Properly packaging infectious substances while observing the necessary regulations can be a complex task. Here's a look at the necessary considerations for the safety of handlers.
The old saying, "good things come in small packages" is far from true when packaging and delivering infectious substances. In fact, even the smallest parcel, if improperly packaged, can often result in the leakage of a dangerous good (DG) and/or the potential harm or even danger to handlers. Thus, shippers must take a proactive approach to minimize the possibility of injury caused when specimens are improperly packaged.
According to Jay Johnson, director of worldwide clinical trials for QuickSTAT, a division of Quick International Courier, New York, NY, the threat of potential harm due to improper packaging of a DG became a frightening reality in 1996 with what is now known as the "Value Jet incident." Due to improperly transported DGs, oxygen generators transported on a Value Jet plane were affected, causing the loss of the plane and passengers, he said.
Motivated by this occurrence, in 1997 the Federal Aviation Administration (FAA) acquired approximately 118 DGs enforcement officers including lawyers and cargo security specialists. It is presently conducting assessments, outreach and several other preventative measures to ensure safety. One such development is the implementation of "strike team operations," said Johnson. Utilizing its new officers, the FAA separates them into groups of five or six, sends them to an airport for a week and has them check every package passing through. Anyone shipping DGs is required to provide identification and proof of training, said Johnson. Considering the possible risks, the need to promote responsible packaging is great for the FAA as well as all those involved in specimen transport.
According to a recent FAA presentation,1 there were 166 incidents reported in 1999 involving infectious substances. Of these incidents, 65 percent were due to damaged packaging; 50 percent occurred because of a leakage detected; 30 percent were due to the incorrect packaging of dry ice and 40 percent were due to undeclared shipments. However, regardless of the several recorded causes of incidents, there is only one person deemed responsible for a shipmentthe shipper.
Linda Durbin, president of EXAKT Technologies Inc., Oklahoma City, asserts that 100 percent of the responsibility of specimens during packaging falls into the hands of the shipper. "The shipper is responsible for everything about that shipment," she said. "He is responsible for knowing whether or not he has a regulated substance, what the regulations are governing that substance and for selecting the appropriate packaging system."
In their presentation, "How to Comply with the Latest Worldwide Transportation Requirements when Shipping Clinical Specimens," presented at the Drug Information Association's (DIA) annual meeting, July 9-11, 2001, Johnson, Mike Mitchell (Covance Central Laboratory Services Inc., Princeton, NJ) and Ann G. Kilrain, RN (Bristol-Myers Squibb, New York) agreed that the shipper carries the full responsibility of the condition of specimens when packaged. They explained that he/she is responsible for "the specimen until it reaches its final destination as well as all aspects of packaging the specimens; careful and accurate completion of all necessary documentation; marking and labeling; and notifying the recipient of the specimen's expected arrival time."
The efficiency of the shipper is extremely crucial to the safety of handlers as well as passengers of the aircraft carrying infectious substances, and there are several challenges involved.
According to Durbin, there are three major challenges facing shippers: 1) regulations, 2) training and 3) package size.
"On a given day, there are any number of regulatory bodies, both domestic and international who provide regulations governing the transport of specimens. And as with any regulation, they are always open to interpretation," she said. Durbin explained that this is especially challenging because as she deals with each customer, she needs to have a full understanding so that she can provide him/her with as much information as possible regarding which regulations might apply to his shipment. She said that this lack of consistency regarding interpretations has made the regulatory environment her single greatest challenge. Interpretations vary even at the level of regulatory agencies, such as the Department of Transportation (DOT).
"One customer may send them a letter and ask for an interpretation about a given substance and how it should be handled based on the regulations, and another customer on another coast may send a similar letter to the DOT asking the same question," she said. "If they speak to two different people, they may receive two different interpretations."
The second challenge, which Durbin says will help combat the misinterpretation of regulations, is training. Shippers must be trained and have an understanding of what the regulations are, Durbin said. "Legally, from a regulatory standpoint, anyone who transports a dangerous good or a hazardous material must be trained. There are no excuses for not being trained," she insisted.
Durbin learned the necessity of training firsthand when she was recently visited by a representative of the FAA and asked to produce training documents. Fortunately, she was able to provide the appropriate paperwork. This can happen to any lab and has already happened to some, she said. "It's scary because the standard fine for not being trained and for inappropriately sending samples can be thousands of dollars." Thus, shippers must make every effort to meet the necessary requirements.
According to the DIA presentation, inspectors are looking for the following seven areas to be up-to-date and in order.
1. Training and records
6. Emergency response
Realizing the great need for training programs for technologists, Saf-T-Pak, a specimen packaging company in Edmonton, Alberta, Canada, hired Dave Cook to rewrite its training curriculum. Cook is now one of Saf-T-Pak's compliance instructors and conducts some of its one-day training seminars and has written his own training manual. During his seminars, he starts with the basics and discusses a broad range of issues regarding proper specimen packaging. Some of the areas covered are the nine classes of DGs, class 6.2infectious substances; diagnostic substancesnon-infectious; shipments using dry ice; how to classify substances; how to identify them in the book of regulations and how to mark, label and document packages properly.
There are usually three types of people who are interested in taking his course, Cook said: those who after years of packaging have noticed that they have been doing it incorrectly, those who package correctly but are obliged by law to obtain a refresher training course and those who were recently hired by labs and have never packaged before.
One recommendation that Cook makes to all laboratorians based on his curriculum is to create a checklist, even if they are extremely experienced in specimen packaging. In his course, participants make customized lists depending upon their individual needs.
Finally, after a full day of rigorous training, participants are given the opportunity to test what they have learned with a hands-on packaging exercise. They are given an actual shipping scenario and documentation with colored water in the place of a specimen. Cook said that this portion of the course is usually a hit with technologists who describe the course as not only informative, but a lot of fun.
According to the DIA, international regulations require that recurrent training must take place within 24 months of a previous training.
The third challenge facing shippers regarding packaging, according to Durbin, is "getting people to understand that one box does not fit all." This problem was initiated at the implementation of infectious substance regulations, she said. Durbin explained that when the DOT passed DG regulations approximately seven years ago, there was only one package available, but that has changed over the years.
"One solution [package] is probably cost effective and very reliable for a significant portion of most shipments, but for the rest of the shipments, it's not cost effective and may not accomplish what the regulations require."
Determining which package size is needed for an individual shipment based on factors such as the number of samples being shipped and the type of container needed can save labs a significant amount of money. For example, four to five vials would fit in almost any infectious substance shipper, but if you're shipping more or less than that, you might want to consider other options, Durbin said. "Shipping five vials at ambient temperature may be $10 while shipping one vial may also be $10."
Another way to save cost is by alternating the type of packaging used based on individual circumstances, she said. "If you're the shipper and twice a year you have an occasion to ship something to the Centers for Disease Control and Prevention, then you don't want to spend a lot of money for a package because you're never going to see it again," Durbin said. "But if you're running a large pharmaceutical lab and you're doing clinical trials that are going to take place over the course of the year, then you can probably afford to buy more expensive packaging. Also, many of the parts can be reused to make it more cost effective."
Finally, Durbin said that there are five questions that technologists need to ask themselves when packaging and shipping specimens. She referred to them as the "Five-Q Test":
1. What is the size of your container and how many do you need to ship?
2. Are you shipping a known infectious substance or a diagnostic specimen? (This will determine what the actual system must look like, she said.)
3. What are your temperature requirements? Do you need to control the outside environment? Are there any special circumstances pertaining to the package?
4. If you are shipping your package internationally, does the packaging need to be larger to accommodate a larger amount of dry ice, so that it remains frozen in case it is shipped to a foreign country?
5. Is it a one-way shipment, or will the package be returned to reuse parts?
When mailing personal packages, we are generally much more concerned about the receipt of the enclosed item than the condition of the package itself. However, when shipping infectious substances, the condition of the package often determines the condition of the specimens once received. Thus, specimen packaging is and will continue to be a vital concern for laboratories, which begins and ends with each individual involved in the packaging process taking responsibility for the package and the necessary precautions. Working together to accomplish this goal will in turn promote safety for specimen handlers.
1. Intrator, F. FAA Regulation of Air Transportation of Infectious Substances. Carolinas Biological Safety Association, Research Triangle Park, NC, May 18, 2001.
Terri Holloway is an editorial assistant at ADVANCE. She can be reached at email@example.com.