[Federal Register: December 19, 2000 (Volume 65, Number 244)]
[Rules and Regulations]
[Page 79561-79579]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19de00-15]
[[pp. 79561-79579]] Procedures for Transportation Workplace Drug and Alcohol Testing
Programs
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the employee did not sign the certification. You would, when the
problem is called to your attention, supply a signed statement that the
employee failed or refused to sign the certification after the result
was obtained, and that your signed statement is true and accurate.
(2) If the problem is the use of a non-DOT form, you must, as the
person responsible for the use of the incorrect form, certify in
writing that the incorrect form contains all the information needed for
a valid DOT alcohol test. You must also provide a signed statement that
the incorrect form was used inadvertently or as the only means of
conducting a test, in circumstances beyond your control, and the steps
you have taken to prevent future use of non-DOT 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.
(c) If you cannot correct the problem, you must cancel the test.
Sec. 40.273 What is the effect of a cancelled alcohol test?
(a) A cancelled alcohol test is neither positive nor negative.
(1) As an employer, you must not attach to a cancelled test the
consequences of a test result that is 0.02 or greater (e.g., removal
from a safety-sensitive position).
(2) As an employer, you must not use a cancelled test in a
situation where an employee needs a test result that is below 0.02
(e.g., in the case of a return-to-duty or follow-up test to authorize
the employee to perform safety-sensitive functions).
(3) As an employer, you must not direct a recollection for an
employee because a test has been cancelled, except in the situations
cited in paragraph (a)(2) of this section or other provisions of this
part.
(b) A cancelled test does not count toward compliance with DOT
requirements, such as a minimum random testing rate.
(c) When a test must be cancelled, if you are the BAT, STT, or
other person who determines that the cancellation is necessary, you
must inform the affected DER within 48 hours of the cancellation.
(d) A cancelled DOT test does not provide a valid basis for an
employer to conduct a non-DOT test (i.e., a test under company
authority).
Sec. 40.275 What is the effect of procedural problems that are not
sufficient to cancel an alcohol test?
(a) As an STT, BAT, employer, or a service agent administering the
testing process, you must document any errors in the testing process of
which you become aware, even if they are not ``fatal flaws'' or
``correctable flaws'' listed in this subpart. Decisions about the
ultimate impact of these errors will be determined by administrative or
legal proceedings, subject to the limitation of paragraph (b) of this
section.
(b) No person concerned with the testing process may declare a test
cancelled based on a mistake in the process that does not have a
significant adverse effect on the right of the employee to a fair and
accurate test. For example, it is inconsistent with this part to cancel
a test based on a minor administrative mistake (e.g., the omission of
the employee's middle initial) or an error that does not affect
employee protections under this part. Nor does the failure of an
employee to sign in Step 4 of the ATF result in the cancellation of the
test. Nor is a test to be cancelled on the basis of a claim by an
employee that he or she was improperly selected for testing.
(c) As an employer, these errors, even though not sufficient to
cancel an alcohol test result, may subject you to enforcement action
under DOT agency regulations.
Sec. 40.277 Are alcohol tests other than saliva or breath permitted
under these regulations?
No, other types of alcohol tests (e,g., blood and urine) are not
authorized for testing done under this part. Only saliva or breath for
screening tests and breath for confirmation tests using approved
devices are permitted.
Subpart O--Substance Abuse Professionals and the Return-to-Duty
Process
Sec. 40.281 Who is qualified to act as a SAP?
To be permitted to act as a SAP in the DOT drug testing program,
you must meet each of the requirements of this section:
(a) Credentials. You must have one of the following credentials:
(1) You are a licensed physician (Doctor of Medicine or
Osteopathy);
(2) You are a licensed or certified social worker;
(3) You are a licensed or certified psychologist;
(4) You are a licensed or certified employee assistance
professional; or
(5) You are a drug and alcohol 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).
(b) Basic knowledge. You must be knowledgeable in the following
areas:
(1) You must be knowledgeable about and have clinical experience in
the diagnosis and treatment of alcohol and controlled substances-
related disorders.
(2) You must be knowledgeable about the SAP function as it relates
to employer interests in safety-sensitive duties.
(3) You must be knowledgeable about this part, the DOT agency
regulations applicable to the employers for whom you evaluate
employees, and the DOT SAP Guidelines, and you keep current on any
changes to these materials. These documents are available from ODAPC
(Department of Transportation, 400 7th Street, SW., Room 10403,
Washington DC, 20590 (202-366-3784), or on the ODAPC web site (http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.dot.gov/ost/dapc).
(c) Qualification training. You must receive qualification training
meeting the requirements of this paragraph (c).
(1) Qualification training must provide instruction on the
following subjects:
(i) Background, rationale, and coverage of the Department's drug
and alcohol testing program;
(ii) 49 CFR Part 40 and DOT agency drug and alcohol testing rules;
(iii) Key DOT drug testing requirements, including collections,
laboratory testing, MRO review, and problems in drug testing;
(iv) Key DOT alcohol testing requirements, including the testing
process, the role of BATs and STTs, and problems in alcohol tests;
(v) SAP qualifications and prohibitions;
(vi) The role of the SAP in the return-to-duty process, including
the initial employee evaluation, referrals for education and/or
treatment, the follow-up evaluation, continuing treatment
recommendations, and the follow-up testing plan;
(vii) SAP consultation and communication with employers, MROs, and
treatment providers;
(viii) Reporting and recordkeeping requirements;
(ix) Issues that SAPs confront in carrying out their duties under
the program.
(2) Following your completion of qualification training under
paragraph (c)(1) of this section, you must satisfactorily complete an
examination administered by a nationally-recognized professional or
training organization. The examination must comprehensively cover all
the elements of qualification training listed in paragraph (c)(1) of
this section.
(3) The following is the schedule for qualification training you
must meet:
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(i) If you became a SAP before August 1, 2001, you must meet the
qualification training requirement no later than December 31, 2003.
(ii) If you become a SAP between August 1, 2001, and December 31,
2003, you must meet the qualification training requirement no later
than December 31, 2003.
(iii) If you become a SAP on or after January 1, 2004, you must
meet the qualification training requirement before you begin to perform
SAP functions.
(d) Continuing education. During each three-year period from the
date on which you satisfactorily complete the examination under
paragraph (c)(2) of this section, you must complete continuing
education consisting of at least 12 professional development hours
(e.g., CEUs) relevant to performing SAP functions.
(1) This continuing education must include material concerning new
technologies, interpretations, recent guidance, rule changes, and other
information about developments in SAP practice, pertaining to the DOT
program, since the time you met the qualification training requirements
of this section.
(2) Your continuing education activities must include documentable
assessment tools to assist you in determining whether you have
adequately learned the material.
(e) 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 contemplating using your services.
Sec. 40.283 How does a certification organization obtain recognition
for its members as SAPs?
(a) If you represent a certification organization that wants DOT to
authorize its certified drug and alcohol counselors to be added to
Sec. 40.281(a)(5), you may submit a written petition to DOT requesting
a review of your petition for inclusion.
(b) You must obtain the National Commission for Certifying Agencies
(NCCA) accreditation before DOT will act on your petition.
(c) You must also meet the minimum requirements of Appendix E to
this part before DOT will act on your petition.
Sec. 40.285 When is a SAP evaluation required?
(a) As an employee, when you have violated DOT drug and alcohol
regulations, you cannot again perform any DOT safety-sensitive duties
for any employer until and unless you complete the SAP evaluation,
referral, and education/treatment process set forth in this subpart and
in applicable DOT agency regulations. The first step in this process is
a SAP evaluation.
(b) For purposes of this subpart, a verified positive DOT drug test
result, a DOT alcohol test with a result indicating an alcohol
concentration of 0.04 or greater, a refusal to test (including by
adulterating or substituting a urine specimen) or any other violation
of the prohibition on the use of alcohol or drugs under a DOT agency
regulation constitutes a DOT drug and alcohol regulation violation.
Sec. 40.287 What information is an employer required to provide
concerning SAP services to an employee who has a DOT drug and alcohol
regulation violation?
As an employer, you must provide to each employee (including an
applicant or new employee) who violates a DOT drug and alcohol
regulation a listing of SAPs readily available to the employee and
acceptable to you, with names, addresses, and telephone numbers. You
cannot charge the employee any fee for compiling or providing this
list. You may provide this list yourself or through a C/TPA or other
service agent.
Sec. 40.289 Are employers required to provide SAP and treatment
services to employees?
(a) As an employer, you are not required to provide a SAP
evaluation or any subsequent recommended education or treatment for an
employee who has violated a DOT drug and alcohol regulation.
(b) However, if you offer that employee an opportunity to return to
a DOT safety-sensitive duty following a violation, you must, before the
employee again performs that duty, ensure that the employee receives an
evaluation by a SAP meeting the requirements of Sec. 40.281 and that
the employee successfully complies with the SAP's evaluation
recommendations.
(c) Payment for SAP evaluations and services is left for employers
and employees to decide and may be governed by existing management-
labor agreements and health care benefits.
Sec. 40.291 What is the role of the SAP in the evaluation, referral,
and treatment process of an employee who has violated DOT agency drug
and alcohol testing regulations?
(a) As a SAP, you are charged with:
(1) Making 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;
(2) Referring the employee to an appropriate education and/or
treatment program;
(3) Conducting 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;
(4) Providing the DER with a follow-up drug and/or alcohol testing
plan for the employee; and
(5) Providing the employee and employer with recommendations for
continuing education and/or treatment.
(b) As a SAP, you are not an advocate for the employer or employee.
Your function is to protect the public interest in safety by
professionally evaluating the employee and recommending appropriate
education/treatment, follow-up tests, and aftercare.
Sec. 40.293 What is the SAP's function in conducting the initial
evaluation of an employee?
As a SAP, for every employee who comes to you following a DOT drug
and alcohol regulation violation, you must accomplish the following:
(a) Provide a comprehensive face-to-face assessment and clinical
evaluation.
(b) Recommend a course of education and/or treatment with which the
employee must demonstrate successful compliance prior to returning to
DOT safety-sensitive duty.
(1) You must make such a recommendation for every individual who
has violated a DOT drug and alcohol regulation.
(2) You must make a recommendation for education and/or treatment
that will, to the greatest extent possible, protect public safety in
the event that the employee returns to the performance of safety-
sensitive functions.
(c) Appropriate education may include, but is not limited to, self-
help groups (e.g., Alcoholics Anonymous) and community lectures, where
attendance can be independently verified, and bona fide drug and
alcohol education courses.
(d) Appropriate treatment may include, but is not limited to, in-
patient hospitalization, partial in-patient treatment, out-patient
counseling programs, and aftercare.
(e) You must provide a written report directly to the DER
highlighting your specific recommendations for assistance (see
Sec. 40.311(c)).
(f) For purposes of your role in the evaluation process, you must
assume that a verified positive test result has conclusively
established that the employee committed a DOT drug and
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alcohol regulation violation. You must not take into consideration in
any way, as a factor in determining what your recommendation will be,
any of the following:
(1) A claim by the employee that the test was unjustified or
inaccurate;
(2) Statements by the employee that attempt to mitigate the
seriousness of a violation of a DOT drug or alcohol regulation (e.g.,
related to assertions of use of hemp oil, ``medical marijuana'' use,
``contact positives,'' poppy seed ingestion, job stress); or
(3) Personal opinions you may have about the justification or
rationale for drug and alcohol testing.
(g) In the course of gathering information for purposes of your
evaluation in the case of a drug-related violation, you may consult
with the MRO. As the MRO, you are required to cooperate with the SAP
and provide available information the SAP requests. It is not necessary
to obtain the consent of the employee to provide this information.
Sec. 40.295 May employees or employers seek a second SAP evaluation if
they disagree with the first SAP's recommendations?
(a) As an employee with a DOT drug and alcohol regulation
violation, when you have been evaluated by a SAP, you must not seek a
second SAP's evaluation in order to obtain another recommendation.
(b) As an employer, you must not seek a second SAP's evaluation if
the employee has already been evaluated by a qualified SAP. If the
employee, contrary to paragraph (a) of this section, has obtained a
second SAP evaluation, as an employer you may not rely on it for any
purpose under this part.
Sec. 40.297 Does anyone have the authority to change a SAP's initial
evaluation?
(a) Except as provided in paragraph (b) of this section, no one
(e.g., an employer, employee, a managed-care provider, any service
agent) may change in any way the SAP's evaluation or recommendations
for assistance. For example, a third party is not permitted to make
more or less stringent a SAP's recommendation by changing the SAP's
evaluation or seeking another SAP's evaluation.
(b) The SAP who made the initial evaluation may modify his or her
initial evaluation and recommendations based on new or additional
information (e.g., from an education or treatment program).
Sec. 40.299 What is the SAP's role and what are the limits on a SAP's
discretion in referring employees for education and treatment?
(a) As a SAP, upon your determination of the best recommendation
for assistance, you will serve as a referral source to assist the
employee's entry into a education and/or treatment program.
(b) To prevent the appearance of a conflict of interest, you must
not refer an employee requiring assistance to your private practice or
to a person or organization from which you receive payment or to a
person or organization in which you have a financial interest. You are
precluded from making referrals to entities with which you are
financially associated.
(c) There are four exceptions to the prohibitions contained in
paragraph (b) of this section. You may refer an employee to any of the
following providers of assistance, regardless of your relationship with
them:
(1) A public agency (e.g., treatment facility) operated by a state,
county, or municipality;
(2) The employer 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);
(3) The 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
(4) The 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).
Sec. 40.301 What is the SAP's function in the follow-up evaluation of
an employee?
(a) As a SAP, after you have prescribed assistance under
Sec. 40.293, you must re-evaluate the employee to determine if the
employee has successfully carried out your education and/or treatment
recommendations.
(1) This is your way to gauge for the employer the employee's
ability to demonstrate successful compliance with the education and/or
treatment plan.
(2) Your evaluation may serve as one of the reasons the employer
decides to return the employee to safety-sensitive duty.
(b) As the SAP making the follow-up evaluation determination, you
must:
(1) Confer with or obtain appropriate documentation from the
appropriate education and/or treatment program professionals where the
employee was referred; and
(2) Conduct a face-to-face clinical interview with the employee to
determine if the employee demonstrates successful compliance with your
initial evaluation recommendations.
(c) (1) If the employee has demonstrated successful compliance, you
must provide a written report directly to the DER highlighting your
clinical determination that the employee has done so with your initial
evaluation recommendation (see Sec. 40.311(d)).
(2) You may determine that an employee has successfully
demonstrated compliance even though the employee has not yet completed
the full regimen of education and/or treatment you recommended or needs
additional asssitance. For example, if the employee has successfully
completed the 30-day in-patient program you prescribed, you may make a
``successful compliance'' determination even though you conclude that
the employee has not yet completed the out-patient counseling you
recommended or should continue in an aftercare program.
(d)(1) As the SAP, if you believe, as a result of the follow-up
evaluation, that the employee has not demonstrated successful
compliance with your recommendations, you must provide written notice
directly to the DER (see Sec. 40.311(e)).
(2) As an employer who receives the SAP's written notice that the
employee has not successfully complied with the SAP's recommendations,
you must not return the employee to the performance of safety-sensitive
duties.
(3) As the SAP, you may conduct additional follow-up evaluation(s)
if the employer determines that doing so is consistent with the
employee's progress as you have reported it and with the employer's
policy and/or labor-management agreements.
(4) As the employer, following a SAP report that the employee has
not demonstrated successful compliance, you may take personnel action
consistent with your policy and/or labor-management agreements.
Sec. 40.303 What happens if the SAP believes the employee needs
additional treatment, aftercare, or support group services even after
the employee returns to safety-sensitive duties?
(a) As a SAP, if you believe that ongoing services (in addition to
follow-up tests) are needed to assist an employee to maintain sobriety
or abstinence from drug use after the
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employee resumes the performance of safety-sensitive duties, you must
provide recommendations for these services in your follow-up evaluation
report (see Sec. 40.311(d)(10)).
(b) As an employer receiving a recommendation for these services
from a SAP, you may, as part of a return-to-duty agreement with the
employee, require the employee to participate in the recommended
services. You may monitor and document the employee's participation in
the recommended services. You may also make use of SAP and employee
assistance program (EAP) services in assisting and monitoring
employees' compliance with SAP recommendations. Nothing in this section
permits an employer to fail to carry out its obligations with respect
to follow-up testing (see Sec. 40.309 ).
(c) As an employee, you are obligated to comply with the SAP's
recommendations for these services. If you fail or refuse to do so, you
may be subject to disciplinary action by your employer.
Sec. 40.305 How does the return-to-duty process conclude?
(a) As the employer, if you decide that you want to permit the
employee to return to the performance of safety-sensitive functions,
you must ensure that the employee takes a return-to-duty test. This
test cannot occur until after the SAP has determined that the employee
has successfully complied with prescribed education and/or treatment.
The employee must have a negative drug test result and/or an alcohol
test with an alcohol concentration of less than 0.02 before resuming
performance of safety-sensitive duties.
(b) As an employer, you must not return an employee to safety-
sensitive duties until the employee meets the conditions of paragraph
(a) of this section. However, you are not required to return an
employee to safety-sensitive duties because the employee has met these
conditions. That is a personnel decision that you have the discretion
to make, subject to collective bargaining agreements or other legal
requirements.
(c) As a SAP or MRO, you must not make a ``fitness for duty''
determination as part of this re-evaluation unless required to do so
under an applicable DOT agency regulation. It is the employer, rather
than you, who must decide whether to put the employee back to work in a
safety-sensitive position.
Sec. 40.307 What is the SAP's function in prescribing the employee's
follow-up tests?
(a) As a SAP, for each employee who has committed a DOT drug or
alcohol regulation violation, and who seeks to resume the performance
of safety-sensitive functions, you must establish a written follow-up
testing plan. You do not establish this plan until after you determine
that the employee has successfully complied with your recommendations
for education and/or treatment.
(b) You must present a copy of this plan directly to the DER (see
Sec. 40.311(d)(9)).
(c) You are 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.
(d) However, you must, at a minimum, direct that the employee be
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.
(1) You may require a greater number of follow-up tests during the
first 12-month period of safety-sensitive duty (e.g., you may require
one test a month during the 12-month period; you may require two tests
per month during the first 6-month period and one test per month during
the final 6-month period).
(2) You may also require follow-up tests during the 48 months of
safety-sensitive duty following this first 12-month period.
(3) You are not to establish the actual dates for the follow-up
tests you prescribe. The decision on specific dates to test is the
employer's.
(4) As the employer, you must not impose additional testing
requirements (e.g., under company authority) on the employee that go
beyond the SAP's follow-up testing plan.
(e) The requirements of the SAP's follow-up testing plan ``follow
the employee'' to subsequent employers or through breaks in service.
Example 1 to Paragraph (e): The employee returns to duty with
Employer A. Two months afterward, after completing the first two of
six follow-up tests required by the SAP's plan, the employee quits
his job with Employer A and begins to work in a similar position for
Employer B. The employee remains obligated to complete the four
additional tests during the next 10 months of safety-sensitive duty,
and Employer B is responsible for ensuring that the employee does
so. Employer B learns of this obligation through the inquiry it
makes under Sec. 40.25.
Example 2 to Paragraph (e): The employee returns to duty with
Employer A. Three months later, after the employee completes the
first two of six follow-up tests required by the SAP's plan,
Employer A lays the employee off for economic or seasonal employment
reasons. Four months later, Employer A recalls the employee.
Employer A must ensure that the employee completes the remaining
four follow-up tests during the next nine months.
(f) As the SAP, you may modify the determinations you have made
concerning follow-up tests. For example, even if you recommended
follow-up testing beyond the first 12-months, you can terminate the
testing requirement at any time after the first year of testing. You
must not, however, modify the requirement that the employee take at
least six follow-up tests within the first 12 months after returning to
the performance of safety-sensitive functions.
Sec. 40.309 What are the employer's responsibilities with respect to
the SAP's directions for follow-up tests?
(a) As the employer, you must carry out the SAP's follow-up testing
requirements. You may not allow the employee to continue to perform
safety-sensitive functions unless follow-up testing is conducted as
directed by the SAP.
(b) You should schedule follow-up tests on dates of your own
choosing, but you must ensure that the tests are unannounced with no
discernable pattern as to their timing, and that the employee is given
no advance notice.
(c) You cannot substitute any other tests (e.g., those carried out
under the random testing program) conducted on the employee for this
follow-up testing requirement.
(d) You cannot count a follow-up test that has been cancelled as a
completed test. A cancelled follow-up test must be recollected.
Sec. 40.311 What are the requirements concerning SAP reports?
(a) As the SAP conducting the required evaluations, you must send
the written reports required by this section in writing directly to the
DER and not to a third party or entity for forwarding to the DER
(except as provided in Sec. 40.355(e)). You may, however, forward the
document simultaneously to the DER and to a C/TPA.
(b) As an employer, you must ensure that you receive SAP written
reports directly from the SAP performing the evaluation and that no
third party or
[[Page 79565]]
entity changed the SAP's report in any way.
(c) The SAP's written report, following an initial evaluation that
determines what level of assistance is needed to address the employee's
drug and/or alcohol problems, must be on the SAP's own letterhead (and
not the letterhead of another service agent) signed and dated by the
SAP, and must contain the following delineated items:
(1) Employee's name and SSN;
(2) Employer's name and address;
(3) Reason for the assessment (specific violation of DOT
regulations and violation date);
(4) Date(s) of the assessment;
(5) SAP's education and/or treatment recommendation; and
(6) SAP's telephone number.
(d) The SAP's written report concerning a follow-up evaluation that
determines the employee has demonstrated successful compliance must be
on the SAP's own letterhead (and not the letterhead of another service
agent), signed by the SAP and dated, and must contain the following
items:
(1) Employee's name and SSN;
(2) Employer's name and address;
(3) Reason for the initial assessment (specific violation of DOT
regulations and violation date);
(4) Date(s) of the initial assessment and synopsis of the treatment
plan;
(5) Name of practice(s) or service(s) providing the recommended
education and/or treatment;
(6) Inclusive dates of employee's program participation;
(7) Clinical characterization of employee's program participation;
(8) SAP's clinical determination as to whether the employee has
demonstrated successful compliance;
(9) Follow-up testing plan;
(10) Employee's continuing care needs with specific treatment,
aftercare, and/or support group services recommendations; and
(11) SAP's telephone number.
(e) The SAP's written report concerning a follow-up evaluation that
determines the employee has not demonstrated successful compliance must
be on the SAP's own letterhead (and not the letterhead of another
service agent), signed by the SAP and dated, and must contain the
following items:
(1) Employee's name and SSN;
(2) Employer's name and address;
(3) Reason for the initial assessment (specific DOT violation and
date);
(4) Date(s) of initial assessment and synopsis of treatment plan;
(5) Name of practice(s) or service(s) providing the recommended
education and/or treatment;
(6) Inclusive dates of employee's program participation;
(7) Clinical characterization of employee's program participation;
(8) Date(s) of the first follow-up evaluation;
(9) Date(s) of any further follow-up evaluation the SAP has
scheduled;
(10) SAP's clinical reasons for determining that the employee has
not demonstrated successful compliance; and
(11) SAP's telephone number.
(f) As a SAP, you must also provide these written reports directly
to the employee if the employee has no current employer and to the
gaining DOT regulated employer in the event the employee obtains
another transportation industry safety-sensitive position.
(g) As a SAP, you are to maintain copies of your reports to
employers for 5 years, and your employee clinical records in accordance
with Federal, state, and local laws regarding record maintenance,
confidentiality, and release of information. You must make these
records available, on request, to DOT agency representatives (e.g.,
inspectors conducting an audit or safety investigation) and
representatives of the NTSB in an accident investigation.
(h) As an employer, you must maintain your reports from SAPs for 5
years from the date you received them.
Sec. 40.313 Where is other information on SAP functions and the
return-to-duty process found in this regulation?
You can find other information on the role and functions of SAPs in
the following sections of this part:
Sec. 40.3--Definition.
Sec. 40.347--Service agent assistance with SAP-required follow-up
testing.
Sec. 40.355--Transmission of SAP reports.
Sec. 40.329(c)--Making SAP reports available to employees on
request.
Appendix E to Part 40--SAP Equivalency Requirements for Certification
Organizations.
Subpart P--Confidentiality and Release of Information
Sec. 40.321 What is the general confidentiality rule for drug and
alcohol test information?
Except as otherwise provided in this subpart, as a service agent or
employer participating in the DOT drug or alcohol testing process, you
are prohibited from releasing individual test results or medical
information about an employee to third parties without the employee's
specific written consent.
(a) A ``third party'' is any person or organization to whom other
subparts of this regulation do not explicitly authorize or require the
transmission of information in the course of the drug or alcohol
testing process.
(b) ``Specific written consent'' means a statement signed by the
employee that he or she agrees to the release of a particular piece of
information to a particular, explicitly identified, person or
organization at a particular time. ``Blanket releases,'' in which an
employee agrees to a release of a category of information (e.g., all
test results) or to release information to a category of parties (e.g.,
other employers who are members of a C/TPA, companies to which the
employee may apply for employment), are prohibited under this part.
Sec. 40.323 May program participants release drug or alcohol test
information in connection with legal proceedings?
(a) As an employer, you may release information pertaining to an
employee's drug or alcohol test without the employee's consent in
certain legal proceedings.
(1) These proceedings include a lawsuit (e.g., a wrongful discharge
action), grievance (e.g., an arbitration concerning disciplinary action
taken by the employer), or administrative proceeding (e.g., an
unemployment compensation hearing) brought by, or on behalf of, an
employee and resulting from a positive DOT drug or alcohol test or a
refusal to test (including, but not limited to, adulterated or
substituted test results).
(2) These proceedings also include a criminal or civil action
resulting from an employee's performance of safety-sensitive duties, in
which a court of competent jurisdiction determines that the drug or
alcohol test information sought is relevant to the case and issues an
order directing the employer to produce the information. For example,
in personal injury litigation following a truck or bus collision, the
court could determine that a post-accident drug test result of an
employee is relevant to determining whether the driver or the driver's
employer was negligent. The employer is authorized to respond to the
court's order to produce the records.
(b) In such a proceeding, you may release the information to the
decisionmaker in the proceeding (e.g., the court in a lawsuit). You may
release the information only with a binding stipulation that the
decisionmaker to whom it is released will make it available only to
parties to the proceeding.
(c) If you are a service agent, and the employer requests its
employee's drug or alcohol testing information from you to use in a
legal proceeding as authorized in paragraph (a) of this
[[Page 79566]]
section (e.g., the laboratory's data package), you must provide the
requested information to the employer.
(d) As an employer or service agent, you must immediately notify
the employee in writing of any information you release under this
section.
Sec. 40.325 [Reserved]
Sec. 40.327 When must the MRO report medical information gathered in
the verification process?
(a) As the MRO, you must, except as provided in paragraph (c) of
this section, report drug test results and medical information you
learned as part of the verification process to third parties without
the employee's consent if you determine, in your reasonable medical
judgment, that:
(1) The information is likely to result in the employee being
determined to be medically unqualified under an applicable DOT agency
regulation; or
(2) The information indicates that continued performance by the
employee of his or her safety-sensitive function is likely to pose a
significant safety risk.
(b) The third parties to whom you are authorized to provide
information by this section include the employer, a physician or other
health care provider responsible for determining the medical
qualifications of the employee under an applicable DOT agency safety
regulation, a SAP evaluating the employee as part of the return to duty
process (see Sec. 40.293(g)), a DOT agency, or the National
Transportation Safety Board in the course of an accident investigation.
(c) If the law of a foreign country (e.g., Canada) prohibits you
from providing medical information to the employer, you may comply with
that prohibition.
Sec. 40.329 What information must laboratories, MROs, and other
service agents release to employees?
(a) As an MRO or service agent you must provide, within 10 business
days of receiving a written request from an employee, copies of any
records pertaining to the employee's use of alcohol and/or drugs,
including records of the employee's DOT-mandated drug and/or alcohol
tests. You may charge no more than the cost of preparation and
reproduction for copies of these records.
(b) As a laboratory, you must provide, within 10 business days of
receiving a written request from an employee, and made through the MRO,
the records relating to the results of the employee's drug test (i.e.,
laboratory report and data package). You may charge no more than the
cost of preparation and reproduction for copies of these records.
(c) As a SAP, you must make available to an employee, on request, a
copy of all SAP reports (see Sec. 40.311).
Sec. 40.331 To what additional parties must employers and service
agents release information?
As an employer or service agent you must release information under
the following circumstances:
(a) If you receive a specific, written consent from an employee
authorizing the release of information about that employee's drug or
alcohol tests to an identified person, you must provide the information
to the identified person. For example, as an employer, when you receive
a written request from a former employee to provide information to a
subsequent employer, you must do so. In providing the information, you
must comply with the terms of the employee's consent.
(b) If you are an employer, you must, upon request of DOT agency
representatives, provide the following:
(1) Access to your facilities used for this part and DOT agency
drug and alcohol program functions.
(2) All written, printed, and computer-based drug and alcohol
program records and reports (including copies of name-specific records
or reports), files, materials, data, documents/documentation,
agreements, contracts, policies, and statements that are required by
this part and DOT agency regulations.
(c) If you are a service agent, you must, upon request of DOT
agency representatives, provide the following:
(1) Access to your facilities used for this part and DOT agency
drug and alcohol program functions.
(2) All written, printed, and computer-based drug and alcohol
program records and reports (including copies of name-specific records
or reports), files, materials, data, documents/documentation,
agreements, contracts, policies, and statements that are required by
this part and DOT agency regulations.
(d) If requested by the National Transportation Safety Board as
part of an accident investigation, you must provide information
concerning post-accident tests administered after the accident.
(e) If requested by a Federal, state or local safety agency with
regulatory authority over you or the employee, you must provide drug
and alcohol test records concerning the employee.
(f) Except as otherwise provided in this part, as a laboratory you
must not release or provide a specimen or a part of a specimen to a
requesting party, without first obtaining written consent from ODAPC.
If a party seeks a court order directing you to release a specimen or
part of a specimen contrary to any provision of this part, you must
take necessary legal steps to contest the issuance of the order (e.g.,
seek to quash a subpoena, citing the requirements of Sec. 40.13 ). This
part does not require you to disobey a court order, however.
Sec. 40.333 What records must employers keep?
(a) As an employer, you must keep the following records for the
following periods of time:
(1) You must keep the following records for five years:
(i) Records of employee alcohol test results indicating an alcohol
concentration of 0.02 or greater;
(ii) Records of employee verified positive drug test results;
(iii) Documentation of refusals to take required alcohol and/or
drug tests (including substituted or adulterated drug test results);
(iv) SAP reports; and
(v) All follow-up tests and schedules for follow-up tests.
(2) You must keep records for three years of information obtained
from previous employers under Sec. 40.25 concerning drug and alcohol
test results of employees.
(3) You must keep records of the inspection, maintenance, and
calibration of EBTs, for two years.
(4) You must keep records of negative and cancelled drug test
results and alcohol test results with a concentration of less than 0.02
for one year.
(b) You do not have to keep records related to a program
requirement that does not apply to you (e.g., a maritime employer who
does not have a DOT-mandated random alcohol testing program need not
maintain random alcohol testing records).
(c) You must maintain the records in a location with controlled
access.
(d) A service agent may maintain these records for you. However,
you must ensure that you can produce these records at your principal
place of business in the time required by the DOT agency. For example,
as a motor carrier, when an FMCSA inspector requests your records, you
must ensure that you can provide them within two working days.
Subpart Q--Roles and Responsibilities of Service Agents
Sec. 40.341 Must service agents comply with DOT drug and alcohol
testing requirements?
(a) As a service agent, the services you provide to transportation
employers must meet the requirements of this part
[[Page 79567]]
and the DOT agency drug and alcohol testing regulations.
(b) If you do not comply, DOT may take action under the Public
Interest Exclusions procedures of this part (see Subpart R of this
part) or applicable provisions of other DOT agency regulations.
Sec. 40.343 What tasks may a service agent perform for an employer?
As a service agent, you may perform for employers the tasks needed
to comply with DOT agency drug and alcohol testing regulations, subject
to the requirements and limitations of this part.
Sec. 40.345 In what circumstances may a C/TPA act as an intermediary
in the transmission of drug and alcohol testing information to
employers?
(a) As a C/TPA or other service agent, you may act as an
intermediary in the transmission of drug and alcohol testing
information in the circumstances specified in this section only if the
employer chooses to have you do so. Each employer makes the decision
about whether to receive some or all of this information from you,
acting as an intermediary, rather than directly from the service agent
who originates the information (e.g., an MRO or BAT).
(b) The specific provisions of this part concerning which you may
act as an intermediary are listed in Appendix F to this part. These are
the only situations in which you may act as an intermediary. You are
prohibited from doing so in all other situations.
(c) In every case, you must ensure that, in transmitting
information to employers, you meet all requirements (e.g., concerning
confidentiality and timing) that would apply if the service agent
originating the information (e.g., an MRO or collector) sent the
information directly to the employer. For example, if you transmit drug
testing results from MROs to DERs, you must transmit each drug test
result to the DER in compliance with the MRO requirements set forth in
Sec. 40.167 .
Sec. 40.347 What functions may C/TPAs perform with respect to
administering testing?
As a C/TPA, except as otherwise specified in this part, you may
perform the following functions for employers concerning random
selection and other selections for testing.
(a) You may operate random testing programs for employers and may
assist (i.e., through contracting with laboratories or collection
sites, conducting collections) employers with other types of testing
(e.g., pre-employment, post-accident, reasonable suspicion, return-to-
duty, and follow-up).
(b) You may combine employees from more than one employer or one
transportation industry in a random pool if permitted by all the DOT
agency drug and alcohol testing regulations involved.
(1) If you combine employees from more than one transportation
industry, you must ensure that the random testing rate is at least
equal to the highest rate required by each DOT agency.
(2) Employees not covered by DOT agency regulations may not be part
of the same random pool with DOT covered employees.
(c) You may assist employers in ensuring that follow-up testing is
conducted in accordance with the plan established by the SAP. However,
neither you nor the employer are permitted to randomly select employees
from a ``follow-up pool'' for follow-up testing.
Sec. 40.349 What records may a service agent receive and maintain?
(a) Except where otherwise specified in this part, as a service
agent you may receive and maintain all records concerning DOT drug and
alcohol testing programs, including positive, negative, and refusal to
test individual test results. You do not need the employee's consent to
receive and maintain these records.
(b) You may maintain all information needed for operating a drug/
alcohol program (e.g., CCFs, ATFs, names of employees in random pools,
random selection lists, copies of notices to employers of selected
employees) on behalf of an employer.
(c) If a service agent originating drug or alcohol testing
information, such as an MRO or BAT, sends the information directly to
the DER, he or she may also provide the information simultaneously to
you, as a C/TPA or other service agent who maintains this information
for the employer.
(d) If you are serving as an intermediary in transmitting
information that is required to be provided to the employer, you must
ensure that it reaches the employer in the same time periods required
elsewhere in this part.
(e) You must ensure that you can make available to the employer
within two days any information the employer is asked to produce by a
DOT agency representative.
(f) On request of an employer, you must, at any time on the request
of an employer, transfer immediately all records pertaining to the
employer and its employees to the employer or to any other service
agent the employer designates. You must carry out this transfer as soon
as the employer requests it. You are not required to obtain employee
consent for this transfer. You must not charge more than your
reasonable administrative costs for conducting this transfer. You may
not charge a fee for the release of these records.
(g) If you are planning to go out of business or your organization
will be bought by or merged with another organization, you must
immediately notify all employers and offer to transfer all records
pertaining to the employer and its employees to the employer or to any
other service agent the employer designates. You must carry out this
transfer as soon as the employer requests it. You are not required to
obtain employee consent for this transfer. You must not charge more
than your reasonable administrative costs for conducting this transfer.
You may not charge a fee for the release of these records.
Sec. 40.351 What confidentiality requirements apply to service agents?
Except where otherwise specified in this part, as a service agent
the following confidentiality requirements apply to you:
(a) When you receive or maintain confidential information about
employees (e.g., individual test results), you must follow the same
confidentiality regulations as the employer with respect to the use and
release of this information.
(b) You must follow all confidentiality and records retention
requirements applicable to employers.
(c) You may not provide individual test results or other
confidential information to another employer without a specific,
written consent from the employee. For example, suppose you are a C/TPA
that has employers X and Y as clients. Employee Jones works for X, and
you maintain Jones' drug and alcohol test for X. Jones wants to change
jobs and work for Y. You may not inform Y of the result of a test
conducted for X without having a specific, written consent from Jones.
Likewise, you may not provide this information to employer Z, who is
not a C/TPA member, without this consent.
(d) You must not use blanket consent forms authorizing the release
of employee testing information.
(e) You must establish adequate confidentiality and security
measures to ensure that confidential employee records are not available
to unauthorized persons. This includes protecting the physical security
of
[[Page 79568]]
records, access controls, and computer security measures to safeguard
confidential data in electronic data bases.
Sec. 40.353 What principles govern the interaction between MROs and
other service agents?
As a service agent other than an MRO (e.g., a C/TPA), the following
principles govern your interaction with MROs:
(a) You may provide MRO services to employers, directly or through
contract, if you meet all applicable provisions of this part.
(b) If you employ or contract for an MRO, the MRO must perform
duties independently and confidentially. When you have a relationship
with an MRO, you must structure the relationship to ensure that this
independence and confidentiality are not compromised. Specific means
(including both physical and operational measures, as appropriate) to
separate MRO functions and other service agent functions are essential.
(c) Only your staff who are actually under the day-to-day
supervision and control of an MRO with respect to MRO functions may
perform these functions. This does not mean that those staff may not
perform other functions at other times. However, the designation of
your staff to perform MRO functions under MRO supervision must be
limited and not used as a subterfuge to circumvent confidentiality and
other requirements of this part and DOT agency regulations. You must
ensure that MRO staff operate under controls sufficient to ensure that
the independence and confidentiality of the MRO process are not
compromised.
(d) Like other MROs, an MRO you employ or contract with must
personally conduct verification interviews with employees and must
personally make all verification decisions. Consequently, your staff
cannot perform these functions.
Sec. 40.355 What limitations apply to the activities of service
agents?
As a service agent, you are subject to the following limitations
concerning your activities in the DOT drug and alcohol testing program.
(a) You must not require an employee to sign a consent, release,
waiver of liability, or indemnification agreement with respect to any
part of the drug or alcohol testing process covered by this part
(including, but not limited to, collections, laboratory testing, MRO,
and SAP services).
(b) You must not act as an intermediary in the transmission of drug
test results from the laboratory to the MRO. That is, the laboratory
may not send results to you, with you in turn sending them to the MRO
for verification. For example, a practice in which the laboratory
transmits results to your computer system, and you then assign the
results to a particular MRO, is not permitted.
(c) You must not transmit drug test results directly from the
laboratory to the employer (by electronic or other means) or to a
service agent who forwards them to the employer. All confirmed
laboratory results must be processed by the MRO before they are
released to any other party.
(d) You must not act as an intermediary in the transmission of
alcohol test results of 0.02 or higher from the STT or BAT to the DER.
(e) Except as provided in paragraph (f) of this section, you must
not act as an intermediary in the transmission of individual SAP
reports to the actual employer. That is, the SAP may not send such
reports to you, with you in turn sending them to the actual employer.
However, you may maintain individual SAP summary reports and follow-up
testing plans after they are sent to the DER, and the SAP may transmit
such reports to you simultaneously with sending them to the DER.
(f) As an exception to paragraph (e) of this section, you may act
as an intermediary in the transmission of SAP report from the SAP to an
owner-operator or other self-employed individual.
(g) Except as provided in paragraph (h) of this section, you must
not make decisions to test an employee based upon reasonable suspicion,
post-accident, return-to-duty, and follow-up determination criteria.
These are duties the actual employer cannot delegate to a C/TPA. You
may, however, provide advice and information to employers regarding
these testing issues and how the employer should schedule required
testing.
(h) As an exception to paragraph (g) of this section, you may make
decisions to test an employee based upon reasonable suspicion, post-
accident, return-to-duty, and follow-up determination criteria with
respect to an owner-operator or other self-employed individual.
(i) Except as provided in paragraph (j) of this section, you must
not make a determination that an employee has refused a drug or alcohol
test. This is a non-delegable duty of the actual employer. You may,
however, provide advice and information to employers regarding refusal-
to-test issues.
(j) As an exception to paragraph (i) of this section, you may make
a determination that an employee has refused a drug or alcohol test,
if:
(1) You are authorized by a DOT agency regulation to do so, you
schedule a required test for an owner-operator or other self-employed
individual, and the individual fails to appear for the test without a
legitimate reason; or
(2) As an MRO, you determine that an individual has refused to test
on the basis of adulteration or substitution.
(k) You must not act as a DER. For example, while you may be
responsible for transmitting information to the employer about test
results, you must not act on behalf of the employer in actions to
remove employees from safety-sensitive duties.
(l) In transmitting documents to laboratories, you must ensure that
you send to the laboratory that conducts testing only the laboratory
copy of the CCF. You must not transmit other copies of the CCF or any
ATFs to the laboratory.
(m) You must not impose conditions or requirements on employers
that DOT regulations do not authorize. For example, as a C/TPA serving
employers in the pipeline or motor carrier industry, you must not
require employers to have provisions in their DOT plans that RSPA or
FMCSA regulations do not require.
(n) You must not intentionally delay the transmission of drug or
alcohol testing-related documents concerning actions you have
performed, because of a payment dispute or other reasons.
Example 1 to Paragraph (n): A laboratory that has tested a
specimen must not delay transmitting the documentation of the test
result to an MRO because of a billing or payment dispute with the
MRO or a C/TPA.
Example 2 to Paragraph (n): An MRO or SAP who has interviewed an
employee must not delay sending a verified test result or SAP report
to the employer because of such a dispute with the employer or
employee.
Example 3 to Paragraph (n): A collector who has performed a
urine specimen collection must not delay sending the drug specimen
and CCF to the laboratory because of a payment or other dispute with
the laboratory or a C/TPA.
Example 4 to Paragraph (n): A BAT who has conducted an alcohol
test must not delay sending test result information to an employer
or C/TPA because of a payment or other dispute with the employer or
C/TPA.
(o) While you must follow the DOT agency regulations, the actual
employer remains accountable to DOT for compliance, and your failure to
implement any aspect of the program as required in this part and other
applicable DOT agency regulations makes the employer subject to
enforcement action by the Department.
[[Page 79569]]
Subpart R--Public Interest Exclusions
Sec. 40.361 What is the purpose of a public interest exclusion (PIE)?
(a) To protect the public interest, including protecting
transportation employers and employees from serious noncompliance with
DOT drug and alcohol testing rules, the Department's policy is to
ensure that employers conduct business only with responsible service
agents.
(b) The Department therefore uses PIEs to exclude from
participation in DOT's drug and alcohol testing program any service
agent who, by serious noncompliance with this part or other DOT agency
drug and alcohol testing regulations, has shown that it is not
currently acting in a responsible manner.
(c) A PIE is a serious action that the Department takes only to
protect the public interest. We intend to use PIEs only to remedy
situations of serious noncompliance. PIEs are not used for the purpose
of punishment.
(d) Nothing in this subpart precludes a DOT agency or the Inspector
General from taking other action authorized by its regulations with
respect to service agents or employers that violate its regulations.
Sec. 40.363 On what basis may the Department issue a PIE?
(a) If you are a service agent, the Department may issue a PIE
concerning you if we determine that you have failed or refused to
provide drug or alcohol testing services consistent with the
requirements of this part or a DOT agency drug and alcohol regulation.
(b) The Department also may issue a PIE if you have failed to
cooperate with DOT agency representatives concerning inspections,
complaint investigations, compliance and enforcement reviews, or
requests for documents and other information about compliance with this
part or DOT agency drug and alcohol regulations.
Sec. 40.365 What is the Department's policy concerning starting a PIE
proceeding?
(a) It is the Department's policy to start a PIE proceeding only in
cases of serious, uncorrected noncompliance with the provisions of this
part, affecting such matters as safety, the outcomes of test results,
privacy and confidentiality, due process and fairness for employees,
the honesty and integrity of the testing program, and cooperation with
or provision of information to DOT agency representatives.
(b) The following are examples of the kinds of serious
noncompliance that, as a matter of policy, the Department views as
appropriate grounds for starting a PIE proceeding. These examples are
not intended to be an exhaustive or exclusive list of the grounds for
starting a PIE proceeding. We intend them to illustrate the level of
seriousness that the Department believes supports starting a PIE
proceeding. The examples follow:
(1) For an MRO, verifying tests positive without interviewing the
employees as required by this part or providing MRO services without
meeting the qualifications for an MRO required by this part;
(2) For a laboratory, refusing to provide information to the
Department, an employer, or an employee as required by this part;
failing or refusing to conduct a validity testing program when required
by this part; or a pattern or practice of testing errors that result in
the cancellation of tests. (As a general matter of policy, the
Department does not intend to initiate a PIE proceeding concerning a
laboratory with respect to matters on which HHS initiates certification
actions under its laboratory guidelines.);
(3) For a collector, a pattern or practice of directly observing
collections when doing so is unauthorized, or failing or refusing to
directly observe collections when doing so is mandatory;
(4) For collectors, BATs, or STTs, a pattern or practice of using
forms, testing equipment, or collection kits that do not meet the
standards in this part;
(5) For a collector, BAT, or STT, a pattern or practice of ``fatal
flaws'' or other significant uncorrected errors in the collection
process;
(6) For a laboratory, MRO or C/TPA, failing or refusing to report
tests results as required by this part or DOT agency regulations;
(7) For a laboratory, falsifying, concealing, or destroying
documentation concerning any part of the drug testing process,
including, but not limited to, documents in a ``litigation package'';
(8) For SAPs, providing SAP services while not meeting SAP
qualifications required by this part or performing evaluations without
face-to-face interviews;
(9) For any service agent, maintaining a relationship with another
party that constitutes a conflict of interest under this part (e.g., a
laboratory that derives a financial benefit from having an employer use
a specific MRO);
(10) For any service agent, representing falsely that the service
agent or its activities is approved or certified by the Department or a
DOT agency;
(11) For any service agent, disclosing an employee's test result
information to any party this part or a DOT agency regulation does not
authorize, including by obtaining a ``blanket'' consent from employees
or by creating a data base from which employers or others can retrieve
an employee's DOT test results without the specific consent of the
employee;
(12) For any service agent, interfering or attempting to interfere
with the ability of an MRO to communicate with the Department, or
retaliating against an MRO for communicating with the Department;
(13) For any service agent, directing or recommending that an
employer fail or refuse to implement any provision of this part; or
(14) With respect to noncompliance with a DOT agency regulation,
conduct that affects important provisions of Department-wide concern
(e.g., failure to properly conduct the selection process for random
testing).
Sec. 40.367 Who initiates a PIE proceeding?
The following DOT officials may initiate a PIE proceeding:
(a) The drug and alcohol program manager of a DOT agency;
(b) An official of ODAPC, other than the Director; or
(c) The designee of any of these officials.
Sec. 40.369 What is the discretion of an initiating official in
starting a PIE proceeding?
(a) Initiating officials have broad discretion in deciding whether
to start a PIE proceeding.
(b) In exercising this discretion, the initiating official must
consider the Department's policy regarding the seriousness of the
service agent's conduct (see Sec. 40.365) and all information he or she
has obtained to this point concerning the facts of the case. The
initiating official may also consider the availability of the resources
needed to pursue a PIE proceeding.
(c) A decision not to initiate a PIE proceeding does not
necessarily mean that the Department regards a service agent as being
in compliance or that the Department may not use other applicable
remedies in a situation of noncompliance.
Sec. 40.371 On what information does an initiating official rely in
deciding whether to start a PIE proceeding?
(a) An initiating official may rely on credible information from
any source as the basis for starting a PIE proceeding.
(b) Before sending a correction notice (see Sec. 40.373), the
initiating official informally contacts the service agent to determine
if there is any information that may affect the initiating official's
[[Page 79570]]
determination about whether it is necessary to send a correction
notice. The initiating official may take any information resulting from
this contact into account in determining whether to proceed under this
subpart.
Sec. 40.373 Before starting a PIE proceeding, does the initiating
official give the service agent an opportunity to correct problems?
(a) If you are a service agent, the initiating official must send
you a correction notice before starting a PIE proceeding.
(b) The correction notice identifies the specific areas in which
you must come into compliance in order to avoid being subject to a PIE
proceeding.
(c) If you make and document changes needed to come into compliance
in the areas listed in the correction notice to the satisfaction of the
initiating official within 60 days of the date you receive the notice,
the initiating official does not start a PIE proceeding. The initiating
official may conduct appropriate fact finding to verify that you have
made and maintained satisfactory corrections. When he or she is
satisfied that you are in compliance, the initiating official sends you
a notice that the matter is concluded.
Sec. 40.375 How does the initiating official start a PIE proceeding?
(a) As a service agent, if your compliance matter is not
correctable (see Sec. 40.373(a)), or if have not resolved compliance
matters as provided in Sec. 40.373(c), the initiating official starts a
PIE proceeding by sending you a notice of proposed exclusion (NOPE).
The NOPE contains the initiating official's recommendations concerning
the issuance of a PIE, but it is not a decision by the Department to
issue a PIE.
(b) The NOPE includes the following information:
(1) A statement that the initiating official is recommending that
the Department issue a PIE concerning you;
(2) The factual basis for the initiating official's belief that you
are not providing drug and/or alcohol testing services to DOT-regulated
employers consistent with the requirements of this part or are in
serious noncompliance with a DOT agency drug and alcohol regulation;
(3) The factual basis for the initiating official's belief that
your noncompliance has not been or cannot be corrected;
(4) The initiating official's recommendation for the scope of the
PIE;
(5) The initiating official's recommendation for the duration of
the PIE; and
(6) A statement that you may contest the issuance of the proposed
PIE, as provided in Sec. 40.379.
(c) The initiating official sends a copy of the NOPE to the ODAPC
Director at the same time he or she sends the NOPE to you.
Sec. 40.377 Who decides whether to issue a PIE?
(a) The ODAPC Director, or his or her designee, decides whether to
issue a PIE. If a designee is acting as the decisionmaker, all
references in this subpart to the Director refer to the designee.
(b) To ensure his or her impartiality, the Director plays no role
in the initiating official's determination about whether to start a PIE
proceeding.
(c) There is a ``firewall'' between the initiating official and the
Director. This means that the initiating official and the Director are
prohibited from having any discussion, contact, or exchange of
information with one another about the matter, except for documents and
discussions that are part of the record of the proceeding.
Sec. 40.379 How do you contest the issuance of a PIE?
(a) If you receive a NOPE, you may contest the issuance of the PIE.
(b) If you want to contest the proposed PIE, you must provide the
Director information and argument in opposition to the proposed PIE in
writing, in person, and/or through a representative. To contest the
proposed PIE, you must take one or more of the steps listed in this
paragraph (b) within 30 days after you receive the NOPE.
(1) You may request that the Director dismiss the proposed PIE
without further proceedings, on the basis that it does not concern
serious noncompliance with this part or DOT agency regulations,
consistent with the Department's policy as stated in Sec. 40.365.
(2) You may present written information and arguments, consistent
with the provisions of Sec. 40.381, contesting the proposed PIE.
(3) You may arrange with the Director for an informal meeting to
present your information and arguments.
(c) If you do not take any of the actions listed in paragraph (b)
of this section within 30 days after you receive the NOPE, the matter
proceeds as an uncontested case. In this event, the Director makes his
or her decision based on the record provided by the initiating official
(i.e., the NOPE and any supporting information or testimony) and any
additional information the Director obtains.
Sec. 40.381 What information do you present to contest the proposed
issuance of a PIE?
(a) As a service agent who wants to contest a proposed PIE, you
must present at least the following information to the Director:
(1) Specific facts that contradict the statements contained in the
NOPE (see Sec. 40.375(b)(2) and (3)). A general denial is insufficient
to raise a genuine dispute over facts material to the issuance of a
PIE;
(2) Identification of any existing, proposed or prior PIE; and
(3) Identification of your affiliates, if any.
(b) You may provide any information and arguments you wish
concerning the proposed issuance, scope and duration of the PIE (see
Sec. 40.375(b)(4) and (5)).
(c) You may provide any additional relevant information or
arguments concerning any of the issues in the matter.
Sec. 40.383 What procedures apply if you contest the issuance of a
PIE?
(a) DOT conducts PIE proceedings in a fair and informal manner. The
Director may use flexible procedures to allow you to present matters in
opposition. The Director is not required to follow formal rules of
evidence or procedure in creating the record of the proceeding.
(b) The Director will consider any information or argument he or
she determines to be relevant to the decision on the matter.
(c) You may submit any documentary evidence you want the Director
to consider. In addition, if you have arranged an informal meeting with
the Director, you may present witnesses and confront any person the
initiating official presents as a witness against you.
(d) In cases where there are material factual issues in dispute,
the Director or his or her designee may conduct additional fact-
finding.
(e) If you have arranged a meeting with the Director, the Director
will make a transcribed record of the meeting available to you on your
request. You must pay the cost of transcribing and copying the meeting
record.
Sec. 40.385 Who bears the burden of proof in a PIE proceeding?
(a) As the proponent of issuing a PIE, the initiating official
bears the burden of proof.
(b) This burden is to demonstrate, by a preponderance of the
evidence, that the service agent was in serious noncompliance with the
requirements of this part for drug and/or alcohol testing-related
services or with the requirements of another DOT agency drug and
alcohol testing regulation.
[[Page 79571]]
Sec. 40.387 What matters does the Director decide concerning a
proposed PIE?
(a) Following the service agent's response (see Sec. 40.379(b)) or,
if no response is received, after 30 days have passed from the date on
which the service agent received the NOPE, the Director may take one of
the following steps:
(1) In response to a request from the service agent (see
Sec. 40.379(b)(1)) or on his or her own motion, the Director may
dismiss a PIE proceeding if he or she determines that it does not
concern serious noncompliance with this part or DOT agency regulations,
consistent with the Department's policy as stated in Sec. 40.365.
(i) If the Director dismisses a proposed PIE under this paragraph
(a), the action is closed with respect to the noncompliance alleged in
the NOPE.
(ii) The Department may initiate a new PIE proceeding against you
on the basis of different or subsequent conduct that is in
noncompliance with this part or other DOT drug and alcohol testing
rules.
(2) If the Director determines that the initiating official's
submission does not have complete information needed for a decision,
the Director may remand the matter to the initiating official. The
initiating official may resubmit the matter to the Director when the
needed information is complete. If the basis for the proposed PIE has
changed, the initiating official must send an amended NOPE to the
service agent.
(b) The Director makes determinations concerning the following
matters in any PIE proceeding that he or she decides on the merits:
(1) Any material facts that are in dispute;
(2) Whether the facts support issuing a PIE;
(3) The scope of any PIE that is issued; and
(4) The duration of any PIE that is issued.
Sec. 40.389 What factors may the Director consider?
This section lists examples of the kind of mitigating and
aggravating factors that the Director may consider in determining
whether to issue a PIE concerning you, as well as the scope and
duration of a PIE. This list is not exhaustive or exclusive. The
Director may consider other factors if appropriate in the circumstances
of a particular case. The list of examples follows:
(a) The actual or potential harm that results or may result from
your noncompliance;
(b) The frequency of incidents and/or duration of the
noncompliance;
(c) Whether there is a pattern or prior history of noncompliance;
(d) Whether the noncompliance was pervasive within your
organization, including such factors as the following:
(1) Whether and to what extent your organization planned,
initiated, or carried out the noncompliance;
(2) The positions held by individuals involved in the
noncompliance, and whether your principals tolerated their
noncompliance; and
(3) Whether you had effective standards of conduct and control
systems (both with respect to your own organization and any contractors
or affiliates) at the time the noncompliance occurred;
(e) Whether you have demonstrated an appropriate compliance
disposition, including such factors as the following:
(1) Whether you have accepted responsibility for the noncompliance
and recognize the seriousness of the conduct that led to the cause for
issuance of the PIE;
(2) Whether you have cooperated fully with the Department during
the investigation. The Director may consider when the cooperation began
and whether you disclosed all pertinent information known to you;
(3) Whether you have fully investigated the circumstances of the
noncompliance forming the basis for the PIE and, if so, have made the
result of the investigation available to the Director;
(4) Whether you have taken appropriate disciplinary action against
the individuals responsible for the activity that constitutes the
grounds for issuance of the PIE; and
(5) Whether your organization has taken appropriate corrective
actions or remedial measures, including implementing actions to prevent
recurrence;
(f) With respect to noncompliance with a DOT agency regulation, the
degree to which the noncompliance affects matters common to the DOT
drug and alcohol testing program;
(g) Other factors appropriate to the circumstances of the case.
Sec. 40.391 What is the scope of a PIE?
(a) The scope of a PIE is the Department's determination about the
divisions, organizational elements, types of services, affiliates, and/
or individuals (including direct employees of a service agent and its
contractors) to which a PIE applies.
(b) If, as a service agent, the Department issues a PIE concerning
you, the PIE applies to all your divisions, organizational elements,
and types of services that are involved with or affected by the
noncompliance that forms the factual basis for issuing the PIE.
(c) In the NOPE (see Sec. 40.375(b)(4)), the initiating official
sets forth his or her recommendation for the scope of the PIE. The
proposed scope of the PIE is one of the elements of the proceeding that
the service agent may contest (see Sec. 40.381(b)) and about which the
Director makes a decision (see Sec. 40.387(b)(3)).
(d) In recommending and deciding the scope of the PIE, the
initiating official and Director, respectively, must take into account
the provisions of paragraphs (e) through (j) of this section.
(e) The pervasiveness of the noncompliance within a service agent's
organization (see Sec. 40.389(d)) is an important consideration in
determining the scope of a PIE. The appropriate scope of a PIE grows
broader as the pervasiveness of the noncompliance increases.
(f) The application of a PIE is not limited to the specific
location or employer at which the conduct that forms the factual basis
for issuing the PIE was discovered.
(g) A PIE applies to your affiliates, if the affiliate is involved
with or affected by the conduct that forms the factual basis for
issuing the PIE.
(h) A PIE applies to individuals who are officers, employees,
directors, shareholders, partners, or other individuals associated with
your organization in the following circumstances:
(1) Conduct forming any part of the factual basis of the PIE
occurred in connection with the individual's performance of duties by
or on behalf of your organization; or
(2) The individual knew of, had reason to know of, approved, or
acquiesced in such conduct. The individual's acceptance of benefits
derived from such conduct is evidence of such knowledge, acquiescence,
or approval.
(i) If a contractor to your organization is solely responsible for
the conduct that forms the factual basis for a PIE, the PIE does not
apply to the service agent itself unless the service agent knew or
should have known about the conduct and did not take action to correct
it.
(j) PIEs do not apply to drug and alcohol testing that DOT does not
regulate.
(k) The following examples illustrate how the Department intends
the provisions of this section to work:
Example 1 to Sec. 40.391. Service Agent P provides a variety of
drug testing services. P's SAP services are involved in a serious
violation of this Part 40. However, P's other
[[Page 79572]]
services fully comply with this part, and P's overall management did
not plan or concur in the noncompliance, which in fact was contrary
to P's articulated standards. Because the noncompliance was isolated
in one area of the organization's activities, and did not pervade
the entire organization, the scope of the PIE could be limited to
SAP services.
Example 2 to Sec. 40.391. Service Agent Q provides a similar
variety of services. The conduct forming the factual basis for a PIE
concerns collections for a transit authority. As in Example 1, the
noncompliance is not pervasive throughout Q's organization. The PIE
would apply to collections at all locations served by Q, not just
the particular transit authority or not just in the state in which
the transit authority is located.
Example 3 to Sec. 40.391. Service Agent R provides a similar
array of services. One or more of the following problems exists: R's
activities in several areas--collections, MROs, SAPs, protecting the
confidentiality of information--are involved in serious
noncompliance; DOT determines that R's management knew or should
have known about serious noncompliance in one or more areas, but
management did not take timely corrective action; or, in response to
an inquiry from DOT personnel, R's management refuses to provide
information about its operations. In each of these three cases, the
scope of the PIE would include all aspects of R's services.
Example 4 to Sec. 40.391. Service Agent W provides only one kind
of service (e.g., laboratory or MRO services). The Department issues
a PIE concerning these services. Because W only provides this one
kind of service, the PIE necessarily applies to all its operations.
Example 5 to Sec. 40.391. Service Agent X, by exercising
reasonably prudent oversight of its collection contractor, should
have known that the contractor was making numerous ``fatal flaws''
in tests. Alternatively, X received a correction notice pointing out
these problems in its contractor's collections. In neither case did
X take action to correct the problem. X, as well as the contractor,
would be subject to a PIE with respect to collections.
Example 6 to Sec. 40.391. Service Agent Y could not reasonably
have known that one of its MROs was regularly failing to interview
employees before verifying tests positive. When it received a
correction notice, Y immediately dismissed the erring MRO. In this
case, the MRO would be subject to a PIE but Y would not.
Example 7 to Sec. 40.391. The Department issues a PIE with
respect to Service Agent Z. Z provides services for DOT-regulated
transportation employers, a Federal agency under the HHS-regulated
Federal employee testing program, and various private businesses and
public agencies that DOT does not regulate. The PIE applies only to
the DOT-regulated transportation employers with respect to their
DOT-mandated testing, not to the Federal agency or the other public
agencies and private businesses. The PIE does not prevent the non-
DOT regulated entities from continuing to use Z's services.
Sec. 40.393 How long does a PIE stay in effect?
(a) In the NOPE (see Sec. 40.375(b)(5)), the initiating official
proposes the duration of the PIE. The duration of the PIE is one of the
elements of the proceeding that the service agent may contest (see
Sec. 40.381(b)) and about which the Director makes a decision (see
Sec. 40.387(b)(4)).
(b) In deciding upon the duration of the PIE, the Director
considers the seriousness of the conduct on which the PIE is based and
the continued need to protect employers and employees from the service
agent's noncompliance. The Director considers factors such as those
listed in Sec. 40.389 in making this decision.
(c) The duration of a PIE will be between one and five years,
unless the Director reduces its duration under Sec. 40.407.
Sec. 40.395 Can you settle a PIE proceeding?
At any time before the Director's decision, you and the initiating
official can, with the Director's concurrence, settle a PIE proceeding.
Sec. 40.397 When does the Director make a PIE decision?
The Director makes his or her decision within 60 days of the date
when the record of a PIE proceeding is complete (including any meeting
with the Director and any additional fact-finding that is necessary).
The Director may extend this period for good cause for additional
periods of up to 30 days.
Sec. 40.399 How does the Department notify service agents of its
decision?
If you are a service agent involved in a PIE proceeding, the
Director provides you written notice as soon as he or she makes a PIE
decision. The notice includes the following elements:
(a) If the decision is not to issue a PIE, a statement of the
reasons for the decision, including findings of fact with respect to
any material factual issues that were in dispute.
(b) If the decision is to issue a PIE--
(1) A reference to the NOPE;
(2) A statement of the reasons for the decision, including findings
of fact with respect to any material factual issues that were in
dispute;
(3) A statement of the scope of the PIE; and
(4) A statement of the duration of the PIE.
Sec. 40.401 How does the Department notify employers and the public
about a PIE?
(a) The Department maintains a document called the ``List of
Excluded Drug and Alcohol Service Agents.'' This document may be found
on the Department's web site (http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.dot.gov/ost/dapc). You may
also request a copy of the document from ODAPC.
(b) When the Director issues a PIE, he or she adds to the List the
name and address of the service agent, and any other persons or
organizations, to whom the PIE applies and information about the scope
and duration of the PIE.
(c) When a service agent ceases to be subject to a PIE, the
Director removes this information from the List.
(d) The Department also publishes a Federal Register notice to
inform the public on any occasion on which a service agent is added to
or taken off the List.
Sec. 40.403 Must a service agent notify its clients when the
Department issues a PIE?
(a) As a service agent, if the Department issues a PIE concerning
you, you must notify each of your DOT-regulated employer clients, in
writing, about the issuance, scope, duration, and effect of the PIE.
You may meet this requirement by sending a copy of the Director's PIE
decision or by a separate notice. You must send this notice to each
client within three working days of receiving from the Department the
notice provided for in Sec. 40.399(b).
(b) As part of the notice you send under paragraph (a) of this
section, you must offer to transfer immediately all records pertaining
to the employer and its employees to the employer or to any other
service agent the employer designates. You must carry out this transfer
as soon as the employer requests it.
Sec. 40.405 May the Federal courts review PIE decisions?
The Director's decision is a final administrative action of the
Department. Like all final administrative actions of Federal agencies,
the Director's decision is subject to judicial review under the
Administrative Procedure Act (5 U.S.C. 551 et. seq).
Sec. 40.407 May a service agent ask to have a PIE reduced or
terminated?
(a) Yes, as a service agent concerning whom the Department has
issued a PIE, you may request that the Director terminate a PIE or
reduce its duration and/or scope. This process is limited to the issues
of duration and scope. It is not an appeal or reconsideration of the
decision to issue the PIE.
(b) Your request must be in writing and supported with
documentation.
(c) You must wait at least nine months from the date on which the
Director issued the PIE to make this request.
[[Page 79573]]
(d) The initiating official who was the proponent of the PIE may
provide information and arguments concerning your request to the
Director.
(e) If the Director verifies that the sources of your noncompliance
have been eliminated and that all drug or alcohol testing-related
services you would provide to DOT-regulated employers will be
consistent with the requirements of this part, the Director may issue a
notice terminating or reducing the PIE.
Sec. 40.409 What does the issuance of a PIE mean to transportation
employers?
(a) As an employer, you are deemed to have notice of the issuance
of a PIE when it appears on the List mentioned in Sec. 40.401(a) or the
notice of the PIE appears in the Federal Register as provided in
Sec. 40.401(d). You should check this List to ensure that any service
agents you are using or planning to use are not subject to a PIE.
(b) As an employer who is using a service agent concerning whom a
PIE is issued, you must stop using the services of the service agent no
later than 90 days after the Department has published the decision in
the Federal Register or posted it on its web site. You may apply to the
ODAPC Director for an extension of 30 days if you demonstrate that you
cannot find a substitute service agent within 90 days.
(c) Except during the period provided in paragraph (b) of this
section, you must not, as an employer, use the services of a service
agent that are covered by a PIE that the Director has issued under this
subpart. If you do so, you are in violation of the Department's
regulations and subject to applicable DOT agency sanctions (e.g., civil
penalties, withholding of Federal financial assistance).
(d) You also must not obtain drug or alcohol testing services
through a contractor or affiliate of the service agent to whom the PIE
applies.
Example to Paragraph (d): Service Agent R was subject to a PIE
with respect to SAP services. As an employer, not only must you not
use R's own SAP services, but you also must not use SAP services you
arrange through R, such as services provided by a subcontractor or
affiliate of R or a person or organization that receives financial
gain from its relationship with R.
(e) This section's prohibition on using the services of a service
agent concerning which the Director has issued a PIE applies to
employers in all industries subject to DOT drug and alcohol testing
regulations.
Example to Paragraph (e): The initiating official for a PIE was
the FAA drug and alcohol program manager, and the conduct forming
the basis of the PIE pertained to the aviation industry. As a motor
carrier, transit authority, pipeline, railroad, or maritime
employer, you are also prohibited from using the services of the
service agent involved in connection with the DOT drug and alcohol
testing program.
(f) The issuance of a PIE does not result in the cancellation of
drug or alcohol tests conducted using the service agent involved before
the issuance of the Director's decision or up to 90 days following its
publication in the Federal Register or posting on the Department's web
site, unless otherwise specified in the Director's PIE decision or the
Director grants an extension as provided in paragraph (b) of this
section.
Example to Paragraph (f): The Department issues a PIE concerning
Service Agent N on September 1. All tests conducted using N's
services before September 1, and through November 30, are valid for
all purposes under DOT drug and alcohol testing regulations,
assuming they meet all other regulatory requirements.
Sec. 40.411 What is the role of the DOT Inspector General's office?
(a) Any person may bring concerns about waste, fraud, or abuse on
the part of a service agent to the attention of the DOT Office of
Inspector General.
(b) In appropriate cases, the Office of Inspector General may
pursue criminal or civil remedies against a service agent.
(c) The Office of Inspector General may provide factual information
to other DOT officials for use in a PIE proceeding.
Sec. 40.413 How are notices sent to service agents?
(a) If you are a service agent, DOT sends notices to you, including
correction notices, notices of proposed exclusion, decision notices,
and other notices, in any of the ways mentioned in paragraph (b) or (c)
of this section.
(b) DOT may send a notice to you, your identified counsel, your
agent for service of process, or any of your partners, officers,
directors, owners, or joint venturers to the last known street address,
fax number, or e-mail address. DOT deems the notice to have been
received by you if sent to any of these persons.
(c) DOT considers notices to be received by you--
(1) When delivered, if DOT mails the notice to the last known
street address, or five days after we send it if the letter is
undeliverable;
(2) When sent, if DOT sends the notice by fax or five days after we
send it if the fax is undeliverable; or
(3) When delivered, if DOT sends the notice by e-mail or five days
after DOT sends it if the e-mail is undeliverable.
Appendix A to Part 40--DOT Standards for Urine Collection Kits
The Collection Kit Contents
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 deg.C/90-100 deg.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
[[Page 79574]]
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 B to Part 40--DOT Drug Testing Semi-Annual Laboratory Report
The following items are required on each report:
Reporting Period: (inclusive dates)
Laboratory Identification: (name and address)
Employer Identification: (name; may include billing code or ID code)
C/C/TPA Identification: (where applicable; name and address)
1. Number of specimen results reported: (total number)
By test type:
(a) Pre-employment testing: (number)
(b) Post-accident testing: (number)
(c) Random testing: (number)
(d) Reasonable suspicion/cause testing: (number)
(e) Return-to-duty testing: (number)
(f) Follow-up testing: (number)
(g) Type not noted on CCF: (number)
2. Number of specimens reported as
(a) Negative: (total number)
(b) Negative-dilute: (number)
3. Number of specimens reported as Rejected for Testing: (total
number)
By reason:
(a) Fatal flaw: (number)
(b) Uncorrected flaw: (number)
4. Number of specimens reported as Positive: (total number)
By drug:
(a) Marijuana Metabolite: (number)
(b) Cocaine Metabolite: (number)
(c) Opiates:
(1) Codeine: (number)
(2) Morphine: (number)
(3) 6-AM: (number)
(d) Phencyclidine: (number)
(e) Amphetamines: (number)
(1) Amphetamine: (number)
(2) Methamphetamine: (number):
5. Adulterated: (number)
6. Substituted: (number)
7. Invalid results: (number)
Appendix C to Part 40--[Reserved]
Appendix D to Part 40--Report Format: Split Specimen Failure to
Reconfirm
Fax or mail to: Department of Transportation, Office of Drug and
Alcohol Policy and Compliance, 400 7th Street, SW., Room 10403,
Washington, DC 20590 (fax) 202-366-3897.
1. MRO name, address, phone number, and fax number.
2. Collection site name, address, and phone number.
3. Date of collection.
4. Specimen I.D. number.
5. Laboratory accession number.
6. Primary specimen laboratory name, address, and phone number.
7. Date result reported or certified by primary laboratory.
8. Split specimen laboratory name, address, and phone number.
9. Date split specimen result reported or certified by split
specimen laboratory.
10. Primary specimen results (e.g., name of drug, adulterant) in
the primary specimen.
11. Reason for split specimen failure-to-reconfirm result (e.g.,
drug or adulterant not present, specimen invalid, split not
collected, insufficient volume).
12. Actions taken by the MRO (e.g., notified employer of failure
to reconfirm and requirement for recollection).
13. Additional information explaining the reason for
cancellation.
14. Name of individual submitting the report (if not the MRO).
Appendix E to Part 40--SAP Equivalency Requirements for Certification
Organizations
1. Experience: Minimum requirements are for three years of full-
time supervised experience or 6,000 hours of supervised experience
as an alcoholism and/or drug abuse counselor. The supervision must
be provided by a licensed or certified practitioner. Supervised
experience is important if the individual is to be considered a
professional in the field of alcohol and drug abuse evaluation and
counseling.
2. Education: There exists a requirement of 270 contact hours of
education and training in alcoholism and/or drug abuse or related
training. These hours can take the form of formal education, in-
service training, and professional development courses. Part of any
professional counselor's development is participation in formal and
non-formal education opportunities within the field.
3. Continuing Education: The certified counselor must receive at
least 40-60 hours of continuing education units (CEU) during each
two year period. These CEUs are important to the counselor's keeping
abreast of changes and improvements in the field.
4. Testing: A passing score on a national test is a requirement.
The test must accurately measure the application of the knowledge,
skills, and abilities possessed by the counselor. The test
establishes a national standard that must be met to practice.
5. Testing Validity: The certification examination must be
reviewed by an independent authority for validity (examination
reliability and relationship to the knowledge, skills, and abilities
required by the counseling field). The reliability of the exam is
paramount if counselor attributes are to be accurately measured. The
examination passing score point must be placed at an appropriate
minimal level score as gauged by statistically reliable methodology.
6. Measurable Knowledge Base: The certification process must be
based upon measurable knowledge possessed by the applicant and
verified through collateral data and testing. That level of
knowledge must be of sufficient quantity to ensure a high quality of
SAP evaluation and referral services.
7. Measurable Skills Base: The certification process must be
based upon measurable skills possessed by the applicant and verified
through collateral data and testing. That level of skills must be of
sufficient quality to ensure a high quality of SAP evaluation and
referral services.
8. Quality Assurance Plan: The certification agency must ensure
that a means exists to determine that applicant records are verified
as being true by the certification staff. This is an important check
to ensure that true information is being accepted by the certifying
agency.
9. Code of Ethics: Certified counselors must pledge to adhere to
an ethical standard for practice. It must be understood that code
violations could result in de-certification. These standards are
vital in maintaining the integrity of practitioners. High ethical
standards are required to ensure quality of client care and
confidentiality of client information as well as to guard against
inappropriate referral practices.
10. Re-certification Program: Certification is not just a one-
time event. It is a continuing privilege with continuing
requirements. Among these are continuing education, continuing state
certification, and concomitant adherence to the code of ethics. Re-
certification serves as a protector of client interests by removing
poor performers from the certified practice.
11. Fifty State Coverage: Certification must be available to
qualified counselors in all 50 states and, therefore, the test must
be available to qualified applicants in all 50 states. Because many
companies are multi-state operators, consistency in SAP evaluation
quality and opportunities is paramount. The test need not be given
in all 50 states but should be accessible to candidates from all
states.
12. National Commission for Certifying Agencies (NCCA)
Accreditation: Having NCCA accreditation is a means of demonstrating
to the Department of Transportation that your certification has been
reviewed by a panel of impartial experts that have determined that
your examination(s) has met stringent and appropriate testing
standards.
Appendix F to Part 40--Drug and Alcohol Testing Information that C/TPAs
May Transmit to Employers
1. If you are a C/TPA, you may, acting as an intermediary,
transmit the information in the following sections of this part to
the DER for an employer, if the employer chooses to have you do so.
These are the only items that you are permitted to transmit to the
employer as an intermediary. The use of C/TPA intermediaries is
prohibited in all other cases, such as transmission of laboratory
drug test results to MROs, the transmission of medical information
from MROs to employers, the transmission of SAP reports to
employers, the transmission of positive alcohol test results, and
the transmission of medical information from MROs to employers.
2. In every case, you must ensure that, in transmitting the
information, you meet all
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requirements (e.g., concerning confidentiality and timing) that
would apply if the party originating the information (e.g., an MRO
or collector) sent the information directly to the employer. For
example, if you transmit MROs' drug testing results to DERs, you
must transmit each drug test result to the DER in compliance with
the requirements for MROs set forth in Sec. 40.167.
Drug Testing Information
Sec. 40.25: Previous two years' test results
Sec. 40.35: Notice to collectors of contact information for DER
Sec. 40.61(a): Notification to DER that an employee is a ``no show''
for a drug test
Sec. 40.63(e): Notification to DER of a collection under direct
observation
Sec. 40.65(b)(6) and (7) and (c)(2) and (3): Notification to DER of
a refusal to provide a specimen or an insufficient specimen
Sec. 40.73(a)(9): Transmission of CCF copies to DER (However, MRO
copy of CCF must be sent by collector directly to the MRO, not
through the C/TPA.)
Sec. 40.111(a): Transmission of laboratory statistical report to
employer
Sec. 40.129 (d): Report of test results to DER
Sec. 40.129(f)(1): Report to DER of confirmed positive test in
stand-down situation
Sec. 40.149(b): Report to DER of changed test result
Sec. 40.155(a): Report to DER of dilute specimen
Secs. 40.159(a)(4)(ii); 40.161(b): Reports to DER that test is
cancelled
Sec. 40.167(b) and (c): Reports of test results to DER
Sec. 40.187(a), (b)(1), (c)(1), (d)(1) and (2): Reports to DER
concerning the reconfirmation of tests
Sec. 40.191(d): Notice to DER concerning refusals to test
Sec. 40.193(b)(3): Notification to DER of refusal in shy bladder
situation
Sec. 40.193(b)(4): Notification to DER of insufficient specimen
Sec. 40.193(b)(5): Transmission of CCF copies to DER (not to MRO)
Sec. 40.199: Report to DER of cancelled test and direction to DER
for additional collection
Sec. 40.201: Report to DER of cancelled test
Alcohol Testing Information
Sec. 40.215: Notice to BATs and STTs of contact information for DER
Sec. 40.241(b)(1): Notification to DER that an employee is a ``no
show'' for an alcohol test
Sec. 40.247(a)(2): Transmission of alcohol screening test results
only when the test result is less than 0.02
Sec. 40.255(a)(4): Transmission of alcohol confirmation test results
only when the test result is less than 0.02
Sec. 40.263(a)(3) and 263(b)(3): Notification of insufficient saliva
and failure to provide sufficient amount of breath
Appendix G to Part 40--Alcohol Testing Form
The following form is the alcohol testing form required for use
in the DOT alcohol testing program beginning August 1, 2001. Use of
the form is authorized beginning January 18, 2001.
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[FR Doc. 00-31251 Filed 12-14-00; 2:49 pm]
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