How does a specimen collector know that the sample handed over to him has not been tampered with?
How does a donor know that the specimen he submitted will be handled properly?
How does the employer know that the drug test results they are getting are valid and reliable?
All of these questions, coming from different perspectives are actually asking the same thing: How is the integrity of the entire drug testing process ensured and preserved?
This is the very purpose of the Chain of Custody Form (CCF), to track and document each step in the drug testing process and each responsible entity that touches the specimen from the time it was submitted by the donor up until the results are released.
The sensitivity of drug testing is not confined within the laboratory testing facility: it begins at the collection of the sample and ends as soon as the final drug test result is released. This is the reason why the Department of Transportation (DOT) requires a paper trail of documents called Chain of Custody Form (CCF).
The series of documents included in the CCF records pertinent information about the management of a human-derived specimen. The documentation process starts when the patient in question submits a specimen to the collector, who will then send the sample to the laboratory testing facility. The lab will then analyze the specimen and release the results to the receiving party.
Chain of Custody Drug Test
The Federal CCF (also referred to as CoC – Chain of Custody) is accomplished in quintuplicate, with a copy for each of the concerned entities who gain custody of the sample along its trail in the process, as follows:
Copy 1 – Test Facility
Copy 2 – Medical Review Officer
Copy 3 – Collector
Copy 4 – Employer
Copy 5 – Donor
Each of these 5 entities have specific sections on the CCF which they should fill out. The information they provide on the CCF must be complete, clear and concise.
Any missing or erroneous information may result in unnecessary delays in the process and in some cases, may cause the entire test request to be discarded. For instance if the Specimen ID# written on the top portion of the CCF does not match the specimen ID# on the specimen bottle, the test facility (laboratory) will report a Rejected for Testing result. This particular task falls on the collector, as well as various other sections on each of the 5 copies of the CCF.
The standardized format of the CCF is the result of the collaboration between government and drug testing industry representatives (DATIA / SAPAA) who form a governing oversight group. As the test sample moves along the process, pertinent information is added to the CCF, providing effective tracking and cross-checking points that help ensure the integrity of the sample and pinpoint accountability.
The CCF is a legal document. Any tampering or mishandling of the CCF and all information therein warrants an investigation and subsequent application of penalties in accordance with the law. It is likewise private and confidential.
All these process safeguards serve to assure donors that the specimen they provide will be handled strictly according to the order outlined by the SAMHSA in their mandatory guidelines for Federal Workplace Drug Testing Programs.
The CCF Must Contain the Following Information to Ensure the Integrity of the Specimen and Test Results:
- Details about the specimen’s packaging and seal
- Details about the laboratory personnel conducting the test (i.e. date and time of testing, and signature of the lab personnel)
- Report of the Medical Review Officer (MRO) on the lab test results
Any signs of tampering – may it be a broken seal or a mislabeled specimen container – will render the sample invalid for drug testing. Similarly, any attempt to tamper or mishandle the CCF will be dealt with accordingly by law.
The CCF ensures the person who submitted the specimen that the testing was handled in accordance to the Substance Abuse and Mental Health Services Administration (SAMHSA) guidelines on Mandatory Guidelines for Federal Workplace Drug Testing Programs.
The CCF is usually accomplished in multi-page forms, with a copy or a portion of a page handed to the testing facility, MRO, sample collector, employer, and employee for documentation and archiving purposes.
Instructions for Completing the Federal Drug Testing Custody and Control Form for Urine Specimen Collection
When making entries on a paper CCF, use black or blue ink pen and press firmly. The 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 and the Specimen Identification (I.D.) number on the top of the Federal CCF matches the Specimen I.D. number on the labels/seals.
Chain of Custody Procedures
- The 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.
- The collector gives the collection container to the donor and instructs the donor to provide a specimen. The collector notes any unusual behavior or appearance of the 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, the collector notes the conduct in the remarks line in STEP 2 and takes action as required.
- The collector checks specimen temperature within 4 minutes of receiving the specimen from the donor, and marks the appropriate temperature box in STEP 2. If temperature is outside the acceptable range, the collector enters a remark in STEP 2 and takes action as required.
- The 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.
- The collector determines the volume of specimen in the collection container. If the volume is acceptable, the collector proceeds with the testing. If the volume is less than required by the federal agency, the collector takes action as required, and enters remarks in STEP 2. If no specimen is collected by the end of the collection process, the collector checks the None Provided box, enters a remark in STEP 2, discards Copy 1 and distributes remaining copies as required.
- The collector checks the Split or Single specimen collection box. If the collection is observed, the collector checks the Observed box and enters a remark in STEP 2.
- The donor watches the 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).
- The collector dates the specimen bottle label(s)/seal(s) after placement on the specimen bottle(s).
- The donor initials the specimen bottle label(s)/seal(s) after placement on the specimen bottle(s).
- The 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 the donor refuses to sign the certification statement, the collector enters a remark in STEP 2 on Copy 1.
- The collector completes 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: The collector places Copy 1 in the leak-proof plastic bag. Electronic CCF: The 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, collection site name and contact information) on the outside of the bag.
- The collector seals the bag, prepares the specimen package for shipment, and distributes the remaining CCF copies as required.
Privacy Act Statement: (For Federal Employees Only)
Submission of the information on the Federal Drug Testing Custody and Control Form is voluntary. However, incomplete submission of the information, refusal to provide a specimen, or substitution or adulteration of a specimen may result in delay or denial of your application for employment/appointment or may result in removal from the federal service or other disciplinary action.
The authority for obtaining the specimen and identifying information contained herein is Executive Order 12564 (“Drug-Free Federal Workplace”), 5 U.S.C. Sec. 3301 (2), 5 U.S.C. Sec. 7301, and Section 503 of Public Law 100-71, 5 U.S.C. Sec. 7301 note. Under provisions of Executive Order 12564 and 5 U.S.C. 7301, test results may only be disclosed to agency officials on a need-to-know basis. This may include the agency Medical Review Officer (MRO), the administrator of the Employee Assistance Program, and a supervisor with authority to take adverse personnel action. This information may also be disclosed to a court where necessary to defend against a challenge to an adverse personnel action.
Submission of your SSN is not required by law and is voluntary. Your refusal to furnish your number will not result in the denial of any right, benefit, or privilege provided by law. Your SSN is solicited, pursuant to Executive Order 9397, for purposes of associating information in agency files relating to you and for purposes of identifying the specimen provided for testing. If you refuse to indicate your SSN, a substitute number or other identifier will be assigned, as required, to process the specimen.
Public Burden Statement
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control number for this project is 0930-0158. Public reporting burden for this collection of information is estimated to average: 5 minutes/donor; 4 minutes/collector; 3 minutes/test facility; and 3 minutes/Medical Review Officer. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to SAMHSA Reports Clearance Officer, 1 Choke Cherry Road, Room 2-1057, Rockville, Maryland, 20857.