5Office of Drug and Alcohol Policy and Compliance (ODAPC) Web page:49 CFR Part 40 Questions and AnswersSep 2001Jan 2002Future updates provided automaticallyRegister with address
6Employer Responsibilities: General Subpart B, 40.11 Employers are now responsible for compliance with all the Part 40 requirementsEmployers are also responsible for the actions of their Service Agent(s) (SA)Employers are also responsible for ensuring SA meets all qualificationsSTAND DOWN - 1• Means temporarily removing an employee from performing safety-sensitive functions after laboratory reports a confirmed positive, adulterated, or substituted test but before MRO completes verification process.
7Q&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.
8Employer Responsibilities: Safety Sensitive Employees Subpart B, 40.25 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.
9Q&A 9/2001: Subpart B, 40.25Q: 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.
10Q&A 1/2002: Subpart B, 40.25Q: 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.
11Q&A 1/2002: Subpart B, 40.25Q: 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.
12Medical Review Officer Credentials Subpart G, 40.121 Medical Review Officers (MROs) mustbe licensed MD or DO +have clinical experience in substance abuse +be certified by MROCC, AAMRO, or ASAMFor a copy of EHP MROs’ credentials for your records,
13The New Custody & Control Form Subpart D, 40.45, 40.47 As of August 1, 2001, employersMust use new Custody & Control Form (CCF)Must use new proceduresMay not use form for non-DOT tests5 page formatCCF 1 Lab CopyCCF 2 MRO CopyCCF 3 Collector CopyCCF 4 Employer CopyCCF 5 Donor Copy
14MRO Responsibilities: Negatives Subpart G, 40.127 Prior to reporting Negative results, MRO must have:Copy 1 from lab or electronic lab reportLegible MRO copy (Copy 2), or any legible copy with employee signature
15What EHP Is Doing to Get CCFs ASAP Established a dedicated DOT fax line for CCFs:Goes to fax server with eight incoming linesData base is searchable by date and time fax sent, and by originating fax number
16What EHP Is Doing to Keep Clients Informed Established an “In Process” statusStatus means:EHP has the result but no CCF, orEHP has both the result and the CCF and is trying to contact the donorOur goal is to have no ‘In Process’ tests“In Process” status reports may be sent to the DER weekly
17What Affects Turnaround Time? 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
18Q&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.”
19MRO Responsibilities: Quality Control Subpart 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.
20“Fatal Flaws” Subpart I, 40.199 Lab inspects each specimen & CCFSpecimen & bottle IDs do not matchBottle seal is broken or tampered withCollector’s name and signature omittedInsufficient urineIf found, testing process stopsLab will report to MRO and MRO will report as “Test Cancelled (reason)”No longer called “Lab Reject”
21“Correctable Flaws” Subpart I, 40.83, 40.203 Lab inspects each specimen & CCF–Collector’s signature omittedOutdated DOT CCFIf found, lab documents error, continues testing, attempts to correctIf not corrected, lab may report to MRO as “Lab Reject” (does not go to employer)MRO may report as “Test cancelled (reason)”
22“Correctable Flaws” (cont.) Subpart I, 40.83, 40.203 Lab inspects each specimen & CCF–Specimen temperature not checked and no remarks about outside temperature rangeIf found, lab documents error, continues testing, attempts to correctIf not corrected, lab may still report result to the MRO with note that temperature was not checked and there were no remarks
23“Correctable Flaws” (cont.) Subpart I, 40.203 MRO inspects CCF 2Donor signature omitted with no remarks about donor refusing to signCertifying scientist signature omittedNon-DOT or outdated DOT CCFIf found, MRO attempts to correct. If unable to correct, may report as “Test cancelled (reason)”
24Collector Training Subpart C, 40.33 Error correction training is required when a Collector makes a mistake which causes a test to be cancelledRequired within 30 days of error notificationProvided and documented by trainerMust address area in which error occurredThree consecutive error-free mock collections (1 uneventful; 2 related to error area)
25Q&A 9/2001: Subpart C, 40.33Q: 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.”
26Specimen Validity Testing Subpart 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.
27Specimen Validity Testing (cont.) Done by all major labs to some degreeHHS will define the test requirements and issue NPRM (Notice of Proposed Rule Making) in the Fall of this yearExpect validity testing to become mandatory within 6 months after NPRM issued
28Validity Testing: Dilute Specimens Subpart F, 40.91, 40.93 If validity testing is done, each specimen must be measured forCreatinineSpecific gravity if creatinine is less than 20 mg/dLpHDilute specimen defined as one with creatinine and specific gravity values lower than expected for human urine
29Validity Testing: Dilute Specimens Subpart I, 40.197 A negative dilute specimen does not trigger direct observationEmployer may conduct a 2nd collection – same policy for all employees but can vary by reason for testIf second specimen comes back dilute, it must be accepted as a negativeMUST be included in policy and applied equally throughout the company
30Validity Testing: Adulteration Subpart F, 40.91 Each specimen may be tested for substances that may be used to adulterate the specimenSpecimens suspected of containing an adulterant may be sent to another HHS laboratory for identification
31MRO 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 signatureMake three attempts to contact donor at varying times of day over at least 24 hour periodResult will remain IN PROCESS at EHP until all of the above are complete.
32MRO Responsibilities: Contact Donor Subpart G, 40.129, 40.131 If contact CAN be made with donor, interview the donor, verify and report the resultIf contact CANNOT be made with donor, contact DER
33DER Responsibilities: Contact Donor Subpart 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 lettersIf contact is made, direct donor to call the MRO and explain the consequences of failing to do soSend MRO documentation of contact date and time
34MRO Responsibilities: “Non-contacts” Subpart G, 40.133 The MRO may report a “Non-Contact” Positive result under the following circumstancesIf CONTACT IS MADE and donor does not call, the MRO will report the result as positive in three (3) daysIf 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
35MRO Responsibilities: Adulterated/Substituted Subpart G, 40.145 Employee has burden of proof ADULTERATION: Must demonstrate adulterant entered specimen through physiologic meansSUBSTITUTION: Must demonstrate that he or she can produce urine meeting criteria through physiological meansMRO may allow employee up to 5 days to provide proofMRO must explain split specimen option
36MRO Responsibilities: Invalid Result Subpart G, 40.159 Discuss with certifying scientistContact employee for explanationIf 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 explanationIf no valid medical reason, cancel test, immediate directly observed re-collection
37Q&A 1/2002: ,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.
38MRO 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.
39MRO Responsibilities:Safety Warnings Subpart 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.
40MRO Responsibilities:Safety Warnings Subpart 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.
41Requests for Split Specimen Test Subpart G, 40.153, Subpart H, 40.171 On positive result or refusal to test (adulterated/substituted), MRO must explain split specimen testing process to employeeEmployee has 72 hours after verification to request test of split specimen.
42Requests for Split Specimen Test Subpart G, 40.153, Subpart H, 40.173 Employer is required to make sure that MROs and laboratories process split specimen tests in a timely fashion when requested by donorMRO must process split specimen on verbal request from donor and payment must be guaranteed by the employer; however, employer may seek reimbursement from donor.
43Q&A 1/2002: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.”
44Alcohol Testing Subparts 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
45Q&A 1/2002: Subpart K, ,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.
46Confidentiality & Release of Information Subpart P Employer or Service Agent prohibited from releasing to third parties not specifically authorizedSpecific written consent required; no blanket releasesMRO must not disclose to 2nd employer (NPRM proposal)May release in legal proceedings, criminal or civil actions
47Return-to-duty (RTD) Process Subpart O Provide listing of SAPs at no charge to employeeNo employer requirement to provide SAP evaluation or treatmentNo safety-sensitive duties until employee completes SAP requirementsRTD test only after SAP’s follow-up reportProvide each employee (and applicant) who violates DOT regulations:Listing of SAPs readily available to the employeeInclude: names, addresses, and phone numbersDo not charge employee for this listThere is no employer requirement to provide SAP evaluation or subsequent education or treatmentHowever, the employer must ensure that each employee (and applicant) who violates DOT regulations:Does not perform safety-sensitive duties for you until successfully completing the entire SAP process and you have a SAP follow-up report indicating that the employee was successful.Then, you can conduct the required return-to-duty testing.Following negative RTD test, employer may return the employee to duty if the employee is otherwise qualified (OA certification revocation). No requirement, however, to return someone to duties.
48Q&A 1/2002: Subpart G, 40.25Q: 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