COVER STORY
If Disaster Strikes * If Disaster Strikes
Packaging Key to Specimen Transport Safety
By Gail O. Guterl
ADVANCE Assistant Editor
The pilot and co-pilot hadn’t expected any trouble. The day was sunny– almost spring-like–and the cargo plane appeared to be running smoothly. But about 30 minutes into the flight all that changed.
The plane began to sputter and then lurched and lost altitude. Both the pilot and co-pilot used all their skills to avoid the peaks of the Blue Ridge Mountains. They were fortunate; although a crash couldn’t be avoided, they suffered only minor injuries.
Their cargo wasn’t as lucky! Among other items, the plane was transporting medical specimens to a reference laboratory for analysis.
Laboratorians who pack specimens to be sent to another facility for analysis often don’t give it a thought that they may not arrive safely. But occasionally an accident prevents diagnostic samples–whether transported by truck or commercial or privately-owned aircraft–from reaching their destination.
In 1995 and ’96 there were four air incidents involving infectious substances, according to the U.S. Department of Transportation’s (DOT) Office of Hazardous Materials Safety. There has been at least one in 1997.
In transporting diagnostic specimens and infectious substances, it is the packaging that counts–really counts! The quality of the container, box, packing material and insulation that protect a specimen can make the difference in whether it will arrive unscathed at the laboratory or in unusable condition. Because of strict regulations that begin with the United Nations, diagnostic specimen and infectious substance packaging has been known to even survive devastating air accidents.
What happens when such an accident occurs? What regulations dictate the type of packaging that is required to transport these specimens? And where do these regulations originate?
Accident Clean-Up
The first step in any accident involving diagnostic specimens is planned long before the accident occurs, said a safety expert for a large reference laboratory, who asked not to be identified.
“A facility must have an accident plan in place,” the expert said. “That plan should be overseen by someone knowledgeable about environmental, Federal Aviation Administration, Centers for Disease Control (CDC) and DOT regulations and that should be the person the clean-up crew reports to during the emergency and the liaison between the facility and the authorities.”
The primary concern during any incident involving diagnostic specimens is for the safety of the personnel involved and the public, he said.
“To that end the site of the accident must be secured right away. You have to isolate the scene from the people who shouldn’t be there, and isolate the people from the substance they shouldn’t be exposed to.”
If any hazardous material is involved in the accident, such as fuel or chemicals, it should be neutralized first.
“There should be no interference on the part of the laboratorians at the scene,” he said. “Removing or neutralizing the hazardous materials is a priority. There is more risk from chemical exposure than from the diagnostic specimens.”
While regulations for specimen transport don’t specify that the container needs to withstand a catastrophic event, many packages do, the safety expert noted. “Specimens have been recoverable from accident sites, even from plane crashes.”
But if specimen containers are smashed and blood has seeped out, good old household bleach is still the best method of disinfection, he said. “If vials are cracked but par- tially contain blood then it is recovered from the scene as infectious waste and is disposed of as infectious waste.”
Specimen containers transported on a commercial airline must be clearly marked with the phone number and location of the nearest facility in case any are damaged.
“The lab can be called to neutralize the spill, or the airline may have someone trained in the Bloodborne Pathogens Standards that can handle the problem,” the expert said.
International Concern
Although it might be considered a domestic issue, the transport of dangerous goods–a term under which diagnostic specimens fall–is an international concern.
That concern is well founded, said Jim McKay, director of legislation and education, SAF-T-PAK, Edmonton, Canada, and an inventor of specimen packaging.
“You usually think of dangerous goods as being produced in countries with an industrial base, with the rules and regulations that go along with manufacturing,” McKay said. “But infectious substances require no industrial base and can be created by unskilled help. They can be generated mud-deep, in the middle of a rain forest, where there are no regulations to protect anyone.”
Many of the regulations for transporting dangerous goods in the United States are guided by international rules formulated under the auspices of the United Nations and published in Recommendations on the Transport of Dangerous Goods, now in its 9th edition. New editions are issued every two years.
The UN Committee of Experts with representatives from approximately 20 countries meets twice a year in Geneva, Switzerland to develop recommendations, explained George Cushmac, a chemist with the Office of Hazardous Materials Technology, DOT. This office provides the technical support to develop international and domestic regulatory standards.
“If you ship by aircraft just about everyone requires adherence to In- ternational Air Transport Association (IATA) regulations,” Cushmac said. “That’s an airline association effort and those IATA regs are a mirror of the official regulations for transportation of dangerous goods by aircraft formulated by the International Civil Aviation Organization (ICAO), which publishes the Technical Instructions for the Safe Transport of Dangerous Goods by Air.”
“It’s all about trying to keep national and international regulations harmonized,” said McKay, who also serves on the board of the international Hazardous Materials Advisory Council, which has a seat on ICAO, a UN organization.
“If Delta (Airlines) picks up a shipment in Switzerland and brings it to the UK (United Kingdom) and another carrier takes it from the UK to the CDC in Atlanta, the packaging has to be acceptable to all carriers and countries involved,” McKay explained. “You have to have one set of regulations that are harmonized for everybody.”
With 7-8 billion pounds of dangerous goods shipped worldwide annually, you need a lot of harmony.
In the United States, the DOT is the agency directed by Congress to produce regulations regarding the shipping of diagnostic and infectious substances, said Cushmac.
“We want to be sure that the regs have a sound technical basis,” he said.
Packaging Diagnostic Specimens
“At this time, though, diagnostic specimens aren’t subject to DOT regulations,” he explained. “But there are minimum requirements imposed by the CDC for the transport of etiologic agents, under which diagnostic specimens fall.”
It is a bit confusing, Cushmac agrees.
The ICAO regulations (Part 2 Chapter 6) say “a diagnostic specimen likely to contain infectious substances must meet the requirements for infectious substances, except when the primary receptacles contain less than 500 ml of the specimen, the outer packaging does not contain more than 4 liters, the primary receptacles are leakproof and it passes an 8-foot drop test. The package must be marked ‘diagnostic specimen.'”
“But you don’t know it’s infectious unless you’ve tested it,” Cushmac said.
McKay concurs.
“The diagnostic specimen is a totally unique class of dangerous goods,” McKay said. “You can’t test it before you ship so you don’t know what category it falls into. Basically you have to make a classification on nothing but intuition.”
Cushmac said the DOT is working “on additional rule-making to bring the diagnostic specimen into the regulatory context of the hazardous materials regulations (HMR).”
However, that doesn’t mean there are no regulations for transporting diagnostic specimens in the United States.
“The CDC has regulations for shipping diagnostic specimens interstate,” Cushmac said. The regulations were published in the July 21, 1980 Federal Register under Interstate Shipment of Etiologic Agents.
“There are proposals to update the regulations,” a CDC spokesperson said, “But they’re just that, proposals. The 1980 regs are the operative regulations.”
The CDC regs state that “no person may knowingly transport or cause to be transported in interstate traffic, directly or indirectly, any material including, but not limited to, diagnostic specimens and biological products which such person reasonably believes may contain an etiologic agent unless such material is packaged to withstand leakage of contents, shocks, pressure changes and other conditions incident to ordinary handling in transportation… Materials shall be placed in a securely closed, watertight container (primary container; test tube, vial, etc.) which shall be enclosed in a second, durable watertight container (secondary container). Several primary containers may be enclosed in a single secondary container, if the total volume of all the primary containers so enclosed does not exceed 50 ml.”
The regulations require that absorbent material, such as paper toweling, be placed in the package. If the specimens are more than 50 ml, a shock-absorbent material must be placed between the primary and secondary containers and the outer shipping container. The primary and secondary containers should be enclosed in an outer shipping package made of corrugated fiberboard, cardboard, wood or other material of equivalent strength with an external dimension of no less than 3.9 inches. All packaging must be clearly labeled and capable of passing a 30-foot drop test, a penetration test and a vibration standard.
