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What Makes USDTL Different? 1991

First offering of 5-drug panel meconium testing for in utero drug exposure.

1999

Offered the first test for a direct alcohol biomarker (FAEE) in meconium.

2004

Initiated research on the use of umbilical cord tissue for drugs of abuse testing.

2005

First offering of a 12-drug panel for newborn testing using meconium.

2007

Launched the first 5-drug panel using an umbilical cord tissue segment.

2011

Development of the first test for in utero exposure to designer stimulants (Bath Salts).

2012

Launched first commercial forensic test for a long-term alcohol biomarker in umbilical cord tissue.

2013

Developed the first test for the direct alcohol biomarker, PEth, using newborn heel sticks or umbilical cord blood spots.

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In the late 1980’s our President and Founder, Doug Lewis, first experienced the heartbreak of a newborn in withdrawal. The term at the time was “crack baby”, it was an epidemic, and that experience altered Doug’s career path forever. An assistant professor of clinical pathology at Northwestern University Medical School and head of the toxicology section at the Children’s Memorial Hospital in Chicago, Doug realized that there was an expedient need to determine newborn substance abuse exposure, and his new journey began. By 1991, Doug’s company, USDTL, was the first to offer a 5-panel meconium test for in utero drug exposure. Since then, USDTL has become a world leader in alternate specimen toxicology for substances of abuse, continuously leading the way on multiple fronts, and setting the gold standard in the field. There are three reasons USDTL remains on top as an industry leader. We are • a forensic laboratory, • with the lowest cutoff levels in umbilical cord tissue, • and the fastest turnaround times. The combination of these three factors means our clients can be confident they are making the right choice, for their business, and for the future of each child they are protecting - giving them strength for their future.


What Makes Us a Forensic Laboratory? Along with standard accreditations such as CAP and CLIA, we hold ourselves to the highest forensic standards as one of only four drug testing laboratories in the world to be ISO/IEC 17025 accredited, an international standard.

Forensic tests have two main differences compared to clinical testing:

Chain of Custody

Confirmed Positives

Chain of Custody

The forensic chain of custody guarantees that the result you receive is from the specimen you sent in, because with the chain of custody, the specimen can be tracked through the laboratory, from beginning to end.

Receiving

Order Entry

Accessioning

Extractions

Aliquoting

Certification

Mass Spec

Confirmed Positives

As a forensic laboratory, we also confirm all positives. Confirming positives isn’t about the specificity of the initial instrument. It is about being able to duplicate the results with a completely different method, giving the positive results the greatest validity possible.

Initial Screening Method #1 (ELISA)

Method #2 (LCMSMS) 3


Why Does Forensic Testing Matter? Our test results advocate for the child for the rest of their life.

Unlike clinical tests, having a chain of custody and confirmation on all positives make the results forensically defensible. Our results defend the child for the rest of their life in the event they need evidence of exposure to receive specialized services in the future. Mandatory reporters may be required to use testing that includes confirmations. Check your individual state requirements for details.

Lowest Cutoff Levels in Umbilical Cord Tissue Drug cutoff levels are the minimum concentrations of drugs or metabolites that must be present in specimens, before the drug testing result is positive.

Our cutoff levels in umbilical cord tissue are the lowest in the industry because our laboratory houses some of the most cutting edge instrumentation for detecting substances of abuse, and our toxicologists are continually pushing the envelope to make it even better. This gives you the highest possible chance for exposure detection, because missing even one exposed newborn is not an option.

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Fastest Turn Around Time We run tests 359 days a year. Our laboratory runs 7 days a week, with the exception of 6 major holidays, which are restricted only because courier services do not run on these days, so no specimens are able to be delivered to the lab. Holiday Closures:

● New Years Day

● Memorial Day ● Independence Day ● Labor Day ● Thanksgiving Day ● Christmas Day From the time the specimen is received in the laboratory, negatives are reported within 24 hours, and often reported the same day they are received. Confirmed positives take an additional 24-48 hours to process and report the results.

Cord Negative Results

Cord Confirmed Positive Results

Cord Received in Lab

24h

48h

72h

96h

120h

144h

Meconium Received in Lab Meconium Negative Results

Meconium Confirmed Positive Results

Other Client Benefits Quarterly Positivity Reports

Each quarter, we send our clients positivity reports for all of their associated accounts. This gives them a snap shot of what positivity trends their hospitals are facing. National data from tests performed by our laboratory is also made available to our clients quarterly.

NeoTox

NeoTox is a quarterly news magazine about perinatal toxicology and substance exposure issues.

Research and Development

We work with researchers from hospitals, universities, and industry groups across the globe to provide our clients with the most innovative solutions for their drug and alcohol testing needs. From meconium, to umbilical cord, to dried blood spots, USDTL has been there first to develop the most powerful tools for identifying in utero alcohol and drug exposure.

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Umbilical Cord Tissue Drug Panels 13 12

9

7

5

Amphetamines

l l l l l

Cannabinoids

l l l l l

Cocaine

l l l l l

Opiates

l l l l l

Phencyclidine

l l l l l

Methadone

l l l l

Barbiturates

l l l l

Benzodiazepines

l l l

Propoxyphene

l l l

Oxycodone

l l

Meperidine

l l

Tramadol

l l

Buprenorphine

l

amphetamine, MDA, MDEA, MDMA, methamphetamine carboxy-THC

benzoylecgonine 6-MAM, meconin, codeine, hydrocodone, hydromorphone, morphine phencyclidine (PCP) EDDP, methadone amobarbital, butalbital, pentobarbital, phenobarbital, secobarbital alprazolam, diazepam, midazolam, nordiazepam, oxazepam, temazepam propoxyphene, norpropoxyphene oxycodone, oxymorphone meperidine, normeperidine tramadol

buprenorphine, norbuprenorphine

Optional Add-Ons For Umbilical Cord EtG (Direct Ethanol Biomarker)

ethyl glucuronide

Designer Stimulants (Bath Salts)

mephedrone, methylone, ethylone,, butylone, MBDB, mCPP, TFMPP, MDPV

Cotinine cotinine

1 SAMPLE 1 COLLECTION 1 TIME

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This unique specimen type offers a number of advantages: Availability – Always available and often allows more rapid reporting of results. Convenience – A 6” section of umbilical cord tissue is enough for screening and confirmation. Ease of Collection – A simple collection done in 1-2 minutes means one sample is collected by one person, one time.

Window of Exposure for Cord & Meconium


Meconium Drug Panels 13 12

9

7

5

Amphetamines

l l l l l

Cannabinoids

l l l l l

Cocaine

l l l l l

Opiates

l l l l l

Phencyclidine

l l l l l

Methadone

l l l l

Barbiturates

l l l l

Benzodiazepines

l l l

Propoxyphene

l l l

Oxycodone

l l

Meperidine

l l

Tramadol

l l

Buprenorphine

l

amphetamine, MDA, MDMA, methamphetamine carboxy-THC

benzoylecgonine, cocaethylene, cocaine, meta- hydroxybenzoylecgonine codeine, hydrocodone, hydromorphone, morphine

iStock Photo

phencyclidine (PCP) EDDP, methadone amobarbital, butalbital, pentobarbital, phenobarbital, secobarbital oxazepam

norpropoxyphene oxycodone

normeperidine tramadol

buprenorphine, norbuprenorphine

Optional Add-Ons For Meconium FAEE (Direct Ethanol Biomarker) Fatty Acid Ethyl Esters

up to approximately

20 Weeks

Meconium facts: • Collected within 1-2 days after birth. • A great option if a newborn presents indicators and umbilical cord was not collected. • 3 grams (1 teaspoon) is all that is needed for maximum sensitivity.

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Breast Milk Drug Panels 13 12

9

7

5

Amphetamines

l l l l l

Cannabinoids

l l l l l

Cocaine

l l l l l

Opiates

l l l l l

Phencyclidine

l l l l l

Methadone

l l l l

Barbiturates

l l l l

Benzodiazepines

l l l

Propoxyphene

l l l

Oxycodone

l l

Meperidine

l l

Tramadol

l l

Buprenorphine

l

amphetamine, MDA, MDMA, methamphetamine carboxy-THC

benzoylecgonine, cocaethylene, cocaine, meta-hydroxybenzoylecgonine codeine, hydrocodone, hydromorphone, morphine phencyclidine (PCP) EDDP, methadone amobarbital, butalbital, pentobarbital, phenobarbital, secobarbital alprazolam, diazepam, midazolam, nordiazepam, oxazepam, temazepam propoxyphene, norpropoxyphene oxycodone

meperidine, normeperidine tramadol, o-desmethyltramadol, n-desmethyltramadol buprenorphine, norbuprenorphine

Optional Add-Ons For Breast Milk Ethanol ethanol

77

percent of mothers in the United States in 2013 breast fed their babies, according to the CDC

The high level of participation in breast feeding is due to the growing list of health benefits provided to both the mother and the newborn. Most drugs of abuse readily pass into human breast milk. While therapeutic levels of prescription drugs may be considered compatible with breastfeeding, abuse levels may be problematic for the infant.

Drug and Alcohol Use by Pregnant Women Aged 15-44* 10 8 Percent

6 4 2 0

Current Illicit Drug Users

Current Alcohol Use

Binge Drinking

*Information from the 2012 publication of data from the National Survey on Drug Use and Health.

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Why Use Chain of Custody? The movement and location of physical evidence from the time it is obtained until the time it is presented in court is the legal definition of chain of custody. The results of any newborn alcohol or substance of abuse test performed at USDTL may eventually be presented as evidence in a court of law, and this is why USDTL maintains universal chain of custody regardless of the client source of testing specimens. A court can exclude the results of a test if a chain of custody for the newborn sample was not maintained by the hospital and USDTL. Chain of custody for specimens sent to USDTL is maintained as a chronological paper trail of collection and transfers of specimens throughout the testing process. The paper trail is signed and dated by each person who handles the specimen, both when they receive the specimen into their own hands, and when they hand it off to the next person in the process. Less transfers of a specimen that need to be documented is better for the chain of custody overall. A well-maintained and legal chain of custody begins at the time of specimen collection and continues uninterrupted until test results have been presented in court, if necessary. There are several key elements that must be present when specimens arrive at USDTL. The specimen container must be sealed with an intact security seal. Next, the sample must be accompanied by a Custody and Control Form with an ID number matching the number on the specimen container. Thirdly, the Custody and Control Form must be signed and dated by an authorized agent from the client. An unbroken chain of custody ensures sample integrity in several ways that preserve the legal usefulness of alcohol and drug testing results. Maintaining chain of custody for newborn samples destined for alcohol and drug testing is a simple process, but all those who handle a drug testing specimen need to be vigilant about the process nonetheless. Diligent maintenance of chain of custody is always in the child’s best interest. Ultimately, chain of custody protects the institution that is collecting the specimen, as well as the newborn whose health and well-being may rely on the results of a USDTL alcohol or drug test.

The chain of custody can be completed in a few simple steps and takes approximately a minute.

1. Attach the newborn sticker.

2. Select tests to be performed.

4. Sign the form.

3. Place bar-coded sticker over the specimen container.

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Neonatal Abstinence Syndrome And Variations in Expression By Loretta P. Finnegan, M.D. Burgeoning numbers of infants exposed to a variety of substances which cause untoward effects are seen in major hospitals across the United States. A 2012 report indicated that between 2000 and 2009, the number of mothers using opiates increased from 1.19 to 5.63 per 1,000 hospital births per year. Additional data from this study compared discharges for Neonatal Abstinence Syndrome (NAS) versus all other hospital births in 2009. NAS was diagnosed at a rate of 3.39 per 1000 hospital births per year. Newborns with NAS were 19% more likely than all other hospital births to have low birth weight and 30% more likely to have respiratory complications. Compared with all other hospital births, newborns with NAS, in addition to being significantly more likely to have respiratory diagnoses and low birth weight, also had feeding difficulties and seizures more often. In the US, the incidence of smoking in pregnant women is reported as 17.3 %. Concomitant smoking in opioid dependent women in treatment can approach more than 90%. Because of their low molecular weight and lipid solubility, psychoactive medications easily pass through the placenta from the mother to the fetus at varying degrees depending on the properties of the individual drugs. Once the drugs pass across the placenta and accumulate in the fetus, there is an equilibrium established between maternal and fetal blood. Disruption of the trans-placental passage of drugs at birth, when the umbilical cord is cut, terminates the drug supply to the baby with the potential of the development of symptoms of withdrawal or abstinence. This constellation of symptoms constitutes a multisystem disorder involving the central nervous system, gastrointestinal system, respiratory system and the autonomic nervous system, which is termed the Neonatal Abstinence Syndrome. If not recognized and not treated, NAS can cause death in the infant due to excess fluid losses, high temperatures,

not recommended for NAS since not all drug-exposed newborns experience abstinence symptoms, however, it is very important to closely observe the newborns for symptoms that may occur over the first 4-5 days of life. Treatment should be provided based on principles of accurate assessment and diagnosis. The diagnosis should be confirmed by maternal history of opioid use and a urine or meconium toxicology screen. Assessment for other neonatal conditions should also be considered since the symptoms of NAS can mimic such conditions as septicemia, encephalitis, meningitis, post-anoxic CNS irritation, hypoglycemia, hypocalcemia and cerebral hemorrhage, all of which the infant born to the substance misusing woman are at risk for, especially because of maternal infections and pre-term birth. Pharmacological treatment is provided according to the severity of the score which monitors the infant’s clinical response to medication and the amount necessary to control the symptoms followed by progressive tapering of the dose. Clinicians should provide an opioid medication in the treatment of NAS using a titration method to increase the dose (in mg/ kg) according to severity of the scores. Prompt escalation of dose with aggressive decreases in dose as symptoms abate are essential principles. Specific medications generally administered for neonatal opioid abstinence include oral morphine or methadone according to body weight and score. Both are recommended by the American Academy of Pediatrics (2012). In the United Kingdom 94% and in the United States, 83% of physicians use morphine or methadone to treat neonatal opioid abstinence. Sublingual administration of buprenorphine has been studied in the treatment of neonatal abstinence and a dose schema has been developed. Provision of supportive interventions, many of which are traditional methods of Compared with all other hospital births, newborns with NAS, in soothing a newborn infant, are important in the treatment of addition to being significantly more likely to have respiratory diagnoses neonatal abstinence. Some of and low birth weight, also had feeding difficulties and seizures more often. these supportive interventions include: offer a pacifier seizures, respiratory instability, aspiration of fluid into the (Non-Nutritive Sucking); skin to skin contact with the mother; lungs or cessation of breathing. However, with current medical swaddling snugly with hands available for sucking; do not knowledge concerning drug abuse in pregnancy and the care overdress the baby; aspirate naso-pharynx; feed small amounts of the newborn, no infant mortality should occur as a result of frequently (q 2hrs) if poor feeding persists but do not over feed; NAS. and positioning the baby to right side-lying to reduce aspiration An assessment tool permits an accurate evaluation of the signs if vomiting or regurgitation is a problem. and symptoms and the severity, avoids unnecessary treatment During prenatal exposure and in the postpartum period, many of mildly affected infants and provides a methodology for issues can influence the expression of Neonatal Abstinence effective dosing and tapering of medications. The Finnegan Syndrome. Amongst those identified as having a decreased Neonatal Abstinence Score (FNAS) is recommended by the effect upon NAS expression are the following: the time needed American Academy of Pediatrics for assessment of the baby who to excrete the psychoactive medication (the longer that it may develop NAS as a result of in utero exposure to opioids. takes, as in pre-term babies, the less severe the NAS); illness The FNAS rates the individual signs and symptoms assigning in the neonate; breastfeeding; certain genes such as OPRM1 each a relative weight based on the relationship to newborn and COMT; rooming-in with the mother versus admission morbidity—the higher score of an item relates to more severe to the NICU. Those issues that can enhance NAS expression morbidity. The score becomes a valuable objective measure to include: maternal concomitant drug use (i.e., opioids plus assess the onset, progression, and diminution of symptoms of benzodiazepines); maternal methadone versus buprenorphine; abstinence. Routine prophylactic pharmacological treatment is and maternal smoking.

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Medications provided for the treatment of opioid dependence in pregnant women (methadone or buprenorphine), although providing many benefits to the maternal-fetal-newborn triad, also have the potential risk of abstinence in the newborn. Exposure to methadone in utero can precipitate NAS in about 60-80% of those exposed. Dose of methadone has not been shown to be associated with the severity of NAS. Timing of the doses (once daily versus two or three doses) has been seen to influence the incidence and severity of symptoms. For buprenorphine, NAS has been reported in varying degrees of severity and incidence. Many early studies did not control for other drug abuse concomitant with buprenorphine treatment. NAS occurrence was significant in those studies that included other drug use, however, studies in Austria and the United States have shown minimal abstinence symptoms from buprenorphine alone. A well controlled clinical trial (The MOTHER Study) compared the differences between the occurrence and severity of NAS from methadone and that from buprenorphine. No significant differences between methadone and buprenorphine were found in: overall rates of NAS needing treatment; peak NAS scores; and head circumference. There was a reduction of severity of NAS in buprenorphine-exposed neonates defined as: the total amount of morphine needed in mg; length of hospital stay; and number of days for treatment of NAS. These three items are inter-related in that, the more morphine that is needed, the longer the days for treatment and the hospital stay. Methadone or buprenorphine exposure concomitant with heavy cigarette smoking is associated with greater compromised birth outcomes including obstetrical complications, intrauterine growth restriction, birth defects, and Sudden Infant Death Syndrome. Heavier cigarette smoking has been found to be related to peak NAS score and amount of time to reach peak score in newborns exposed to methadone. Higher NAS severity scores were found with heavier smoking in neonates exposed to methadone, buprenorphine or slow release morphine. Although heavier cigarette smoking was associated with longer duration of NAS treatment in methadone exposed babies, the association was not found in buprenorphine exposed babies. It has been shown that decreasing the amount of cigarettes smoked can decrease the effects upon pregnancy and the newborn. Since heavy smoking during pregnancy has consistently been found to compromise perinatal outcomes, if abstinence in the presence of opioid maintenance therapy is not possible, decreasing the quantity should be the goal. Although there is much that we still need to explore concerning the treatment of Neonatal Abstinence Syndrome, what we do know will provide comfort for the baby and decrease the chances of associated complications such as aspiration pneumonia, dehydration, and seizures. Using supportive care will enhance the baby’s ability to feed normally, gain weight and permit adequate sleep. Through appropriate recognition, assessment and treatment of Neonatal Abstinence Syndrome coupled with good orientation of the future caretaker, we can better assure a nurturing, healthy environment for the child with a good chance of normal developmental outcomes.

Dr. Loretta Finnegan and colleagues first created the Finnegan Neonatal Abstinence Scoring System in 1975, and it is now in widespread use in the United States and other countries. She is the founder and owner of Finnegan Consulting, LLC, of the Greater Philadelphia, PA area. Dr. Finnegan was a Senior Medical Advisor to the National Institutes of Health from 1990 to 2006. She has published more than 170 scientific papers and received numerous awards for her work addressing women’s and newborn health, and perinatal drug addiction. References

Patrick SW, Schumacher RE, Benneyworth BD, Krans EE, McAllister JM, Davis MM. Neonatal abstinence syndrome and associated health care expenditures: United States, 2000-2009. JAMA : Journal of the American Medical Association. 2012 May 9;307(18):1934-40. National Survey on Drug Use and Health 2007. Available from: http://www. samhsa.gov/data/2k7/pregCigs/pregCigs.pdf Finnegan LP. Neonatal abstinence syndrome: assessment and pharmacotherapy. Rubaltelli B, Granati B, editors. New York. 1986. 122-46 p. Hudak ML, Tan RC, Committee On D, Committee On F, Newborn, American Academy of P. Neonatal drug withdrawal. Pediatrics. 2012 Feb;129(2):e540-60. McCarthy JJ, Posey BL. Methadone levels in human milk. Journal of human lactation : official journal of International Lactation Consultant Association. 2000 May;16(2):115-20. Wojnar-Horton RE, Kristensen JH, Yapp P, Ilett KF, Dusci LJ, Hackett LP. Methadone distribution and excretion into breast milk of clients in a methadone maintenance programme. British journal of clinical pharmacology. 1997 Dec;44(6):543-7. Weiner, SM, Finnegan, LP, Drug withdrawal in the Neonate. Handbook of Neonatal Intensive Care, 6th Edition, Carter, B and Gardner, S (Eds), MosbyYear Book, Inc, 2010. Kaltenbach K, Holbrook AM, Coyle MG, Heil SH, Salisbury AL, Stine SM, et al. Predicting treatment for neonatal abstinence syndrome in infants born to women maintained on opioid agonist medication. Addiction. 2012 Nov;107 Suppl 1:45-52. Jones HE, Kaltenbach K, Heil SH, Stine SM, Coyle MG, Arria AM, et al. Neonatal abstinence syndrome after methadone or buprenorphine exposure. The New England journal of medicine. 2010 Dec 9;363(24):2320-31. Choo, RE, Huestis, MA, Schroeder, JR, Shin, AS, Jones, HE Neonatal Abstinence Syndrome in methadone-exposed infants is altered by level of prenatal tobacco exposure. Drug Alcohol Dependence, 2004, Sep 6;75(3):253-60. Dietz, PM, England, LJ, Shapiro-Mendosa, CK, Tong, VT, Farr, SL, Callaghan, WM. Infant morbidity and mortality attributable to prenatal smoking in the US. American Journal of Preventive Medicine, 39, 45-52, 2010. Hackshaw, A, Rodeck, C, Boniface , S, Maternal smoking in pregnancy and birth defects: a systematic review based on 173,687 malformed cases and 11.7 million controls. Human Reproduction Update, 17, 589-604, 2011. Winklbaur B, Baewert A, Jagsch R, Rohrmeister K, Metz V, Aeschbach Jachmann C, et al. Association between prenatal tobacco exposure and outcome of neonates born to opioid-maintained mothers. Implications for treatment. European addiction research. 2009;15(3):150-6. Jones, HE, Heil, SH, Tuten, M, Chisolm, MS, Foster, JM, O’Grady, KE, Kaltenbach, K, Cigarette smoking in opioid-dependent pregnant women:Neonatal and maternal outcomes. Drug and Alcohol Dependence,131:271-277, 2013. Bakstad, B, Sarfi, M, Welle-Strand, GK, Ravndal, E, Opioid maintence treatment during pregnancy: occurrence and severity of neonatal abstinence syndrome.A prospective study. Europeon Addiction Research 2009;15(3):128-34. D`Apolito K, Finnegan LP. Assessing Signs & Symptoms of Neonatal Abstinence Using the Finnegan Scoring Tool, An Inter-Observer Reliability Program 2010. Available from: http://www.neoadvances.com. Finnegan LP, Kandall SR. Maternal and neonatal effects of alcohol and drugs. In J.H. Lowinson. Ruiz P, Langrod J, editors. Baltimore, MD 2005.

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Information is up to date as of April 1, 2016. Our services are not intended to diagnose, treat, cure or prevent any disease. For forensic use only.


USDTL Newborn Catalog