The woman flashing a badge was not someone Dr. Colleen Koch expected to encounter last week in her waiting room full of clients and their pets.
Short-staffed and already behind schedule, the veterinarian was taken aback when a Federal Aviation Administration (FAA) inspector demanded to audit how Koch ships blood and tissue specimens for diagnostic analysis. In question was whether the practice was sending samples in accordance with protocols required by the U.S. Department of Transportation (DOT), which the FAA enforces.
“We were very busy at the time,” recalls Koch, a practitioner in Jacksonville, Ill. “I asked her to come back, and she said, ‘This is a surprise inspection. We don’t do this by appointment.’”
The FAA security and hazardous materials specialist perused several months of Koch’s shipment records to Idexx, a national network of diagnostic reference laboratories that she ships blood and tissue samples to several times per week. The inspector also scrutinized how the practice ships laboratory specimens, paying special attention to the materials and means used for packaging potentially hazardous items.
What prompted the audit of Koch’s practice is unclear. Last March, the American Veterinary Medical Association (AVMA) alerted veterinarians to the potential of surprise FAA inspections, most linked to cases where lab specimens sent by air had leaked or appeared to be improperly packaged, creating the potential for human and environmental exposure to hazardous contaminants.
That does not appear to be the case for Koch, who was not notified that any of her air mailings were flagged for violations. While the VIN News Service was unable to reach the agent responsible for the inspection, FAA officials report that the crackdown isn't new. Random audits of veterinary clinics and other distributors of potentially hazardous materials have been taking place for years.
“This is a nationwide review,” FAA spokeswoman Elizabeth Isham Cory explains. “Just like we customarily spot-check shippers, we want to make sure veterinarians are in compliance and understand the regulations. This is something we normally do.”
That’s news to staff of the AVMA, who believed that the FAA typically audited only facilities that sparked a regulatory concern tied to a specific incident with a package. The FAA has the authority to inspect any facility under its jurisdiction.
Koch, who characterizes her audit experience as similar to a controlled substances inquiry by the U.S. Drug Enforcement Agency, shared her story because she doesn’t want colleagues to be caught unwittingly non-compliant.
“I want veterinarians to be aware,” she says. “We've sent blood work to Antech and Idexx. Both companies have provided us with the materials and instructions on how they want us to ship blood to them,” yet the regulations of the diagnostic laboratories were not as stringent as those enforced by the federal government.
“I would think that Idexx and Antech would have instructed us to send samples according to federal guidelines since they pay for the shipping," Koch says.
Not so, reports Dr. Kristi Henderson, assistant director of the AVMA’s Scientific Activities Division. She contends that the packaging and shipping compliance responsibility lies with the shipper of origin, not diagnostic laboratories or carriers like FedEx and UPS (though they also have regulations pertaining to hazardous materials). What’s more, there often may be disparity between the federal government’s regulations and shipping instructions outlined by reference labs that might be more focused on preserving the integrity of specimens than public health and safety.
“Veterinarians are hazmat employers,” she says. “It's not just infectious substances but certain pharmaceuticals, lab reagents and some pesticides that are used within the veterinary profession and which are regulated as hazardous materials.
“If a package comes to the attention of the FAA or the Department of Transportation that is improperly labeled or leaking, they'll follow that back to its origin,” she adds.
According to the DOT guide “Transporting Infectious Substances Safely,” much of what veterinarians ship in terms of infectious substances needs to be encased in a vial and sealed within two layers of watertight packaging separated by a layer of absorbent material. A list of contents should be affixed to the second watertight container and the entire ensemble needs to fit inside a box that carries an infectious substance label as well as several other specific identification markers.
Civil penalties associated with violations of Federal Aviation Regulations for shipping hazardous materials can reach tens of thousands of dollars depending on the infractions.
Koch, whose violations were minor, was not issued a monetary penalty. Rather, she has 10 days to create a proposal to assure her practice is in compliance with federal regulations.
“We also have to order these special bags from Federal Express,” she says, “and we’re planning on sending someone to get certified in shipping hazardous materials, but so far, we’ve only researched that.
"Ironically FedEx did not have the bags on hand and had to special order them. If the FAA is cracking down on veterinarians then I would think they should alert the carriers so that they have the appropriate bags on hand," she adds.
FedEx Corp. officials reported having no knowledge of the audits performed by the FAA when queried by the VIN News Service.
The training Koch refers to is hazmat certification that's required of those who ship infectious substances that could be deadly, though there is some ambiguity about whether most veterinarians need to seek out such education, usually offered by private companies.
The DOT Pipeline and Hazardous Materials Safety Administration released a guide in 2009 that outlines training requirements and includes a checklist for evaluating a hazmat employer’s needs.
In addition, the DOT has implemented a classification system for assessing infectious substances:
* Category A is defined as “An infectious substance in a form capable of causing permanent disability or life-threatening or fatal disease in otherwise healthy humans or animals when exposure to it occurs." Examples of Category A infectious substances are confirmed cultures of organisms such as Bacillus anthrasis, Brucella abortus, Chlamydia psittaci or Eastern equine encephalitis virus.
* Category B infectious substances are defined as those in a form that’s not “generally capable of causing permanent disability or life-threatening or fatal disease in otherwise healthy humans or animals when exposure to it occurs. This includes Category B infectious substances transported for diagnostic or investigational purposes." Examples of Category B infectious substances are samples that are suspicious for organisms such as leptospirosis or suspected but not confirmed cases of Category A infectious substances.
Because a seemingly benign specimen could unknowingly contain a contagious disease, Koch questions whether everything she sends should be defined as Category B.
“From a veterinary standpoint, there are so many what-ifs. I don't know if my seemingly healthy patients have contagious viruses such as FeLV, or FIV,” she says. "If they are contagious they would not be sent as a Category B."
The AVMA’s Henderson believes that it is not necessary to package and ship everything as Category A. “If it's a typical diagnostic thing, generally they would fall into B.”