Disclosure. Objectives. ~History~ 5/11/2015. ~History~

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1 Disclosure Dr. Reilly has disclosed no relevant financial relationships with any commercial interests Annual WAPC Conference Maureen Reilly DNP, NNP-BC bjectives At the conclusion of the session, participants will be able to articulate three solutions offered by umbilical cord drug testing to common problems associated with urine and meconium drug testing. At the conclusion of the session, participants will be able to list the steps of the umbilical cord drug testing process. At the conclusion of the session, participants will be able to evaluate the pros and cons of umbilical cord drug testing. At the conclusion of the session, participants will be able to evaluate the change process described in moving from conventional drug testing to umbilical cord testing ~History~ 1991 Meconium testing 1994 Hair drug testing 1999 MecStat-EtH tm Umbilical-cord assay development 2007 CordStat-5 tm assay introduced 2008 Blood PEth introduced 2010 NailStat-ETH tm introduced 2012 CordStat-ETH tm introduced Dianne Montgomery ~History~ What is umbilical cord drug testing? The collection of fetal tissue for multi-drug assay to detect drugs of abuse which may affect the newborn s well-being and development. Placenta and umbilical cord may offer an alternative specimen to meconium, with several distinct advantages. Recent studies with umbilical cord tissue suggest promising results that compare well with meconium. Umbilical cord is readily available at birth, provides ample specimen for testing (a typical cord is approximately 22 inches long), and does not reflect drugs administered to the infant after birth. (Emphasis added.) (Marin, Metcalf, Krasowski, Linert, Clark, Strathmann & McMillin, 2014, p. 119) 1

2 Why do we test newborns for drugs? Maternal substance abuse continues to be a significant issue in the United States. The rate of current illicit drug use among pregnant women has been reported as: ages ages 15 to percent ages 18 to percent ages 26 to percent Among pregnant women aged 15 to 44 who reported alcohol use: 10.8 percent reported current alcohol use, 3.7 percent reported binge drinking, and 1.0 percent reported heavy drinking with 10.1 percent of pregnant women reporting binge drinking during the first trimester. The newest A recent study found that cases of NAS have tripled over the last decade and that treatment costs for newborns with NAS most of which are paid by Medicaid are more than five times the cost of treating other newborns at birth. (Emphasis added.) Published February 10, 2015 by the GA $$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$ (United States Government Accountability ffice, 2015, p.2) Umbilical cord drug testing Umbilical cord testing uses umbilical cord tissue -- which makes it an ideal sample matrix because it is: truly universal noninvasive simple to collect a higher level of sensitivity for specific drugs Time and Umbilical cord drug testing What are the time windows reflecting perinatal drug use in umbilical cord samples? The following list reflects the drug window of exposure normally seen in umbilical cord samples: THC can be detected up to the last 20 weeks of pregnancy. Amphetamine/Methamphetamine can be detected up to the last 4-5 weeks of pregnancy. Cocaine can be detected up to the last 5-6 weeks of the pregnancy. pioids can be detected up to the last 20 weeks of the pregnancy. NTE: **Monitoring illicit drug use in pregnancy is a complex issue that may be affected by a number of variables. usdtl.org What does science say? Umbilical cord tissue performs as well as meconium in assessing fetal drug exposure to amphetamines, opiates, cocaine, and cannabinoids. Results of studies using the cord may have a more rapid return to the clinician, because waiting for meconium to be passed sometimes requires several days. Moreover, in some cases the meconium is passed in utero making collection impossible, whereas cord should always be available for drug testing (p. 11). Montgomery, D., Plate, C., Alder, S.C., Jones, M., Jones, J., & Christensen, R.D. (2006). Variables affecting detected drug levels the concentration of drugs crossing the placenta frequency of dose individual placental metabolism timing of drug use during gestation Additional drug characteristics affect drug transfer across the placenta, including: molecular weight ph lipid solubility state of ionization protein binding **Note: Drug transfer increases in the third trimester due to increase in placental blood flow, decreased thickness and increased surface area of the placenta. from usdtl.org 2

3 Motivating Reasons to try CordStat Nursing work hours and frustration More motivators Voiding and stooling during delivery/loss of samples Growing numbers of drug-affected newborns ccasional discharges before samples were collected Lag time for results (Hudak and Tan, 2012) Lack of ability to screen once first urine and meconium were no longer available Lack of chain of custody Steps Along the Way Presented to MD/NNP group Talking to administrative staff Involving Lab administrators Talking with RN staff Communication with USDTL The process used was Kotter s 8 Step Process for Leading Change Model Kotter s Model 1. Create a sense of urgency 2. Build a guiding coalition 3. Form a strategic vision and initiatives 4. Enlist a volunteer army 5. Enable action by removing barriers 6. Generate short term wins 7. Sustain acceleration 8. Institute CHANGE The Tipping Point The Process Top-level Lab cooperation Process walk-through Lab Nursing/B Technicians Leadership/Medical Director USDTL Engaging personnel/ne on one education Monitoring and incremental adjustment 3

4 Collection Web Portal and Access USDTL supported group access was made available for all personnel with HIPAA approved access: Physicians NPs RNs Social Services Web Portal results Result format Pros and Cons Advantages Universal collection, not universal screening Chain of custody established Minimized nursing time for collection Ability to send sample for up to 5 days Result times improved Sample available on every infant 12 rather than 6 drug assay + add-ons Pain-free for infant Pros and Cons Disadvantages No process is perfect Multi-step paperwork process FedEx restrictions Holidays and Sundays USDTL work hours Environmental surprises storms in IL Need for re-education Storage needs Clarifying responsibilities, e.g., later sample orders 4

5 Did CordStat increase screening numbers? Lab and Administrative levels may need reassurance of intent: clarify and define evidence-based need for screening before starting the process. Staff Reactions What? h, yeah, I forgot about that. The null factor ne-year Anniversary Learning points: Physicians like it and cooperate readily Nurses like it and B technicians accept it Still learning metabolites and meaning Embedded in care VN Quality Improvement 1 Develop and implement a standardized process for the identification, evaluation, treatment and discharge management of an infant with neonatal abstinence syndrome 2 Develop and implement a standardized process for measuring and reporting rates of neonatal abstinence syndrome and drug exposure 3 Create a culture of compassion, understanding, and healing for the mother infant dyad affected by the problem of neonatal abstinence syndrome Schumacher and Patrick, 2013 References Hudak, M.L., & Tan, R.C. (2012). Neonatal drug withdrawal. Pediatrics, 129, e540. doi: /peds Kotter International. The 8-Step Process for Leading Change. the-8-step-process-for-leading-change/ Marin, S.J., Metcalf, A., Krasowski, M.D., Linert, B.S., Clark, C.J., Strathmann, F.G., & McMillin, G. A. (2014). Detection of neonatal drug exposure using umbilical cord tissue and liquid chromatography time-of-flight mass spectrometry. Therapeutic Drug Monitoring, 36, pp doi: /FTD.0b013e3182a0d18c. Montgomery, D., Plate, C., Alder, S.C., Jones, M., Jones, J., & Christensen, R.D. (2006). Testing for fetal exposure to illicit drugs using umbilical cord tissue vs meconium. Journal of Perinatology, 26, doi: /sj.jp Schumacher, R.E., & Patrick, S.W. (Eds). (2013). Controversies in caring for infants and families impacted by neonatal abstinence syndrome. VN Quality Improvement Toolkit: INICQ United States Government Accountability ffice (2015). Prenatal drug use and newborn health: Federal efforts need better planning and coordination. Report to Congressional Requesters. (GA ). Retrieved from 5