Investigations find hair-strand analysis at hospital-based laboratory was ‘inadequate and unreliable’ for tests performed over a period lasting five years or more
Another case of a medical laboratory that produced inaccurate test results for an extended period of time has been making headlines in Canada. It demonstrates, once again, that both the news media and consumers are keenly interested in stories involving systemic lab test errors that could possibly lead to patient harm.
In this specific instance, the lab testing involved forensic testing for drugs and alcohol that were part of the Canadian legal system and thus were not clinical laboratory tests used by physicians to diagnose and treat patient care. Concerns center on the methodology used by the lab in question to perform forensic toxicology tests over a period of at least five years. Another source of concern is how proficiency testing was conducted at this laboratory.
In covering this case, the Toronto Star published a story pointing out that “flawed” results from Canadian forensic testing laboratory Motherisk may have been used in thousands of child protection cases and numerous criminal proceedings. Because of this fact, the owner of Motherisk, Toronto’s Hospital for Sick Children (SickKids) has been put into an unwelcome spotlight.
Issues surrounding the Motherisk Drug Testing Laboratory at SickKids first made headlines during 2014. At that time, it was reported that the government was launching an independent review of the forensic testing performed by Motherisk.
The following year, the Toronto Star (Star) ran a series of investigative stories about hair-strand tests for drug and alcohol that were conducted by the Motherisk laboratory. The Star found that, from at least 2005 to 2010, “Motherisk used a method to test hair for drugs that some experts criticized as falling short of the gold standard.”
Criminal Conviction Thrown-Out Due to Questions over ‘Validity’ of Test Results
The Star’s investigation into the laboratory’s testing procedures followed a court of appeal decision overturning the 2009 child abuse conviction that sent a Toronto mother, Tamara Broomfield, to jail. Broomfield’s conviction on cocaine-related charges was thrown out based on questions related to the “validity of the results” of a hair-strand analysis by Motherisk, as well as concerns over how the hair sample was prepared and then analyzed, the Star reported.
“Scientific evidence is often complicated and cloaked in a belief that reputable and experienced doctors providing expert evidence in court can’t be wrong,” Brown continued. “The public too easily accepts these experts at face value.”
Internal Review Concludes SickKids was Misled for Years
The Star later reported that SickKids’ internal review determined that it had been misled about Motherisk’s proficiency testing process for “several years.” In October, 2015, SickKids apologized for “unacceptable” practices at Motherisk.
“We deeply regret that the practices in the Motherisk drug-testing laboratory didn’t meet the high standards of excellence that we have here at SickKids, and we extend our sincere apologies to children, families, and organizations who feel that they may have been impacted in some negative way,” Hospital for Sick Children CEO Michael Apkon, MD, PhD, stated in the Star. “We remain resolved in our efforts to ensure that we have the highest standards of quality and safety in all of our program so that unacceptable events like this never happen again.”
Motherisk Lab Did Not Meet International Forensic Analytical Standards
Broomfield, however, is far from the only potential victim of Motherisk’s faulty testing methods. Vice News reported that hair test results from Motherisk were used in as many as 16,000 child protection cases as well as six criminal cases that resulted in convictions. By the early 2000s, the laboratory was advertising its testing services throughout Canada, and by 2015, it was testing approximately 2,000 hair samples a year for child protective agencies.
One month after SickKids apologized for its lack of oversight, results of an independent investigation by retired Ontario Appeal Court Justice Susan Lang, who had been appointed by the province of Ontario to conduct a probe, underscored the controversy’s potentially far-reaching impact.
When Lang released her 366-page report in December 2015, she concluded that, for at least a decade, Motherisk’s hair-strand drug and alcohol analysis was “inadequate and unreliable for use in child protection and criminal proceedings.”
“From 2005 to 2010, the laboratory employed a preliminary screening test that specifically cautioned users about its limitations. Despite this caveat, the laboratory represented that this preliminary test could both identify and quantify drugs in hair. It could not. Also, the laboratory fell short of meeting international forensic analytical standards in other important ways that I describe in my report. Finally, the laboratory lacked expertise in the interpretation of the purported test results, which it frequently misinterpreted or over-interpreted,” Lang wrote in her report.
Even After Improvements Motherisk Remained Flawed
Although Motherisk made improvements to its testing procedures in 2010 and moved to what it referred to as the “gold standard” of confirmation testing for certain drugs, Lang found its “analytical procedures remained flawed,” causing the laboratory to continue to “misinterpret and over-interpret its results.”
“Despite extensive testing for child protection agencies, neither the laboratory nor the hospital appears to have appreciated that the testing was forensic in nature or that it was required to meet forensic standards. At no time did the hospital provide meaningful oversight over the laboratory,” Lang concluded.
As reported by Vice News, Lang discovered that from 2005 to 2010 Motherisk was routinely relying on the enzyme-linked immunosorbent assay (ELISA) test to determine if a hair sample was positive and did not confirm results of the screening test with a second testing method.
“According to the review, Motherisk communicated all ‘maybe’ results as ‘positives’ to their clients from child protective agencies, instead of carrying out a follow-up test,” Vice News reported.
“No forensic toxicology laboratory in the world uses ELISA testing the way [Motherisk] did,” Lang stated in her report.
SickKids Conducts Internal Probe; Halts Controversial Testing at Motherisk
In the midst of its own internal probe last April, SickKids permanently halted drug and alcohol hair testing at Motherisk.
Retired judge Judith Beaman, a family law expert, currently is leading a follow-up investigation into individual cases involving Motherisk lab results.
Hundreds of Adoption Cases Halted
Meanwhile, the aftershocks from the Motherisk controversy continue. The Star reported this month that the Ontario Association of Children’s Aid Societies has halted up to 300 adoption cases that involved evidence from the Motherisk drug-testing program. Meanwhile, Yvonne Marchand, who claims she lost custody of her only child due to a “false positive” hair test result for alcohol abuse by Motherisk, is suing SickKids and Motherisk’s former director and manager in what could become a class-action lawsuit.
“The disruption and removal of children from parents is unfathomable,” one of Marchand’s lawyers, Rob Gain, told the Star, “and has a dramatic effect that no amount of money will be able to make these families whole again.”
Although the problems at Motherisk involve forensic testing for alcohol and drugs and not clinical laboratory tests performed in support of patient care, pathologists and medical laboratory professionals should take note of how the outside review panel was critical of a variety of laboratory processes common to all medical laboratories. Included in the list of problems was not having appropriately-trained lab professionals with “expertise in the interpretation of the purported test results,” lack of “meaningful oversight” by the parent organization, and continued use of “flawed analytical procedures” that caused the lab to “misinterpret and over-interpret its results.”
—Andrea Downing Peck