Confused over the Specimen Transport Regs

Confused over the Specimen Transport Regs?

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Education, Training Important, Say Experts

By Gail O. Guterl

When it comes to shipping specimens for diagnosis, “better safe than sorry” is a good creed to follow! The best way to be really safe is to get the proper training in how to package specimens for shipment.

“After all, without training, how can you even know if what you are shipping is exempt from or subject to the regulations?” emphasized Eric Cook, biological technical specialist with Saf-T-Pak Inc., Edmonton, Alberta, Canada.

Education is an essential component of the regulations regarding shipping of hazardous materials. It is also important because knowing exactly what regulations apply to what specimens being shipped can be very confusing.

Specimens being shipped in the United States that meet the definition for diagnostic specimens–“any human or animal material including but not limited to, excreta, secreta, blood, blood components, tissue and tissue fluids being shipped for purposes of diagnosis,” Code of Federal Regulations (CFR) Title 49 173.134 paragraph 2–are not regulated by the Hazardous Materials Regulations (HMR) if, as packaged, they do not contain any other dangerous goods, Cook told ADVANCE.

While diagnostic specimens are excepted from the U.S. Department of Transportation (DOT) HMR as cited in the CFR regarding packaging and shipping, they are not excepted under the International Civil Aviation Organization (ICAO) regulations or the International Air Transport Association (IATA) Dangerous Goods Regulations.

“The ICAO Technical Instructions do not include the same exceptions for diagnostic specimens as the HMR,” explained Cook. “In most cases when shipping by air the broad exception in the HMR for diagnostic specimens does not apply.”

The bottom line: it’s a good idea to be trained in what the transportation regulations require and how materials should be packaged, Cook advocates.

“Unfortunately, 49 CFR does not provide a definition of “diagnosis,” he explained. “For example, let’s say I’m shipping a blood sample known to be HIV positive for the purpose of DNA sequencing which may not have anything to do with diagnosis. Could we say that the sample is being sent for diagnosis?

“Another example may be sending a sample for confirmatory testing. In this case, it could be argued that it is not being sent for the purpose of diagnosis, it is being sent for confirmation.”

However, according to Ed Mazzullo, director of the Office of Hazardous Materials Standards, Research and Special Programs Administration, DOT, “The diagnostic tests performed on a specimen are not restricted to those leading to a determination of whether a material is infectious.”

Required Training

Basically, when it comes to training employees on what the regulations require and how packages should be handled, the responsibility lies with the employer.

“The employer, not the government, is the party best suited to determine the employees’ training needs,” said Cook. “The HMR outlines the employers’ four areas of responsibility for training employees. They include the types of training, the time period for training, testing and recordkeeping.”

Under types of training, the regulations outline three broad areas:

* General awareness training, to familiarize the employee with the HMR and enable him to recognize hazardous materials.

* Function-specific training, which includes such things as how infectious substances are classified and the type of packaging needed, marking and labeling of the package and how to prepare the package and shipper’s document. Part of that training includes how to classify a diagnostic specimen, infectious substance and biological product, and the requirements for shipping by air, sea, land or rail.

* Safety training covers what to do in case of a spill, emergency response information and methods for avoiding accidents and the proper handling of packages.

The HMR, according to Cook, outlines “when you have to have initial training done and when recurrent training needs to be done.

“A new employee can work under the direct supervision of someone who is trained for up to 90 days. After the 90 days that employee must be trained in shipping and handling according to their job function,” said Cook. “If someone changes jobs within the company, the same rule applies. They have to be retrained and that training has to be recertified by the employer.”

The CFR stipulates recurrent training every three years; international requirements for air transport call for retraining every two years.

“But if there’s a change to the HMR, an employee has to be trained in that change,” said Cook. “It can be in the form of a memo by the employer that he notified the employee of the change or it can be a formal day-long or half-day seminar, but the retraining in new regulations must be done. Employers need to keep on top of current regulations.”

While the code requires that an employee be tested on what he has learned in training, it doesn’t outline the exact form the testing must take.

“The CFR doesn’t say what kind of test or even whether an employee has to pass the test, but they must be tested,” explained Cook. “The employer can determine what constitutes trained and tested, and that leads to the last requirement, recordkeeping.”


The employer must keep track of the training for each and every employee that falls under the regulations, Cook said. And the employer must certify that the employee has been trained.

“It is up to the employer’s discretion to decide when an employee is considered ‘trained’ and tested.”

The record of training should include the name of the employee, when the training was completed, a description of the training or copies of the training materials, the name of the person providing the training–no specific credentials to be a trainer are mentioned–and that the employee has been tested.

Cook said employers do not have to send the certification of training for each employee to the government. “The government doesn’t have a certification process. However, for the employer’s sake, if the DOT comes to them, they need to be able to demonstrate that they have met all training requirements.

“In the case of an incident, such as the recent ValuJet disaster, the regulators will be asking employers for training records.”

Gail Guterl is a staff writer for ADVANCE.

Durable Specimen Packaging Important Part of Transport

Protecting a diagnostic specimen and the people who handle and ship these samples is an essential responsibility of the laboratory.

It is important that the specimen packaging doesn’t leak, that caps remain tightly sealed and that vials arrive at their destination intact and at the proper temperature. Many quality packaging products are available.

OpenStat double-pocketed bags by Duramark Inc. are liquid-tight and can be purchased with an absorbent material to soak up any fluids that may have escaped from specimen containers. OpenStat can be placed in Duramark locked boxes containing coolants. The boxes, in fabric, metal and plastic, are designed and tested for thermal efficiency and can be placed in a Duramark tote, especially designed to maintain proper temperature, such as frozen, refrigerated or room (ambient) temperature, during transport.

SafeTex Clinical Shipper from Andwin Scientific has a four-part shipping device that includes a foam insert impregnated with a biological detergent shown effective in breaking down the walls of most protein substances; a bag which serves as the secondary container (enclosing the specimen and paperwork); a snap-in-place lid and a cylindrical device approximately 7.5 inches tall.

Fully assembled, SafeTex Clinical Shipper is leak resistant and tamper-evident.

Trans-Pak Biohazard Specimen Transport Bags from Nasco International Inc. have a unique specimen security system with a positive closure that is guaranteed leakproof. Patented “Puncture Proof Tabs” protect bags against piercing. An outside pouch separates important patient paperwork from the inside of the bag and the specimen, eliminating misplaced documents.

Trans-Pak features the biohazard symbol required by OSHA, is made of unbreakable polyethylene, is easy to handle, and requires minimum storage and carrying space.

ShipSafe Infectious Substance Shipper Overpack by Polyfoam Packers Corp. maintains frozen samples for more than 96 hours. The shipper, Model 670, has space for up to 25 pounds of dry ice and includes a foam insert to hold the infectious substance shipper firmly in place while dry ice sublimates. The shipper includes two Class 6 Infectious Substance Labels.

Speci-Gard® with Gelok Super Absorbent by Uniflex Inc., a patented line of liquid-tight specimen transport bags, is available with a super absorbent laminate pre-inserted into each bag. The Gelok 16000 s/s super absorbent has been positively tested to absorb 60 ml of urine.

Speci-Gard has a one-step sealing system with no glove-to-adhesive contact. It is tamper evident and meets or exceeds OSHA and DOT regulations.

Specialty Zipper Bags from Associated Bag Co. includes an assortment of styles to transport, store and dispose of specimens, medications, samples and other medical supplies. There are specimen/document bags with separate pockets for paperwork, sampling bags, chemotherapy/cytotoxic bags, infectious waste and biohazard transport bags, Infecon™ leakproof bags and unit dose bags. Zipper bags come in a wide range of sizes with special imprints to meet OSHA standards for labeling. Bags are imprinted with biohazard symbols.

Bags can be custom printed with individual hospital or lab names, addresses, logos or special instructions using Associated Bag’s Quick Printing service.

Exakt-Pak by Exakt Technologies is a line of packaging designed to fulfill all the needs of many different facilities who must ship diagnostic samples/infectious substances, retrieved medical devices and biological products. The company also specializes in custom packaging.

The sample tube from Sample-Pak I & II has been accepted by certain carriers as sufficient packaging for shipments of diagnostic specimens and is ideal for shipping one or two samples cost-effectively. All Exakt-Paks are available for ambient, cold or frozen conditions.

STP-360 by Saf-T-Pak is a diagnostic specimen shipper suitable for up to 112 evacuated blood collection tubes. The shipper stacks for storage and transport and is durable and leakproof. Customized inserts are available.

The shipper includes a 15 X 8 X 9 inches outer package which acts as a carrying case for the 13 X 7 X 7 inches inner pack.

Both No Leak specimen vials and Snap-Lok caps by Precision Laboratory Plastics Inc. (PLP) have unprecedented records for consecutive customer shipments of transport vials without leaks or specimen contamination due to cap failure. Most of PLP’s specimen vials come in screw cap or Snap-Lok styles and are made from clarified polypropylene or polystyrene, are available plain, generic or custom-printed in white or colored inks and with a variety of cap colors.

The latest No Leak vial is the 16X120 15 mL screw cap centrifuge vial requested by customers with leaks in urine sample vials that were sent through pneumatic mailing tubes within a hospital.

–Gail O. Guterl

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