identified in 25
states, as of October, 2013.3
1. http://www.cdc.gov/parasites/cyclosporiasis/outbreaks/investigation-2013.html
2. http://images.magnetmail.net/images/clients/APHL/attach/CyclosporaCall_081413_Minutes.pdf
3. http://www.cdc.gov/parasites/cyclosporiasis/outbreaks/investigation-2013.html
During this timeframe, the Iowa Public
Health Laboratory was also working to
confirm positive cases that had been
identified by clinical labs or national
reference labs.
The Cyclospora outbreak in Iowa soon
prompted increased testing in laboratories
throughout the US.This testing eventually
led to the investigation of a multi-state
Cyclospora outbreak in Iowa and Nebraska
that was linked to a bagged salad mix sup-
plied to Red Lobster and Olive Garden from
Taylor Farms de Mexico.1
During this time,
25 other states notified the CDC about per-
sons ill with Cyclospora; investigations are
ongoing but, to date, these outbreaks have
not been linked to Taylor Farms de Mexico or
to each other. Increased surveillance caused
by media coverage of the outbreak may have
elevated the number of cases, some of which
would have normally gone unidentified.
Nebraska’s experience during the Cyclospora outbreak differed from Iowa’s
because the majority of the parasitology testing was conducted within
the state’s clinical laboratories. Specimens only came to the public health
laboratory when specifically requested by epidemiologists. Dr. Peter Iwen,
associate director at the Nebraska Public Health Laboratory, found that,
“The Nebraska PHL reported negative results in several specimens that
were initially deemed positive by the clinical laboratory. It was requested
that they send specimens to CDC for molecular method testing however,
the 10% formalin preservative that clinical laboratories use makes molecu-
lar analysis impossible.This outbreak has been an opportunity to provide
education to clinical labs to ensure testing for parasites is being done
properly from specimen collection to reading the slides.”2
Laboratories still rely primarily on conventional microscopy methods, in-
cluding modified acid fast and auto-fluorescence examination, to identify
Cyclospora. However, this outbreak showed that an increasing number of
public health and clinical laboratories are eliminating conventional para-
sitology testing due to budget constraints, which raises concerns about
the country’s ability to handle future outbreaks. CDC and FDA are now
working with public health laboratories to explore the use of PCR and DNA
sequencing to identify cases and link different strains among states.These
techniques may ease future response efforts.
Jaye Boman, interim general supervisor
for bacteriology, stacks containers of the
thousands of specimens that the Hygienic
Laboratory has tested for Cyclospora since
the outbreak began in July. Photo Credit: State
Hygienic Laboratory at the University of Iowa
Michael Last, clinical laboratory technical specialist at the State Hygienic Laboratory, identified the first cases in the outbreak.
Photo Credit: State Hygienic Laboratory at the University of Iowa
Year 2012
Specimens
3787
Year 2012
Tests
July 2013 Tests
(% of 2012)
July 2013
Specimens
Total Specimens
Cyclospora Tests
O&P (ova and
parasite tests)
Trichrome Tests
Total Tests
1991 (53%)
9
3777
1309
5095
1635 (18,167%)
1131 (30%)
591 (45%)
3357 (66%)

food safety
Developing the Technology
I
n the 1990s, DNA sequencing-based technologies made headlines as
academic centers, government and private companies began the
monumental feat of mapping the entire human genome. The genome-
mapping project transformed the way scientists and clinicians viewed
sequencing technology, as predictive medicine emerged as an area of
interest in clinical medicine. Research science began moving from aca-
demia to the clinical and public health sectors. Since then, public health
practitioners have used sequencing-based technologies to uncover the
epidemiology of many genetic and infectious diseases. The investigation
into the October 2010 cholera outbreak in Haiti demonstrated the utility
of this technology in a public health setting.
Today, the possibility of applying whole genome sequencing (WGS) to
national disease surveillance is within reach due to the declining costs of
the technology and the development of bioinformatics pipelines capable
of analyzing massive amounts of DNA data. Although it is an exciting time
in public health, as new tools are used to track diseases, many challenges
have emerged that must be addressed. Some of the challenges are build-
ing a public health infrastructure for next generation sequencing technol-
ogies, identifying analysis tools that meet public health needs, and issues
surrounding secure data storage.
Worldwide Participation: The Global Microbial
Identiﬁer Network
On a global level, an informal community of scientists is attempting to
address these challenges in order to develop an international, inter-labo-
ratory platform for storing WGS data of microorganisms. The initiative’s
participants intend to create a platform for connecting databases that will
allow international scientists to sequence, analyze and compare genomes
for the detection of outbreaks and emerging pathogens. In 2011, the first
meeting of the Global Microbial Identifier (GMI) initiative was organized
in Brussels, under the leadership of the US Food and Drug Administration
(FDA) and the Technical University of Denmark (DTU).
Since then, five additional meetings have been organized, and a charter
and several working groups have been developed. According to the
GMI Charter:
“The (network of) databases will include all kinds of microorganisms (i.e.
bacteria, viruses, parasites and fungi) and be accessible through user-friendly
interfaces for end-users in academia, industry and government (e.g. clinicians,
veterinarians, epidemiologists, microbiologists). The use of the platform and
linked databases is seen as a public good and would significantly improve
health systems, as well as systems aiming at a safe food supply and environ-
mental control systems.”
A GMI steering committee comprised of scientists from the FDA, DTU, the
National Center for Biological Information (NCBI), the United Kingdom’s
Health Protection Agency (HPA) and Food Standards Agency (FSA), the
World Health Organization, the Thai Ministry of Public Health, and the
Dutch National Institute for Public Health and Environment has
been organized.
Several projects, formed by both public and private partnerships, will
provide the research foundation for GMI. Among the food safety-related
projects, the FDA Genome Trakr Network and CDC’s Listeria WGS real-
time proof-of-concept study have begun. These projects are attempting to
Launching Whole Genome Sequencing in
the Public Health Realm
by Jennifer Adams, lead specialist, PulseNet Quality Assurance, and Kristy Kubota, senior specialist, PulseNet
demonstrate the utility of next generation sequencing methods for public
health surveillance and detection of outbreaks.
US Applications of WGS
Genome Trakr is a collaboration among seven state public health laborato-
ries (NY, WA, FL, AZ, MD, MN and VA), FDA’s Center for Food Safety and
Applied Nutrition, FDA’s Center for Veterinary Medicine, and nine FDA
field-based laboratories under the Office of Regulatory Affairs. The goal of
this network is the real-time exchange of WGS data of foodborne patho-
gens in order to detect and investigate foodborne outbreaks more rapidly,
thus preventing further spread of illness. Data is publicly accessible via
www.fda.gov/Food/FoodScienceResearch/WholeGenomeSequencing
ProgramWGS/default.htm. The participating laboratories have received
Illumina MiSeq sequencers and funding for personnel, supplies, and
reagents to perform WGS of Salmonella isolates. The genomic data and
corresponding metadata are being uploaded to a database at NCBI for
analysis and comparison.
At the first Genome Trakr Pilot Users Group Meeting held in Baltimore, MD,
in September 2013, participants discussed the needs of the participating
laboratories and identified improvements that could be made to current
processes. Topics included training and quality of data, limitations on
the type of metadata that can be submitted due to patient confidential-
ity, standardization and accurate entry of metadata, rapid bioinformatics
analysis and results turnaround time, and criteria for defining a cluster
or outbreak. Directors and scientists from all seven participating public
health laboratories were in attendance.
The CDC Listeria real-time genome-based surveillance proof-of-concept
study is a collaborative effort involving all PulseNet-participating pub-
lic health laboratories and their foodborne epidemiology counterparts.
Laboratories submit their Listeria isolates to CDC in real-time for whole
genome sequencing, while epidemiologists submit Listeria Initiative case
report forms rapidly to enhance surveillance. (Listeria isolates must be
submitted within four working days and Listeria Initiative case report
forms within seven days of interview.) Laboratories participating in FDA’s
Genome Trakr Network may choose to sequence their own Listeria isolates,
if they can do so in real-time. The goal of this study is to demonstrate the
potential of WGS to enhance surveillance and identify clusters of
listeriosis rapidly.
The official launch of this proof-of-concept study was September 1, 2013.
Two conference calls were held in conjunction with APHL to explain the
study, the connection to FDA’s Genome Trakr Network, and the requests
being made of public health laboratories. During these difficult economic
times, it is nice to see sister federal agencies encouraging dual-use of new
instrumentation while simultaneously including state laboratories in
cutting-edge applied research.
The continued development of the networks and the commitment from
these laboratory institutions is sure to have a positive effect on the future
use of WGS in foodborne outbreak detection. These projects may illus-
trate the power of WGS and its utility in public health surveillance and
response. Ideally these projects will encourage policymakers to fund the
CDC’s Advanced Molecular Detection and Response to Infectious Diseases
Initiative, which is a $40 million proposal in the President’s 2014 budget.
Now is the time for public health laboratories to be on the frontlines of
this remarkable and transformative journey shaping the next generation
of public health surveillance.

newborn screening and genetics
The Newborn Screening Technical Assistance and
Evaluation Program (NewSTEPs) wrapped up its first
year of activities this summer. The program has gotten
off to a great start implementing quality improvement
initiatives for newborn screening (NBS) systems.
NewSTEPs is pleased to announce that its Data
Repository is now live, with the ability to accept data
in a secure and streamlined fashion. Ease of use and
opportunities to integrate data with other systems
have been an important consideration during the
development of the repository.
During the past year, a set of data elements has been developed with community
input, including state profile information, case definitions, quality indicators, and
data on diagnosed cases that will, in turn, inform the quality indicators. APHL will enter
into Memorandums of Understanding (MOUs) with all state public health laboratories and
NBS programs to ensure that data sharing activities are transparent and conducted with
the highest levels of security and privacy in place. NewSTEPs worked with the Colorado
Multiple Institutional Review Board (COMIRB) and the Department of Health and Human
Services’ Office of Human Research Protection (OHRP) to determine the oversight needed
for the repository. Both COMIRB and OHRP declared in August 2013 that NewSTEPs’ activi-
ties are classified as Non-Human Subject Research.
The NewSTEPs Data Repository offers a comprehensive set of variables for programs to
run queries and generate reports with the end goal of quality improvement and achieving
better outcomes for newborns. These include:
• Case Information, guided by NBS surveillance case definitions developed with
community input.
• Quality Indicators, developed by NBS stakeholders in order to evaluate program quality
and measure improvement.
• State Profiles, including demographic data, health information technology information,
NBS policies, disorders screened, and NBS program structure.
NewSTEPs looks forward to continued collaborations with partners in state NBS
programs and stakeholders across the country. These collaborations are realized through
the NewSTEPs’ steering committee, workgroups to guide daily activities, and partnerships
with other NBS organizations at the regional and national levels. The NewSTEPs’ Data
Repository is an exciting opportunity to analyze, compare and continuously improve
NBS systems.
NewSTEPs Data Repository: NOW LIVE!by Sikha Singh, MHS, PMP, manager, NewSTEPs
NewSTEPs Website and Data Repository:
https://www.newsteps.org
NewSTEPs Vision
Dynamic newborn screening systems have
access to and utilize accurate, relevant
information to achieve and maintain excellence
through continuous quality improvement.
NewSTEPs Mission
To achieve the highest quality for newborn
screening systems by providing relevant,
accurate tools and resources and to facilitate
collaboration between state programs and
other newborn screening partners.
The NewSTEPS Data Repository website

newborn screening
W
rapping up a yearlong celebration of the 50th anniversary of
newborn screening, APHL hosted a day of events on Capitol
Hill during National Newborn Screening Awareness Month.
On September 18, family advocates visited congressional staff, NFL
Hall-of-Famer Jim Kelly held a congressional briefing and ABC News’ Dr.
Richard Besser hosted a panel discussion. Later, a reception and awards
program at the US Capitol Visitor Center drew more than 200 guests,
including parents, public health leaders, newborn screening advocates,
policymakers, and federal, local and private partners. The day’s activities
were designed to highlight newborn screening’s scientific accomplish-
ments, as well as its human impact on thousands of families.
At the reception, Patricia Guthrie discussed her father, Dr. Robert Guth-
rie, who developed the first screening test for phenylketonuria (PKU) 50
years ago. Today, Robert Guthrie is often credited as the father of newborn
screening in America. His novel concept ultimately led to screening for
other genetic and metabolic disorders, including congenital hypothyroid-
ism and sickle cell disease. “When people asked me what my father did,
I told them, he was the one who made your baby cry in the hospital,” said
Patricia Guthrie. It wasn’t until years later that Guthrie realized that her
father was responsible for saving the lives of thousands of babies.
ABC News medical editor Dr. Richard Besser led a panel discussion that
brought together parents of children born with newborn screening
conditions, an adult with PKU and federal partners. Throughout the night,
the message was the same: newborn screening saves lives. Representa-
tive Lucille Roybal-Allard (D-CA) was honored with the Champion of
Newborn Screening award for her continued sponsorship of the Newborn
Screening Saves Lives Act. Other notable speakers included March of
Dimes Chief Medical Officer Edward McCabe and Assistant Secretary of
Health and Human Services Howard Koh.
Family advocates, accompanied by APHL staff and colleagues, visited
Congressional offices to “advocate for the renewal of the Newborn
Screening Saves Lives Act with their local state senators and
Newborn Screening
CELEBRATES
50 Years
representatives,” said Peter Kyriacopoulos, APHL’s policy director. The six
families and individuals were from Michigan, Utah, Arizona, California,
Pennsylvania and Louisiana.
“It was a huge honor to take part in the forward momentum of such an
important cause,” said parent advocate Sara Rose Barth of Utah, whose
four-year-old daughter, Avery, screened positive for malonic aciduria as
a newborn. “One voice joining with many more can make things happen
and watching this in action was memorable.”
Hunter’s Hope Foundation President and former NFL quarterback Jim
Kelly held a congressional briefing on the importance of screening
newborns and securing funds to add additional conditions to newborn
screening panels. Kelly’s son passed away from Krabbe Disease in 2004.
The briefing drew more than 50 representatives. Other participants
included Jana Monaco and her family, who are a testament to the
incredible power of newborn screening. Both of Monaco’s children have
isovaleric academia, but one was diagnosed by newborn screening and
the other was not, with dramatically different outcomes.
Participant Jordann Coleman of California, whose 10-month-old son,
Carter, screened positive for maple syrup urine disease, said that the
event allowed her to “advocate on behalf of families and babies to get
them the quality of life they deserve.”
The reception and awards ceremony was the first of its kind for APHL.
“Hosting the DC event will remain a highlight of my career—to have
welcomed so many people to the US Capitol for the celebration was
spectacular,” said APHL Executive Director Scott Becker. APHL staff thanks
the many individuals and organizations that contributed to the success of
this celebration.
APHL would like to acknowledge PerkinElmer Inc., Jeffrey Modell Foundation and
Amicus Therapeutics for their generous support of the 50th Anniversary Event.
by Elizabeth Jones, MPH, senior specialist, newborn
screening and genetics, and Ruhiyyih Degeberg, MPH,
specialist, newborn screening and genetics

newborn screening
APHL hosted this event to draw attention to the
need to reauthorize the NBS Saves Lives Act,
but also to celebrate one of public health’s
greatest achievements.
Scott Becker, APHL executive director
“““““
”
Congresswoman Lucille Roybal-Allard (D-CA), with APHL Executive
Director Scott Becker and APHL President Christine Bean, was honored
as a Champion of Newborn Screening for her stalwart efforts to support
newborn screening legislation
Sara Barth with daughter Teagan listen intently during the Hill visit preparation meeting
A graphic artist illustrates discussions and presentations during the event
United States Capitol Building
Jordann Coleman poses with a sign displaying a photo of
her son Carter who was diagnosed with maple syrup urine
disease through his newborn screening test
Jordann Coleman visits with Congresswoman
Roybal-Allard (D-CA) and shares the story
of her son Carter, pictured in the newborn
screening book
Newborn screening advocates Mara and Kevin Alexander (center) along
with Sara Barth and daughters Riley and Teagan (both with cystic ﬁbrosis)
meet with Sen. Debbie Stabenow’s staff

newborn screening
Dr. Richard Besser, ABC News chief health and medical editor, moderates a panel discussion on newborn screening. From left, Besser; Jana Monaco
(member of Organic Acidemia Association Board of Directors); Michael Lu (US Department of Health and Human Services associate administrator
of the Maternal and Child Health Resources and Administration); Jim Kelly (co-founder of Hunter’s Hope Foundation and NFL Hall of Fame quarter-
back); Andrea Williams (Children’s Sickle Cell Foundation executive director); Kevin Alexander (Creative Control Films president and founder);
Coleen Boyle (Centers for Disease Control and Prevention director of National Center of Birth Defects and Developmental Disabilities)
Dr. Richard Besser, ABC News chief health and medical editor, moderates a panel discussion on newborn screening. From left, Besser; Jana Monaco
Jim Kelly with Jana Monaco and children Stephen and Caroline
US Rep. Jim Matheson (D-UT) meets with Sherry and Abe Dilworth and their daughter
Avery as part of the newborn screening Hill Day visits
Digital Extra!
Click here to watch a video about the
newborn screening story.
Newborn Screening
CELEBRATES
50 Years

newborn screening
ABC News Dr. Richard Besser (center); Susan Tanksley, branch manager, Biochemistry and Genetics Laboratory Section, Texas Department
of State Health Services (second from right) and APHL staff (from left) Scott Becker, Elizabeth Jones, Richard Besser, Careema Yousef, Susan
Tanksley and Jelili Ojodu
Newborn screening advocates listen intently during the program in the Congressional
Auditorium at the US Capitol Visitor Center
Charles Brokopp, APHL past president
Edward McCabe, March of Dimes senior vice president and chief medical ofﬁcer, discusses
the newborn screening system advances
APHL Executive Director Scott Becker
addresses the crowd
US Department of Health and Human Services
Assistant Secretary of Health Howard Koh
Newborn screening advocate Kevin Alexander, president and
founder of Creative Control Films, and Patricia Guthrie, health
journalist and daughter of Dr. Robert Guthrie
Edward McCabe, March of Dimes senior vice president and chief medical ofﬁcer, discusses
Charles Brokopp, APHL past president
Wanda “Willie” Andrews and Scott Palubiak mingle during the reception

feature
NANOTECHNOLOGY:
BYNANCYMADDOX,WRITER

feature
In both science and commerce, small is the new big thing. Really small. Nanosize. That’s 10-9
meter—more than
100,000 times finer than human hair or about half the thickness of DNA.
Nanotechnology—the science of engineering functional materials on an atomic scale—was the foreseeable result of the
relentless miniaturization of electronics components and tools. Today, it has been called the third industrial revolution.
And, like the transition to mechanized manufacturing in the 18th
and 19th
centuries, and the 20th
century computer
revolution, it promises massive disruption of the status quo.
Charles (“Chuck”) Geraci, PhD, CIH, who coordinates the National Institute of Occupational Safety and Health’s (NIOSH’s)
nine-year-old Nanotechnology Research Center, said, “Nanotechnology has given us the next generation of material
science...It’s making everything you can think of ten times better or 100 times better or more efficient.”
A simple example of what nanomaterials can do is self-cleaning glass in windows, shower stalls or automobiles.
The inorganic compound titanium dioxide, said Geraci, has been around for centuries. “When taken down to a
very small size it becomes a potent photocatalyst. When sunlight or UV light hits it, the surface of the particle
goes through a higher state of activity and can oxidize materials that are on it or near it. Dirt is oxidized off
the surface of the glass.”
Geraci envisions nanotechnology making water more clean, fossil fuel energy more efficient and less
polluting, and cellphones “better, cheaper, smarter, lighter.” Current health applications range from
liquid condoms to nano-scaffolding for bone and tissue repair (developed by the US military) to a vast
assortment of antimicrobial products.
A professor at the University of California at Riverside has engineered an “electronic nose” that uses
a nano-sensor array to detect airborne toxicants at the parts-per-billion level. The “nose” is being
adapted to detect everything from harmful pesticides in food to biological and chemical warfare
agents. Georgia Institute of Technology researchers are using nanofluidics for sample handling
for DNA analysis. And Nanobiosym®
, a biotech company based in Cambridge, MA, employs
The principles of physics, as far as I can see, do
not speak against the possibility of maneuvering
things atom by atom. It is not an attempt to
violate any laws; it is something, in principle,
that can be done; but in practice, it has not been
done, because we are too big.
- Richard Feynman, Nobel Prize winner in physics, 1965
Nano windshield ﬁlm

feature
nanotechnology in its Gene-RADAR®
—a por-
table, rapid testing device that delivers results
in minutes, using only droplets of a patient’s
saliva or blood. The Gene-RADAR®
is already in
use diagnosing HIV infection in Rwanda, as part
of an extensive clinical trial.
In the food arena, Canola Active Oil, made by an
Israeli company, touts its use of “nanodrops” to
enhance absorption of vitamins, minerals and
phytochemicals while simultaneously inhibiting
the uptake of cholesterol.
And the list goes on and on.
Not only is nanotechnology changing the nature
of material goods, it is changing the nature of
science itself. “Boundaries between chemistry,
biology, physics—they all disappear when you
go into nanotechnology,” said Geraci. An
effort to use single-strand carbon nanotubes
as a probe to mitigate the effects of Parkinson’s
disease, for example, employs an organic chem-
ist to design the nanotubes, a neuroscientist to
explain the brain biology, and an electrical engi-
neer to apply the technology to a semiconductor
chip. On the worksite, the project must address
biosafety, chemical safety, radiation safety, laser
safety and semiconductor safety, as well as FDA
good laboratory practices for medical devices.
The Strangeness of Small
In general, anything with at least one dimen-
sion between roughly one and 100 nanometers
qualifies as a nanomaterial. But in addition to
absolute size, nanotechnology is also defined by
the emergence of unique or enhanced func-
tional characteristics driven by a material’s size
or shape. The International Organization for
Standardization defines nanoscience as the study
of matter in the nanoscale “where size –
and structure-dependent properties and
phenomena, as distinct from those associated
with individual atoms or molecules or with bulk
materials, can emerge” (emphasis added).
In fact, when substances are reduced to the
nanoscale, things get really weird. Electrostatic
and nuclear forces become stronger than the
force of gravity. And the ratio of surface area to
volume explodes, vastly increasing chemical
reactivity (unless surface coatings are applied).
As the renowned, and prescient, physicist
Richard Feynman wrote in 1960, “Atoms on a
small scale behave like nothing on a large scale,
for they satisfy the laws of quantum mechan-
ics. So, as we go down and fiddle around with
the atoms down there, we are working with
different laws, and we can expect to do different
things. We can manufacture in different ways.”
The National Nanotechnology Initiative website
notes that “a fascinating and powerful result
of the quantum effects of the nanoscale is the
concept of ‘tunability’ of properties. That is, by
changing the size of the particle, a scientist
can literally fine-tune a material property
of interest.”
It is this ability to create novel, customized
characteristics that is so eagerly exploited for
commercial use. For example, gold, in its bulk
state, is a chemically inert precious metal. At
the nanoscale, it is a promising alternative to
more costly platinum catalysts in fuel cells.
Bulk titanium dioxide is bright white and often
used as a white pigment. Reduced to nanosize,
it becomes colorless, but retains its high refrac-
tive index and UV light absorbing capabilities,
prompting its widespread use as a UV blocker
in sunscreens.
Ken Aldous, PhD, who
oversees environmental health
research at New York’s state
public health laboratory, the
Wadsworth Center, said,
“We’re forging ahead with
using these particles, we’re
implementing them into
consumer products, and we’re
not really sure what the health
issues are at this point.”
Bulk carbon exists as diamond, graphite or other
allotropes. At the nanoscale, ultrafine carbon
particles are commonly assembled into single-
or multi-walled tubes or spherical buckyball
structures that exhibit amazing new attributes.
Carbon nanotubes have greater tensile strength
and stiffness than any known material, can
withstand pressures over 500 million pounds-
per-square-foot and display exceptional thermal
conductivity along their long axis, while acting
as insulators laterally. Their final structure
can be tweaked to achieve a range of
electrical properties.
Yet, despite the seemingly endless possibilities
of nanomaterials, novelty turns out to be a
double-edged sword. Although nanosize
substances abound in nature, synthetic nano-
materials are new. And while manufacturers are
investing billions of dollars in never-before-seen
substances, public health and safety agencies
are racing to catch up.
Ken Aldous, PhD, who oversees environmen-
tal health research at New York’s state public
health laboratory, the Wadsworth Center, said,
“We’re forging ahead with using these particles,
we’re implementing them into consumer
products, and we’re not really sure what the
health issues are at this point.”
Applications versus Implications
Wadsworth toxicologists XinXin Ding, PhD and
Jun Gu, PhD, are studying the biodistribution
and genotoxicity of titanium dioxide in mice.
Yet the research has been challenging, owing
to the difficulty of detecting low doses of the
ultrafine nanoparticles in mouse tissues.
Inductively coupled plasma mass spectrometry
A model of molecules of water being channeled through a single-walled carbon nanotube

feature
and electron microscopy have, so far, offered
the best results. Still, Jun said, “We can deter-
mine dose-response qualitatively in the body,
not quantitatively. Either relatively high or
relatively low.”
Following large, oral exposure, the scientists
detected titanium dioxide in mouse blood cells
and multiple major organs. At high doses – on
the order of 500 mg/kg—they found changes in
gene expression related to oxidative stress, but
the effect of those changes is unclear.
“It’s too early to say if it poses a risk at low
doses,” said Ding. “How does it relate to environ-
mental exposure? That is the question. We have
to have a better way to assess this.”
APHL’s Environmental Laboratory Sciences
Committee is in the early stages of developing
a white paper on nanotechnology addressing
laboratory analysis to protect environmental
and human health, necessary laboratory
technology and sample preparation techniques.
The final version is planned for release
sometime next year.
Christine Ogilvie Hendren, PhD, executive direc-
tor of the Center for the Environmental Impact
of Nanotechnology (CEINT) at Duke University,
distinguishes between the applications of nano-
technology in science and commerce versus the
unintended, and largely unknown, implications
of nanomaterials in biological and
environmental systems.
She said, “Studying pristine nanoparticles is
not going to be sufficient to predict actual risk.
The transformations they undergo in the
environment are critical.”
What happens, for example, when nanosilver
washes out of antibacterial clothing and into
the municipal wastewater stream?
Using simulated natural environments or
mesocosms, CEINT researchers are examining
the fate of several priority nanomaterials. In
the case of nanosilver, which is already in
widespread use as an antibacterial agent, the
probable pathway is from wastewater to
biosolids to land application. CEINT investiga-
tors found that, compared to controls, nanosil-
ver-treated mesocosms produced more nitrous
oxide, a potent greenhouse gas and ozone-
depleter. In addition, several plant species were
found to accumulate silver in their tissues at
levels at or above those in the soil—an impor-
tant finding, since the plants could become
food for people or animals.
On the other hand, researchers found that
children’s exposure to nanosilver from toys,
breast milk storage bags and other products is
likely to be minimal, although there exists the
possibility of chronic exposure from
multiple products.
“Back to Square One”
Jason White, PhD, a chief scientist at the Con-
necticut Agricultural Experiment Station,
Department of Analytical Chemistry, believes
nanomaterials may well constitute an emerging
class of toxicants. If so, he said, current safety
assumptions may not hold.
“If silver is okay, the assumption is that nanopar-
ticle silver is okay. We’ve been putting nanoma-
terials into our products for over a decade, and
The ease with which some
nanomaterials cross the blood-
brain barrier, she said, could
be a therapeutic advantage:
“If we can achieve targeted
drug delivery into the central
nervous system using a nano-
drug formulation, we could
make great strides in treating
certain neurological diseases,
such as Parkinson’s disease
or Alzheimer’s, or a bacterial
disease such as meningitis.”
Dr. Roberto De La Torre Roche (left) and Joseph Hawthorne (middle), both from
the CT Agricultural Experiment Station Department of Analytical Chemistry,
work with Supervising Chemist Susan Isch (right), of the Dr. Katherine A. Kelley
State Public Health Laboratory (CT), to view engineered nanomaterials in
exposed food crops by Scanning/Transmission Electron Microscopy (S/TEM)
with Energy Dispersive X-ray Spectroscopy (EDS)
Sandia researcher Mike Lilly observes two individually powered nanowires, embedded one above the other, in a few atomic layers of Sandia-grown crystal. The test has yielded new information about nanoworld electrical ﬂows. Photo
Credit: Randy Montoya

feature
Geraci, however, pointed out that human expo-
sure decreases dramatically once nanomaterials
are incorporated into a product. “Where NIOSH
focuses a lot of its attention is where you’ve
got exposure to the fairly pure, concentrated
materials—a research lab, somebody manufac-
turing these materials or somebody blending
them into a product.”
White, in contrast, is focused on the nanomateri-
als deliberately and unintentionally released into
the environment. Engineered nanomaterials,
we’ve had this assumption about toxicity...What
I say when I present my work is that it seems
to me this may have been a bad assumption.
Nanomaterials behave different chemically,
they behave different physically. If it’s different
chemically and it’s different physically,
why would you assume it behaves the
same biologically?”
Indeed, there is reason to believe at least some
engineered nanomaterials do behave differently.
There is evidence, for example, of nanosize
particles crossing dermal and blood-brain
barriers when the bulk materials do not.
NIOSH scientists have found that carbon
nanotubes, with their exceptionally high aspect
ratio—100 to 1,000 times long as wide—behave
much like asbestos and other fibrous substances
that can penetrate into the deep spaces of the
lungs, triggering inflammation, collagen
production and loss of lung elasticity.
Based on animal inhalation and epidemiologic
studies, the agency has labeled ultrafine
(including nanoparticle) titanium dioxide a
potential occupational carcinogen.
NIOSH has no regulatory authority, but in
2011 and 2013 issued its first recommended
occupational exposure limits for nanomateri-
als considered high-risk based on their ubiquity
and expected toxicity: ultrafine titanium dioxide
and carbon nanotubes as measured by
elemental carbon.
Not only is nanotechnology
changing the nature of
material goods, it is changing
the nature of science itself.
“Boundaries between chemis-
try, biology, physics—they all
disappear when you go into
nanotechnology,” said Geraci.
The European Union (EU) and the International Standards Organization (ISO) lead
international efforts related to nanomaterials. The international community advances
risk assessment, data gathering and a variety of other issues regarding nanomaterials
through EU regulations and ISO technical committees.
Via the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH)
regulation, EC 1907/2006, the EU controls the manufacture, use and import of nanomaterials.
Although the EU imposes controls over nanomaterials, the authorizing regulation does not
specifically mention nanoscale substances. Instead the EU determined that nanomaterials fit
under existing regulatory definitions.
Because nanomaterials constitute “chemical substances,” all nanomaterial manufacturers
and importers must register their products and identify the known risks with the European
Chemicals Agency. Moreover, those nanomaterials that meet Europe’s definition of “hazard-
ous” must also adhere to certain labeling and packaging requirements. These registration,
labeling and packaging requirements differ from current treatment in the United States,
which has little-to-no requirements for registration and labeling.
Regarding risk assessment, REACH requires nanomaterial manufacturers and importers to
conduct specific risk analyses based on hazard classifications. Once registered with the EU,
chemicals subject to REACH, including nanomaterials, are placed in the Classification
& Labeling Inventory—a database that includes the types of physical hazards (i.e.,
flammable, explosive, etc.), human health hazards (i.e., eye irritant, toxicity, carcinogenicity,
etc.), and labeling requirements. Although companies can omit hazard classification
and other information in the absence of data, the government system provides the available
information. While some debate the overall effectiveness and depth of information REACH
provides, the EU takes a proactive role in nanotechnology.
Finally, in addition to the EU’s work, and related to general international efforts, the ISO
formed a technical committee to address nanotechnology issues. “ISO/TC 229 Nanotech-
nologies” produced 35 standards related to nanomaterial issues, including terminology,
occupational health and safety, characterizations and risk assessments. Thirty-five countries
participate in this technical committee, including the United States, and another 13 coun-
tries are observers. It is important to note that the ISO issues voluntary standards. While the
standards may reflect a general consensus on specific topics, they do not reflect binding
requirements absent a government mandate adopting them.
Government actions regarding nanomaterials change frequently. Interested observers
should check government sources routinely for the latest information. For more information
on the EU’s activities regarding nanomaterials, see: http://ec.europa.eu/nanotechnology/
index_en.html and http://ec.europa.eu/enterprise/sectors/chemicals/reach/nanomaterials/
index_en.htm.
For more information on the EU’s use of hazard classifications, see: http://ec.europa.eu/
enterprise/sectors/chemicals/classification/index_en.htm
For more information on ISO/TC 229 Nanotechnologies, see: http://www.iso.org/iso/home/
standards_development/list_of_iso_technical_committees/iso_technical_committee.
htm?commid=381983
International Efforts to
Monitor Nanotechnology
by Michael Heintz, senior specialist, environmental laboratories

feature
A Fine Line
Sara Brenner, MD, MPH, who oversees nano-
health initiatives at the State University of New
York College of Nanoscale Science & Engineer-
ing (CNSE) in Albany, is sanguine about the
future of nanotechnology. CNSE, she says,
represents a unique trifecta of industry, govern-
ment and academia working together to apply
nanotechnology to everything from computer
chips to solar cells to clinical diagnostic tools.
With over $17 billion of infrastruture—including
140,000 square feet of clean rooms—CNSE
epitomizes the lure of molecular engineering,
as nanotechnology is also known.
Brenner, the first physician to join the college,
said, “There really is no ‘just good’ or ‘just bad’
when it comes to nanoparticles. It’s all about
the context and what you’re trying to achieve.
A toxic nanoparticle in a cancer cell is a great
thing; a toxic nanoparticle in a healthy cell is a
bad thing.”
The ease with which some nanomaterials
cross the blood-brain barrier, she said, could
be a therapeutic advantage: “If we can achieve
targeted drug delivery into the central nervous
system using a nanodrug formulation, we could
make great strides in treating certain neuro-
logical diseases, such as Parkinson’s disease or
Alzheimer’s, or a bacterial disease such as
meningitis. These diseases are deadly. One rea-
son they’re so deadly is because we can’t
get drugs into the brain.”
he said, are or will soon be present in most
agricultural fields, where they are used as soil
amendments and additives to agrichemicals
or may accumulate through the widespread
application of biosolids containing nanomateri-
als that enter the waste stream. In addition, he
said, “It’s fairly clear that some large companies
are adding nanoparticle copper and silver to
agricultural pesticides to extend shelf life. The
current regulatory framework does not require
labeling or release of that information.”
Researchers at the University of Missouri dipped
pears into a silver nanoparticle solution meant
to mimic pesticide application. Four days after
the treatment—and after repeated rinsing—
silver nanoparticles were still present on the
fruit’s skin; some nanoparticles had penetrated
to the pulp.
In his own research, White has traced the
transfer of nano cerium from soil to zucchini
plants to crickets that consumed the plants.
He said, “In my mind, if cerium is transferred
from one trophic level to another, that’s not
necessarily bad. But I want to see if the nano
cerium is transferred differently from the
bulk material.
That would show materials behaving differently
as a function of size...We don’t have the
answer yet.”
In August, the US Environmental Protection
Agency (EPA) proposed the first “conditional
registration” of a nanoparticle pesticide
ingredient: Nanosilva®
, a silica-sulfur-nanosilver
complex used to inhibit the growth of bacteria,
mold and mildew in textiles and plastics, rather
than food. Based on published studies, industry
data and its own evaluation, the EPA concluded
that Nanosilva®
“will not cause unreasonable
adverse effects on people...or the environment.”
White said, “We don’t necessarily need to
change the regulatory framework. But if a
nanoparticle has a different mechanism of
toxicity [from the bulk material], it’s essentially
a different chemical, and you have to go back to
square one with the risk assessment.”
In fact, he said, “Some evidence now indicates
instances where the mechanism of toxicity
seems to be specific to the nanoparticle...And,
of course, the real question is whether this
difference in toxicity is really significant. Does
it matter? That is an open question that will
take some time to answer.”
Carbon nanotubes have greater
tensile strength and stiffness
than any known material, can
withstand pressures over 500
million pounds-per-square-foot
and display exceptional thermal
conductivity along their long
axis, while acting as insulators
laterally. Their final structure
can be tweaked to achieve a
range of electrical properties.
Dr. Jason C. White (right), Craig Musante (center front), Dr. Roberto De La Torre
(center back) and Joseph Hawthorne (left), all of the CT Agricultural Experiment
Station Department of Analytical Chemistry, use Inductively Coupled Plasma-
Mass Spectrometry to quantify engineered nanomaterials in exposed food crops
The image is from a scanning electron microscope of silver nanoplates
decorated with silver oxy salt nanoparticles along the edges.
Photo Credit: Argonne National Laboratory
Buckyball

feature
American Biological Safety Association
The American Biological Safety Association (ABSA) was founded in 1984 to promote biosafety
as a scientiﬁc discipline and serve the growing biosafety and biosecurity needs of scientists,
laboratorians, health care workers, and biosafety professionals throughout the world.
Your Source for Biosafety
ABSA Activities and Resources
• Biosafety Conference, Courses, and Seminars
• Applied Biosafety: Journal of the American Biological Safety Association – www.absa.org/pubabj.html
• Biosafety Publications – Including Anthology of Biosafety Series
• Animal Biosafety Training Video – www.absa.org/resanimal.html
• Credentialed Biosafety Professionals –
Registered Biosafety Professional (RBP) and Certiﬁed Biological Safety Professional (CBSP)
• ListServe, Training Tools, Risk Group Table, and more…
Go to www.absa.org
Brenner’s work focuses largely on methods to quantify and characterize nanomaterials to
assess workplace exposure. She said, “We want a testing strategy that’s faster, cheaper
and gives more definitive results. Right now, we are just on the frontier of developing
these tools. They do not exist.”
While Brenner avers that industry is “willingly leading the charge” to assure nano-
technology safety, she also notes that product research and development budgets are
“tremendous,” compared with the tiny budgets for safety research.
Said Geraci, “Are there unknowns? Yes, there are unknowns. But there are also knowns.
We know how to handle highly hazardous materials. If it comes right down to it, there are
good ways to do things and there are not good ways to do things. The challenge is, if we
don’t do the development responsibly, we might not realize the societal benefits.”
In the meantime, we are all part of a massive experiment involving low dose exposure to
engineered nanomaterials.
As of March 2011, the Project on Emerging Nanotechnologies compiled an inventory of
more than 1,300 consumer products or product lines touting the advantages of their
nano-components. A random sampling includes the 350 thread count Nano-Tex®
sheet
set sold at JCPenny®
Company, Acticoat®
wound dressings, Ecosynthetix adhesive (used in
McDonald’s hamburger containers), Apagard®
Oral Care Toothpaste, Benny the Bear Plush
Toy, CeNano anti-graffiti nano sealant, and Nanoceuticals TM Slim Shake chocolate
powder with nutritional supplements.
“The critical thing is balance,” said Brenner. “We don’t want fear and hysterics to thwart
scientific progress. At the same time, we don’t want to be negligent with regard to public
health. It’s a fine line.”
Size of the Nanoscale. Photo Credit: National Center for Electron Microscopy,
Lawrence Berkeley Lab, US Department of Energy

environmental health
Embracing New Standards for
Occupational Blood Lead Levels
by Surili Sutaria, senior specialist, environmental health
This document was adopted by the Council of State and Territorial
Epidemiologists’ (CSTE) Occupational Health Surveillance Subcommit-
tee during the 2013 CSTE Annual Conference: http://c.ymcdn.com/sites/
www.cste.org/resource/resmgr/OccupationalHealth/Management-
GuidelinesforAdult.pdf.
The National Institute of Occupational Safety
and Health (NIOSH)—a US federal agency that
conducts research and recommends workplace
safety practices—provides national and global
leadership to prevent workplace illnesses and
injuries. NIOSH, created by the Occupational
Safety and Health Act of 1970, works closely
with Occupational Safety and Health Administra-
tion (OSHA) to protect American employees from
harmful working conditions. OSHA, a part of the US
Department of Labor, sets and enforces health and
safety standards (often based on NIOSH recom-
mendations) to assure safe and healthful working
conditions and provides training, outreach,
education and assistance.
This document was adopted by the Council of State and Territorial
Epidemiologists’ (CSTE) Occupational Health Surveillance Subcommit-
tee during the 2013 CSTE Annual Conference: http://c.ymcdn.com/sites/
www.cste.org/resource/resmgr/OccupationalHealth/Management-
GuidelinesforAdult.pdf.
Fall 2013 LAB MATTERS 19
Lead is a highly toxic metal that, when found in the bloodstream, can affect almost
every system in the human body. While children are more vulnerable to lead than
adults, occupational lead exposure can pose health threats. Adults with elevated blood
lead levels can experience anemia, nervous system dysfunction, kidney problems, hyper-
tension, decreased fertility and increased chances of miscarriages. The workplace remains
the leading environment for adult exposure: approximately 94% of adults with elevated
blood lead levels were exposed through work. Employees can also carry lead home in their
hair and on their skin and clothing, and expose family members.
In the US, approximately 3 million workers are exposed to lead on the job. Although blood
lead levels over 10 ug/dL are considered harmful to adults, OSHA’s lead standards compel
workers to be removed from lead exposure only when blood lead levels are equal to or
greater than 50 µg/dL in the construction industry, and 60 µg/dL in general industries.
Workers are allowed to return to lead-exposed work when their blood lead levels return
to 40 µg/dL or below. However, OSHA’s lead standards also give the examining physician
broad flexibility to tailor special protective procedures to the needs of individual employ-
ees. As such, in an effort to reduce the overall rate of adult elevated blood lead levels in
the US, NIOSH recommends that actions to reduce lead exposures be taken when levels
reach 10µg/dL or higher.
NIOSH seeks the help of public health laboratories who test adult blood lead levels to:
1. Include the NIOSH reference blood lead level (10 µg/dL) in laboratory reports;
2. Consider also including a shortened version of the Medical Management Guidelines
for Adults with Elevated Blood Lead Levels, or a reference to these guidelines.1
NIOSH
is preparing an alert based on these recommendations;
3. Include employer’s name and industry, and the patient’s occupation information in
the laboratory report (if possible);
4. Move to electronic reporting of blood lead levels.
From limited outreach to members, APHL understands that few public health laboratories
receive adult blood samples for lead testing. APHL’s Environmental Health Committee and
representatives from NIOSH hope to develop a reporting template for public health
laboratories in the event they receive adult samples.

global health
APHL, in conjunction with the African Center for Integrated Laboratory
Training, conducted the first Laboratory Information Management
Systems (LIMS) Workshop to provide an overview of key considerations
involved in the LIMS implementation process. The training, September 30 –
October 4 in Johannesburg, South Africa, was designed for experienced and
senior public health professionals and laboratory managers responsible for
overseeing LIMS implementation at the provincial and national levels.
Nineteen participants from nine different countries across sub-Saharan
Africa participated in the four-day meeting. They discussed resources
required for implementation, support for these systems and how LIMS
can serve to strengthen laboratory and healthcare systems throughout the
diaspora. The workshop also served as a forum for participants to share
their implementation experiences broadly and gain useful insights from
other participants and faculty.
APHL Informatics and Global Health Committee members collaborated on
content development and served as faculty. Garrett Peterson (Informatics
Committee co-chair), Martin Evans (Informatics Committee member), Bob
Sokolow (Informatics and Global Health Committee member) and Kim Lewis
(APHL Global Health consultant) shared examples of challenges and lessons
learned through LIMS implementation in the US and Africa.
The workshop featured the following topics:
• What is a LIMS and Why Do I Need One?
• Process for Successful Implementation
• Defining Success for a LIMS Implementation
• Measuring the Success of a Sustainable LIMS
• Human Resource Allocation and Maintenance Plan
• LIMS Data Input Needs and its Role in Quality Assurance
• Gaining Efficiencies, Enhancing Quality and Helping with Decision
Making Using LIMS Data
• LIMS Strategic Planning, Long Term Planning
• Case Study – A Modified Example from the APHL Global LIS Guidebook
• Lesotho LIMS Experiences
• Developing a Budget
• Participant Forum – Sharing Strategies that have Worked in
Your Laboratory
• The Way Forward (Strategic Planning Assessment)
APHL will continue to work with these countries individually, as needed, to
facilitate discussion of LIMS planning and implementation. APHL supports
many countries in sub-Sahara Africa under a cooperative agreement with
Centers for Disease Control and Prevention funded by PEPFAR.
First International LIMS Workshop in
Sub-Saharan Africa
APHL Informatics and Global Health Committees present training
for laboratorians and IT staff on LIMS fundamentals.
by Ava Onalaja, specialist, global health, and Cassandra Hadley, senior specialist, informatics
Trevor Tawanda Chisenga, Swaziland MOH, presents a
SWOT analysis of a LIMS
The faculty and participants of the inaugural offering of the APHL LIMS workshop held at ACILT. The course is the result
of a combined effort of the Informatics and Global Health Programs. Members from program committees served as faculty
and contributed to content creation
APHL member consultant Kim Lewis (top left) facilitates a SWOT
analysis exercise with participants from Uganda, Malawi, Zambia
and Swaziland. APHL Mozambique ﬁeld consultant Samuel Masaka
(bottom right) shares his experiences
Dr. Geoffrey Chipungu, CDC Malawi, represents his
multinational, interdisciplinary group during the
presentation session. APHL member and group
facilitator Garrett Peterson assists
Tshepiso Ramothwa of Botswana MOH stands ready to review group ﬁndings with Kgomotso Makhaola (Botswana
MOH); Alex Gondwe, Malawi; and Dumile Fikile Sibandze, Swaziland MOH. In front, Henry Kajumbula, Uganda MOH, and
facilitator Garrett Peterson

public health prepardness and response
Of the thousands of viruses known to exist, one in
particular has caught the eye of public health officials
recently—the Middle Eastern Respiratory Syndrome
Coronavirus (MERS-CoV). MERS-CoV is a novel
coronavirus closely related to the Severe Acute
Respiratory Syndrome (SARS) Coronavirus that was
responsible for 774 deaths (9.6% fatality) in south
China in 2002-2003. Within a few months, SARS had
spread to at least 37 countries and sickened more
than 3000 people. All coronaviruses cause similar
symptoms, including fever, cough and shortness of
breath; however, unlike SARS, MERS-CoV does not
seem to transmit readily from person to person. While
this is encouraging, viruses do evolve quickly and the
method of transmission could change. It is possible
that MERS-CoV could cause a similar outbreak.
As of October 22, 2013, the global count for MERS-CoV cases had risen to 139.
In a world of 6 billion people, this statistic is not alarming. However, the 50%
case-fatality rate is.
At this time, no cases have been reported in the United States. Most have been
isolated to the Arabian Peninsula, with a few reports in Europe associated with
travelers to the affected areas.
Scientists have not been able to identify the source of the virus. Some virologists
have suggested that bats, which are carriers of a number of coronaviruses, may be a
host. In addition, the nucleotide sequencing of bats in the affected regions has shown
promising matches to the virus found in patients. Nevertheless it is likely these
positive matches are just a related coronavirus and not specifically MERS-CoV.
Although few protections are available, US public health organizations are prepar-
ing for the possibility of an outbreak here. In addition to issuing guidance to health
care providers who suspect a MERS-CoV infection, the CDC implemented polymerase
chain reaction testing capabilities at its headquarters. Since there were no FDA-
approved tests at that time, CDC was approved for emergency use authorization to
perform testing immediately. Since then, 46 public health laboratories and four
Department of Defense laboratories have implemented the testing through the
resources of the Laboratory Response Network (LRN). The LRN has gained expertise
with emerging infectious disease through its response to anthrax, West Nile virus,
H1N1, SARS and other recent public health threats such as ricin.
For more information, visit the CDC’s MERS-CoV information page.
The Hype About the Middle Eastern Respiratory
Syndrome (MERS-CoV): Should We Be Worried?
by Tyler Wolford, MS, specialist, laboratory response network, APHL

The Laboratory Information Management Systems Integration Project,
known as LIMSi, is currently in its fourth year of operation and
growing steadily. Twenty-seven LRN-B laboratories have completed the
program, with another nine in process. The project has improved labs’
capability to enter data rapidly and share information with partners such
as the CDC. At present, LIMSi is focused on sending LRN biothreat data to
CDC, but there are plans underway to use the LIMSi approach to send data
for other threat agents.
What is LIMSi? A Behind the Scenes Look
LIMSi is a CDC initiative that, in partnership with APHL, aims to optimize
the flow of information between CDC and participating LRN facilities by
leveraging existing capabilities in the labs. Laboratories are supported
as they develop the capability of LIMS and ancillary systems to support
the same functions as the LRN Results Messenger application now in
use. Support is provided no matter which information technology tools,
or combinations of tools, are being used—commercial, open source or
custom-developed.
Behind the Scenes: A Technical Overview of
LIMS Integration for LRN-B Laboratories
by Kara MacKeil, associate specialist, public health preparedness and response
Following the completed conﬁguration of all
scheduled assays, the CDC LIMSi team provides
a set of HL7 test cases for the laboratory to work
through in a test environment. These cases are
designed to highlight coding problems and provide
a further check that all is working as it should be.
Using a lab’s in-house technology translates into improved response times
and increased effectiveness, but it also means adding a huge burden on
the numerous resources managing each and every change made in LIMSi.
Each change has to be tested multiple times in many different scenarios,
as failure of the system could result in critical alerts not being received by
the CDC. This can make for a lengthy process, but it ends with a reliable
system capable of transmitting information rapidly and securely.
First, a laboratory’s PHINMS (Public Health Information Network Messag-
ing System) is configured to allow transmission of messages directly to
the CDC. Depending on the laboratory and its LIMS software, this can be
sent as a direct message or routed through an RnR (Route not Read) hub.
Once this connection has been established, staff at the initiating labora-
tory must configure the data messaging terms for each and every assay
that will be transmitted via LIMSi, each using HL7 (Health Level 7) mes-
saging. This step can take time because the correct configuration must be
tested by sending HL7 result messages to the CDC in a test environment.
Errors in configuration prevent data from being communicated properly,
and must be corrected before moving forward. To save time, laboratories
typically pick one agent to test their configurations. Once this preliminary
agent’s assays are transmitting properly, labs move on to configuring all
scheduled assays.
Following the completed configuration of all scheduled assays, the CDC
LIMSi team provides a set of HL7 test cases for the laboratory to work
through in a test environment. These cases are designed to highlight
coding problems and provide a further check that all is working as it
should be. Working through these cases and correcting the resulting errors
can be extremely time-consuming, but this round of testing increases the
value of LIMSi by ensuring its data is reliable. As this program is designed
to transmit essential messages in the event of an emergency, it’s critical
that it can be trusted.
Until this point, the work will have been completed entirely in a test
environment to prevent errors from affecting the regular work of the
laboratory. Upon successful completion of test cases, the laboratory staff
performs a migration of their new LIMSi updates into their real-world
production environment.
Following this move, the LIMSi team at the CDC sends a second round of
HL7 test cases, again testing each and every assay for correct configura-
tion. Problems with configurations previously thought to be correct are a
common finding after migration, and laboratories typically find that more
configuration work is needed following the move.
When all test cases have been satisfied, laboratory staff sends a final test
message to the CDC team to confirm connectivity and appropriate data
mapping. If this message is received correctly, the laboratory switches
their PHINMS route for direct messages to their LRN production environ-
ment, and the laboratory is considered fully LIMSi compliant. The LRN
Results Messenger is maintained as a back-up system, but from this point,
LIMSi is the primary method of transmitting LRN threat agent results to
the CDC.
The steps described here may appear straightforward, but LIMSi is a major
undertaking and can take several months to complete. The project poses
many challenges and often requires extra financial and personnel resourc-
es in addition to the laboratory’s own. As such, APHL encourages laborato-
ries to be mindful of its resources to ensure that LIMSi is completed within
a specified timeframe. Laboratory directors must also consider budgeting
for any maintenance and upgrades.
LIMSi is a very beneficial program that enhances response capabilities and
further strengthens national disaster preparedness.

The LRN-B is composed of national, refer-
ence and sentinel clinical laboratories. The
sentinel clinical laboratories, such as those
found in hospitals, have been tasked with
the initial identification of potential biothreat
agents based upon the American Society for
Microbiology’s Sentinel Level Clinical Laboratory
Protocols. According to these protocols, sentinel
laboratories can either rule-out potential bio-
threat agents or refer them to their designated
LRN Reference Laboratory, based on the results
of classical biochemical tests. However, today,
many of those classical microbiological tests are
being sidelined for emerging technologies such
as mass spectrometry and sequencing.
For decades, chemists have utilized mass
spectrometry to analyze the elemental compo-
sition of samples by means of unique spectra;
recently, microbiological laboratories, including
sentinel clinical laboratories, have been using it
for the rapid identification of biothreat agents.
Mass spectrometry can be used to analyze many
biomolecules (e.g., DNA, proteins, and sugars),
but is mainly used in clinical settings to analyze
microbial proteins.
The specific mass spectrometry technology
present in some larger sentinel clinical labora-
tories is matrix assisted laser desportion/ioniza-
tion time of flight (MALDI-TOF). Starting with a
12-24 hour culture, the laboratorian transfers a
colony to the machine’s target plate, allows it to
air dry, and covers it with a matrix solution that
lyses cell walls and extract proteins. Following
the absorption of laser energy by the matrix,
desportion and ionization allow the proteins to
enter the gas phase where the acidic matrix will
donate a positive charge to ionize the proteins.
The final time of flight analysis is based on the
time for the ions to reach a detector resulting
in a spectrum where intensity is plotted against
Emerging Technologies in
Sentinel Clinical Laboratories
Pose Challenges to
LRN Procedures
by Christopher Chadwick, MS, specialist,
public health preparedness and response
mass-to-charge ratio. By matching the spectrum
of an unknown microorganism against known
spectra in a library, the laboratorian can
determine if there is a reliable or highly
probable match at the genus and species levels.
For decades, chemists have
utilized mass spectrometry
to analyze the elemental
composition of samples by
means of unique spectra;
recently, microbiological
laboratories, including sentinel
clinical laboratories, have been
using it for the rapid
identification of biothreat agents.
Laboratorians from the Laboratory Services Section at the Texas Department of State Health
Services analyze MALDI-TOF results. Photo courtesy of Rahsaan Drumgoole
Times are changing and technologies are evolv-
ing such that automation is the goal. The mass
spectrometry/MALDI-TOF technology is rapid,
trendy and cost-effective in terms of consum-
ables and staff time. Despite the many benefits
of this technology, clinical laboratories must
take precautions when implementing it. For the
identification of biothreat agents, there is signif-
icant concern for laboratorian safety due to the
potential of creating aerosols of microbes that
require BSL-3 conditions. Additionally, many
sentinel clinical laboratories lack the biothreat
agent libraries as they are not typically included
with the initial purchase of the technology;
therefore, laboratories may falsely identify un-
known samples with true biothreat agents, thus
putting the rule-out or refer mechanism of the
LRN at risk for error. And finally, with the push
towards complete automation in the clinical
Rule-out or Refer. Within the Laboratory Response Network
for Biological Threats Preparedness (LRN-B), these two words
make all the difference between identifying a biothreat agent
(e.g., Bacillus anthracis) versus a mostly harmless near
neighbor (e.g., Bacillus cereus).
laboratory, there is the potential that the next
generation of laboratorians will lack classical
microbiology skills to troubleshoot problematic
organisms and technologies.
APHL and its member laboratories recognize
that emerging technologies will play a key role
in the rapid identification of potential bio-
threats. As such, the association, via its Public
Health Preparedness and Response Committee
and the Sentinel Laboratory Partnerships and
Outreach Subcommittee, is working to address
the role of these technologies and how they
impact the rule-out or refer system implement-
ed in the LRN.
For information on APHL’s sentinel laboratory
preparedness activities, contact Christopher
Chadwick at christopher.chadwick@aphl.org.
Benefits of MALDI-TOF
c Allows analysis of bacteria, yeasts and fungi
c Does not require Gram staining
c Delivers species-level identification
within minutes
c Has a low consumable cost
c Cultural conditions (e.g., media used,
temperature at which specimen was
incubated) have little to no influence on
the spectra analysis
c Antibiotic resistance can be monitored
c Spores and powders can be analyzed

laboratory systems and standards
In response to a thread on the APHL Quality Assurance
listserv, the association hosted a teleconference to
discuss the problems stemming from the production of
in-house media and the handling of purchased media. The
subject garnered substantial interest across APHL’s mem-
bership: approximately 31 state public health laboratories,
four local public health laboratories, and staff from some
CDC programs joined the call to share experiences,
problems and best practices.
Several topics were discussed, including media acquisi-
tion, production, inventory and validation in the labora-
tory. Laboratories have experienced difficulties ordering
media due to a lack of availability and the vendors’ pricing
differences. In those situations, testing halts, causing a
backlog at the laboratory. To circumvent these obstacles,
laboratories have tried to produce more media in-house.
However, purchasing raw materials and plates can be more
expensive than buying the finished plates, depending on
volume and type of media. Call participants discussed
possible solutions, including the creation of a compre-
hensive list of vendors for supplies and the development
of standing orders/agreements for media that cannot be
made in-house.
APHL Hosts Teleconference About Media
Preparation and Inventory Difﬁculties
by Tina Su, MPH, senior specialist, laboratory systems and standards, and Kathryn Wangsness,
MHA, chief/quality assurance manager, Office of Laboratory Services, Arizona State Public
Health Laboratory
Taking inventory of the media supplies, even for types
that are only made once or twice a year, is another chal-
lenge. Many states use manual systems of inventory
management, which are not always kept up-to-date or
performed efficiently. Many states have also found that
their Laboratory Information Management Systems’
tracking systems are not robust enough. One alternative,
explored at the Texas Public Health Laboratory, is to use a
barcode scanner system, such as Wasp, to manage inven-
tory. Many facilities, especially larger laboratories, use
manual systems, in which each laboratory unit is respon-
sible for tracking their inventory needs. A periodic order
is placed based on that information from each section
and not always from the laboratory as a whole. A more
global solution needs to be identified to help staff per-
form the inventory more efficiently and collaboratively.
Laboratories have experienced
difﬁculties ordering media due
to a lack of availability and the
vendors’ pricing differences. In
those situations, testing halts,
causing a backlog at
the laboratory.
Finally, it is important to ensure that the validation of
media occurs and that proficiency in making media is
maintained. Having standard operating procedures in
place, along with an established training process, will
help laboratory staff handle media produced in-house.
Some states have done their own expiration date valida-
tion in order to extend the life of media to create a more
efficient system, reduce costs and maximize resources. On
a national scale, it would be helpful to build a database of
media recipes, references, expiration date testing,
techniques and tools used, and laboratory findings.
A post-teleconference discussion of media has continued
on the QA listserv with members providing input on what
steps should be taken next. Representatives from all US
member laboratories are invited to join the listserv. To join,
view an archive of previous listserv postings or propose
other topics for a discussion, contact Tina Su at
bertina.su@aphl.org.
In-house media waiting for pick up at the Arizona PHL

www.LaboratoryTraining.org
Your Lab Training Partner!
The Association of Public Health
Laboratories (APHL) webinars offer
convenient, cost-effective training your
staff can complete almost anywhere. All of
our webinars are available as on-demand courses,
for everyone in your lab, offering unlimited access
and CEUs for 6 months for the same low site
registration fee as the live webinars!
Recent On-Demand Webinars
Challenging Cases in Hematology (in partnership with ASCLS)
AST of Bacteria That Cause Gastroenteritis
Management of Patients with Bacterial Gastroenteritis
Changes in LRN Sentinel Lab Protocols
Improving the Gram Stain
An Update on Hepatitis C Virus Diagnostic Testing
Ensuring the Quality of Blood Spots Collected From Newborns (in partnership with CLSI)
Federal Government and Health Care Reform Update (in partnership with ASCLS)
Upcoming Live Programs
November 19: Work-Up of Relevant Fungal Isolates
November 21: Ensuring the Quality of Blood Spots Collected from Newborns (in partnership with CLSI)
December 3: Non-molecular Methods for Detection of Infectious Diseases
December 10: Detect and Protect: Carbapenem Resistant Enterobacteriaceae
December 11: Enhance the Quality of Follow-Up Services for Newborn Screening (in partnership with CLSI)
January 28: Verification/Validation of Non-FDA Approved Tests
February 5: CLSI 2014 AST Update
February 6: CLSI 2014 AST Update
February 18: Impact of MALDI-TOF and Antibiotic Stewardship on Patient Care
Visit www.laboratorytraining.org
today and find out why
thousands of your colleagues
depend on APHL for their
continuing education needs.
Questions? Email
webinar@aphl.org.
... and many more!
Fall 2013 LAB MATTERS 25

informatics
APHL and CDC launched the Vaccine Preventable Disease (VPD) Project
in the summer of 2012 to establish four public health laboratories
as VPD Reference Centers. The selected laboratories in California, New
York, Minnesota and Wisconsin have begun to implement a unidirectional
Electronic Laboratory Surveillance Message (ELSM) data flow to send VPD
results to CDC.
The California and New York Reference Centers are serving as viral refer-
ence laboratories; Minnesota as a viral and bacterial reference laboratory;
and Wisconsin as a viral and bacterial laboratory, as well as a provider of
performance evaluation panels. The Reference Centers receive specimens
from forty state and local public health laborato-
ries. They perform the molecular assays for nine
VPDs using standard CDC protocols and return re-
sults to both CDC and the submitting laboratories.
While the laboratory personnel were learning
and validating the new protocols with support
from APHL’s infectious diseases program led by
Kelly Wroblewski, the Reference Centers began
implementing HL7 Messaging with the assistance
of the VPD technical assistance team. The team,
pictured to the right during a site visit to the
Minnesota PHL, consists of a project coordinator, a
terminologist and a technical architect, under the
direction of APHL’s informatics program manager, Linda Cohen. At the
beginning of the project, the team met with CDC VPD subject matter
experts to finalize the new message specification to meet the business
needs of the CDC end data users.
The goals of the VPD Project are multi-faceted: to provide reference
capacity for molecular and serologic testing to support public health
laboratories and CDC; to create surge capacity for VPDs in the event of an
outbreak; to ensure quality control and proficiency standards for the VPD
tests utilized; and to improve informatics capability and data capture by
creating a standard HL7 message across all Reference Centers. The project
is currently targeting VPD testing for measles, mumps, rubella and
B. pertussis.
Technical Assistance Team Troubleshoots
IT Issues for New VPD Reference Centers
by Linda Cohen, informatics program manager, APHL
The technical assistance team is helping to achieve these goals by sup-
porting the Reference Centers as they establish electronic communication
with the CDC to enable near-real time reporting in a HL7 2.5.1 ELSM for-
mat. The team has been deployed to the laboratories as needed to provide
concentrated hands-on help. This collaborative approach allows APHL to
understand the internal informatics capacity of each laboratory and im-
plement the best technical solution. The technical assistance team’s visits
allows the laboratories ready access to national subject matter experts
and facilitates a dialogue and knowledge exchange that can be reused
during subsequent project phases or future HL7 messaging initiatives.
The VPD Project represents a novel data flow of information from the
states to CDC. Instead of each state maintaining
laboratory capability and informatics messaging,
the VPD initiative has created capacity within
existing highly functioning laboratories and ex-
panded their capacity to serve as reference labs.
This method consolidates data streams that flow
into CDC, yet still delivers high quality, timely
information.
As the project enters Phase II, the Reference
Centers will work to implement HL7 messaging
for Varicella zoster virus (VZV), S. pneumoniae,
and H. influenza while continuing to report other
VPDs through a secure file transport protocol. With this project, APHL is
on the forefront of informatics: the VPD Project expands members’
messaging capabilities and delivers critical data into the hands of key
decision makers.
For more information, contact Linda Cohen, informatics program
manager, at linda.cohen@aphl.org.
The APHL VPD TAT onsite with members of the CA PHL. From left to right: David Sanderson, Christopher Anderson,
Renika Montgomery, Jean Bishop, Don Swiden, Joao Sousa and Stephen Pendergrass
APHL VPD technical assistance site visit with members of the MN PHL. From left to right: Patricia Burns, Angie
Jacobsen, David Sanderson and Jennifer Adams
The APHL VPD TAT onsite with members of the MN PHL. From left to right:
Renika Montgomery, Larry Christianson, Jean Bishop, Linda Cohen,
Lisa Dunning, Patricia Burns, Jennifer Adams and David Sanderson
APHL hosted a webinar about the VPD Reference Laboratory
Project on September 10, 2013. The recording of this event is
available on APHL’s website at www.aphl.org/aphlprograms/infec-
tious/emerging/Pages/re-emergence.aspx.

2014 APHL AnnuAL AwArds
Lifetime Achievement Award
Recognizes individuals who have
established a history of distinguished
service to APHL, made significant
contributions to the advancement of public
health laboratory science or practice,
exhibited leadership in the field of public
health, or positively influenced public
health policy on a national or global level.
Champion of the Public Health
Laboratory Award
Acknowedges elected officials and
executive branch employees who support
legislation or federal agency decisions
affecting governmental laboratories
that perform testing of public health
significance.
Gold Standard for Public
Health Laboratory Excellence
Recognizes an APHL member individual
or laboratory that makes or has made
significant contributions to the technical
advancement of public health laboratory
science and practice.
Silver Award
Honors a laboratorian with 10-15 years of
service in a governmental public health,
environmental or agricultural laboratory.
APHL’s Annual Awards Program highlights outstanding achievements in
laboratory science, creative approaches to solve today’s public health
challenges, and exemplary support of laboratories serving the public’s
health. APHL award honorees are recognized at the awards breakfast
held in conjunction with APHL’s Annual Meeting.
Visit www.aphl.org to see past awards
winners and to nominate your colleagues!
On the Front Line Award
Honors an individual or laboratory outside
of the APHL membership (e.g., public
health program leader, state health official,
federal agency) who makes significant
contributions to the advancement of public
health laboratory science and practice.
Emerging Leader Award
Honors a laboratorian whose leadership
has been instrumental in one or more
advances in laboratory science, practice,
management, policy or education.
Thomas E. Maxson Education,
Training and Workforce
Development Award
Recognizes an APHL member who is
a public health or clinical laboratory
practitioner, trainer or educator who has
made significant contributions in the
continuing education of laboratorians.
Healthiest Laboratory Award
Celebrates excellence in environmental
stewardship and health promotion in both
practice and policy. It recognizes APHL
member laboratories demonstrating
outstanding efforts to reduce their
collective environmental impact and to
promote health and wellness programs.

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