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are printed. The donor and collector sign using a “wet” ink signature on all paper copies. This Type 1 protocol requires the use of one sheet of special paper with integrated blank seals. The CCF number is printed onto the blank seal by scanning a paper chain of custody, or by assignment by the computer system. Type 1 CCFs distribution would follow the manual distribution that is currently in use. The primary benefit of this scenario is the improved legibility of the collector and donor’s name or telephone number. The Type 2 system uses a collection


wizard, and incorporates an electronic pad to record the donor and collector signatures at the proper steps in the collection process. Once the collection is complete, the document containing the digitalized signatures of the donor and collector is printed. Copy 1—the


laboratory copy—which accompanies the specimen to the laboratory and is referred to as the “authoritative copy,” is used by the laboratory to document receipt and initiate chain of custody. The remaining copies (two to five) are sent to the respective parties. The advantage of the Type 2 system is that it facilitates the CCF distribution electronically to all parties, and has the digitalized image of the signature on the form. It can then be uploaded into a computer system for the MRO, employer, and donor; thereby eliminating the need for printing and/or faxing. A third, completely digital option


is available, but is not in use today. In this option, the laboratory copy of the CCF is not printed or included with the specimen shipment to the laboratory. In this situation, a label is printed and applied to the specimen bag with the


specimen ID, test facility name and contact information, and collection site name and contact information. All of the electronic information contained on the ECCF is sent to the laboratory electronically. Before this option can be used for federal samples, further clarification from SAMHSA is needed to specify the acceptable protocols to be followed by the collection site and at the laboratory. The federal guidance for receiving and reporting a sample without an originating paper copy is still in the discovery phase, but resolution is anticipated in the near future.


Accelerate Adoption to Realize Automation Advantages The approval of the ECCF system for sample collections is arguably the most impactful change since the


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