Properly Securing a Collected Specimen
Recently we received a call from a customer inquiring about steps he should take in properly securing a collected specimen obtained for a DOT drug test. Specifically, he wanted to know if he was required by the regulations to keep the collected specimen under padlock at all times until it was collected by the courier. The DOT rules and regulations speak to security, but the regulations do not go so far as to provide step by step instructions for properly securing a collected specimen, which may lead to different interpretations by professional specimen collectors who are responsible for the proper handling of a specimen after the collection and before it ships to the laboratory. So what security measures are collectors responsible for and what are the proper security protocols?
Securing the collection site, materials and specimens are some of the security responsibilities outlined in the regulations for professional specimen collectors. Part of handling and securing the specimen is to ensure the specimen ships to the laboratory in a timely manner. 49 CFR Part 40, Section 40.73 paragraph (b) states, “As a collector or collection site, you must ensure that each specimen you collect is shipped to a laboratory as quickly as possible, but in any case within 24-hours or during the next business day”. But how must collectors properly secure the specimen after the collection, but before the specimen is shipped?
There appear to be no specifics in the DOT regulations in terms of how to properly secure the collected specimen. Steps to protect the security and integrity of collections are addressed in 40.43 in paragraph (c)(1), “Access to the collection materials and specimens is effectively restricted”. This encompassing mandate includes storage of the specimen until it is picked up by courier or shipping service personnel. The DOT Specimen Collection Guidelines, revised in July of 2014, further address security; “It is expected that collection sites will use reasonable security to ensure that all of their packages are relatively secure and not subject to damage, theft or other actions that would potentially raise questions related to the integrity of the specimens”.
I should pause to acknowledge that only two offices are equipped to provide official interpretations of the regulations, The Office of Drug and Alcohol Policy and Compliance (ODAPC) and the Office of General Council. Both resources are authorized to provide direct interpretations of the proper storage and security of a collected specimen and take calls regularly when collectors have these types of questions. Although AlcoPro is not sanctioned to provide official interpretations of 49 CFR Part 40, we can pass along what we know to be best practices.
As part of effective security and integrity, collectors must first minimize the number of persons handling the specimen. The rules and regulations are clear that the donor must deliver the specimen to the collector and the collector must ensure that the donor and collector are the only persons who have handled the specimen before it is split and sealed with tamper evident tape. After this point, the collector is required to ensure the security of the specimen before it ships.
Some obvious security measures include storing collected specimens in a restricted area of the collection site. Restricted access signs are a requirement of the DOT to ensure unauthorized personnel does not gain access to these sensitive areas containing materials and specimens. Other suggested best practices include securing the specimen in a locked environment. Padlocking cabinets or refrigerators containing collected specimens after hours would be an added layer of security but not required. Whatever the identified security measures, directors and managers of collection sites should ensure all specimens cannot be accessed, damaged or compromised in any manner as part of a reliable collection process.