Collection of specimens
The proper collection, packaging and transportation of urine specimens is a crucial part of a drug-testing programme. Although this is the most frequently challenged aspect of the process in any legal proceeding, it is also the least regulated one.
It has been accepted practice, and is now a requirement, in most workplace drug testing programmes and certainly in the industries regulated by the DOT, that a urine specimen be collected and split into two portions (sometimes referred to as bottles A and B). Under DOT regulations, during the collection process the collector is required to monitor the temperature of the urine (within 4 minutes of the collection), ensure that the donor does not substitute or adulterate the specimen, and to complete the necessary chain-of-custody documents. This process includes the following major steps:
• preparation of the collection area, for example adding a blue dye to the toilet water and taping of the taps
• confirmation of the donor’s identity using photographic evidence and requesting him or her to remove outer clothing and to empty pockets
• having the donor randomly select a collection container and two bottles, which should be wrapped separately (only the collection container should be taken into the toilet enclosure)
• checking the temperature of the sample within 4 minutes of voiding and noting the result on the chain-of-custody form. The collector has then to ensure that there is at least 45 mL of urine in the container and that the specimen has no unusual odour, colour or physical properties (e.g. excessive frothing) that may indicate attempted adulteration
• pouring at least 30 mL into bottle A and 15 mL into bottle B in the presence of the donor, and immediately closing the bottles and applying tamper-evident seals across the lids or caps of the bottles
• ensuring that the donor initials the seals and completes his or her section of the chain-of-custody form. The collector then completes the remaining sections of the form
• preparing the specimen bottles for shipment to the laboratory. Although these are there commended steps for the completion of a regulated chain of custody, it is also the general procedure used to collect all urine specimens. The steps most often challenged are that the collector did not complete the process in the presence of the donor and that more than one specimen was being collected at the same time (i.e. there were multiple specimens and chains of custody in various stages of collection.) Completion of the chain-of-custody form is an important part of this process Almost all drug testing programmes in the USA have provisions for ‘shy bladder syndrome’. In this situation the donor fails to provide an adequate urine volume after remaining at the collection site for up to 3 hours and being provided with 1.25 L of liquid. The donor is deemed to have a ‘shy bladder’ and is required to undergo a medical examination. If there is a reasonable medical explanation, the test is cancelled. If the donor requires a negative test for employment, specimens other than urine may be used, for example hair or oral fluid. In the regulated industries, observed collections have to be performed by same-sex collectors and can currently only be performed in five special cases:
• when the specimen temperature is out of range at the collection site. In this case there has to be an immediate observed collection
• where the collector has identified an apparent tampering with the specimen at the collection site, for example the addition of bleach to the urine. Again, there has to be an immediate observed collection
• if the previous specimen has been declared invalid by the laboratory and when there is no obvious medical explanation for this. The most obvious example of this is where the laboratory has proof of adulteration, but cannot specifically identify the adulterant
• when the MRO has cancelled the test because the Bottle B specimen was unavailable or had been adulterated and was so identified by the laboratory performing the re-confirmation
• in return-to-work and follow-up tests, for which the employer can, in certain circumstances, decide to conduct observed collections.
These general guidelines are also followed outside the regulated industries, although some employers and some sectors may have more rigorous ones. For example, the US military requires observed collections for all specimens. Despite these safeguards, donors are still able to adulterate urine specimens by adding oxidising agents after voiding. The amount of such material added is extremely small (a vial of it can be hidden easily in a shoe or sock) and, if it is liquid, the volume is insufficient to alter the temperature of the specimen. Alternative specimens to urine have advantages that their collection can be considered noninvasive and can be observed. For example, collection of oral fluid is usually performed using a pad or swab and the donor can do this themselves in the presence of the collector. Collection of hair is also ‘observed’, although some questions remain as to the invasive nature of this process, particularly when non-head hair has to be collected.