Delaware Health and Social Services
Division of Public Health
Laboratory

Delaware LabOrator
Volume 31, Issue 1
Spring 2006

Inside this Issue:
DPHL Celebrates Fifteen Years In Smyrna
New Employees
Select Agent Inspection
Employee of the Quarter


Implementing Cystic Fibrosis Testing in Delaware
By: Pat Scott, Jane Getchell DrPH, Louis Bartoshesky MD, Betsy Voss

In the summer of 2006, the Delaware Public Health Laboratory (DPHL)
will begin validating a test method for cystic fibrosis (CF) 
screening to be used to screen all babies born in Delaware. The 
incidence of CF is common, about 1 in 5,000 births (1 in 2,500 among 
northern Europeans).  CF screening as part of the newborn screening 
panel has been recommended by the American College of Medical Genetics
(ACMG), the American Academy of Pediatrics (AAP) and the March of 
Dimes, as well as the Delaware Newborn Screening Advisory Committee. 
Currently about 20 states screen for CF and many others are planning 
to add CF to their screening panel soon.  

There have been many studies on the issue of CF as part of newborn 
screening. Some studies have shown that babies screened at birth and 
found to have CF have better growth and reduced risk of malnutrition 
when early treatments are established.  Other reports indicate greater
height-for-age and to a lesser degree, weight-for-age among children
detected through screening. Still other studies suggest improved 
pulmonary outcome in children with CF who are identified in the first 
few months of life and treated promptly. In November 2003, the Centers 
for Disease Control and Prevention (CDC) and the Cystic Fibrosis 
Foundation cosponsored a workshop to review the benefits and risks 
associated with newborn screening for CF. The resulting report, 
Newborn Screening for Cystic Fibrosis Evaluation of Benefits and Risks
and Recommendations for State Newborn Screening Programs, published 
in the October 15, 2004 issue of the Morbidity and Mortality Weekly 
Report, recommended the following [FN1]: 

“The magnitude of the health benefits from screening for CF is 
sufficient that states should consider including routine newborn 
screening for CF in conjunction with systems to ensure access to 
high-quality care.”

This statement  recommends two things: 1) that states include CF in 
routine newborn screening testing panels; and 2) that testing is in 
conjunction with follow-up systems that ensure access to high quality 
are. To implement a successful screening program for cystic fibrosis, 
DPHL, the screening laboratory, and the Newborn Screening Program 
staff will have to work closely together. 

In Delaware, initial CF screening will be accomplished by measuring 
for Immunoreactive Trysinogen (IRT) in the dried blood spot. The test 
will use the same blood specimens already collected.  Infants who 
screen positive will be referred for definitive diagnosis.

Delaware currently requires two specimens on all babies, and utilizes 
extensive tracking mechanisms to assure both specimens are collected. 
This second specimen, which is collected at about two weeks of age, 
will also be tested for IRT. Delaware has chosen to do this IRT/IRT 
two specimen sequence as opposed to an IRT/DNA marker sequence on one 
specimen for several reasons: 1) unaffected carriers are less likely 
to be detected and therefore not require follow-up; 2) additional 
costs will be minimal; 3) no additional laboratory staff will be 
required; 4) additional laboratory space for new technology will not 
be necessary; 5) it will be easier to bring on one new technology at a 
time. Most importantly, a number of states (Colorado, Washington and 
South Carolina) have shown the IRT/IRT test sequence to be effective 
in detecting cases of CF when second specimens are collected on all 
babies.  [FN2]  States that implemented CF testing using the IRT/DNA 
algorithm (Wisconsin, Pennsylvania, Massachusetts, New Jersey, New 
York, Mississippi and Oklahoma), confirm elevated IRT’s with DNA 
testing for anywhere from 1-50 different CFTR mutations, the most 
prevalent mutation being ?508.  While Delaware is not choosing this 
algorithm initially, we will continue to monitor the effectiveness of 
both algorithms for a possible change in the future.

Implementation

Arrival of the Perkin Elmer  Delphia instrumentation for IRT testing 
and subsequent training is expected to begin in July/August 2006 at 
which time the laboratory will begin validation studies.  Soon after, 
the Newborn Screening Program will be hiring an additional Senior 
Health Program Representative who will be coordinating the transition 
and be responsible for follow-up activities.  A price increase in our 
screening fee will be unavoidable due to the new technology and 
increase in CF follow-up. The fee increase is anticipated to take 
effect mid-2006.  All babies who are positive on both an initial and 
a second IRT screen will be referred to the Cystic Fibrosis Program 
of Alfred I. duPont Hospital for Children. Division of Public Health 
Newborn Screening Program staff will assist in referring babies who 
are positive on IRT screening to CF programs and centers and continue 
to follow them for other positive screens within the newborn screening 
program. It is anticipated that approximately 600 babies will be 
referred to cystic fibrosis centers and that we will identify two or 
three infants with CF each year.

References for Cystic Fibrosis Implementation
FN1- Grosse SD, Boyle CA, Botkin JR, Comeau AM, Kharrazi M, Rowenfeld 
M, Wilfond BS.  Newborn Screening for Cystic Fibrosis Evaluation of 
Benefits and Risks and Recommendationsfor State Newborn Screening 
programs. MMWR;53(RR13);1-36, 10/15/04.
FN2 - Sontag MK, Hammond KB, Zielenski J, Wagener JS, Accurso FJ. 
Immunoreative trypsinogen by newborn screening for cystic fibrosis in 
Colorado: recall rate, genotyping and borderline sweat test results. 
J Pediatr (suppl) (in press).

The Delaware Public Health Laboratory Celebrates fifteen years in 
Smyrna:  DPHL Historical Timeline

(This article contains a picture of the present DPH Laboratory)

The Delaware Public Health Laboratory was established in April 1899 
in Newark. The trustees of Delaware College, now the University of 
Delaware, provided space and renovations in the main building’s east 
wing.  The laboratory tested water and food, and for infectious 
diseases including diphtheria and tuberculosis. As technology evolved, 
the laboratory’s testing capabilities expanded to include various 
bacterial and viral agents. To keep health care providers and agencies 
informed of significant developments, the laboratory began publishing 
a quarterly bulletin which today is called the Delaware LabOrator.  

The lab moved five more times in a perennial search for additional 
space. First, the laboratory moved above Hinkley’s Feed Store in 
Dover, its municipal home for many years.  Then it moved to the 
Margaret O’Neill Building on Federal Street. In 1960, the lab moved 
to the basement of the Jesse Cooper Building across the street and, 
by 1985, the laboratory had outgrown its space. The discovery of 
Asbestos precipitated relocation to three modular buildings at the 
Department of Natural Resources and Environmental Control on Kings 
Highway in Dover.

By May 1989 plans were underway to build a new facility in Smyrna on 
the grounds of the Delaware Hospital for the Chronically Ill.  
The new lab opened in 1990. 

Since then, the facility expanded its services by leaps and bounds. 
The lab’s newborn screening section tests for metabolic diseases in 
every Delaware newborn to prevent mental retardation, serious illness, 
and even death. The laboratory tests drinking water for bacteria and 
chemicals, and identifies rabies.  It also tests for sexually trans-
mitted infections and monitors the emergence of drug-resistant 
microorganisms to prevent the spread of infection and save lives.  

In 2001, the facility added a Bio-Safety Level III lab to the clinical 
microbiology section. Its new DNA-amplified testing for gonorrheaand 
chlamydia produces fast results for health care providers. The 
environmental and molecular microbiology section introduced new 
technology, including pulse field gel electrophoresis for food 
borne illness, molecular testing for Norovirus, B. pertussis, West 
Nile virus and rapid detection methods for potential bioterrorism 
gents.  

DPHL embarks on a new journey in testing performance. The new Chemical 
Terrorism Laboratory detects metals at trace levels, and cyanide and 
nerve agents in clinical samples.  The Bio-Level Safety III lab is 
redesigned to include a 100 square foot addition for testing samples 
of potential terrorist origin.

WELCOME

Jeff "The Inquisitor" Roberts joined Environmental & Molecular 
Microbiology as contract employee from Franklin Tech on February 13th. 
Jeff has a diverse background including pharmaceutical research and 
clinical drug testing. He graduated from Millersville University with 
a concentration in Biology. Jeff has proven himself to be a quick 
learner, thinker, and an asset to the lab. We are glad to have him 
aboard.

William Spinden received his laboratory technician training in the 
U.S. Navy in the 1980's. He was assigned to the Philadelphia Naval 
hospital where he worked in the Chemistry and Microbiology sections. 
After he left the Navy he worked for Astra Zenaca for 16 years in the 
microbiology lab. He currently resides in Bear, Delaware.

The DPHL is please to have both of our new staff members on board!


Select Agent Program Update—Certification Inspection
By: Tara M. Lydick, B.S Chemistry, Chemical Terrorism Coordinator

(This article contains a graphic of a magnifying glass)

On February 7, 2006, the Delaware Public Health Laboratory (DPHL) 
participated in a facility inspection by the Centers for Disease 
Control and Prevention (CDC) Select Agent Program.  Each of the three 
bio-safety leve-3 (BSL-3) areas, including the remodeled biological 
preparedness laboratory , were inspected as part of the three-year 
registration cycle established by the Public Health Security and 
Bioterrorism Preparedness and Response Act of 2002.

An ongoing effort to update the continuity of operations plan to 
reflect current capabilities (such as avian influenza) needs, and 
expectation is also in progress. The manual for send out procedures 
for testing not performed at DPHL is also being updated and reviewed 
to avoid delays for sentinel laboratories in transport and analysis 
of specimens. A timely issue is the capability and willingness of 
outside facilities to provide surge capacity during a public health
emergency or incident. Memoranda of understanding are being developed 
through the Public Health preparedness section based on the latest l
aboratory assessments.  For Division of Public Health staff 
assignments and rotations, call down procedures, go-bags, physical 
support requirements are being detailed. Cross-training, testing 
capabilities and capacities, and surge testing prioritizations are 
being formalized. Due to the continual change in operations at any 
laboratory, this plan must be updated vigorously, remain flexible, 
and also be communicated in a timely manner.

NATIONAL MEDICAL LABORATORY PROFESSIONALS WEEK

National Medical Laboratory Professionals Week (NMLPW) is a time of 
recognition for the approximately 265,000 medical laboratory 
professionals and 15,000 board-certified pathologists who play a 
vital role in every aspect of health care.  NMLPW is a chance for 
medical laboratory personnel to celebrate their professionalism and 
be recognized for their efforts.  Often, they use this time to 
educate and inform medical colleagues and the public about the 
medical laboratory. Since laboratorians often work behind the scenes, 
few people know about the critical testing they perform every day.

The 2006 theme will emphasize the women and men who provide answers 
and guide cures in healthcare: “Laboratory Professionals: 
Providing Answers, Guiding Cures.”

Employee of the quarter

Installing a computer  system for the entire Delaware Public Health 
Laboratory is a huge undertaking. When Dr. Getchell decided to put 
Kathy Gray in charge, she couldn’t have picked a better person.  

Kathy has worked with the LabWare staff and individual lab sections 
to tailor the new software to their unique needs. Then she trained 
everyone in virology to use the system before going live. Now she is 
doing the same with microbiology and chemistry. 

Regardless of how busy she may be, Kathy is always available to “fix” 
problems. Her patience is unlimited, and if she can’t answer a 
questions (which is not often), she will persist until she finds 
someone who can.

With five children and a husband to care for, she still finds time to 
bake cakes for birthdays and make things for fundraisers.  All in all,
the Public Health Laboratory certainly made a great decision the day 
we offered Kathy Gray a position on our staff.

National Medical Laboratory Professionals Week April 23-29, 2006

(This article contains the 2006 National Medical Laboratory 
Professionals Logo).

The 2006 Lab Week will be held April 23-29, 2006. After 30 years of 
being called "National Medical Laboratory Week," the name has been 
changed to reflect the fact that a laboratory is more "people" than a 
"place." Starting in 2006, the observance will be called "National 
Medical Laboratory Professionals Week." The 2006 theme will also 
emphasize the women and men who provide answers and guide cures in 
healthcare.
For more information on National Medical Laboratory Professionals 
Week, visit the website for theAmerican Society of Clinical Pathology 
at www.ascp.org/labweek.

(DPH Logo:  Changing Faces)
"To Protect and Enhance the Health of the People of Delaware"

Jaime "Gus" Rivera, MD, FAACP
Director
Delaware's Division of Public Health

Jane P. Getchell, DrPH
Director
Delaware Public Health Laboratory

Christina Pleasanton, MS
Deputy Director
Delaware Public Health Laboratory

Christine L. Shipengrover, BS
Newsletter Editor
Delaware Public Health Laboratory

If you would like to receive this publication via e-mail, contact:
Christine Shipengrover
Phone: (302) 223.1520 or
E-Mail: Christine.shipengrover@state.de.us

Document No.:35-05-20/06/05/01