Sometimes they just get it wrong.
I have been reflecting on a truth that I have held about laboratory Quality (and Quality in general) that the greatest mover of quality is an angry public and the actions of the public action arm (the media, legislators and the litigators). We have good examples of this. The Clinical Laboratory Improvement Act and Amendments would never have occurred if the public had not been outraged by poor PAP test readings. The Cameron Commission would not have demanded Newfoundland laboratories start along a quality improvement path if the public had not been aghast at the incompetence of laboratory diagnosis. There are all sorts of examples that make the point.
But recently I have been aggravated by the other side of public engagement in laboratory decision making when it drives excessive utilization and huge TEEM* expenditures with absolutely no tangible benefit.
Transportation concerns. For programs like proficiency testing programs, or clinical laboratories sending samples to reference laboratories, or research sending samples, in particular microbial samples, a major concern is the cost and procedures required to ship a sample container. This is one of the best examples of governmental excess response to public unknowledged anxiety. (Unknowledged anxiety is the easy but inappropriate over-response of the public or its representatives to perceptions of risk or danger predicated solely on myth or misunderstanding.
Any laboratory that is involved in long distance transport of samples by road, rail, ship or air learns about “Transport of Dangerous Goods” regulations, affectionately known as TDG. In order to send a simple sample one needs to have specially trained and certified personnel, access to special packaging materials, special labels, special way-bills and then pay really outrageous transport surcharges on top of already expensive regular shipping fees. It is the perfect example of lost time, effort, energy and money.
I would like to be able to say that all this TEEM is well spent, but the reality is that it is not. It is near impossible to find even a single accident that all this regulation has prevented.
I have been railing against the TDG impediment for a long time. I have been involved in transport issues since the late 1970’s and have been engaged in trying to modify regulations since the mid 1990’s. In Canada, I have had some successes, but we still are plagued by huge costs and lost time.
Over the years in my program we have shipped approximately 40,000 boxes containing proficiency testing materials without a single reported leak, damage, or exposure event reported. For programs like UK NEQAS or CAP the numbers would likely be 100 times that much but again one can’t find any examples of published exposure events. But in the meantime this is costing our laboratories collectively millions of lost dollars. Even if we push the cost on to the receiving laboratory it is still lost dollars.
We have performed and reported upon and published transport studies looking at the risks associated with leaks and damage. We have studied other contributions to the literature. And we have come to the clear conclusion that the levels of risk are completely theoretical.
I calculated the risk of an exposure being about 1:250 billion over a 10 year time with adding in estimated under-reporting raising the risk to 1:2.5 billion. These are both below the level for calculating a risk sigma value. In addition, for transport that may cross an international border it can cause delays of near a week, which can cause all sorts of sample damage.
You might argue that what we are doing protects us from illicit exposure to dangerous pathogens, but of course that would be wrong as well because the true illicit plan would be to purposefully NOT add the markings. Truth be told it would be impossible to know how many samples are transported without any markings.
A few years ago I had a discussion with a senior person in transport administration when the comment was made that if one of my packages containing live organisms was to fall out of the sky from a damaged airplane, then I could be held responsible for an outbreak. When I commented that the jettisoned jet fuel or lost metal parts from said damaged plane would be a much bigger concern, there was not even a crack of a smile. And my comments about the risks associated with falling body parts only made things worse.
So what does all this have to do with Quality? Well clearly the first job of the Quality Manager is to take their lumps and make sure that TDG training and certification is up to date. Make sure that the packaging is correct as well as the labelling and resultant paper work. While you probably would get away without it, the TEEM costs of getting cost would be infinitely worse.
But knowing that TDG is driven by myth and misunderstanding creates an obligation and knowing that the incumbent costs in time and money and potential damage to samples is a call to Quality arms. Engage your colleagues and start a letter campaign or better yet, a telephone campaign. Apply pressure, respectfully but directly and with reasonable force. Seek the exemptions possible as described within the regulation.
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