A Great Article in American Laboratory

As I have written before and will unfortunately have to keep on writing, forensic science is like the “wild, wild west.” Just like in the bygone days of the wild wild west, in forensic science today there is a lack of the rule of law, some vigilantes, some rough characters who are up to no good who lie, cheat, and steal. There is a lack of standards in terms of behavior or process. Life back then was indeed nasty, brutish and short. Back then just like today, the innocent got swept up in it all. It was a dangerous place to be. Being judged (guilty or not guilty or life versus death) by forensic science in America today is a shaky proposition. It is getting better, but this modern day wild wild west has yet to be tamed.

More and more mainstream press are publicizing the situation. Hopefully, there will come a tipping point. We need commutability. We need standards. We need science in forensic science, and not science fiction.

American Laboratory has lent its voice for reform. In a well-written article “The Time has Come for a Forensic Laboratory Improvement Act” Robert L. Stevenson, the Separation Science Editor, wrote about this need for reform. I have included it in full because it is so very true.

Forensic laboratories are relied upon to provide science-based evidence for a variety of purposes and stakeholders. Since people’s lives are involved, the reports generated need to be based on the best available science and practices. Findings from the forensic laboratory need to be free from even the suspicion of conflict of interest.

According to a report by the National Academy of Sciences (NAS) in 2009, forensic labs and their assays often fail to live up to this expectation. As stated in the report, “The forensic science disciplines currently are an assortment of methods and practices used in both the public and private arenas. Forensic science facilities exhibit wide variability in capacity, oversight, staffing, certification, and accreditation across federal and state jurisdictions. Too often they have inadequate educational programs, and they typically lack mandatory and enforceable standards founded on rigorous research and testing, certification requirements, and accreditation programs.”

The report criticizes what is viewed as the isolation, perhaps even ignorance, on the part of forensic laboratories on advances in the best available technology. “The forensic science system is underresourced also in the sense that it has only thin ties to an academic research base that could support the forensic science disciplines and fill knowledge gaps.” The NAS also added: “The committee thus concluded that the problems at issue are too serious and important to be subsumed by an existing federal agency,” and “No existing federal agency has the capacity or appropriate mission to take on the roles and responsibilities needed to govern and improve the forensic science enterprise.”

National Institute of Forensic Science

The NAS report calls upon Congress to authorize and fund a new independent federal entity, the National Institute of Forensic Science (NIFS). NIFS should have a full-time administrator and an advisory board with expertise in research and education, the forensic science disciplines, physical and life sciences, forensic pathology, engineering, information technology, measurements and standards, testing and evaluation, law, national security, and public policy.

NIFS seems to have merit, since the problems are serious and other agencies are not suitable. For example, the inclusion under the NIFS seems to have merit, since the problems are serious and other agencies are not suitable. For example, the inclusion under the Department of Justice would perpetuate the conflict between laboratory objectivity and prosecutorial pressures for convictions. The same is true for the FBI, FDA, DEA, and Homeland Security.

However, there are models in place that have improved performance in scientific laboratories. For example, the FDA’s Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER) are effective in establishing and enforcing high technical standards for laboratory protocols. CDER’s approach for biologics has provided a science-based framework that encourages innovation in technology, but also relies upon rigorous evaluation to assure the various stakeholders, including the public, that the therapeutics are safe and effective. The FDA’s performance on biologics suffered in the early days, but now, the regulated and regulators appear to be working toward the common goal of improving health care. For biologics, the state-of-the-art has improved tremendously. The FDA deserves commendation for leading with several initiatives (Well Characterized Biological Products, Process Analytical Technology, and Quality by Design) to improve the technology for drug discovery, evaluation, and production.

Clinical Laboratory Improvement Amendments as a prototype for forensic labs

The Clinical Laboratory Improvement Amendments (CLIA) is an even better model for analytical labs. The cited problems in forensic labs are similar to deficiencies in clinical labs in the 1970s and early ’80s. The problem was so severe that Congress responded by creating CLIA under the Centers for Medicare and Medicaid Services. CLIA defines a clinical laboratory as a facility that performs laboratory testing on human specimens for diagnosis, prevention, or disease treatment. CLIA’s staff works to assure the public that test results are timely, reliable, and independent on the particular lab performing the assay. The labs pay user fees to support CLIA.

It seems that the U.S.A. needs an analogous Forensics Laboratory Improvement Act (FLIA) to ensure that forensic science is using the best available technology in situations involving law enforcement or legal disputes. The need is similar to the need for improved data quality prior to the introduction of CLIA in the late 1980s. This program should be placed in the NIFS.

Whatever reporting and funding relationship is chosen, it is essential that the structure intuitively assures the public and other stakeholders that the best available science is being applied objectively to the particular situation. Information, including opinions, should be available to all stakeholders on a timely basis.

Challenges in forensic testing

At the Fall 2012 National Meeting of the American Chemical Society, one session focused on the Innocence Project. The leading cause of wrongful convictions was eyewitness misidentification, but the second cause, at 45%, was faulty forensics. This included testimony that is not scientifically supported, including exaggeration, mistakes, or misconduct (e.g., dry-labbing).

Legacy or grandfathered methods are another problem, according to John J. Lentini (Scientific Fire Analysis, LLC, Big Pine, FL), who characterizes forensic tests for arson as “witchcraft that passes for science,” despite the fact they are codified by a publication of the National Bureau of Standards (now NIST). Historically, crazed glass was used as a marker for accelerants, but now, it is correctly recognized as arising from rapid cooling, often from water used for fire suppression. These examples show that America has a serious problem with forensic evidence.

To weed out legacy misinformation, FLIA should initiate a review of forensic assays, possibly modeled after, or, better yet, in cooperation with ASTM. ASTM has a review process that schedules periodic reviews and updates of methods. Plus, ASTM already has an active forensics program that provides methods for physical characterization of evidence such as glass and paint. There is precedence for a cooperative approach. The FDA enjoys a close working relationship with the U.S. Pharmacopeia. Hopefully, a similar relationship between NIFS and ASTM will facilitate rapid expansion of validated protocols.

Avoiding conflicts of interest

For FLIA to be successful, conflicts of interest must be actively designed out. For example, there should be no political motivation to withhold information during a criminal trial in an attempt to increase the number of convictions. All stakeholders should have open and timely access to all relevant data and reports, and the legal defense team should have access to critical reviews of the performance of the methods, laboratory, and staff. Delving into potential conflicts of interest is essential to evaluating potential sources of bias or fraud.

Finally, NIFS and FLIA need to mount a public education program. Popular television has created an aura surrounding forensics that severely distorts reality. DNA is billed as the infallible standard. However, DNA assays can be too sensitive. At the ACS meeting, Prof. Greg Hampikian (Boise State University, ID) reported that detectable amounts of DNA can transfer between specimens (such as the vial of the suspect and evidence from the crime scene) if the sample handler does not change gloves. This transfer could be interpreted as proving that the suspect was at the crime scene. Minute details can be important. The public needs to be aware that what passes for science on television probably does not exactly correspond to reality, and need to keep a critical, open mind.

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