dot urine specimen collector training manual revised

DOT URINE SPECIMEN COLLECTOR TRAINING MANUAL

Revised: January 2020

Joe Reilly & Associates, Inc.

www.joereilly.com

Collector Training of 137

http://www.joereilly.com/

TABLE OF CONTENTS

SECTION General Information Drug Testing Terminology — Terms You Need to Know Urine Specimen Collection Guidelines - Revised January 2018DOT Collector Training Required Reading Employer Collection Site Audit Brochure Differences Between HHS and Department of Transportation DOT CCF Instructions DOT Custody & Control Form (CCF) Sample Drug Testing Using eCCF Altering a Drug Testing CCF Form Non-DOT Urine Specimen Collections Non-DOT CCF Instructions Non-DOT Custody & Control Form Sample

Collector Training Frequently Asked Questions and Scenarios Final Remarks

Forms and Resources: • DOT 10 Steps Collection Site Security and Integrity• 23 STEPS TO DOT URINE SPECIMEN COLLECTION• Custody & Control Form (CCF)• DOT Direct Observation Procedures Instruction Sheet• Shy Bladder Log• Mock Collections Checklist


GENERAL INFORMATION

Welcome to the DOT URINE SPECIMEN COLLECTOR TRAINING MANUAL for DOT urine specimen collector training. It is very important that you read the entire manual in order to successfully complete your DOT urine specimen collector training.

The specimen collector is an essential person in any drug testing program. It is imperative the collector is properly trained and supervised. This collector’s manual will provide a collector with all the basic information necessary to assure a professional and correct collection.

There are several web links that you are required to follow. These will be sent to you via e-mail for easy click through, but they are also listed below. Please review them all.

DOT 49 CFR Part 40 Regulation https://www.transportation.gov/odapc/part40

Video: DOT’s 10 Steps to Collection Site Security and Integrity https://www.transportation.gov/odapc/collection-site-security-integrity-video

Video: DOT Mock Collection Video https://www.transportation.gov/sites/dot.dev/files/asset_videos/collection_video/OSTVideoPlayer3.htm

Urine Specimen Collection Handbook for Federal Agency Workplace Drug Testing Programs: https://www.samhsa.gov/sites/default/files/specimen-collection-handbook-2014.pdf

Collector Training Video. Please review in its entirety (1 hour and 14 minutes):

Collector Training DOT https://www.ndsadmin.com/collector-training/

The above link for DOT 49 CFR Part 40 regulation is critically important. To be permitted to act as a collector in the DOT drug testing program, you must meet each of the requirements as outlined in 49 CFR Part 40:

a) Basic information. You must be knowledgeable about 49 CFR Part 40, the current“DOT Urine Specimen Collection Procedures Guidelines,” and DOT agency regulationsapplicable to the employers for whom you perform collections. DOT agencyregulations, the DOT Urine Specimen Collection Procedures Guidelines, and othermaterials are available from the Office of Drug & Alcohol Policy & Compliance(ODAPC) and on the ODAPC web site (http://www.transportation.gov/odapc). Youmust keep current on any changes to these materials. You must subscribe to theODAPC list-serve at https://www.transportation.gov/odapc/get-odapc-eamil-updates.


https://www.transportation.gov/odapc/part40

https://www.transportation.gov/odapc/collection-site-security-integrity-video

https://www.transportation.gov/sites/dot.dev/files/asset_videos/collection_video/OSTVideoPlayer3.htm

https://www.transportation.gov/sites/dot.dev/files/asset_videos/collection_video/OSTVideoPlayer3.htm

https://www.samhsa.gov/sites/default/files/specimen-collection-handbook-2014.pdf

https://www.ndsadmin.com/collector-training/


https://www.transportation.gov/odapc/part40

http://www.transportation.gov/odapc

https://www.transportation.gov/odapc/get-odapc-email-updates


b) Qualification Training c) Initial Proficiency Demonstration – Mock Collections d) Refresher training at least every 5 years e) Error correction training after a fatal flaw, test cancelled f) Maintain documentation of your training, proficiency demonstration, any error

correction, and refresher training

The next section includes the following:

Drug Testing Terminology — Terms You Need to Know Urine Specimen Collection Guidelines (01/2018) DOT Collector Training Required Reading Employer Collection Site Audit Brochure Differences Between HHS and Department of Transportation


Drug Testing Terminology ‐ Terms You Need to Know

Term Description

49 CFR Part 382The drug and alcohol testing regulations of the FMCSA for carriers and commercial driver's license holders (CDL).

49 CFR Part 40

Known as the Code of Federal Regulations on Drug and Alcohol Testing; Issued by the Department of Transportation. Contains the DOT procedures for Transportation Workplace Drug Testing Programs.

Accession Number

A number assigned to each specimen by the laboratory. This number stays with the specimen it's entire lifetime. It is used to identify and track a specimen every step from the time it arrives to the laboratory until the result is reported.

Adulterated Specimen

A specimen that contains a substance that is not expected to be present in human urine, or contains a substance expected to be present but is at a concentration so high that it is not consistent with human urine.

AffidavitA form that must be signed by the collector to correct a problem on the original Chain of Custody form. For example, if the date was missing, incorrect, or the collector's signature was missing.

Air Blank In evidential breath testing devices (EBTs) using gas chromatography technology, a reading of the device's internal standard. In all other EBTs, a reading of ambient air containing no alcohol.

AlcoholThe intoxicating agent in beverage alcohol, ethyl alcohol or other low molecular weight alcohols, including methyl or isopropyl alcohol.

Alcohol ConcentrationThe alcohol in a volume of breath expressed in terms of grams of alcohol per 210 liters of breath as indicated by a breath test under this part.

Alcohol Confirmation TestA subsequent test using an EBT, following a screening test with a result of 0.02 or greater, that provides quantitative data about the alcohol concentration.

Alcohol Screening Device (ASD)A breath or saliva device, other than an EBT, that is approved by the National Highway Traffic Safety Administration (NHTSA) and placed on a conforming products list (CPL) for such devices.

Alcohol Screening Test (AST)An analytic procedure to determine whether an employee may have a prohibited concentration of alcohol in a breath or saliva specimen.

Alcohol Testing form (ATF) Form used for alcohol testing.

Alcohol Testing SiteA place selected by the employer where employees present themselves for the purpose of providing breath or saliva for an alcohol test.

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Alcohol UseThe drinking or swallowing of any beverage, liquid mixture or preparation (including any medication), containing alcohol.

Blind Specimen or Blind Performance Test Specimen

Blind specimen or blind performance test specimen. A specimen submitted to a laboratory for quality control testing purposes, with a fictitious identifier, so that the laboratory cannot distinguish it from an employee specimen.

Breath Alcohol Technician (BAT)A person who instructs and assists employees in the alcohol testing process and operates an evidential breath testing device.

Canceled Test

A drug or alcohol test that has a problem identified that cannot be or has not been corrected, or which this part otherwise requires to be cancelled. A cancelled test is neither a positive nor a negative test.

CDL Driver

Any permanent, probationary, temporary, or intermittent employee occupying a position in a job classification which requires possession of a CDL to operate a commercial motor vehicle; or commercial motor vehicle as a part of their assigned duties. For the purpose of pre‐employment testing/pre‐duty testing, the term CDL driver includes all prospective employees applying for positions requiring a valid CDL.

Chain of Custody (COC)

The procedure used to document the handling of the urine specimen from the time the employee gives the specimen to the collector until the specimen is destroyed. This procedure uses the Federal Drug Testing Custody and Control Form (CCF).

Clinic A medical facility that can be used as a collection site. Collection Container A container into which the employee urinates to provide the specimen for a drug test.

Collection SiteA place selected by the employer where employees present themselves for the purpose of providing a urine specimen for a drug test.

Collector

A person who instructs and assists employees at a collection site, who receives and makes an initial inspection of the specimen provided by those employees, and who initiates and completes the CCF.

Commercial Motor Vehicle (CMV)

A motor vehicle or combination of motor vehicles which: 1) has a gross combination weight of 26,001 or more pounds inclusive of a towed until with a gross vehicle weight rating of more than 10,000 pounds; 2) has a gross vehicle weight rating of 26,001 or more pounds; 3) is designed to transport 16 or more passengers, including the driver; or 4) is used in the transport of hazardous material requiring placards.

Confirmation Drug TestA second analytical procedure performed on a urine specimen to identify and quantify the presence of a specific drug or drug metabolite.

Confirmation Validity Test A second test performed on a urine specimen to further support a validity test result.



Confirmed Drug Test A confirmation test result received by an MRO from a laboratory.

Consortium/Third Party Administrator (C/TPA)

A service agent that provides or coordinates the provision of a variety of drug and alcohol testing services to employers. C/TPAs typically perform administrative tasks concerning the operation of the employers' drug and alcohol testing programs. This term includes, but is not limited to, groups of employers who join together to administer, as a single entity, the DOT drug and alcohol testing programs of its members. C/TPAs are not “employers” for purposes of this part.

Continuing Education

Training for medical review officers (MROs) and substance abuse professionals (SAPs) who have completed qualification training and are performing MRO or SAP functions, designed to keep MROs and SAPs current on changes and developments in the DOT drug and alcohol testing program.

Custody & Control Form (CCF)Form used for specimen collections for drug testing sometimes referred to as chain of custody form or COC.

Cutoff Level (Threshold)

The results of a test at or above the level are defined as positive, and the results below this level are called negative. The concentration of the resulted components is often much larger than the assay can detect.

DATIADrug & Alcohol Testing Industry Association ‐ industry association for the drug and alcohol testing industry, www.datia.org

Department of Transportation (DOT)

These terms encompass all DOT agencies, including, but not limited to, the United States Coast Guard (USCG), the Federal Aviation Administration (FAA), the Federal Railroad Administration (FRA), the Federal Motor Carrier Safety Administration (FMCSA), the Federal Transit Administration (FTA), the National Highway Traffic Safety Administration (NHTSA), the Pipeline and Hazardous Materials Safety Administration (PHMSA), and the Office of the Secretary (OST). These terms include any designee of a DOT agency.

Designated Employer Representative (DER)

An employee authorized by the employer to take immediate action(s) to remove employees from safety‐sensitive duties, or cause employees to be removed from these covered duties, and to make required decisions in the testing and evaluation processes. The DER also receives test results and other communications for the employer, consistent with the requirements of this part. Service agents cannot act as DERs.

Dilute Specimen A specimen with creatinine and specific gravity values lower than expected for human urine. Donor The person whom is subject to providing a specimen for drug testing



Double Collection Two separate urine specimens are collected.

Drug Free Workplace (DFW)

A substance abuse prevention program for employers that consists of five components: a written substance abuse policy, employee awareness & education, supervisor training, employee assistance plan, and finally drug & alcohol testing as appropriate.

Drug Metabolites A chemical that is released from the ingesting process. This is what is checked for in a drug screen. Particular substances produce particular metabolites.

Drug Test or Drug Screen

An examination of biologic material (such as urine, hair, saliva, or sweat) to detect the presence of specific drugs and determine prior drug use. Drug tests may be performed to detect illegal drug use as well as the use of drugs and substances not permitted in specific occupations or athletic competitions. Also known as a drug screen.

DrugsThe drugs for which tests are required under this part and DOT agency regulations are marijuana, cocaine, amphetamines, phencyclidine (PCP), and opiates.

Emit Screen (EIA)Enzyme immunoassay ‐ an immunoassay procedure used to identify drugs of abuse in urine by attaching an enzyme tag to the drug in question.

Employee

Any person who is designated in a DOT agency regulation as subject to drug testing and/or alcohol testing. The term includes individuals currently performing safety‐sensitive functions designated in DOT agency regulations and applicants for employment subject to pre‐employment testing. For purposes of drug testing under this part, the term employee has the same meaning as the term “donor” as found on CCF and related guidance materials produced by the Department of Health and Human Services.

Employee Assistance Program (EAP)

Services offered by employers to their employees to help them overcome problems that may negatively affect job satisfaction or productivity. Services may be provided on‐site or contracted through outside providers. They include counseling for alcohol dependence and drug dependence, marital therapy or family therapy, career counseling, and referrals for dependent care services.

Employee Awareness & Education

Employees are made aware of and receive education about the drug free workplace policy, responsibilities, consequences, alcohol and drug information, their rights and the resources available to them through the company and community if they (or one of their family members) need help.



Employer

A person or entity employing one or more employees (including an individual who is self‐employed) subject to DOT agency regulations requiring compliance with this part. The term includes an employer's officers, representatives, and management personnel. Service agents are not employers for the purposes of this part.

Error Correction Training

Training provided to BATs, collectors, and screening test technicians (STTs) following an error that resulted in the cancellation of a drug or alcohol test. Error correction training must be provided in person or by a means that provides real‐time observation and interaction between the instructor and trainee.

Evidential Breath Testing Device (EBT)

A device approved by NHTSA for the evidential testing of breath at the .02 and .04 alcohol concentrations, placed on NHTSA's Conforming Products List (CPL) for “Evidential Breath Measurement Devices” and identified on the CPL as conforming with the model specifications available from NHTSA's Traffic Safety Program.

FAA Federal Aviation AdministrationFMCSA Federal Motor Carrier Safety AdministrationFRA Federal Railroad AdministrationFTA Federal Transit Administration

Gas chromatography/mass spectrometry (GC/MS):

Gas chromatography/mass spectrometry. A specialized form of gas chromatography used in conjunction with mass spectrometry. GC/MS is considered the method of choice for the unequivocal identification of a drug. Also, when a laboratory suspects adulterants, dilution, or other sample abnormality, GC/MS will identify the exact chemicals compounds present in suspicious samples.

HHSThe Department of Health and Human Services or any designee of the Secretary, Department of Health and Human Services.

Initial Drug TestThe test used to differentiate a negative specimen from one that requires further testing for drugs or drug metabolites.

Initial Validity Test The first test used to determine if a specimen is adulterated, diluted, or substituted.

Invalid Drug Test

The result of a drug test for a urine specimen that contains an unidentified adulterant or an unidentified interfering substance, has abnormal physical characteristics, or has an endogenous substance at an abnormal concentration that prevents the laboratory from completing or obtaining a valid drug test result.



Laboratory (Lab)

Any U.S. laboratory certified by HHS under the National Laboratory Certification Program as meeting the minimum standards of Subpart C of the HHS Mandatory Guidelines for Federal Workplace Drug Testing Programs; or, in the case of foreign laboratories, a laboratory approved for participation by DOT under this part. (The HHS Mandatory Guidelines for Federal Workplace Drug Testing Programs are available on the internet at http://www.health.org/workpl.htm or from the Division of Workplace Programs, 1 Choke Cherry Road, Room 2‐1035, Rockville, MD 20857.)

Medical Review Officer (MRO)

A person who is a licensed physician and who is responsible for receiving and reviewing laboratory results generated by an employer's drug testing program and evaluating medical explanations for certain drug test results.

Monitored Collection

A collection whereby the collector or an observer is directly near the enclosed area for voiding the specimen and observes for sounds or other indications of an attempt to tamper with a specimen.

Negative Result

A result that indicates that the specimen did not exceed certain levels of drug metabolites. The average turn around time for a negative result is 24 hours from the time the laboratory receives the specimen, though this could vary.

Non Negative ResultA specimen identified at or above the screening test threshold but not yet subjected to confirmation testing.

Non‐DOT Drug Screen

A Non‐DOT screen is a screen that can test for a wide range of drug types. A standard five‐panel would include testing for Opiates, PCP, Amphetamines/Methamphetamines, Marijuana, and Cocaine, but can be expanded to add additional drug categories such as Barbiturates, Benzodiazepines, Methadone, Methaqualone, Propxyphene, etc.

Observed CollectionA witnessed collection whereby the collector or an observer witness the specimen going from the donor's body into the collection container.

Office of Drug and Alcohol Policy and Compliance (ODAPC)

The office in the Office of the Secretary, DOT, that is responsible for coordinating drug and alcohol testing program matters within the Department and providing information concerning the implementation of this part.

On‐SiteAt a client‐specified location (i.e., usually mobile services) client's site, or an agreed‐upon alternate location.

Point of care testing (POCT)This term refers to whenever drug testing is carried out directly beside or near the individual being tested, generally immediately after they have provided a sample for detection.



Positive ResultA result that indicates that the specimen exceeded certain drug or drug metabolite cutoff levels. It is usually sent to the MRO for review.

Post‐Accident Testing

Testing of an employee who is involved in an on‐the‐job accident (vehicular or otherwise) which may have involved human error and may have caused a fatality, serious injury, or significant property damage.

Pre‐Employment TestingA candidate for employment must pass the drug and/or alcohol test as a condition of employment

Primary Specimen

In drug testing, the urine specimen bottle that is opened and tested by a first laboratory to determine whether the employee has a drug or drug metabolite in his or her system; and for the purpose of validity testing. The primary specimen is distinguished from the split specimen, defined in this section.

Public Interest Exclusion (PIE)

A mechanism designed to protect the public from the affects of serious noncompliance by service agents. A service agent who engages in serious misconduct could be excluded from participating in DOT‐required drug and alcohol testing for a period of time.

Qualification Training

The training required in order for a collector, BAT, MRO, SAP, or STT to be qualified to perform their functions in the DOT drug and alcohol testing program. Qualification training may be provided by any appropriate means (e.g., classroom instruction, internet application, CD–ROM, video).

Random Testing

The testing of employees who are chosen for immediate testing randomly and without advance notice. USAMDT recommends that clients familiarize themselves with applicable state laws; some states prohibit random testing while others restrict it to “safety sensitive" positions.

Reasonable Suspicion/Cause Testing

The "cause" required is an objective, factual, individualized basis for testing, such as when an employee's observed behavior or physical appearance suggests drug and/or alcohol use or possession of drugs and/or alcohol.

Refresher Training

The training required periodically for qualified collectors, BATs, and STTs to review basic requirements and provide instruction concerning changes in technology (e.g., new testing methods that may be authorized) and amendments, interpretations, guidance, and issues concerning this part and DOT agency drug and alcohol testing regulations. Refresher training can be provided by any appropriate means (e.g., classroom instruction, internet application, CD–ROM, video).



Retest The testing at a second independent laboratory of the split specimen or a portion of the originalspecimen if a split was not collected.

Return‐to‐Duty/Follow Up Testing

Depending upon employer policy and applicable regulations, employees who fail a drug test may be required to undergo one or more return to duty drug tests before being allowed to return to the job. Follow up testing may be required for a period of time thereafter.

RSPA Research and Special Programs Administration (the pipeline industry)

Safety‐Sensitive Position

A position in which the normal or periodic job responsibilities of the employee entail, at some point and to some degree, a higher level of concern for the safety, health, and/or welfare of the employee in that position, his or her co‐workers, those who use our products or services, those who come onto or in contact with Company property, and the public at large [and for whom the illicit use of drugs and/or misuse of alcohol by the employee in that position could create a greater danger to the safety, health, and/or well‐being of those individuals]. 1 Drug Free Workplace

SAMHSA

Substance Abuse Mental Health Services Administration (formerly NIDA, National Institute of Drug Abuse) is the department of the federal government that regulates and certifies laboratories currently processing DOT specimens. Laboratories with the SAMHSA certification are also available to test Non‐DOT samples. These laboratories confirm all positive drug screen samples by GC/MS testing.

SAPAASubstance Abuse Program Administrators Association, industry association for substance abuse program administrators.

Screening testAn initial test that is used to detect drugs of abuse in urine. Screening tests are less expensive and not as accurate as confirmation tests.

Screening Test Technician (STT)A person who instructs and assists employees in the alcohol testing process and operates an ASD.



Security‐Sensitive Position

A position in which the normal or periodic job responsibilities of the employee entail, at some point and to some degree, access to cash, securities, bonds, or other negotiable instruments, and/or precious and/or valuable commodities; involve the use of, or access to, firearms and/or other weapons and/or armaments; involve protection of property, valuables, and/or individuals; relate to matters of national security, military, or law enforcement; and/or entail access to assets and/or information vital to, sensitive for, and/or with high proprietary interest to the Company [and for whom the illicit use of drugs and/or misuse of alcohol by the employee in that position could compromise the interests of the Company and/or any individual or entity affiliated to, or in contact with, the Company]. 1 Drug Free Workplace

Service Agent (SA)

Any person or entity, other than an employee of the employer, who provides services specified under this part to employers and/or employees in connection with DOT drug and alcohol testing requirements. This includes, but is not limited to, collectors, BATs and STTs, laboratories, MROs, substance abuse professionals, and C/TPAs. To act as service agents, persons and organizations must meet the qualifications set forth in applicable sections of this part. Service agents are not employers for purposes of this part.

Shipping ContainerA container that is used for transporting and protecting urine specimen bottles and associated documents from the collection site to the laboratory.

Shy Bladder refers to an individual who is unable to provide a sufficient specimen either upon demand.Specific Gravity The specific gravity of a substance is a comparison of its density to that of water

Specimen BottleThe bottle that, after being sealed and labeled according to the procedures in this part, is used to hold the urine specimen during transportation to the laboratory.

Specimen ID NumberEach CCF has a unique number assigned to the form and to the labels that get affixed to the specimen containers.

Split Specimen

In drug testing, a part of the urine specimen that is sent to a first laboratory and retained unopened, and which is transported to a second laboratory in the event that the employee requests that it be tested following a verified positive test of the primary specimen or a verified adulterated or substituted test result.



Stand‐Down

The practice of temporarily removing an employee from the performance of safety‐sensitive functions based only on a report from a laboratory to the MRO of a confirmed positive test for a drug or drug metabolite, an adulterated test, or a substituted test, before the MRO has completed verification of the test result.

Substance Abuse Policy

A well drafted policy outlines what type of testing will be conducted, the terms and definitions surrounding drug screening, and recourse for positive test results. A policy is also utilized to convey a strong message of zero tolerance towards drugs and alcohol in the workplace.

Substance Abuse Professional (SAP)A person who evaluates employees who have violated a DOT drug and alcohol regulation and makes recommendations concerning education, treatment, follow‐up testing, and aftercare.

Substituted SpecimenA specimen with creatinine and specific gravity values that are so diminished that they are not consistent with human urine.

Supervisor Training

Supervisors need to be trained in their role within the company's substance abuse program. They should receive training about the impact of alcohol and drugs on the workplace; how to recognize , document and confront a possible substance abuse problem; the company policy and procedures; how to refer a troubled employee to available resources and/or testing; and how to support an employee returning from treatment.

Temperature StripA strip that is used to determine whether or not the urine is in the 90‐100 degree range. This helps to ensure that tampering has not occurred.

USCG United States Coast Guard

Verified TestA drug test result or validity testing result from an HHS‐certified laboratory that has undergone review and final determination by the MRO.


Urine Specimen Collection Guidelines

United States Department of Transportation

Office of Drug and Alcohol Policy and Compliance

Revised January 2018


DOT Urine Specimen Collection Guidelines 2

Office of Drug and Alcohol Policy and Compliance Revised – January 2018

DOT Urine Specimen Collection Guidelines

for the

U.S. Department of Transportation Workplace

Drug Testing Programs (49 CFR Part 40)

Revised January 2018 [previous editions become obsolete].

These guidelines apply only to employers and individuals who come under the regulatory authority of the U.S. Department of Transportation (DOT) and those individuals who conduct urine specimen collections under DOT regulations. The term “employee” is used throughout this document and has the same meaning as “donor” as used on the Federal Drug Testing Custody and Control Form (CCF).

These guidelines are a complete revision of the DOT Urine Specimen Collection Procedures Guidelines, 49 CFR Part 40, for Transportation Workplace Drug Testing Programs.

It contains minimal graphics and formatting to ease transmission and downloading of the document from the Internet.

All information appearing in these guidelines is in the public domain and may be used or reproduced without permission from DOT or others. Citation of the source is appreciated.

This document may be updated or modified based on additional interpretations or other procedural changes. Collectors and service agents should check the ODAPC web site periodically to ensure that they have the latest version: www.dot.gov/odapc .


http://www.dot.gov/ost/dapc



INTRODUCTION The Department of Transportation's (DOT) Operating Administrations – Federal Aviation Administration, Federal Motor Carrier Safety Administration, Federal Railroad Administration, Federal Transit Administration, Pipeline and Hazardous Materials Safety Administration – and United States Coast Guard (now with the Dept. of Homeland Security) have issued regulations requiring anti-drug programs in the aviation, highway, railroad, transit, pipeline, and maritime industries. The DOT Agencies' rules require that employers conduct drug testing according to provisions of 49 CFR Part 40, "Procedures for Transportation Workplace Drug Testing Programs."

The procedures for collection of urine under these rules are very specific and must be followed whenever a DOT-required urine specimen collection is performed. (The only exception is the Federal Railroad Administration's Post-Accident Toxicological Testing Program in which a railroad representative will provide the collector specific instructions and a testing kit.) These procedures, including use of the Federal Drug Testing Custody and Control Form (CCF), apply only to DOT-required testing.

While employers may use our collection and testing procedures for testing under employer or state authority, they must not use a Federal CCF, nor can they imply that company tests are conducted using DOT authority.

The collector has a major role in the success of the DOT’s drug testing program. The collector is the one individual in the testing process with whom all employees have direct, face-to-face contact. Without the collector assuring the integrity of the specimen and collection process, the test itself may lose validity. Without the collector's sensitivity to an employee's privacy, the entire testing program may be subject to criticism. It is imperative that collectors fully understand and follow these procedures. These guidelines, together with 49 CFR Part 40 and the DOT operating administrations' rules, will provide collectors with the information needed in the performance of their collection duties.

The information in this document addresses and provides guidance concerning normal collection procedures and some of the more common problems or situations encountered. However, information contained in this publication should not be used to interpret or be viewed as adding to or modifying the legal requirements of the actual rule.




TABLE OF CONTENTS

SECTION 1. COLLECTOR ............................................................................................................... 5

SECTION 2. COLLECTION SITE .................................................................................................... 6

SECTION 3. COLLECTION SUPPLIES ........................................................................................... 7

SECTION 4. FEDERAL DRUG TESTING CUSTODY AND CONTROL FORM .......................... 8

SECTION 5. INFORMATION EMPLOYERS PROVIDE TO COLLECTORS ............................ 10

SECTION 6. EMPLOYEE IDENTIFICATION ............................................................................... 10

SECTION 7. COLLECTION PROCEDURES ................................................................................. 11

SECTION 8. SHY BLADDER PROCEDURES .............................................................................. 20

SECTION 9. DIRECTLY OBSERVED COLLECTIONS ............................................................... 22

SECTION 10. MONITORED COLLECTIONS ............................................................................... 24

SECTION 11. PROBLEM COLLECTIONS .................................................................................... 25

SECTION 12. CORRECTING COLLECTION PROBLEMS......................................................... 28

APPENDIX A – TRAINING REQUIREMENTS FOR COLLECTORS ......................................... 30

APPENDIX B – COLLECTION SITE SECURITY AND INTEGRITY ......................................... 32

APPENDIX C – DOT STANDARDS FOR URINE COLLECTION KITS .................................... 33

APPENDIX D – DIRECT OBSERVATION PROCEDURES ......................................................... 35

APPENDIX E – QUESTIONS AND ANSWERS ............................................................................ 36

APPENDIX F – OPERATING ADMINISTRATIONS’ RULES (SUMMARY) ............................ 36




SECTION 1. COLLECTOR

Part 40 defines a collector as a trained person who instructs and assists employees at a collection site, who receives and makes an initial inspection of the urine specimen provided by those employees, and who initiates and completes the Federal Drug Testing Custody and Control Form (CCF).

Note: DOT does not require or provide collector certification. Collectors need to have documentation reflecting that they have met appropriate training requirements at Appendix A.

Any individual, who has received training specified in 49 CFR Part 40 (§40.33) for conducting the required collection procedure, may serve as a collector except in the following situations:

1. The immediate supervisor of a particular employee may not act as the collector when that employee is tested, unless no other collector is available and the supervisor is permitted to do so under a DOT operating administration’s drug and alcohol regulation. (The immediate supervisor may act as a monitor or observer (same gender) if there is no one else available at the collection site to conduct a monitored or observed collection.);

2. An employee who is in a safety-sensitive position and subject to the DOT drug testing rules should not be a collector, an observer, or a monitor for co-workers who are in the same testing pool or who work together with that employee on a daily basis. This is to preclude any potential appearance of collusion or impropriety;

3. An individual working for an HHS-certified drug testing laboratory (e.g., as a technician or accessioner) may not act as a collector if that individual can link the employee with the specimen drug test result or laboratory report; and,

4. The employee may not be the collector of his or her own urine specimen.

Note: To avoid a potential conflict of interest, a collector should not be someone that is related to the employee (e.g., spouse, ex-spouse, relative) or a close personal friend (e.g., fiancée).

A collector should have appropriate identification, which includes the collector’s name and the name of the Collection Company or clinic. The collector is required to provide his or her identification if requested by the employee. There is no requirement for the collector to have a picture I.D. or to provide his or her driver's license with an address or telephone number. Also, the collector is not required to provide any certification or other documentation to the employee documenting the collector's training. However, the collector must provide this documentation on request to DOT agency representatives and to employers and service agents (SA) or Consortium/Third Party Administrators (C/TPAs) who are using or negotiating to use that collector’s services.

The employer must provide the collector with the name and telephone number of the appropriate Designated Employee Representative (DER) and C/TPA, where applicable, to contact about any problems or issues that may arise during the collection process.




SECTION 2. COLLECTION SITE

A collection site is a place (permanent or temporary) selected by the employer where employees present themselves for the purpose of providing a urine specimen for a DOT-required drug test.

Generally, there are two types of collection facilities:

1. A single-toilet restroom, with a full-length privacy door, or

2. A multi-stall restroom, with partial-length doors.

A collection site must have:

1. A restroom or stall with a toilet for the employee to have privacy while providing the urine specimen. Whenever available, a single toilet restroom, with a full-length privacy door, is preferred. All types of restrooms including a mobile facility (e.g., a vehicle with an enclosed toilet) are acceptable.

2. A source of water for washing hands that, if practical, is external to the restroom where urination occurs. If the only source of water available is inside the restroom, the employee may wash his or her hands, and then the collector must secure the water source (e.g., use tamper-evident tape, cut off the water supply) before the collection takes place. If water is not available at the collection site, the collector may provide moist towelettes outside the restroom.

3. A suitable clean surface for the collector to use as a work area and for completing the required paper work.

A second type of facility for urination, which can be used as a collection site, is a multi-stall restroom. Such a site must provide substantial visual privacy (e.g., a toilet stall with a partial- length door) and meet all other requirements listed above (2 and 3). Additionally, if a multi-stall restroom is used, the collector must either:

1. Secure all sources of water and other substances that could be used for adulteration and substitution (e.g., water faucets, soap dispensers) and place bluing agent in all toilets or secure the toilets to prevent access; or

2. Conduct all collections as monitored collections (See Section 10).

No one but the employee may be present in the multi-stall restroom during the collection, except the monitor in the event of a monitored collection or the observer in the event of a directly observed collection.

Note: The collector’s work area may be located outside the restroom. However, if there is no appropriate space available outside the restroom to serve as a secure, clean work area and the restroom is either a multi-stall facility or a single stall facility with a partial door for privacy, and is large enough to accommodate a work area, the collector may locate the work area inside the restroom as long as all procedures for a monitored collection are met.




All collection sites must meet the requirement of §40.43 including the following security requirements:

1. Procedures or restrictions to prevent unauthorized access to the site during the collection;

2. Procedures to prevent the employee or anyone else from gaining unauthorized access to the collection materials/supplies. The collector must also ensure that the employee does not have access to items that could be used to adulterate or dilute the specimen (e.g., soap, disinfectants, cleaning agents, water);

Note: See “DOT’s 10 Steps to Collection Site Security and Integrity” at Appendix B.

3. Procedures to ensure that all authorized persons are under the supervision of a collector or appropriate site personnel at all times when permitted into the site; and,

4. Procedures to provide for the secure handling and storage of specimens.

Note: The testing site is that portion of the facility where the collector performs the paper work, seals the specimens, and where urination occurs. It does not necessarily include the total physical facility (e.g., clinic). Additionally, unauthorized personnel are any individuals that are not specifically authorized by the regulation, the collector, or employer to be present at the collection site.

SECTION 3. COLLECTION SUPPLIES

The following items must be available at the collection site in order to conduct proper collections:

1. For each DOT drug test, a collection kit meeting the requirements listed at Appendix C of these guidelines.

2. Federal Drug Testing Custody and Control Forms (CCF).

3. Bluing (coloring) agent to add to the toilet bowl/water tank to prevent an employee from diluting the specimen.

4. The collector should have available tamper-evident tape for securing faucets, toilet tank tops, and other appropriate areas, and signs, when necessary, that can be posted to prevent entry into collection areas.

Note: Single use disposable gloves are recommended for use by collectors while handling specimens.




SECTION 4. FEDERAL DRUG TESTING CUSTODY AND CONTROL FORM

The CCF must be used to document every urine collection required by the DOT drug testing program. The CCF must be a five-part carbonless manifold form. This form may be viewed on the DOT web site [ http://www.dot.gov/odapc/ ] or the Department of Health and Human Services (HHS) web site [ http://workplace.samhsa.gov/ ]. CCFs are also available from a number of different sources (e.g., laboratories, service agents) although they are usually part of the urine collection kits provided by a laboratory.

The CCF consists of the following five copies:

Copy 1. Test Facility Copy - accompanies the specimen to the laboratory Copy 2. Medical Review Officer Copy - sent to the MRO Copy 3. Collector Copy - retained by the collector Copy 4. Employer Copy - sent to the employer Copy 5. Employee Copy - given to the employee

The CCF is completed as follows:

Step 1 (Copy 1). This step is completed by the collector or employer representative prior to the employee providing a urine specimen. The employer and MRO names, addresses, and telephone and fax numbers may be preprinted or handwritten. If the employer has designated a service agent to receive the results from the MRO, the employer’s address may be omitted and the service agent’s address may be used. However, in all cases, the specific employer’s name, telephone and fax numbers must be included. A clinic or collection site name may not be used in lieu of an employer name. The collector enters the employee’s social security number or employee’s ID number after verifying the employee’s identity. The collector also marks the appropriate box to indicate the reason for the test and the appropriate box for the type of drug tests to be performed (all DOT drug tests are for five drugs). The collector is to check the DOT Agency whose authority the specimen is collected. For example, if the employee’s specimen is collected under the authority of the Federal Motor Carrier Safety Administration (FMCSA) regulation, the collector would check the “DOT” and “FMCSA” boxes. The collector then enters the information required for the collection site (this information may also be preprinted).

The collector’s telephone number is critical, since the laboratory or the MRO may need to contact the collector if they have questions related to a collection.

Step 2 (Copy 1). This step is completed by the collector after receiving the specimen from the employee and observing the temperature of the specimen. This step requires the collector to mark the appropriate box to indicate if the temperature of the specimen is within the required temperature range. This step also requires the collector to indicate whether it is a split specimen or single specimen collection, to indicate if no specimen was collected and why, and to indicate if it was an observed collection and why.

Note: Because all DOT collections are split specimen collections, the collectors should ALWAYS check the split specimen box.


http://www.dot.gov/ost/dapc/

http://workplace.samhsa.gov/



Step 3 (Copy 1). This step instructs the collector to seal and date the specimen bottles, to date the bottles seals after placing them on the bottles, to have the employee initial the bottle seals after placing them on the bottles, and then instruct the employee to complete step 5 on the MRO copy (Copy 2).

Step 5 (Copy 2). This step is completed by the employee (listed as donor on the CCF). The employee reads the certification statement, prints his or her name, provides date of birth, daytime and evening telephone numbers, date of collection, and signs the form. After the employee completes this portion of the CCF, the collector reviews it to ensure that all the required information was provided.

Step 4 (Copy 1). This step is initiated by the collector and then completed by the laboratory after the laboratory accessions the specimen. This step requires the collector to sign the form to certify that the specimen was collected, labeled, sealed, and released for shipment to the laboratory in accordance with Federal requirements. The collector is also required to note the time of the collection, the date of collection, and the specific name of the delivery service to whom the specimen is released for shipment to the laboratory.

Note: There is no requirement for couriers, express carriers, or postal service personnel to add additional documentation to the chain of custody for the specimens during transit because they do not have direct access to the specimens or the CCF. Chain of custody annotations resume when the shipping container/package is opened and accessioned at the laboratory.

Step 5(a) (Copy 1). This step is completed by the laboratory to report the test result of the primary specimen.

Step 5(b) (Copy 1). This step is completed by the laboratory to report the test result of the split specimen if the split specimen is tested.

Step 6 (Copy 2). This step is completed by the MRO in reporting the results of the primary specimen to the employer.

Step 7 (Copy 2). This step is completed by the MRO in reporting the results of the split specimen to the employer.

The bottom area of Copy 1 is reserved for the tamper-evident specimen bottle seals/labels. There must be two seals/labels to accommodate collecting split specimens (i.e., one marked with the letter "A" to designate the primary specimen and the other marked with the letter "B" to designate the split specimen) to accommodate collecting split specimens.

Note: No one (including collection site personnel or the collector) is permitted to require an employee to sign a consent, release, or waiver of liability, or indemnification agreement with respect to any part of the drug testing process. Collection sites (clinics) may not use “generic” consent forms for DOT-required urine specimen collections, even if their clinic policy requires consent from the general patient population.




SECTION 5. INFORMATION EMPLOYERS PROVIDE TO COLLECTORS

49 CFR Part 40 requires the employer or its service agent – for example a C/TPA -- to ensure the collector has the following information when conducting a urine specimen collection for it:

(a) Full name of the employee being tested.

(b) Employee SSN or ID number.

(c) Laboratory name and address (can be pre-printed on the CCF).

(d) Employer name, address, phone number, and fax number (this can be pre-printed on the CCF at Step 1-A).

(e) DER name and telephone number (and C/TPA, where applicable).

(f) MRO name, address, phone number, and fax number (can be pre-printed on the CCF at Step 1-B).

(g) The DOT Agency that regulates the employee’s safety-sensitive duties (the checkmark can pre-printed in the appropriate box on the CCF at Step 1-D)

(h) Test reason, as appropriate: Pre-employment; Random; Reasonable Suspicion/Reasonable Cause; Post-Accident; Return-to-Duty; and Follow-up.

(i) Whether the test is to be observed or not [see 40.67(a) & (b)].

(j) (Optional) C/TPA name, address, phone, and fax number (can be pre-printed on the CCF).

SECTION 6. EMPLOYEE IDENTIFICATION

The employee must provide appropriate identification to the collector at the outset of the collection process. Acceptable forms of identification include:

1. A photo identification (e.g., drivers license, employee badge issued by the employer,

or any other picture identification issued by a Federal, state, or local government agency), or

2. Identification by an employer or employer representative, or 3. Any other identification allowed under an operating administration’s rules.

Note: If the employee cannot produce positive identification, the collector must contact a DER to verify the identity of the employee. The collection should not proceed until positive identification is obtained. However, if an owner/operator or other self-employed individual does not have proper identification, the collector should record in the remarks section that positive identification is not available. The owner/operator or other self-




employed individual should be asked to provide two items of identification bearing his/her signature. The collector then proceeds with the collection. When the donor signs the certification statement, the collector should then compare the signature on the CCF with the signatures on the identification provided previously by the owner/operator or other self-employed individual. If the signatures appear consistent, the collection process continues. If the signature does not match signatures on the identification presented, the collector should make an additional note in remarks section stating "signature identification is unconfirmed."

Unacceptable forms of identification include:

1. Identification by a co-worker,

2. Identification by another safety-sensitive employee,

3. Use of a single non-photo identification card (e.g., social security card, credit card, union or other membership cards, pay vouchers, voter registration card), or

4. Faxed or photocopies of identification document.

SECTION 7. COLLECTION PROCEDURES

The collector must do the following before each collection to deter potential tampering, adulteration, alteration, or substitution of the specimens:

1. Secure any water sources or otherwise make them unavailable to employees (e.g., turn off water inlet, tape handles to prevent opening faucets);

2. Ensure that the water in the toilet and tank (if applicable) has bluing (coloring) agent in it. Tape or otherwise secure shut any movable toilet tank lid, or put bluing in the tank;

3. Ensure that no soap, disinfectants, cleaning agents, or other possible adulterants are present;

4. Inspect the site to ensure that no foreign or unauthorized substances are present;

5. Ensure that undetected access (e.g., through a door or window not in your view) is not possible;

6. Secure areas and items (e.g., ledges, trash receptacles, paper towel holders, under-sink areas, dropped ceilings) that appear suitable for concealing contaminants; and

7. Recheck items (1) through (6) following each collection to ensure the site’s continued integrity.

If the collection site uses a facility normally used for other purposes, such as a public restroom or hospital examining room, the collector must also ensure before the collection that:




1. Access to collection materials and specimens is effectively restricted; and 2. The facility is secured against access during the procedure to ensure privacy to the employee and prevent distraction of the collector. Limited-access signs must be posted.

Note: See “DOT’s 10 Steps to Collection Site Security and Integrity” at Appendix B.

To avoid distraction that could compromise security, the collector is limited to conducting a collection for only one employee at a time. However, during the 3 hour waiting period that an employee can consume fluids (shy bladder), the collector may conduct a collection for another employee. In this case, the employee with the shy bladder must be monitored to ensure the continued integrity of the test (see Section 8).

When a specific time for an employee's test has been scheduled, or the collection site is at the employee’s work site, and the employee does not appear at the collection site at the scheduled time, the collector must contact the DER to determine the appropriate interval within which the DER has determined the employee is authorized to arrive. If the employee's arrival is delayed beyond that time, the collector must notify the DER that the employee has not reported for testing.

Note: For a pre-employment test, if an employee fails to appear, fails to provide a urine specimen, or fails to remain at the collection site, this is not considered a refusal provided the employee left the testing site or did not provide a specimen before the testing process commenced (i.e., the employee was given the collection kit or cup by the collector).

Note: There is no requirement for a collector to inform the employee that failure to remain at the collection site or otherwise fails to cooperate with the testing process constitutes a refusal. It is a best practice for the collector to inform the employee that such behavior could lead an employer to determine that a refusal occurred.

The following steps describe a typical urine collection conducted under the DOT-mandated procedures:

1. The collector prepares the collection site to collect urine specimens. All collection supplies must be available, the area properly secured, water sources secured, and bluing (coloring) agent placed in all toilets as required by Part 40 and reiterated in Sections 2 and 3 of these guidelines.

2. The collector begins the collection without delay after the employee arrives at the collection site. Do not wait because the employee is not ready or states he or she is unable to urinate. In most cases, employees who state they cannot provide a specimen will, in fact, provide sufficient quantity to complete the testing process.

Note: If an alcohol breath test is also scheduled, the alcohol test should be conducted first, if practicable, though the rule (§40.61(b)(1)) example suggests some situations where there can be an exception to this normal process.

3. The collector requests the employee to present an acceptable form of identification. If the employee cannot produce positive identification, the collector must contact the DER to verify the identity of the employee (see Section 6 for further guidance). If the employee asks the collector




to provide identification, the collector must show the employee some form of identification. It must include the collector’s name and the name of the collector’s employer. It does not have to be picture identification or include the collector’s home address or telephone number.

4. The collector explains the basic collection procedures to the employee and shows the employee the instructions on the back of the CCF.

5. The collector ensures that the required information is provided at the top of the CCF (the laboratory name and address and a pre-printed specimen ID number which matches the ID number on the specimen bottle seals). If the information is not already preprinted, the collector begins entering the required information in Step 1 of the CCF:

- Employer's name, address, telephone and fax number, and I.D. number (if

applicable); - MRO name, address, telephone and fax number; - Employee SSN or employee ID number (refusal by the employee to provide a SSN is

not a refusal to test, but requires the collector to annotate this in the remarks section); - Reason for test; - Drug test to be performed; and - Collection site information.

Note: Part 40 requires a specific MRO's name and address on the CCF rather than the name of the clinic or medical facility. An employer must provide to the collector the name and telephone number of the appropriate DER. This may be part of the CCF information that is pre-printed or may be separately documented. If there is no employer or DER telephone number on the CCF, the collector should write in the DER name and telephone number on the CCF (if this information is available) so that either the collector or the MRO may get in touch with a company representative when any problems arise related to that specimen.

Note: The CCF may be pre-printed with the DOT and Agency designation boxes already checked. If it is not, the employer must ensure the collector has this information.

6. The collector directs the employee to remove any unnecessary outer clothing (e.g., coat, jacket, hat, etc.) and to leave any briefcase, purse, or other personal belongings he or she is carrying with the outer clothing. The employee may retain his or her wallet. If the employee asks for a receipt for any belongings left with the collector, the collector must provide one.

Note: To safeguard employee’s belongings, procedures may be established where the belongings are locked (at the collection site or in the bathroom) or other alternate methods may be developed. For example, if an employee comes to the collection site with his or her medications and desires that the collector secure the medication, the collector may place the medication in a locked cabinet, if available, or alternately, could seal the medication in an envelope, secure the envelope with tamper-evident tape and retain the envelope in a secure place.




Note: The collector may encourage the employee to also leave, with his or her other belongings, any other items that the employee will not need or may be prohibited from carrying into the restroom.

Note: The employee must not be asked to remove other articles of clothing, such as shirt, pants, dress, or under garments. Additionally, the employee must not be requested or required to remove all clothing in order to wear a hospital or examination gown. An exception may be made, if the employee is also undergoing a physical examination authorized by a DOT operating administration’s rule, in conjunction with the drug test, which normally includes wearing a hospital gown. Work boots or cowboy boots do not have to be removed unless the collector has a reason to suspect that the employee has something in them that may be used to adulterate or substitute a specimen. When an employee is asked to remove his or her hat or head covering, and refuses to do so based on religious practice, the collector may exempt the employee from removal of the head covering, unless the collector has an observable indicator that the employee is attempting to hide inside the head covering adulterants or other substances which may be used in an attempt to adulterate or substitute a specimen.

7. The collector directs the employee to empty his or her pockets and display the items to ensure that no items are present that could be used to adulterate the specimen. If nothing is there that can be used to adulterate a specimen, the employee places the items back into the pockets and the collection procedure continues. If the employee refuses to empty his or her pockets, this is considered a refusal to cooperate in the testing process.

Note: If an item is found that appears to have been brought to the collection site with the intent to adulterate the specimen, a directly observed collection procedure becomes a requirement. If the item appears to be inadvertently brought to the collection site, secure the item and continue with the normal collection procedure. For example, a bottle of eye drops may have been brought inadvertently and would have to be secured by the collector and the collection would proceed. However, a bottle of liquid or urine would suggest intent to tamper with the specimen and a directly observed collection would be required. Whatever the employee brings into the collection site, the collector should return it to the employee at the end of the collection. Items, such as suspected urine, plastic bags with fluid in them, artificial or mechanical objects for providing substituted urine, etc., should be fully described in an attached memorandum for record, copies of which should be sent to the MRO and the employer.

8. The collector instructs the employee to wash and dry his or her hands, under the collector's observation, and informs the employee not to wash his or her hands again until after the employee provides the specimen to the collector. The employee must not be allowed any further access to water or other materials that could be used to put into the specimen. If the employee refuses to wash his or her hands – after being directed to do so – this is a refusal to test.

Note: The employee may use soap and, if practicable, it should be a liquid or cream. A solid bar of soap gives the employee the chance to conceal soap shavings under his or her fingernails and subsequently use them to attempt to adulterate the specimen.




9. The collector either gives to the employee or allows the employee to select the collection kit or collection container (if it is separate from the kit) from the available supply. Either the collector or the employee, with both present, then unwraps or breaks the seal of the kit or collection container.

Note: Ensure the employee takes only the collection container into the room used for urination. The sealed specimen bottles remain with the collector.

Note: Even if the collection kit is sealed, the collection container must still be sealed or individually wrapped in a plastic bag or shrink wrapping; or must have a peelable, sealed lid or other easily visible tamper-evident system. Do not unwrap or break the seal on any specimen bottle at this time. Unwrap only the collection container.

10. The collector directs the employee to go into the room used for urination, provide a specimen of at least 45 mL, not to flush the toilet, and return with the specimen as soon as possible after completing the void. (In many restrooms, a toilet tank into which bluing agent may be placed is not accessible to the collector. When the employee flushes the toilet, he or she can use the clear (un-blued) water to potentially dilute the specimen. Inadvertently flushing the toilet does not automatically require any corrective action by the collector or a recollection. However, to guard against this action, the collector may want to place a card with instructions not to flush by the toilet handle or tape or otherwise secure the handle with tamper-evident tape.) The collector may set a reasonable time limit for the employee to be inside the bathroom and this time frame should be explained to the employee.

Note: The collector should also tell the employee that the temperature of the specimen is a critical factor and that the employee should bring the specimen to the collector as soon as possible after urination. The collector should inform the employee that if it is longer than 4 minutes from the time the employee urinates into the container and the collector takes the specimen temperature, the potential exists that the specimen may be out of range and an observed collection may be required.

Note: The collector must pay close attention to the employee during the entire collection process to note any conduct that clearly indicates an attempt to substitute or adulterate a specimen. If the collector detects such conduct, the collector must complete the collection and immediately begin a new collection under direct observation using a second CCF and a new kit. The collector then provides an appropriate comment on the "Remarks" line in Step 2 on the first CCF and second CCF indicating that this is the first of two or second of two (i.e., 1 of 2, 2 of 2) collections, the specimen ID numbers of the first and second CCF, the reason for the second collection, and that the second collection was conducted under direct observation (check appropriate box in Step 2 of the CCF). This will ensure that the laboratory and the MRO know that two separate specimens are being submitted for testing; the first one possibly being adulterated or substituted. Additionally, the collector must inform the collection site supervisor and the DER that a collection took place under direct observation and the reason for having done so.

11. After the employee gives the specimen to the collector, the collector must check the temperature of the specimen, check the specimen volume, and inspect the specimen for adulteration or substitution, as described below:




- The collector should check the temperature of the specimen as soon as the employee hands over the specimen, but no later than four minutes after the employee comes out of the restroom. The acceptable temperature range is 32°-38°C/ 90°-100°F. Temperature is determined by reading the temperature strip originally affixed to or placed on the outside of the collection container. If the temperature is within the acceptable range, the "Yes" box is marked in Step 2 on the CCF and the collector proceeds with the collection procedure. (If the temperature is out of range, the collector marks the “No” box in Step 2 and initiates an observed collection.)

- The collector then checks to make sure that the specimen contains a sufficient amount

of urine (a minimum of 45 mL for all DOT collections). If the volume is sufficient, the collector checks the box on the CCF (Step 2) indicating that this was a split specimen collection. (This may be done at the same time that the collector checks the temperature box.)

- The collector must inspect the specimen for unusual color, presence of foreign objects

or material, or other signs of tampering or adulteration. If it is apparent from this inspection that the employee has adulterated or substituted the specimen (e.g., the specimen is blue, exhibits excessive foaming when shaken, has smell of bleach), a second collection using direct observation procedures must be conducted immediately.

If the temperature is outside the acceptable range, the volume is less than 45 mL, or the specimen may have been adulterated, the collector follows procedures in Section 11- Problem Collections.

12. After the employee hands the collection container to the collector, the collector unwraps or opens the specimen bottles. (The employee may be permitted to do this, however, the recommended “best practice” is for the collector to perform this procedure.) Bottles may be shrink-wrapped or secured by other easily discernable tamper-evident methodology and may be wrapped separately or together.

Note: Both the collector and employee will maintain visual contact of the specimen to the greatest extent possible until the labels/seals are placed over the specimen bottle caps/lids. If practical, the collector may permit the employee to wash his or her hands right after the employee gives the collection container to the collector (and the collector checked the temperature), provided the employee and the collector can still maintain visual control of the specimen collection container.

Note: The following are considered refusals to test:

• The employee admits to the collector that he or she adulterated or substituted

their specimen.

• The employee behaves in a confrontational way that disrupts the collection process.

In either of these refusal situations, the collector discards any specimen the employee provided previously and notifies the DER as soon as possible.




13. The collector, not the employee, then pours at least 30 mL of urine from the collection container into a specimen bottle and places the lid/cap on the bottle. This will be the primary specimen or "A" bottle. The collector, not the employee, then pours at least 15 mL into a second bottle and places the lid/cap on the bottle. This will be the "B" bottle used for the split specimen. (The collector may first pour the requisite amount of specimen into each bottle and then secure the lids/caps on each bottle.)

Note: The collector should not fill the primary or split specimen bottle up to the cap because a completely full bottle is more likely to leak in transit. Additionally, when a split specimen bottle is full and subsequently frozen, it may cause the bottle material to crack and then leak during transit as the specimen thaws.

14. The collector, not the employee, must then remove the tamper-evident seals from the CCF and place them on each bottle. The collector should also ensure that the seal labeled as “A” is placed on the primary bottle with at least 30 mL of urine and that the seal labeled as “B” is placed on the bottle with at least 15 mL of urine. The seal must be centered over the lid/cap and down the sides of the bottle to ensure that the lid/cap cannot be removed without destroying the seal. The collector, not the employee, writes the date on the seals. The employee is then requested to initial the seals. The employee must be present to observe the sealing of the specimen bottles. If the employee fails or refuses to initial the seals, the collector must note this in the “Remarks” line of the CCF and complete the collection process; this is not considered a refusal to test.

Note: The collector must not ask the employee to initial the labels/seals while they are still attached to the CCF; they must be initialed after they are placed on the bottles. The collector should also inform the employee to use care during the initialing process to avoid damaging the labels/seals.

Note: Occasionally, the tamper-evident label/seal provided with the CCF will not properly adhere to the specimen bottle because of environmental conditions (e.g., moisture, temperature, specimen bottle material) or may be damaged or broken during the collection process. When this occurs, the collector should use the following corrective procedures:

(a) If the seal is broken while being removed from the chain of custody form or during

the application of the first seal on the primary bottle, the collector should transfer the information to a new CCF and use the seals from the second form.

(b) If one seal is already in place on a bottle and the second seal is broken while being

removed from the CCF or is broken during application on the second bottle or while the employee is initialing either seal, the collector should initiate a new CCF and provide an appropriate comment on the “Remarks” line in Step 5. The seals from the second CCF should be placed perpendicular to the original seals to avoid obscuring information on the original seals and must be initialed by the employee (both sets of employee initials should match). The collector should draw a line through the Specimen ID number and bar code (if present) on the original seals to ensure that the




laboratory does not use that number for reporting the results. The collector should not pour the specimen into new bottles.

(c) In both cases, the collector should ensure that all copies of the original (first) CCF are destroyed or disposed of properly (e.g., shredded, torn into pieces).

(d) If the collector inadvertently reverses the seals (i.e., places the “A” bottle seal on the split bottle and vise-versa) and the collector subsequently notices this, the collector should note this in the “Remarks” line and continue the collection process. Laboratories have procedures that permit them to “re-designate” the bottles.

Note: There is no corrective procedure available if the seal is broken after the employee leaves the collection site.

Note: Since the specimen bottle is now sealed with tamper-evident tape and does not have to be under the employee's direct observation, the employee is allowed to wash his or her hands if he or she desires to do so.

15. The collector directs the employee to read, sign, and date the certification statement, and provide date of birth, printed name, and day and evening contact telephone numbers in Step 5 of Copy 2 of the CCF.

Note: If the employee refuses to sign the form or provide date of birth, printed name, or telephone numbers, the collector must make a notation on the "Remarks" line to that effect and complete the collection. If the employee refuses to fill out any information, the collector must, as a minimum, print the employee’s name in the appropriate place. This does not constitute a refusal to test.

16. The collector completes the collector’s portion in Step 4 on the CCF (Copy 1) by printing his or her name (the name may be pre-printed), recording the date and time of the collection, signing where indicated, and entering the specific name of the delivery or courier service transferring the specimens to the laboratory.

17. The collector then ensures that all copies of the CCF are legible and complete. The collector removes Copy 5 from the CCF and gives it to the employee.

Note: At this time, the collector can suggest that the employee list any prescription and over-the-counter medications he or she may be taking on the employee’s copy (Copy 5) of the CCF, but not on any other copy. This information may help the employee remember what medications he or she may have taken if a non-negative result is reported by the laboratory to the MRO.

18. The collector places the specimen bottles and Copy 1 of the CCF inside the appropriate pouches of the leak-resistant plastic bag, and seals both pouches. If the employee has not had the opportunity to wash his or her hands, they may do so now. The collector then informs the employee that he or she may leave the collection site.




19. Any urine specimen left over in the collection container after both specimen bottles have been appropriately filled and sealed should be discarded at this time. Excess urine may be used to conduct clinical tests (e.g., protein, glucose) if the collection was conducted in conjunction with a physical examination required by a DOT operating administration’s regulation. No further testing (e.g., adulteration testing, DNA, additional drugs) may be conducted on this excess urine and the employee has no right to demand that the excess urine be turned over to the employee.

20. The collector places the sealed plastic bag in an appropriate shipping container (e.g., box, express courier mailer) designed to minimize the possibility of damage during shipment. More than one sealed plastic bag can be placed into a single shipping container if there are multiple collections. The collector seals the shipping container as appropriate. If a laboratory courier hand-delivers the specimens from the collection site to the laboratory, the collector prepares the shipment as directed by the courier service. In this case, the plastic bag may not need to be placed into a shipping container, but still needs to be transported by the courier in a manner that protects the bottles from damage.

Note: If the laboratory courier does not hand-deliver the specimens to the laboratory, but subsequently places the specimens into a commercial delivery system, the specimens must be placed into a shipping container to minimize damage in transit.

21. The collector then sends Copy 2 of the CCF to the MRO and Copy 4 to the DER (or service agent if authorized by the employer). The collector must fax or otherwise transmit these copies to the MRO and DER within 24 hours or during the next business day and keep Copy 3 for at least 30 days, unless otherwise specified by applicable DOT operating administration’s regulations.

Note: The MRO copy (Copy 2) may be faxed to the MRO’s secure fax machine, it may be scanned and the image sent to the MRO’s secure computer, or it may be mailed or sent by courier to the MRO. (It is recommended that the MRO copy be faxed, since it is critical for the MRO to have this document to expeditiously conduct the verification process.) In the case where the MRO copy (Copy 2) is faxed or the scanned image is sent securely to the MRO, the collector or the collection site should maintain the MRO copies together with the collector’s copies for 30 days. Retention is necessary in case the MRO’s copy is lost in the mail or the faxed or scanned copy is not legible and another copy is required by the MRO. The transmission process must be coordinated between the collection site and the MRO to ensure that transmission procedures meet the MRO’s requirements (e.g., MROs must provide secure fax numbers to collection sites, some MROs may want hard copies mailed; others may want only faxed copies).

22. The collector or collection site must ensure that each specimen collected is shipped to a laboratory as quickly as possible, but in any case within 24 hours or during the next business day.

23. If the specimen will not be shipped immediately, the collector is responsible for ensuring its integrity and security. Specimens in plastic bags, which have not been placed into shipping containers or which are awaiting a laboratory courier, must be kept in a secure location. Access to the specimens must be effectively restricted.




Note: After specimens are placed into shipping containers that are subsequently sealed, the shipping containers may be placed with other containers or packages that the collection site has waiting to be picked up by a courier. It is expected that collection sites will use reasonable security to ensure that all of their packages are relatively secure and not subject to damage, theft, or other actions that would potentially raise questions related to the integrity of the specimens.

Note: Couriers, postal employees, and other personnel involved in the transportation of the sealed shipping container are not required to make, and should not attempt to make, additional chain of custody entries on the custody and control form.

The entire collection process is now complete.

SECTION 8. SHY BLADDER PROCEDURES

The term "shy bladder" refers to a situation when the employee does not provide a sufficient amount of urine (45 mL) for a DOT-required drug test. If an employee tells the collector, upon arrival at the collection site, that he or she cannot provide a specimen, the collector must still begin the collection procedure regardless of the reason given. The collector should tell the employee that most individuals can provide 45 mL of urine, even when they think they cannot urinate, and direct the employee to make the attempt to provide the specimen.

At the point in the collection procedure where the collector and employee unwrap/open a collection container, the collector does the following:

1. The collector requests the employee to go into the rest room and try to provide a specimen.

Note: The employee demonstrates his or her inability to provide a valid specimen when the employee comes out of the rest room with an insufficient quantity of specimen or an empty collection container.

2. If the employee provided an initial insufficient specimen, the collector discards the insufficient specimen. The collector then annotates in the “Remarks” line the time when the employee provided the insufficient specimen. This is the time when the “shy bladder” collection process starts.

Note: If there was actually no specimen provided on an attempt, the same collection container may be used for the next attempt (the employee may keep possession of the container during the waiting period). The collector uses the same CCF and continues to document subsequent collections on the same form.

Note: If the insufficient specimen is also out of temperature range (assuming there was sufficient specimen to activate the temperature strip) or shows evidence of adulteration or tampering, the collector completes the collection process, does not discard the specimen, but instead sends the insufficient specimen (temperature out of range or adulterated) to the laboratory and immediately initiates another collection under direct observation.




3. The collector explains to the employee the process for a shy bladder collection and urges the employee to drink up to 40 ounces of fluids, distributed reasonably through a period of up to three hours, or until the individual has provided a sufficient urine specimen, whichever occurs first. It is not a refusal to test if the employee declines to drink.

Note: Collectors should be sensitive to how frequently they should ask the employee to provide a specimen. For example, asking the employee to provide a specimen every half hour may not produce sufficient specimen, although in total, the amount would have been at least 45 mL. In this case, the collector needs to determine if a longer time is needed for the employee to consume fluids and produce a sufficient volume of specimen. If the employee refuses to drink fluids, this is not considered a refusal to test, although the collector should explain to the employee that not drinking sufficient fluids may result in the employee’s inability to provide a sufficient specimen and would require a medical evaluation. Under no circumstances can a collector “combine” urine collected from separate voids to create one specimen of sufficient volume.

4. If the employee refuses to make the attempt to provide a new urine specimen or leaves the collection site before the collection process is completed, the collector must discontinue the collection, note the fact on the “Remarks” line of the CCF (Step 2), and immediately notify the DER. This is a refusal to test.

Note: As with other collections situations, there is no requirement for the collector to inform the employee in a shy bladder situation that failure to remain at the collection site or otherwise fails to cooperate with the testing process constitutes a refusal. It is a best practice for the collector to inform the employee that such behavior could lead an employer to determine that a refusal occurred.

5. If the employee has not provided a sufficient specimen within three hours of the first unsuccessful attempt to provide the specimen, the collector must discontinue the collection, note the fact on the “Remarks” line of the CCF (Step 2) and immediately notify the DER. 6. Discard any specimen the employee provided (to include any specimen that is “out of temperature range” or “shows signs of tampering”). If the employee provided an “out of temperature range specimen” or “specimen that shows signs of tampering”, note in the “Remarks” section that it was discarded because the employee did not provide a second sufficient specimen.

Note: The collector should maintain a record in the “Remarks” line on the CCF of the time of each attempt, whether there was any specimen provided or the quantity of specimen provided, and the amount of fluids that the employee was given to drink. During the waiting period that the employee can consume fluids, the employee must be monitored to ensure the continued integrity of the test. While, as noted above, there is no requirement for the collector to do so, it is a good practice for the collector to inform the employee that he or she is not permitted to leave the collection site and that doing so could lead an employer to determine that a refusal occurred.

7. The collector then sends Copy 2 of the CCF to the MRO and Copy 4 to the DER. This is done even if the employee did not provide any specimen in order to notify the MRO and the




employer of the problem. The collector must send or fax these copies to the MRO and DER within 24 hours or the next business day.

SECTION 9. DIRECTLY OBSERVED COLLECTIONS

A directly observed collection procedure is the same as a routine collection procedure with the additional requirement that an observer directly watches the urine go from the employee’s body into the collection container. The observer must be the same gender as the employee; there are no exceptions to this requirement.

Note: See “DOT’s Direct Observation Procedures” at Appendix D.

An observed collection is required when:

1. The employer or DER directs the collector (or collection site) to conduct a collection under direct observation.

Note: The employer is required to conduct a directly observed collection, with no advance notice to the employee when:

1. The laboratory reports an invalid specimen and the MRO reports that there was

not an adequate medical explanation for the result.

2. Because the split specimen test could not be performed (e.g., split lost, inadequate volume).

3. The MRO reports a negative-dilute result with a creatinine concentration greater

than or equal to 2 mg/dL but less than or equal to 5 mg/dL.

4. The test is a return-to-duty or follow-up test.

Note: An employee may not “volunteer” to have his or her specimen collected under direct observation.

2. The collector observed materials brought to the collection site or the employee’s conduct clearly indicated an attempt to tamper with a specimen.

3. The temperature on the original specimen was out of range or the specimen appeared to have been tampered with.

Note: The collector may serve as the observer when the collector is the same gender as the employee. If not, the collector must call upon another individual (who is the same gender as the employee) to act as the observer. The collector must verbally instruct the observer as to the procedures the observer must follow and specifically inform the observer not to take the specimen from the employee, but have the employee bring it to the collector. It is recommended that the collector have a short written outline of the direct observation procedures to provide to and review with the observer.




An observed collection is conducted in the following manner:

1. The collector must explain to the employee why a directly observed collection is being conducted. If the directly observed collection is requested by the employer, the collector may state the reason (if known) or may only state that the employer requested a directly observed collection.

2. The collector must complete a new CCF for the directly observed collection and mark the “reason for test” block (Step 1) the same as for the first collection (unless it is a return-to-duty or follow-up test).

3. The collector then checks the “Observed, (Enter Remark)” box and enters the reason in the “Remarks” line (Step 2) and the name of the observer if it is someone other than the collector.

4. In a case where two sets of specimens are being sent to the laboratory because of suspected tampering with the first specimen, the collector enters on the “Remarks” line of the CCF (Step 2) for each specimen a notation to this effect (e.g., collection 1 of 2, or 2 of 2) and the CCF specimen ID number of the other specimen.

5. The collector, if the same gender as the employee, or the same gender observer enters the restroom or facility where urination occurs with the employee. The observer must request the employee to raise his or her shirt, blouse, or dress/skirt, as appropriate, above the waist or navel, and lower clothing and underpants sufficient to show the observer – by turning around – that the employee does not have a prosthetic device. After the observer has determined that the employee does not have such a device, the observer may permit the employee to return clothing to its proper position and then conduct the observed collection.

Note: There are three basic types of devices employees could “wear.” [Of course, there could be other devices, here are examples of some devices]:

1. One device has a long plastic tube connected to a bottle containing heated urine.

2. Another device consists of a short plastic tube attached to a battery- heated plastic bag.

3. One device goes a step further by replacing the tube with very realistic prosthetic genitalia designed to match the employee’s skin tone.

6. The observer must watch the employee urinate into the collection container. Specifically, the observer must personally and directly watch the urine go from the employee’s body into the collection container (use of mirrors or video cameras is not permitted).

Note: If it is a multi-stall restroom, the observer must enter the stall with the employee.

Note: With respect to direct observation collections, the following situations are considered refusals to test:




• The employee declines to allow a directly observed collection required or permitted by Part 40 to occur.

• The employee fails to follow the observer’s instructions to raise and lower

their clothing and to turn around to permit the observer to determine if the employee has a prosthetic or other device that could be used to interfere with the collection process.

• The employee possesses or wears a prosthetic or other device that could be

used to interfere with the collection process.

In either of these situations, the collector discards any specimen the employee provided previously and notifies the DER as soon as possible.

7. After the employee has completed urinating into the collection container, the employee and observer leave the enclosed toilet stall/restroom and the employee hands the collection container directly to the collector. The observer must maintain visual contact of the collection container until the employee hands the container to the collector. If the observer is the collector, the collector may receive the collection container from the employee while they are both in the enclosed toilet stall/restroom.

8. If the collector learns that a directly observed collection should have taken place, but was not, the collector must inform the employer that the employee must be directed to return for an immediate recollection under direct observation.

SECTION 10. MONITORED COLLECTIONS

A monitored collection is one that is conducted under less than completely private conditions, utilizing a multi-stall restroom. If there is no practicable work place outside of the restroom, the collector may set up an area within the multi-stall restroom to be used as a work area and for finalizing the required paper work. (A collection which is not monitored may also be conducted in a multi-stall restroom, provided that the collector secures all of the stalls (bluing agent, etc.), secures all water sources and other potential sources of adulterants (soap dispensers) in the restroom, and posts signs or otherwise secures the restroom from entry by unauthorized personnel.)

A monitored collection is conducted in the following manner:

1. The collector must secure the room being used for the monitored collection so that no one except the employee and the monitor can enter it until after the collection has been completed.

2. The monitor must be the same gender as the employee, unless the monitor is a medical professional (e.g., nurse, doctor, physician’s assistant, technologist or technician licensed or certified to practice in the jurisdiction in which the collection takes place). The monitor can be a different person from the collector and need not be a qualified collector.




3. If someone other than the collector is to monitor the collection procedure (i.e., the collector is not a medical professional), the collector must verbally instruct that person to use the following procedures (if the collector is the monitor, the collector must also follow these procedures):

(a) A monitor stands outside the stall and does not watch the employee urinate. If the monitor hears sounds or makes other observations indicating an attempt to tamper with a specimen by the employee, there must be an additional collection conducted under direct observation.

(b) A monitor must ensure that the employee takes the collection container directly to the collector as soon as the employee has exited the enclosure.

4. When someone besides the collector has acted as the monitor, the collector must note that person’s name in the “Remarks” line of the CCF (Step 2).

5. If the employee declines to permit a collection authorized under Part 40 to be monitored, it is a refusal to test.

SECTION 11. PROBLEM COLLECTIONS

CATHETERIZATION. If an employee needs medical attention (e.g., an injured employee in an emergency medical facility who is required to have a post-accident test), treatment takes priority and should not be delayed to collect a specimen. If an employee is catheterized as part of a medical procedure (following an accident), once the employee’s medical condition is stabilized and the employee can give his or her consent to the collection (e.g., understand that a DOT collection is required, can sign the CCF), a urine specimen should be obtained from that employee. Procedures similar to those listed below may be used when an external urine bag is involved. A urine specimen must not be collected, by catheterization or other means, from an unconscious employee to conduct a DOT-required drug test. Catheterization of a conscious employee to obtain a urine specimen for a DOT-required test is also not authorized.

However, an employee who normally voids through intermittent or self-catheterization is required to provide a specimen in that manner if he or she is required to produce a specimen for a DOT test. If able to, the employee may provide the specimen directly from the catheter into the collection container in the privacy of a restroom. If an employee, who normally voids through self-catheterization, declines to do so, this would constitute a refusal to test.

EXTERNAL URINE BAG. The following procedures should be used in the collection of a urine specimen from an employee who has a medical condition requiring an indwelling catheter or excretion of urine into an external bag. The urine specimen should be a freshly voided specimen. An employee with an indwelling catheter may urinate directly into a collection container. In the case of an employee with an external bag, the employee should be asked to empty his or her bag in the privacy of a bathroom, show the empty bag to the collector, and then drink sufficient fluids at the collection site to provide 45 mL of urine, which can be subsequently poured by the employee from the bag into a collection container in the privacy of a bathroom. In this case, the temperature of the specimen would not be a critical factor. If the specimen temperature is out of range, a direct




observation collection would not necessarily be required because of the nature of the collection. The collector should be keenly aware of the potential embarrassment that this type of collection can cause the employee and should conduct the collection with appropriate decorum.

This procedure would not have to be done in a medical environment/health clinic or by a collector of the same gender, although the collector may try to accommodate the employee (e.g., conduct the collection at a medical facility, have the same gender collector) if the employee requests this and if it would not significantly delay the collection process. If the employer is aware of this situation prior to the actual collection (e.g., because the employee had previously expressed a desire to provide the specimen in a medical setting, requested a same gender collector, told the employer about the medical condition and its impact on urine collection for drug testing), the employer (collection site) may establish or modify procedures as needed to permit the employee to provide a specimen in a way consistent with the employee’s privacy while still meeting regulatory requirements. In the case of a collection based on a post-accident or reasonable suspicion requirement, the collector may attempt to honor the employee’s request (for the collection to be conducted in a medical setting or for the collector to be the same gender) if the collection can be accomplished within a reasonable time frame.

The above scenario assumes that the employee’s medical condition is not one that decreases or completely prohibits renal output, and that the employee can produce normal amounts of urine that is excreted into an external bag. Therefore, an employee with this or similar medical conditions would be subject to the same testing requirements (e.g., pre-employment, random) and to the “shy bladder” protocol (three hours and 40 ounces of fluids) as an employee with no medical condition. If an employee who normally voids in this manner declines to provide a urine specimen under these conditions, it would constitute a refusal to test.

TEMPERATURE. The collector should check the temperature of the specimen as soon as the employee hands over the specimen, but no later than four minutes after the employee comes out of the restroom. The acceptable temperature range is 32°-38°C/ 90°-100°F. Temperature is determined by reading the temperature strip originally affixed to or placed on the outside of the collection container after the employee hands the specimen to the collector.

(a) If the temperature is within the acceptable range, the "Yes" box is marked in Step 2 on the CCF and the collector proceeds with the collection procedure.

(b) If the temperature is outside the acceptable range, the "No" box is marked in Step 2 on the CCF and if the temperature was below or above the acceptable range should be noted in the “Remarks” line. The collector completes the collection process for the “first” specimen and immediately begins a “second” collection under direct observation using a second CCF and a new kit. The collector then provides an appropriate comment on the "Remarks" line in Step 2 on the first CCF and second CCF indicating that this is the first of two or second of two collections, the specimen ID numbers of the first and second CCF, the reason for the second collection, and that the second collection was under direct observation. This will ensure that the laboratory and the MRO know that two separate specimens are being submitted for testing; the first one possibly being adulterated or substituted. Additionally, the collector must inform the collection site supervisor and the DER that a collection took place under direct observation and the reason for doing so.




Note: There is no requirement to take the employee’s body temperature if the specimen temperature is out of range. If the collector suspects that the temperature strip was not activated, the collector should pour the urine specimen into another collection container with a temperature strip or into a specimen bottle which has a temperature strip attached, and use this method to determine the specimen temperature. Collectors should not introduce any other object (e.g., litmus paper, testing strips, etc.) into the specimen in the collection container or the bottles.

SPECIMEN VOLUME. The collector checks to make sure that the specimen contains a sufficient amount of urine (a minimum of 45 mL for all DOT collections). If the volume is sufficient, the collector checks the box on the CCF (Step 2) indicating that this was a split specimen collection. (This may be done at the same time that the collector checks the temperature box.)

If the volume is less than 45 mL, the action taken will depend on whether the temperature of the specimen is in or outside the acceptable temperature range.

(a) If the temperature is in the acceptable range, the specimen is discarded and a second specimen is collected. The collector may use the original CCF for the second specimen, but should annotate in the “Remarks” line the time that the first insufficient specimen was provided by the employee and the fact that this is a second collection (the time annotation is important since this may become a “shy bladder” situation). The collector should use a new specimen collection container, if these are available separately or a new kit.

(b) If the temperature is outside the acceptable range, a second specimen must be collected under direct observation and both specimens are sent to the laboratory for testing. The collector must use a separate CCF and kit for each specimen and provide an appropriate comment on each CCF to indicate why two specimens were collected.

ADULTERATION OR SUBSTITUTION. The collector must inspect the specimen for unusual color, presence of foreign objects or material, or other signs of tampering or adulteration. If it is apparent from this inspection that the employee has adulterated or substituted the specimen (e.g., the specimen is blue, exhibits excessive foaming when shaken, has smell of bleach), a second collection using direct observation procedures must be conducted immediately. The first specimen and the second specimen collected using direct observation are both sent to the laboratory for testing.

If the employee does not provide the required amount of urine for the second collection using direct observation, the collector annotates the time the second specimen was not provided and initiates the shy bladder procedures. If after 3 hours the employee still cannot provide a sufficient amount of specimen, the collector ends the collection process, notes the fact on the “Remarks” line of the CCF (Step 2) and immediately notifies the DER. The collector discards any specimen the employee provided (to include any specimen that is “out of temperature range” or “shows signs of tampering”). If the employee provided an “out of temperature range specimen” or “specimen that shows signs of tampering”, note in the




“Remarks” section that it was discarded because the employee did not provide a second sufficient specimen. The collector must send or fax Copy 2 of the CCF to the MRO and Copy 4 to the DER within 24 hours or the next business day.

Note: In a case where the employee refuses to provide another specimen, refuses to provide a specimen under direct observation, or admits to the collector that he or she adulterated or substituted their specimen, the collector discards any specimen the employee provided previously during the collection and then notifies the DER that the employee refused to comply with a DOT test.

SECTION 12. CORRECTING COLLECTION PROBLEMS

The collector has the responsibility of trying to successfully complete a collection procedure for each employee.

1. If, during or shortly after the collection process, the collector becomes aware of any event that prevents the completion of a valid test or collection (e.g., a procedural or paperwork error), the collector must try to correct the problem promptly, if doing so is practicable. The collector may initiate another collection as part of this effort. There is one exception: when the collector learns that a directly observed collection should have been conducted, but was not, the collector must notify the employer to direct the employee to return for an immediate recollection under direct observation.

2. If another collection is necessary, the collector must begin the new collection procedure as soon as possible, using a new CCF and a new collection kit.

Note: If the collector becomes aware of a problem that can be corrected, but which has not already been corrected, the collector must take all practicable actions to correct the problem so that the test is not cancelled.

3. If the problem resulted from the omission of required information, the collector must, as the person responsible for providing that information, supply in writing the missing information and a statement that it is true and accurate. For example, suppose the collector forgot to make a notation on the “Remarks” line of the CCF that the employee did not sign the certification. The collector would, when the problem is called to his or her attention, supply a signed statement that the employee failed or refused to sign the certification and that the collector’s signed statement is true and accurate. The collector must supply this information on the same business day on which he or she is notified of the problem, transmitting it by fax or courier.

4. If the problem is the use of a non-Federal CCF or an expired Federal form, the collector must provide a signed statement (e.g., a memorandum for record). The documentation must state that the incorrect form contains all the information needed for a valid DOT drug test, and that the incorrect CCF was used inadvertently or as the only means of conducting a test, in circumstances beyond the collector’s control. The memorandum must also list the steps the collector took to prevent future use of non- Federal or expired Federal CCFs for DOT tests. This information must be supplied to the laboratory on the same business day that the collector is notified of the problem, and




may be transmitted by fax or courier. The use of a non-Federal form does not, in and of itself, present a reason for the laboratory to reject the specimen for testing or for the MRO to cancel the test.

5. The collector must maintain a copy of the written and dated documentation of correction with the appropriate CCF. The collector must also mark the CCF in such a way (e.g., stamp noting correction, written notation) that it would be obvious on the face of the CCF that the corrected (missing) information was supplied.

When an HHS certified laboratory receives specimen bottles and the associated CCF, it checks to see if the specimen ID number on the specimen bottle labels/seals matches the number on the CCF, that the specimen bottle seals are intact, that there is sufficient specimen volume, and that the CCF has been properly completed by the collector. If there is any discrepancy and/or error of omission (i.e., the collector did not sign the chain of custody, the collector did not check the temperature box), the laboratory will contact the collector to determine if the discrepancy and/or missing information can be recovered. That is, the collector can provide a signed statement attesting to the fact that he or she inadvertently forgot to properly document the CCF.

Note: If a fatal flaw exists in the collection process or a memorandum for record or other written statement cannot be provided by the collector to related to a correctable flaw, the laboratory will report "Rejected for Testing" to the MRO and provide an appropriate comment as to why the specimen was not tested. If the reason for rejecting the test was a collector error, when a test is cancelled by the MRO, the collector who collected the specimen will need to go through an error correction training process within 30 days addressing the specific problem that caused the specimen to be cancelled.

Note: Once contacted by the laboratory or the MRO, the collector should immediately provide a statement or memorandum to recover the discrepancy and/or error of omission. Laboratories are required by HHS to retain these specimens for a minimum of 5 business days before they may be discarded; therefore, it is critical that the collector respond immediately to the laboratory’s request for corrective action.




APPENDIX A – TRAINING REQUIREMENTS FOR COLLECTORS

To be permitted to act as a collector in the DOT drug testing program, you must meet the following requirements:

(a) Basic information. You must be knowledgeable about 49 CFR Part 40, the current “DOT Urine Specimen Collection Procedures Guidelines,” and DOT agency regulations applicable to the employers for whom you perform collections, and you must keep current on any changes to these materials. The DOT Urine Specimen Collection Procedures Guidelines document is available from ODAPC, U.S. Department of Transportation, 1200 New Jersey Ave, SE, W62- 300, Washington DC, 20590, 202-366-3784, or on the ODAPC web site: http://www.dot.gov/odapc. You must subscribe to the ODAPC list-serve: https://www.transportation.gov/odapc/get-odapc-email-updates.

(b) Qualification training. You must receive qualification training that provides instruction on the following subjects:

(1) All steps necessary to complete a collection correctly and the proper completion and transmission of the CCF;

(2) “Problem” collections (e.g., situations like “shy bladder” and attempts to tamper with a specimen);

(3) Fatal flaws, correctable flaws, and how to correct problems in collections; and (4) The collector’s responsibility for maintaining the integrity of the collection process,

ensuring the privacy of employees being tested, ensuring the security of the specimen, and avoiding conduct or statements that could be viewed as offensive or inappropriate;

(c)Initial Proficiency Demonstration. Following your completion of qualification training under paragraph (b) above, you must demonstrate proficiency in collections by completing five consecutive error-free mock collections.

(1) The five mock collections must include two uneventful collection scenarios, one insufficient quantity of urine scenario, one temperature out of range scenario, and one scenario in which the employee refuses to sign the CCF and initial the specimen bottle tamper-evident seal.

(2) Another person must monitor and evaluate your performance, in person or by a means that provides real-time observation and interaction between the instructor and trainee, and attest in writing that the mock collections are “error-free.” This person must be a qualified collector who has demonstrated necessary knowledge, skills, and abilities by --

(i) Regularly conducting DOT drug test collections for a period of at least a year; (ii) Conducting collector training under this part for a year; or (iii) Successfully completing a "train the trainer" course.

(d) You must meet the requirements of paragraphs (b) and (c) above before you begin to perform collector functions.

(e) Refresher training. No less frequently than every five years from the date on which you satisfactorily complete the requirements of paragraphs (b) and (c) above, you must complete refresher training that meets all the requirements of paragraphs (b) and (c).






(f) Error Correction Training. If you make a mistake in the collection process that causes a test to be cancelled (i.e., a fatal or uncorrected flaw), you must undergo error correction training. This training must occur within 30 days of the date you are notified of the error that led to the need for retraining.

(i) Error correction training must be provided and your proficiency documented in writing by a person who meets the requirements of paragraph (c)(2) above.

(ii) Error correction training is required to cover only the subject matter area(s) in which the error that caused the test to be cancelled occurred.

(iii) As part of the error correction training, you must demonstrate your proficiency in the collection procedures of this part by completing three consecutive error-free mock collections. The mock collections must include one uneventful scenario and two scenarios related to the area(s) in which your error(s) occurred. The person providing the training must monitor and evaluate your performance and attest in writing that the mock collections were “error-free.”

(g) Documentation. You must maintain documentation showing that you currently meet all requirements of this section. You must provide this documentation on request to DOT agency representatives and to employers and C/TPAs who are using or negotiating to use your services.




APPENDIX B – COLLECTION SITE SECURITY AND INTEGRITY DOT’s 10 Steps to Collection Site Security and Integrity

Office of Drug and Alcohol Policy and Compliance U.S. Department of Transportation

1. Pay careful attention to employees throughout the collection process.

2. Ensure that there is no unauthorized access into the collection areas and that undetected access (e.g., through a door not in view) is not possible.

3. Make sure that employees show proper picture ID.

4. Make sure employees empty pockets; remove outer garments (e.g., coveralls, jacket, coat, hat); leave briefcases, purses, and bags behind; and wash their hands.

5. Maintain personal control of the specimen and CCF at all times during the collection.

6. Secure any water sources or otherwise make them unavailable to employees (e.g., turn off water inlet, tape handles to prevent opening faucets, secure tank lids).

7. Ensure that the water in the toilet and tank (if applicable) has bluing (coloring) agent in it. Tape or otherwise secure shut any movable toilet tank top, or put bluing in the tank.

8. Ensure that no soap, disinfectants, cleaning agents, or other possible adulterants are present.

9. Inspect the site to ensure that no foreign or unauthorized substances are present.

10. Secure areas and items (e.g., ledges, trash receptacles, paper towel holders, under-sink areas, ceiling tiles) that appear suitable for concealing contaminants.




APPENDIX C – DOT STANDARDS FOR URINE COLLECTION KITS

1. Collection Container

a. Single-use container, made of plastic, large enough to easily catch and hold at least 55 mL of urine voided from the body.

b. Must have graduated volume markings clearly noting levels of 45 mL and above.

c. Must have a temperature strip providing graduated temperature readings 32-38 º C / 90-100 º F, that is affixed or can be affixed at a proper level on the outside of the collection container. Other methodologies (e.g., temperature device built into the wall of the container) are acceptable provided the temperature measurement is accurate and such that there is no potential for contamination of the specimen.

d. Must be individually wrapped in a sealed plastic bag or shrink wrapping; or must have a peelable, sealed lid or other easily visible tamper-evident system.

e. May be made available separately at collection sites to address shy bladder situations when several voids may be required to complete the testing process.

2. Plastic Specimen Bottles

a. Each bottle must be large enough to hold at least 35 mL; or alternatively, they may be two distinct sizes of specimen bottles provided that the bottle designed to hold the primary specimen holds at least 35 mL of urine and the bottle designed to hold the split specimen holds at least 20 mL.

b. Must have screw-on or snap-on caps that prevent seepage of the urine from the bottles during shipment.

c. Must have markings clearly indicating the appropriate levels (30 mL for the primary specimen and 15 mL for the split) of urine that must be poured into the bottles.

d. Must be designed so that the required tamper-evident bottle seals made available on the CCF fit with no damage to the seal when the employee initials it nor with the chance that the seal overlap would conceal printed information.

e. Must be wrapped (with caps) together in a sealed plastic bag or shrink wrapping separate from the collection container; or must be wrapped (with cap) individually in sealed plastic bags or shrink wrapping; or must have peelable, sealed lid or other easily visible tamper-evident system.

f. Plastic material must be leach resistant.




3. Leak-resistant Plastic Bag

a. Must have two sealable compartments or pouches which are leak-resistant; one large enough to hold two specimen bottles and the other large enough to hold the CCF paperwork.

b. The sealing methodology must be such that once the compartments are sealed, any tampering or attempts to open either compartment will be evident.

4. Absorbent material

Each kit must contain enough absorbent material to absorb the entire contents of both specimen bottles. Absorbent material must be designed to fit inside the leak-resistant plastic bag pouch into which the specimen bottles are placed.

5. Shipping Container

a. Must be designed to adequately protect the specimen bottles from shipment damage in the transport of specimens from the collection site to the laboratory (e.g., standard courier box, small cardboard box, plastic container).

b. May be made available separately at collection sites rather than being part of an actual kit sent to collection sites.

c. A shipping container is not necessary if a laboratory courier hand-delivers the specimen bottles in the plastic leak-proof bags from the collection site to the laboratory.




APPENDIX D – DIRECT OBSERVATION PROCEDURES DOT’s Direct Observation Procedures

Office of Drug and Alcohol Policy and Compliance U.S. Department of Transportation

1. DOT’s 49 CFR Part 40 directly observed collections are authorized and required only when:

● The employee attempts to tamper with his or her specimen at the collection site.

-- The specimen temperature is outside the acceptable range;

-- The specimen shows signs of tampering ~ unusual color / odor / characteristic; or

-- The collector finds an item in the employee’s pockets or wallet which appears to be brought into the site to contaminate a specimen; or the collector notes conduct suggesting tampering.

● The Medical Review Officer (MRO) orders the direct observation because:

-- The employee has no legitimate medical reason for certain atypical laboratory results; or

-- The employee’s positive or refusal [adulterated / substituted] test result had to be cancelled because the split specimen test could not be performed (for example, the split was not collected).

● The test is a Follow-Up test or a Return-to-Duty test.

2. The observer must be the same gender as the employee.

3. If the collector is not the observer, the collector must instruct the observer about the procedures for checking the employee for prosthetic or other devices designed to carry “clean” urine and urine substitutes AND for watching the employee urinate into the collection container.

● The observer requests the employee to raise his or her shirt, blouse or dress / skirt, as appropriate, above the waist, just above the navel; and lower clothing and underpants to mid-thigh and show the observer, by turning around, that the employee does not have such a device.

● If The Employee Has A Device: The observer immediately notifies the collector; the collector stops the collection; and the collector thoroughly documents the circumstances surrounding the event in the remarks section of CCF. The collector notifies the DER. This is a refusal to test.

● If The Employee Does Not Have A Device: The employee is permitted to return clothing to its proper position for the observed collection. The observer must watch the urine go from the employee’s body into the collection container. The observer must watch as the employee takes the specimen to the collector. The collector then completes the collection process.

4. Failure of the employee to permit any part of the direct observation procedure is a refusal to test.




APPENDIX E – QUESTIONS AND ANSWERS

Periodically, DOT will publish questions and answers specific to the collector and the collection process. These will be posted on the ODAPC web site: www.dot.gov/odapc . All collectors are encouraged to check the site to ensure that they have the most current information to help them conduct DOT-required specimen collections appropriately. Collectors who do not have access to the Internet may obtain copies of the questions and answers from ODAPC by calling 1-202-366- 3784.

APPENDIX F – OPERATING ADMINISTRATIONS’ RULES (SUMMARY)

49 CFR Part 40 (§40.33(a)) states that collectors must be knowledgeable about the DOT agency regulations applicable to the employers for whom the collectors conduct urine specimen collections. The following is a list of regulations which govern an employer’s implementation of the DOT drug and alcohol testing rules:

The FMCSA regulation is 49 CFR Part 382.

The FRA regulation is 49 CFR Part 219.

The FAA regulation is 14 CFR Part 120.

The FTA regulation is 49 CFR Part 655.

The PHMSA regulation is 49 CFR Part 199.

The USCG regulation is 46 CFR Parts 4, 5, and 16.

Drug and alcohol testing (including collection) procedures are 49 CFR Part 40.

The following pages contain a short summary of some of the operating administrations’ requirements. Copies of the complete rule texts are available on the ODAPC web site: http://www.dot.gov/odapc.






Federal Motor Carrier Safety Administration - (FMCSA)

Covered employee: A person who operates (i.e., drives) a Commercial Motor Vehicle(CMV) with a gross vehicle weight rating (gvwr) of 26,001 or more pounds; or is designed to transport 16 or more occupants (to include the driver); or is of any size and is used in the transport of hazardous materials that require the vehicle to be placarded.

Types of tests for drugs: Pre-employment, random, reasonable suspicion, post-accident, return- to-duty, and follow-up.

Types of tests for alcohol: Pre-employment (optional), random, reasonable suspicion, post- accident, return-to-duty, and follow-up.

Definition of accident requiring testing: Any accident involving a fatality requires testing. Testing is also required in accidents in which one or more motor vehicles are towed from the scene or in which someone is treated medically away from the scene; and a citation is issued to the CMV driver.

Reasonable-suspicion determination: One trained supervisor or company official can make the decision based upon specific, contemporaneous, articulable observations concerning the appearance, behavior, speech, or body odors of the employee.

Pre-duty alcohol use prohibitions: Four (4) hours prior to performance of duty.

Actions for BACs 0.02 – 0.039: The employee cannot be returned to duty until the next day or the start of the employee’s next regularly scheduled duty period, but not less than 24 hours following the test.

Employee training: Employer must provide educational materials explaining drug and alcohol regulatory requirements and employer’s policies and procedures for meeting regulation requirements. Distribution to each employee of these educational materials and the employer’s policy regarding the use of drugs and alcohol is mandatory.

Supervisor training: One-hour of training is required on the specific, contemporaneous physical, behavioral, and performance indicators of probable drug use. One-hour of training is also required on the specific, contemporaneous physical, behavioral, and performance indicators of probable alcohol use.

Reportable employee drug and alcohol violations: No requirements to report violations to FMCSA.

Other: Drivers are prohibited from using alcohol for eight hours following an accident (as described above) or until they have undergone a post-accident alcohol test, whichever occurs first.




Federal Railroad Administration - (FRA)

Covered employee: A person who performs hours of service functions at a rate sufficient to be placed into the railroad’s random testing program. Categories of personnel who normally perform these functions are locomotive engineers, trainmen, conductors, switchmen, locomotive hostlers/helpers, utility employees, signalmen, operators, and train dispatchers.

Types of tests for drugs: Pre-employment, random, reasonable suspicion, reasonable cause, post-accident, return-to-duty, and follow-up.

Types of tests for alcohol: Pre-employment (optional), random, reasonable suspicion, reasonable cause, post-accident, return-to-duty, and follow-up.

Definition of accident requiring testing: FRA’s post-accident testing rule requires urine and blood specimen collection from surviving employees and also tissue from deceased employees (these collection procedures go well beyond the normal Part 40 procedures). For surviving employees, these specimens are collected at an independent medical facility. FRA regulation, 49 CFR Part 219 Subpart C, stipulates the level of events requiring testing and who has to be tested. The collected specimens are analyzed only at FRA’s contract laboratory. Post-accident testing provides FRA with accident investigation and usage data.

Reasonable-suspicion determination: One trained supervisor can make the decision for alcohol testing based upon specific, contemporaneous, articulable observations concerning the appearance, behavior, speech, or body odors of the employee. A decision to conduct a drug test requires two supervisors (only the on-site supervisor must be trained).

Reasonable-cause determination: Employers are authorized to use federal authority to test covered employees after specific operating rule violations or accidents/incidents which meet the criteria in 49 CFR Part 219 Subpart D.

Pre-duty alcohol use prohibitions: Four (4) hours prior to performance of duty or after receiving notice to report for covered service, whichever is the shorter period.

Actions for BACs 0.02 – 0.039: The employee cannot be returned to duty until the start of the employee’s next regularly scheduled duty period, but not less than 8 hours following the test. Railroads are prohibited from taking further disciplinary action under their own authority.

Employee training: Employer must provide education materials that explain the requirements of the FRA rules as well as railroad policies and procedures with respect to meeting these requirements.

Supervisor training: A total of three hours of training is required: one-hour on the specific, contemporaneous physical, behavioral, and performance indicators of probable drug use; one- hour of similar training on probable indicators of alcohol use; and one-hour of training on how to determine if an accident qualifies for post-accident testing. FRA (continued)




Reportable employee drug and alcohol violations: No requirements to report violations to FRA. Engineers, who are the only certificate holders in the rail industry, will have their certificates reviewed for suspension or revocation by the employer when a FRA violation occurs. Note that a FRA alcohol violation occurs at 0.04 percent or greater. When a locomotive engineer is in a voluntary referral program, the counseling professional must report the engineer’s refusal to cooperate in the recommended course of counseling or treatment.

Other: Anyone with direct or immediate supervisory authority over an employee may not collect that person’s urine, saliva, or breath.

Refusal to test results in a mandatory minimum nine-month removal from covered service. During this nine-month period, there is no prohibition against the employee working a non- covered service position if agreeable to the employer.

Locomotive engineers (or other employees certified as a locomotive engineer at the time of the alcohol or drug violation) required both alcohol and drug return-to-duty tests; and both alcohol and drug follow-up tests.

Locomotive engineers who have a DUI are required by Part 240 to be evaluated to determine whether they have an active substance abuse disorder. A DUI is not considered to be a violation of FRA regulations if it occurred during the employee’s off-duty time; therefore, any testing would be conducted under employer authority.

Employers must provide a voluntary referral program which allows an employee to self-refer for treatment, and a co-worker report program which allows one employee to refer another for treatment before the employer identifies a problem. Both of these employee assistance programs guarantee that employees will retain their jobs if they cooperate and complete the required rehabilitation program. For an engineer who is in a voluntary referral program, the counseling professional must report the engineer’s refusal to cooperate in the recommended course of counseling or treatment to the employer.




Federal Aviation Administration - (FAA)

Covered employee: A person who performs flight crewmember duties, flight attendant duties, flight instruction duties, aircraft dispatch duties, aircraft maintenance or preventive maintenance duties; ground security coordinator duties; aviation screening duties; air traffic control duties, and operations control specialist duties. Note: Anyone who performs the above duties directly or by contract for a part 119 certificate holder authorized to operate under parts 121 and/or 135, air tour operators defined in 14 CFR part 91.147, and air traffic control facilities not operated by the Government are considered covered employees.

Types of tests for drugs: Pre-employment, random, reasonable cause, post-accident, return to duty, and follow-up.

Types of tests for alcohol: Pre-employment (optional), random, reasonable suspicion, post- accident, return to duty, and follow-up.

Definition of accident requiring testing: Accident means an occurrence associated with the operation of an aircraft which takes place between the time any person boards the aircraft with the intention of flight and all such persons have disembarked, and in which any person suffers death or serious injury, or in which the aircraft receives substantial damage. Testing must occur if employee's performance either contributed to the accident or cannot be completely discounted as a contributing factor of the accident. The decision not to test an employee must be based on a determination, using the best information available at the time of the determination that the employee's performance could not have contributed to the accident.

Reasonable cause determination (drugs): Two of the employee's supervisors, one of whom is trained, shall substantiate and concur in the decision to test the employee. If the employer is not an air carrier operating under 14 CFR part 121 and has 50 or fewer employees, a single trained supervisor can make the determination. A trained supervisor makes the determination based upon specific contemporaneous physical, behavioral or performance indicators of probable drug use.

Reasonable suspicion determination (alcohol): One trained supervisor makes the determination based upon specific, contemporaneous, articulable observations concerning the employee's appearance, behavior, speech, or body orders.

Pre-duty alcohol use prohibitions: Eight (8) hours prior to performance of flight crewmember duties, flight attendant duties, and air traffic controller duties. Four (4) hours prior to performance of other duties.

Actions for BACs 0.02 - 0.039: If the employer chooses to return the employee to covered services within 8 hours, the BAC retest must be below 0.02.




FAA (continued)

Employee training (drugs): An employer must train all employees who perform safety- sensitive duties on the effects and consequences of prohibited drug use on personal health, safety, and work environment, and on the manifestations and behavioral cues that may indicate drug use and abuse. Employers must also implement an education program for safety-sensitive employees by displaying and distributing informational materials, a community service hot-line telephone number for employee assistance and the employer's policy regarding drug use in the work place which must include information regarding the consequences under the rule of using drugs while performing safety-sensitive functions, receiving a verified positive drug test result, or refusing to submit to a drug test required under the rule.

Employee training (alcohol): Employers must provide covered employees with educational materials that explain the alcohol misuse requirements and the employer's policies and procedures with respect to meeting those requirements. The information must be distributed to each covered employees and must include such information as the effects of alcohol misuse on an individual's health work, personal life, signs and symptoms of an alcohol problem; and the consequences for covered employees found to have violated the regulatory prohibitions.

Supervisor training (drugs): One-hour of training is required on the specific, contemporaneous physical, behavioral, and performance indicators of probable drug use. In addition, supervisors must receive employee training as defined above. Reasonable recurrent training is also required.

Supervisor training (alcohol): One-hour of training is required on the physical, behavioral, speech, and performance indicators of probable alcohol misuse.

Reportable employee drug and alcohol violations:

Each employer must notify the FAA about any covered employee who holds a certificate issued under 14 CFR Parts 61 (pilots and flight and ground instructors), 63 (flight engineers and navigators), or 65 (air traffic control tower operators, aircraft dispatchers, airframe or power plant mechanics, and repairmen) who has refused to take a drug or alcohol test. The MRO may report a positive or refusal (i.e. adulterated, substituted results or no medical explanation for providing an insufficient specimen) on behalf of the employer.

Each employer must notify the FAA about any safety-sensitive employee who is required to hold an airman medical certificate issued under 14 CFR Part 67 who has a positive drug test result, an alcohol test result of 0.04 or greater, or who has refused to submit to testing. The MRO may report a positive or refusal (i.e. adulterated, substituted results or no medical explanation for providing an insufficient specimen) on behalf of the employer.

Each employer must not permit an employee who is required to hold a medical certificate under part 67 to perform a safety-sensitive function to resume that duty until the employee has received a new medical certificate issued by the FAA Federal Air Surgeon and the employer has ensured that the employee meets the return to duty requirements of Part 40. (Medical certificates are not operating certificates but employees cannot continue to perform airman duties without a medical certificate.)




FAA (continued)

According to FAA’s regulation 14 CFR part 120, Subpart E, section 120.113(d), when a MRO verifies a drug test result or a SAP performs the initial evaluation, they must ask the employee whether he or she holds or would be required to hold an airman medical certificate issued under 14 CFR part 67 of this chapter to perform a safety-sensitive function for the employer. [This requirement only applies to MROs and SAPs who provide services for FAA regulated employers.] If the employee answers in the affirmative, the employee must obtain an airman medical certificate issued by the Federal Air Surgeon dated after the drug and/or alcohol violation date.

The SAP must wait until the employee obtains their airman medical certificate before reporting to an employer that the employee demonstrated successful compliance with the SAP's treatment and/or education recommendations.




Federal Transit Administration - (FTA)

Covered employee: A person who performs a revenue vehicle operation; revenue vehicle and equipment maintenance; revenue vehicle control or dispatch (optional); Commercial Drivers License non-revenue vehicle operation; or armed security duties.

Types of tests for drugs: Pre-employment, random, reasonable suspicion, post-accident, return- to-duty, and follow-up.

Types of tests for alcohol: Pre-employment (optional), random, reasonable suspicion, post- accident, return-to-duty, and follow-up.

Definition of accident requiring testing: Any accident involving a fatality requires testing. Testing following a non-fatal accident is discretionary: If the employer can show the employee’s performance could not have contributed to the accident, no test is needed. Non-fatal accidents that may require testing must have disabling damage to any vehicle or immediate medical attention away from the scene to meet the testing threshold.

Reasonable-suspicion determination: One trained supervisor or company official can make the decision based upon specific, contemporaneous, articulable observations concerning the appearance, behavior, speech, or body odors of the employee.


Actions for BACs 0.02 – 0.039: If the employer chooses to return the employee to covered service within 8 hours, the BAC re-test must be below 0.02.

Employee training: Employer must provide education with display and distribution of informational materials and a community service hot-line telephone number, if available. One-hour of training on the effects and consequence of prohibited drug use on personal health, safety, and the work environment, and on the signs and symptoms that may indicate prohibited drug use. Distribution to each employee of the employer’s policy regarding the use of drugs and alcohol with signed receipt is mandatory.


Reportable employee drug and alcohol violations: No requirements to report violations to FTA.

Other: Anyone with direct or immediate supervisory authority over an employee may not collect that person’s urine, saliva, or breath.




Pipeline and Hazardous Materials Safety Administration - (PHMSA)

Covered employee: A person who performs on a pipeline or liquefied natural gas (LNG) facility an operation, maintenance, or emergency-response function.

Types of tests for drugs: Pre-employment, random, reasonable cause, post-accident, return-to- duty, and follow-up.

Types of tests for alcohol: Post-accident, reasonable suspicion, return-to-duty, and follow-up.

Definition of accident requiring testing: An accident is one involving gas pipeline facilities or LNG facilities or involving hazardous liquid or carbon dioxide pipeline facilities.

Reasonable-suspicion determination: One trained supervisor can make the decision based upon signs and symptoms.

Reasonable-cause determination: One trained supervisor can make the decision based upon reasonable and articulable belief that the employee is using prohibited drugs on the basis of specific, contemporaneous physical, behavioral, or performance indicators of probable drug use.


Actions for BACs 0.02 – 0.039: If the employer chooses to return the employee to covered service within 8 hours, the BAC retest must be below 0.02.

Employee training (Drugs): Employer must provide EAP education with display and distribution of informational materials; display and distribution of a community service hot-line telephone number; and display and distribution of the employer’s policy regarding the use of prohibited drugs.

Employee Training (Alcohol): Employer must develop materials that explain policies and procedures (as well as names of those who can answer questions about the program) and distribute them to each covered employee.


Reportable employee drug and alcohol violations: No requirements to report violations to PHMSA.




United States Coast Guard - (USCG)

Covered employee: A person who is on board a vessel acting under the authority of a license, certificate of registry, or merchant mariner's document. Also, a person engaged or employed on board a U.S. owned vessel and such vessel is required to engage, employ or be operated by a person holding a license, certificate of registry, or merchant mariner's document.

Types of tests for drugs: Pre-employment, periodic, random, reasonable cause, and post- serious marine incident (SMI), return-to-duty, and follow-up.

Types of tests for alcohol: 49 CFR Part 40 alcohol-testing requirements do not apply to the Maritime Industry. 46 CFR Part 4.06 requires post-SMI chemical testing for alcohol use. 33 CFR Part 95.035 allows for a marine employer or a law enforcement officer to direct an individual to undergo a chemical test for intoxicants when reasonable cause exists or a marine casualty has occurred.

Definition of incident requiring testing: An SMI is defined in 46 CFR 4.03-2. In general, an SMI is: A discharge of 10,000 gallons or more of oil into the navigable waters of the United States, whether or not resulting from a marine casualty; a discharge of a reportable quantity of a hazardous substance into the navigable waters or into the environment of the United States, whether or not resulting from a marine casualty; or a marine casualty or accident required to be reported to the Coast Guard, involving a vessel in commercial service, and resulting in any of the following: One or more deaths; an injury to any person (including passengers) which requires professional medical treatment beyond first aid, and, in the case of a person employed on board a commercial vessel, which renders the person unable to perform routine vessel duties; damage to property in excess of $100,000; actual or constructive total loss of any inspected vessel; or actual or constructive total loss of any uninspected, self-propelled vessel of 100 gross tons or more.

Reasonable-cause determination (drugs): The marine employer must have a reasonable and articulable belief that the individual has used a dangerous drug. This belief should be based on the direct observation of specific, contemporaneous physical, behavioral, or performance indicators of probable use and where practicable based on the observation of two persons in supervisory positions.

Reasonable-cause determination (alcohol): The employee was directly involved in the occurrence of a marine casualty or the individual operated a vessel and the effect of the intoxicant(s) consumed by the individual on the person's manner, disposition, speech, muscular movement, general appearance or behavior is apparent by observation.

Pre-duty alcohol use prohibitions: Four (4) hours prior to performance of scheduled duty.

Employee training: Employer must provide education with display and distribution of informational materials and a community service hot-line telephone number. Distribution to each employee of the employer’s policy regarding the use of drugs and alcohol is mandatory. Training must include the effects of drugs and alcohol on personal heath, safety, and work environment; and manifestations and behavioral cues that may indicate drug and alcohol use and abuse.




USCG (continued)

Supervisor training: One-hour of training is required on the effects of drugs and alcohol on personal heath, safety, and work environment; and manifestations and behavioral cues that may indicate drug and alcohol use and abuse.

Reportable employee drug and alcohol violations: Results of all post-SMI tests and positive drug test results for all mariners who hold a license, certificate of registry or merchant mariner's document must be reported to the nearest Coast Guard Officer in Charge, Marine Inspection.




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U.S. Department of Transportation Office of the Secretary


1200 New Jersey Avenue, S.E. W62-300

Washington, D.C. 20590

202.366.3784

202.366.3897 fax

www.dot.gov/odapc

[email protected]

Changes from previous version [July 3, 2014]:

o Updated ‘Shy Bladder Procedures’ new paragraph # 6 - to include the requirement to discard any specimen the employee provided when the employee does not provide a sufficient specimen by the end of the shy bladder waiting period [pg. 21],

o Updated ‘Adulteration or Substitution’ section – to include the requirement to discard any specimen the employee provided when the employee does not provide a sufficient specimen by the end of the shy bladder waiting period [pg. 27],

o Updated Appendix A – paragraphs a) & d) to include the requirement to subscribe to the

ODAPC List Serve and removed the outdated schedule for qualification training and initial proficiency demonstration, respectively [pg. 30],

o Removed the references to ‘Blind Quality Control Samples’


http://www.dot.gov/odapc

mailto:[email protected]

DOT Collector Training Required Reading Page 1 of 8

DOT Collector Training REQUIRED READING

Training Topics Covered

Training Requirements ................................................................................................................ 2

Qualification Training ...................................................................................................................... 2 Initial Proficiency Demonstration ................................................................................................... 2

Federal Drug Testing Custody and Control Form .................................................................... 2 What is a refusal to test? .............................................................................................................. 3 Monitored Collections .................................................................................................................. 3 Donor Refuses to Sign ................................................................................................................... 4 Correctable Flaws ......................................................................................................................... 5 Fatal Flaws ..................................................................................................................................... 5 Error Correction Training ........................................................................................................... 5 Temperature Out of Range .......................................................................................................... 5 Direct Observation Collection ..................................................................................................... 7 Shy Bladder ................................................................................................................................... 7


TRAINING REQUIREMENTS Collectors are required to meet the following training requirements: Qualification Training

You must receive qualification training meeting the requirements of this paragraph. Qualification training must provide instruction on the following subjects:

1. All steps necessary to complete a collection correctly and the proper completion and transmission of the CCF;

2. “Problem” collections (e.g., situations like “shy bladder” and attempts to tamper with a specimen);

3. Fatal flaws, correctable flaws, and how to correct problems in collections; and 4. The collector's responsibility for maintaining the integrity of the collection process, ensuring the

privacy of employees being tested, ensuring the security of the specimen, and avoiding conduct or statements that could be viewed as offensive or inappropriate;

Initial Proficiency Demonstration

1. Following your completion of qualification training you must demonstrate proficiency in collections under this part by completing five consecutive error-free mock collections.

2. The five mock collections must include two uneventful collection scenarios, one insufficient quantity of urine scenario, one temperature out of range scenario, and one scenario in which the employee refuses to sign the CCF and initial the specimen bottle tamper-evident seal.

3. Another person must monitor and evaluate your performance, in person or by a means that provides real-time observation and interaction between the instructor and trainee, and attest in writing that the mock collections are “error-free.” This person must be a qualified collector who has demonstrated necessary knowledge, skills, and abilities by:

a) Regularly conducting DOT drug test collections for a period of at least a year; b) Conducting collector training under this part for a year; or c) Successfully completing a “train the trainer” course.

FEDERAL DRUG TESTING CUSTODY AND CONTROL FORM The Federal Drug Testing Custody and Control Form or CCF must be used to document every urine collection required by the DOT drug testing program. The CCF must be a five part carbonless manifold form. The CCF consists of the following five copies: 1. Laboratory Copy – accompanies the specimen to the laboratory 2. Medical Review Officer Copy – faxed to the MRO within 24 hours


3. Collector Copy – retained by the collector 4. Employer Copy – sent to the employer 5. Donor Copy – given to the employee Do not use a Federal Drug Testing Custody and Control Form or CCF for Non-DOT collections. WHAT IS A REFUSAL TO TEST?

If the donor refuses to test, the event is over. The collector needs to document the event and the circumstances around the refusal to test. Always complete the CCF form with the donor name on Copy 2 – Step 5 and complete also Step 4 on Copy 1 the collector certification. Always distribute the Employer copy, Donor copy and the MRO copy. The lab copy can be discarded or kept with your collector copy. Call the DER as the event ends. The collector is documenting the actions of the donor which lead to the refusal the MRO and/ DER make the official determination of the refusal to test. Donor Actions Causing a Refusal to Test:

• Donor fails to appear for any test (except a pre-employment) within a reasonable amount of time • Donor fails to remain at the testing site until the testing process is complete (pre-employment

exception) • Donor fails to provide a urine specimen for any drug test required by DOT agency regulations;

without documented medical explanation obtained after the collection • In the case of a directly observed drug test - failure to permit the observation of the provision of

a specimen or fail to raise the donor’s shirt, blouse or dress/skirt above the waist and lowering clothing and underpants to show the collector that the donor does not have a prosthetic device

• Donor fails to cooperate with any part of the testing process (e.g., refuse to empty pockets, behave in a confrontational way, donor fails to wash hands after being directed to do so)

• Donor is found to possess or wear a prosthetic device that could be used to interfere with the collection process

• Donor admits to the collector or MRO that he/she attempted to adulterate or substitute the specimen

If the donor refuses to sign the CCF form or refuses to initial the specimen security labels, this is NOT a refusal to test. Note this in the remarks section of the CCF. If you have a refusal to test, afterwards always call and notify the DER. MONITORED COLLECTIONS If you use a multi-stall restroom, you must either:


Secure all sources of water and other substances that could be used for adulteration and substitution (e.g., water faucets, soap dispensers) and place bluing agent in all toilets or secure the toilets to prevent access; or Conduct all collections in the multi-stall facility as monitored collections. This is the only circumstance in which you may conduct a monitored collection. No one but the employee may be present in the multistall restroom during the collection, except for the monitor in the event of a monitored collection or the observer in the event of a directly observed collection. For a monitored collection the monitor goes into the restroom with the donor but not into the individual stall. The stall secured for the collection should have bluing agent in the toilet and no items in that stall. The purpose of the monitored is so the collector does not have to secure the entire multi-stall restroom. As the collector, you must secure the room being used for the monitored collection so that no one except the employee and the monitor can enter it until after the collection has been completed. As the collector, you must ensure that the monitor is the same gender as the employee, unless the monitor is a medical professional (e.g., nurse, doctor, physician's assistant, technologist, or technician licensed or certified to practice in the jurisdiction in which the collection takes place). The monitor can be a different person from the collector and need not be a qualified collector. As the monitor, you must not watch the employee urinate into the collection container. If you hear sounds or make other observations indicating an attempt to tamper with a specimen, there must be an additional collection under direct observation. As the collector, when someone else has acted as the monitor, you must note that person's name in the “Remarks” line of the CCF (Step 2). As the employee being tested, if you decline to permit a collection authorized under this section to be monitored, it is a refusal to test. Review Monitored Collection:

• Monitor is same gender as employee unless monitor is licensed medical professional • Monitor may be someone other than collector to ensure same gender (note name on CCF if not

collector) • Sounds or observations indicating an attempt to tamper with the specimen by the monitor

result in observed collection • Monitor, who is not the collector, does not handle the urine specimen

DONOR REFUSES TO SIGN If the donor does not initial the seal or refuses to initial, the collector must indicate it on the CCF in the “Remarks” section. This is not a refusal to test.


If the donor refuses to sign Step 5 on Copy 2 the donor certification section, this is not a refusal to test. Print the donor name where indicated in Step 5 on Copy 2. Make a note in the “Remarks” section on Copy 1 that the donor refused to sign. Complete the collection, again this is NOT a refusal to test. CORRECTABLE FLAWS If a laboratory discovers a “correctable flaw” during the processing of incoming specimens, the laboratory will attempt to correct the flaw. If the laboratory is unsuccessful it will report the specimen as “Rejected for Testing.” As a collector you will receive a Memorandum for Record or an Affidavit from the lab for you to sign off on the correctable flaw. Complete this Memorandum for Record or an Affidavit from the lab immediately, if the lab does not receive it back within five business days; the test will be canceled and reported as “Rejected for Testing.” The following are correctable flaws:

1. Donor refuses to sign and no remarks indicating this 2. Wrong form used – (i.e. post accident test no other form available) 3. Collector’s signature or printed name omitted 4. Specimen temperature not checked & no remarks

FATAL FLAWS The following errors or omissions are considered “fatal flaws” according to the Department of Transportation. These errors or omissions will result in a rejection of a specimen or a cancelled test. 1. The collector’s printed name and signature are omitted from the custody and control form. 2. The specimen identification numbers on the bottle and the CCF do not match. 3. The specimen bottle seal is missing, broken or shows evidence of tampering. 4. An insufficient quantiy of specimen (less then 45ml) is received at the lab. When the laboratory discovers a “fatal flaw” during its processing of incoming specimens the laboratory will report that the specimen has been “Rejected for Testing” (with the reason stated). The MRO must always cancel such a test. ERROR CORRECTION TRAINING When a collector makes a mistake that causes a drug or alcohol test to be cancelled, he or she must complete Error Correction Training within 30 days of being notified of the error. The Error Correction Training is only required to cover the subject matter relating to the error that caused the test to be cancelled, but must include a proficiency demonstration. The required demonstration must include one uneventful scenario and two scenarios related to the area or areas in which the error occurred. TEMPERATURE OUT OF RANGE


When the donor comes out of the bathroom with the urine specimen, the collector takes the collection container from the donor and immediately views to see if the temperature is in range. Then also check the bathroom to make sure it is still secure and nothing left behind to indicate adulteration, substitution or any kind of tampering with the specimen.

If the temperature of a urine specimen is outside the range of 90-100°F (32-38°C), there is reason to believe that the donor may have altered or substituted the specimen. In this case another urine specimen must be collected under direct observation. First and foremost, complete the first collection, all paperwork and seal up the specimen bottles and Copy 1 of the custody and control form. Prior to completing this first collection, once you

know the temperature is out of range; explain to the donor the requirement for a second collection under direct observation. Explain the direct observation procedures. Ask the donor “Do you want to proceed?” If the donor does not want to proceed this is a refusal to test, follow the steps to complete a refusal to test. Now, complete the first collection. Check the box ‘NO’ temperature is not in range and record remarks – ‘Temp out of range’. Also, in the remarks area write “Spec 1 of 2 – (123).” The (123) should be the specimen ID number from the second custody and control form you will be using. The specimen ID number for each collection must be cross referenced on the other custody and control form. Once the first collection with the out of temperature range is complete, you will start the second collection under direct observation. All of the information in Step 1 of the second collection will be the same as in Step 1 of the first collection, just copy it over. On the second custody and control form, once the new specimen is collected, mark the box Observed, and add remarks: “1st specimen out of range, spec 2 of 2 (456).” The (456) should be the specimen ID number from the first custody and control form. Complete the second collection using the direct observation procedures. If you have another person do the observation, indicate this in the remarks on the custody and control form. Make sure you review the direct observation procedures with this person. Upon completion of the second collection, you will have two sealed specimen bags and two sets of custody and control forms. You will disburse all copies of all form as appropriate.


DIRECT OBSERVATION COLLECTION There are certain situations where a collection must be direct observed – a witness in the bathroom with the donor. The observed collection must be gender specific – no exceptions. DOT has a document called DOT’s Direct Observation Procedures available to address when a direct observation is conducted and the instructions for this direct observed collection. Please review this document carefully – Click Here. Always in advance of a direct observed collection inform the donor of the procedures and then state “Are you willing to proceed?” If they are not willing to proceed this is a refusal and the event is over, document everything and follow procedure for a Refusal to Test. For opposite sex collections you can have a co-worker or other individual perform the observation, you must give them the instructions for the observation located on the DOT’s Direct Observation Procedures document. Also record the observers name on the Remarks section of the custody and control form. If the collector learns that a directly observed collection should have taken place, but was not, the collector must inform the employer that the employee must be directed to return for an immediate recollection under direct observation. After a direct observation collection, always call and notify the DER. SHY BLADDER In a DOT collection, the donor is always required to make an attempt to void a specimen. If thy say they cannot go right now, they are required to try anyway. Once an unsuccessful attempt is made this starts the shy bladder process. A Shy Bladder Log is used to document the shy bladder process. When you start the Shy Bladder Log you stay on the log until it is complete. Then you go back to custody and control form. Instruct the donor to not drink any fluids except the water provided (NO MORE THAN 40 OUNCES). A clinic employee must monitor the donor during the three-hour period or until an appropriate specimen is provided, whichever comes first. All fluids provided and collection attempts made after the initial attempt must be documented. Be prepared to stay after-hours if the three-hour interval extends beyond your shift. Note: A refusal to drink fluids is not a refusal to test. Make a remark and proceed with the collection. Specimens are never combined to get the 45ml needed for a successful collection. Each insufficient quantiy of specimen is discarded unless it appears to be tampered or temperatue out of range – these are packaged up with a complete custody and control form for testing at the laboratory. The second


http://www.dot.gov/sites/dot.dev/files/docs/ODAPC%20DOTs_Direct_Observation_Procedures_Instruction_Sheet_August312009.pdf

http://www.dot.gov/sites/dot.dev/files/docs/ODAPC%20DOTs_Direct_Observation_Procedures_Instruction_Sheet_August312009.pdf

collection is performed under direct observation procedures. Both specimens are sent to the lab with one referencing the other. Also, in the remarks area write “Spec 1 of 2 – (123).” The (123) should be the specimen ID number from the second custody and control form you will be using. The specimen ID number for each collection must be cross referenced on the other custody and control form. Once the first collection is complete, you will start the second collection under direct observation. All of the information in Step 1 of the second collection will be the same as in Step 1 of the first collection, just copy it over. At the three hour mark, if the donor could not provide a specimen, the collector notifies the DER and makes a note in the remarks section of the custody and control form. Attach the Shy Bladder Log to your collector copy so it is available upon request to the MRO or employer. Review Shy Bladder Procedure:

• Provide instructions to donor and document

• Instruct donor to drink up to 40 oz. of fluid, reasonably distributed - Refusal to drink fluids is not a refusal to test

• Donor has 3 hours to provide a sufficient specimen

• Donor cannot leave collection site before the collection process is completed - this is a Refusal to Test

• If no specimen is provided, immediately notify the DER, mark “None-Provided” box on CCF & note on “Remarks” line that additional notes are on the Shy Bladder Log. Send the CCF copies to MRO & Employer. Keep the shy bladder log for your collection site records.


Monitoring Collection Sites – May, 2016 Page 20 of 20

What Employers Need To Know About

Monitoring Collection Sites [Guidance and Best Practices]

Revised May, 2016

U.S. Department of Transportation Office of the Secretary


1200 New Jersey Avenue, S.E. W62-300

Washington, D.C. 20590

202.366.3784

202.366.3897 fax

www.transportation.gov/odapc

[email protected]

Changes from previous version [April 2016]: • New Page 2: A blank placeholder page • Page 19: Amended 3rd bullet point and ‘Note’ • Document reformatted as needed


http://www.transportation.gov/odapc



[This page intentionally left blank]



Table of Contents

Introduction ............................................................................................................................................................................ 4

Overview ................................................................................................................................................................................. 6

Level 1: What can I do without visiting the collection site? – The Desk Audit ...................................................................... 7

Overview ............................................................................................................................................................................. 7

What I should look for during a desk audit? ....................................................................................................................... 7

What are the basics I need to know about the collections? ............................................................................................... 8

What do I look for on the testing forms? ............................................................................................................................ 9

General: ........................................................................................................................................................................... 9

For alcohol tests: ........................................................................................................................................................... 10

For drug tests: ............................................................................................................................................................... 10

Complete the Testing Event: ......................................................................................................................................... 11

Error Correction Training: ............................................................................................................................................. 12

For Refusals: .................................................................................................................................................................. 12

Level 2 – What if I have some time to visit a collection site, but am not sure what to look for when I am there? – The Basics of Collection Site Visits ............................................................................................................................................... 13

Overview ........................................................................................................................................................................... 13

Items to review annually ................................................................................................................................................... 14

Level 3 – How would I conduct an expanded collection site visit? – Enhanced Collection Site Review .............................. 15

Overview ........................................................................................................................................................................... 15

Staying Proactive ............................................................................................................................................................... 15

APPENDIX .............................................................................................................................................................................. 17



Introduction Do you employ safety-sensitive employees who must take drug and alcohol tests regulated by the United States Department of Transportation (DOT)? If so, this brochure can help you understand what you can do to monitor the activities of the collection sites that are performing those drug and alcohol test collections. Having an effective substance abuse prevention and testing program is vital to your organization’s success and to public safety. An excellent drug and alcohol testing program starts with a collection site that fully meets all requirements for the safety, privacy, security and integrity of the testing site and the testing process. As the drug and alcohol program manager for the employer, you are the employer’s representative and are responsible for ensuring that the collections are performed in compliance with the various DOT regulations.

Ensuring the fairness, accuracy, security and integrity of the specimen collection process is fundamental to transportation safety. If you allow your collection sites to slip below the requirements that ensure safety and security for the required collections, you open the door to those who want to mask their illicit drug use by cheating or otherwise subverting a test so that they can continue to use illegal drugs undetected. At the same time, those employees without a previous violation have a reasonable expectation of privacy while providing a sample. As the employer, it is your responsibility to play a key role in quality assurance and consistency in the success of the DOT-regulated collections performed for your company.

We realize that running the drug and alcohol testing program for your company may not be your full-time job, so you need efficient and cost-effective strategies for monitoring a collection site in the least amount of time and most efficient way. Monitoring your collection site does not have to be difficult – but it does need to be smart and efficient so that it produces the desired outcome with the minimal amount of time, so that you can still have time for your other workplace responsibilities.

We recognize that monitoring your collection site can involve several varying levels of oversight depending upon how much time you can spend accomplishing this task. In this brochure, we will describe three levels of collection site monitoring commonly used in the transportation industry. The three levels are: Level 1 – the desk audit; Level 2 – collections site visits; Level 3 – enhanced collection site review.

Based on the number and locations of the collection sites your company uses, your resources and availability, and any problems that have occurred at collection sites, you can choose the levels that will work most effectively for your program. In some situations, it can be reasonable to mix and match your approaches. For example, for small numbers of trouble-free collection sites, an annual desk audit might be sufficient; larger volume sites or sites that have more problems might call for more active oversight. Ideally, you want to provide the highest degree of oversight, as explained in Level 3. The employer is likely to be held responsible for the actions of the collector(s), so it is important for you to take the steps necessary to monitor your collectors at the highest level possible.



This is not a legal document that adds to or makes any official interpretations of DOT rules. This publication is for educational purposes only. This brochure is a supplement to and should be read along with our earlier publication for employers, ―What Employers Need to Know About DOT Drug & Alcohol Testing at: http://www.transportation.gov/odapc/employer_handbook.

For questions about the rules, please contact the Office of Drug and Alcohol Policy and Compliance (ODAPC) at 202.366.3784 or e-mail us at [email protected]. You can find contact information about DOT Agency and United States Coast Guard drug and alcohol program managers on our website at: http://www.transportation.gov/odapc/agencies


http://www.transportation.gov/odapc/employer_handbook


http://www.transportation.gov/odapc/agencies


Overview As an employer, especially as the Designated Employer Representative (DER), you will find Appendix C of our Employer’s Handbook (http://www.transportation.gov/odapc/employer_handbook) to be a good place to find the basic administrative details of what to ask of and expect from your collection sites. It is also a good resource regarding what to ask about completing the Federal Drug Testing Collection Custody and Control Form (CCF) and the DOT Alcohol Testing Form (ATF). For your convenience, we have reprinted that information here:

The following is a list of the most common service agents and some starting points to help you select them: URINE SPECIMEN COLLECTORS, BREATH ALCOHOL TECHNICIANS (BATs) AND SCREENING TEST TECHNICIANS (STTs) There are a number of things to look for when selecting collectors, BATs, and STTs:

1. Ensure they offer the services you want. For example, do they offer both urine collections and alcohol testing? Will they come to your worksite to conduct the testing if that is what you want?

2. Make sure they are open for business at the times you need them. Are they open during the times your employees are on duty and may need to have tests? Will they remain open after their closing time if an employee presents an insufficient amount of urine?

3. Make sure they show you training documentation for their personnel. 4. Have them explain their procedures for notifying you or the DER of test results – especially refusals,

positive alcohol tests, and problems with employees. 5. Check-out their collection sites for security and site integrity. [See the ODAPC 10 Steps to Collection

Site Security and Integrity video]. 6. Determine if their facilities are conveniently located and offer parking. 7. Find out if they have the correct CCFs, ATFs, collection kits, and alcohol test equipment. 8. Ask if they have a fax machine and intend to use it immediately after each DOT collection and/or

alcohol test to appropriately distribute the paperwork. 9. Have them explain their procedures for collecting specimens under direct observation and whether

they have same gender observers readily available. 10. Ask if they have DOT’s Urine Specimen Collection Guidelines, Part 40, and the ODAPC 10 Steps to

Collection Site Security and Integrity poster on the premises. 11. See if they have references from other employers and records of DOT inspections and audits.

A best practice is to visit collection facilities from time to time, when your employees are there for tests to see for yourself how the process is going. You may discover that the site does not ensure the integrity of the process or you may find that they do ensure the integrity of the process. You should also talk with your MRO to see how often tests are cancelled because of collector errors for any DOT-regulated employer. If collection companies are not doing a good job for you, look elsewhere for the service. Don’t risk being out of compliance with the various DOT regulations.

Note: The points above and in this brochure are fundamental points for you to cover, regardless of which level of monitoring you choose to do and whether the collections occur at your place of business or at an off-site collection site facility.


http://www.transportation.gov/odapc/employer_handbook

http://www.dot.gov/ost/dapc/video.html

http://www.dot.gov/odapc/urine-specimen-collection-guidelines

http://www.dot.gov/odapc/part40

http://www.dot.gov/odapc/dot-10-steps-collection-site-security-and-integrity-english


Level 1: What can I do without visiting the collection site? – The Desk Audit

Overview If monitoring your collection site(s) is a new task for you, the most basic level of monitoring is a desk audit, which allows you to provide a basic level of monitoring from within your office. Small employers or those with very limited resources may want to use this level of review. One of your first steps is to establish the basics. For example: the name, location, and distance to your collection site and confirm that the facility and its manager(s) are aware that they are providing you with DOT-regulated drug and alcohol tests. Ask them what their hours of operation are to determine their availability during your company’s hours of operation. Will the site be able to conduct testing during all of the hours your employees are performing safety-sensitive operations? How will they handle events that occur after their normal operating hours, such as reasonable cause/reasonable suspicion tests and post-accident testing?

Also, think about whether the collection site knows how to contact you about any problems. Are you available to the collection site at any time that your collections are occurring? What I should look for during a desk audit? When you have established the basics, you must now solidify the expectations between you and the collection site. Many employers take this for granted, and only discover that their expectations are not met after it is too late for corrections. You need to establish and communicate your specific expectations to ensure that the requirements for the integrity and accuracy of DOT-regulated collections are being met. You also need to make sure that the collection site’s capabilities meet your expectations. Whenever a collection site is not meeting your expectations, you need to revisit the issues and require the collection site to revise its procedures to meet your expectations under the various DOT regulations. Here are some best practices and expectations to communicate to your collection site(s):

1. Whether or not you, as the employer, can set appointments for each collection; 2. The name of your primary point of contact at the collection site for questions or concerns; 3. Whether the collection site or you will keep the supply of testing forms (pre-printed CCFs and/or ATFs)

to be used (often it will be more convenient for the collection site to keep the forms in stock); 4. A definite set of phone numbers, emails, fax numbers, etc. for the collection site to contact you or your

designee at all times (on Step 1 of the CCF); 5. The method and frequency by which the collection site will send paperwork and other information to

you; 6. Use of employer-specific CCFs for your employees; 7. Establish a secure way of communicating orally and/or by other means between you and the collection

site. For example, set up a password for confirming identities between you and the collection site;



8. Whether or not the collection site has the ability to conduct both drug and alcohol testing (if the collection site cannot perform DOT alcohol tests, you will need to establish a method to do so elsewhere);

9. What the collection site will do in the event that a directly observed collection is needed. Be sure to ask what they will do to obtain an appropriate same-gender observer;

10. What the collection site will do when your company needs a collection to be performed after the collection site closes and whether they would provide mobile or on-site collection site services after hours;

11. What procedures the collection site will use to handle and to notify you of abnormal occurrences, such as dealing with a belligerent donor, employees arriving late, or situations arising at the collection site that appear to be a refusal under the DOT regulations.

These procedures will define how the collection site handles your collections. Communicate your directions and expectations clearly in writing and orally to the collection site. These directions and expectations may need to be reiterated or revisited, as collection site staff changes.

At times, new collection site management unfamiliar with DOT regulations may institute changes that bring the process out of compliance. Normal staff turnover throughout the course of the year is also common, so a good monitoring program will keep up to date with the changes. You can establish, as an expectation, the requirement that the collection site inform you of staff changes that alter the pool of available DOT drug and alcohol test collectors. When they update you, have them also include a statement or documentation that confirms the training requirements were met.

As the person responsible for the drug and alcohol testing program, you should regularly read DOT email updates (subscribe at no charge at: https://www.transportation.gov/odapc/get-odapc-email-updates ) and federal newsletters, stay current with regulatory changes, and consult with a representative from your DOT Agency https://www.transportation.gov/odapc/agencies or ODAPC at: [email protected], as needed.

Remember, as the employer, you remain responsible for the actions of the collection site! You can contract out testing functions, but you can never contract away your responsibilities.

At this basic level of oversight, you may choose not to visit the collection site yourself, so it is important to set up and communicate your expectations very specifically.

What are the basics I need to know about the collections? Once you’ve established the expectations and communicated them to the collections site, ask how many collectors are trained to perform DOT-regulated drug and alcohol tests. Ask for copies of any proof of training for each collector, Breath Alcohol Technician (BAT) or Saliva Testing Technician (STT) on the staff who might be performing your DOT-regulated drug or alcohol test(s).



https://www.transportation.gov/odapc/agencies



The DOT regulation states that a collector must maintain documentation showing that he/she meets all the training requirements. The DOT regulation also requires that the collectors, BATs and STTs, provide this documentation to you by if you request it.

Remember that the DOT does not certify collectors. In addition, we do not recognize any training certificates. We only recognize documentation of the qualification training required under 49 CFR Section 40.33 for urine collectors and under 49 CFR Section 40.213 for BATS and STTs. The documentation must show that the requirements for qualification training have been met and that the individual collector, BAT or STT has successfully demonstrated that he/she is able to properly perform the required DOT mock collections. The collector must also have documented any required requalification training.

If the collection site also performs DOT alcohol tests, ask for the model number of their Alcohol Screening Device (ASD) or Evidential Breath Testing Device (EBT). Compare it to the Conforming Products List to ensure that it is valid:

Screening devices: https://www.transportation.gov/odapc/approved-alcohol-screening-devices

Evidentiary Devices: https://www.transportation.gov/odapc/approved-evidential-breath-testing-devices

(or search for NHTSA Conforming Products List on the Internet for other sources)

Make sure that the BATs know how to employ the manual mode and understand that there is an option for using the manual mode on the EBT if an employee cannot provide sufficient breath for the automatic mode.

What do I look for on the testing forms?

General: Once you have confirmed that you have a collection site with qualified personnel who can perform DOT urine collections and alcohol tests and you have established your basic expectations, you should review copies of the completed testing forms that the collection site provides to you for your company (they are marked “Employer Copy”). The easiest way to review a CCF (for a urine collection) or an ATF (for an alcohol test) is to check each step for completeness and accuracy. Here are the overarching ideas:

• Are the date and time the employee reported for testing listed on the CCF or ATF what you expected them to be? Was there a delay between when you notified the employee of the need to go for the test and the time the employee arrived at the testing site?

• Is the employee identified on the forms the same employee you sent? • Did the collector and the employee both sign the CCF or ATF as needed?


https://www.transportation.gov/odapc/approved-alcohol-screening-devices

https://www.transportation.gov/odapc/approved-evidential-breath-testing-devices

https://www.transportation.gov/odapc/approved-evidential-breath-testing-devices


For alcohol tests: Was an alcohol test ordered at all? If so, was it completed? If a drug test was also ordered, was the

alcohol test conducted first? (If both tests are required, to the greatest extent practicable, the alcohol test is to be completed before the urine collection process begins.) You can determine this by examining the time printed or written on the ATF versus the time written by the collector in Step 4 of the CCF.

Note the time on the ATF: either a printout affixed to the form, printed directly onto the form, or written in by hand if the device is not designed to print.

Are the dates and times accurate?

What was the final screening test result? (Was the screening test result between 0.00 – 0.019?)

What was the confirmation test result (if the screening test was 0.02 or greater)?

If required, was an air-blank performed?

Is the description, name, or serial number of the device used clearly indicated?

For drug tests: Was a drug test ordered at all? If so, was it completed?

Did the collection site use the correct Federal CCF? (Sometimes collection sites mistakenly use non-

Federal forms.)

Does the CCF contain accurate information is Step 1, Parts A and B?

Are the appropriate modal boxes checked in Step 1, Part D? For example, if you are a trucking company, the FMCSA box should have been checked.

Can you read the handwriting of the collector?

Did the collector press hard enough when writing that the carbon images are clearly visible and legible?

Check Step 2 to ensure that the temperature was in range and that a split specimen was collected and checked.



If “Observed” has been indicated, ensure that an explanation is clearly written in the REMARKS section. Unless it is a return-to-duty test or a follow-up test, it is a good business practice for you to confirm by telephone or by immediate email, why the collection was directly observed, making absolutely certain that it was justified, and if it did actually occur.

o If “Observed” is not indicated, and it was a return-to-duty test or follow-up test, it is a good business practice to for you to confirm with the collector and/or employee to verify this. It could be that the box wasn’t checked. However, if it wasn’t collected under direct observation, the employee must have another collection immediately under direct observation.

Are there carbon shadows visible on the bottom of the CCF? Specifically, shadows indicate that the

donor initialed the labels while they were on the CCF and not after the collector applied them to each of the 2 specimen bottles.

If an employee is unable to provide a specimen, we call it a “shy bladder” situation. After a shy bladder has occurred, was it written up in the Remarks in Step 2? Does your protocol with the collection site require additional documentation to record shy bladders?

Do the dates in Steps 4 and 5 match? They should.

Complete the Testing Event: Using your first-hand knowledge of the collection process you gained during your visit, you can compare your expected level of performance with what the testing forms are showing you. When a test has been performed, the testing process is not complete just because your employee left the collection site. The testing event is still open until you receive:

(1) your copy of the testing form,

(2) the test result (if it arrives separately), and

(3) resolution of any errors from the process

Make notes or keep a log or list of the errors you have found. Communicate the errors directly to the collection site and require written responses acknowledging the errors. Request that the collection site provide you with the steps that they have taken to ensure that the mistakes do not reoccur.



Error Correction Training:

(1) If the collector or alcohol technician is notified by the employer or service agent that error correction training was required because the collector’s or alcohol technician’s error caused the test to be cancelled, the collector or alcohol technician must complete the training within thirty days of being notified of the error.

(2) The collector or alcohol technician must provide documentation that he/she completed the error correction training within 30 days of being notified of the error that caused the test to be cancelled.

(3) If the collector or alcohol technician did not complete error-correction training within 30 days of being notified that error correction training was required, he/she is not qualified to act as a collector or alcohol technician.

Notify the collection site with any questions you have and/or any errors you found. If you do require corrections that would be correctible flaws under the DOT regulation, ask for and receive the corrections in writing (emails are allowable as documentation for this purpose and provide an excellent correspondence chain record).

For Refusals: A critical part of running your program is to familiarize yourself with the situations that the DOT rules described as refusals to test and look at the chart entitled “What exactly is a refusal to test and who determines it?” in the DOT Employer’s Handbook, "What Employers Need to Know About DOT Drug and Alcohol Testing”: https://www.transportation.gov/odapc/employer_handbook

Because the majority of the refusals are only possible during the collection process, you should understand the actions that are considered to be a refusal under the regulations, as these may trigger further action between your company and the employee. In many cases, the decision about whether an employee has refused a test must be made by you on the basis of information provided to you by the collector. In those cases, this decision is not made by the collector.


https://www.transportation.gov/odapc/employer_handbook


Level 2 – What if I have some time to visit a collection site, but am not sure what to look for when I am there? – The Basics of Collection Site Visits

Overview The second level of monitoring begins with the steps mentioned in Level 1, but then adds one or more visits to the collection site. Employers who might want to use this level of monitoring often include those who have gone through an audit or inspection, or those are interested in increasing their involvement with the program. Before visiting the collection site, a good first step would be to view the “10 Steps” video and the mock collection video produced by the DOT at these links:


https://www.transportation.gov/odapc/dot-mock-collection-instructional-video

After viewing the video and familiarizing yourself with the collection process, schedule an appointment with your collection site. Be sure to set aside at least one hour for this visit to the collection site. Before your appointment, spend at least five minutes reading the steps of a drug test (listed on the back of Copy 5 of the Federal CCF). The front of the CCF also lists each step instructively in steps one through five. Also, it’s a good idea to review the DOT’s one-page instruction sheet for the collection process entitled, “DOT’s 10 Steps to Collection Site Security and Integrity”: https://www.transportation.gov/odapc/dot-10-steps-collection-site-security-and-integrity-english, reprinted here for your convenience:

“DOT’s 10 Steps to Collection Site Security and Integrity”

1. Pay careful attention to employees throughout the collection process.

2. Ensure that there is no unauthorized access into the collection areas and that undetected access (e.g., through a door not in view) is not possible.

3. Make sure that employees show proper picture ID.

4. Make sure employees empty pockets; remove outer garments (e.g., coveralls, jacket, coat, hat); leave briefcases, purses, and bags behind; and wash their hands.

5. Maintain personal control of the specimen and CCF at all times during the collection.

6. Secure any water sources or otherwise make them unavailable to employees (e.g., turn off water inlet, tape handles to prevent opening faucets, secure tank lids).

7. Ensure that the water in the toilet and tank (if applicable) has bluing (coloring) agent in it. Tape or otherwise secure shut any movable toilet tank top, or put bluing in the tank.

8. Ensure that no soap, disinfectants, cleaning agents, or other possible adulterants are present.

9. Inspect the site to ensure that no foreign or unauthorized substances are present.

10. Secure areas and items (e.g., ledges, trash receptacles, paper towel holders, under-sink areas, ceiling tiles) that appear suitable for concealing contaminants.




https://www.transportation.gov/odapc/dot-10-steps-collection-site-security-and-integrity-english

https://www.transportation.gov/odapc/dot-10-steps-collection-site-security-and-integrity-english


It is a good idea for you to have an agreement with a collection site that will allow you to schedule site visits. When you arrive at the collection site, ask to be given a walk-through of each step in the collection process. The collector or collection site representative should actually take you to each location where the various steps occur. Note the number of people at the facility, both staff and customers. If the waiting area is full and you have to wait for your walk-through, you can assume that your employees will have a similar experience while waiting to take their tests.

After the collector shows you the intake process, which usually includes showing identification or signing an arrival sheet or list, you will likely be shown the area where the collection process will begin. The collector should walk you through each step of the collection process for both an alcohol test and a drug test (if the site does both), explaining each step along the way.

Refer to the Appendix of this brochure for a simplified list of the steps with tips for monitoring how a collection site should carry out the collection procedures.

After your demonstration, you can gauge how well the collector understands the collection process and you may have a better sense of the dynamics at the facility as it relates to customers.

From your office, you should continue to monitor the site’s performance. You should still review each testing form as it arrives or is electronically transmitted following a drug or alcohol test. When the form arrives, you should check it for accuracy and completeness, carefully noting that each step has been completed as you would expect and in a way that is consistent with the type of collection that was conducted.

Items to review annually As the employer, when you monitor the CCFs that are sent to you throughout the year, it is important to remember that you should continue to communicate with the collection site. Ask the collection site manager or representative if new collectors have been hired to perform DOT-regulated tests, or if any collectors have been through requalification training. Collector names are printed on the testing forms, so you can monitor the staff members who are performing these duties and inquire as to the completeness of their training.

When reviewing the collection site for alcohol testing, you should also verify that the collection site is using equipment from the Conforming Products List; regularly performing accuracy checks, calibrating (if qualified), and submitting the equipment for timely manufacturer overhaul; and that their alcohol devices are operated as required by the manufacturer’s Quality Assurance Plan (QAP) for the device. After daylight savings time changes, or if you are near a time-zone border, check to see that the internal clock on the alcohol testing device is adjusted appropriately.

Because collection site management and personnel can change over time, it is a good idea to schedule follow-up visits to the collection site. You need to make sure the facility and its staff are continuing to do the job right so that you can ensure that you are compliant with DOT drug and alcohol regulations.



Level 3 – How would I conduct an expanded collection site visit? – Enhanced Collection Site Review

Overview The top level of collection site monitoring involves a system of both proactive efforts to identify potential problems and reactive measures to fix what has gone wrong. This level of review should include all aspects of Level 1 and Level 2 reviews. As in the lower levels of review, communication with your collection site(s) throughout the year is very important. Remember, collection site staff turnover is common and you want to make sure that each collection site you use is continuing to perform in compliance with the DOT regulations.

Staying Proactive Your enhanced level of monitoring should still include having the collector walk you through the process but you have other options for taking a closer look. One way is to perform a “mock-collection” where you are the donor, but the collector is demonstrating and you are not actually providing a specimen. The advantages of a mock-collection involve exploring the depth to which the collector has been trained and is familiar with the regulations by asking them the required steps for several different scenarios that fall outside of everyday occurrence.

Different DOT Agencies have checklists their inspectors/auditors use for performing mock collections. You can download many of the DOT Agency checklists from these websites:

The Federal Aviation Administration’s website (http://www.faa.gov/go/drugabatement) includes a link to their Drug and Alcohol Compliance and Enforcement Inspector’s Handbook, Order 9120.1, which includes an audit guide for the collection site. It is available at:

http://www.faa.gov/documentlibrary/media/order/full%209120.1a1.pdf

The Federal Motor Carrier Safety Administration’s Checklist is found at pages 6-25 to 6-32 of:

https://www.fmcsa.dot.gov/sites/fmcsa.dot.gov/files/docs/Implementation_Guidelines_for_Alcohol_and_Drug_Regulations.pdf

The Federal Transit Administration’s Checklist is found at: http://transit-safety.fta.dot.gov/publications/substance/CollectorSiteChecklist/pdf/CCF_Collection_Site_Checklist_2012-08.pdf

The Pipeline and Hazardous Materials Safety Administration Inspection Forms found at:

http://www.phmsa.dot.gov/pipeline/drug/inspect


http://www.faa.gov/go/drugabatement

http://www.faa.gov/documentlibrary/media/order/full%209120.1a1.pdf



http://transit-safety.fta.dot.gov/publications/substance/CollectorSiteChecklist/pdf/CCF_Collection_Site_Checklist_2012-08.pdf



http://www.phmsa.dot.gov/pipeline/drug/inspect


In addition to asking the questions on a DOT Agency’s checklist, a good monitoring program will determine the protocols for all of the collection scenarios that are listed in the regulation but rarely occur. Review the DOT’s mock collection video at: https://www.transportation.gov/odapc/dot-mock-collection-instructional-video to refresh your recollection on the following:

(1) Does the collection site know when and how a directly observed collection is to take place? (2) Do they have the personnel available to perform it? (3) Do they have a method to ensure that donors are provided with up to 40 ounces of fluid during a shy-

bladder waiting period? (4) Does the facility monitor the employee during the (up to three hour) waiting period? Will the

collection site allow the donor to remain on-site and supervised after normal business hours if an employee requires all or part of their three-hour allotment?

A Level 3 monitoring program allows you to have an on-going relationship with the collection site(s) and the collectors. This generally means that you, as the employer, speaks, meets, or corresponds regularly with the collectors to ensure that they are conducting all DOT urine collections as prescribed in the regulations. At this top level, employers who build and maintain a strong peer network of other managers from different-sized organizations often have much stronger programs.




APPENDIX Breath Alcohol Testing Steps:

For the screening test:

• The technician verifies the identity of the employee by checking his/her photo identification;

• The technician explains testing procedure and shows the employee the instructions on the back of the ATF;

• The technician completes Step 1 of the ATF;

• The technician instructs the employee to complete Step 2 of the ATF;

• The technician administers the screening test;

• The technician shows the employee the screening result;

• The technician documents the result on the ATF.

If the screening test result is less than 0.02:

• The technician completes Step 3 by dating and signing the certification;

• The technician distributes Copy 1 to the employer, Copy 2 to the employee, and retains Copy 3.

If the screening test result is 0.02 or greater, a confirmation test must be conducted by a BAT:

• The BAT observes a 15 minute waiting period;

• After the waiting period, the BAT is to conduct an air-blank (which must read 0.00);

• • The BAT administers a confirmation test using a new mouthpiece;

• The BAT shows the employee the displayed result;

• The BAT prints the result and attaches it to the ATF;

• The BAT completes Step 3;

• The BAT has the employee complete Step 4 (frequently the employee will choose not to sign);

• The BAT distributes the ATF accordingly.

Note: A confirmation test must be conducted on an EBT that appears on the Conforming Products List (CPL) and prints a result.



APPENDIX (continued)

Urine Collection Steps:

• The collector verifies the identity of the employee by checking his/her photo identification;

• The collector instructs the employee to remove any outer garments (e.g., jacket, coat, hat) and leave their personal belongings such as purses or briefcases in a locked box;

• The collector instructs the employee to empty their pockets and display the contents;

• The employee is given the option to keep their wallet after being inspected;

• The collector explains the basic collection procedure/shows donor instructions on the back of the CCF;

• The collector completes Step 1 of the CCF (parts of this may be pre-printed);

• The collector instructs the donor to wash and dry their hands;

• The collector unwraps a sealed collection container in front of the donor;

• The donor is provided with a single-use plastic container from collection kit;

• The donor remains in the presence of the collector until entering the privacy enclosure to provide the specimen;

• The collector ensures that privacy for urination is secure and a bluing agent is in the toilet.

--The donor then provides a specimen and brings the specimen to the collector--

• The collector observes that the specimen quantity is at least 45mL and checks the split specimen box in Step 2;

• The collector determines the temperature reading and checks off the temperature box in Step 2 within 4 minutes of the collection taking place;

• The collector pours at least 30 mL of urine into the primary specimen bottle and at least 15 mL in the second specimen bottle;

• The collector securely places tamper-evident bottle seals over the bottle caps/lids;

• The collector dates specimen seal bottles only after they are affixed to the specimen bottles;

• The donor initials specimen seal bottles only after they are affixed to the specimen bottles;



APPENDIX (continued)

• The collector folds away Copy 1 of the CCF to reveal Copy 2 (the MRO Copy), with Copies 3, 4, and 5 underneath as well) and instructs the donor to read and complete Step 5 of the CCF;

• The collector reviews Step 5 for completion and accuracy;

• Collector returns to Copy 1 and completes Step 4, (prints and signs his/her name, notes the time and date of the collection and the delivery system transporting the specimen to the lab);

Note: This means that the compliant order of the collection is Step 1, then the actual collection of the specimen, followed by Steps 2, 3, 5, and finally Step 4 (making the required order 1, 2, 3, 5, THEN 4)

• The collector puts the specimen bottles and Copy 1 of CCF in a leak proof plastic bag and seals the bag;

• The collector distributes Copy 5 to the employee and retains the collector copy (Copy 3);

• The collector faxes or otherwise transmits Copy 2 to the MRO and Copy 4 to the DER (you);

• The collector puts the sealed specimen bag in the secure designated area to be picked up by a courier.


Urine Collection Differences Between HHS and Department of Transportation

HHS is the Department of Health and Human Services a part of the Substance Abuse and Mental Health Services Administration (SAMHSA) Center for Substance Abuse Prevention. HHS publishes the Mandatory Guidelines for Federal Workplace Drug Testing Programs which apply to employees of the Federal government.

The Mandatory Guidelines for Federal Workplace Drug Testing Programs are considered the foundation of drug free workplace programs in the United States. They specifically apply only to Federal employees.

If you are performing specimen collections for Federal Agencies, you do not follow DOT specimen collection guidelines, you follow the urine specimen guidelines for Federal Agency Workplace Drug Testing Programs. The latest version of the Urine Specimen Collection Handbook for Federal Agency Workplace Drug Testing Programs is available at https://www.samhsa.gov/sites/default/files/workplace/urine-specimen-collection-handbook-oct2017_2.pdf

The urine specimen collection guidelines for Federal agencies are very similar to the guidelines for DOT urine collection for DOT drug testing. However, there are some differences, the chart on the following pages outlines these differences.


https://www.samhsa.gov/sites/default/files/workplace/urine-specimen-collection-handbook-oct2017_2.pdf

https://www.samhsa.gov/sites/default/files/workplace/urine-specimen-collection-handbook-oct2017_2.pdf

Requirement DOT HHS Who may act as a collector of an employee?

The immediate supervisor of an employee may not serve as the collector unless no other collector is available. DOT guidelines do not stipulate that the supervisor must be a trained collector.

If no other collector is available then a supervisor who is trained as a collector may act as the collector.

Monitoring of Collection Sites

To determine collection site adherence to DOT requirements i) more effective monitoring by collection site parent companies and ii) on-site audits and inspections by DOT agencies.

A federal agency must i) inspect five percent of up to a maximum of 50 collection sites each year and must ii) investigate any reported collection site deficiencies and institute appropriate action such as inspecting the involved site.

Testing DOT does not allow the use of IITF's thus collector must continue to send specimens to a HHS certified laboratory that has confirmation testing capabilities.

When appropriate, collector may send specimen to an Instrumental Initial test Facility (IITF).

Custody and Control Form

The collector or collection site must maintain their copy of the CCF for no less than 30 days.

The collector or collection site must maintain their copy of the CCF for no less than two years.

Direct Observation Collections

It is the collector's decision based on specific guidelines. If an observer is required, the observer only needs to be given precise directions at the time of the collection. It is required that the donor raise clothing and turn around to demonstrate the absence of any thing that could adulterate the specimen or be used as a substitution. The collector (or observer) must watch the urine leave the body and go into the container. Direct observations must be done on all return-to-duty and follow-up collections.

Before a collector may initiate an observed collection, the collector must contact a supervisor who must concur that a direct observed collection is appropriate. The collector must make the agency representative aware that a situation exists warranting a direct observed collection and explain to the donor why a direct observed collection is being conducted. If an "observer" is required, the observer must be trained in directly observed collections. The collector only watches the urine leave the donor's body and into the collection container. Return-to-duty and follow-up testing are not automatically designated for a direct observed collection.

of 135Collector Training Page 91 of 137

DOT CCF Instructions

Instructions for Completing the Federal Drug Testing Custody and Control Form (CCF) for Urine Specimen Collection

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

Collector ensures that the name and address of the 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.

STEP 1: • Effective 01/06/2020, the SSN or Employee I.D. number for FMCSA testing is to be replaced with the CDL number and State of issue. Use State initials first and then the license number; no spaces, dashes, or other special characters. (example FL123456789) Collector ensures that the required information is in STEP 1. Collector enters a remark in STEP 2 if Donor refuses to provide his/her CDL # (for FMCSA only), SSN, or Employee I.D. number. • Collector gives collection container to Donor and instructs Donor to provide a specimen. 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 specimen temperature within 4 minutes after receiving the specimen from Donor and marks the appropriate temperature box in STEP 2. If 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. It 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 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. • 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. 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. 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 bottle(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.

DOT Custody & Control Form (CCF) Sample


FEDERAL DRUG TESTING CUSTODY AND CONTROL FORM

SPECIMEN ID NO.

ACCESSION NO.STEP 1: COMPLETED BY COLLECTOR OR EMPLOYER REPRESENTATIVE

STEP 2: COMPLETED BY COLLECTOR (make remarks when appropriate) Collector reads specimen temperature within 4 minutes.

A. Employer Name, Address, I.D. No.

C. Donor SSN or Employee I.D. No.

D. Specify Testing Authority: c HHS c NRC Specify DOT Agency: c FMCSA c FAA c FRA c FTA c PHMSA c USCG

E. Reason for Test: c Pre-employment c Random c Reasonable Suspicion/Cause c Post Accident c Return to Duty c Follow-up c Other (specify)

F. Drug Tests to be Performed: c THC, COC, PCP, OPI, AMP c THC & COC Only c Other (specify)

Collector Phone No.

Collector Fax No.

G. Collection Site Address:

B. MRO Name, Address, Phone No. and Fax No.

0000001

Temperature between 90º and 100º F? c Yes c No, Enter Remark Collection: c Split c Single c None Provided, Enter Remark c Observed, Enter RemarkREMARKS

OM

B N

o. 0930-0158

STEP 3: Collector affixes bottle seal(s) to bottle(s). Collector dates seal(s). Donor initials seal(s). Donor completes STEP 5 on Copy 2 (MRO Copy)STEP 4: CHAIN OF CUSTODY - INITIATED BY COLLECTOR AND COMPLETED BY TEST FACILITYI certify that the specimen given to me by the donor identified in the certification section on Copy 2 of this form was collected, labeled, sealed and released to the Delivery Service noted in accordance with applicable Federal requirements.

SPECIMEN BOTTLE(S) RELEASED TO:

Name of Delivery Service

Signature of Collector

(PRINT) Collector’s Name (First, MI, Last) Date (Mo/Day/Yr) Time of Collection

AMPM/ /

X

COPY 1 - TEST FACILITY COPY

80308

PR

ES

S H

AR

D - Y

OU

AR

E M

AK

ING

MU

LTIP

LE

CO

PIE

S

STEP 5A: PRIMARY SPECIMEN REPORT - COMPLETED BY TEST FACILITYc POSITIVE for: c Marijuana Metabolite (∆ 9-THCA) c Methamphetamine c MDMA

c Amphetamine c MDA c PCP

c ADULTERATED c SUBSTITUTED c INVALID RESULT

c NEGATIVE

/ / Signature of Certifying Technician/Scientist (PRINT) Certifying Technician/Scientist’s Name (First, MI, Last) Date (Mo/Day/Yr)

RECEIVED AT LAB OR IITF: SPECIMEN BOTTLE(S) RELEASED TO:

Signature of Accessioner

(PRINT) Accessioner’s Name (First, MI, Last)

Primary SpecimenBottle Seal Intact

c YES c NO

If NO, Enter remark in Step 5A.Date (Mo/Day/Yr)

/ /

X

X

Ver

sion

C 1

4May

2010

A SPECIMEN BOTTLESEALSPECIMEN ID NO.

0000001

0000001Date (Mo/Day/Yr)

B(SPLIT)

SPECIMEN BOTTLESEALSPECIMEN ID NO.

0000001

0000001Date (Mo/Day/Yr)

STEP 5b: COMPLETED BY SPLIT TESTING LABORATORY

Laboratory Name

Laboratory Address Date (Mo/Day/Yr)/ /

Signature of Certifying Scientist (PRINT) Certifying Scientist’s Name (First, MI, Last)X

RECONFIRMED FAILED TO RECONFIRM - REASON I certify that the split specimen identified on this form was examined upon receipt, handled using chain of custody procedures, analyzed,and reported in accordance with applicable Federal requirements.

c 6-Acetylmorphine c Morphine

c Codeine

REMARKS:

Test Facility (if different from above) : I certify that the specimen identified on this form was examined upon receipt, handled using chain of custody procedures, analyzed, and reported in accordance with applicable Federal requirements.

c REJECTED FOR TESTING

c OXYCc OXYM

c HYC c HYM c Cocaine Metabolite (BZE)c DILUTE



SPECIMEN ID NO.





D. Specify Testing Authority: c HHS c NRC



Collector Phone No.

Collector Fax No.



0000001


OM

B N

o. 0930-0158






AMPM/ /

X

COPY 2 - MEDICAL REVIEW OFFICER COPY

STEP 5: COMPLETED BY DONOR

STEP 6: COMPLETED BY MEDICAL REVIEW OFFICER - PRIMARY SPECIMEN

STEP 7: COMPLETED BY MEDICAL REVIEW OFFICER - SPLIT SPECIMEN

I certify that I provided my urine specimen to the collector; that I have not adulterated it in any manner; each specimen bottle used was sealed with a tamper-evident seal in my presence; and that the information provided on this form and on the label affixed to each specimen bottle is correct.

After the Medical Review Officer receives the test results for the specimen identified by this form, he/she may contact you to ask about prescriptions and over-the-counter medications you may have taken. Therefore, you may want to make a list of those medications for your own records. THIS LIST IS NOT NECESSARY. If you choose to make a list, do so either on a separate piece of paper or on the back of your copy (Copy 5). – DO NOT PROVIDE THIS INFORMATION ON THE BACK OF ANY OTHER COPY OF THE FORM. TAKE COPY 5 WITH YOU.

Signature of Donor (PRINT) Donor’s Name (First, MI, Last) Date (Mo/Day/Yr)/ /

Daytime Phone No. ( ) Evening Phone No. ( ) Date of Birth / /

In accordance with applicable Federal requirements, my verification is:

c NEGATIVE c POSITIVE for: c DILUTE

c REFUSAL TO TEST because – check reason(s) below: c TEST CANCELLEDc ADULTERATED (adulterant/reason):

c SUBSTITUTEDc OTHER:

REMARKS:

/ /

In accordance with applicable Federal requirements, my verification for the split specimen (if tested) is:

c RECONFIRMED for: c TEST CANCELLED

c FAILED TO RECONFIRM for:

REMARKS:

/ /

Signature of Medical Review Officer


(PRINT) Medical Review Officer’s Name (First, MI, Last)


Date (Mo/Day/Yr)

Date (Mo/Day/Yr)

(Mo/Day/Yr)

X

X

X

Specify DOT Agency: c FMCSA c FAA c FRA c FTA c PHMSA c USCG



SPECIMEN ID NO.








Collector Phone No.

Collector Fax No.



0000001


OM

B N

o. 0930-0158






AMPM/ /

X

COPY 3 - COLLECTOR COPY












REMARKS:

/ /




REMARKS:

/ /





Date (Mo/Day/Yr)

Date (Mo/Day/Yr)

(Mo/Day/Yr)

X

X

X




SPECIMEN ID NO.








Collector Phone No.

Collector Fax No.



0000001


OM

B N

o. 0930-0158






AMPM/ /

X

COPY 4 - EMPLOYER COPY












REMARKS:

/ /




REMARKS:

/ /





Date (Mo/Day/Yr)

Date (Mo/Day/Yr)

(Mo/Day/Yr)

X

X

X



Public Burden Statement: Anagencymaynotconductorsponsor,andapersonisnotrequiredtorespondto,acollectionofinformationunlessitdisplaysacurrentlyvalidOMBcontrolnumber.TheOMBcontrolnumberforthisprojectis0930-0158.Publicreportingburdenforthiscollectionofinformationisestimatedtoaverage:5minutes/donor;4minutes/collector;3minutes/testfacility;and3minutes/MedicalReviewOfficer.Sendcommentsregardingthisburdenestimateoranyotheraspectofthiscollectionofinformation,includingsuggestionsforreducingthisburden,toSAMHSAReportsClearanceOfficer,5600 Fishers Lane, Room 15E57B, Rockville, Maryland, 20852.

Paper CCF: Back of Copy 1-4Electronic CCF: Separate Page



SPECIMEN ID NO.








Collector Phone No.

Collector Fax No.



0000001


OM

B N

o. 0930-0158






AMPM/ /

X

COPY 5 - DONOR COPY












REMARKS:

/ /




REMARKS:

/ /





Date (Mo/Day/Yr)

Date (Mo/Day/Yr)

(Mo/Day/Yr)

X

X

X



Paper CCF: Back of Copy 5Electronic CCF: Separate Page

Instructions for Completing the Federal Drug Testing Custody and Control Form for Urine Specimen CollectionWhen making entries on a paper CCF, use black or blue ink pen and press firmly

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.

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 gives collection container to Donor and instructs Donor to provide a specimen. 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 anattempt 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 specimen temperature within 4 minutes after receiving the specimen from Donor, and marks the appropriate

temperature box in STEP 2. If temperature is outside the acceptable range, Collector enters a remark in STEP 2 and takes action asrequired.

• Collector inspects the specimen and notes any unusual findings in the remarks line in STEP 2 and takes action as required. Anyspecimen with unusual physical characteristics (e.g. unusual color, presence of foreign objects or material, unusual odor) cannot be sentto 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 thecollection. If the volume is less than required by the federal agency, Collector takes action as required, and enters remarks in STEP 2.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.

• Collector checks the Split or Single specimen collection box. If the collection is observed, Collector checks the Observed box and entersa remark in STEP 2.

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.

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 bottle(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 andcontact 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.

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 StatementPublic 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, 5600 Fishers Lane, Room 15E57B, Rockville, Maryland, 20852.


Altering A Drug Testing CCF Form There are times when you don’t have the correct custody and control to properly complete the specimen collection. You can alter a form, sometimes called “markup” a form or “doctor up” a form. It is a similar process for DOT and Non-DOT. Collectors and collection sites that will not alter a drug testing CCF form to properly compete a collection are not providing professional services to the drug testing industry.

It is very important that the correct lab account number be written on the CCF form to be altered and that the existing account number be crossed out. A single line through any information to be disregarded is sufficient. There is not a lot of room on the form, so write very neatly, but be as clear as possible.

The employer name should always be written in on the form to be altered. Cross out with a single line any information about the existing employer that was on the form to be altered. Also write in the correct Medical Review Officer (MRO) information.

For a Non-DOT test, it is critical to write in the correct test panel on to the CCF form. Just put a single line through the test panel that is not to be used.

DOT Rule 49 CFR Part 40 Section 40.45 Q&A

QUESTION:

Can a collector mark through pre-printed employer, MRO, collection site, and/or laboratory information on the CCF if that information is not accurate for a particular collection?

ANSWER:

Yes. When the collector has no “blank” CCFs and the CCFs on-hand contain inaccurate pre-printed employer, MRO, collection site, and/or laboratory information, the collector is permitted to “line through” the inaccurate information and insert legibly the proper information.

The likelihood of a collection site having CCFs with inaccurate information increases with unexpected collection events (e.g., employee arrives unannounced for post-accident testing).

If the specimen will be sent to a laboratory different than the one pre-printed on the available CCF, it becomes important for the collector to modify the CCF so that it reflects the name and address of the laboratory to which the specimen will actually be sent. It is also important for the collector to line through any pre-printed billing code and insert the appropriate one, if it is available.

Finally, laboratories should honor collection site requests to provide an adequate number of “blank” CCFs for use during unexpected collection events. It is important to note that the DOT permits overprinting or pre-printing of CCFs in an effort to streamline the entire testing process, not to limit the distribution of the forms to collection sites. See below an example of an altered CCF form.


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Drug Testing Using eCCF An electronic Custody and Control Form (eCCF) is the digital version of the traditional, five-part paper Custody and Control Form — the document used for drug test ordering, specimen collection processing, and chain of custody documentation for workplace drug testing. The CCF documents the external specimen chain of custody — i.e., the handling of the drug test specimen from the time it is collected until it is received at the laboratory. As a collector the eCCF is available to you through an application called FormFox. You can contact FormFox directly to get set up to perform eCCF collections for DOT and Non -DOT – www.formfox.com. Please discuss any questions directly with FormFox. Go to https://www.formfox.com/?page_id=8002 for a simulated eCCF collection.

Non-DOT Urine Specimen Collections

A Non-DOT drug test is a drug test given to a worker in an industry that's not regulated by the U.S. Department of Transportation (DOT).

Non-DOT collections are not regulated, and there are no formal training resources available. The employer decides how to manage and run their drug testing program based on their needs. It is highly recommended that specimen collectors for Non-DOT testing be trained initially for DOT specimen collections.

Basically, the same procedures are followed as in DOT specimen collections. It is very important that you fill out the Non-DOT Custody and Control (CCF) form correctly. For any CCF form, always read the instructions on the back of the form.

In some cases, you may be asked to collect specimens for both DOT and Non-DOT testing from the same donor. Non-DOT tests must be performed separately — i.e., separate samples and separate procedures. DOT testing must be done first, and a positive DOT test remains positive, even if non-DOT testing conducted later results in a negative.

Here is the general process very similar to a DOT specimen collection:

Collectors will explain the basic collection procedure to the employee. In some collections, the Company will provide the employee with a kit and Non-Regulated CCF to carry to the collection site. In other collections, collectors will provide the employee with an individually wrapped or sealed collection container from the collection kit materials. Precautions will be taken to ensure that unadulterated specimens are obtained and correctly identified.

Specimen integrity will be maintained by: bluing agents being added in the toilet tank and all water sources secured; positive photo identification of the employee for collection; notification of the DER if the employee fails to arrive at the assigned time; having the


http://www.formfox.com/

https://www.formfox.com/?page_id=8002

employee remove any unnecessary outer garments (purses or briefcases will remain with outer garments); having employees wash and dry their hands; and, to the greatest extent possible, having the collector keep an employee's collection container within view of both the collector and the employee between the time the employee has urinated and the specimen is sealed. Any unusual behavior will be noted on the Non-Regulated CCF.

Following the collection, the specimen will be checked for sufficient volume (i.e., 30mL-60mL), acceptable temperature range (i.e., between 90-100 degrees F), and no signs of tampering (e.g., color, odor). Having problematic issues with specimen volume, the collector will follow DOT’s “shy bladder” procedures; problems with temperature or tampering will result in the collector conducting a second collection. All collections are completed by the specimens being sealed and labeled, the Non-Regulated CCF being properly executed, and the specimens and the Non-Regulated CCF being sealed in a plastic bag for shipment to the laboratory.

Review some important distinctions for Non-DOT collections:

1. Be familiar with any state laws for drug testing and specimen collections in your state. Reach out for assistance if you don’t know the laws in your state.

2. A split specimen is not necessarily required. This would be a client (employer) preference.

3. Donor name is recorded on Copy 1. 4. Step 4 of the form is on Copy 1; unlike the DOT form, you do not have to flip over to

Copy 2 of the form for the Donor Certification. 5. Check with the client (employer) as to whether direct observation should be

performed. There may be state laws that prohibit or require direct observation. 6. A drug test panel for which the specimen is to be tested must be on the form in order

for the laboratory to know what drugs to test for. 7. When you have a specimen with an out of range temperature, DO NOT send the out

of range specimen to the laboratory. 8. Always call the client or the TPA while the donor is still at your facility if you have

issues that are preventing you from completing the specimen collection.

Non-DOT CCF Instructions

INSTRUCTIONS FOR COMPLETING NON -DOT DRUG TESTING CUSTODY AND CONTROL FORM (CCF)


A. Collector ensures that the name and address of the drug testing laboratory appear on the top of the CCF and the Specimen I.D. number on the top of the CCF matches the specimen I.D. number on the labels/seals.

B. Collector provides the required information in STEP 1 on the CCF. The collector provides the remark in STEP 2 if the donor refuses to provide his/her SSN or Employee I.D. number.

C. Collector gives a collection container to the donor for providing a specimen. D. After the donor gives the specimen to the collector, the collector checks the temperature of

specimen within 4 minutes and marks the appropriate temperature box in STEP 2 on the CCF. The collector provides a remark if the temperature is outside the acceptable range.

E. Collector checks the split or single specimen collection box. If no specimen is collected, that box is checked, and a remark is provided. If it is an observed collection, that box is checked, and a remark is provided. If no specimen is collected, Copy 1 is discarded and the remaining copies are distributed as required.

F. 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).

G. Collector dates the specimen bottle label(s) after placing the label(s) on the specimen bottle(s).

H. Donor initials the specimen bottle label(s) after placing the label(s) on the specimen bottle(s). I. Collector turns to COPY 2 (MRO Copy) and instructs the donor to read the certification

statement in STEP 5 and to sign, print name, date, provide phone numbers, and provide date of birth after reading the certification statement. If the donor refuses to sign the certification statement, the collector provides a remark in STEP 2 on Copy 1.

J. Collector completes STEP 4 (i.e. provides signature, printed name, date, time of collection, and name of delivery service), immediately places the sealed specimen bottle(s) and Copy 1 of the CCF in a leak-proof plastic bag, releases specimen package to the delivery service, and distributes the other copies as outlined in the standard operating procedure manual as required.

Non-DOT Custody & Control Form


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B. MRO Name, Address, Phone No. and Fax No.A. Employer Name, Address, I.D. No.

STEP 5A: PRIMARY SPECIMEN REPORT - COMPLETED BY TEST FACILITYNEGATIVE POSITIVE for: Marijuana Metabolite (9-THCA) 6- Acetylmorphine Methamphetamine MDMA

REJECTED FOR TESTING ADULTERATED SUBSTITUTED INVALID RESULTPCP Codeine MDEA

MDAAmphetamine MorphineDILUTE Cocaine Metabolite (BZE)


X(Print) Certifying Scientist’s Name (First, MI, Last) Date (Mo./Day/Yr.)Signature of Certifying Scientist

Date (Mo./Day/Yr.)X

(Print) Certifying Scientist’s Name (First, MI, Last)Signature of Certifying Scientist

I certify that the specimen identified on this form was examined upon receipt, handled using chain of custody procedures, analyzed, and reported in accordance with applicable requirements.

Primary Specimen Bottle Seal Intact

RECEIVED AT LAB OR IITF:(Print) Collector’s Name (First, MI, Last) Date (Mo./Day/Yr.)

Date (Mo./Day/Yr.)(Print) Accessioner’s Name (First, MI, Last)

X

Time of Collection


XSignature of Accessioner

AMPM

I certify that the specimen given to me by the donor identified in the certification section on Copy 2 of this form was collected, labeled, sealed, and released to the Delivery Service noted in accordance with applicable requirements.

REMARKSTemperature between 90° and 100° F? � Yes � No, Enter Remark Collection: � Split � Single � None Provided, Enter Remark � Observed, (Enter Remark)

REMARKS:

Test Facility (if different from above):



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STEP 3: Collector affixes bottle seal(s) to bottle(s). Collector dates seal(s). Donor initials seal(s). Donor completes STEP 5 on Copy 2 (MRO Copy)STEP 4: CHAIN OF CUSTODY - INITIATED BY COLLECTOR AND COMPLETED BY TEST FACILITY



� Yes � No

If No, Enter remarks in Step 5A.

___________________________________________Laboratory Name

___________________________________________Laboratory Address

� RECONFIRMED� FAILED TO RECONFIRM - REASON ____________________________________________I certify that the split specimen identified on this form was examined upon receipt, handled using chain of custody procedures, analyzed and reported in accordance with applicable requirements.

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� Quest Diagnostics Courier� FedEx� Other

F. Collection Site Name: Collection Site Code:

Address:

City, State and Zip:

Collector Phone No.:

Collector Fax No.:

STEP 1: COMPLETED BY COLLECTOR OR EMPLOYER REPRESENTATIVE

FORENSIC DRUG TESTING CUSTODY AND CONTROL FORM

LAB ACCESSION NO.SPECIMEN ID NO.

800-877-7484

E. Drug Tests to be Performed: THC, COC, PCP, OPI, AMP THC & COC Only Other (specify) _______________________________________________


D. Reason for Test: Return to Duty (6)

Pre-employment (1) Random (3)Follow-up (23) Other (specify) (99)

Reasonable Suspicion/Cause (5) Post-Accident (2) Promotion (22)


Plate: Black

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STEP 5A: PRIMARY SPECIMEN REPORT - COMPLETED BY TEST FACILITYNEGATIVE POSITIVE for: Marijuana Metabolite (9-THCA) 6- Acetylmorphine Methamphetamine MDMA

REJECTED FOR TESTING ADULTERATED SUBSTITUTED INVALID RESULTPCP Codeine MDEA

MDAAmphetamine MorphineDILUTE Cocaine Metabolite (BZE)


X(Print) Certifying Scientist’s Name (First, MI, Last) Date (Mo./Day/Yr.)Signature of Certifying Scientist

Date (Mo./Day/Yr.)X

(Print) Certifying Scientist’s Name (First, MI, Last)Signature of Certifying Scientist

I certify that the specimen identified on this form was examined upon receipt, handled using chain of custody procedures, analyzed, and reported in accordance with applicable requirements.

Primary Specimen Bottle Seal Intact

RECEIVED AT LAB OR IITF:(Print) Collector’s Name (First, MI, Last) Date (Mo./Day/Yr.)

Date (Mo./Day/Yr.)(Print) Accessioner’s Name (First, MI, Last)

X

Time of Collection


XSignature of Accessioner

AMPM



REMARKS:

Test Facility (if different from above):



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� Yes � No

If No, Enter remarks in Step 5A.

___________________________________________Laboratory Name

___________________________________________Laboratory Address

� RECONFIRMED� FAILED TO RECONFIRM - REASON ____________________________________________I certify that the split specimen identified on this form was examined upon receipt, handled using chain of custody procedures, analyzed and reported in accordance with applicable requirements.

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Address:



Collector Fax No.:

STEP 1: COMPLETED BY COLLECTOR OR EMPLOYER REPRESENTATIVE


LAB ACCESSION NO.SPECIMEN ID NO.

800-877-7484






Page 106 of 135Collector Training of 137

Plate: Black

Daytime Phone No. ( ) Evening Phone No. ( ) Mo. Day Yr.

Date of Birth

In accordance with applicable requirements, my verification is:

� NEGATIVE � POSITIVE for: __________________________________________________________________________________________________________________ � DILUTE� REFUSAL TO TEST because – check reason(s) below: � TEST CANCELLED � ADULTERATED (adulterant/reason): _____________________________________________________________ � SUBSTITUTED � OTHER ______________________________________________________________________________

REMARKS: __________________________________________________________________________________________________________________________________________

______________________________________________________________________________________________________________________________________________________________________

In accordance with applicable requirements, my verification for split specimen (if tested) is:

� RECONFIRMED for: ___________________________________________________________________________________ � TEST CANCELLED � FAILED TO RECONFIRM for: _____________________________________________________________________REMARKS: ________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

After the Medical Review Officer receives the test results for the specimen identified by this form, he/she may contact you to ask about prescriptions and over-the-counter medications you may have taken. Therefore,you may want to make a list of those medications for your own records. THIS LIST IS NOT NECESSARY. If you choose to make a list, do so either on a separate piece of paper or on the back of your copy (Copy 5). – DO NOT PROVIDE THIS INFORMATION ON THE BACK OF ANY OTHER COPY OF THE FORM. TAKE COPY 5 WITH YOU.


XDate (Mo./Day/Yr.)(PRINT) Donor’s Name (First, MI, Last)Signature of Donor

Signature of Medical Review Officer Date (Mo./Day/Yr.)(PRINT) Medical Review Officer’s Name (First, MI, Last)

X


STEP 6: COMPLETED BY MEDICAL REVIEW OFFICER – PRIMARY SPECIMEN


X

STEP 7: COMPLETED BY MEDICAL REVIEW OFFICER – SPLIT SPECIMEN

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(Print) Collector’s Name (First, MI, Last) Date (Mo./Day/Yr.)

X

Time of Collection

Signature of CollectorAMPM







800-877-7484





Address:



Collector Fax No.:

STEP 1: COMPLETED BY COLLECTOR OR EMPLOYER REPRESENTATIVE LAB ACCESSION NO.SPECIMEN ID NO.







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Date of Birth



REMARKS: __________________________________________________________________________________________________________________________________________

______________________________________________________________________________________________________________________________________________________________________







X



Signature of Medical Review Officer (PRINT) Medical Review Officer’s Name (First, MI, Last)

X



X

Time of Collection







Date (Mo./Day/Yr.)


800-877-7484





Address:



Collector Fax No.:








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Date of Birth



REMARKS: __________________________________________________________________________________________________________________________________________

______________________________________________________________________________________________________________________________________________________________________







X




X



X

Time of Collection







Date (Mo./Day/Yr.)


800-877-7484





Address:



Collector Fax No.:








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Date of Birth



REMARKS: __________________________________________________________________________________________________________________________________________

______________________________________________________________________________________________________________________________________________________________________







X




X


(Print) Collector’s Name (First, MI, Last) Date (Mo./Day/Yr.) Time of Collection

AMPM






Date (Mo./Day/Yr.)


800-877-7484





Address:



Collector Fax No.:








Plate: Black

Plate: 352

INSTRUCTIONS FOR COMPLETING DRUG TESTING CUSTODY AND CONTROL FORM

A Collector ensures that the name and address of the drug testing laboratory appear on the top of the CCF and the Specimen I.D. number on the top of the CCF matches the specimen I.D. number on the labels/seals.

B Collector provides the required information in STEP 1 on the CCF. The collector provides the remark in STEP 2 if the donor refuses to provide his/her SSN or Employee I.D. number.

C Collector gives a collection container to the donor for providing a specimen.

D After the donor gives the specimen to the collector, the collector checks the temperature of specimen within 4 minutes and marks the appropriate temperature box in STEP 2 on the CCF. The collector provides a remark if the temperature is outside the acceptable range.

E Collector checks the split or single specimen collection box. If no specimen is collected, that box is checked and a remark is provided. If it is an observed collection, that box is checked and a remark is provided. If no specimen is collected, Copy 1 is discarded and the remaining copies are distributed as required.

F Donor watches the collector pouring the specimen from the collection container into the specimen bottle(s), placing the cap(s) on the specimen bottle(s), and affixing the label(s)/seal(s) on the specimen bottle(s).

G Collector dates the specimen bottle label(s) after they are placed on the specimen bottle(s).

H Donor initials the specimen bottle label(s) after the label(s) have been placed on the specimen bottle(s).

I Collector turns to COPY 2 (MRO Copy) and instructs the donor to read the certification statement in STEP 5 and to sign, print name, date, provide phone numbers and date of birth after reading the certification statement. If the donor refuses to sign the certification statement, the collector provides a remark in STEP 2 on Copy 1.

J Collector completes STEP 4 (i.e. provides signature, printed name, date, time of collection, and name of delivery service), immediately places the sealed specimen bottle(s) and Copy 1 of the CCF in a leak-proof plastic bag, releases specimen package to the delivery service, and distributes the other copies as outlined in the standard operating procedure manual as required.


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Collector Training Frequently Asked Questions And Scenarios

1. How should collectors perform direct observation collections?

a. The observer must be the same gender as the employee.

b. If the collector is not the observer, the collector must instruct the

observer about the procedures for checking the employee for prosthetic

or other devices designed to carry “clean” urine and urine substitutes AND

for watching the employee urinate into the collection container.

c. The collector or observer requests the employee to raise his or her shirt,

blouse or dress/skirt, as appropriate, above the waist, just above the

navel; and lower clothing and underpants to mid-thigh and show the

observer, by turning around, that the employee does not have such a

device.

d. If the Employee Has A Device: The observer immediately notifies the

collector; the collector stops the collection; and the collector thoroughly

documents the circumstances surrounding the event in the remarks

section of CCF. The collector notifies the DER. This is a refusal to test.

e. If the Employee Does Not Have A Device: The employee is permitted to

return clothing to its proper position for the observed collection. The

observer must watch the urine go from the employee’s body into the

collection container. If the observer is not the collector, the observer must

watch as the employee takes the specimen to the collector. The observer

does not handle the specimen. The collector then completes the

collection process.

2. What do I do if after the donor provides the specimen, I find something in the

restroom that may indicate tampering or substitution?

a. If you have checked the restroom as required immediately prior to the

collection and then notice something that may have been used to tamper

with the specimen, the collector would document the situation and


perform an immediate re-collect under direct observation. Refusal to

provide a direct observed collection would be documented as a refusal to

test.

3. What happens if I tear the second bottle seal after having secured the first on

bottle A?

a. Draw a single line through the barcode on the “A” label already on the

bottle A.

b. Obtain another Federal Custody and Control Form.

c. Complete the 2nd form exactly as the first form.

d. Place the seals on the bottles perpendicular to the original seal.

e. Complete the collection.

4. What should I do if a donor brings in a single Federal CCF and then the temp is

out of range and they don’t have another form?

a. You may use another Federal form and follow the procedures to alter the

form to reflect the correct lab account #, employer information, and MRO

information.

5. Urine bubbles some when shaken and fake urine typically does not. Can I use this

as a basis for a direct observed test?

a. See iii below. Collectors must follow the Urine Specimen Collection

guidelines when conducting Federal drug test collections. There are

specific situations when a direct observed collection would be authorized.

These include:

i. The employee attempts to tamper with his or her specimen at the

collection site.

ii. The specimen temperature is outside the acceptable range.


iii. The specimen shows signs of tampering, such as unusual color, an

odor, or other characteristics.

iv. The collector finds an item in the employee’s pockets or wallet

which appears to have been brought into the site to contaminate a

specimen, or the collector notes conduct suggesting tampering.

v. The Medical Review Officer (MRO) orders the direct observation.

vi. The test is a Follow-Up test or a Return-to-Duty test.

6. What happens if I am called onsite at an accident scene to conduct a DOT urine

collection but there are no facilities nearby to use for the collection?

a. If there are no facilities available at the location of the accident, the

collector should contact the employer to provide transportation of the

employee to a location suitable to conduct the collection. This would be

done once the employee has been freed to leave the scene of the

accident. The employer has a maximum of 32 hours to complete the drug

screen and may opt to send the employee for testing the following

morning if the accident was after hours.

7. What do I do in a Direct Observed situation if I am not the same gender as the

donor and I do not have someone else available as an observer?

a. You would need to either find someone of the same gender to be the

observer or contact the employer to send someone to act as the observer.

If conducting DOT collections, you should always be prepared for this

situation as it could arise at any time.

8. What happens when an employee does not provide a sufficient amount of urine

for a drug test?

a. As the collector, you must do the following:


i. Discard the insufficient specimen, except where the insufficient

specimen was out of temperature range or showed evidence of

adulteration or tampering (see §40.65(b) and (c)).

ii. Urge the employee to drink up to 40 ounces of fluid, distributed

reasonably through a period of up to three hours, or until the

individual has provided a sufficient urine specimen, whichever

occurs first. It is not a refusal to test if the employee declines to

drink. Document on the Remarks line of the CCF (Step 2) and

inform the employee of the time at which the three-hour period

begins and ends.

iii. If the employee refuses to make the attempt to provide a new

urine specimen or leaves the collection site before the collection

process is complete, you must discontinue the collection, note the

fact on the “Remarks” line of the CCF (Step 2), and immediately

notify the DER. This is a refusal to test.

iv. If the employee has not provided a sufficient specimen within

three hours of the first unsuccessful attempt to provide the

specimen, you must discontinue the collection, note the fact on

the “Remarks” line of the CCF (Step 2), and immediately notify the

DER. You must also discard any specimen the employee previously

provided to include any specimen that is “out of temperature

range” or shows signs of tampering. In the remarks section of the

CCF that you will distribute to the MRO and DER, note the fact that

the employee provided an “out of temperature range specimen”

or “specimen that shows signs of tampering” and that it was

discarded because the employee did not provide a second

sufficient specimen.

v. Send Copy 2 of the CCF to the MRO and Copy 4 to the DER. You

must send or fax these copies to the MRO and DER within 24 hours


or the next business day.

9. What do I do if I used a non-Federal form or an expired Federal form?

a. You must provide a signed statement (i.e., a memorandum for the

record). It must state that the incorrect form contains all the information

needed for a valid DOT drug test, and that the incorrect form was used

inadvertently or as the only means of conducting a test, in circumstances

beyond your control. The statement must also list the steps you have

taken to prevent future use of non-Federal forms or expired Federal forms

for DOT tests. For this flaw to be corrected, the testing of the specimen

must have occurred at an HHS-certified laboratory where it was tested

consistent with the requirements of this DOT 49 CFR Part 40. You must

supply this information on the same business day on which you are

notified of the problem, transmitting it by fax or courier.

10. How is a monitored collection conducted?

a. Remember, a monitored collection is based on the use of a multi-stall

restroom.

b. As the collector, you must secure the room being used for the monitored

collection so that no one except the employee and the monitor can enter

it until after the collection has been completed.

c. As the collector, you must ensure that the monitor is the same gender as

the employee, unless the monitor is a medical professional (e.g., nurse,

doctor, physician's assistant, technologist, or technician licensed or

certified to practice in the jurisdiction in which the collection takes place).

The monitor can be a different person from the collector and need not be

a qualified collector.

d. As the collector, if someone else is to monitor the collection (e.g., in order

to ensure a same-gender monitor), you must verbally instruct that person


to follow the procedures and if you, the collector, are the monitor, you

must follow these procedures.

i. As the monitor, you must NOT watch the employee urinate into

the collection container. If you hear sounds or make other

observations indicating an attempt to tamper with a specimen,

there must be an additional collection under direct observation.

ii. As the monitor, you must ensure that the employee takes the

collection container directly to the collector as soon as the

employee has exited the enclosure.

e. As the collector, when someone else has acted as the monitor, you must

note that person's name in the “Remarks” line of the CCF (Step 2).

Final Remarks We hope you have enjoyed this collector training manual. If you have questions, you can call Joe Reilly direct at 321-622-2020 or e-mail him at [email protected].

The next and last section, “Forms and Resources,” is very valuable to help you perform DOT urine specimen collections proficiently. You should thoroughly read over these forms and resources and use as tools to perform compliant collections.

Please remember, just reading this manual does not certify you as a trained and qualified DOT urine specimen collector. You must receive training and you must perform the required proficiency examination (5 Mock Collections) in order to be fully qualified. Also, refresher training and 5 mock collections are required every 5 years. Good luck with your training!

Forms and Resources: This section includes:

DOT 10 Steps Collection Site Security and Integrity 23 STEPS TO DOT URINE SPECIMEN COLLECTION DOT Direct Observation Procedures Instruction Sheet Shy Bladder Log Mock Collections Checklist

Don’t forget the DOT Collector Training Video at:

Collector Training DOT | https://www.ndsadmin.com/collector-training/ ____________________





DOT’s 10 Steps to Collection Site Security and Integrity Office of Drug and Alcohol Policy and Compliance

U.S. Department of Transportation

1. Pay careful attention to employees throughout the collection process. 2. Ensure that there is no unauthorized access into the collection areas and that undetected access (e.g., through a door not in view) is not possible. 3. Make sure that employees show proper picture ID. 4. Make sure employees empty pockets; remove outer garments (e.g., coveralls, jacket, coat, hat); leave briefcases, purses, and bags behind; and wash their hands. 5. Maintain personal control of the specimen and CCF at all times during the collection. 6. Secure any water sources or otherwise make them unavailable to employees (e.g., turn off water inlet, tape handles to prevent opening faucets, secure tank lids). 7. Ensure that the water in the toilet and tank (if applicable) has bluing (coloring) agent in it. Tape or otherwise secure shut any movable toilet tank top, or put bluing in the tank. 8. Ensure that no soap, disinfectants, cleaning agents, or other possible adulterants are present. 9. Inspect the site to ensure that no foreign or unauthorized substances are present. 10. Secure areas and items (e.g., ledges, trash receptacles, paper towel holders, under-sink areas, ceiling tiles) that appear suitable for concealing contaminants.


23 STEPS TO DOT URINE SPECIMEN COLLECTION (49CFR PART 40)

1. Inspect and prepare collection site, have all supplies; properly secure area

2. Collector begins collection without delay once the employee arrives at collection site

3. Check ID of Donor, no ID, contact DER. If requested show collector ID to donor

4. Explains procedures & reviews the instructions on the back of the CCF with the donor

5. Check over CCF for required information in administrative section, add information if necessary

6. The collector asks the employee to remove any unnecessary outer clothing (e.g., coat, jacket, hat, etc.) and

to leave any briefcase, purse, or other personal belongings he or she is carrying with the outer clothing

7. The collector directs the employee to empty his or her pockets and display the items to ensure that no

items are present that could be used to adulterate the specimen

8. The collector instructs the employee to wash and dry his or her hands, under the collector's observation,

and informs the employee not to wash his or her hands again until after the employee provides the specimen

to the collector.

9. Select collection kit, unwrap or break seal

10. The collector directs the employee to go into the room used for urination, provide a specimen of at least

45 mL, not to flush the toilet, and return with the specimen as soon as possible after completing the void.

11. Check the temperature of the specimen, check the specimen volume, and inspect the specimen for

potential adulteration or substitution

12. Collector unwraps or opens the specimen bottles

13. Collector pours at least 30 mL of urine from the collection container into a specimen bottle “A” and 15 mL

into Specimen bottle “B” and secure lids on bottles.

14. Place the tamper-evident seals from the CCF and place them on each bottle, date the seals. Employee is

then requested to initial the seals

15. Collector directs the employee to read, sign, and date the certification statement, and provide date of

birth, printed name, and day and evening contact telephone numbers in Step 5 of Copy 2 of the CCF

16. Complete the collector’s portion of the chain of custody on the CCF (Copy 1, Step 4)

17. Ensure that all copies of the CCF are legible and complete. Give copy 5 to the donor

18. Place specimen bottles and copy 1 of CCF inside the plastic bag, employee can wash hands and leave

19. Discard any excess specimen

20. Place sealed plastic bag in shipping container and keep in a secure area for pick up by courier

21. Send copy 2 to MRO and copy 4 to DER, within 24 hours or next business day – FAX. Retain copy 3 for 30

days

22. Ensure specimen is shipped to laboratory within 24 hours or next business day

23. Ensure security of specimen if not to be shipped immediately

Temperature out of range or signs of adulteration or substitution

A second collection using direct observation procedures must be conducted immediately

Return-to-duty or follow-up tests

All conducted under direct observation procedure


DIRECT OBSERVATION COLLECTION (script in bold italic, adjust whether you are collector or using an observer)

Explain to the employee why a directly observed collection is being conducted. Explain the procedure. If using an

observer who is not the collector, explain to observer what he/she must do.

Request the donor to employee to raise his or her shirt, blouse, or dress/skirt, as appropriate, above the waist,

just above the navel; and lower clothing and underpants to mid-thigh; and to show you the observer – by turning

around – that the employee does not have a prosthetic device. After you have determined that the employee

does not have such a device, you may permit the employee to return clothing to its proper position and then

conduct the observed collection. Then watch the employee urinate into the collection container. Specifically, you

must personally and directly watch the urine go from the employee’s body into the collection container. Please

do not handle the specimen only observe; once the donor has competed the urination, the donor should hand the

collection container to the collector.

SHY BLADDER PROCEDURE

If the donor cannot provide a specimen after an attempt to do so; or if he/she provides an insufficient quantity of specimen – start the shy bladder procedure.

Provide instructions to donor and document

Instruct donor to drink up to 40 oz. of fluid, reasonably distributed - Refusal to drink fluids is not a refusal to test

Monitor the donor

Document all fluids provided and attempts to provide a specimen with times

Donor has 3 hours to provide a sufficient specimen, after 3 hours discontinue collection and immediately notify DER

Donor cannot leave collection site before the collection process is completed - this is a Refusal to Test

If no specimen is provided, immediately notify the DER, mark “None-Provided” box on CCF & note on “Remarks” line, send CCF copies to MRO & Employer

WHEN TO DISCARD SPECIMEN AND NOT SEND ANYTHING TO LAB, BUT ALWAYS SEND CCF COPIES TO THE DER AND

TO THE MRO: Any Refusal to Test:

Failure to appear for any test (except a pre-employment) within a reasonable amount of time

Failure to remain at the testing site until the testing process is complete (pre-employment exception)

Failure to provide a urine specimen for any drug test required by DOT agency regulations

In the case of a directly observed drug test - fail to permit the observation of the provision of a specimen or fail to raise the donor’s shirt, blouse or dress/skirt above the waist and lowering clothing and underpants to show the collector that the donor does not have a prosthetic device

Donor admits to the collector or MRO that he/she attempted to adulterate or substitute the specimen

Donor is found to possess or wear a prosthetic device that could be used to interfere with the collection process

Failure to cooperate with any part of the testing process (e.g., refuse to empty pockets, behave in a confrontational way, fail to wash hands after being directed to do so)

FATAL FLAWS – TEST IS CANCELLED

There is no printed collector's name and no collector's signature

The specimen ID numbers on the specimen bottle and the CCF do not match

The specimen bottle seal is broken or shows evidence of tampering (and a split specimen cannot be redesignated

Because of leakage or other causes, there is an insufficient amount of urine in the primary specimen bottle for analysis and the specimens cannot be redesignated


DOT’s Direct Observation Procedures Office of Drug and Alcohol Policy and Compliance

U.S. Department of Transportation

1. DOT’s 49 CFR Part 40 directly observed collections are authorized and required only when:

● The employee attempts to tamper with his or her specimen at the collection site.

-- The specimen temperature is outside the acceptable range; -- The specimen shows signs of tampering ~ unusual color / odor / characteristic; or -- The collector finds an item in the employee’s pockets or wallet which appears to be brought into the site to contaminate a specimen; or the collector notes conduct suggesting tampering.

● The Medical Review Officer (MRO) orders the direct observation because:

-- The employee has no legitimate medical reason for certain atypical laboratory results; or

-- The employee’s positive or refusal [adulterated / substituted] test result had to be cancelled because the split specimen test could not be performed (for example, the split was not collected).

● The test is a Follow-Up test or a Return-to-Duty test.

2. The observer must be the same gender as the employee. 3. If the collector is not the observer, the collector must instruct the observer about the procedures for checking the employee for prosthetic or other devices designed to carry “clean” urine and urine substitutes AND for watching the employee urinate into the collection container.

● The observer requests the employee to raise his or her shirt, blouse or dress / skirt, as appropriate, above the waist, just above the navel; and lower clothing and underpants to mid-thigh and show the observer, by turning around, that the employee does not have such a device. ● If The Employee Has A Device: The observer immediately notifies the collector; the collector stops the collection; and the collector thoroughly documents the circumstances surrounding the event in the remarks section of CCF. The collector notifies the DER. This is a refusal to test. ● If The Employee Does Not Have A Device: The employee is permitted to return clothing to its proper position for the observed collection. The observer must watch the urine go from the employee’s body into the collection container. The observer must watch as the employee takes the specimen to the collector. The collector then completes the collection process.

4. Failure of the employee to permit any part of the direct observation procedure is a refusal to test.


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Shy Bladder Log

Date: __________________________ Collector: _____________________________________________

Donor Name: _______________________________________________________________

Time of initial collection: ____________________ - Shy bladder time interval begins.

Initial time plus 3 hours: ____________________ - Shy bladder time interval ends.

Instruct the donor to not drink any fluids except the water provided (NO MORE THAN 40 OUNCES) according to this log. A

clinic employee must monitor the donor during the three-hour period or until an appropriate specimen is provided,

whichever comes first. All fluids provided and collection attempts made after the initial attempt must be documented. Be

prepared to stay after-hours if the three-hour interval extends beyond your shift.

Note: A refusal to drink fluids is not a refusal to test. Make a remark and proceed with the collection.

CUP NO. (10 oz.)

TIME PROVIDED

INITIALS ATTEMPT NO.

TIME MADE RESULT INITIALS

1 1

2 2

3 3

4 4

---------------- ---------------- ---------------- 5

---------------- ---------------- ---------------- 6

REMARKS:_________________________________________________________________________________________

FINAL STATUS OF THE COLLECTION (Complete one of the following):

STATUS TIME

1) The donor provided the specimen at

OR

2) The donor could not provide a specimen.The collector notifies the DER and makes anote in the remarks section of the CCF.

Donor Signature: ________________________________ Attach to Collector Copy of Chain of Custody


MOCK COLLECTIONS

DOT SPECIMEN COLLECTION PROFICIENCY

Collector Name:

Employer Name:

Date of Completion:

Monitor Name:

Mock Collection # 1 Uneventful Split Specimen Collection

In this scenario, no abnormal events occur and all aspects (quantity, temperature, smell, etc.) of the

specimen are normal.

Donor positively identified via an acceptable means of identification. (government issued

photo identification or employer identifies donor in person or over the phone).

Collector reviews collection instructions with donor - located on back of CCF.

Collector checks to see that laboratory name, address, and specimen ID number are printed

on the CCF and the required number of copies are provided.

Collector checks to ensure that the specimen ID number on the CCF matches the specimen ID

number on the specimen bottle seals.

Collector completes administration portion of the CCF to include ensuring that the following

information is preprinted or inserted by the collector.

o Employer name, address, fax number, and phone number

o MRO name, address, fax number, and phone number

o Collection site name, address of collection, fax number, and phone number

o Donor social security number or employee ID #; CDL # for FMCSA DOT testing

o Reason for test

o Test to be performed

Collector has donor remove any unnecessary outer clothing, briefcase, purse or personal

belongings.

Collector instructs donor to empty his/her pockets and display items. If there are no possible

adulterants, the collector instructs the donor to return the items to his/her pockets. A wallet

should be inspected for potential items for cheating.

Collector instructs donor to wash his/her hands.

Collector either selects a collection kit or allows the donor to select one.

Collector conducts pre-collection inspection of the collection area to include:

o Secure all water sources

o Ensure bluing is in toilet

o Ensure that no soap, disinfectant, cleaning agents or other potential adulterants are


present

o Ensure that no foreign or unauthorized substances are present

o Tape/secure any movable toilet tank top or put bluing in the tank

o Ensure that undetected access is not possible

o Secure areas and items that appear suitable for concealing contaminants.

Collector unwraps collection cup and instructs the donor to enter the rest room to provide the

specimen, do not flush toilet, and to return as soon as specimen is provided.

Donor gives specimen to collector. Both the donor and the collector must maintain visual

contact with the specimen until the specimen bottles are sealed.

Collector conducts post-collection inspection of the collection area.

Collector checks specimen temperature to ensure that it is between 90 - 100 deg. F. (this

should be done immediately but no later than 4 minutes).

Collector checks temperature box in step two of the CCF.

Collector examines the specimen for unusual color, odor, or other signs of adulteration.

Collector checks volume of specimen to ensure 45ml are present.

Collector checks Split Specimen in step 2 of the CCF.

Collector unwraps specimen bottles in the presence of the donor.

Collector transfers specimen to specimen bottles.

Collector affixes specimen bottle seals to each specimen bottle and dates each seal.

Donor initials both specimen bottle seals, verifying that Specimen ID # on the CCF is the same as the Specimen ID # on the specimen bottle seals

Collector turns to MRO copy of CCF and instructs the donor to read the certification statement

and sign the appropriate sections. Donor provides his/her daytime phone number, evening

phone number (cell phone #) and date of birth. Donor or collector then prints donors name,

and today’s date.

Collector provides his/her printed name, date and time collection, signature and name of the

specific delivery courier service transporting the specimen to the laboratory in step four of the

Laboratory copy of the CCF.

Collector ensures that all copies of the CCF are legible and complete.

Collector removes and gives the donor copy (copy 5) of the CCF to the donor.

Collector informs donor to list any medication on his/her copy of the CCF in case the MRO

calls.

Collector places specimen bottles and laboratory copy of the CCF into the leak proof bag and

seals the pouch.

Collector returns personal belongings to donor and allows donor to wash hands

Collector discards excess specimen in the presence of the donor.

Collector informs donor that he/she is free to go.

Collector places the sealed package into a shipping container.

Collector faxes the MRO copy of the CCF to the MRO.

Collector retains the Collector copy of the CCF for a minimum 30 days


Collector sends employer copy of CCF to employer

Specimen is shipped via Lab or commercial courier. (Example: FedEx)

Collector ensures that specimen is shipped within 24 hours or during the next business day.

Collector Initials: Monitor signature:

Mock Collection # 2 Refusal by Donor to Sign and Initial Collection

In this scenario, the donor refuses to initial the seals or to sign Copy 2 the MRO copy in the donor

certification section.














o Reason for test



belongings.










present





















The donor refuses, and the collector notes this in the remarks section of the CCF.




and today’s date.

The donor refuses to sign the CCF or provide his/her date of birth and phone number, and the

collector notes this in the remark’s section of the CCF and prints the donor’ name in the space

provided on MRO Copy 2 Section 5.


specific delivery courier service transporting the specimen to the laboratory in step four on

the Laboratory copy of the CCF.




calls.


seals the pouch.







Collector retains the Collector copy of the CCF.

Collector sends employer copy of CCF to employer.




Mock Collection # 3 Insufficient Quantity of Specimen

In this scenario, the donor does not provide sufficient specimen, Shy Bladder Log is needed. After

three hours donor is not able to provide a sufficient specimen.














o Reason for test



belongings.










present














Collector examines the specimen for unusual color, odor, or other signs of adulteration

Collector checks volume of specimen. It is less than 45ml.

Collector discards specimen in the presence of the donor but retains the original CCF.

Collector starts and finishes the Shy Bladder Log before going back to CCF form.

Collector notes the time of the first unsuccessful attempt to provide a specimen in the

remarks section of the CCF.

Collector instructs the donor to remain at the collection site, drink up to 40 oz of liquids,

distributed reasonably over a period of up to three hours, and to notify the collector when

he/she feels he/she can provide a specimen of sufficient quantity. It is recommended that the

collector maintain a log of the fluid intake by the donor, as well as the result of each attempt

to provide a specimen. (Use Shy Bladder Log)

After the required time, if a specimen of sufficient quantity has not been provided, the

collector discontinues the collection and notes the fact on the remarks line of the CCF.

Collector immediately notifies the Designated Employer Representative (DER) of the “shy

bladder” situation and the DER will need to send the donor to a physician to be evaluated as

soon as possible.

Collector completes the CCF form including MRO Copy 2 Step 5 writing in the Donor name and

today’s date.

Collector provides his/her printed name, date, and time of collection, signature.

Collector marks “None Provided” in the appropriate box on the CCF.


Collector removes and gives the donor copy of the CCF to the donor.


calls.


Since there is no specimen, nothing goes to the lab.

Collector discards the laboratory copy of the CCF.



Collector sends employer copy of CCF to employer.


Mock Collection # 4 Specimen Temperature Out of Range














o Reason for test



belongings.










present













The specimen temperature is out of range, and the collector checks “no” in step two of the

CCF.

Collector makes notes in remarks section of the CCF to indicate that a second observed

collection will take place.

Collector notifies the donor of the need and reason for a second collection under direct

observation. Collector explains the process.

Collector checks volume of specimen to ensure that 45ml are present.

Collector checks “Split Specimen” in step 2 of the CCF.




Donor initials both specimen bottle seals.





and today’s date.

Collector provides his/her printed name, date and time of collection, signature, and name of

the specific delivery or courier service transporting the specimen to the laboratory in step four

on the Laboratory copy of the CCF.

Collector pulls new CCF for second observed collection and notes the Specimen ID number of

the second CCF in the remarks line of the of the original CCF.

Collector cross references the first specimen ID number on the second observed collection

CCF marking 1 of 2 and 2 of 2 on the first and second CCF form.

Collector ensures that all copies of the first collection’s CCF are legible and complete

Collector removes and gives the donor copy of the first collection’s CCF to the donor.


calls


seals the pouch.


Collector places shipping container in secure location

Second Collection Under Direct Observation:


Collector checks new CCF to see that laboratory name, address, and specimen ID number are

printed on the CCF and the required number of copies are provided





o Donor name, address, fax number, and phone number


o Collection site name, address, fax number, and phone number


o Reason for test

o Test to be performed (same as original)


Collector unwraps collection cups and directs donor to rest room.

Collector (or observer if collector is not the same gender as the donor) asks the donor to raise

his/her shirt, blouse, or dress/skirt above the waist and to lower clothing and underpants below

the waist and to turn around to show the collector that there is no prosthetic device on the

donor’s person.

Donor gives specimen to collector. Both the donor and collector must maintain visual contact

with the specimen until the specimen bottles have been sealed.

Collector checks specimen temperature to ensure that it is between 90 - 100 deg. F.

Collector checks “yes” in step two of the CCF.



Collector checks “Split Specimen” in step 2 of the CCF.

Collector marks “Observed” in step two of the CCF.

Donor indicates in Remarks the reason for “Observed” - “1st Specimen Temp out Range.”




Donor initials both specimen bottle seals after confirming that the Specimen ID numbers on the CCF and the specimen bottle seals match.




and today’s date.


specific delivery or courier service transporting the specimen to the laboratory in step four on

the Laboratory copy of the CCF.



Collector removes and gives the donor copy of the CCF to the donor.


calls.


seals the pouch.




Collector places shipping container in secure location.

Collector contacts the Designated Employer Representative (DER) to inform him/her of the

direct observed collection and the reason for its occurrence.

Collector faxes both MRO copies of the CCF’s to the MRO.

Collector retains the Collector copies of the CCF’s

Collector sends employer copies of the CCF’s to employer.

Specimens are shipped via Lab or commercial courier. (Example: FedEx)

Collector ensures that specimen is shipped within 24 hours or during the next business day


Mock Collection # 5 Uneventful Split Specimen Collection

In this scenario, no abnormal events occur and all aspects (quantity, temperature, smell, etc.) of the

specimen are normal.














o Reason for test




belongings.










present























and today’s date.


specific delivery courier service transporting the specimen to the laboratory in step four of the

Laboratory copy of the CCF.





calls.


seals the pouch.






Collector retains the Collector copy of the CCF for a minimum 30 days

Collector sends employer copy of CCF to employer





Training Provided By:

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