Clarity in Newborn Toxicology | v.6 i.3
Revealing the Future Today USDTL embarks on new research in the detection of prenatal alcohol exposure.
2015 4 Investigating the potential of PEth testing in newborn dried blood spot specimens. 8 What ISO 17025 certification means for USDTL clients. 10 National positivity rates in umbilical cord and meconium specimens.
Letter from the editor
HOPE IN THE FUTURE Despite a landscape of increasing newborn drug and alcohol exposure, we have faith in the future and the potential to create positive change for positive outcomes. Solid research efforts and the will to make a difference will get us there.
Sometimes the outlook is just too bleak. It can be hard to see hope. The numbers can be discouraging. More than 5% of pregnant women in the U.S. are current illicit drug users at any given time. As many as 8.5% of pregnant women consume alcohol during pregnancy, and 2.7% consume alcohol heavily. Almost 16% - 1 in 6 - women smoke during pregnancy. Research conducted over the past decade has led many healthcare professionals to believe these numbers are underestimates, due to the stigma associated with selfreporting any kind of substance use during pregnancy. Research has never found a safe level of drugs, cigarettes, or alcohol for a woman to consume during pregnancy, so any level of newborn substance exposure is discouraging. For us, this is what drives our vision as a toxicology lab - leveraging our newborn toxicology knowledge to â€œEnrich and Protect Lives.â€? In service to that vision, we have held ourselves to the highest possible standard since day one. To that end, we have sought and achieved the most stringent laboratory accreditation standard in the world, ISO/IEC 17025 laboratory accreditation. This achievement confirms our commitment to our clients, and to the newborn lives they serve and protect. We are also pushing the limits of our knowledge to break through the barriers of the impossible and find the solutions that lie on the other side. Our recent undertaking of an international research collaboration with investigators at Northwestern University (Evanston, IL) and Hospital Pereira Rossell in Montevideo, Uruguay, will expand the edges of what is possible in the service of alcohol exposed newborns. It would be wonderful to think that some day our expertise and services will no longer be needed. But for now they are. For now, we can see hope for the future, because that is the premise that USDTL was founded on. No matter how grim the outlook, the future holds promise as long as we try a little harder and push the boundaries, every moment of every day.
Thanks for reading, Michelle Lach, Editor-in-Chief
Fall 2015 NeoTox
NeoTox Fall 2015 volume 6 issue 3
Michelle Lach, MSIMC Managing & Design Editor
Joseph Salerno, MS Graphic Designer
Dru Wagner, MA Science Advisory Board
Table of Contents
BREAKING THE BLOOD BARRIER Joseph Salerno, MS
A new research collaboration between Northwestern University Feinberg School of Medicine, Hospital Pereira Rossell, Montevideo, Uruguay, and USDTL will investigate the potential for routine newborn screening for prenatal alcohol exposure measuring PEth in dried blood spots.
Douglas Lewis, D.Sc. Joseph Jones, MS NRCC-TC Adam Negrusz, Ph.D. F-ABFT
NeoTox is a quarterly news magazine of science, data, and news about perinatal toxicology and substance exposure issues. It is our mission to distill the technical world of toxicology, drug testing, and addiction science into plain words. If you have suggestions for topics you would like to know more about, let us know.
Following on 25 years of industry leading innovation, experience, and professionalism, USDTL reaffirms the commitment to quality by achieving accreditation for the international ISO/IEC 17025 laboratory standard.
A HABIT OF EXCELLENCE Joseph Salerno, MS
NATIONAL POSITIVITY RATES USDTL quarterly national results for drug and alcohol testing in umbilical cord and meconium specimens.
1700 S. Mount Prospect Rd. Des Plaines, IL, 60018 847.235.2367 ÂŠ 2015 USDTL, Inc. All Rights Reserved.
Cover illustration by Joseph Salerno.
BREAKING THE BLOOD BARRIER A new research collaboration between Northwestern University Feinberg School of Medicine, Hospital Pereira Rossell, Montevideo, Uruguay, and USDTL will investigate the potential for routine newborn screening for prenatal alcohol exposure measuring PEth in dried blood spots. by Joseph Salerno, MS
United States Drug Testing Laboratories, Inc. was created from the need to more effectively address the issue of neonatal exposure to drugs and alcohol. In our 25 years since that inception we have spearheaded the wave of innovation in neonatal toxicology testing. Continuing a 25 year conviction to protect and enrich newborn lives, researchers at USDTL have embarked on a new research collaboration to investigate routine screening of newborns for prenatal alcohol exposure by measuring the direct alcohol biomarker phosphatidylethanol (PEth) in dried blood spots from both umbilical cord blood and newborn heel sticks. The four year international research grant from the National Institute on Alcohol Abuse and Alcoholism (NIAAA) will provide large-scale data to support routine screening. Research Scientist Dr. Aileen Baldwin, Ph.D., M.P.H., will spearhead USDTLâ€™s efforts in collaboration with
States. Alcohol use during pregnancy can result in a range of adverse outcomes known as fetal alcohol spectrum disorders (FASD). The most severe cases of FASD, known as fetal alcohol syndrome (FAS) can lead to severe negative impacts on the child, including growth deficiency, central nervous system dysfunction, and changes from normal physiology and behavior.  It is estimated that 8% of U.S. women drink during their pregnancy, leading to an estimated incidence of FASD of 2-5% of all newborns.  The effects of FASD/FAS can manifest as ongoing developmental issues and can affect a child throughout their lifetime. Early diagnosis of FASD is key to effective interventions and treatments. Children under the age of three may benefit from early neuroplasticity, and early identification of FASD/FAS may reduce long-term adverse effects and help affected children achieve parity with their peers.  PEth has been shown to be research aims to examine the potential for PEth to be a highly a highly sensitive and specific sensitive and specific indicator of prenatal alcohol exposure. direct alcohol biomarker for adult alcohol testing.  This prominent neonatal researchers from Northwestern research aims to examine the potential for PEth Universityâ€™s Feinberg School of Medicine (Chicago, to be a highly sensitive and specific indicator of IL) and Hospital Pereira Rossell, Montevideo, prenatal alcohol exposure. If successful, the analysis Uruguay. of PEth in dried blood spot cards would be a Prenatal alcohol exposure is the leading powerful, universally available testing sample and preventable cause of birth defects in the United Continued on page 9, Research.
Fall 2015 NeoTox
Formation of phosphatidylethanol (PEth) = ethanol = PEth PEth is an abnormal phospholipid that is created by red blood cells as they encounter alcohol in the blood. PEth is stored in the cell membrane and can be extracted from dried blood spot specimens and measured to identify alcohol exposure. ne
Advantages of PEth* 100% specific for ethanol. PEth can only be formed in the presence of ethanol. Identifies heavy episodic drinking (5 or more drinks in one sitting) for up to the last 30 days prior to measurement. PEth levels are not affected by race, gender, BMI, or disease state. Dried blood spot specimens for PEth analysis are easy to collect and non-invasive. * These statements have only been established in adult PEth testing. The research outlined here aims to establish these characteristics for newborn PEth testing as well.
A HABIT OF EXCELLENCE Following on 25 years of industry leading innovation, experience, and professionalism, USDTL reaffirms the commitment to quality by achieving accreditation for the international ISO/IEC 17025 laboratory standard. by Joseph Salerno, MS
ISO/IEC 17025 accreditation is the single most important competency standard applied to testing and calibration laboratories around the globe. Laboratories accredited to this standard have demonstrated significant technical ability to reliably generate and reproduce accurate, precise and consistent data. Immediately after accepting his new leadership role in 2014, USDTL Laboratory Director, Dr. Adam Negrusz, began the endeavor to achieve ISO/IEC 17025 accreditation. Working closely with QC/QA Manager, Michelle Pilkington, Dr. Negrusz set out to successfully finish the process within two years. All their efforts, combined with a company-wide determination, allowed us to achieve accreditation within 14 months time - 10 months less than our original goal. That accomplishment is
International Electrotechnical Commission in the field of Forensic Testing. It is important to point out that this standard and level of expertise is nothing new to us. Since our beginnings in 1991, we have always maintained the highest level of quality and competency, providing our clients with the most responsive and personal service in the drug and alcohol testing industry. ISO/IEC 17025 accreditation reaffirms that commitment to our clients, and officially codifies it for all aspects of our testing and client advocacy. Now, as before, our clients can always have absolute confidence that the results of every specimen tested by our laboratory will meet the international standards. The scope of our accreditation encompasses all aspects of our laboratory system, well beyond just our accredited general are proud to announce that we are the first laboratory in the world laboratory methodologies. Not to be ISO/IEC 17025 accredited for drug and alcohol testing in one single function within umbilical cord, fingernail, and toenail specimens. the umbrella of our testing services is outside the scope of our accreditation. All a testament to USDTLâ€™s historical adherence to the specimen types analyzed by USDTL are accredited, highest possible laboratory and business standards. including umbilical cord, meconium, breast milk, We are proud to announce that we are the first all keratinized specimens (fingernails, toenails, laboratory in the world to be ISO/IEC 17025 hair), urine, oral fluid, and blood. USDTL is now accredited for drug and alcohol testing in umbilical the only lab in the United States to offer PEth cord, fingernail, and toenail specimens. On (phosphatidylethanol) testing for alcohol use under September 4, 2015, USDTL attained ISO/IEC the ISO/IEC 17025 standard. 17025 accreditation showing full compliance with As a global innovator in the science and the competency standards of the International Continued on page 8, Accredited. Organization for Standardization and the
Fall 2015 NeoTox
ISO / IEC 17025
Accredited, continued from page 6.
technology of substance abuse toxicology, we have maximized the capabilities of our instruments to achieve the lowest positive result cutoffs in the industry for many toxicology tests. Our carboxyTHC cutoff level for a positive cannabinoid test result is the lowest achieved by any reference lab in the U.S. Exhaustive research and maximization of our technology led us to develop the lowest umbilical testing cutoffs in the industry. Our use of technology to improve our clientsâ€™ data has always been a premier aspect of our work. Now, in addition to being at the forefront of toxicology expertise, our methodologies and instrumentation are fully accredited to the ISO/ IEC 17025 standard. Accreditation under this standard increases the evidential acceptance of our laboratory results in virtually all jurisdictions. As a forensic testing laboratory this is of the highest importance to us, because every testing result has
the possibility of becoming evidence in a court of law. The 17025 standard was first codified by ISO and IEC in 1999, and was further amended and improved in 2005. Explicit requirements for continuing improvement of management systems, with an emphasis on the responsibilities of senior management, is central to the 2005 revisions. An efficient management system ensures fast resolution of laboratory issues regarding methods and equipment. Even before ISO/IEC 17025 accreditation, this was one of the cornerstones to USDTLâ€™s results turn-around time - one of the fastest in the industry - and outstanding customer advocacy, and will remain so moving forward. To view our certificate of accreditation, visit us online at www.usdtl.com/media/certifications/ USDTL-ISO17025.pdf. If you have questions about ISO/IEC 17025 accreditation, please contact us at email@example.com or 800.235.2367. Page 7 illustration by Joseph Salerno.
DID YOU KNOW? USDTL holds several international, state, and federal certifications and accreditations. Oklahoma State Department of Health Certified Laboratory
Iowa Department of Health Approved Laboratory Lists
Maryland Department of Health and Mental Hygiene Office of Health Care Quality Medical Laboratory Permit
New York State Department of Health Clinical Laboratory Permit
Illinois Department of Financial and Professional Regulation Controlled Substances Licensee
College of American Pathologists Accreditation
Florida Agency for Health Care Administration Licensed Clinical Laboratory Fall 2015 NeoTox
Research, continued from page 4.
measurements. PEth is a newer biomarker that detects episodic heavy drinking (5 or more drinks in one sitting) for up to the last 30 days. PEth testing is 100% specific in detecting recent alcohol use with no known false positives. A strong correlation between maternal and neonatal PEth levels would offer the possibility of a universally available tool that will prevent undetected cases of prenatal alcohol exposure, increasing the potential for newborns to receive early developmental interventions when necessary and prevent them from slipping through the cracks. “A new biomarker for alcohol, more accurate and
assay to identify prenatal alcohol exposure. The four year study, awarded to the Feinberg School of Medicine, is an international collaboration involving USDTL, Dr. Michael Fleming, M.D., M.P.H., (Project Leader and Principle Investigator, Feinberg School of Medicine), and Dr. Raquel Magri, M.D. (Colegio Iberoamericano de Adicciones at Hospital Pereira Rossell, Montevideo, Uruguay), with expert Consultation from Dr. Phillip May, Ph.D. (University of North Carolina, Gillings School of Global Public Health, Kannapolis, NC). “We are A strong correlation between maternal and neonatal PEth levels very interested in discerning would offer the possibility of a universally available tool that will the detailed characteristics of prevent undetected cases of prenatal alcohol exposure... maternal risk and protection for fetal alcohol spectrum disorders in this unique binge drinking population easy to collect will probably present more positive that will guide prevention and intervention in the results in a population with highest prevalence,” future,” said Dr. May, “This research will help to said Dr. Magri, “There is strong experience with ensure healthier babies in the future, not just in this group of researchers, who have worked together Montevideo and Uruguay, but in other countries in this area in three previous studies.” The future with similar risk profiles and similar social and of neonatal alcohol screening is promising. public health conditions. ” References This work will focus on a cross-sectional study 1. Barr, HM, Streissguth, AP. (2001). Identifying of 1500 women, ages 18 years and older, and their maternal self-reported alcohol use associated with fetal newborns in the city of Montevideo, Uruguay. alcohol spectrum disorders. Alcoholism: Clinical and Previous work in public health care hospitals in Experimental Research, 25, 283-287. Montevideo, Uruguay documented high rates of 2. May PA, Baete A, Russo J, Elliott AJ, Blankenship J, alcohol use during pregnancy (60%) as well as PEth Kalberg WO, Buckley D, Brooks M, Hasken J, Abdullevels in newborns (79%).  “The country has a Rahman O, Adam MP, Robinson LK, Manning M, high prevalence of alcohol consumption among Hoyme HE. (2014). Prevalence and characteristics of young women, including those who are pregnant fetal alcohol spectrum disorders. Pediatrics, 134, 855-866. and in low and middle-low socioeconomic and 3. Mitchell, KT. (2002). Fetal alcohol syndrome: Practical educational status, whose babies might be more at suggestions and support for families and caregivers. risk for FASD,” said Dr. Magri, “The results will Washington, DC: National Organization on Fetal help to start the actions in a strategy to lessen this Alcohol Syndrome. consumption.” 4. Hartmann, S, Aradottir, S, Graf, M, Wiesbeck, G, Alcohol use in the previous studies was Lesch, O, Ramskogler, K, Wurst, FM. (2007). Addiction documented through self-report surveys of pregnant Biology, 12(1), 81-84. women. The current undertaking will also 5. Unpublished data, NIAAA Small Business Innovation examine PEth levels in mothers and investigate the Research Funding. correlation between maternal and neonatal PEth Page 5 illustration by Joseph Salerno.
USDTL NATIONAL POSITIVITY RATES* Umbilical Cord Specimens
Amphetamines | 3.6% Cocaine | 1.8% Opiates | 10.1%
Cannabinoids | 16.8% Barbiturates | 1.7% Methadone | 3.0% Benzodiazepine | 2.6% Oxycodone | 3.8% Meperidine | 1.1% Tramadol | 0.9% Buprenorphine | 10.0% Ethyl Glucuronide | 2.2% Cotinine | 47.9%
Not shown: Phencyclidine 0.0%, Propoxyphene 0.0%
Fall 2015 NeoTox
Report date range: April 1, 2015 â€“ September 30, 2015 * These data report national positivity rates for newborn toxicology tests conducted by USDTL on behalf of external clients and are not reflective of systematic research results.
Amphetamines | 5.0% Cocaine | 3.5% Opiates | 9.5%
Cannabinoids | 20.7% Barbiturates | 1.1% Methadone | 5.0% Benzodiazepine | 0.1% Oxycodone | 1.4% Meperidine | 1.0% Tramadol | 1.5% Buprenorphine | 6.3% Fatty Acid Ethyl Esters | 11.0%
Not shown: Phencyclidine 0.1%, Propoxyphene 0.1%
United States Drug Testing Laboratories, Inc. 1700 S. Mount Prospect Road|Des Plaines, IL|60018 Main: 847.375.0770|www.USDTL.com|Fax: 847.375.0775
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EVENTS & EXHIBITS • February 17-20 – The 29th Annual Gravens Conference on the Physical and Developmental Environment of the High Risk Infant, in collaboration with the March of Dimes – Clearwater Beach, FL • February 25-28 – NEO: The Conference for Neonatology & Specialty Review in Neonatology – Orlando, FL • April 30 - May 5 – 2016 Pediatric Academic Societies Annual Meeting – Baltimore, MD
The Leader in Newborn Toxicology
1700 S. Mount Prospect Rd. | Des Plaines, IL 60018 | 800.235.2367 | www.USDTL.com
Fall 2015 NeoTox
Despite a landscape of increasing newborn drug and alcohol exposure, we have faith in the future and the potential to create positive change...