Implementation Guidelines for Alcohol and Drug Regulations - Chapter 6
Controlled Substances Testing Procedures
DOT's final rule, 49 CFR part 40, "Procedures for Transportation Workplace Drug and Alcohol Testing Programs," took effect August 1, 2000. The rule modified and expanded the procedural requirements for controlled substances testing, including specimen collection procedures, laboratory testing procedures, medical review officer (MRO) procedures, and substance abuse
professional (SAP) procedures, and service agents (SA) procedures.
The remainder of this chapter discusses the interaction of DOT and FMCSA regulations in defining your controlled substances testing program. At the end of this chapter you will find a section titled "Regulatory Revisions," which discusses the old DOT and FMCSA regulations and the revised DOT and FMCSA regulations.
Under the FMCSA controlled substances regulation, you are required to conduct laboratory testing of urine specimens for five types of controlled substances. Identification of either a controlled substance or its metabolite in the urine indicates use of the controlled substance in the recent past. A metabolite is a modified form of a controlled substance that has been chemically altered by the body's metabolic system.
The FMCSA regulation requires testing for the following controlled substances (or their metabolites): marijuana, cocaine, opiates, phencyclidine (PCP), and amphetamines. The regulatory requirement is found in 49 CFR, section 40.85.
You may test for additional controlled substances under your own authority provided that
1. A separate void (act of urination) is used to collect the specimen under company authority.
2. The specimen is not poured off from the DOT-mandated specimen.
3. Your drivers are informed that testing for additional controlled substances is not required under the DOT regulations.
4. The non-DOT specimen is collected after the DOT specimen.
It is also important to establish the exact purpose of each testing process so that your drivers are not confused or unclear about what is required of them by the DOT controlled substances testing regulations and procedures, versus additional requirements imposed by your company's policy.
You will need certain specialized services to establish an effective controlled substances testing program and implement the requirements of the DOT and FMCSA regulations. These services include specimen collection, laboratory testing, MRO and SAP.
Section 1. SPECIMEN COLLECTION
DOT regulations require that all urine specimens be collected at an appropriate collection site. A collection site is defined as "a place designated by the employer where individuals present themselves for the purpose of providing a specimen of their urine to be analyzed for the presence of controlled substances." You are required to designate such a site or sites, depending on your needs. Typically, collection sites are at physicians' offices, commercial collection sites, or a local hospital or clinic. You may also wish to establish collection sites on your premises.
In all cases, the person who performs the collection must be properly qualified (see 49 CFR subpart C).
Regardless of where the collection site is located, it must meet the DOT guidelines established in "Procedures for Transportation Workplace Drug and Alcohol Testing Programs" (49 CFR part 40). That regulation requires, in part, that the site provide a privacy enclosure for urination, a toilet, a suitable clean writing surface, and a water source for hand washing, which, if practicable, should be outside the privacy enclosure. The collection site must be secured when not in use or, if this is not possible (e.g., when a public restroom is used), the site must be visually inspected prior to specimen collection to ensure that
unauthorized persons are not present and that there are no unobserved entrance points. Access to the site must be restricted during specimen collection. To assist the specimen collector in determining if your driver has attempted to dilute his/her specimen, a bluing agent must be added to the toilet water, and other sources of water (such as a sink or shower) should be turned off or taped to prevent use (if they are located within the privacy enclosure where urination occurs). At a minimum, other sources of water must be monitored to ensure that they are not used to adulterate the sample.
If you use an off-site collection site staffed by medical/technical personnel, it must meet DOT requirements. You should provide acomplete copy of 49 CFR part 40 to the contract facility representative and require compliance with all applicable DOT requirements as part of the contract. The site personnel should acknowledge receipt of the regulations and maintain a copy in their files. In addition, the minimum collection site facility specifications should be included in the contract.
Collection Site Personnel
The collection site personnel are responsible for the integrity of the specimen collection and transfer process and for ensuring the dignity and privacy of the donor. They should avoid any remarks that may be construed as accusatory, offensive, or inappropriate. You should ensure that all collection site staff are trained to prepare the collection site, collect specimens, examine specimens for tampering or sample adulteration, observe collections, split the specimens, and properly label and preserve the chain of custody of specimens.
You may choose to contract for collection site services or you may establish your own site with trained staff. Contracting for this service eliminates the need to establish a secure collection site and to train staff in collection procedures. Further, it removes your staff from direct involvement in the collection
and testing process and turns these functions over to impartial outside technical persons who have no direct relationship with your drivers. Contracting for collection services, however, does not relieve you from responsibility for ensuring that the complete collection process meets all applicable regulatory requirements established by the FMCSA and the DOT.
You may operate your own collection site if staff receive proper training on preparing the collection site, collecting samples, examining samples for tampering or adulteration, observing collections, and properly labeling and preserving the chain of custody of samples, and have met the qualification requirements found in 49 CFR, section 40.33. Medical professionals and technicians are obvious choices for collection site staff by virtue of their training; however, they are also required to meet the same qualifications for collectors. Regardless of the background and training of collection site staff, you should provide them with clear written instructions on collecting specimens. These instructions should emphasize their responsibilities to maintain the integrity of the specimen collection and transfer process and to protect the dignity and privacy of the driver providing the sample.
The direct supervisor of the driver should not serve as the collection site person for a urine test, unless there is no other way to collect the specimen.
Chain-of-custody procedures ensure that each specimen is monitored throughout the collection and analysis process. This ensures that the results you receive are from tests conducted on your drivers' specimens. The requirements for the proper way to fill out the Custody and Control Form (CCF) are found at 49 CFR, section 40.45.
The following supplies, equipment, and documents will be needed at each collection site you use.
Single-Use Collection Cups: the cups must be individually and securely wrapped and shall be unwrapped in the presence of the driver at the time of specimen collection.
Single-Use Specimen Bottles The specimen bottles should be constructed of high-density plastic or similar synthetic material with a leakproof cap. The bottles must be capable of being shipped in appropriate packing material without leaking or breaking, and must meet the technical specifications of the
carrier selected for specimen transfer. Each bottle shall be individually and securely wrapped and shall be unwrapped in front of the driver at the time of specimen collection. One bottle must be capable of holding at least 60 ml of urine.
Single-Use Temperature Measurement Device: the device shall be capable of measuring temperatures within the range of 32 to 38 Centigrade.
Urine CCF: this form is used by the collector to document the exchanges of the specimen from the time of production by the donor until the test is completed. It documents the chain of custody and is legal evidence that the reported test results apply to the donor. A sample form is included in the appendix at the end of this chapter.
Tamper-Evident Sealing System: Preprinted labels and seals should be provided that reveal whether the specimen bottle has been opened. The bottle must be identified with a unique identifying number identical to that appearing on the urine CCF.
Shipping Containers: the containers should be acceptable to the carrier you will be using and should be sealable to prevent undetected tampering.
Writing Instruments: a pen or other instrument suitable for making permanent markings on labels and seals and for legibly completing the urine CCF should be provided.
Written Instructions: written instructions should be provided for collection site personnel. The instructions should describe in detail the procedures for collecting and transporting specimens and completing the CCF. These instructions should be available at all times for reference and may be provided in a checklist format to allow the collection site personnel to indicate when each step in the collection process has been accomplished.
Drivers subject to testing must be provided written instructions explaining their responsibilities. Examples written instructions for drivers and collection site personnel are provided in the appendix at the end of this chapter.
Specimen collection is the most critical aspect of the controlled substances testing program. There is a greater opportunity for human error or compromising a driver's privacy and dignity in the collection process than anywhere else in the controlled substances
testing process. However, strict maintenance of the chain of custody of the specimen and personnel training can minimize the problems and number of test cancellations resulting from flawed specimen collections. Driver confidence in, and acceptance of, the testing process is enhanced when your collection is conducted with efficiency and professionalism. You should, therefore, ensure that the collection site personnel rigorously follow your guidelines for specimen collection.
An overview of key steps and criteria for the collection process follows. The collection site personnel must follow these steps during the collection process. For specific requirements, refer to 49 CFR subpart E.
- Make sure that only approved DOT urine CCFs are used. Some collection sites do testing for a number of clients who may require different forms, including non-DOT collections.
- Inspect the collection room before and after each specimen collection. Remove any unauthorized persons and materials that could be used to adulterate the specimen. Secure any other doors or windows opening into the collection room. Restrict access to the room while the collection is taking place.
- Verify the identity of the driver through the use of an official photo identification card (CDL). If the driver cannot produce the CDL have the designated driver representative (DDR verify the driver. If identity cannot be verified, the collection should not proceed. The employer must be notified if the driver fails to report or arrives more than 30 minutes late for the appointment.
- Request that drivers check their belongings and remove any unnecessary outer garments, including purses, briefcases, and bulky outerwear (sweaters, jackets, vests, etc.). The collector must request that the driver empty his/ her pockets, display any personal items, and the collector must determine whether or not the items could be used to adulterate the specimen. The collector must allow the driver to retain his/her wallet.
- Have the driver wash and dry his/her hands.
- Select or allow the driver to select an individually wrapped or sealed collection container from collection kit materials. Unwrap the collection cup or specimen bottle in front of the driver and direct the driver to the privacy enclosure. Do not enter the enclosure. Do not observe the specimen collection. Instruct the driver that at least 45 ml of urine are required and that the temperature will be taken to ensure the integrity of the sample. The donor must urinate into a collection cup or specimen bottle. Only one specimen should be collected at a time. If you test for controlled substances other than those specified by the FMCSA regulation, a completely separate urine collection with its own non-DOT custody-and-control form is required.
- If the driver is unable to provide at least 45 ml, the collection site technician shall discard the insufficient specimen and instruct the driver to drink not more than 48 ounces of fluids during a period of up to 3 hours. The driver will then attempt to provide a complete sample using a fresh collection container. If the driver is still unable to provide an adequate specimen, testing shall be discontinued and the employer notified. The MRO shall refer the driver for a medical evaluation to determine whether the driver's inability to provide a specimen is genuine or constitutes a refusal to submit to a controlled substances test.
- If a collection container is used, the collection site person pours the urine into two specimen bottles in the presence of the donor. Thirty (30) ml shall be poured into one bottle, to be used as the primary specimen. At least 15 ml shall be poured into the other bottle, to be used as the split specimen. If a specimen bottle is used as a collection container, the collection site person shall pour 15 ml of urine from the specimen bottle into a second specimen bottle (to be used as the split specimen) and retain the remainder (at least 30 ml) in the collection bottle (to be used as the primary specimen).
- Within 4 minutes of receiving the specimen, record the temperature. The temperature must be between 32 and 38 Centigrade (90 and 100 Fahrenheit). Any specimen temperature that is out of range requires the specimen temperature box to be checked "No." and Enter in the "remarks" line the findings concerning the temperature. If the specimen temperature is out of range, the collector must immediately collect a new specimen using direct observation procedures (see 40.67). The collector will then send both specimens to the laboratory.
- The collector must inspect the specimen for unusual color, presence of foreign material, or other signs of tampering. The collector must immediately collect a new specimen using direct observation procedures (see 40.67). The collector will then send both specimens to the laboratory.
- If the driver refuses to cooperate with the collection process, inform the DER and document the noncooperation on the urine CCF. Discard any specimen the driver has provided during the collection process.
- Seal and label both bottles in the presence of the donor. The label(s) must be printed with the same specimen identification number as the CCF and be attached to the specimen bottles. The donor initials the labels, verifying that the specimen is his/hers.
- Complete the CCF. The collection site technician and the donor must sign the appropriate certification statements on the form regarding authenticity of the specimen information provided and the integrity of the collection process. Each transfer of custody must be noted on the chain-of-custody portion of the urine CCF. Every effort should be made to minimize the number of persons handling the specimen.
- Seal both the primary specimen and the split specimen in a single shipping container, together with the appropriate pages of the CCF. The tape seal on the container shall bear the initials of the collection site person and the date of closure.
- Place the specimen in secure storage until dispatched to the laboratory.
The urine specimen must be split and poured, except as noted in item 10 above, into two specimen bottles. This provides the driver with the option of having an analysis of the split sample. This analysis must be performed at a separate DHHS laboratory should the primary specimen test result be verified positive. The driver has 72 hours after being informed of a verified positive test by the MRO to request a test of the split sample. The request must be made to the MRO, and the employer must ensure the test is conducted.
Direct Observation Collections
Procedures for collecting urine specimens shall allow individual privacy unless there is a reason to believe that a particular individual may alter or substitute the specimen to be provided. As an employer you must direct an immediate collection under direct observation with no advance notice to the driver if
- The laboratory reported to the MRO that a specimen is invalid and the MRO reported to you that there was not an adequate medical explanation for the result; or
- The MRO reported to you that the original positive, adulterated, or substituted test result had to be cancelled because the test of the split specimen could not be performed.
- As an employer, you may direct a collection under direct observation of a driver if the drug test is a return-to-duty test or a follow-up test.
As a collector, you must immediately conduct a collection under direct observation if you are directed by the DER to do so.
The DOT has issued the following guidance identifying certain errors and omissions as "fatal flaws" that occur at a collection site and can result in a specimen being rejected by the testing laboratory:
- No printed collector name and no collector signature.
- The specimen identification number on specimen bottle does not match the number on the CCF.
- The specimen bottle seal is broken or shows evidence of tampering.
- Because of leakage or other causes, there is an insufficient amount of urine in the primary specimen bottle for analysis.
Under the new collection rules, laboratories must attempt to correct any of the following flaws:
- The collector's signature is omitted on the certification statement on the CCF.
- The driver's signature is omitted from the certification statement, unless the driver's failure or refusal to sign is noted on the "Remarks" line of the CCF.
- The certifying scientist's signature is omitted on the laboratory copy of the CCF for a positive, adulterated, substituted, or invalid test result.
- The collector uses a non-Federal form or an expired Federal form for the test. This flaw may be corrected through the procedure set forth in 40.205(b)(2), provided that the collection testing process has been conducted in accordance with the procedures of this part in a DHHS-certified laboratory. The collector 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. You must supply this information on the same business day on which you are notified of the problem, transmitting it by fax or courier.
Section 2. LABORATORY TESTING
The scientific techniques used in controlled substances testing are virtually error-free when properly applied. The combination of immunoassay screening with confirmation by gas chromatography/mass spectrometry (GC/MS) makes the possibility of error extremely remote. In the past, most errors in test results were the result of human error in specimen handling or documentation, both of which have been reduced in recent years by using detailed test protocols and stringent quality control checks.
All controlled substances testing under the FMCSA regulations must be completed in a laboratory certified by the Department of Health and Human Services (DHHS). These laboratories have been rigorously inspected and tested and meet the highest standards for analytical competence. A list of certified
laboratories is updated on a monthly basis, and current lists are printed in the Federal Register and are found on the Web at www.dot.gov/ost/dapc.
You should enter into a contract for primary laboratory services that specifically states the activities to be performed and the cost for such services. You should also enter into a contract with a second laboratory for split-sample analysis, and to serve as a back-up in case problems arise with the first laboratory.
The DOT regulation requires an immunoassay test as the initial test. If any prohibited controlled substance registers above the cut-off level on the immunoassay screen, an aliquot of the same urine specimen must be confirmed by GC/MS.
The initial test result is based on the ability of antibodies to recognize controlled substances in biological fluids. Immunoassay tests, called screens, are simple to run, often automated, and relatively inexpensive.
The confirmatory tests are more accurate, more time-consuming, require sophisticated laboratory equipment, and thus are more expensive than immunoassay screens. The only confirmatory test permitted by 49 CFR part 40 is GC/MS.
You must ensure that the laboratory meets the following standards for analytical controlled substances testing:
The laboratory must be DHHS- certified.
The laboratory must use an immunoassay technique to screen urine specimens for the specific controlled substances.
The laboratory must confirm all positive screens with GC/MS.
All confirmed positive specimens must be retained by the laboratory for a minimum of 1 year.
The laboratory must provide secure storage for the split-sample. If directed by the MRO, the laboratory shall forward the split-specimen bottle (with seal intact), a copy of the MRO request, and the split-specimen copy of the CCF to a different DHHS-approved laboratory.
Prior to finalizing the contract with the laboratory, you and driver representatives may want to personally inspect the laboratory.
The laboratory must provide to you a statistical summary report every 6 months, on January 20 and July 20 each year. You should also request a copy upon an audit by FMCSA. This summary must be consistent with 49 CFR part 40.
Section 3. MEDICAL REVIEW OFFICER
The FMCSA regulation requires that all controlled substances testing laboratory results be reviewed by a qualified MRO. The purpose of this review is to verify and validate test results.
An MRO is defined in the regulation as a licensed physician (M.D. or D.O.) responsible for receiving laboratory results generated by an employer's controlled substances testing program. The MRO must have knowledge of substance abuse disorders and appropriate medical training to interpret and evaluate an individual's confirmed positive test result, together with his or her medical history and any other relevant biomedical information.
The MRO is required to perform the functions found in 49 CFR subpart G.
Receive all of the results of controlled substances tests from the laboratory.
Review the CCF to ensure its accuracy.
Review and interpret a driver's confirmed positive, adulterated, substituted, or invalid test result by (1) reviewing the driver's medical history, including any medical records and biomedical information provided; (2) affording the driver an opportunity to discuss the test result; and (3) deciding whether there is a legitimate medical explanation for the result, including legally prescribed medication.
Report each verified test result to the DER or to the C/TPA if you are using one.
Maintain all necessary records and send the test results to the DER or to the C/TPA if you are using one.
Protect the driver's privacy and testing program confidentiality.
Contact the driver directly (i.e., actually talk to the driver), on a confidential basis, to determine whether the driver wants to discuss the test result. In making this contact, the MRO must explain to the driver that, if he/she declines to discuss the result, you will verify the test as positive or as a refusal to test because of adulteration or substitution, as applicable.
Notify drivers who have verified positive tests that they have 72 hours in which to request a test of the split specimen. If a driver requests an analysis of the split specimen within 72 hours of having been informed of a verified positive test, the MRO shall direct the laboratory, in writing, to ship the split specimen to another DHHS-certified laboratory for analysis. Reporting a verified positive result is not delayed pending the split-specimen analysis.
If the analysis of the split specimen fails to confirm the presence of a controlled substance(s) or metabolite(s), or if the split specimen is unavailable or inadequate for testing, cancel the test and report the cancellation and the reasons for it to the employer, the DOT, and the driver.
If the driver has not contacted the MRO within 72 hours of being notified of a verified positive controlled substances test, the driver may present to the MRO information documenting that serious illness, injury, inability to contact the MRO, lack of actual notice of the verified positive test, or other circumstances unavoidably prevented the driver from contacting the MRO in time.
- If the MRO concludes that there is a legitimate explanation for the driver's failure to contact the MRO within 72 hours, the MRO shall direct that the analysis of the split specimen be performed.
- If there is no legitimate explanation for the driver's failure to contact the MRO within 72 hours, then a split specimen does not have to be tested..
- If, after making three reasonable efforts within 24 hours (and documenting them), the MRO is unable to reach the driver directly, the MRO shall contact the DER, who shall direct the driver to contact the MRO within 72 hours. If, after making three reasonable efforts within 24 hours (and documenting them), your DER is unable to contact the driver,
the MRO will report the positive results. This will occur 10 days after the date of the laboratory report.
Medical Information Obtained From the Driver During the Verification Process
The MRO must disclose medical information provided by the individual as part of the testing verification process to a third party without the driver's consent. The circumstances under which the MRO must disclose such information are in 40.327:
- The information is likely to result in the driver being determined to be medically unqualified under any applicable DOT agency regulation; or
- The information indicates that continued performance by the driver in a safety-sensitive function could pose a significant safety risk; or
- The third parties include the employer, a physician, or other health care provider responsible for the medical qualification of the driver, an SAP, the FMCSA, or the National Transportation Safety Board (NTSB).
Discussions With the Driver
The MRO must tell the driver that the laboratory has determined that the driver's test result was positive, adulterated, substituted, or invalid, as applicable. The MRO must also tell the driver of the drugs for which his/her specimen tested positive, or the basis for the finding of adulteration or substitution.
The MRO must explain the verification interview process to the driver and inform the driver that the decision will be based on information the driver provides in the interview.
The MRO must explain that, if further medical evaluation is needed for the verification process, the driver must comply with the MRO's request for this evaluation and that failure to do so is equivalent to expressly declining to discuss the test result.
The MRO must warn a driver who has a confirmed positive, adulterated, substituted, or invalid test that the MRO is required to provide to third parties drug test result information and medical information affecting the performance of safety-sensitive duties that the driver discloses in the verification process, without the driver's consent (see 40.327).
The MRO must give this warning to the driver before obtaining any medical information as part of the verification process.
The MRO must also advise the driver that, after informing any third party about any medication the driver is using pursuant to a legally valid prescription under the Controlled Substances Act, the MRO will allow 5 days for the driver to have the prescribing physician contact him/her to determine if the medication can be changed to one that does not make the driver medically unqualified or does not pose a significant safety risk. If the MRO receives such information from the prescribing physician, he/she must transmit this information to any third party to whom the MRO previously provided information about the safety risks of the driver's other medication.
The driver must provide documentation (e.g., a doctor's report, a copy of a prescription) as proof of the legitimate use of medication. The MRO should be certain to set a deadline for receipt of any medical information offered by the driver.
Explanations for Legitimate Confirmed Positive Test Results
Explanations for a legitimate confirmed positive test result might include the use of legally prescribed or dispensed medication or the ingestion of substances that produce the same metabolites as an illegal substance. Examples of legitimate medical treatment are
- Codeine prescriptions for coughing and/or pain
- Narcotic analgesics prescribed for pain
- Tetrahydrocannabinol prescribed to cancer patients for anti-emetic purposes and to Acquired Immune Deficiency Syndrome (AIDS) patients for weight loss
- Cocaine prescribed as a topical or a vasoconstrictive anesthetic
- Schedule V opiate-containing preparation (e.g., cough suppressants and antidiarrheal preparations containing paregoric).
Medical judgment is required on a case-by-case basis. If satisfied that there is a valid medical reason for the confirmed positive test, the MRO will assure the driver that all information relating to the confirmed positive test and valid explanation will remain confidential. The MRO will verify the test result as negative and any report to the employer will indicate that the test is negative. The original laboratory-confirmed positive result should never be provided to you, the employer, and would be a violation of the rule.
Reporting a Verified Positive Test Result
If, after appropriate review, the MRO concludes that no legitimate medical reason exists for a confirmed positive test, and that the
chain-of-custody and laboratory procedures were correct, the MRO must report the verified positive test and the identity of the substance(s) to the employer or designated agent according to established company procedure and DOT regulations( 40.163.) Once a positive test result is verified, the MRO signs the verification statement of Copy 2 of the CCF. A copy of Copy 2 is the recommended way to report the results. The MRO should also document for his/her own files the basis for having made the positive determination. The MRO must retain the testing results for positive, adulterated or substituted results for a minimum of 5 years.
49 CFR section 40.163 requires the MRO to report to you the results of every controlled substances test. If the MRO does not use a copy of Copy 2 of the CCF, the report must, at a minimum, include the following information:
(1) Full name, as indicated on the CCF, of the driver tested,
(2) Specimen ID number from the CCF and the donor SSN or driver ID number,
(3) Reason for the test, if indicated on the CCF (e.g., random, post-accident),
(4) Date of the collection,
(5) Date you received Copy 2 of the CCF,
(6) Result of the test (i.e., positive, negative, dilute, refusal to test, test cancelled) and the date the result was verified by the MRO,
(7) For verified positive tests, the drug(s)/ metabolite(s) for which the test was positive,
(8) For cancelled tests, the reason for cancellation and
(9) For refusals to test, the reason for the refusal determination (e.g., in the case of an adulterated test result, the name of the adulterant).
The MRO may report negative results using an electronic data file; however, the report must contain, at a minimum, the information specified above. The report also must contain the MRO's name, address, and phone number, the name of any person other than the MRO reporting the results, and the date the electronic results report is released.
Copy 1 of the CCF must not be used to to report drug test results.
The MRO and the Medical Examiner
Under the regulations, controlled substances tests are not required as part of a periodic physical exam under 49 CFR part 391, subpart E. If the employer is an interstate motor carrier and wants to do periodic testing, the employer must not do so under FMCSA authority, but under its own separate authority.
If the Medical Examiner is qualified, he or she may be designated to also serve as the MRO. Such an arrangement would simplify the certification process.
National associations, including organizations affiliated with the American Medical Association, offer certification programs for MROs. When selecting a qualified MRO, you should conduct the following activities and retain documents resulting from these activities:
1. Review qualifications, medical licenses, memberships, and other relevant training and experience to ensure that minimum standards are met.
2. Have the MRO describe his/her methods for remaining informed of MRO policies and practices (e.g., attending conferences, additional training, memberships, newsletters, reviewing the regulations, etc.).
3. Assess ability to work with collection sites, testing laboratories, SAPs, and individual drivers; assess the proposed method of notifying drivers of verified positive test results and the method used to afford drivers the opportunity to discuss test results.
4. If not based locally, have the MRO indicate how interviews with drivers will be conducted and how the MRO will coordinate with your Designated Employer Representative (DER).
When the services of an MRO have been retained, you should do the following:
Describe procedures for disclosure of verified positive test results and the confidentiality that is required for medical information not specifically related to use of controlled substances.
Describe specimen collection procedures, collection sites, laboratories, and chain-of-custody procedures, and provide them to the MRO.
Provide the MRO with copies of 49 CFR part 40 and part 382.
Section 4. SUBSTANCE ABUSE PROFESSIONAL (SAP)
DOT regulation 49 CFR part 40, subpart O requires that any individual who has a verified positive controlled substances test result or has refused to be tested, must be immediately removed from his/her safety-
sensitive position. In addition, he/she must be advised of the resources available to evaluate and resolve problems associated with controlled substances use, including the names, addresses, and telephone numbers of SAPs and counseling and treatment programs. The driver must also be evaluated by an SAP, who shall determine what assistance the driver needs in resolving problems associated with controlled substances use.
An SAP can be (1) a licensed physician (medical doctor or doctor of osteopathy), or a licensed or certified psychologist, social worker, or driver assistance professional, with knowledge of and clinical experience in the diagnosis and treatment of controlled substances and alcohol-related disorders; or (2) an addiction counselor certified by the National Association of Alcoholism and Drug Abuse Counselors Certification Commission (NAADAC) or by the International Certification Reciprocity Consortium/Alcohol and Other Drug Abuse (ICRC).
The SAP must be knowledgeable about:
1. The diagnosis and treatment of alcohol and controlled substances-related disorders (and have clinical experience in this area),
2. The safety-sensitive duties of a driver and the employer's interests, and
3. 49 CFR part 40, part 382, and the DOT SAP guidelines.
The SAP must keep current on any changes to these materials. These documents are available from ODAPC (Department of Transportation, 1200 New Jersey Avenue SE, Washington DC, 20590, (202) 366-3784, or on the ODAPC Web site (http:// www.dot.gov/ost/dapc).
An SAP must maintain documentation showing that he/she currently meet all requirements of this section. Upon request, the SAP must provide this documentation to DOT agency representatives and to employers and C/TPAs who are using or contemplating using his/her services.
An SAP evaluation is required when a driver has violated FMCSA drug and alcohol regulations. As an employer, you are not required to provide an SAP evaluation or any subsequent recommended education or treatment for a driver who has violated FMCSA drug and alcohol regulations. However, if you offer that driver an opportunity to return to any FMCSA safety-sensitive duty following a violation, you must, before the driver again performs that duty, ensure that the driver receives an evaluation by an SAP meeting the requirements of 40.281 and that the driver successfully complies with the SAP's evaluation recommendations.
The SAP must make a face-to-face clinical assessment and evaluation to determine what assistance is needed by the employee to resolve problems associated with alcohol and/or drug use.
In all cases, the SAP must refer the employee to an appropriate education and/or treatment program. SAPs cannot refer an employee requiring assistance to their own private practices, or to a person or organization from which they receive payment, or to a person or organization in which they have a financial interest.
However, the employer and driver may use
A public agency (e.g., treatment facility) operated by a state, county, or municipality; or
A person or organization under contract to the employer to provide alcohol or drug treatment and/or education services (e.g., the employer's contracted treatment provider); or
A sole source of therapeutically appropriate treatment under the employee's health insurance program (e.g., the single substance abuse in-patient treatment program made available by the employee's insurance coverage plan); or
A sole source of therapeutically appropriate treatment reasonably available to the employee (e.g., the only treatment facility or education program reasonably located within the general commuting area.)
The SAP must conduct a face-to-face follow-up evaluation to determine if the employee has actively participated in the education and/or treatment program and has demonstrated successful compliance with the initial assessment and evaluation recommendations, provide the DER with a follow-up drug and/or alcohol testing plan for the employee, and provide the employee and employer with recommendations for continuing education and/or treatment.
The SAP's written reports are to be in a specific format found in 49 CFR, section 40.311. Keep in mind that the return-to-duty test cannot be conducted until the SAP makes the follow up interview and you receive the fit for duty letter.
The SAP must establish a written follow-up testing plan for any driver who seeks to resume the performance of safety-sensitive functions. The SAP must not establish this plan until after he/she determines that the employee has successfully complied with the
recommendations for education and/or treatment. A copy of this plan must be given directly to the DER (see 40.311(d)(9)).
The SAP is the sole determiner of the number and frequency of follow-up tests and whether these tests will be for drugs, alcohol, or both, unless otherwise directed by the appropriate DOT agency regulation. For example, if the employee had a positive drug test, but your evaluation or the treatment program professionals determined that the employee had an alcohol problem as well, you should require that the employee have follow-up tests for both drugs and alcohol. However, at a minimum, the employee is subject to six unannounced follow-up tests in the first 12 months of safety-sensitive duty following the employee's return to safety-sensitive functions.
As an employer, you must maintain your reports from SAPs for 5 years from the date you received them.
Chapter 6 Appendix
Collection Site Checklist
(To be Used by Specimen Collection Personnel)
The following 23 steps summarize a "typical" urine collection conducted under the DOT-mandated procedures. Changes in the sequence of these procedures, errors, or omissions in some of the steps may result in the collection being unacceptable for testing at the laboratory or the results being declared invalid upon review by the MRO.
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 specified under 49 CFR 40.43.
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 test process. (If an alcohol breath test is also scheduled, the alcohol test should be conducted first, if practicable.)
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. 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 employer's (or collection site) name. It does not have to be a picture identification or include the collector's home address or telephone number.
4. The collector explains the basic collection procedures to the employee and reviews the instructions on the back of CCF with the employee.
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 enters the required information in Step 1 of the CCF (employer's name, address, telephone, 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); 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 under separate documentation. 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.
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. 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, which 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 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 process would continue.
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 material that could be used to put into the specimen.
Note: The employee may use soap and, if practicable, it should be a liquid or cream. A solid bar or soap gives the employee the chance to conceal soap shaving under his or her fingernails and subsequently use them to attempt to adulterate the specimen.
9. The collector either gives 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: 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. Only unwrap the 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.
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. 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 should 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.
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. 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 of out of the restroom. The acceptable temperature range is 32-38C/90-100F. 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. 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 (e.g., the specimen is blue, exhibits excessive foaming when shaken, or has smell of bleach).
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 with 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.
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 of urine 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 urine 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, ensuring that the seal labeled "A" is placed on the primary bottle with at least 30 mL of urine and that the seal labeled "B" is placed on the bottle of 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 seal 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) chain of custody form 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 on 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 of the chain of custody on the CCF (Copy 1, Step 4) 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 medication he or she may have taken if a positive 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 need 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 copy together with the collector's copy for 30 days. Retention is 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 shipment 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. The specimens need not be under lock and key; however, procedures must exist that would ensure specimens cannot be subject to tampering.
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 the 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 above 23 steps represent a "typical" collection and are the basic requirements for a DOT mandated urine specimen collection. They are presented in chronological order to represent the proper order for the steps in obtaining, documenting, and securing a urine specimen.
To obtain more specific information regarding the procedures of collecting a specimen,
visit the Office of Drug and Alcohol Policy and Compliance website at http://www.dot.gov/ost/dapc/ .
Driver Specimen Collection Checklist
(For Drivers Required to Provide Urine Specimens for Drug Testing)
1. Report to the specimen collection site as soon as possible after notification to report. Refusal to report for collection or refusal to cooperate with the collection process will result in a refusal to test essentially a positive test.
2. The employee must provide appropriate identification to the collector upon arrival at the collection site. Acceptable forms of identification include:
(a) 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
(b) Identification by an employer or employer representative, or
(c) Any other identification allowed under an operating administrator's rules.
3. Check your outer garments with the collection site personnel for safekeeping. You have the right to retain your wallet and to ask for a receipt for your belongings. Also, at the direction of the specimen collector you must empty your pockets and display items to ensure that no items are present that could be used to adulterate the specimen.
4. Wash and dry your hands.
5. Observe the specimen collector unwrap a specimen container.
6. Proceed to the room used for urination and provide a specimen in the collection container. At least 45 mL of urine is required for analysis. Do not tamper with the specimen or make substitutions. The specimen will be visually inspected for unusual color and sediment.
7. Give the specimen to the specimen collector and observe while the collector checks the specimen for temperature, volume, and visually inspects the specimen for signs of tampering or substitution. The specimen must be of sufficient volume (45 mL) and within acceptable temperature range. If the specimen fails to meet sufficient volume or falls outside the acceptable temperature range, you will be required to undergo a second collection. If for temperature, the second collection will be by direct observation.
8. Observe the specimen collector pour the required amount of urine into specimen bottles, place the tamper-evident seals on specimen bottles and label them accordingly. Initial the labels verifying that the specimen is yours.
9. You may wish to indicate on the back of your copy of the custody and control form any medications you are currently using. This list may serve as a memory jogger in the event a Medical Review Officer (MRO) calls you to discuss the results of your test.
10. The results of the laboratory analysis will be forwarded to your employer's Medical Review Office (MRO). If the results are negative (no controlled substances detected), the MRO will notify your employer. If the laboratory confirms a positive test result (controlled substances detected), the MRO will contact you at the telephone number you provided to give you the opportunity to discuss the test results and submit information demonstrating authorized used of the controlled substances in question.