Vol. 16 Issue 7
Guarding Specimen Integrity
Protecting samples requires proper packaging.
A snippet of a patient's health, specimens demand the utmost attention and care during transport. With features such as temperature control and a sturdy exterior, proper packaging guards specimen integrity.
The University of Pittsburgh Medical Center (UPMC) network requires such features to protect specimens that travel across the city to affiliated centers, explained Eugene Petrarca, MT(ASCP), lab manager, Presbyterian-Shadyside Hospitals. For instance, bone marrow samples collected at the affiliated Hillman Cancer Center travel via pneumatic tubing to UPMC. There, a laboratorian packages the specimen for the courier service, which takes it to Presbyterian Hospital for flow cytometry. Concurrently, the laboratory sends the cytogenetics sample to Magee Women's Hospital for testing.
Substandard packaging could compromise specimen quality, especially for the more vulnerable ones. Labs like UPMC depend on the latest in packaging products when transporting specimens.
Every type of specimen needs a high level of care, though some are more vulnerable than others with varying time and temperature requirements. Temperature control is a primary challenge in guarding specimen integrity. Packaging should protect specimens from extreme temperatures and altitude changes, said Barry Johnston, president, HighQ LLC, McDonald, PA.
"This is a growing concern among laboratorians," Johnston said. "Ambient specimens are shipped without any insulation in a package and many times see elevated temperatures in the summer and freezing temperatures in the winter. Even during the summer months, samples traveling at high altitudes see low temperatures. Many tests are temperature-sensitive."
Specimens unprotected from the heat can cause the proteins to become denatured, impacting chemistry, hematology, serology and coagulation tests, added Marty Hinkel, MT(AMT), microbiology/coagulation supervisor and phlebotomy instructor, Washakie Medical Center, Worland, WY. Bacteriological specimens, for instance, are extremely susceptible to temperature changes. Improper shipping, Hinkel said, can cause the bacteria to die, rendering them unable to grow and be identified. Whole blood specimens in the winter's extreme cold, if not packaged properly, will freeze, becoming hemolyzed–and unable to be processed.
Time-sensitive specimens, such as blood gas samples, also are vulnerable during transport, Petrarca said. In addition to the need to be tested within 30 minutes of collection, blood gas samples must be kept on ice.
From the anatomic pathology lab, two types of vulnerable specimens include fresh muscle biopsies, shipped on wet ice or cold packs, and infectious specimens, such as frozen brain tissues from a Creutzfeldt-Jakob disease case. Infectious specimens must be shipped on dry ice and require very specific packaging, said Konnie Zeitner, HT(ASCP)HTL, SLS, histotechnologist, neuropathology lab, The Nebraska Medical Center, Omaha.
"In the case of sputum swabs or urine for culture, a broken container could affect the culture result," she added. "And a fresh muscle biopsy, which must be transported cold for enzymes studies, could yield inaccurate stain results if the muscle is held at ambient temperature for longer than 4 hours."
Damage also occurs if the package leaks when the closure is vibrated loose. The package also could be crushed when placed under heavier packages or caught in a type of conveyor at a sorting facility, Johnston explained. A specimen could be damaged if the primary container a broken in transit.
Damaged specimens could lead to an invalid result, misdiagnosis or recall of the patient to obtain another specimen. The legal, financial and re-collection implications of damaged specimens apply more pressure to deliver a well-preserved sample.
"For irreplaceable specimens–tissue cultures, amniotic fluid chromosome studies–the [consequences] could be huge," said Debbi Tiffany, MSEd, MT(ASCP)SC,SLS, POCT/Safety/QA director at Swedish American Hospital, Rockford IL. "Consider the legal liability for a specimen that cannot be tested due to some negligence in transport."
Further, specimens such as cerebral spinal fluid, bone marrow aspirate or biopsy are difficult to re-collect, Petrarca added. "Compromising these samples can delay diagnosis or treatment of a patient. For oncology patients, it could delay vital chemotherapy or radiologic treatment if something [should] happen to their bone marrow aspirate or biopsy."
Improperly packaged specimens could also pose a public health risk. From the transportation workers who pick up, sort and deliver to the recipient of the packaging, everyone involved in the courier service could become exposed to a potential pathogen, Johnston said. Special attention should be given to infectious specimens that leak, such as bacteriology specimens for identification, Hinkel said.
To prevent such consequences, packaging should have a tight closing capability, be sturdy, comply with federal shipping regulations and have a cost that will not add too much to the test cost, which would make the test impractical to perform, Hinkel stressed.
"Essential packaging features include specimen containers with leak-proof lids, inner packing, which is resistant to breaking or crushing such as sturdy cardboard or [plastic foam] mailers for tubes, and zip lock bags that do not leak. In the case of infectious material transported via FedEx, UPS, or the U.S. Postal Service, the packaging must meet specific DOT/IATA criteria," Zeitner reminded.
Packaging products for transporting ambient specimens, specimen transport bags and packaging frozen/refrigerated specimens each have special features to ensure specimen integrity.
• Products for transporting ambient specimens–Specimens must be in a leak-proof sealed container with either a stoppered blood tube or sealed serum transport tube. Specimens then should be placed in a sealed transportation bag marked "biohazard."
• Specimen transport bags–Specimen transport bags should be zip-locked sealed bags that have an outer pocket for the paperwork accompanying the specimen. Bags need to be leak-proof and contain an absorbent cloth to soak spilled specimens.
• Packaging frozen/refrigerated specimens–Frozen or refrigerated specimens should be put in a plastic serum transport vial with a screw-type top to prevent leaking, and placed either upright in the freezer to freeze or upright in the refrigerator. Once frozen, they should be transported in a frozen transport plastic foam container. All specimens need to be packaged in a second outer package such as a zip lock baggie and be placed in the proper outer container for shipping.
"One of the most essential packaging features is that you have a primary or secondary container that meets a 95 kPa (13.8psi) pressure test," Johnston added. "This ensures that when this container is closed, it will not leak regardless of a loss of pressure in the cargo hold of an airplane or a change in altitude. Also, have sufficient absorbent in the event of a leakage and finally an outer box that can withstand the drop and stacking tests."
Quality Products, Vendors
Though reference labs supply hospital and physician office labs with packaging materials, keep these features in mind when you need to buy additional packaging. Check with your state public health laboratory for a list of acceptable transportation vendors or check with the CDC, U.S. Department of Transportation or U.S. Postal Service for their suggested shipping requirements and venders that carry the necessary supplies.
Because specimen integrity is essential in achieving accurate results, you want to purchase a quality product without spending too much. Cost may not always reflect quality, and you can save cost by purchasing in bulk, Petrarca said.
If the product does not meet your specifications, cost is immaterial, added Zeitner. By trying the products offered by various vendors, you can evaluate the quality and may find that lower cost items can be just as effective as their more costly counterparts. One can start a product research by using the information in vendor catalogs.
"Check with consumer groups on pricing," Hinkel advised. "Visit with other health care institutes in your area and see what they pay and where they get their supply. Networking at a national convention can be one of the best ways to find out about products that are available. It might take some time to find the best fit for your needs."
Erin James is an assistant editor for ADVANCE. She can be reached at firstname.lastname@example.org.
State-of-the-Art Packaging Materials Protect Specimens
Whether a specimen is rejected due to damage or lost, both require recollection, resulting in patient inconvenience and delayed testing. Packaging products should be leak-proof, meet OSHA labeling requirements and meet advertised specifications. ADVANCE examines a sampling of vendors whose products consistently meet these criteria.
EXAKT Technologies Inc.
EXAKT Technologies Inc.'s (Oklahoma City, OK) EXAKT-PAK™ D-Pak is just one part of EXAKT's new product line of diagnostic specimen packaging. Together with the new Uni-Paks, EXAKT provides cost-effective flexibility in choosing packaging for shipping diagnostic specimens. The D-Paks can hold up to 12 vials in an ambient outer box and up to 18 vials in an insulated box. The Uni-Paks use the familiar white canisters that come in four sizes and hold items such as jars, Petri dishes, slants, vials and bottles. With outer packaging for multiple canisters, Uni-Pak can accommodate hundreds of vials or small receptacles in the Uni-Pak Multi. All packages meet U.S. Department of Transportation diagnostic specimen packaging requirements and IATA Packing Instruction 650.
Regulatory changes governing the transport of diagnostic specimens by air and ground have created a demand for two types of packaging manufactured by Saf-T-Pak Inc., Edmonton, Alberta, Canada. The STP 210 and 250 can be used to ensure ambient specimens are transported in compliance with revised regulations. The STP 210 is a simple package that comes with one patented soft-secondary container capable of holding one to five 10 mL specimens. The package is sold 10 to a bundle and is flattened for easy shipment and storage. The outer packaging is reusable. The STP 250 is a larger shipper capable of carrying up to six soft-secondary containers or four, 5" ´ 5" ´ 2" tall grid boxes. It is also sold flattened in a bundle of 10.
Uniflex Inc., Hicksville, NY, provides Speci-Gard® specimen transport bags. These bags feature the patented liquid-tight, Press and Close® adhesive closure system. The bag will stay closed even when transported in a pneumatic tube system. Speci-Gard bags are available in single pocket versions or diagnostic kit packaging. This product meets both OSHA and NCCLS regulations for liquid-tight transport.
Custom Pack Inc.
Custom Pack Inc., Exton, PA, offers multi-use shippers that meet IATA requirements for ambient, frozen or refrigerated specimens. These shippers include absorbent pouches, a leak-proof poly bag for specimen paperwork, vacuum-insulated panels and temperature control. Insulated shippers such as the CP-100 are for temperature-sensitive specimens and is constructed with vacuum panels. They have a two-piece vacuum-insulated panel box design and temperature control. The company's bulk specimen shipper is approved as a 6.2 shipper for clinical labs. It incorporates the vacuum process, which eliminates manual wrapping and is capable of shipping up to 400 specimen tubes.
Com-Pac International Inc.
Com-Pac International Inc., Carbondale, IL, manufactures a comprehensive line of simple solutions for shipping diagnostic specimens and infectious substances. Bitran liquid-tight zipper bags provide containment. The patented manufacturing process guarantees the elimination of leaks. Independently tested and certified, the Bitran and Infecon bags meet 49 CFR section 178.604. Commonly used for both primary and secondary containment, they are available in sizes from 2" ´ 4" up to 24" ´ 24." Infecon shippers are used when shipping infectious substances. Available in multiple sizes, these U.N. 6.2-certified packages come complete with all packing components, labels and declarations to simplify packing and compliance.
Air Sea Atlanta
Air Sea Atlanta, Atlanta has a comprehensive line for shipping infectious, diagnostic or biological specimens (class 6.2) within IATA Packing Instructions 602 and 650 and DOT 49 CFR. One of Air Sea's packages, the BioTransporterCargo (Code 424), is used for transporting large volumes of tubes, 1 liter bottles, cryo-boxes, medical devices, or even moving a lab. This U.N. certified package (16" ´ 16" ´ 23") offers a large, 10 or 12 liter, secondary container within an outer package that also holds "cool packs" or up to 25 kilos of dry ice. Also available is an overpack for the BioTransporterCargo when needing to maintain temperature over extended periods of time.
BagCo, Kennesaw, GA, offers the patented TearZone® specimen transport bag that allows for easy access to the specimen in the bag without using a blade or knife to cut the bag open. It is specially designed with a double-zipper system, which ensures the bags will not leak under normal use. There are no perforations, which can cause leakage, and no scorelines that have the potential to cause microholes in the bag's material. The company's Zippit® and TearZone® bags come packed in soft-pack Dispenser Bags™.
Starplex Scientific Inc.
Starplex Scientific Inc., Etobicoke, Ontario, Canada, makes premium quality plastic disposables that provide reliable specimen transportation. Included are the LeakBusters, specimen containers for harsh transport conditions, and HistoPlex™ polypropylene containers for the storage of histology specimens.