Friday, September 6, 2013

Ethics and Fraud in Forensic Laboratories

It's been a long time since I've written a post here. Having an incredibly cute baby will do that to you, but now that the incredibly cute baby is an incredibly cute toddler, (and the older two are back in school) I'm hoping to get posting back here more regularly.

Laboratory Fraud

Anyone who has talked to me about science for any length of time knows I'm pretty passionate about ethics. Part of this is just growing up with a strong sense of justice, but the other part comes from my first full-time laboratory job out of college. Not because the ethics training was amazing (it was pretty standard), and not even because the quality control section was ruthless (sometimes it was).

No, what made the biggest impact was that the laboratory had just been re-organized after being purchased by a new company. This in itself is not too surprising, but the reason for it was fairly uncommon. You see, the previous company had been found guilty of fraud and people were facing federal charges, not at the laboratory where I worked but one of the sister labs in the corporation. This makes an impact. When you know that in deliberately not meeting ethic standards that not only can you be reprimanded or fired, but that you can go to jail, that is a nice little wake-up call.

Over the years allegations of wrong-doings have been made in laboratories performing forensic work, I've made them myself. Sometimes an individual is reprimanded or fired, sometimes the laboratory is shut down and cases are reviewed. In the most recent case currently in the news the drug lab at the William Hinton State Laboratory was closed, individuals fired and now a chemist at the center of the controversy, Annie Dookhan, faces charges.

What happened?

While we don't know exactly what happened at the state lab in Massachusetts, there are many allegations in this case ranging from not calibrating instruments to actively manipulating samples. We do know that over 60,000 samples are involved affecting approximately 34,000 cases. Does that mean that all of these results are all inaccurate? No, it doesn't, we just know that the results are in doubt, and if the results are in doubt they should not be used.

The focus seems to be on one chemist though certainly the higher ups have since been removed and rightfully the focus should fall on them too. There were certainly signs that something was going on, complaints over the years of lack of staff, lack of space and a lack of interest to correct problems. “It is very discouraging,” the note concludes from an employee to the director of the program, “to watch the situation get worse month by month and hear of no plans to improve things.”

To me one of the biggest red flags comes from this: In 2004, for example, Dookhan processed 9,239 samples while her peers tested an average of only 2,938 samples.

How does that get ignored by higher ups? Did they think she was a super star? Did they think her peers were lazy? Now, there may have been other reason why that would be acceptable. Perhaps her peers worked in other labs and only worked in the drug lab part time, but I doubt it.

Extractions take x amount of time. An instrument takes x amount of time to run. Is it possible that this kind of discrepancy in work performed can exist in individuals following procedures? This should have warranted closer review.

And speaking of review. Who was doing the review? Unfortunately under economic constraints laboratories will often cut their quality control department if they have one to begin with. These labs can often still meet accreditation standards by having a quality control director who may have little understand of the methods being performed and spend most of their time making preparation for audits or approving Standard Operating Procedures. Review often falls on other analysts who may or may not have ever performed the method themselves. While this isn't always bad, a reviewer who has never performed a method they're reviewing can easily be convinced that something is "ok."

On top of these constraints and seemingly a lack of desire to fix the problems, there were the ever present pleas of prosecutors to work faster. So is this a case of an overworked employee taking the blame for a faulty system? Perhaps. The trend in the workforce is to get the most out of each employee, placing the priority on quantity over quality, and the forensic lab is no exception, especially with the current trend of vilifying any public employee and reducing funds. Even still, Ms. Dookhan did not have to commit fraud even if she felt she was being pressured to. She should not have done it and should have pushed back upon receiving pressure to get through more samples.

So how do we prevent this?

I think the matter of public or private labs in itself does not affect the situation. A public lab will be pressured to get through more samples with the least amount of money spent. A private lab will be pressured to get through more samples with the most amount of profit gained.

What we need is a greater focus on ethics and quality control in the education of our chemists/biologists/toxicologists. Not just on-the-job training and not just one class in their undergraduate or graduate programs. Ethics needs to be part of every class. There needs to be focused training on not just the obvious fraudulent behavior but focusing entire courses on scientific method. These "values" have to be instilled before they get into the workforce.

In the case of my first lab's predecessor, lower level chemists were not prosecuted because they were unknowingly committing fraud. They were performing the method as they were trained and the higher-ups were telling them what was ok. Did Ms. Dookhan know she was committing fraud or had she been trained to? I would suspect that she knew, though there had to be others complicit since her data was reviewed and released.

It takes a strong person to not yield to pressure when you consider that most of your waking life, sad though it is, is spent at your job. But, if we instill this before scientists enter the workforce, eventually we will have labs where all individuals have this mindset, including the higher ups. It's much easier to do what's right when you have support.

Additionally, laboratories need to have quality control departments who act as quality control, and not just fill the need of accreditation requirements. Reviewers, experienced in the methods, whose only jobs are to review testing data. Yes, this is more money, but it's money that needs to be spent.

Ultimately the culture has to change where shortcuts are not accepted. The culture has to change so that quality is what matters and investments made to ensure this is done are valued. Unfortunately that has to be communicated and the scientific community needs to make their voices heard.

Prosecutors need to understand that pressure on a chemist to get a case done faster is a pressure to violate procedure. Should long wait times be acceptable? No, but those problems require systemic changes in the addition of more staffing and better resources, not phone calls to busy analysts.

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