Updated: 3/4/2021

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

• Collector marks the Urine box above STEP 2. 

• Collector ensures that the name and address of the HHS-certified Instrumented Initial Test Facility (IITF) or HHS-certified laboratory are on the top of the Federal CCF. 

• Collector verifies 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 that the required information is in STEP 1.

• Collector enters a remark in STEP 2 if Donor refuses to provide his/her SSN or Employee I.D. number. 

• 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 specimen collection box. If the collection is observed, Collector checks the Observed box and enters a remark in STEP 2. 

• Collector gives collection container to Donor and instructs Donor to provide a specimen. 

• Collector checks specimen temperature within 4 minutes after receiving the specimen from Donor, and marks the appropriate temperature box in STEP 2. If the temperature is outside the acceptable range, Collector enters a remark in STEP 2 and takes action as required. 

• Collector inspects the specimen and notes any unusual findings in the remarks line in STEP 2 and takes action as required. Any specimen with unusual physical characteristics (e.g., unusual color, presence of foreign objects or material, unusual odor) cannot be sent to an IITF and must be sent to an HHS-certified laboratory for testing as required. 

• Collector determines the volume of specimen in the collection container. If the volume is acceptable, Collector proceeds with the collection. If the volume is less than required by the federal agency, Collector takes action as required, and enters remarks in STEP 2. 

• If no urine 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 pour the specimen from the collection container into the specimen bottle(s), place the cap(s) on the specimen bottle(s), and affix the label(s)/seal(s) on the specimen bottle(s). 

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

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

• Collector instructs the Donor to read and complete the certification statement in STEP 5 on Copy 2 (signature, printed name, date, phone numbers, and date of birth). If Donor refuses to sign the certification statement, Collector enters a remark in STEP 2 on Copy 1. Electronic CCF: 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 Collector chain of custody in STEP 4 on Copy 1 (signature, printed name, date, time of collection, and name of delivery service) and places the sealed specimen bottle(s) in a leak-proof plastic bag. 

• Paper CCF: Collector places Copy 1 in separate compartment of the leak-proof plastic bag. Electronic CCF: Collector places printed copy of Copy 1 in separate compartment of the leak-proof plastic bag and/or places package label (with Specimen I.D. number, 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 version of these instructions in a .pdf file format, please click here.