Clinical vs. Forensic: The Differences Cost More Than Just Money

Originally published in NeoTox, Summer 2016.
The differences between a clinical toxicology test and a forensic toxicology test as they relate to a newborn toxicology specimen.

by Joseph Jones, MS, NRCC-TC

One of the great misconceptions of recent years is the notion that a newborn toxicology specimen should be treated as a clinical toxicology test. It is easy to see why some laboratories would want you to think that. A clinical toxicology testing strategy does not include a few vital expenses that forensic toxicology demands. First, clinical testing does not include confirmation testing, which uses a second portion/aliquot of the original specimen that is run via different, more sophisticated, instruments in order to duplicate positive screening results. This is a fail-safe to catch false positives. Second, clinical testing also lacks a clearly documented chain of custody. Initially, this may make a clinical toxicology strategy seems like the less expensive option, but playing the game of chance with the child’s, and the organization’s, future is measured by much more than just money.

Forensic toxicology tests are done with the purpose of being used as evidence in legal proceedings, and have a number of stringent requirements because of that purpose:

1. The data generated during the analysis is expected to be used for the provision of legal scientific evidence.1  
2. The subject must consent to the test or there must be a surrogate official requesting the test such as a judge demanding a court ordered test or a physician/government official acting in the best interest of a minor or incapacitated adult.2
3. The identity of the specimen, its aliquots and/or extracts must have complete assurance from the time of collection to the destruction of the specimen.3 This is what we refer to as chain of custody.
4. All positives must be confirmed using a second aliquot or portion of the original specimen.4,5 

Forensic newborn toxicology tests have everything that is required to create evidence that a newborn was exposed to substances of abuse. The forensic results defend the child for the rest of their life, giving them an invaluable tool for challenges they might face in the future.

A clinical toxicology test does not require any of these elements because the test is not being generated for the purpose of legal action.2 The results are being used for diagnosis or treatment, along with the results of many other tests and clinical observations. Documented patient consent is not required for clinical testing, and the identity of the specimen is assumed until proven otherwise. If there is a suspected error in the identity or analysis of a clinical specimen, it may simply be recollected or repeated to verify. Due to the nature of forensic testing, this option does not hold true for forensic toxicology specimens due to the potential donor deceit and discrepant results due to the lapse of time. 

Newborn toxicology is not performed on every birth because of the great expense of collecting, handling, and testing difficult neonatal specimens, such as meconium and umbilical cord tissue segments. Hospital policies direct that only newborns at high-risk of prenatal exposure to substances of abuse be tested. Though each hospital has its own individual policies, several indicators are commonly used to identify newborns that are at high-risk to prenatal exposure: history of maternal drug use, prostitution, sexually-transmitted diseases, lack of prenatal care, unexplained placental abruption, unexplained premature labor, admission to the neonatal intensive care unit, and the observation of withdrawal symptoms.6 Therefore, when newborn toxicology is ordered, there is a documented suspicion of prenatal exposure to substances of abuse.

At the time the decision is made to conduct a newborn toxicological analysis, an elevated expectation exists that the results of the newborn specimen will be positive for substances of abuse. Due to the time involved with collection, transportation, and analysis, it is highly unlikely that the result of the analysis will be available to be utilized in the diagnosis or treatment of the neonate. Instead, the test is used as a measure of documenting scientific legal evidence of prenatal exposure to substances of abuse. 

Several jurisdictions in this country accept the presence of substances of abuse in newborn specimens (such as neonatal urine, hair, meconium, or umbilical cord tissue) as per se evidence of child abuse. A positive result must be reported to the State in most jurisdictions. The State may take a number of actions upon receiving a report, such as: initiating a case file, conducting a home interview, initiating mandatory substance abuse treatment for the mother, or termination of parental rights. These actions are contingent on the circumstances of each specific case and are individually judged accordingly. Under these circumstances, with the likelihood of a positive result and the likelihood of legal action, it is imperative that these specimens are collected and analyzed under forensic conditions.

A hospital must be very careful when selecting an organization to conduct its newborn toxicology testing. Simply being housed at a well-respected nationally/internationally acclaimed organization is not assurance that staff and processes are properly executed in a competent forensic environment.7 Recently, it was discovered that the Motherisk Drug Testing Laboratory (MDTL), which was housed at the Hospital for Sick Children at the University of Toronto (two distinguished institutions), was serving as a forensic toxicology laboratory but never met any recognized forensic standards.8 MDTL had marketed these services for over 10 years and their leadership had provided expert testimony across Canada, yet leadership never appreciated the difference between clinical and forensic testing. As a consequence of a very public inquiry, the laboratory has been dismantled and now over 20,000 cases may need to be reviewed.9 Legal outcomes for these indiscretions are still unknown, but are sure to affect the organization, and its reputation, for years to come.

A newborn toxicology specimen is a once in a lifetime specimen. There is just one opportunity to provide a voice for the voiceless; one opportunity to provide help to the helpless. It is our duty to our smallest, most vulnerable patients to provide testing that is sound and correct, as opposed to just being the cheapest option available. Organizations must factor in all costs associated with their decisions for newborn toxicology, including the cost for the baby if results do not hold up in court, and the costs for the organization if they choose the wrong testing option.

References

1. Reisfield, G. M., Goldberger, B. A., & Bertholf, R. L. (2015). Choosing the right laboratory: A review of clinical and forensic toxicology services for urine drug testing in pain management. Journal of Opioid Management, 11(1), 37-44. doi: 10.5055/jom.2015.0250
2. Bertholf, R. (2016). Forensic Drug Testing. Retrieved from: http://slideplayer.com/slide/1598348/
3. Society of Forensic Toxicologists (SOFT) and American Academy of Forensic Sciences (AAFS). (2006). Forensic Toxicology Laboratory Guidelines 2006 Version. Retrieved from: http://www.soft-tox.org/files/Guidelines_2006_Final.pdf
4. Orfila, M. P. (1818). Traité des poisons tirés des règnes minéral, végétal et animal, ou toxicologie générale. (Vol. 2). Paris: Crochard.
5. College of American Pathologists. (2013) Forensic Drug Testing Checklist. College of American Pathologists: Northfield, IL.
6. ARUP Laboratories. (2016). Neonatal Drug Testing. Retrieved from: http://www.aruplab.com/pediatrics/neonatal-drug-screen
7. Mendleson, R. (2014, November 21). Expert concedes limits to Motherisk’s hair test for drugs. The Toronto Star. 
8. 8. Lang, S. E. (2015). Report of the Motherisk Hair Analysis Independent Review. Ontario Ministry of the Attorney General: Toronto, Ontario, Canada. Retrieved from: http://www.m-hair.ca/
9. 9. Gallant, J. (2016, Jan 22). Mom who lost custody launches lawsuit against Motherrisk lab. The Toronto Star. Retrieved from: http://www.thestar.com/news/gta/2016/01/22/mom-who-lost-custody-launches-lawsuit-against-motherisk-lab.html

Joseph Jones is the Senior Vice President for USDTL with more than 25 years of experience in the forensic toxicology industry. Jones has provided expert testimony in a variety of venues throughout the country and appears as an author on over a dozen peer-reviewed scientific articles. Jones, M.S., N.R.C.C.-T.C. is listed by The National Registry of Certified Chemists as a Toxicological Chemist, CAP Laboratory Inspector, and qualified as an expert in drug testing in several venues including union arbitration, unemployment hearings, family court, civil court, criminal court and Military courts-martial and frequently gives workshops, presentations and webinars.