DOT RegulationsTeleconference IIAn Update for Employers

August 29, 2002

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If You Have Questions…

• If you have questions at any time during the teleconference, please email them to

teleconference@ehp.com

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Department of Transportation

F e d e ra l T ra n s itA d m in is tra tion

(F T A )2 02 .36 6 .10 80

U n ited S ta tesC o as t G u a rd

(U S C G )2 02 .26 7 .06 84

F e d era l R a ilro adA d m in is tra tion

(F R A )2 02 .49 3 .63 13

R e sea rch a ndS p e c ia l P rog ra m s

(R S P A )2 02 .36 6 .61 99

F e d era l A via tionA d m in is tra tion

(F A A )2 02 .26 7 .84 42

F e d e ra l M oto r C a rrie rsS a fe ty A d m in istra tion

(F M C S A )2 02 .36 6 .40 16

D e pa rtm e n t o f Tra n sp o rta tion2 0 2-3 66 -37 84

w w w .d o t.g o v/o s t/d a pc

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DOT and HHS

L e ve ls

D ru g s

B rea th

H a ir

S w e at

U rin e

B lo od

S a liva

T yp es o f te s ting V a lid ity

S A M H S AS u bs ta nce A b use a n d M en ta l

H e a lth S e rvice s A d m in istra tion

H H SD e pa rtm e nt o f H ea lth a nd

H u m an S erv ices

R e g u la tio nsa n d R e q u ire m e n ts

O p era ting A g e nc iesF M C S A , FA A ,R S P AU S C G , F T A , F M C S A

D O TD e pa rtm e nt o fT ra nsp o rta tion

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Office of Drug and Alcohol Policy and Compliance (ODAPC)

• Web page: www.dot.gov/ost/dapc/– 49 CFR Part 40 Questions and Answers

• Sep 2001• Jan 2002

– Future updates provided automatically• Register with email address

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Employer Responsibilities: GeneralSubpart B, 40.11

• Employers are now responsible for compliance with all the Part 40 requirements

• Employers are also responsible for the actions of their Service Agent(s) (SA)

• Employers are also responsible for ensuring SA meets all qualifications

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Q&A 9/2001:Subpart A, 40.3; Subpart B 40.15(d)

• Q:If a consortium/third party administrator (C/TPA) is hired to execute all aspects of the employer’s safety and drug and alcohol testing programs, can the C/TPA act as DER?

• A: No. C/TPAs are prohibited from acting as DER under any circumstances.

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• Employers must request the drug and alcohol testing record for the past two years of employees intended to be used in safety sensitive duties.

• Must have employee’s written consent.• Employee who refuses to give consent may not

be used in safety sensitive duties.

Employer Responsibilities:Safety Sensitive Employees

Subpart B, 40.25

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Q&A 9/2001:Subpart B, 40.25

• Q: Is the previous employer required to provide information it may have received from other employers in the past?

• A: Yes. All information in that employer’s possession must be provided, and it does not violate the rules if more than two years of information is provided.

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Q&A 1/2002: Subpart B, 40.25

• Q: If an applicant admits to testing positive in the last two years, but did not complete the return to duty (SAP) process, must that applicant be held out of safety sensitive duties?

• A: Yes. There also must be proof the employee completed this process.

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Q&A 1/2002:Subpart B, 40.25

• Q: If an employee leaves an employer for less than two years, then returns, does the employer again seek to obtain the information it may have previously received?

• A: No. But the employer must seek information from all employers the employee worked for in the period of absence.

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Medical Review Officer CredentialsSubpart G, 40.121

• Medical Review Officers (MROs) must– be licensed MD or DO +– have clinical experience in substance abuse +– be certified by MROCC, AAMRO, or ASAM

• For a copy of EHP MROs’ credentials for your records, e-mail EHPCS@EHP.com

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The New Custody & Control FormSubpart D, 40.45, 40.47

• As of August 1, 2001, employers– Must use new Custody & Control Form (CCF)– Must use new procedures– May not use form for non-DOT tests

• 5 page format– CCF 1 Lab Copy– CCF 2 MRO Copy– CCF 3 Collector Copy– CCF 4 Employer Copy– CCF 5 Donor Copy

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MRO Responsibilities: NegativesSubpart G, 40.127

• Prior to reporting Negative results, MRO must have:– Copy 1 from lab or electronic lab report– Legible MRO copy (Copy 2), or any legible

copy with employee signature

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What EHP Is Doing toGet CCFs ASAP

• Established a dedicated DOT fax line for CCFs: 301-841-0463

– Goes to fax server with eight incoming lines

– Data base is searchable by date and time fax sent, and by originating fax number

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• Established an “In Process” status– Status means:

• EHP has the result but no CCF, or• EHP has both the result and the CCF and is trying to

contact the donor

– Our goal is to have no ‘In Process’ tests– “In Process” status reports may be sent to the

DER weekly

What EHP Is Doing to Keep Clients Informed

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• Turnaround time hinges on collector compliance with DOT regulation 49 CFR 40.73, which requires collector to transmit CCF to MRO within 24 hours of collection

What Affects Turnaround Time?

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Q&A 9/2001: Subpart F, 40.73; Subpart I, 40.193

• Q: What is the preferred method for the collector to get the MRO CCF to the MRO?

• A: “Even though we permit other means of transmitting MRO copies, collectors should fax the MRO copies when possible.”

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MRO Responsibilities: Quality ControlSubpart G, 40.127

• MROs must review 5% of negative CCFs that they receive per quarter, including all of those requiring corrective action.

• Reviewed CCFs must be identifiable and retrievable for MRO audit.

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“Fatal Flaws”Subpart I, 40.199

• Lab inspects each specimen & CCF– Specimen & bottle IDs do not match– Bottle seal is broken or tampered with– Collector’s name and signature omitted– Insufficient urine

• If found, testing process stops• Lab will report to MRO and MRO will report

as “Test Cancelled (reason)”• No longer called “Lab Reject”

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“Correctable Flaws”Subpart I, 40.83, 40.203

• Lab inspects each specimen & CCF–– Collector’s signature omitted– Outdated DOT CCF

• If found, lab documents error, continues testing, attempts to correct

• If not corrected, lab may report to MRO as “Lab Reject” (does not go to employer)

• MRO may report as “Test cancelled (reason)”

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“Correctable Flaws” (cont.)Subpart I, 40.83, 40.203

• Lab inspects each specimen & CCF–– Specimen temperature not checked and no

remarks about outside temperature range

• If found, lab documents error, continues testing, attempts to correct

• If not corrected, lab may still report result to the MRO with note that temperature was not checked and there were no remarks

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“Correctable Flaws” (cont.)Subpart I, 40.203

• MRO inspects CCF 2– Donor signature omitted with no remarks about

donor refusing to sign– Certifying scientist signature omitted– Non-DOT or outdated DOT CCF

• If found, MRO attempts to correct. If unable to correct, may report as “Test cancelled (reason)”

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• Error correction training is required when a Collector makes a mistake which causes a test to be cancelled– Required within 30 days of error notification– Provided and documented by trainer– Must address area in which error occurred– Three consecutive error-free mock collections

(1 uneventful; 2 related to error area)

Collector TrainingSubpart C, 40.33

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Q&A 9/2001:Subpart C, 40.33

• Q: Who is responsible for notifying a collector that error correction is needed?

• A: “The employer or service agent designated by the employer is responsible for notifying the collection site of the error and the retraining requirement, and for ensuring that the training takes place.”

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Specimen Validity TestingSubpart F, 40.89

• Definition: The evaluation of a specimen to determine if it is consistent with normal human urine.

• Specimen validity testing is authorized but not required under the existing regulations.

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Specimen Validity Testing (cont.)

• Done by all major labs to some degree• HHS will define the test requirements and

issue NPRM (Notice of Proposed Rule Making) in the Fall of this year

• Expect validity testing to become mandatory within 6 months after NPRM issued

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Validity Testing: Dilute SpecimensSubpart F, 40.91, 40.93

• If validity testing is done, each specimen must be measured for – Creatinine– Specific gravity if creatinine is less than 20 mg/dL– pH

• Dilute specimen defined as one with creatinine and specific gravity values lower than expected for human urine

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Validity Testing: Dilute SpecimensSubpart I, 40.197

• A negative dilute specimen does not trigger direct observation

• Employer may conduct a 2nd collection – same policy for all employees but can vary by reason for test

• If second specimen comes back dilute, it must be accepted as a negative

• MUST be included in policy and applied equally throughout the company

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Validity Testing: AdulterationSubpart F, 40.91

• Each specimen may be tested for substances that may be used to adulterate the specimen

• Specimens suspected of containing an adulterant may be sent to another HHS laboratory for identification

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MRO Responsibilities: Contact Donor Subpart G, 40.129, 40.131

• Before contacting the DER about a donor with a Non-negative result, the MRO must:– Have CCF Copy 1 from lab (faxed copy or image)– Have CCF Copy 2 (MRO Copy), legible copy, or any

copy with employee signature– Make three attempts to contact donor at varying

times of day over at least 24 hour period

• Result will remain IN PROCESS at EHP until all of the above are complete.

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MRO Responsibilities: Contact Donor Subpart G, 40.129, 40.131

• If contact CAN be made with donor, interview the donor, verify and report the result

• If contact CANNOT be made with donor, contact DER

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DER Responsibilities: Contact DonorSubpart G, 40.131

• Once contact to the DER is made, the DER takes responsibility for contacting the donor.

• DER must:– Try to contact the donor by all means available,

including certified letters– If contact is made, direct donor to call the MRO and

explain the consequences of failing to do so– Send MRO documentation of contact date and time

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• The MRO may report a “Non-Contact” Positive result under the following circumstances– If CONTACT IS MADE and donor does not call, the MRO will

report the result as positive in three (3) days– If CONTACT IS NOT MADE, and if DER has exhausted all

means of contacting the donor, the MRO will report as positive after ten (10) days without contact.

• 60 Day window for employee to present documentation for no contact

MRO Responsibilities: “Non-contacts”Subpart G, 40.133

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MRO Responsibilities:Adulterated/Substituted

Subpart G, 40.145 • Employee has burden of proof 

– ADULTERATION: Must demonstrate adulterant entered specimen through physiologic means

– SUBSTITUTION: Must demonstrate that he or she can produce urine meeting criteria through physiological means

• MRO may allow employee up to 5 days to provide proof

• MRO must explain split specimen option

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MRO Responsibilities: Invalid ResultSubpart G, 40.159

• Discuss with certifying scientist• Contact employee for explanation• If valid medical reason, cancel test (no re-

collection unless negative needed)– MRO may involve a “referral physician”,

acceptable to both MRO and employer, to help verify medical explanation

• If no valid medical reason, cancel test, immediate directly observed re-collection

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Q&A 1/2002:40.193, 40.265

• Q: Do the five days within which an employee is given to obtain a medical evaluation after an insufficient urine or breath specimen include holidays or weekends?

• A: The five day limit refers to business days.

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MRO Responsibilities:Rejected for Testing

Subpart G, 40.161

• Report to DER cancelled test and the reason.• MRO will direct DER if further action or re-

collection is required.

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MRO Responsibilities:Safety WarningsSubpart P, 40.327

• MROs must report drug test results and medical information gained during the interview if in the MRO’s reasonable medical judgment the information is likely to result in the employee being determined to be unqualified under an agency regulation or is likely to pose a significant safety risk.

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MRO Responsibilities:Safety WarningsSubpart G, 40.135

• When a safety warning will be issued, MROs may allow up to five days for the employee to have the prescribing physician contact the MRO to determine if the medication can be changed to one that does not make the employee unqualified or pose a significant safety risk.

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Requests for Split Specimen TestSubpart G, 40.153, Subpart H, 40.171

• On positive result or refusal to test (adulterated/substituted), MRO must explain split specimen testing process to employee

• Employee has 72 hours after verification to request test of split specimen.

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• Employer is required to make sure that MROs and laboratories process split specimen tests in a timely fashion when requested by donor

• MRO must process split specimen on verbal request from donor and payment must be guaranteed by the employer; however, employer may seek reimbursement from donor.

Requests for Split Specimen TestSubpart G, 40.153, Subpart H, 40.173

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Q&A 1/2002:40.171

• Q: Can someone other than the employee direct that the MRO have the employee’s split specimen tested?

• A: “No. The split specimen exists to provide the employee with ‘due process’. Only the employee can request the split be tested.”

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Alcohol TestingSubparts K-M

• Screening may either be breath or saliva (QED)

• Confirmation must be done within 30 minutes by breath only (EBT)

• Results are reported directly to DER

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Q&A 1/2002:Subpart K, 40.229, 40.231

• Q: Is an employer considered to be in compliance with Part 40 if EBTs are not available within 30 minutes of an alcohol screening test location?

• A: No. An employer is not considered in compliance in this case. However, there may be unusual circumstances in which an EBT is not available. If documentation shows the employer made a “good faith” effort to get an EBT, the employer would not be considered out of compliance in that case.

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Confidentiality & Release of InformationSubpart P

• Employer or Service Agent prohibited from releasing to third parties not specifically authorized

• Specific written consent required; no blanket releases

• MRO must not disclose to 2nd employer (NPRM proposal)

• May release in legal proceedings, criminal or civil actions

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Return-to-duty (RTD) ProcessSubpart O

• Provide listing of SAPs at no charge to employee• No employer requirement to provide SAP

evaluation or treatment• No safety-sensitive duties until employee

completes SAP requirements• RTD test only after SAP’s follow-up report

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Q&A 1/2002:Subpart G, 40.25

• Q: If an applicant admits to testing positive or refusing to test within the past two years, must he/she be held out of safety sensitive duties if he/she hasn’t completed the return-to-duty (SAP) process?

• A: Yes

Thank you

For questions contact:

Ehpcs@ehp.com