When making entries on a paper CCF, use black or blue ink pen and press firmly.

Collector ensures the name and address of the HHS-certified laboratory are on the top of the Federal CCF, and that the Specimen Identification (I.D.) number on the top of the Federal CCF matches the Specimen I.D. number on the labels/seals.

STEP 1

• Collector ensures the required information is in STEP 1. Collector enters a remark in STEP 2 if Donor refuses to provide his/her Social Security Number, Employee I.D., or CDL state and number.

• Collector marks the oral fluid box above STEP 2.

• Collector notes any unusual behavior or appearance of Donor in the Remarks line in STEP 2. If the Donor’s conduct at any time during the collection process clearly indicates an attempt to tamper with the specimen, Collector notes the conduct in the Remarks line in STEP 2 and takes action as required.

STEP 2

• Collector checks the Split or Single Collection box in STEP 2. For split specimen collections, Collector checks the appropriate split type box (i.e., Serial, Concurrent, or Subdivided).

• Collector checks that each collection device is within its expiration date before use and marks the appropriate box in STEP 2.

For serial split collections

• Collector records times in STEP 2 when Donor removes the A specimen device from their mouth and when Donor places the B specimen device in their mouth (time between A and B collections must not exceed two minutes).

• If two minutes is exceeded, Collector discards the first specimen, collects the second specimen as the A specimen, and collects a third specimen as the B specimen. Collector enters explanatory remarks in STEP 2.

• Collector observes volume indicator(s) for A and B specimens during collection and marks the appropriate box in STEP 2. If the volume is less than required by the federal agency, Collector takes action as required, and enters remarks in STEP 2.

• Collector inspects the specimen and notes any unusual findings (e.g., unusual color, presence of foreign objects or material) in the Remarks line in STEP 2 and takes action as required.

• If no specimen is collected by the end of the collection process, Collector checks the None Provided box, enters a remark in STEP 2, discards Copy 1, and distributes remaining copies as required.

STEP 3

• Donor watches Collector cap each specimen tube and affix the label/seal on each specimen tube.

• Collector dates the specimen tube label(s)/seal(s) after placement on the specimen tube(s).

• Donor initials the specimen tube label(s)/seal(s) after placement on the specimen tube(s).

• Collector instructs Donor to read and complete the certification statement in STEP 5 on Copy 2 (signature, printed name, date, email address, phone numbers, and date of birth). If Donor refuses to sign the certification statement, Collector enters a remark in STEP 2 on Copy 1.

For ECCFs

If the donor refuses to sign electronically but is willing to sign a paper CCF, Collector prints ECCF Copies 1-5. Donor signs in STEP 5 of Copies 2-5 using a wet-ink signature, and Collector signs in STEP 4 of Copies 1-5 using a wet- ink signature.

STEP 4

• Collector completes STEP 4 on Copy 1 (signature, printed name, date, time of collection, and name of delivery service) and places the sealed specimen tube(s) in a leak-proof plastic bag.

• Paper CCF: Collector places Copy 1 in the leak-proof plastic bag. Electronic CCF: Collector places printed copy of Copy 1 in the leak-proof plastic bag and/or places package label (with Specimen I.D., test facility name and contact information, and collection site name and contact information) on the outside of the bag.

• Collector seals the bag, prepares the specimen package for shipment, and distributes the remaining CCF copies as required.

To download a copy of these instructions in a .pdf file format, please click here.