Mediterranean

CONFIDENTIALITY:  DRUGSCAN® shall protect the identity of all laboratory results. Records will only be made available to authorized, designated Medical Review Officer representatives or their designate.

CHAIN OF CUSTODY PROCEDURES

SPECIMEN RECEIVING/ACCESSIONING

Specimens are received in a limited access secure area. Each specimen is in a sealed box and/or bag. The accessioning staff opens the individual packages one at a time. In that individual package should be one specimen or one pair of specimens if a split specimen was collected and a chain of custody document which was initiated at the collection site. The accessioner compares identifying information on the specimen bottle(s) with that on the chain of custody form and continues the external chain of custody. The accessioner verifies that there are initials and a date on the specimen bottle seal(s) and that these seal(s) show no evidence of tampering. The volume of the primary specimen is verified to be acceptable. The specimen is observed for unusual color or appearance. The CCF is examined to verify a reason for testing; that the temperature of the specimen was noted, that the CCF was properly initiated at the collection site and that the collector signed the statement verification. Any discrepancies are noted on a Problem Documentation form and are attached to the CCF. Clients are notified within 24 hours of any problems and if a memorandum for the record will complete the missing information.

Specimens are accessioned into batches which contain a maximum of 60 samples which includes a blind QC sample. The internal Batch Chain of Custody forms for the specimens and aliquots are attached. Each specimen is processed to completion one at a time.  No other specimens are processed or opened until the specimen in hand is complete.

Specimens are maintained in the secure accessioning area until testing is completed. Aliquots are maintained in temporary storage racks until they are transferred securely to the initial screening personnel.

ALIQU0TING PROCEDURES

Specimens are aliquoted for initial screening one at a time by pouring the specimen bottle into a barcode labeled aliquot vial with the accessioning number.

Upon completion of initial testing negative and presumptive positive specimens are separated from each other. Aliquots for confirmation testing are poured from the specimen bottle into properly labeled vial. These specimens are transferred to a positive storage bin. This action is annotated on the Batch Specimen Chain of Custody form.  A positive aliquot chain of custody form is initiated for the aliquots to be transferred for GC/MS analysis.

INITIAL AND CONFIRMATORY TESTS

The disposition of all aliquots at all times during the testing process is annotated on internal aliquot chain of custody documents. This applies to both initial screening and confirmation testing.

DISPOSITION OF SPECIMENS AND ALIQUOTS

At the completion of both initial screening and confirmation testing the aliquots used in those functions are discarded. A separate aliquot is used for confirmation testing. At the completion of initial testing (after certification) negative specimens are separated from presumptive positive specimens. The presumptive positives are aliquoted and transferred to a storage bin. Transfer is noted on the Batch Specimen Chain of Custody.