Specimen Submission Requirements

Acceptable specimen types and documentation, storage, and shipping guidance

• Specimen tubes are required to have at least two unique patient identifiers (name, date of birth, and/or medical record number (MRN)). This information must be attached to the body of the tube directly containing the sample, not to the lid or any other part of the specimen’s packaging.
• All specimens must arrive with either a paper requisition or an electronic requisition. Specimens received without appropriate paperwork will be held for 5 business days. If paperwork is not received within that time period the specimen will be rejected.
• The accompanying requisition must have at least two unique patient identifiers that match the identifiers on the tube.
• Draw/Collection date and time of specimens must be included on accompanying paperwork
• If there is any breach of the container containing a specimen (e.g., leaky containers, covers that have fallen off, etc.), the specimen will be rejected.

Shipping guidance

Introduction

This document is a guideline in the shipment of biological materials to Henry Ford Center for Precision Diagnostics, in compliance with the US Department of Transportation (DOT) and the International Air Transporters Association (IATA). Anyone participating in the following steps must be trained and certified according to DOT and IATA regulations. For the purposes of this document, instructions are only provided in relation to shipping Infectious Substances and Diagnostic Specimens as defined by regulation. For more detailed information regarding DOT and IATA regulations, please refer to www.dot.gov and www.iata.org. Diagnostic Specimens are any human or animal material, including but not limited to blood, saliva, urine, tissue, and tissue fluids being transported for diagnostic or investigational purposes. Diagnostic Specimens must be assigned to UN3373 (Biological Substance, Category B) unless the source patient has or may have a serious human or animal disease which can be readily transmitted from one individual to another, directly or indirectly, and for which effective treatment and preventable measures are not usually available, in which case they must be assigned to UN2814 (Category A: Infectious Substance Affecting Animals).

Packaging instructions and example packaging and labels

Please follow these packaging and shipping instructions:

1. Packages must be of good quality, strong enough to withstand the rigors of transport with a minimum dimension of 100 mm.
2. Triple packaging consisting of leak proof primary receptacles with uniquely identifiable labeling for each individual collection, leak proof secondary packaging (see example in Figure A) for each individual specimen, outer packaging of sufficient strength to meet the design type test (1.2 meter drop test).
3. For liquid shipments, primary receptacle or secondary packaging capable of withstanding a 95Kpa internal pressure differential.
4. Absorbent material within each secondary receptacle sufficient to absorb the entire contents of the primary receptacle (see example in Figure A).
5. Completed requisition form and non-diagnostic consent form (if applicable) for each individual specimen matching the labeling on the primary receptacle. This will be included between the secondary and outer packaging.
6. “Biological Substance, Category B” must appear on the package.
7. Adhere the proper labeling to the outside of the package denoting UN3373