Oral Fluid Specimen Collection Device shall Sample Clauses

Oral Fluid Specimen Collection Device shall a) Contain a collection pad affixed to a plastic stick, and a sealed vial, containing buffer. Both must be sealed within an outer package to insure integrity of the product. The collection pad/stick must be sealed within its own inner-package further insuring product integrity; b) Be capable of storage at room temperature prior to use for shelf-life of product; c) Allow for use as a stand-alone oral fluid collection device , requiring no other devices or machinery to collect a sample, to allow for oral fluid sample collection in remote locations independent from the laboratory performing the DOA screening; d) Be capable of collecting an oral fluid sample within 2-3 minutes; e) Allow for collection of oral fluid samples directly by the client/offender and must allow for fully observed collection by an agent/officer/counselor; f) Once the oral fluid sample is collected by the client/offender, the pad/stick must be able to be inserted directly into the vial of the oral fluid collection device, allow the client/offender to break the sample collection stick at the score mark on the stick, and allow for the vial cap to be handed to the client/offender, who finally seals their own sample within the vial. The client/offender can then initial the vial and/or allow the agent/officer/counselor ability to apply their unique bar code label to the vial thus minimizing any argument of sample mix-up or in chain of custody. (all labels and bar codes shall be provided by CONTRACTOR) g) Include a vial that 1) contains a unique combination of buffer and preservative to stabilize oral fluid samples prior to analysis for DOA; 2) provides ample space for writing in patient/client identification information or accommodates a bar code label, provided by the CONTRACTOR; 3) contains a cap that provides a tight seal to prevent leakage of the oral fluid sample; and, 4) allows for a chain of custody seal that must be applied to the vial to ensure closure and prevent contamination/tampering of the collected sample. h) Must ensure that the oral fluid collection device collects sufficient oral fluids at the time the original oral fluid sample is collected to allow for both screening and confirmation testing from the original fluid sample.