are no laboratories with eCCF approval, however, DATIA will keep its members informed as approvals are issued. Te eCCF requires the same collection
of information and distribution of information to the relevant parties as the paper CCF requires. With the approved eCCF, HHS is not requiring collection of any new or different information. Te only change from the paper CCF to the eCCF is the mechanism for collecting and transmiting the requisite information. Before implementing an eCCF, HHS-certified laboratories must provide a detailed plan and proposed standard operating procedures (SOPs) for SAMHSA to review and approve through SAMHSA’s National Laboratory Certification Program (NLCP). Te review of validation records, specimen records, SOPs, staff training records, and practices associated with the eCCF will be part of the NLCP inspection process. Once the eCCF is approved for use through the NLCP inspection process, it may be used in the DOT drug testing program, as well as the Federal Workplace Drug Testing Program. For more information regarding this approval process, please contact the Department of Health and Human Services, Substance Abuse and Mental Health Services Administration, Division of Workplace Programs, National Laboratory Certification Program at (919) 541–7242, or via email at
nlcp@rti.org. It is important to note that electronic
signatures are not otherwise acceptable in Part 40. Te use of the eCCF will create an exception so that electronic signatures will be acceptable on these forms only and not throughout the rest of Part 40.
Defined Formats for the Federal Custody and Control Form (CCF) Te Federal Custody and Control Form (CCF) and information regarding the use
www.datia.org
of the CCF are available at the SAMHSA website. Additional information was presented at the October 19, 2014 NLCP Inspector/Lab Director Workshop and made available to HHS-certified laboratory staff and NLCP inspectors on April 10, 2015.3 Tis information includes defined formats for use of the Federal CCF as a paper (hardcopy) form, an electronic (digital) form, or a combination electronic and paper format. Some HHS-certified laboratories have
proposed a type of combination electronic/ paper CCF system that differs from that defined by SAMHSA. Te proposed systems employ an electronic CCF signed by the collector using an electronic signature and a paper CCF (i.e., printed copy of the eCCF) signed by the laboratory accessioner using a wet signature. SAMHSA has determined that, for
this type of combination electronic/ paper system to meet forensic chain of custody requirements, the single printout of the Federal eCCF Copy 1 (i.e., with printed electronic signature of the collector) that is sent to the laboratory with the specimen and used as the chain of custody form by the laboratory must be identified as a unique copy (i.e. the authoritative copy). The accessioner must verify that the CCF received is identified as the authoritative copy prior to signing, thereby providing the necessary link to the eCCF for maintenance of the chain of custody. Te defined format for the Federal CCF
will be included in the NLCP Manual for Urine Laboratories and the NLCP Manual for Urine Instrumented Initial Test Facilities (IITFs), which are currently under revision:
Defined Formats for the Federal CCF
Paper CCF A paper Federal CCF may be either: 1. A preprinted, multiple-part carbonless form, or
2. A multiple-part CCF that is printed at the collection site, prior to the collec- tion (i.e., “print on-demand” form). A paper CCF must conform to the
formating requirements of the OMB- approved Federal CCF. Te collector, the donor, and the test facility personnel atesting to receipt and certification of test results sign using wet signatures. For option 2: at a minimum, the
collector prints Copies 1 and 2 on carbonless paper. Te collector distributes copies of Copy 2 (with signatures) to the employer and donor, and maintains a copy for the collection site records. Copy 1 is sent to the test facility with
the specimen. Te hardcopy CCF sent with the specimen is the chain of custody.
Electronic CCF (eCCF) An electronic CCF is an electronic document used to record all CCF events from collection through reporting. Te collector and the test facility personnel atesting to receipt and certification of test results sign the eCCF using electronic signatures. Te donor signs the eCCF using a digitized signature. Te electronic CCF is the chain of custody. Te collector must either:
1. Include a printed copy of the Test Facil- ity copy (i.e., Copy 1) of the Federal CCF with the specimen, or
2. When a printed copy is not included, apply a label to the outside of the specimen package, with the specimen identification number, test facility name and contact information, and collection site name and contact information.
As noted above, the eCCF is the chain
of custody. If included, the printed copy of the Test Facility copy is for informational purposes only and cannot serve as the chain of custody. Te laboratory may, but is not required to, maintain the printed copy in its records.
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