Combination Electronic and Paper CCF Tere are two options for a combination electronic/paper Federal CCF: 1. Te collector uses an electronic CCF to document the collection process, then prints Copy 1 and Copy 2-5 (without signatures) on carbonless paper. Te collector, the donor, and the test facility personnel (e.g., accessioner, certifying technician, certifying scientist) sign the CCF using wet signatures. Te electronic form is not signed. a. Te collector distributes copies of Copy 2–5 (with signatures) to the MRO, the employer, and the donor, and maintains a copy for the collection site records.
b. Te collector sends Copy 1 to the test facility with the specimen. Te hardcopy CCF sent with the specimen is the chain of custody. Te eCCF with steps completed during the collection process may be transmited to the test facility electronically and checked by test facility staff against the hardcopy CCF upon receipt of the specimen. Te electronic copy of the Test Facility copy is for informational purposes only and cannot serve as the chain of custody.
2. Te collector uses an electronic CCF to document the collection process, the collector and donor sign using electronic signatures (the donor uses a digitized signature), and the collector prints Copy 1 with his or her electronic signature. Te test facility personnel (e.g., accessioner, certifying technician, certifying scientist) sign the CCF using wet signatures. a. Te collector distributes copies of Copy 2–5 (with signatures) to the MRO, the employer, and the donor, and maintains a copy for the collection site records.
b. Te printout of the eCCF Copy 1 must be designated as the single authoritative copy of the eCCF:
38 datia focus
Te collector designates the printed Copy 1 as the authoritative copy by signing it using a wet signature, or
Te copy must be produced as the single authoritative copy using the validated eCCF system.
Note: the identification as the authoritative copy must be evident to the laboratory accessioner.
c. Te collector sends Copy 1 to the test facility with the specimen. Te hardcopy CCF (i.e., the authoritative copy) sent with the specimen is the chain of custody. Te eCCF with steps completed during the collection process may be transmited to the test facility electronically and checked by test facility staff against the authoritative upon receipt of the specimen. Te electronic copy of the Test Facility copy is for informational purposes only and cannot serve as the chain of custody.
If you have any questions concerning
this issue, please contact NLCP staff at
NLCP@rti.org or (919) 541-7242.
Two NLCP Notices: Electronic Reporting Methods and Oxidant Testing On April 8, the NLCP issued a notice that concerned NLCP assessment of the reporting of regulated specimens using electronic reporting methods. Beginning in May 2015, to verify the information provided and assess the knowledge of appropriate laboratory staff, the following will occur at each maintenance inspection:
Inspectors will verify that the laboratory has described all electronic/web reporting methods in item C–16 and Section P (i.e., questions P–21 through P–23)
Inspectors will interview appropriate staff, including each RP, to assess and verify their knowledge of all reporting methods used for regulated
specimens. Inspectors will request that the laboratory identify a real regulated donor specimen that was reported using each method and demonstrate how the reporting method was determined.
Early during the inspection, the lead auditor will select several (e.g., 5–10) specimens from the non-negative specimen list (NNSL) and will present the list of specimens to the RP. Laboratory staff must identify the reporting method used and verify the location (website, fax number, etc.) to which the reports were sent electronically. Also on April 8, the NLCP issued a
notice on “Specimens Meeting Invalid Criteria based on Oxidant Testing.” In it, it said, laboratories must contact the Medical Review Officer (MRO) before reporting a regulated specimen meeting certain “Invalid Result” criteria, including results indicating the possible presence of an oxidizing adulterant. Te purpose is to enable a discussion between the laboratory and the MRO, to decide whether additional or different testing might lead to identification of an “Adulterated” result for a specific oxidant.
Proposed Updates to Mandatory Guidelines for Federal Workplace Drug Testing Program On May 15, the Department of Health and Human Services (HHS) published two important notices regarding oral fluid and urine testing. Tese rules are important not only for HHS, but DOT will also follow these should they move forward with oral fluid testing. Te proposed changes address the following:
Oral Fluid Mandatory Guidelines. Te proposed OFMG establish standards and technical requirements for oral fluid collection devices, initial oral fluid drug test analytes and methods, confirmatory oral fluid drug test analytes and methods, processes for review by
summer 2015
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