Published in Advance For Laboratory, Vol. 23 • Issue 12 • Page 22: http://laboratory-manager.advanceweb.com/the-cost-of-shipping-specimens-15372/
By David Creighton is the regulatory and training manager at Saf-T-Pak.
Have you ever stopped to think how much it costs to ship infectious and biological substances? These substances are regulated at national and international levels, so there are a number of things to keep in mind-training, packaging (both the act of and the actual product) and labeling requirements. If the regulations are overlooked or ignored, it can lead to additional costs through fines and package rejection.
The transportation of infectious and biological substances is regulated at both national and international levels. In the United States, the Department of Transportation (DOT) assigns the enforcement of federal regulations to two of its branches, the Pipeline and Hazardous Materials Association (PHMSA) and the Federal Aviation Administration (FAA). Both of these organizations are authorized to inspect facilities involved in the transportation of all dangerous goods, including infectious and biological substances, and will issue fines and penalties for violations.
International shipments by air of infectious and biological substances are governed by the regulations published in the International Civil Aviation Organization (ICAO) Technical Instructions for the Safe Transport of Dangerous Goods (TI). The ICAO TI is also the basis for the Dangerous Goods Regulations (DGR), which are published by the International Air Transport Association (IATA). The DGR is used by all of IATA’s member-carriers, including most major airlines (FedEx, UPS, United, Delta). The air carrier’s employees responsible for accepting and loading packages are trained to recognize non-compliant packaging, so package rejection is a real possibility if packaging and labeling have not been properly performed.
As all of the various regulatory authorities require anyone who prepares a package for transportation to be trained to understand the regulations and perform their functions accordingly, it is the responsibility of an employer to ensure that both initial and recurrent training is completed in a timely manner. Since training is mandatory, failure to provide it to employees will result in fines should your facility be inspected. Untrained employees are also more likely to make packaging and shipping errors, which can lead to costly package rejection.
To help with training, PHMSA has developed a guide1 outlining the requirements and options for this training. However, developing a proper training program can be expensive, requiring significant hours for initial development, as well as composing and producing training materials. There are also additional costs for the implementation of the program through classroom instruction or online production. Many organizations don’t have the time or resources to develop a proper and comprehensive training program and will contract out the training through a reputable vendor. Recurrent training is also required on a regular basis, so it is prudent to include training costs in your annual budget.
While avoiding fines might seem an obvious way to save time and money, package rejection is where the most significant costs are often incurred. Every infectious substance package requires an employee’s time to prepare it properly for shipment. If the package is rejected, more time is required to assess the mistakes made, then to prepare it again for shipment. Also, keep in mind that many infectious and biological shipments are temperature-sensitive. Rejection of these kinds of shipments may cause exposure to unfavorable temperatures that may, in all likelihood, spoil the sample. This would require a new sample to be obtained, causing undo stress and anxiety for the patient, as well as a delay in the diagnosis. This delay could reflect negatively on the institution and potentially negatively affect future income.
Additionally, some biological samples used in research may represent many days or weeks of preparation, so a sample that has been rejected may require the work to be repeated, at a substantial cost of materials and man-hours.
Fines incurred for an improperly prepared shipment are a common occurrence for a number of reasons:
• A package is inspected (including the inner packagings) and it is discovered to be non-compliant
• An institution is inspected and deficiencies are revealed
• A non-compliant package causes a dangerous goods accident or incident
• The shipping documents are not completed properly
• Lack of training
Whatever the reason for the fine, the outcome will be the same. The violating party will be notified of the violation and given a short period of time to comply with the regulations. Failure to comply with the legal requirements within the specified time frame will result in fines.
PHMSA publishes an annual list of fines closed,2 and although there are very few fines closed for shippers of biological and infectious substances, this can be misleading. When a fine is issued it is often a notice of potential or probable violation and can be avoided if certain conditions are met. For example, if the violation is for lack of training, the notice of violation will require training in a very timely manner. Therefore, further costs will be incurred to comply with the notification of violation. Avoiding the fine may cause the incident to seem inconsequential, but if the fine was due to a rejected package, there will be additional costs incurred by the initial package rejection than meeting the required conditions within the set deadline.
Proper and comprehensive training is the critical factor here and should be taken into consideration when choosing a training method. Training that is advertised as “free” or “low-cost” may seem enticing, but will often be poor quality. The regulations clearly outline the topics that must be covered to be compliant with the regulations. If the training is not thorough, comprehensive and/or does not cover all of the regulatory requirements, fines and package rejection will probably end up costing more in the long run. Don’t cut corners; it makes more sense to budget training up front than to deal with emergency compliance and potential damage to your company’s image.
David Creighton is the regulatory and training manager at Saf-T-Pak. He is actively engaged in a number of national and international organizations and currently sits on the Dangerous Goods Training Association’s Board of Certification.